Pfizer
Flu-like symptom reports
Female, 60 - 75 years
| Age | Reported | Symptoms | Notes |
|---|---|---|---|
| 60 | 2021-01-01 | sweating, headache |
Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling h...
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Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling hot/cold
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| 60 | 2021-01-01 | malaise, headache, chills |
Starting at 0100 am I noticed chills, body aches, vomited, then felt crappy all day. Thursday night ...
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Starting at 0100 am I noticed chills, body aches, vomited, then felt crappy all day. Thursday night 12/31 symptoms worsened with above & headache
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| 60 | 2021-01-03 | chills, fatigue, headache |
12/18/20 08:00PM Mild headache; 12/19/20 headache resolved; chills, loose bowel movement, fatigue. ...
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12/18/20 08:00PM Mild headache; 12/19/20 headache resolved; chills, loose bowel movement, fatigue. 12/20/20 loose bowel movement, rash on back and disappeared face red lips swollen. 12/21/20 symptoms continued medications taken Benadryl. Imodium; rash resolved and loose bowel movements later in the day. Abd discomfort, pain and nausea present since vaccine given.
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| 60 | 2021-01-03 | chills, headache |
* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, ...
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* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, cold and unable to get warm even with multiple blankets * Severe dizziness and vomiting * Headache not relieved by Ibuprofen; took 25 mg Benadryl at midnight
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| 60 | 2021-01-03 | headache, fatigue | Debilitating frontal headache, accompanied by nausea and vomiting, and fatigue for 16 hours |
| 60 | 2021-01-03 | influenza like illness, sweating | Flu-like symptoms - nausea, sweat. Arm sore immediately after injection - sore for 2 days. |
| 60 | 2021-01-04 | chills, cough |
Some swelling of arm; Rash developed 5cm x 4cm at injection site; Chills and shivers; Bronchospasm c...
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Some swelling of arm; Rash developed 5cm x 4cm at injection site; Chills and shivers; Bronchospasm cough; Bronchospasm cough; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Spasm; she has a lot of allergies; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 to 23Dec2020 at 0.3 mL single on left deltoid to prevent getting the COVID vaccine, for protection. Medical history included ongoing asthma diagnosed in her mid twenties, in the 80s, she had asthma when she was a child, then it stopped and resurfaced in her mid twenties, ongoing eczema diagnosed years already, a long time ago and unspecified allergies with medications. There were no concomitant medications. She received the vaccine on 23Dec2020. She has a lot of allergies in Dec2020, and had some side effects, and she got through it ok. Her side effects were some swelling of arm, a rash developed, like 5cm x 4cm at site of injection, chills and shivers, and a bronchospasm cough on 24Dec2020. Arm swelling event started 24 hours later, no more, it was stable for 24 hours, and the 3rd day, went down, was a little raised, the next day was flat but still red. She had recovered completely. The 4th day was a good day. The patient stated she had some allergy shots she had to go through before, this was no different. Rash was no more, it was gone by 27Dec2020. She was still able to go to work. Chills and shivers started 24 hours later, and took for 48 hours intermittently, she had since recovered completely. The patient stated this was all nothing different than getting like the flu shot. Bronchospasm cough event only took another 48 hours, the difference was, even when she calls it bronchospasm, it was close to when she had an asthma attack, but no chest tightness, shortness of breath, she just would cough, spasm in Dec2020 and stop. She had recovered completely. The patient stated she had no symptoms at all before the vaccine, she was healthy, she made sure nothing was going on, that she was not tired, had no cold, she took no medications for this, as she wanted to know how her body reacted and if it can handle it. They says it was ok to take paracetamol (TYLENOL), but she did not, but the second dose she would, now that she knows and she was comfortable through it. She did have some mild eczema flare ups, itchiness and sores that came up in Dec2020, but nothing to run to the hospital to the doctor for. Clarifies this occured after she received the vaccine. The outcome of the event allergies, mild eczema flare ups, itchiness and sores were unknown. The outcome of rash at site of injection was recovered on 27Dec2020. The outcome of other events was recovered in Dec2020. The causality between Pfizer COVID vaccine with some swelling of arm, rash developed 5cm x 4cm at injection site, chills and shivers, bronchospasm cough was related (Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection). Information on the lot/batch number has been requested.
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| 60 | 2021-01-04 | chills, fatigue, sleepiness, fever, malaise |
generally not feeling well; a low grade fever; chills; freezing; couldn't get warm; tired and run do...
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generally not feeling well; a low grade fever; chills; freezing; couldn't get warm; tired and run down; sleepy; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EK5730), via an unspecified route of administration on 16Dec2020 08:40 AM at right deltoid, at single dose for covid-19 immunization. Medical history included sleep disorder. Concomitant medication included alprazolam prn (as needed) for sleep, HCTZ; losartan; metoprolol; montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL). On 18Dec2020 the patient had temperature of 98.8 which is low grade fever for her because she runs low. On 18Dec2020, she experienced a low grade fever, chills and was freezing. On 18Dec2020 she had chills and couldn't get warm. She had three layers on and a heating vest. It passed and she was doing fine. Those symptoms passed, but reappeared on 26Dec2020, last Saturday. Since then, she mentioned generally not feeling well, in addition to being freezing cold and experiencing chills every day. She had been monitoring her temperatures, and had no fever. Since 26Dec2020, she had chills, couldn't get warm, and no fever. She was tired and run down. She was sleepy and usually she was very energetic. The patient asked if have heard of such experience in other people. Seriousness Criteria was reported as it was not disabling, but annoying. It was unusual. She had on a thermal shirt that she would wear for skiing and that is not normal. Then on the 26Dec2020 the chills started back again. She felt kind of tired. She didn't feel sick, but not up to snuff. No AE required emergency room/physician office. The outcome of the event fever was recovered on 19Dec2020. The outcome of the events freezing; sleepy; tired and run down was unknown. The outcome of the other events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
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| 60 | 2021-01-04 | chills, fever |
Received the first dose of vaccine, no problems for 12 hours, then I started to have non-stop shiver...
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Received the first dose of vaccine, no problems for 12 hours, then I started to have non-stop shivering and fevers for almost 18 hours then felt better.
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| 60 | 2021-01-04 | fatigue, throat irritation, chills | tired Chills Muscle aches Throat irritation weakness no energy hot flashes |
| 60 | 2021-01-04 | headache, chills, sleepiness |
Vomiting, chills, headache. Began 18 hours post injection. Lasted for 12 hours. Continued to have ch...
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Vomiting, chills, headache. Began 18 hours post injection. Lasted for 12 hours. Continued to have chills and excessives sleepiness for 48 hours.
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| 60 | 2021-01-04 | headache, fatigue |
Fatigue on Friday 1/1/21 (2 naps resolved fatigue on 1/1/21) and daily napping resolve fatigue 1/2/2...
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Fatigue on Friday 1/1/21 (2 naps resolved fatigue on 1/1/21) and daily napping resolve fatigue 1/2/21-1/4/21 Headache on Saturday, 1/2/21. Took nap to resolve Blurry vision Sunday when reading began on 1/3/21 and has not resolved as of 1/5/21. Pain behind left eye on morning of 1/5/21
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| 60 | 2021-01-04 | headache |
nausea/waves of nausea; lower abdominal pain; headache; This is a spontaneous report from a contacta...
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nausea/waves of nausea; lower abdominal pain; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2; reported as COVID19 Vaccine; lot number: EJ1685; expiration date: Mar2021), via an unspecified route of administration right arm on 18Dec2020 15:00 at single dose for Covid-19 vaccination. Medical history included IBS (irritable bowel syndrome), hysterectomy at age 42 and she doesn't have periods (amenorrhea). The patient family medical history included her family are all dead and has been for a long time. The patient's concomitant medications were not reported. It was reported that vaccinations within 4 weeks included shingles vaccination 5 weeks before covid-19 vaccine wherein the patient first singles shot was fine. Her second shingles shot made her sick, body aches, and fever for about 24 hours. She received it from a pharmacy inside a store. The reporter mentioned that she took her first covid vaccine shot and was able to experience nausea, headache lower abdominal pain. She inquired if there was information on until when she will be experiencing this or how long the symptoms will last. She mentioned that she had headaches and waves of nausea, and before nausea, she had lower abdominal pain. She doesn't know if abdominal pain was coincidental. She had a hysterectomy, so she doesn't have periods. She lives with IBS, but this abdominal pain was different. Immediately after COVID-19 Vaccine within about 20 minutes after injection (18Dec2020 15:20), she had headaches and she still has been having headaches. She had strange lower abdominal pain that lasted a minute and a half then shortly after that started having waves of nausea. She added that the waves of nausea began 24 hours after the COVID-19 Vaccine (19Dec2020 15:00). The outcome of the event headache was not recovered, as for nausea was unknown while the outcome of the other event was recovered on Dec2020.
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| 60 | 2021-01-04 | throat pain |
Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation...
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Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation and the soreness in tongue; vomiting severely 5 times; could not eat and breathe; could not eat and breathe; abdomen was upset; cramps and pain; cramps and pain; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 60-years-old at a single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: palpitations (non-serious) on 22Dec2020 with outcome of unknown , weakness (non-serious) on 22Dec2020 with outcome of unknown, sore throat (non-serious) on 22Dec2020 with outcome of unknown, burning sensation and the soreness in tongue (non-serious) on 22Dec2020 with outcome of unknown, vomiting severely 5 times (non-serious) in Dec2020 with outcome of unknown, could not eat and breathe (non-serious) in Dec2020 with outcome of unknown, abdomen was upset (non-serious) in Dec2020 with outcome of unknown, cramps and pain (non-serious) in Dec2020 with outcome of unknown, diarrhea (non-serious) in Dec2020 with outcome of unknown. The nurse stated she received the COVID vaccine on 21Dec2020. The nurse stated she did not have any adverse reaction immediately on the first day but on the second day, after 24 hours, she started to have "little bit palpitations that too for a short period of time and a little bit weakness for a short period of time and sore throat. It is not just soring or swelling but it is burning sensation and, on my tongue, also I feel the same thing, burning sensation and the soreness. That was for a small period of time but on my tongue, it is still there, and my throat is still there and last night I experienced vomiting severely 5 times. After the vomiting, I could not eat and breathe." Then, the nurse slept about 3-5 hours, and woke up and her abdomen was upset. The nurse had cramps and pain and when she went to the bathroom and she had huge diarrhea, 2 times."
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| 60 | 2021-01-04 | runny nose, fever, chills |
Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a...
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Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a non-contactable other-HCP (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231) (Brand= Pfizer), via an unspecified route of administration on 24Dec2020 07:15AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was workplace clinic. None medical history. The patient's concomitant medications was not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The known allergies included Ibuprofen based pain medicine. On 24Dec2020, patient experienced injection site pain; chills; facial flushing. 25Dec2020 fever. 26Dec2020 rhinorrhea. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. No follow-up attempts are possible. No further information is expected.
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| 60 | 2021-01-04 | throat irritation |
Immediately after injection into patient's left deltoid, site swelling and felt firm. Some bruising...
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Immediately after injection into patient's left deltoid, site swelling and felt firm. Some bruising noted. Ice applied and patient monitored for over 30 minutes. Patient did complain of scratchy throat while being monitored, but refused Benadryl at this time. Patient will notify her physician of this reaction to the vaccine.
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| 60 | 2021-01-05 | cough |
Pfizer BioNTech COVID-19 Vaccine EUA Patient given vaccine and nurse used CDC screening check list....
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Pfizer BioNTech COVID-19 Vaccine EUA Patient given vaccine and nurse used CDC screening check list. Patient's noted yes to allergies made nurse talk to lead nurse regarding allergies. Plan of care was to vaccinate but have patient stay at least 20 minutes. During the 20 minute wait, the observer was notified by patient she was having some throat tickling and tightening. Observer notified lead nurse. Lead nurse approached patient and had her move from waiting area back into her nurses room. Patient complained of throat tickling and tightening but stated she was fine. Nurses noted increasing coughing. Pulse ox and respirations checked. Patient continued to state she was fine and was not in physical distress. Nursing director was called and nurses advised to give epi and follow protocol. Epi given in left thigh. Patient vitals monitored and patient was able to tell throat started to loosen and coughing stopped. 911 called but patient refused transport after EMS assessed patient. Nursing Director discussed patient incident with Medical Director and nurses were advised to administer a IM dose of benadryl. Patient agreed and verbalized understanding her risks of not going to ER for monitoring. Patient signed refusal for treatment form and planned to call her doctor when she left. Patient vitals were stable and patient left clinic on her own accord around 11:00 am.
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| 60 | 2021-01-05 | headache, fatigue, fever |
Dizzy right after vaccine, foggy increased through evening, tired in the evening of injection, muscl...
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Dizzy right after vaccine, foggy increased through evening, tired in the evening of injection, muscle aches, headache, and nausea about 2am, fever 99.8 at 1pm on 1/6/21. All these symptoms still persist now 5:40pm 1/6/20
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| 60 | 2021-01-05 | headache, malaise, fatigue, chills |
INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINES...
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INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINESS, TIREDNESS, MUSCLE PAIN, CHILLS ALL BY 13:30PM AND LASTED FROM 1.04.21 AND CURRENTLY ON 1.06.21 STILL TIRED, DIZZY, HEADACHE, CHILLS AND ITCHY BUT IS BETTER THAN ON 1.04.21.
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| 60 | 2021-01-05 | headache |
Itching but no hives; dizziness; slight headache; This is a spontaneous report from a contactable nu...
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Itching but no hives; dizziness; slight headache; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received first dose of BNT162B2 (Batch/lot number: EK5730) intramuscular at Left arm, on 31Dec2020 at single dose for covid-19 immunisation. Medical history included mild Hypertension (HTN), Hypothyroidism, Anxiety, Gastrooesophageal reflux disease (GERD), Hyperlipidemia. Known allergies included Shellfish, SSRI, Demerol, Codeine. The patient did not have covid prior vaccination. Patient had no other vaccine in four weeks. Concomitant medication included lisinopril, levothyroxine, aluminium hydroxide gel, dried, magnesium carbonate (PEPCID), bupropion hydrochloride (WELLBUTRIN), atorvastatin calcium (LIPITOR), acetylsalicylic acid (BABY ASPIRIN), vitamin c [ascorbic acid], calcium, linum usitatissimum seed oil (FLAX SEED OIL), glucosamine, curcuma longa (TURMERIC), ubidecarenone (COQ 10), collagen. The patient experienced itching but no hives, slight headache, dizziness on 31Dec2020 15:30. The patient received Benadryl 25mg for the events. The patient did not have covid tested post vaccination. The outcome of events was recovering.
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| 60 | 2021-01-05 | headache | Tingling of toes and finger on the on side of body vaccine occurred, light headed, HEAD ACHE |
| 60 | 2021-01-05 | malaise, chills, fatigue |
19th received Covid Vaccine at noon 21st negative Covid surveillance test completed due to ED Clust...
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19th received Covid Vaccine at noon 21st negative Covid surveillance test completed due to ED Cluster 22nd Bedtime approx. 2100 A very strange feeling of overwhelming fatigue "spacey feeling"" 23rd nausea dizzy general malaise 24th nausea dizzy general malaise 25th nausea dizzy general malaise Contacted Health Service 26th still nauseous dizzy general malaise and then chills Health Service Ordered Covid Test 26th negative Covid. 26th video appointment with PCP states no need for labs feels it's Vaccine related 27th minimal nausea no chills episodes of feeling ?spacey? and tired 28th Minimal nausea 29th Morning nausea and fatigue 30th Morning nausea and fatigue 31st increased nausea and fatigue all day easing as day progresses "spacey" with fatigue
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| 60 | 2021-01-05 | malaise, headache, influenza like illness, chills, body temperature increased |
Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in b...
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Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.
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| 60 | 2021-01-05 | fever |
dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to...
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dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to feel flushed; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on 29Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included COVID-19, hypertension and depression. Concomitant medications included vitamins received within 2 weeks of vaccination. The patient previously took duloxetine and experienced allergies. Facility that the most recent COVID-19 vaccine was administered in Workplace clinic. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 29Dec2020, the patient was dizzy, had fever, elevated blood pressure, and flushed feeling day of vaccine. The next day she continued to feel flushed that moved through her face and down her neck. It felt like she was on fire. The adverse events resulted in the following: Emergency room/department or urgent care. Outcome of the event feel flushed was recovered on 30Dec2020, outcome of other events was recovered in Dec2020. Treatment received for the adverse events included IV fluids, prednisone, diphenhydramine hydrochloride (BENADRYL). Events were reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events dizzy, fever, elevated blood pressure and flushed feeing cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 60 | 2021-01-05 | fever |
I have had a fever ranging from 100.1 to 100.5 since 7 pm on the day I received the 2nd dose vaccine...
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I have had a fever ranging from 100.1 to 100.5 since 7 pm on the day I received the 2nd dose vaccine on 1/4/2021. Symptoms include extreme body aches, joint aches, and headache. Today is 1/6/2021 my temp at 7:30 am was 100.3. I have had to miss work yesterday and today so far.
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| 60 | 2021-01-05 | sneezing, body temperature increased, runny nose |
Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse Al...
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Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/6/2021  Date: 1/6/2021 MRN: 3274958  Subjective Patient is a 60 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.  She denied any history of previous adverse reactions to vaccines.  She was given the Pfizer vaccination in the right deltoid muscle.  During her 15 minute waiting period after the injection, the patient began to experience dizziness and flushing. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.  This provider was notified of patient reaction and she was then assessed in the emergency bay area.  Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting.  Pt reports she saw an allergist this am for runny nose, SOB, and sneezing. He determined her symptoms was a neurological response. Previous COVID infection November 30, 2020  PREVIOUS REACTION: Pt reports first Pfzier covid shot she had symptoms of Chills, HA, nausea and fever of 102 that occurred 12 hours afterwards. She states her symptoms lasted 6-8 hours.   ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness    Objective  Vitals Vitals:  01/06/21 1235 BP: (!) 152/82 Pulse: 57 Temp: 99.2 °F (37.3 °C) SpO2: 100% BS 94 at 12:38  Physical Exam Vitals signs and nursing note reviewed. HENT: Head: Normocephalic. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are dry. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal.    Assessment/Plan Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.   Pt was observed and given water and food (peanut butter). Felt better within a few minutes. She was released to go home 12:55pm   APRN Electronically Signed 1/6/2021 12:45 PM  Â
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| 60 | 2021-01-06 | chills, fever, headache |
1/6/21 - 3pm. Experiencing chills, headache, heart rate at 103/min sitting. - 10:06...
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1/6/21 - 3pm. Experiencing chills, headache, heart rate at 103/min sitting. - 10:06 pm, chills, headache, fever 99.6 - 10:38 pm, chills headache, fever 100.1 - 11:05pm, chills headache, fever 101.5 -
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| 60 | 2021-01-06 | chills |
30-40 min felt flush skin on body face bright red. Numbness tingling in hands and feet. Took some a...
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30-40 min felt flush skin on body face bright red. Numbness tingling in hands and feet. Took some advil. Over next two days on and off hot flashes tingling numbness on hands and feet. Very cold feet couldn't get warmed up till wrapped up on heating pad. Ño fever but felt chills. Sore arm site of injection.
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| 60 | 2021-01-06 | fatigue, headache, headache, fatigue | Fatigue, body aches, headache x 1 day now resolved. |
| 60 | 2021-01-06 | fatigue, headache | Extreme fatigue, muscle aches ,joint pain. Have slight headache. |
| 60 | 2021-01-06 | headache, fatigue |
Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. wit...
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Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. without any issues. Came home, had 2 glasses of wine, as usual, at 1:00 a.m. feeling body aches and headache continued sleeping, woke up at 9:00 a.m. with dry heaves with phlegm with small streaks of blood, rapid heart rate, fatigue with body aches, pain in location of injection, occasional headache, loss of appetite. The body aches, fatigue continued the following day, appetite returned slightly. Thankful these were my scheduled days off from work. Third day after injection body aches dissipating able to go out of the house to do errands.
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| 60 | 2021-01-06 | fever, chills, cough | Severe Body aches cough fever 100.8 chills diarrhea |
| 60 | 2021-01-06 | fever, chills |
Employee with low grade fever, chills and shaking starting at 2am. Tmax at 5:30 am of 101.2. Self ...
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Employee with low grade fever, chills and shaking starting at 2am. Tmax at 5:30 am of 101.2. Self medicated with Motrin with some improvement of symptoms.
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| 60 | 2021-01-06 | fever, fatigue |
12 hours post injection 7:30p, low grade fever 99F, queasy, brain fog and exhaustion. Fever went awa...
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12 hours post injection 7:30p, low grade fever 99F, queasy, brain fog and exhaustion. Fever went away over night, the rest of the symptoms stayed through the day.
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| 60 | 2021-01-06 | fever, headache, fatigue |
APPROXIMATELY 24 HOURS AFTER THE INJECTIONS I RAN A FEVER OF 100.7, BODY ACHES OVER ALL JOINTS, EXT...
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APPROXIMATELY 24 HOURS AFTER THE INJECTIONS I RAN A FEVER OF 100.7, BODY ACHES OVER ALL JOINTS, EXTREME FATIGUE AND HEADACHE ADN THE INJECTION SITE WAS PAINFUL. I HAD THE COVID VIRUS DIAGNOSED 10/23/2020 WITH THE EXACT SAME SYMPTOMS EXCEPT I RAN A HIGHER TEMP
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| 60 | 2021-01-07 | chills, fatigue |
chills; fatigue; small rash on left arm (size of half dollar); 1 pinpoint spot "hive": under chin, o...
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chills; fatigue; small rash on left arm (size of half dollar); 1 pinpoint spot "hive": under chin, on right arm, under left foot; This is a spontaneous report from a contactable nurse (patient). A 60-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1284), via intramuscular route of administration in the right arm on 28Dec2020 at 05:30 AM (at the age of 60 years-old) as a single dose for COVID-19 vaccination. Medical history included diabetic and asthma. The patient's allergies included sulfa, iodine, shellfish and latex/rubber. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported; however, there were other medications the patient received within 2 weeks of the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 28Dec2020 at 06:30 AM, the patient experienced chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot. The report was reported as non-serious. The patient was not treated for chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot. The clinical outcome of chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 60 | 2021-01-07 | chills, sweating | Chest pain Abdominal pain Fever, severe chills, diaphoresis Seizure like activity for two night |
| 60 | 2021-01-07 | headache | Diarrhea Headache Narrative: |
| 60 | 2021-01-07 | sweating, malaise |
very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt real...
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very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt really really sick/ didn't feel good/felt very bad; Sweating; Nauseous; loose stool; her injection site had a lump and was red; a little pain in her arm/ it was just a little sore; her injection site had a lump and was red; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 11:30 at single dose in the arm for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient received the vaccine 29Dec2020 at 11:30 am. She went to work at 11 at night and only had a little pain in her arm. At 4 am on 30Dec2020, she felt really sick. She felt like her blood pressure dropped. She was very dizzy. She was scared. She didn't feel good. She felt like she was going to faint and was sweating. She was going to try to finish her work and go home. She went to the house, and was very sick. She got into bed because she believed she needed rest. At 3 pm on 30Dec2020, nothing was wrong. She was going to rest more. That night time on 30Dec2020, she felt better. She had also got nauseous. She stated the symptoms only lasted a day, and also said the side effects only lasted from 4 o'clock to 8 o'clock when she got home. She did go to the bathroom and experienced loose stool. She felt very bad when she laid down in bed. By 10 o'clock pm (30Dec2020) she felt better. The patient said she had no problem moving her arm as it was just a little sore. When she got home from work her husband noticed her injection site had a lump and was red. Her arm recovered in a week's time. The patient stated she would go for her second shot on 13Jan2021. The symptoms which started on 30Dec2020 04:00 (dizzy/felt like her blood pressure dropped/she felt like she was going to faint, feeling sick/bad, sweating, nauseous, loose stool) were resolved on 30Dec2020. The events pain in her arm and injection site lump and red were resolved on an unspecified date in Jan2021. Information about lot and batch number was requested.
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| 60 | 2021-01-07 | fever, headache | Headache & Fever |
| 60 | 2021-01-08 | chills, fatigue | Arthralgia chills, swollen glands, fatigue x 2 days; |
| 60 | 2021-01-08 | head discomfort |
c/o itching and pressure in her head. Narrative: c/o of itching and pressure in head. Staff gave Di...
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c/o itching and pressure in her head. Narrative: c/o of itching and pressure in head. Staff gave Diphenhydramine HCL VS 178/85, 72, 18, 98% O2sat. at 1340 states she felt better.
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| 60 | 2021-01-08 | headache, fatigue, fever |
Severe fatigue, headache, joint pain, fever. Started around 0700 next day of injection and these sym...
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Severe fatigue, headache, joint pain, fever. Started around 0700 next day of injection and these symptoms lasted 24 hours. Took Tylenol, Ibuprofen for fever. Even with these two onboard, continued low grade temp.
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| 60 | 2021-01-08 | headache, fatigue | Headache very fatigue, soreness at injection site Narrative: stayed home from work |
| 60 | 2021-01-08 | headache | Headache |
| 60 | 2021-01-08 | sweating, chills, fatigue, fever, malaise |
17 hours after vaccine, developed gradually worsening fatigue, myalgias, arthralgias, chills, sweats...
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17 hours after vaccine, developed gradually worsening fatigue, myalgias, arthralgias, chills, sweats, malaise, and fever up to 103. Sxs peaked at approx 24 hrs post vaccine administration, resolving nearly completely by the following morning. Would have reported via v-safe but had no info to access the app.
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| 60 | 2021-01-09 | chills |
Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improve...
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Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improved with Meloxicam. The keratitis flared up. Developed keratitis after the first dose on 12/17/2020. Lot EK5730. The keratitis presented with dry eyes, photophobia and reduced reading ability. I am treated with steroid drops and artificial tears.
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| 60 | 2021-01-09 | headache |
HEADACHE (MIGRAINE) 8/10 . PATEINT REFUSED EMERGENCY SERVICES AND/OR CALL MD B/P 141/94 PR 64 @11:35...
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HEADACHE (MIGRAINE) 8/10 . PATEINT REFUSED EMERGENCY SERVICES AND/OR CALL MD B/P 141/94 PR 64 @11:35 PM B/P 185/98 PR 60 @11:45 NO N/V NO CHEAT PAIN
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| 60 | 2021-01-10 | chills, fatigue |
fatigue, chills started about 8 hours after the vaccine; went to bed early and by 24 hrs the reacti...
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fatigue, chills started about 8 hours after the vaccine; went to bed early and by 24 hrs the reactions had gone away. No pain at the injection site.
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| 60 | 2021-01-10 | chills, fever, headache |
Woke up morning after 2nd dose of COVID-19 vaccine with noticeable left armpit swelling (noticed whi...
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Woke up morning after 2nd dose of COVID-19 vaccine with noticeable left armpit swelling (noticed while applying my deodorant for the day). Swelling was the size of large lemon. Smaller amount of swelling noticed in right armpit, also. Vaccinations had both been done in my LEFT arm and greater swelling was in left armpit. Had fever, chills and headache this same day requiring me to take round the clock doses of Tylenol. By the following day, fever and chills were gone but swelling of armpit still present. Swelling is slowly diminishing but still present by day 3, as I send this notification.
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| 60 | 2021-01-10 | cough, fever |
COVID vaccine #2 given Thursday January7th 12:30. Body aches and chills started Friday January 8th ...
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COVID vaccine #2 given Thursday January7th 12:30. Body aches and chills started Friday January 8th approx. 1700. Worsening symptoms through the night. Fever and slight cough on Saturday morning with body aches, joint pain and chills.
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| 60 | 2021-01-10 | fatigue, headache, head discomfort |
Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache...
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Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache/ So much pain in my head; Couldn't talk; Complete brain fog; nausea; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (Patient) reported that received bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included Atrial fibrillation, Chronic Lyme, Lupus and Autoimmune. Concomitant medications included Metoprolol at 12.5 mg for Atrial fibrillation and acetylsalicylic acid (BABY ASPIRIN). No diabetes, no hypertension. None of the usual common diseases. Registered Nurse stated, "I received vaccine this past Wednesday. I was just talking to a couple of my colleagues and honestly I received the vac. at work. I did not really read through the paperwork and was 'weird' sharing reactions to the vaccine which for me was pretty bad reaction and thought like I need to go through your paperwork and report it. So I thought I should call and just give some information. The usual fatigue which I go to after being normal, my arm was not sore. However, as the week progressed into Friday I had a constant headache but it was manageable and then by Friday night my glands swelled, my nerves behind my ears, my neck and I was extremely fatigued, bad headache and went to bed and I had not gone out and finally I got out today I spoke with my Physician yesterday. What happened it looked like an encephalopathy but my head swelled, my face was all swollen, complete brain fog, fatigue and I couldn't talk. I was in so much pain in my head resulting in (incomplete sentence)." Lab work included the only thing is the PCR swabbing. No blood test. Registered Nurse further stated, "I don't know if that is important. But I will tell you and if it is you can send me the questions. I do have a history of Autoimmune. So my Physician thought that this was just like an enhancement of like my bodies reaction I have Chronic Lyme and I have lupus like my ANA has always been stressful. But we think that it is a family thing. No treatment for the Lyme. I did a lot of antibiotic and a lot of naturopathic stuff but that is in the past. But anyhow for anything else what I did was when I got the injection they said try and just take Tylenol not Ibuprofen but there was no way I was going to make it through with just that . So I took Ibuprofen. I called my Physician yesterday morning because I was not sure about what was is happening and I thought it might be secondary sinus infection or something else going on and it reassured me that it is definitely due to the vaccine. He said it is just your body's reaction, take the Ibuprofen, hydrate. Had me take what I had in my house Tigan for nausea. So I was extremely nauseous from the severity of the headache." Registered Nurse stated, "I just wanted to let you know what happened and the intensity of what it was because normally I would expect a headache. But this was a 'go dated'. Registered Nurse stated, "I guess the only question that I have is so do my work has this question and I was going to call my doctor tomorrow may be might know it better. I know that I have to take the second dose. But I understand the second round can be worse than the first. Is there anything that they are recommending that I can do may be prior to ease the reaction?" The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The reported clinical manifestations including swelling face and head swelled, which was suspected as encephalopathy by the reporting nurse, was probably related to the bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), due to temporal relationship. The subject's underlying Chronic Lyme, Lupus and Autoimmune were likely the risk factors to the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees and Investigators, as appropriate.
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| 60 | 2021-01-10 | fatigue, headache |
Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after receiving vaccination patient became tired and expe...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after receiving vaccination patient became tired and experienced a headache. The next day at 2:15pm the patient reported a temperature of 99.0 degrees Fahrenheit, not being as tired, but starting at 9:30 am that morning experiencing "tongue being tied" and having difficulty communicating described as "know what they want to say but it... doesn't come out" that lasted three hours. The patient denied problems walking or being confused. The patient was immediately referred to the emergency department for evaluation. Upon arrival to the emergency department patient had clear speech speaking in complete sentences and ambulating independently with a steady gait. Physical and neurological exams both normal: no aphasia and no focal neurological deficits, normal strength and sensation throughout. Initial vital signs within normal ranges except blood pressure 149/88 mmHg. Patient remained asymptomatic and stable throughout emergency department stay. Repeat vital signs were within normal ranges and patient was discharged to home with a diagnosis of transient ischemic attack. On follow-up visit with primary care physician four days after vaccination patient reports feeling much better and no new symptoms reported.
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| 60 | 2021-01-10 | fatigue, headache |
dizziness around 8:00pm, fatigue, severe headache, neck & shoulder pain, body aches, joint pain, nau...
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dizziness around 8:00pm, fatigue, severe headache, neck & shoulder pain, body aches, joint pain, nauseous, mild shortness of breath
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| 60 | 2021-01-10 | headache, malaise |
1/1/2021: soreness at site 01/08/2021: headache,malaise 01/09/2021: redness & inflammation, hot to t...
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1/1/2021: soreness at site 01/08/2021: headache,malaise 01/09/2021: redness & inflammation, hot to touch, swelling 3" x 3", small raised blisters. 01/11/2021: symptoms are subsiding; pink, warm to touch, swelling 2" x 2", blisters fading
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| 60 | 2021-01-10 | sweating, sinus pain, headache |
She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion ...
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She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion and when wearing a mask. Aching in left arm, in chest and in right arm pit. Very dry eyes and bloodshot. Sweating and very warm. Temperature 1-11-21 96.2°F
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| 60 | 2021-01-10 | sweating |
Have very bad body aches and hot and cold sweats . I have been taking ibuprofen 2 times and symptoms...
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Have very bad body aches and hot and cold sweats . I have been taking ibuprofen 2 times and symptoms get better.
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| 60 | 2021-01-10 | throat pain, headache | Injection site slightly sore to the touch, very slight sore throat and very slight headache |
| 60 | 2021-01-10 | fever, chills, fatigue, headache |
Had shot at 11am on Fri. 1/8. Woke up at 230 am Sat. morning 1/9 with chills, fever 101, aches, head...
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Had shot at 11am on Fri. 1/8. Woke up at 230 am Sat. morning 1/9 with chills, fever 101, aches, headache and fatigue. Started to feel better later in the day, but still had fever 100, bad headache and very fatigued. Still had fever at bedtime at 830 of 100.2. Woke up at 430 am for work on Sunday 1/10 feeling better and no fever. I was still somewhat tired but that was it. Nothing since this writing.
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| 60 | 2021-01-10 | fever, chills | Fever 102.2, chills, body aches, nausea. |
| 60 | 2021-01-10 | fever, chills | nausea,weakness,chills , fever , muscle and joint pain , no appetite |
| 60 | 2021-01-10 | fever, fatigue |
four hours after receiving vaccine, I experienced diarrhea, then fever. Weakness, fatigue and incre...
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four hours after receiving vaccine, I experienced diarrhea, then fever. Weakness, fatigue and increased fever continued thru the night and not able to sleep, very restless. The next morning after I had more weakness and major flair up with my MS, where I fell several times and was not able to get myself off the floor. Each time I fell it too approximately 20 minutes for me to get either in bed or a chair. Still had fever of a 100-101 through out the day, took ibuprofen to help, which it did for a short time but then fever was back. About 7pm I took some Benadryl and was finally able to fall asleep. The next morning, no fever but very weak. Went to health club to help with my legs. This day was ok, weak but improved. No falls
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| 60 | 2021-01-11 | chills, fatigue, headache, fever |
Pain at injection site; Tiredness; Headache; Chills; Joint pain; Fever; Felt paralyzed at one point;...
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Pain at injection site; Tiredness; Headache; Chills; Joint pain; Fever; Felt paralyzed at one point; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: K5730, via an unspecified route of administration from 29Dec2020 16:15 at a SINGLE DOSE for covid-19 immunization. Medical history included migraine with aura. Concomitant medication included gabapentin, pravastatin, estradiol, diphenhydramine hydrochloride (ALLERGY), and ascorbic acid, calcium pantothenate, colecalciferol, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol (VITAM). The patient previously took amoxicillin and had allergies. On 30Dec2020 15:00, the patient experienced pain at injection site, tiredness, chills, joint pain, fever and felt paralyzed at one point. The outcome of events was recovering. No follow-up attempts possible. No further information expected.
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| 60 | 2021-01-11 | chills | TEMP 99 AFTER TYLENOL s shaking chills |
| 60 | 2021-01-11 | cough |
Discomfort in throat caused coughing which then led to Bronchospasm. Patient used own Albuterol Inh...
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Discomfort in throat caused coughing which then led to Bronchospasm. Patient used own Albuterol Inhaler for 3-4 inhalations. Given Epinephrine, Benadryl, Solu-Medrol IM injections administered. 2L O2 via NC applied. Elevated BP and HR noted. Patient transported to ER. Duo-Neb nebulizer treatment provided. Bronchospasm and Wheezing subsided after approximately 45 minutes. Patient discharged hone with Prednisone and EPI pen prescriptions.
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| 60 | 2021-01-11 | fatigue, headache, fever, chills |
Fever; chills; headache; fatigue; This is a spontaneous report from a non-contactable other HCP (pat...
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Fever; chills; headache; fatigue; This is a spontaneous report from a non-contactable other HCP (patient) reported for herself. A 60-years-old female patient received first dose of BNT162B2 (lot number unknown), via an unspecified route of administration, in left arm, on 05Jan2021 13:00 at single dose for COVID-19 immunization. Reason why batch/lot is unknown was misplaced/discarded. The patient was not pregnant at the time of vaccination. Medical history included known allergies: Penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was other. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced fever, chills, headache, fatigue on 06Jan2021 01:00 AM. No treatment was received for the events. The outcome of the events was recovering. Since the vaccination, patient hasn't been tested for COVID-19. No follow-up attempts are possible, information about lot/batch cannot be obtained.
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| 60 | 2021-01-11 | headache, chills |
developed more severe arm pain, headache, rigors, muscle aches- lasted approx 3 -4 hour- took tyleno...
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developed more severe arm pain, headache, rigors, muscle aches- lasted approx 3 -4 hour- took tylenol, used heating pad
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| 60 | 2021-01-11 | headache |
Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat an...
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Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat and chest
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| 60 | 2021-01-11 | headache |
Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheez...
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Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheezing; Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing asthma (asthmatic) which had been under control for years. The patient's concomitant medications were not reported. In Jan2021, the patient had arm pain; full body aches; headaches; had frequent bathroom use (not diarrhea "more of a mix"); mild wheezing; and nausea. The patient had received paracetamol (TYLENOL) as treatment for the arm pain. The outcome of the events, 'arm pain', 'full body aches', 'headaches', 'frequent bathroom use', 'mild wheezing' and 'nausea', was unknown. Information on the lot/batch number has been requested.
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| 60 | 2021-01-12 | fatigue, headache, chills |
About 22 hours after administration I had chills, headache,blood shot eyes, total body aches and ext...
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About 22 hours after administration I had chills, headache,blood shot eyes, total body aches and extreme fatigue. I slept off and all day and at 3:00 am 1/13/2021 I woke up and felt much better. chills, headache and body aches all gone. Some fatigue still lingers. I did not have fever at any time.. My arm injection site was less sore than the first vaccine.
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| 60 | 2021-01-12 | headache, body temperature increased |
achy knees/ achy joints/ achy right elbow; Headache; her temperature was 96, but not a fever; Achy b...
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achy knees/ achy joints/ achy right elbow; Headache; her temperature was 96, but not a fever; Achy back; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received second dose of BNT162B2 (Batch/lot number: EJ1685, Pfizer product), via an unspecified route of administration in in left arm on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was receiving concomitant therapy. The patient previous received first dose of BNT162B2 on 08Dec2020 and experienced left arm a little sore at the injection site. The patient experienced achy knees/ achy joints/ achy right elbow, headache, her temperature was 96, but not a fever, achy back, all on 07Jan2021. She got her 2nd vaccine (COVID-19 Vaccine) on 06Jan2021 and this morning, the longer the morning goes on, she felt achy, has a headache, feels like she has a fever but does not. Had temperature taken this morning going into work and it was 93. Just now, her temperature was 96, but not a fever. She stated that this was nothing major, but the information she received said to call and report anything. First temperature taken this morning was from a forehead thermometer. The type of thermometer used for her second temperature this morning was not provided. She was a secretary for environmental services at the hospital she works at. She stated that she thought she could go to work and had to leave. She was going to bed as soon as she hangs up. Height: she used to be 5 feet 8 inches. She was counting on feeling better by tomorrow. She further described her achy feeling as her joints are achy including her knees, back and her elbow, but only her right elbow. She received the injection in her left arm. All she wanted to do now, was to crawl into a warm bed. She stated that she was fine after the first shot. Her arm was a little sore and that was it. She had her first COVID-19 Vaccine injection in her left arm. The soreness at the injection site lasted 2 days and then recovered completely. She did not provide her concomitant medications, stating that she took the same medications that she usually took and had not started anything new. She stated that she was 60 and has the what she had, but she did not have anything of concern; further stating that she had no breathing difficulties or anything like that. The patient underwent lab tests and procedures which included body height: 172.72 cm, body temperature: 93, body temperature: 96, all on an unspecified date. The outcome of events was not resolved.
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| 60 | 2021-01-12 | headache |
Ringing in ears; Triggered to migraine; Cannot hear, Sounded like everything was muffled; Headache; ...
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Ringing in ears; Triggered to migraine; Cannot hear, Sounded like everything was muffled; Headache; This is a spontaneous report from a contactable Nurse. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK9231), via an unspecified route of administration on 04Jan2021 14:56 at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, previously had an allergic reaction to just one antibiotic. Concomitant medication included nifedipine, carvedilol. Consumer stated, "About 15 minutes into after getting the injection, I was sitting to the site they asked me to stay longer because I previously had an allergic reaction to just one antibiotic (Unspecified Medication).So that was within the 15 minute mark I started getting ringing in my ears and at the 20 mark I had migraine. I had them since I was about 9, they were diagnosed, it triggered a migraine. Although the ringing had gotten better in the last year but it is really bad in the right and it is now causing me (incomplete sentence)." Consumer stated, "I am probably say like I am yelling at you. I cannot hear and my son keeps telling me mom you are yelling. I did not see that I am 'ringing to your sheath' ringing in the ear, the headache. I just see my headache is better today. I had a little bit of it but nothing you know Excedrin or something would take care of not enough for me to go take that but it is the ringing and I cannot hear out of that ear. I put my phone up and ringed up. Consumer stated, "Recently my mom had COVID (further not clarified), I barely heard it. On the 23rd of Dec and I keep in contact with my family,they are 13 of us and I picked up the phone and instinctively put it to my right ear, I could not hear and I kept looking at the phone and I thought wait a minute and I put it to my left seems to be okay. It is the right I cannot hear." Consumer further added, "I am a Nurse so you expect this, that is why I waited this long because I got the injection at like 3 O'clock yesterday and I waited even longer thinking maybe it will just go away and So I know you guys want to know everything that is going on. So I said wise better to call." Date of vaccination: Consumer stated, "04Jan2021 (Clarified as 04Jan2021) and the time was 2:56 PM." Consumer further added, "It is the only thing I could think of. It is the only thing that I could think of that I did differently out of my daily habits to go get this injection. I would say within 15 minutes it just started turning my head and I was like wait a minute I am having ringing and then they had music playing above our head, it sounded like everything was muffled then I turn my head to the right I could hear better and they kept turning my head and one of the administrators at the table started looking at me so I get up and I said you know what I am having ringing in my ear so they had me seated there a bit longer." Dose and route of administration: Consumer stated, "I think she pulled up one cc that I saw and I got it in my left deltoid." Treatment: Consumer stated, "No." Causality: Consumer stated, "I would have to say because it started like say in the 15 minute mark and then the headache came in about 20 minute mark." The outcome of the event Headache was resolved while the outcome of the other events was unknown.
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| 60 | 2021-01-12 | throat pain, headache, throat irritation |
Initially, sore throat, body aches and headache, then on 1/11/21 she developed red raised rash on he...
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Initially, sore throat, body aches and headache, then on 1/11/21 she developed red raised rash on her neck and chest. Denies difficulty breathing however she reports her throat is very painful, scratchy, dry and irritated. For treatment patient took a zyrtec 24 hour 10 mg tablet on 1/11/21 which reduced some inflammation of rash, however still present 1/12/21. Has increased fluids, is taking tylenol and tea with honey. These were self care done by patient. MD suggested to Zyrtec every 6-8 hours as needed for symptom control. Ibuprofen / tylenol as needed for headache if no provider has told you not to use these in the past. If any progressive Sx than you should be seen at URI clinic.
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| 60 | 2021-01-12 | fever | Fever for over 24 hours. Temp 101.9 |
| 60 | 2021-01-13 | headache |
flushing/ felt feverish and it was not a rash, she just felt flushed; hot/ felt really hot; soreness...
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flushing/ felt feverish and it was not a rash, she just felt flushed; hot/ felt really hot; soreness in the arm; little headache; experiencing tingling in hands and feet (mostly in feet); experiencing tingling in hands and feet (mostly in feet) and they feel cold; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via unspecified route on left upper arm at single dose for COVID-19 immunization on 05Jan2021, 12:30pm at 60-year-old. Medical history included: ongoing diabetes type 2; ongoing gout; went through menopause 10 years ago (2011). She had pulmonary emboli 3 years ago (2018) and had some scar tissue but not on oxygen though she did get short of breath. No relevant family medical history. The only reactions she has ever had was 15 years ago (2006), she had a CAT scan and experienced hives the next day due to the contrast medium. She thought it had since been changed as she had had it twice since then and was given diphenhydramine hydrochloride (BENADRYL) but experienced nothing again. Concomitant medication included: ongoing dulaglutide (TRULICITY) for diabetes type 2 and ongoing oral medication (unspecified) for gout. No additional vaccines administered on same date of BNT162B2. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) single dose for COVID-19 immunization on 19Dec2020 around 12pm and 2 pm. The patient previously got the flu shot (unspecified) every year, 3 years ago (in 2018) she got the shingles vaccine and had also had the pneumonia vaccine (in 2018) but never experienced anything from those products. The patient previously took allopurinol for pulmonary emboli and had had no reoccurrence. She took warfarin for short of breath. The patient had flushing on 05Jan2021, she was hot and turned red like a cherry. She had an episode where she felt really hot like hot flashes or almost like she was flushed. Her face was red as beet and her arm and hands were red, this lasted about an hour and she took ibuprofen (ADVIL) for it. It seemed to be resolved but had come and gone through the night. She was up checking on her puppies so that was how she noticed. She had taken her temperature and it had been 97.6-98.1 which was normal for her, but she was still getting the hot flashes and flushing. She felt feverish and it was not a rash, she just felt flushed. After the vaccine, the patient reported soreness in the arm on 05Jan2021. The patient was experiencing tingling in hands and feet (mostly in feet) on 05Jan2021 and they feel cold. Tingling started about 45 minutes to an hour after the dose. The first time lasted 3-4 hours and then went away. It came back in the middle of the night for a couple hours and then again this morning. This morning it had been going on for 2-3 hours and was still going on right now; it started about 6:30am-7am. They feel cold but her feet were really cold. She had socks and slippers on, but they didn't seem to get warm. She went on to explain that her hands and feet have profusion. During this she had checked her pulse ox (oximetry) related to her cold hands and it had been 92-95% (on unknown date) which was good. She had also checked her pedal pulses even though they were cold, and a little they were a little on white side, they blanch although might be a little slow but nothing alarming. The patient had a little headache on 05Jan2021. Other than that, the patient felt fine. No emergency room or physician office visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events flushing, hot/ felt really hot, soreness in the arm, tingling in hands and feet (mostly in feet) and they feel cold was not resolved; outcome of the other events was unknown. Causality assessment between the Pfizer product (BNT162B2) and the events (tingling, flushing, soreness in the arm) per the reporter was reported as related.
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| 60 | 2021-01-13 | sleepiness, headache |
Within 15 min of admin; pt reported feeling super drowsy and complained of Headache. She was given w...
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Within 15 min of admin; pt reported feeling super drowsy and complained of Headache. She was given water and Acetaminophen, 25mg of Diphenhydramine. BP 140/64 Pulse 74
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| 60 | 2021-01-14 | chills, headache |
Chills; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 60-...
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Chills; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246), via an unspecified route of administration on 08Jan2021 11:45 AM at single dose on the right arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), on 18Dec2020 12:00 PM on right arm. COVID-19 vaccine was administered in the hospital. The patient experienced chills, nausea and headache on 09Jan2021 01:30 AM. No treatment received for the events. The events were assessed as non-serious. Outcome of the events was recovered in Jan2021. The patient has not been tested for COVID-19 since the vaccination.
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| 60 | 2021-01-14 | chills, fever, headache |
I got the vaccine in the AM and I was fine all day just a little itchy in the morning. Around 2AM in...
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I got the vaccine in the AM and I was fine all day just a little itchy in the morning. Around 2AM in the morning I had high fever, chills, and a very bad headache, and shooting pain like a shock in legs and arms (I had the same when had covid around 04/2020 and was out of work until June 2020 - I developed double pneumonia). It lasted until 11AM the next day. Got a covid test around noon and it was negative and on the 25th I started feeling better. Got second dose on 01/13/2021 had the same symptoms but not as severe.
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| 60 | 2021-01-14 | chills, fever | Fever 38.8 Chills Muscle and joint pain |
| 60 | 2021-01-14 | fatigue, chills, headache, fever | Low grade fever, chills, headache, fatigue |
| 60 | 2021-01-14 | fatigue, chills, headache |
Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus,...
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Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus, and pressure on her upper back. She reported feeling anxious when she laid down. She went to see her doctor last week and was treated with benadryl.
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| 60 | 2021-01-14 | fatigue |
Right after shot body felt on fire, within 5 minutes tongue start swelling, face, neck and injection...
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Right after shot body felt on fire, within 5 minutes tongue start swelling, face, neck and injection site red, BP went to 170/120, very fatigued and throat closing.
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| 60 | 2021-01-14 | headache, chills, fever | this was my second shot for covid, experienced chills fever bad headache |
| 60 | 2021-01-14 | headache, fatigue, chills, fever |
Patient reports chills, fever, muscle aches, headache, 100.1 within 24 hours. Also report loss of ap...
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Patient reports chills, fever, muscle aches, headache, 100.1 within 24 hours. Also report loss of appetite, fatigue.
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| 60 | 2021-01-14 | headache, fatigue | Headache, Body Aches, Fatiguenone |
| 60 | 2021-01-15 | cough, fatigue |
I lost my voice, my face tingled, my eyes Got puffy, itchy, and watery, extreme fatigue, and minor ...
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I lost my voice, my face tingled, my eyes Got puffy, itchy, and watery, extreme fatigue, and minor difficulty breathing. I had an increased you can buildup up in my throat and nose, with coughing. I took two Benadryl; about 45 minutes later my breathing improved. I took the Benadryl at 8:15 AM. It?s now 2:25 PM and my eyes are getting itchy and starting to feel puffy again. My voice is still very hoarse.
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| 60 | 2021-01-16 | body temperature increased, fatigue, malaise, throat irritation |
Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: ...
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Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: light headed, dizziness, pale, tachycardia, scratchy throat, heaviness in chest, tightness in throat, spike in blood pressure (initial 144/88, 168/96, 152/87, 146/84-final). Monitored symptoms 45 min to one hour. Temp 97.3. Symtoms lasted approx one hour, then began improving, with exception of light headedness and general malaise and fatigue for 4 hrs. Additional event at approx 10 hours post vaccine: excruciating upper arm pain (left shoulder to elbow), felt "down to the bone". Unable to move arm and very painful to touch. Took 600 mg ibuprofen. Severe pain lasted approximately 3-4 hours (unable to sleep). Then became moderate soreness at injection site x 8 hrs. Mild soreness x 12 hrs, no pain 36 hrs after vaccine. Continued fatigue and malaise for 3-4 days after vaccine.
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| 60 | 2021-01-16 | headache |
1) I sat for 30 minutes after shot since I have a mild shellfish allergy. When I stood up, I was br...
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1) I sat for 30 minutes after shot since I have a mild shellfish allergy. When I stood up, I was briefly dizzy but only for a few seconds at most. 2) By the time I reached my car, I had developed a mild headache which lasted until around noon the next day. The headache was not severe. 3) Shoulder that received the shot was sore for about two days.
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| 60 | 2021-01-17 | headache | 01/05/2021 AT 6PM: BODY ACHES, SEVERE HEADACHES. LOCAL SORENESS, SWELLING |
| 60 | 2021-01-17 | sweating | Clammy, sweating and rash to BUE and chest. Patient will be seeing PCP for treatment. |
| 60 | 2021-01-17 | malaise, headache |
SORE ARM 8 HRS POST VACCINE. THEN, HEADACHES AND MALAISE. MINOR BODY ACHES UPON AWAKENING THE NEXT M...
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SORE ARM 8 HRS POST VACCINE. THEN, HEADACHES AND MALAISE. MINOR BODY ACHES UPON AWAKENING THE NEXT MORNING. ALL LASTED UNTIL ABOUT 28 HRS POST VACCINE.
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| 60 | 2021-01-17 | throat irritation | PATIRNT PRESENT THROAT AND BODY ITCH |
| 60 | 2021-01-18 | fatigue, headache, throat pain, malaise |
Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Head...
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Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Headache; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (batch/lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient worked at a hospital doctor's office. On 22Dec2020, the next day of vaccination, patient immediately for two days had "immense" (not clarified) headache and then had two days of vomiting and diarrhea. And she had been sick "ever felt" (not clarified) on an unspecified date. She had extreme exhaustion. She had been tested for everything from "manual" to mild "disease" (not clarified). She had extreme exhaustion, dizziness, shakiness, sore throat and Monday would be three weeks that she had been feeling like this. She had never been sick like that she felt like this way. She was supposed to get the second vaccine the day after the time of the report yeah so any way. They wouldn't give her because she was not feeling well but she wished just going to hold off and might be try it all over again in couple of weeks when she felt better but she really felt not well since had gotten this vaccine. She had never felt like this before in her life had ever felt this way all ever. She had taken an over the counter medication cold and flu medication (further clarified CareOne (batch/lot number: OCE2948, expiry date: Nov2021)), and ibuprofen (ADVIL, batch/lot number: R85569, expiry date: Mar2023) and she had been doing lot of sleeping. She had been sleeping nonstop. The patient underwent lab tests and procedures which included EKG and all kind of blood work with unknown results. Outcome of the events was unknown. Causality was reported as yes by the consumer.
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| 60 | 2021-01-18 | headache | Daily Headaches |
| 60 | 2021-01-18 | malaise |
Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and fo...
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Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and foggy. Unable to fully concentrate on tasks. Flushed in face and unsteady lasting approximately 1 hour. Developed headache lasting remainder of shift. Developed body aches/chills in evening
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| 60 | 2021-01-18 | malaise |
WHEN I GOT TO WORK I DIDN'T FEEL AT MYSELF. I WAS DIZZY AND VERY SHAKEY AND DIDN'T FEEL RIGHT THE M...
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WHEN I GOT TO WORK I DIDN'T FEEL AT MYSELF. I WAS DIZZY AND VERY SHAKEY AND DIDN'T FEEL RIGHT THE MAIN PROBLEM IS IF I CLOSE MY EYES AND GET REALLY DIZZY AND GET SICK AT MY STOMACH
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| 60 | 2021-01-18 | nasopharyngitis, fatigue, paranasal sinus discomfort, throat pain |
6PM DAY OF SHOT ITCHING IN EXTREMITIES LOWER LEGS AND ARMS JUST ABOVE WRIST. PAINFUL LOWER BACK PAIN...
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6PM DAY OF SHOT ITCHING IN EXTREMITIES LOWER LEGS AND ARMS JUST ABOVE WRIST. PAINFUL LOWER BACK PAIN. TOOK TWO BENEDRYL AND SYMPTOMS RESOLVED BY AM. 1/16 HAD SYMPTOMS OF AN ON-COMING COLD, SLIGHT SORE THROUGH, SINUS PRESSURE AND FELT WARM. NO TREATMENT OTHER THAN FLUIDS AND REST AND RESOLVED BY MORNING. 1/17 AND 1/18 ONLY SYMPTOM MILD FATIGUE
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| 60 | 2021-01-18 | fever, chills, influenza like illness |
fever (100,4, 101 and 100); I was a little ache like a flu; I was a little ache like a flu; Felt rea...
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fever (100,4, 101 and 100); I was a little ache like a flu; I was a little ache like a flu; Felt really hot in my face; I just kind of felt little nauseous; Little bit of chills; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included ongoing hypertension. Concomitant medication included amlodipine besilate at 5 mg once a day for hypertension, acetylsalicylic acid (BABY ASPIRIN) at 81 mg once a day, vitamins and metoprolol succinate at 50 mg twice a day for hypertension. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. On Jan2021, the patient reported that: " I was running a fever like above 100.4, I was a little ache like a flu" and " I woke up and I just felt really hot in my face, I just kind of felt little nauseous and a little bit of chills and I took my temperature and it was like a 100, so I went to work and I did take a TYLENOL, 2 extra strength TYLENOL around 9:00 and I felt much better and now I am feeling like a fever is coming back so I took my temperature and I was getting like chills again and I took my temperature and it is 101". The patient outcome of the events was unknown.
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| 60 | 2021-01-18 | fever, malaise |
Lot number for the first dose was EK5730. After receiving the 2nd dose on the 01/11/2021 went to lun...
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Lot number for the first dose was EK5730. After receiving the 2nd dose on the 01/11/2021 went to lunch and in the evening started feeling nausea and was throwing and abdominal pain. Went to work sick Tuesday and Wednesday low grade fever, nausea and abdominal pain, wasn't eating was to sick to eat. Thursday early morning hours the pain was unbearable so she went to the ER and the cat scan. It was determined that she had appendicitis and they removed my appendix same day. Feels so much better now.
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| 60 | 2021-01-18 | fever | Systemic: Fever-Medium, Systemic: rapid heartbeat-Medium |
| 60 | 2021-01-18 | runny nose | Watery eyes, runny nose |
| 60 | 2021-01-18 | throat clearing |
Metallic taste in mouth, tingling of sides of tongue, dry throat/unable to clear throat. Resolved wi...
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Metallic taste in mouth, tingling of sides of tongue, dry throat/unable to clear throat. Resolved within 1 hour of injection.
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| 60 | 2021-01-19 | fatigue, headache, cough, throat pain, fever | Cough, fever, headache, sore throat,fatigue |
| 60 | 2021-01-19 | headache, fatigue, chills | chills, headache, body aches, loss of taste, flush, red eyes, extreme fatigue |
| 60 | 2021-01-19 | headache |
Day 1-3: had headache, generalized itching and swelling of the right side of the face and eyelid. To...
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Day 1-3: had headache, generalized itching and swelling of the right side of the face and eyelid. Took Tylenol Day 6: diagnosed with Bells Palsy by PCP 1/8: went to doctors for evaluation by PCP of symptoms currently patient still experiencing swelling of the right side of face and slight itching
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| 60 | 2021-01-19 | throat irritation |
Within 5 minutes of getting injected, felt heat over entire body, from top of head to toes, heart ra...
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Within 5 minutes of getting injected, felt heat over entire body, from top of head to toes, heart rate increased. Nurses came over and took VS. BP 180/100, P128, Throat scratchy and hard to swallow. Monitored continuously and had epinephrine ready but didn't inject as about 10 minutes later symptoms started to subside. Stayed in hospital for longer period (unsure of exact time) and then went home. Over the next 2 days, felt listless, weak and no appetite.
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| 60 | 2021-01-20 | chills, headache, body temperature increased |
received 2nd dose at 7pm 1/18/21. woke up tuesday with sore arm went to work and while working after...
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received 2nd dose at 7pm 1/18/21. woke up tuesday with sore arm went to work and while working afternoon progressed to chills and total body aches. temp 101 through evening up and down after motrin to next day Wednesday. wednesday had some chills but during night into Thursday had joint pain no fever. woken up thursday with joint pain and headache no fever.
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| 60 | 2021-01-20 | chills, fever |
1. Fever lasting 30 hours. It began approximately 11 hours after my shot, and ended 30 hours later....
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1. Fever lasting 30 hours. It began approximately 11 hours after my shot, and ended 30 hours later. Fever ran about 102 degrees most of the time. 2. Chills 3. Loss of appetite and body aches lasting approximately 3 days 4. Hives in armpits, worse on the side of the injection. I noticed it 48 hours after the injection, and I still have them 1 week later. They are much better, but still visible and itchy. 5. Sensitive and painful gums
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| 60 | 2021-01-20 | fatigue, chills, fever |
chills; fatigue; deep muscle aching in both arms; fever ranged between 100-101 F; This is a spontane...
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chills; fatigue; deep muscle aching in both arms; fever ranged between 100-101 F; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration at left arm on 08Jan2021 at 09:30 at single dose for COVID-19 immunization. The patient medical history included seasonal allergy from an unknown date and unknown if ongoing and COVID-19 from Oct2020 (as reported: "I had been diagnosed with COVID-19 on 21Oct2020 with symptoms onset on 15Oct2020") to an unknown date. The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY), aspirin, calcium/cholecalciferol (CALCIUM + D3), docusate. The patient previously took COMPAZINE and BACTRIM DS and experienced allergies. The patient reported that on 08Jan2021 at 21:00 developed chills, fatigue, deep muscle aching in both arms and fever ranged between 100- 101 F. On 09Jan2021 at 09:00 he felt fine, until approximately 17:00 and again developed chills, muscle aching and fatigue. On 10Jan2021 at 08:30 all symptoms were gone and never returned. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 21Oct2020. The patient outcome of the events was recovered on 10Jan2021 at 08:30.
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| 60 | 2021-01-20 | fatigue, sinus disorder |
Within an hour of the vaccine face was hot and muscle in face were painful in the jaws, sinuses up i...
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Within an hour of the vaccine face was hot and muscle in face were painful in the jaws, sinuses up in nose felt weird and dry like menthol. Put ice on face. Took Tramadol. Having fatigue. Next day felt better, then started having brain fog difficulty remembering, vision is blurry, no energy and feel exhausted.
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| 60 | 2021-01-20 | fatigue | Heart palpatations, fatigue, light hededness |
| 60 | 2021-01-20 | headache, chills, fatigue, fever |
chills; headache; fatigue; fever 101; body aches; This is a spontaneous report from a contactable he...
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chills; headache; fatigue; fever 101; body aches; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration in right arm on 09Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included hypothyroidismand arthritis from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID), progesterone and estradiol (DOTTI). The patient previously took ace inhibitors and experienced allergies. The patient had first dose of BNT162B2, via unspecified route of administration on 18Dec2020 11:00 AM, lot number: EK507, in right arm at single dose for COVID-19 immunization. On 09Jan2021 2:30 AM, the patient woke up and experienced chills, fever 101, headache, fatigue and body aches and it lasted most of the day. The patient went back to bed at 8:30 PM and still had fever 100.2 and fatigue but most other symptoms getting better. The patient woke on 10Jan2021 at 4:30 am for work, no fever and some fatigue but that was it. No other reactions since this writing. The outcome of the event fever was recovered on 10Jan2021 and the outcome of the remaining events was recovering. No treatment was given for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 60 | 2021-01-20 | headache |
taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the co...
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taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the corners of my mouth; sore arm; nausea; headache; This is a spontaneous report from a contactable consumer. This consumer reported for that the 60-year-old female patient who received first dose of bnt162b2 (Pfizer Pfizerbiontech covide-19 Vaccine EUA), via an unspecified route of administration on 03Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. She is not pregnant. Medical history included Known allergies: Penicillin sulfa. No other vaccine in four weeks. Concomitant medications included in two weeks: escitalopram oxalate (LEXAPRO), valaciclovir hydrochloride (VALTREX). The patient experienced Day 1 sore arm, nausea, headache from 05Jan2021 12:00AM, Day 2 nausea from 06Jan2021, Day 3 rash around the corners of my mouth from 07Jan2021, Day 4 bumps on roof of mouth from 08Jan2021, Day 5 red spots on roof of mouth from 09Jan2021, Day 6 Continued red spots went to Doctor, Day 7 taking new meds for allergic reaction from 11Jan2021, Day 8 headache mouth improving. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Treatment was received included Doxycycline. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
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| 60 | 2021-01-20 | sweating |
Received vaccine at 1:10pm. At 1:30pm, while in observation lot,patient complained of chest pressur...
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Received vaccine at 1:10pm. At 1:30pm, while in observation lot,patient complained of chest pressure 8/10 and appeared ashen and diaphoretic. Paramedics from the vaccine facility immediately responded to the patient. Patient stated these were the same symptoms she has had in the past when she has an allergic reaction, and stated she has reactions to 10 different "things". Patient carried an epi pen but stated she usually went to the ER and was treated there. On-site paramedics gave 0.5 mg IM to Left deltoid. Patient stated chest pressure went down to a 3/10, and she felt better. Ambulance arrived and patient was transported to Hospital.
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| 60 | 2021-01-20 | sleepiness |
Very sleepy 4 hours after second dose; This is a spontaneous report from a contactable healthcare pr...
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Very sleepy 4 hours after second dose; This is a spontaneous report from a contactable healthcare professional (patient herself). A 60-year-old female patient received the second dose of bnt162b2 (lot number: Ek9231), intramuscularly on the left arm on 11Jan2021 09:30 at a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient was not pregnant. The patient had no COVID prior vaccination. The patient was not COVID tested post vaccination. The patient has no known allergies. The patient previously took the first dose of BNT162B2 (lot number: Ek5730) intramuscularly on the right arm on 22Dec2020 at 08:00 AM. On 11Jan2021 14:00, the patient became very sleepy four hours after second dose. The patient was recovering from the event. No treatment was given in response to very sleepy 4 hours after second dose.
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| 60 | 2021-01-21 | fatigue, headache |
right deltoid pain, fatigue, headache, neck pain, low back pain, right axillary lymph node swollen/d...
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right deltoid pain, fatigue, headache, neck pain, low back pain, right axillary lymph node swollen/discomfort
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| 60 | 2021-01-21 | fatigue |
Extreme fatigue day of and following week of vaccine. On 1/20/21 had episode of brain fog or complet...
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Extreme fatigue day of and following week of vaccine. On 1/20/21 had episode of brain fog or complete lapse in memory of event I talked to a person just the day before. (Never happened before) Today, 1/22/21 I was sitting at my desk talking to another person and fainted for no reason. (Never happened before). I came to and after short while felt better.. Left work to rest at home. Have not seen a doctor yet but worried about 2nd vaccine dose. The syncope episode concerns me.
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| 60 | 2021-01-21 | fever, chills, headache |
Sore arm, severe headache- severe body aches, chills, low grade fever. Symptoms started 10 hrs afte...
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Sore arm, severe headache- severe body aches, chills, low grade fever. Symptoms started 10 hrs after vaccination and lasted approximately 36 hours.
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| 60 | 2021-01-21 | fever, lethargy | LETHARGY AND LOW GRADE FEVER |
| 60 | 2021-01-24 | chills, headache, head discomfort, body temperature increased, influenza like illness |
Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate...
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Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 60 | 2021-01-24 | dehydration |
Awoke in the early morning hours of 1/23/21 with severe vertigo, almost fell over twice while walkin...
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Awoke in the early morning hours of 1/23/21 with severe vertigo, almost fell over twice while walking to the bathroom. Vertigo caused severe nausea and vomiting, with inability to drink or eat for 36 hours. I became dehydrated. Went to the ED and was admitted overnight for vertigo, orthostatic hypotension, dehydration.
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| 60 | 2021-01-24 | fatigue, chills | Severe fatigue, muscle weakness and chills |
| 60 | 2021-01-24 | fatigue |
I had a rash on my face, started with itchy nose and eyes. The hives spread to the neck. I told the ...
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I had a rash on my face, started with itchy nose and eyes. The hives spread to the neck. I told the male nurse that was present and he said that had Epinephrine, I had benadryl and he said that I could take one. Half an hour later my rash got worse and I took 20 mg prednisone that I had for my asthma. During the next two days I have had palpitations, fatigue and tiredness. Today my blood pressure was high and I have never had it like that before.
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| 60 | 2021-01-24 | headache, chills, sweating |
12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours l...
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12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours later turned into sweating/heat. Mild upset stomach throughout. Soreness/brusing at injection site. After 18 hours headache persisted with mild body aches and upset stomach. Still soreness /brusing at injection site. 24 hours after injection very mild backache. No headache. Soreness at injection site. No other issues.
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| 60 | 2021-01-24 | fever, headache |
Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at s...
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Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at site of injection with swelling- took total of 4 tylenol over a course of 20 hours- symptoms lasted about 20 hours- arm swelling and pain lasted about 3 days
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| 60 | 2021-01-24 | throat irritation | Patient had tingling in the mouth and a scratchy feeling in her throat. Evaluated by EMS. |
| 60 | 2021-01-24 | throat irritation |
Patient has history of anaphylaxis, and carries her own EpiPen. Patient received dose 2 at 1640, ...
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Patient has history of anaphylaxis, and carries her own EpiPen. Patient received dose 2 at 1640, and was instructed to wait in observation area for 30 minutes. At 1650 patient reported that her tongue and back of throat were beginning to itch. No other symptoms. No difficulty breathing. Vital signs stable. Symptoms persisted, so decision was made to send patient to hospital emergency department. Patient did not want emergency transport, and was stable, and husband transported to hospital in POV. Onsite and hospital care team agreed to this plan. RN escorted patient from clinic to car. Patient and husband knew how to use EpiPen and drove directly to nearby ED for observation.
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| 60 | 2021-01-25 | chills, upper-airway cough syndrome, fever, headache |
increased postnasal drip; had a fever of 100.7 orally; bodyaches; headache; chills; This is a sponta...
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increased postnasal drip; had a fever of 100.7 orally; bodyaches; headache; chills; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient (not pregnant) received the second dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 09Jan2021 09:30 at single dose in right arm for COVID-19 immunization. Medical history included asthma, hypertension/ Blood pressure, acid reflux, food allergies, Known allergies: tree nuts, peanut, shell fish, Penicillin, Erythromycin, IVP dye, Rocephin. The patient's concomitant medications in two weeks included Blood pressure, acid reflux. The patient previously took the first dose of bnt162b2 on 19Dec2020 for COVID-19 immunization and experienced Sore arm. No other-vaccine-in-four weeks. Second dose on 09Jan2021 within 17 hours had a fever of 100.7 orally, body aches, headache, chills and increased postnasal drip on 10Jan2021 02:30. No treatment received. No covid-prior-vaccination and no covid tested post vaccination. The outcome of the events was recovering.
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| 60 | 2021-01-25 | chills |
Very swollen and erythematous arm; Very swollen and erythematous arm; chills; severe neck pain; myal...
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Very swollen and erythematous arm; Very swollen and erythematous arm; chills; severe neck pain; myalgias; This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female patient (not pregnant) received first dose of bnt162b2 (Lot number: Ek5730), via an unspecified route of administration in left arm on 22Dec2020 11:30 at single dose for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing (COVID prior vaccination: Yes). There were no concomitant medications. The patient experienced very swollen and erythematous arm, chills, severe neck pain, myalgias, all on 22Dec2020 14:00. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment given. The outcome of events was resolved. Facility type vaccine: Hospital. No other vaccine in four weeks. No other medications in two weeks. No COVID tested post vaccination. Not known allergies or other medical history.
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| 60 | 2021-01-25 | cough |
Pfizer BioNTech COVID-19 Vaccine EUA approximately 10 minutes after receiving her second dose, patie...
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Pfizer BioNTech COVID-19 Vaccine EUA approximately 10 minutes after receiving her second dose, patient report throat tingling and tightness. Later started to have an intermittent cough
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| 60 | 2021-01-25 | fatigue, fever, headache |
Fever 100.7; dizziness; fatigue; labile hypertension; confusion; forgetfulness; difficulty concentra...
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Fever 100.7; dizziness; fatigue; labile hypertension; confusion; forgetfulness; difficulty concentrating; nausea; severe headaches; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ElL0142), via an unspecified route of administration in left deltoid on 03Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included wheat allergy, celiac disease, and hypotension from an unknown date and unknown if ongoing. Concomitant medication included buspirone, cefixime (FLEXERIL), paracetamol (TYLENOL) and esomeprazole. On 05Jan2021 09:00 PM, the patient experienced fever 100.7, dizziness, fatigue, labile hypertension, confusion/forgetfulness, difficulty concentrating, nausea and severe headaches. No treatment was given to the patient for the events. The outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, PCR and Nasal swab both negative on 06Jan2021.
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| 60 | 2021-01-25 | fatigue, fever, malaise, headache |
horrible headache; felt really bad; 102 fever; achy; fatigued; This is a spontaneous report from a c...
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horrible headache; felt really bad; 102 fever; achy; fatigued; This is a spontaneous report from a contactable other health professional reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 12Jan2021 11:15 AM, at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Medical history included known allergies to penicillin and COVID. The patient had COVID prior to vaccination. Concomitant medications included lisinopril and escitalopram; these are the other medications the patient received in two weeks. The patient previously took betadine and experienced allergies. On 13Jan2021 02:30 AM (as reported), the patient experienced a horrible headache, felt really bad, 102 fever, achy, and fatigued. The patient woke up at about 2:30 am and had a horrible headache. Got out of bed at 4:30 and felt really bad. She had 102 fever. She was still running 100 at 5:42 pm. She was achy, still have a headache and am very fatigued at the time of report. She asked if she can take something for the fever and headache. The patient was not tested for COVID post vaccination. The patient did not receive any treatment for the reported adverse events. Outcome of the events was not recovered. Information on the Lot/Batch number has been requested.
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| 60 | 2021-01-25 | fatigue |
Very tired; This is a spontaneous report from a contactable other hcp. A 60-year-old female patient ...
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Very tired; This is a spontaneous report from a contactable other hcp. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm on 12Jan2021 14:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]). The patient experienced very tired on 12Jan2021 with outcome of recovering. Information on the lot/batch number has been requested.
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| 60 | 2021-01-25 | headache, fatigue | Very fatigued, HA, Body aches, symptoms resolved within 48 hours |
| 60 | 2021-01-25 | headache, fatigue |
Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizz...
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Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizziness, and horrible fatigue. Feeling out of it.
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| 60 | 2021-01-25 | headache |
body aches; major headache all night long, all over her head. It was a pressure headache; This is a ...
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body aches; major headache all night long, all over her head. It was a pressure headache; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: E49899), via an unspecified route of administration in the right deltoid on 18Dec2020 10:30 at a single dose for COVID-19 immunization. The patient's medical history included wolff-parkinson-white syndrome (WPW syndrome) from 2000, heart surgery from 2000, and allergic to sulfa with hives. Mother is diabetic and sister is prediabetic. There were no concomitant medications. On an unspecified date, she experienced body aches. She took paracetamol (TYLENOL). She also had major headache all night long, all over her head. It was a pressure headache. Someone gave her ibuprofen (MOTRIN) and within 3 hours she was totally fine. Outcome of the body aches was unknown and of the headache was recovered on an unspecified date.
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| 60 | 2021-01-25 | nasal congestion |
Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestio...
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Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestion; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown, vaccine location: right arm), intramuscular on 04Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included hypertension/high blood pressure controlled, GERD/acid reflux, fast heart rate, and prediabetic. Concomitant medications included losartan, metoprolol, gemfibrozil (LOPID), aspirin [acetylsalicylic acid], atorvastatin, vitamin D3, zinc, magnesium, ascorbic acid (VIT C), vitamin B complex (VIT B COMPLEX), alpha-d-galactosidase (BEANO), angelica keiskei leaf, sambucus nigra extract (SAMBUCOL), and unspecified stress supplement. The patient is not pregnant. The patient received a flu shot administered on the right arm on 28Oct2020 and pneumo vacc administered on the left arm on 28Oct2020. The patient received no other vaccine in four weeks. The patient had no COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: COVID PCR) on 22Dec2020 with result negative. On 04Jan2021 13:15, the patient experienced bumpy red rashes in arms and legs, shortness of breath, mild chest pain, severe dizziness, and congestion. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering. Information about lot/batch number has been requested.
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| 60 | 2021-01-25 | fever, chills, headache | Fever 103.5, shaking chills, headache, pain in chest on inspiration |
| 60 | 2021-01-25 | fever, chills |
Slight fever, 99.2, with chills and muscle aches. Event occurred about 2:00 am on 01/26/2021. I took...
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Slight fever, 99.2, with chills and muscle aches. Event occurred about 2:00 am on 01/26/2021. I took a Tylenol went back to bed. No fever upon waking. Minor muscle aches and mild soreness at injection site.
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| 60 | 2021-01-25 | throat irritation, headache |
Pfizer-BioNTech COVID- 19 Vaccine EUA Symptoms included exacerbated blood pressure of 200/90, chest...
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Pfizer-BioNTech COVID- 19 Vaccine EUA Symptoms included exacerbated blood pressure of 200/90, chest tightness, itching throat, and headache,
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| 60 | 2021-01-26 | cough |
C/o muscle aches, calf cramps, (B) feet numbness, cough, nausea, diarrhea, all began after #2 vaccin...
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C/o muscle aches, calf cramps, (B) feet numbness, cough, nausea, diarrhea, all began after #2 vaccine. No problems with #1 vaccine Tx antiemetic, H2 blocker, anti histamine, Tylenol push fluids
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| 60 | 2021-01-26 | headache, chills |
Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that c...
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Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that caused chest discomfort. Nothing concerning, just more curious. With second vaccine, developed chills within one hour and went to bed. Upon awakening, had headache, nausea, chills, kidney area pain, chest discomfort from irregular heart beat. This resolved for about 18 hours, then started again and lasted for 1 week. Chest pain became sharp at times spreading to arm with mild shortness of breath. Having had a full heart workup last year, did not pursue tests. wanted to see if would pass on it's own. After one week, only have occasional chest discomfort. Arrhythmia has returned to baseline occasional PVC. No further chills, headache, nausea or other pains.
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| 60 | 2021-01-26 | headache |
like an anaphylactic reaction but not in her throat; itching and inflammation, in eyes as well/eyes ...
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like an anaphylactic reaction but not in her throat; itching and inflammation, in eyes as well/eyes were swollen and itchy; itching and inflammation, in eyes as well; swelling on her eyes and itching on her eye lids; swelling on her eyes and itching on her eye lids; welts; whelps on her hip, inflamed and itchy/general arthritis symptoms; Headache dull; shingle like rash on tailbone, genital area / raised itchy rash on the tailbone like shingles; itching on her face that she couldn't see / raised itchy area on her left cheek and eyes; rash / rash down her thighs/rash that was across her body; rash vulva; swelling / vulva was swollen; itching / itching around the genital area, vulva; itching / itching around the genital area, vulva; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse (patient) worked in outpatient mental health reported that a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, Expiry Date: Apr2021) via an unspecified route of administration on 04Jan2021 at 16:20 in the left arm at single dose for COVID-19 vaccination. Vaccine administered at hospital and not military facility. No additional vaccines administered on same date of the Pfizer suspect. Medical history included ongoing Graves' disease (the patient had her thyroid irradiated away for Grave's disease 25 years ago). Family Medical History was none. Concomitant medication included ongoing levothyroxine 1.25 mcg once daily by mouth Graves' disease taking for 25 years. Prior vaccination within 4 weeks was none. The patient received her Pfizer COVID 19 vaccine on 04Jan2021. Since then she started to experience a genital itch immediately; a rash that was across her body; eyes were swollen and itchy; new itchy rash 13Jan2021. She felt okay going home then she started to have itching around the genital area. She thought she might have a yeast infection but she didn't have any other symptoms for a yeast infection. Her vulva became swollen from 05Jan2021 and itchy from 04Jan2021 and she noticed rash around her body. It all started in the genital area. The next day the rash spread down her thighs and she noticed an itchy place on her face, but you couldn't see it. Her thighs were inflamed and she noticed patches of angry whelps on her hips as well as a itchy rash area on her tailbone that seemed more like shingles; size of a quarter; raised, itchy, rash, that felt like it was radiating out. Then she noticed the rash on her face on her cheek, general swelling on her eyes and itching on her eye lids. Now the genital itching was less and most of her symptoms were improved but her eye was driving her crazy and it was more swollen on the outside. She tried to treat her eyes with eye drops Dry Eye Relief (manufacturer Similasan; no UPC seen, lot number: 15942; expiration date: Sep2022, ingredients include Belladonna) but it didn't help. They were still itchy and weepy. The eye drops were not working. She also treated the rash and itching with Benadryl at night and it improved the symptoms overall. She took Tylenol (UPC 300043760; lot number: PMA003; expiration date: Aug2022) and Bayer Aspirin (81mg; lot number: NAA93E1; expiration date: Feb2023. No UPC code on bottle) every day for general arthritis symptoms, but they didn't touch her dull headache she has had on and off since the vaccine. Before she got the vaccine, she had a little tag on her vulva, it was tiny. Now after experiencing the itching, swelling, rash on her vulva, the tag was gone. It just took a layer of skin right off. It was not uncomfortable but the whole layer of the skin was gone. It was very uncomfortable while it was happening but now it was okay. When she noticed these symptoms, she tried to call occupational health and a institute but didn't get anyone. She also contacted her HCP but had not heard back. It seemed to her like a lot of side effects and a lot of itching. She didn't have it in her throat, but all that itching seems a lot like an anaphylactic reaction. She was curious whether we would recommend her to take the second dose since they say the reaction to the second dose was worse. She had multiple COVID tests that have all come back negative. A friend tested positive so she had a test; and she had a test when she traveled. The events did not require a visit to physician or emergency room. The patient had reactions: itching, rash, swelling, welts, shingle like rash on tailbone, genital area, hips moving to her face, itching and inflammation, in eyes as well. She wanted to know if the 2nd dose was recommended. It was "like an anaphylactic reaction but not in her throat." itching around the genital area, vulva started from 04Jan2021, vulva was swollen started from 05Jan2021; Rash vulva started from 06Jan2021 to 10Jan2021; rash down her thighs started from 07Jan2021; Raised itchy rash on the tailbone like shingles started from 06Jan2021, whelps on her hip, inflamed and itchy from 07Jan2021; itching on her face that she couldn't see started from 06Jan2021; raised itchy area on her left cheek and eyes started from 07Jan2021; Headache dull started from 06Jan2021. The events Headache dull, itching on her face that she couldn't see; whelps on her hip, inflamed and itchy and raised itchy rash on the tailbone like shingles were reported as non-serious by the reporter and other events were considered as medical significant by the reporter. Investigation assessment for the events was reported as No. The outcome of the event anaphylactic reaction, inflammation in eye, welts was unknown, outcome of the event Rash vulva was recovered on 10Jan2021; of Headache dull, swelling eye was not recovered, of other events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 60 | 2021-01-26 | nasal congestion, runny nose |
allergy like symptoms/allergy; nose running; congested and blockage in her nose; shortness of breath...
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allergy like symptoms/allergy; nose running; congested and blockage in her nose; shortness of breath; couldn't sleep during the night; burning sensation in her chest; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on the upper left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. The patient reported that she took it yesterday and an hour into it she started having a burning sensation in her chest. What happen next, around 8pm, she started having allergy like symptoms that lasted throughout the night. She was experiencing nose running, congested and blockage in her nose, and shortness of breath. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. For treatment, she took Mucinex tablets for allergy. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. This was the first dose, her second dose is due on 02Feb2020 and she wants to know if she can skip it. Before she got it she contacted her primary care due to having allergies before the vaccine and asked if she should take; she was told to hold on but then she went ahead and took it. Within the first 30 minutes she was ok but in an hour is when she had the burning sensation in her chest. The burning sensation lasted about an hour. The dose was administered around 4pm on 12Jan2021.The caller reports that the Mucinex and she has breathing treatment, nebulizer treatments for her lungs, that she did and these things helped. Early this morning she felt she can now close her mouth and breathe normally. It was administered in the upper left arm. She did not require a visit to the doctor or ER. The patient has had no reactions to vaccines in the past nor were any administered on the day of or within the prior 4 weeks. Therapeutic measures were taken as a result of allergy like symptoms, congested and blockage in her nose and shortness of breath which included Mucinex. The patient recovered from burning sensation in her chest on 12Jan2021, from allergy like symptoms/allergy and shortness of breath on 13Jan2021 while the outcome of the other events was unknown. Information on the lot/batch number has been requested.
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| 60 | 2021-01-27 | chills | Red, warm rash around injection site cold sweat, chills, and swelling to Left arm |
| 60 | 2021-01-27 | chills |
Muscle pain; Chills; Nausea; This is a spontaneous report from a contactable consumer. A 60-year-old...
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Muscle pain; Chills; Nausea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in left upper arm on 11Jan2021 around 3:45-4:00pm at a single dose for COVID-19 vaccination. Medical history included hypothyroidism. Concomitant medication included levothyroxine from 2006 for hypothyroidism. The patient was administered the first dose of Pfizer-BioNTech COVID Vaccine on 11Jan2021 at work. On 12Jan2021, the patient experienced muscle pain, chills, nausea. The outcome of the events was not recovered. The patient underwent rapid COVID-19 nasal swab test and the result was negative on 12Jan2021. Second dose scheduled to be administered on 01Feb2021 with no dose change made. Information on the Lot/batch number has been requested.
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| 60 | 2021-01-27 | fatigue, fever |
Had normal site pain, fatigue and began running fever of about 100.0 the evening of injection howeve...
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Had normal site pain, fatigue and began running fever of about 100.0 the evening of injection however the fever has continued x7 days, getting as high as 101.9. I began noticing soreness in the lymph nodes in my neck and underarms on the evening of 1/25 and that lasted until midmorning of 1/27.
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| 60 | 2021-01-27 | fatigue | body aches and fatigue lasting 48 hours after the vaccination |
| 60 | 2021-01-27 | headache | significant headache |
| 60 | 2021-01-28 | body temperature increased | My wife had a temperature of 102 and has since gone down a little bit to 101. |
| 60 | 2021-01-28 | chills, headache, fatigue |
Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneo...
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Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:15 (at the age of 60-years-old) at a single dose for COVID-19 immunization. Medical history included arthritis (knees), sulfa drugs allergy, poison ivy allergy (severe), and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) and furosemide (LASIX). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain on 16Jan2021 at 13:00. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative (test name: Binex) on 12Jan2021 and COVID-19 test: unknown results (post vaccination) on an unspecified date. Therapeutic measures were taken as a result of the events, which included naproxen sodium (ALEVE); it was reported that the treatment did not work. The clinical outcome of headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain was unknown. The batch/lot number for the vaccine, BNT162B2, was provided and has been requested during follow up.
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| 60 | 2021-01-28 | cough |
After my vaccine, started coughing so bad. I had a Covid test which was negative and they gave me an...
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After my vaccine, started coughing so bad. I had a Covid test which was negative and they gave me antibiotics. They also gave me an inhaler for my wheezing. I also felt a tightness sensation in my chest and lungs from all the coughing.
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| 60 | 2021-01-28 | cough |
itchy, swollen soft pallet, need to cough started approx. 15 mins after vaccine given and continued ...
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itchy, swollen soft pallet, need to cough started approx. 15 mins after vaccine given and continued and plateaued for hour and half. Benadryl and prednisone given in ED. Monitored and D/C with no further progression of sx.
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| 60 | 2021-01-28 | fatigue, fever | FEVER AND FATIGUE |
| 60 | 2021-01-28 | headache, chills, fatigue, fever | Chills, Fever, Headache, Fatigue, Body aches;12 hrs duration; treated with Tylenol |
| 60 | 2021-01-28 | headache, fever | 101 fever, body aches, headache, joint aches |
| 60 | 2021-01-28 | headache |
Moderate Swelling and pain under right axilla Redness swelling at site Nausea Aches Abdominal pain ...
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Moderate Swelling and pain under right axilla Redness swelling at site Nausea Aches Abdominal pain Headache
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| 60 | 2021-01-28 | malaise, fatigue |
day 5 vertigo just morning dizziness all day better the next day. very tired no energy feeling cru...
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day 5 vertigo just morning dizziness all day better the next day. very tired no energy feeling crummy, migraines by day 6, 7 and 8... worst than normal and lasting longer than normal. usually get relief after 1 dose but it would take at least 2 before feeling somewhat better. some diarrhea, body aches. pain in my left arm and side around lung area. had chest x-ray on 1-11-21 clear. this all lasted until 1-27 or 1-28 felling a lot better today 1-29-21.... these are all the symptoms i had when i had covid in Nov. it was like having it all over again......
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| 60 | 2021-01-28 | malaise, headache, cough, fever, chills, fatigue |
I received the vaccine at approximately 8:10 a.m. Approximately 12 hours post-injection, I began to ...
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I received the vaccine at approximately 8:10 a.m. Approximately 12 hours post-injection, I began to feel malaise and fatigue. Upon waking around midnight, I had developed a 102.4 degree (F) fever, total body ache, headache, chills, and cough. Most symptoms lasted approximately 24 hours. The headache, although now mild, persists into the third day. On the third morning following the injection, I woke to find a slightly painful triangular-shaped red, raised patch on the same arm as the injection (left). The "rash" measures approximately 4.5 cm x 7 cm.
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| 60 | 2021-01-28 | nasal congestion, influenza like illness, headache |
FLU LIKE SYMPTOMS STARTED 3AM 1/29/2021 WITH GENERALIZED BODYACHE, LEFT AXILLARY PAIN, TENDER LEFT C...
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FLU LIKE SYMPTOMS STARTED 3AM 1/29/2021 WITH GENERALIZED BODYACHE, LEFT AXILLARY PAIN, TENDER LEFT CERVICAL NODES, HOT AND COLD FLASHES AND HEADACHE. NASAL CONGESTION.
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| 60 | 2021-01-28 | nasal congestion | nasal congestion. chest congestion. chest discomfort. Has been persistent to today 1/29/21. |
| 60 | 2021-01-29 | chills, headache, nasopharyngitis, fatigue |
Headache, cold chills, body ache started about 10:00am on 1/29/2021. It is now 1/30/2021 @ 7:56pm a...
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Headache, cold chills, body ache started about 10:00am on 1/29/2021. It is now 1/30/2021 @ 7:56pm and still have a headache and feel tired as have been all day.
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| 60 | 2021-01-29 | fatigue, runny nose, body temperature increased, nasal congestion |
Temperature of 100.7, chilling, tired, brain fog, runny/stuffy nose. Took Tylenol and rested. Felt ...
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Temperature of 100.7, chilling, tired, brain fog, runny/stuffy nose. Took Tylenol and rested. Felt fine the next morning.
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| 60 | 2021-01-30 | headache |
Headache from approximately 1300 to 2000. I took naproxen at 1600 which did not help headache. Fel...
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Headache from approximately 1300 to 2000. I took naproxen at 1600 which did not help headache. Fell asleep at 2000. Headache gone next morning.
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| 60 | 2021-01-31 | fatigue, malaise, headache |
nose bleed/kind of "blew like a quarter size of blood clot"; congestion in her throat; headache; tir...
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nose bleed/kind of "blew like a quarter size of blood clot"; congestion in her throat; headache; tired, very tired and just wanted to sleep; nausea, some nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140 and expiry date unknown) via unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization on her job (nursing home). Medical history included blood pressure high. Concomitant medications vitamins. The patient took that COVID-19 vaccine shot yesterday (later clarified the date as 14Jan2021) on her job. The patient informed that she was okay the first day, but yesterday (15Jan2021) last night she had some new problems and she wanted to talk about and see it's a clinical sign. The patient informed that it was headache, tired, very tired and just wanted to sleep. The patient had no swelling/no swelling in arm, nausea, some nausea and even she has been just feeling unwell. The patient informed that today (16Jan2021) this morning, she was having nosebleed until the last time she felt like congestion in her throat and she kind of "blew like a quarter size of blood clot". The patient blew her nose and it bled a while, but then a quarter size blood clot come out and since then it wasn't bleeding, her nose was not bleeding. The patient did not receive treatment due to the events. The patient underwent lab tests and procedures which included COVID testing; swab the nose: negative on 13th or maybe 14th (Jan2021). The outcome of the events headache, tired, very tired and just wanted to sleep, nausea, some nausea, feeling unwell, nose bleed/kind of "blew like a quarter size of blood clot", congestion in her throat was unknown.
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| 60 | 2021-01-31 | headache, fever, chills |
6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days...
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6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days later 12 hrs after vaccination: Nausea, vomiting, headache, body aches, fever (100.7 at peak), chills. Lasted approximately 36 hours. 48 hours after vaccination: vaccinated arm has tingling sensation and weakness when raised, armpit lymph nodes tendor/sore - still have this symptom 3 days later. Took Aleve to alleviate symptoms. It lessened them somewhat but I was still not able to function fully for several days.
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| 60 | 2021-02-01 | fatigue, headache, chills, fever |
Received Phizer vaccine dose #2 Tuesday 1/26/21 at 0915. Feverish and tired at 6pm(8hrs 45 min lat...
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Received Phizer vaccine dose #2 Tuesday 1/26/21 at 0915. Feverish and tired at 6pm(8hrs 45 min later) Wed 1/27/21 5am fever, aches, chills, foggy, slight headache, exhausted. Wed 1/27/21 7pm exhausted, foggy Thurs 1/28/21 5am exhausted, foggy, no reserve Fri 1/29/21 5am tired, foggy Sat 1/30/21 Much better.
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| 60 | 2021-02-01 | headache, chills, fever |
Developed chills, a low grade fever and headache on same day of her vaccination. The next day, she ...
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Developed chills, a low grade fever and headache on same day of her vaccination. The next day, she developed an itchy rash on her left arm which became panful. She saw her PCP who diagnosed shingles.
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| 60 | 2021-02-01 | headache, fever |
FEVER FOR ABOUT 24 HOURS, HEADACHE FOR ABOUT 24 HOURS AND LEFT ARM RED AND WARM TO TOUCH FOR 36 HOU...
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FEVER FOR ABOUT 24 HOURS, HEADACHE FOR ABOUT 24 HOURS AND LEFT ARM RED AND WARM TO TOUCH FOR 36 HOURS
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| 60 | 2021-02-01 | headache |
headache, joint & bone pain, red lump at injection site, injection site warm to the touch, soreness ...
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headache, joint & bone pain, red lump at injection site, injection site warm to the touch, soreness at injection site, some wheezing 40 x 40 mm
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| 60 | 2021-02-01 | fever, chills, headache |
Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On ...
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Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On 1/25/21 I also had fever (highest was 101.4), chills, weakness, and aching bones. I also had a terrible headache that started 1/20 and lasted until 1/ 28 or 1/29. There was the normal injection site soreness on the evening of the first day.
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| 60 | 2021-02-01 | fever, fatigue, headache, chills |
Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, s...
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Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, sensitive to touch, movement and unable to lift arm beyond 45 degree angle. 17 hours after vaccine chills, fever of 102, muscle aches, severe headache, fatigue. 53 hours after vaccine, fever 101, severe headache, muscle aches, fatigue. Arm pain much less severe.
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| 60 | 2021-02-01 | fever, headache, fatigue, malaise |
Received vaccine #1 Phizer on Jan 5th 2pm. Started to feel tired by 7pm. 5am woke up achey with gene...
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Received vaccine #1 Phizer on Jan 5th 2pm. Started to feel tired by 7pm. 5am woke up achey with general malaise. Took Tylenol 500mg and came to work. I started the attestation form and called employee health to let them know about my aches. They recommended me getting tested for Covid 19 in which I did before I left at 8:30am. My health continued to decline as I became ferverish, with a headache, nauseas, foggy, and exhausted. When I got home, I couldn't get off the couch. I felt horrible for 36hrs. My headache lasted for 5 days. Covid 19 test and flu test negative.
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| 60 | 2021-02-01 | fever, headache |
Rash raised, red, warm, and itchy in area covering about 7 cm underneath injection site. This starte...
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Rash raised, red, warm, and itchy in area covering about 7 cm underneath injection site. This started on Feb. 2. Also had fever of 100 degrees, body aches, headache for about 36 hours, it started 12 hours after I received the vaccine.
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| 60 | 2021-02-01 | fever, throat pain, headache, fatigue, sleepiness |
Fatigue; headache; earache; sore throat; fever of 101.4 for 24 hours; Diarrhea; Could do nothing but...
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Fatigue; headache; earache; sore throat; fever of 101.4 for 24 hours; Diarrhea; Could do nothing but sleep; administration date=15Jan2021 (dose number: 2); administration date=23Dec2020 (dose number=1); This is a spontaneous report from a contactable other health professional (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on 15Jan2021 at 13:30 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included allergies when younger, known allergies to wheat, dairy, cats, and mold. There were no concomitant medications. The patient previously took levofloxacin (LEVAQUIN) and nitrous oxide and experienced allergies; also had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231) on 23Dec2020 at 11:30 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 15Jan2021, the patient experienced fatigue, headache, earache, sore throat, and fever of 101.4 for 24 hours, and diarrhea. The patient could do nothing but sleep. The patient did not receive any treatment for the reported events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.
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| 60 | 2021-02-01 | fever, throat pain |
10 days after vaccine(1-31-20) I felt flushed in my face and sore throat. My temp was 99.5 which is ...
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10 days after vaccine(1-31-20) I felt flushed in my face and sore throat. My temp was 99.5 which is abnormal for me because my normal is 96.5-97. I called my employer and had COVID test on 1-2-21 negative. Employer instructed me to go to get flu A and B test and strep test which were all negative on 1-3-21. On 1-5-21 had second covid test that was negative. On 1-6-21 video visit at PCP since I wanted to be released to go back to work. Had CXR(negative) and started doxycyline 100mg for possible sinus infection. Flushing sensation stopped on 1-9-21. No flushing sensation until 1-22-21(10 days after 2nd vaccine) but temp 98.5 at highest and I continue to have today. I continued to work through this second episode since I believe it was my body's reaction to the virus.
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| 60 | 2021-02-02 | headache |
Prolonged HA starting after receiving Pfizer COVID-19 vaccine on 29 Dec 2020-over 2 weeks. No fever/...
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Prolonged HA starting after receiving Pfizer COVID-19 vaccine on 29 Dec 2020-over 2 weeks. No fever/nausea/vomiting/photophobia/visual disturbances. Felt like a constant "vice grip". Not relieved with NSAIDS. Has a history of occasional migraines, but this HA presenting very differently. Resolved after 2 weeks. She did receive dose 2 on 1/19/2020 without recurrence of HA or ant concerning side effects.
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| 60 | 2021-02-02 | headache |
Was okay Friday morning then stomach started getting upset Friday night and I tried to eat food to c...
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Was okay Friday morning then stomach started getting upset Friday night and I tried to eat food to calm down. A slight headache was starting. The next morning I had a massive headache all day Saturday, by 8 PM it was a full-fledged nauseating migraine. The severe migraine lasted from 8 PM the previous night to 10 PM on Sunday night. By Monday I was doing better but a bit confused and having difficulty thinking. Now it is Wednesday and I am a bit exhausted and still having trouble thinking but doing so so much better! I am so happy to be feeling better!
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| 60 | 2021-02-02 | sweating | Pt reports feeling "out of body", lightheaded, impending doom, nauseated and diaphoretic. |
| 60 | 2021-02-03 | chills, fever, fatigue |
I had covid Sept 26th 2020.The day after the second shot I had covid symptoms. Seven days later I st...
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I had covid Sept 26th 2020.The day after the second shot I had covid symptoms. Seven days later I still have chills,fever,muscle aches and fatigue. I am going for a covid test today.I have missed days of work due to this vaccine.
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| 60 | 2021-02-03 | chills, fever |
Starting about 30 minutes after the injection she had nausea and occasional dizziness. About 12 hour...
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Starting about 30 minutes after the injection she had nausea and occasional dizziness. About 12 hours later she began having fever, chills and muscle aches. Fever improved with Motrin.
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| 60 | 2021-02-03 | chills |
chills/major chills and could not warm up; was cold all night; This is a spontaneous report from a c...
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chills/major chills and could not warm up; was cold all night; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the right arm on 11Jan2021 15:00 at single dose for COVID-19 immunisation. Medical history included allergies to sulfa. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included citalopram, topiramate, zinc, and ergocalciferol (VIT D). On 12Jan2021 07:00, the patient started having chills in the morning that was gradually increasing throughout day. At 6:00pm, that patient had major chills and could not warm up. The patient got into the bed with numerous covers. She was cold all night. The last time she woke up was at 3:00am, and then when she woke at 6:00am, and she was fine. No treatment was received for feeling cold. Clinical outcome of the events was recovered on an unspecified date. Information about lot/batch number has been requested.
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| 60 | 2021-02-03 | chills | Rigors that lasted about 10 minutes at around 45 mins to 1 hour post vaccine. Elevated heart rate. |
| 60 | 2021-02-03 | fatigue, headache |
I got up and had a really bad headache and fatigue. I did not go to work due to the headache. I to...
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I got up and had a really bad headache and fatigue. I did not go to work due to the headache. I took a Tramadol, got an ice pack, placed it on my head and put some lavender on my pillow, called into work and went back to bed. I still have the headache and fatigue, but I am able to work so far.
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| 60 | 2021-02-03 | headache |
light headed; vertigo; feel flushed; headache; This is a spontaneous report from a contactable healt...
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light headed; vertigo; feel flushed; headache; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=ELC142) via intramuscular on 13Jan2021 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. Medical history included allergies: Reactive airway to chemicals/perfumes/smoke. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), calcium, fish oil, echinacea purpurea root, olea europaea leaf, sambucus nigra fruit (ELDERBERRY ECHINACEA & OLIVE LEAF). The patient previously received first dose of BNT162B2 (lot number=EJ1685) via intramuscular on 23Dec2020 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. No other vaccine in four weeks. On 13Jan2021, the patient had a headache in the evening and took Ibuprofen before bed. She woke up about 3:30 AM 14Jan2021 to use the bathroom and had vertigo. She carefully maneuvered to the bathroom and back to the bedroom, drank some Powerade and sat on the bed for a bit before she slowly laid back down. She did feel flushed while experiencing the vertigo. She was able to get back to sleep for a few more hours. When she got up about 7:15 am she felt light headed but did not have any more vertigo. Treatment for event headache included Ibuprofen, no treatment received for other events. Patient did not have COVID prior vaccination, did not test COVID post vaccination, patient was not pregnant. The outcome of events was recovered.
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| 60 | 2021-02-03 | lethargy, headache, chills |
11pm evening of shot woke with body aches. Approx. 2am woke again with extreme chills, headache & na...
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11pm evening of shot woke with body aches. Approx. 2am woke again with extreme chills, headache & nausea. Somewhat lethargic throughout the day but no symtoms other than slight headache. Woke the next morning at 3am with extreme chills again. Seem to feel ok but not 100% today.
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| 60 | 2021-02-04 | chills, headache, fever |
After less then 48 hours I woke up with diarrhea. Then I started throwing up followed by severe chil...
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After less then 48 hours I woke up with diarrhea. Then I started throwing up followed by severe chills & body aches, a fever & a headache
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| 60 | 2021-02-04 | fatigue, throat pain, headache |
Radiating pain the first night in the arm and in the muscle behind her breast. Continual head ache w...
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Radiating pain the first night in the arm and in the muscle behind her breast. Continual head ache with fatigue and sore throat swollen glands since the vaccine in the evenings.
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| 60 | 2021-02-04 | headache | headache dizziness |
| 60 | 2021-02-04 | fever, chills |
1/12 vaccine 1/13 woke up at 5-6am, shaking, chills, fever, dizziness and vertigo. ER later that da...
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1/12 vaccine 1/13 woke up at 5-6am, shaking, chills, fever, dizziness and vertigo. ER later that day; blood work. Declined IV fluid. Monitored vitals. Body aches continued that weekend, went back to work the 14-15th but 'pushed it' to go back. 1/17 ER - blood panel; negative. Admitted to Inpatient to monitor heart and MRI of brain. still experiencing dizziness, 'disorientated'
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| 60 | 2021-02-04 | fever, headache |
12 hours after shot, all over body aches, sore arm and shoulder, fever. Shortly after, a headache o...
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12 hours after shot, all over body aches, sore arm and shoulder, fever. Shortly after, a headache occurred. The symptoms lasted all day and were mostly gone except for a small headache and fuzzy brain after 30 hours. All clear after about 36 hours.
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| 60 | 2021-02-06 | fatigue, headache, sleepiness, body temperature increased |
One hour after receiving the shot I was extremely exhausted. Slept for 5 hours. Woke up with 99.8. F...
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One hour after receiving the shot I was extremely exhausted. Slept for 5 hours. Woke up with 99.8. Felt like I had been drugged. Next day felt groggy with headache.
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| 60 | 2021-02-06 | fatigue, headache |
High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking ...
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High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking on the outside. Headache & extreme stomach pain. Which all of this has made it to where I'm unable to work.
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| 60 | 2021-02-07 | chills, fever | Fever 100.2F; chills, nauseous, weakness |
| 60 | 2021-02-07 | fatigue, chills |
injection site pain; chills; muscle aches; fatigue; Rash on torso, arms; This is a spontaneous repor...
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injection site pain; chills; muscle aches; fatigue; Rash on torso, arms; This is a spontaneous report from a non-contactable other hcp (patient). A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 14:30 at single dose in Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Medical history was none. Concomitant drug received within 2 weeks of vaccination included Multivitamin. The patient previously received first dose of BNT162B2 on 29Dec2020 03:15 PM at single dose in Left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After 6 hrs on 19Jan2021 21:00 PM, the patient experienced injection site pain. After 12 hrs the patient experienced chills, muscle aches, fatigue in Jan2021. The patient experienced Rash on torso, arms 36 hours after in Jan2021. The outcome was Recovering. No treatment received for events. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible, information about batch number cannot be obtained.
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| 60 | 2021-02-07 | headache, fatigue |
Swollen glands; severe headache; muscle pain; extremely tired; body hurts; This is a spontaneous rep...
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Swollen glands; severe headache; muscle pain; extremely tired; body hurts; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number El3248/expiration date: unknown), via unknown route of administration, on 09Jan2021 12:30 PM (at the age of 60 years old) as a single dose on left arm for COVID-19 immunisation for COVID-19 immunisation at a Public Health Clinic/Veterans Administration facility. Relevant medical history included breast cancer last year. The patient had no allergies to medications, food or other products. Relevant concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient experienced swollen glands, severe headache, muscle pain, extremely tired, body hurts on 14Jan2021. The outcome of the events swollen glands, severe headache, muscle pain, extremely tired, body hurts was not recovered. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19.
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| 60 | 2021-02-07 | headache, fever |
high fever/100.1 degrees Fahrenheit/100.8 degrees Fahrenheit/99.8 degrees Fahrenheit; arm swelling; ...
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high fever/100.1 degrees Fahrenheit/100.8 degrees Fahrenheit/99.8 degrees Fahrenheit; arm swelling; arm was very sore; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via an unspecified route of administration in left arm on 20Jan2021 15:15 at single dose for COVID-19 vaccination. Medical history included ongoing coeliac disease diagnosed four years ago in 2017, allergic to dairy and corn, COVID in Nov2020. There were no concomitant medications, no other recent vaccinations and had started no new medications. The patient had a reaction with a high fever, a headache, and her arm was very sore after vaccination, that were similar to how she felt when she had COVID in Nov2020. The patient's arm was swollen and sore that evening on 20Jan2021. Her first fever was yesterday morning on 21Jan2021, probably at about 10:00AM or 11:00AM, and at that time it was 100.1 degrees Fahrenheit then later in the afternoon at 02:00PM it was 100.8 degrees Fahrenheit. She took Tylenol, applied cold moist cloth, drank lots of liquid for treatment, and she did sleep. Tylenol was clarified to be generic pain reliever, Acetaminophen 500mg. Acetaminophen 500mg, EXP Apr2021, LOT P114992, UPC: 1191717759. Her temperature improved after taking this medication, and it was 99.8 degrees Fahrenheit before bed. She hadn't taken any Acetaminophen this morning on 22Jan2021, but she took two tablets the first time yesterday on 21Jan2021 and then one tablet right before bed. She didn't go to the doctor for this. The outcome of events was unknown.
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| 60 | 2021-02-07 | headache |
Severe headache; This is a spontaneous report from a contactable consumer. A 60-year-old female pat...
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Severe headache; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3249), via an unspecified route of administration on 14Jan2021 05:15 at single dose on left arm for COVID-19 immunisation. Medical history included diabetes. Patient had no known allergies to medications, food, or other products. The patient's concomitant medications included metformin. The patient experienced severe headache on 14Jan2021 with outcome of unknown. No treatment was received for the event. Since the vaccination, the patient had been tested for COVID-19 on 14Jan2021 with unknown result. This case was reported as non-serious.
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| 60 | 2021-02-07 | fever |
Had a very mild case of COVID in November. Slight muscle tenderness for 1 day after first shot. Ha...
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Had a very mild case of COVID in November. Slight muscle tenderness for 1 day after first shot. Have had same symptoms as COVID but much worse after 2nd shot. Symptoms started Day 4 after vaccine and continue today. Running fever for 5 days now. Still sick. Flu test was negative although I doubted it was anything else since I rarely get sick and when I do it only lasts a day or two. Will have a few hours where I finally think I am getting better and then another wave hits.
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| 60 | 2021-02-07 | sinus headache |
Sinus headache; Can feel the sinuses draining; This is a spontaneous report from a contactable consu...
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Sinus headache; Can feel the sinuses draining; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included sinus issues from the past couple of days from an unknown date. Concomitant medications were not reported. It was reported that the patient woke up with a sinus headache, but as the day went on, it's gotten worse and she can feel the sinuses draining. She reported she got the 1st dose of the COVID-19 vaccine at the morning of the report. Outcome of the events was unknown. Information on the batch/lot number has been requested.
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| 60 | 2021-02-07 | sluggishness, headache, chills, lethargy |
Started to feel achy, then it got worse; very painful. Some nausea, chills, headache, lethargic. Mos...
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Started to feel achy, then it got worse; very painful. Some nausea, chills, headache, lethargic. Most symptoms gone in 20 hrs. After that a few days feeling sluggish.
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| 60 | 2021-02-07 | sleepiness |
12/22 Vaccination 4 hours later, chest pain. Felt heavy. Got extremely sleepy. I tried to lay down,...
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12/22 Vaccination 4 hours later, chest pain. Felt heavy. Got extremely sleepy. I tried to lay down, episode of syncope. Chest discomfort. ER for observation
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| 60 | 2021-02-08 | influenza like illness, chills, headache |
her face got swollen; lymph node right there it was extremely swollen and very tender and very painf...
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her face got swollen; lymph node right there it was extremely swollen and very tender and very painful; She had a lump at the site of the injection; chills; headache; flu like symptoms; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL8982) vaccine , via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation . Medical history included hypertension. Concomitant medication included telmisartan (MICARDIS). On 30Dec2021 the patient received the first dose of BNT162B2 vaccine. The patient experienced her face got swollen on an unspecified date with outcome of unknown , lymph node right there it was extremely swollen and very tender and very painful on an unspecified date with outcome of unknown , she had a lump at the site of the injection on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of unknown , flu like symptoms on an unspecified date with outcome of unknown. The events swollen face and lymph adenopathy were considered important medical Events. The remaining events were considered non serious. The patient stated she got the second vaccine shot of Pfizer on Wednesday the 20Jan2021. She got like a weird side effect like under her armpit it got really swollen and painful, like the lymph node right there it was extremely swollen and very tender and very painful. It still is but not as much. The next day the right side of her face was swollen The patient received Tylenol as treatment for the events. Follow up information has been requested.
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| 60 | 2021-02-08 | paranasal sinus discomfort, respiratory tract congestion, headache, fatigue, cough |
Tested Positive on day 19 after the 2nd dose. Case starting having symptoms early Sunday morning wit...
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Tested Positive on day 19 after the 2nd dose. Case starting having symptoms early Sunday morning with a really bad headache and sinus pressure. Now has cough and fatigue. Headache is starting to get better. Cough and congestion is not.
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| 60 | 2021-02-08 | fever |
left upper arm redness and swelling. She reports she got the second Pfizer COVID-19 vaccine on Mond...
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left upper arm redness and swelling. She reports she got the second Pfizer COVID-19 vaccine on Monday 2/1. She reports the area is red right after the vaccine. She reports she has had increased swelling, redness, warmth. She reports she did have reaction to her first vaccine with redness and swelling, but that occurred 10 days after. She reports she has had some fever and body aches that she associates with having the second vaccine. Constitutional: Negative for chills and fever. HENT: Negative for sore throat. Eyes: Negative for visual disturbance. Respiratory: Negative for cough and shortness of breath. Cardiovascular: Negative for chest pain. Gastrointestinal: Negative for abdominal pain, nausea and vomiting. Genitourinary: Negative for dysuria. Musculoskeletal: Positive for joint swelling and arthralgias. Negative for back pain. Skin: Positive for color change. Negative for rash. Neurological: Negative for weakness and numbness.
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| 60 | 2021-02-09 | cough, fever |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous re...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer reported for herself. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL3249, exp.date May2021 on 15Jan2021 16:00 at single dose for COVID-19 immunization, via unspecified route of administration at the left arm. The patient had get earlier in January a DPT (diphtheria, pertussis, and tetanus) vaccine in the left arm. The patient had have a Pneumonia and Shingles vaccines in the last 2 years and she had no problems in past with vaccines, but stated she did get a little bit of swelling and had to put heat to the area with vaccines, but never had a fever afterwards. The patient had not medical history. Concomitant medications were not reported. No other vaccines given the same day. Since 16Jan2021, he started having symptoms, fever, cough and Diarrhea. On 17Jan2021 the patient was positive to SARS-CoV-2 test. On 19Jan2021 she received monoclonal antibody therapy. The outcome of the event was not recovered.
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| 60 | 2021-02-09 | fatigue, fever |
fatigue; low grade fever; incredible body ache; rash/looks like measles on her face; first dose 22De...
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fatigue; low grade fever; incredible body ache; rash/looks like measles on her face; first dose 22Dec2020, second dose 15Jan2021; first dose 22Dec2020, second dose 15Jan2021; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) on 15Jan2021 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient previously received first dose of BNT162B2 (lot number: EL0140) on 22Dec2020 at single dose for COVID-19 immunization, and experienced fatigue, low grade fever and rash. The patient received the vaccine and had minor side effects that were explained like fatigue, low grade fever, everything responded to the ibuprofen (ADVIL) a NSAID. The booster received on time on 15Jan2021 and she had a quite a challenge with it for about a week, she had the increased fatigue, really incredible body ache, the fever went away in about 2 days but fatigue lasted definitely a full week. About the 3rd day a rash started and that was not going away, she was not sure what to so about it, it became worst if she exercise, very prominent if she exercise. It's been a little over a week with symptoms of fatigue and body ache went away. The rash that she can not get rid of; It was very disturbing the rash; looks like measles on her face. Treatment included the body ache was responding to ibuprofen but fatigue she just trying to take more rest. Lab data included CBC (Full blood count) on unspecified date, that was normal. The outcome of fatigue, low grade fever, incredible body ache was recovered on unspecified date, outcome of other events was not recovered. Causality assessment from the reporter between the vaccine and events was related.
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| 60 | 2021-02-09 | headache, headache | Next day bad headache, two days later bad GI upset, stomach pain inflammation ; 2nd vaccine Psfizer |
| 60 | 2021-02-09 | fever, chills, headache |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous re...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at arm right on 20Jan2021 at 10:00 at single dose for COVID-19 immunization. The patient medical history included diabetes from an unknown date and ongoing. The patient's concomitant medication included metformin. The patient experienced COVID-19 on 27Jan2021 (she got all the symptoms: sinus, headache, body aches, pain, chills, joint pain, fever). The patient was admitted to emergency room due to the event. The patient underwent lab test and procedure which included blood test and chest X-ray both on an unspecified date and both resulted that "everything was good" values not provided, in Jan2021 body weight: between 114-115 lbs, but probably 110 (lost a lot of weight in the past two weeks because of the virus) and SARS-CoV-2 test (nasal swab): positive on 27Jan2021. Therapeutic measures were taken as result of COVID-19 and included treatment with benzonatate (lot: 7893614, dose: 100 mg; one pill a day), ivermectin (dose: 3 mg, 4 pills a day for 2 days, exp: 28Apr2021), prednisone (dose: 20 mg, 3 tablets once daily lot: 7893618 ), azithromycin (dose: 500 mg, for five days, lot: 7893308). Medications she was prescribed in the emergency room were helping a little bit. The patient outcome of the events was unknown.
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| 60 | 2021-02-10 | chills, headache, body temperature increased |
Could not raise my arm the next morning with out extreme pain from the site to the arm pit to the ne...
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Could not raise my arm the next morning with out extreme pain from the site to the arm pit to the neck. Then my arm pit was swollen, hot and the swelling went down my arm. I also had diarrhea, Nausea, slight head ache, chills, body ache with a temp of 101.5. Went to the doctor yesterday because of my armpit swelling, hot to touch and it had a red band. She said where they gave it was not in a muscle. It was given sub Q & that it went into my lymph gland and leaked down my arm to swell. Right now I just have on and off nausea , pain in my lymph glands in my arm pit. The swelling and pain has gone down and the other symptoms have faded away.
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| 60 | 2021-02-10 | chills |
Severe chills; joint pain; This is a spontaneous report from a contactable other healthcare professi...
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Severe chills; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old female patient received bnt162b2, via an unspecified route of administration on 30Jan2021 at 04:45, single dose in the Left arm for covid-19 immunization. Medical history included Hashimotos Thyroiditis. Concomitant medication included thyroid (ARMOUR THYROID). The patient previously took Levoquine and experienced allergies. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. In Feb2021, the patient experienced severe chills and joint pain still 4 days later. The patient did not receive treatment for the adverse events. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 60 | 2021-02-10 | fatigue |
The skin on my arms and legs (mostly noticed arms) looked marbled red immediately after vaccine. It...
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The skin on my arms and legs (mostly noticed arms) looked marbled red immediately after vaccine. It is still there but not as bad as it was initially. I googled skin conditions and it looks like Livedo reticularis. I went to my Cardiologist on 2/5/21 and he took bloodword CBC, Prothrombin Time and bloodwork was normal. Cardiologist told me to go to a dermatologist. My arm was sore also where the injection was and it was hard to lift my arm. That lasted one day. I also had aches and pains and was fatigued on 2/3/21 for 24 hours.
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| 60 | 2021-02-10 | headache, fatigue, chills |
02/05/21 Developed headache 3-4 hours after receiving COVID vaccine, along w/ metallic taste in mout...
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02/05/21 Developed headache 3-4 hours after receiving COVID vaccine, along w/ metallic taste in mouth & tingling in right hand. 6 hours after COVID vaccine had tingling in both hands. 02/06/21 4 AM felt chilled. 8 AM had mild headache & fatigue, tingling in both hands continued all day. 02/07/21 Tingling in both hands continued. Then developed tingling in left foot & increased tingling in left hand. 02/08/21 Increased tingling in both hands, worse in left 3rd digit. 6 PM had increased tingling in left hand & tingling up into left elbow. 9 PM had increased tingling in right hand. 02/09/21 Tingling in both hands continued all day. Fingers feel cold off &on. 02/10/21 Tingling in both hands continued all day. Fingers feel cold off & on. Tingling in feet, left leg up to knee in evening. 02/11/21 Tingling in both hands continues, fingers feel cold in both hands. Tingling in feet.
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| 60 | 2021-02-10 | headache, sweating, lethargy, body temperature increased, chills |
on 2/6/2021 woke up in am with headache, chills, temperature . Symptoms continued with chills, sweat...
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on 2/6/2021 woke up in am with headache, chills, temperature . Symptoms continued with chills, sweating, lethargic with muscle aches and pains along with temp. Temperature returned to normal in pm on 2/7/2021. Muscle aches and pains, itchy at injection site and being tired lasted another couple of days. Feeling back to normal by 2/10/2021
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| 60 | 2021-02-10 | headache |
On Tuesday she woke up with a headache that gradually worsened. The headache was behind the right ey...
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On Tuesday she woke up with a headache that gradually worsened. The headache was behind the right eye, the right ear, and the teeth on the right side also hurt. Nothing helped taking Acetaminophen; Ibuprofen. She went to sleep around 4:00 am finally, and then woke up 6 hours and the headache was gone. Then you had hives located behind the right ear and down the neck, into the right shoulder. They are also in her scalp. They have now down to the tops of her legs, hips, and back and are spreading. She called her doctor who called her in some prescriptions.
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| 60 | 2021-02-10 | headache |
pt reported mild dull headache and warm head.given water and saltines with improvement. BP slightl...
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pt reported mild dull headache and warm head.given water and saltines with improvement. BP slightly elevated. Pt admitted to stress. Monitored for additional 30 min. Pt felt ok to go.
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| 60 | 2021-02-10 | fever, headache, fatigue |
Evening of vaccine. Slight itching. Day after vaccine - Headache, mild "fever /chills" No Rigor, All...
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Evening of vaccine. Slight itching. Day after vaccine - Headache, mild "fever /chills" No Rigor, All over body aches worse than flu, fatigue.
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| 60 | 2021-02-14 | chills | Injection site pain, body aches, lightheadedness, chills |
| 60 | 2021-02-14 | headache, fatigue |
shortness of breath, heart rate high, dizziness, low blood pressure, dry mouth, feeling faint, weakn...
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shortness of breath, heart rate high, dizziness, low blood pressure, dry mouth, feeling faint, weakness, fatigue all over, numbness in feet and hands, two -three weeks of morning anxiety, difficult to operate a car, two tp three weeks stiffness in joints, and headache.
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| 60 | 2021-02-14 | sweating, fatigue, chills |
About 12:30 AM on 2/14/21, I woke with extreme chills, muscle weakness, possible fever and sweats, j...
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About 12:30 AM on 2/14/21, I woke with extreme chills, muscle weakness, possible fever and sweats, joint pains. About 2:30 AM, I took two 325 MG aspirin. About 9:30 AM, I woke again with the same extreme symptoms listed above. I took an additional two 325 MG aspirin. About 4 PM, my symptoms were not as severe, but I was still unable to engage in daily activities, and I took an additional two 325 MG aspirin. Symptoms continued, but lessened, and about 9 PM, I told an additional two 325 MG aspirin and a zolpedim CR to help me sleep throughout the night. I woke about 6:45 AM on 2/15/21, with mild muscle weakness, joint pain, and feeling slow and tired. As of this report at 11:15 AM on 2/15/21, I am functioning at about 80% capacity, some chills and muscle/joint pain.
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| 60 | 2021-02-14 | respiratory tract congestion, headache, sneezing |
2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYE...
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2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED IN A FOG. VERY CONGESTED , SNEEZING, ITCHY EYES, STUFFY EARS, VERY CONFUSED. STRANGE FEELING INSIDE MY BODY - TINGLING . FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES. NAUSAUES. 6 HRS LATER SWOLLEN FACE RIGFHT SIDE.
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| 60 | 2021-02-14 | throat irritation, fatigue |
Sore arm at injection site. Itchy throat and itchy body. Extreme Fatigue. Heavy and fast heartbea...
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Sore arm at injection site. Itchy throat and itchy body. Extreme Fatigue. Heavy and fast heartbeat with severe pressure and chest pain. Ongoing muscle and joint pain that moves from location to location. Redness on chest and facial - cheeks.
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| 60 | 2021-02-15 | chills, headache, influenza like illness, fatigue |
About 4 hours after my administered 2nd dose I experienced severe pain in my TMJ mostly on the left ...
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About 4 hours after my administered 2nd dose I experienced severe pain in my TMJ mostly on the left but milder on the right. That developed into a bad headache but was relieved with 200mg Motrin in the evening. The following day I experienced flu-like symptoms, chills (I did not take my temperature), muscle joints, fatigue, continued headache and milder pain in my bilateral TMJ. I continue to take Motrin every few hours. I did not experience the TMJ pain with my first dose in January 2021 but I did have mild flushing, flu-like symptoms. I thought I would report this as I have bilateral TMJ implants since 1997.
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| 60 | 2021-02-15 | cough |
Right after the vaccine I felt a little funny. Within 10 minutes of receiving the vaccine I started ...
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Right after the vaccine I felt a little funny. Within 10 minutes of receiving the vaccine I started coughing, lost my voice, Itchy eyelids, my chest was pounding, and overall just did not feel right. EMS Took my blood pressure and it was 255, then they waited a smidge and decided to give me an injection of Benadryl, within 10 minutes of the Benadryl my blood pressure went down to 225, and I overall felt a little bit better. My eyelids were still swollen and itchy and I didn?t have a voice, they took my blood pressure again and it went down to 218. They stayed with me. I was starting to feel a little bit better. My blood pressure went down to 180 and there?s no wheezing in my chest. They let me leave shortly after that. I still do not have a voice. My eyelids are still swollen slightly and very itchy and my lips tingle.
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| 60 | 2021-02-15 | fatigue, body temperature increased, chills, headache |
8:30 pm - extreme shivering, teeth chattering, extremities freezing cold, particularly the feet; sev...
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8:30 pm - extreme shivering, teeth chattering, extremities freezing cold, particularly the feet; severe body aches; injection site throbbing; upset stomach and a feeling of nausea. Temperature 100.2 at 8:45. Took temp every hour. By midnight temp reached 102.7. Head ache started. Couldn?t sleep on my left side because of the extreme pain around the injection site and down my left arm. Finally fell asleep around 2:30 and woke at 5:30. Fever was gone. Temp read 98.9. Body aches still present but not as severe. Arm pain had eased but head ache remained most of the day. Felt much better but just very tired.
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| 60 | 2021-02-15 | fatigue, headache, chills |
12/19/2020 130 vaccination. When got up to leave, near syncope episode. Monitored for 15+ more minu...
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12/19/2020 130 vaccination. When got up to leave, near syncope episode. Monitored for 15+ more minutes. Left after. Later that evening, I felt like I was on 'speed'. Chills, HA, couldn't sleep. HR was increased. I wasn't able to eat; no appetite. Symptoms lasted for several days. Don't think I ran a fever. I was very dizzy, double vision, extreme fatigue. Did what i could with work online. *HX of aura migraines and happened during this episode. Within that week, saw NP.
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| 60 | 2021-02-15 | headache, fatigue, cough, malaise |
Day 4 sudden feeling unwell, out of it, severe burning pain throughout whole body, joint pain , head...
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Day 4 sudden feeling unwell, out of it, severe burning pain throughout whole body, joint pain , headache, cough, fatigue, upset stomach, diarrhea. Subsided in about 36 hours.
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| 60 | 2021-02-15 | headache |
1/6 1:30 vaccination Later that evening, I had extreme HA. I had 2-3 aura migraines, a day or 2 late...
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1/6 1:30 vaccination Later that evening, I had extreme HA. I had 2-3 aura migraines, a day or 2 later. Insomnia. *still experiencing insomnia and anxiety
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| 60 | 2021-02-15 | fever, chills |
The day of the vaccine there was no reaction. Day 2 I woke up with red angry lump at the injection s...
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The day of the vaccine there was no reaction. Day 2 I woke up with red angry lump at the injection site, about the size of a 0.50 cent piece. Later that day I had a fever of 102.5 and chills. Day 3 the redness had spread and still had the lump. Day 4 or 5 the color changed to purple and the lump had decreased. It took about a week for the lump to go away. I still have a discoloration on my arm where the vaccine was given. It looks a bruise but no pain. The whole time the area blanched well. The first dose I had on my left arm and the next day I had a small welt with redness. I am on my second round of steroids to try and get my asthma under control and had to increase my Advair to the highest dose. My doctor put me on a antibiotic as well with the second round of steroids. My asthma is a little better but not at my baseline.
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| 60 | 2021-02-16 | fatigue |
2nd dose pizer 2/11; 2/12 fatigue, body aches, 2/16 rash noticed 5PM (bra line, breast, back, legs,...
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2nd dose pizer 2/11; 2/12 fatigue, body aches, 2/16 rash noticed 5PM (bra line, breast, back, legs, down thighs at bedtime, under arms), rash was spreading, pt put calamine lotion on rash, woke up 2/17/21 and rash is gone.
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| 60 | 2021-02-16 | headache, fatigue, chills |
Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for...
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Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for about 10-12 hours, then lessening to feeling tired, bouts of vertigo and occasional headache. Five days later on 1/25 I experienced blurry vision, nausea, confusion, dizziness, and impaired speech (to a co-worker). This lasted about an hour.
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| 60 | 2021-02-16 | malaise, chills, fatigue |
Pfizer-BioNTech COVID-19 Vaccine EUA At 2:30 am woke up with nausea and stomach ache. Continued thr...
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Pfizer-BioNTech COVID-19 Vaccine EUA At 2:30 am woke up with nausea and stomach ache. Continued through the night. I could not sleep. In the morning (9:00) I tried to sleep but had very bad chills for over an hour. Went down to couch and covered up with many blankets. Chills continued for 4-5 hours. Also experienced tiredness, and general 'feeling unwell' throughout the day, as well as extreme heartburn. I stayed home from work and sat on the couch all day, feeling unwell. By about 8pm all of the symptoms disappeared.
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| 60 | 2021-02-16 | throat clearing, cough |
Within 30 seconds: Dry Throat, patient requested water, request was denied. 1 minute after vaccinati...
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Within 30 seconds: Dry Throat, patient requested water, request was denied. 1 minute after vaccination: Coughing and difficulty breathing 2 minutes after vaccination: Patient refuses EpiPen administration stating she will not go to the hospital and not to call 911. 3 minutes after vaccination: Patient attempts to leave observation area to go use her own EpiPen in her apartment. 4 minutes after vaccination: Patient agrees to EpiPen administration into left leg and 911 is called. 5 minutes after vaccination: Patient continues to cough and clear throat. Patient throws herself out of her chair onto the floor while coughing. 6 minutes after vaccination: Patient hoarsely requests a second administration of EpiPen. EpiPen is administered into right leg. 7-10 minutes after vaccination: Patient is breathing easier however is forcing herself cough. 11 minutes after vaccination: EMTs arrive. Patient's HR: 141 bpm, SpO2: 96% 13 minutes after vaccination: Patient's SpO2: 99% 18 minutes after vaccination: Patient goes outside with EMTs 20 minutes after vaccination: Patient signs "Against Medical Advice" form - refusing to go to the hospital 22 minutes after vaccination: Patient is walked by to her apartment by EMTs.
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| 60 | 2021-02-17 | malaise |
lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded...
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lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded to the point of nearly passing out; cold sweat; loss of appetite; pain in upper shoulder/back area; pain in upper shoulder/back area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL-9265), via an unspecified route of administration on 29Jan2021 12:30 in left arm, at single dose for covid-19 immunization. Medical history included chronic low BP, hypothyroidism, HRT, nasal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), multivitamin NOS (MULTIVITAMIN). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and known allergies: Augmentin, being treated for nasal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, general feeling of being unwell, lightheaded to the point of nearly passing out; cold sweat, loss of appetite, pain in upper shoulder/back area, on 01Feb2021 06:30. No treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
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| 60 | 2021-02-17 | fever |
This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female pat...
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This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3247) intramuscular in right arm on 01Feb2021 at 11:30 am (at 60 years) at single dose for covid-19 immunisation . Medical history included hypertension (HTN) , hypergammaglobulinaemia benign monoclonal (MGUS) , mononucleosis (recent mononucleosis one year before). Patient was not pregnant. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), hydrochlorothiazide/ losartan potassium (HYZAAR), amfepramone hydrochloride (TENUATE). The patient previously took IV dramamine, tetanus and ceclor and experienced allergy. Previously, on 18Jan2021 at 10:30 am (at 60 years) she took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3248) intramuscular in right arm for covid-19 immunisation. Patient took the 1st dose of the vaccine on 18Jan2021 and 2nd dose on 01Feb2021 (inappropriate schedule of vaccine administered). Events were described as follows: next day, on 02Feb2021 at 06:00 temperature of 100.6, arthralgias and myalgias, dizziness. Second day (Feb2021), temp lower but still around 99.8 (normal for her 97.2), vasovagal, dizziness, arthralgias and myalgias. Events were non serious. Patient (a nurse) treated herself with dramamine for the dizziness, Nyquil and Advil. The final outcome of pyrexia, vasovagal, dizziness, arthralgias and myalgias was recovering.
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| 60 | 2021-02-18 | chills, fever, headache | Chills, fever, headache, body ache. Three Advil. Symptoms went away after about 9 hours |
| 60 | 2021-02-18 | fever | Fever, pain in the arm where I got the shot. nauseated |
| 60 | 2021-02-21 | fatigue, chills, headache |
Woke up during the night with chills that had my body shivering and a headache. Did not get up unt...
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Woke up during the night with chills that had my body shivering and a headache. Did not get up until morning because I didn't want to get out of the covers even though I was cold. Took some ibuprofen which helped with both the chills and headache. I had no energy and was very tired. I slept most of the day and woke up to go to the bathroom and take more ibuprofen. Towards the evening I could tell that I was feeling a bit better. I was able to take a bath, more ibuprofen and went to bed. Slept pretty well. Woke up once and took ibuprofen because of headache and body aches. Felt much better on Sunday. Was still tired and slept a good part of the day. My arm continues to ache, but is not really painful unless I try to lift it.
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| 60 | 2021-02-21 | throat irritation |
During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations...
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During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations/dizziness with BP of 157/99, requested transfer to ED for further evaluation. Began experiencing scratchy sensation to throat, difficulty swallowing with hoarseness of voice 5 minutes after vaccination. Received epinephrine 0.5mg IM once, protonix 40mg IV once, and solu-medrol 125mg IVPB once in ED. Patient was observed in ER for 3 hours and reported having EpiPen and Benadryl at home, was discharged with Prednisone 20mg, 2 tablets daily for 3 days.
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| 60 | 2021-02-22 | chills, pneumonia |
presented 1/27 to ED with rigors, dyspnea chest pain and R ear pain post COVID vaccine, thought to i...
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presented 1/27 to ED with rigors, dyspnea chest pain and R ear pain post COVID vaccine, thought to initially be systemic SEs from the vaccine but found to have re-collapse of the BI on chest CT with probable post obstructive pneumonia. still admitted as of 2/23/2021
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| 60 | 2021-02-22 | fever, headache | Fever, Body ache, headache |
| 60 | 2021-02-22 | fever, lethargy | Very lethargic, feverish, SOB |
| 60 | 2021-02-23 | chills, runny nose, sinus headache |
Other than mild soreness at the injection site she experienced no adverse reactions during the first...
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Other than mild soreness at the injection site she experienced no adverse reactions during the first 24 hours post-vaccine. On the second day after vaccination she developed chills without fever followed by the appearance of rhinorrhea and sinus headache that persisted for about one week. As she has a past history of genital herpes and this resembled her prodrome for recurrence she self-administered valacyclovir for several days. On the eighth day after vaccination she noted mild hand tingling. The following morning she awoke with numbness and hyperesthesia of the left shin that is still present.There was no persistent tingling and no pins and needles sensation
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| 60 | 2021-02-23 | fever, chills |
I only had 1 dose on 2/16/2021 and got the reaction 1 week later 2/23/2021.. Not sure if that's pos...
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I only had 1 dose on 2/16/2021 and got the reaction 1 week later 2/23/2021.. Not sure if that's possible but wanted to report it anyway. body ache, joint discomfort, migraine headache all day, fever, chills & nausea - this started about 10am on 2/23/2021 and lasted until 2am the following morning 2/24/2021. I took 600 mg of motrin every 6 hrs and 600 mg of tylenol every 4 hrs. I feel fine today
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| 60 | 2021-02-23 | fever, fatigue, headache |
2/9: redness and blue color and pain around the shot site 2/13: fever 101F, body ache, headache, tir...
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2/9: redness and blue color and pain around the shot site 2/13: fever 101F, body ache, headache, tiredness, - Tylenol every 5 hours 2/14: fever 99 F, body ache, headache, tiredness, hives on chest, stomach, back, arms, - Tylenol every 6 hours 2/15: no fever, hives fading out 2/16: tiredness, hives cleared up
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| 60 | 2021-02-24 | fatigue | 10 min. After shot developed rash to chest, torso. On 4th day developed SOB, chest pain and fatigue. |
| 60 | 2021-02-24 | headache, fatigue |
Approximately 4 hours after injection, I developed a severe, one sided headache. Extreme fatigue dev...
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Approximately 4 hours after injection, I developed a severe, one sided headache. Extreme fatigue developed the following morning, headache less severe. Extreme fatigue continued for 6 days, headache for 5 days. OTC analgesic was not helpful.
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| 60 | 2021-02-24 | headache, sweating, malaise |
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details:...
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Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient explained she was very anxious, light headed, flustered, headache - more than 15 mins after the dose. She waited the 15 mins and when heading home, felt sick and returned to the pharmacy where the staff sat with her for an additional 30 mins
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| 60 | 2021-02-25 | cough |
Horseness and cough after 30 minutes of monitoring. She has a history of anaphylaxis with bees and 2...
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Horseness and cough after 30 minutes of monitoring. She has a history of anaphylaxis with bees and 2 antibiotics. She was given 25 mg of benadryl and symptoms improved. She was given instructions to take more benadryl in 4 hours to help with symptoms and to go to the ED if symptoms got worse
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| 60 | 2021-02-25 | fatigue, headache | third day, fatique, headache, aching joints |
| 60 | 2021-02-26 | headache, fever, fatigue, chills |
IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatig...
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IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatigue brief chills LATER & NEXT DAY Pain left arm Muscile aches, especially legs Brief episode of nausea Slight fever
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| 60 | 2021-02-26 | headache |
Patient reported dizziness and blurred vision initially. Vital signs checked, BP 174/73, HR 87, SpO2...
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Patient reported dizziness and blurred vision initially. Vital signs checked, BP 174/73, HR 87, SpO2 97% on intial check. She also reported a right frontal headache 5/10. Moved to cot to lie down, VS re-checked. Dizziness did not resolve with lying down. BP remained elevated as well. Once lying down, patient also reported "heaviness" in chest. A nurse remained with patient throughout entire incident and VS assessed frequently. After about 45 minutes, patient still reported HA, dizziness. Patient reported chest heaviness had resolved, but BP and dizziness did not resolve. Discussed calling EMS with patient, she agreed to allow us to call EMS. She was transported to local hospital by EMS at approximately 11:30am.
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| 60 | 2021-02-26 | fever, chills, fatigue | Chills fever fatigue |
| 60 | 2021-02-26 | fever | Fever 101.1, aching joints, shortness of breath that I still have week later, loss of taste, |
| 60 | 2021-02-27 | fatigue, influenza like illness, chills, fever |
slight fever for 2 days, then flu-like symptoms (body aches, fever, chills, lack of appetite, loss o...
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slight fever for 2 days, then flu-like symptoms (body aches, fever, chills, lack of appetite, loss of taste and smell, fatigue) since Wednesday 2/24/21. Missed work due to symptoms on Thursday 2/25/21. Returned to work amidst continuing flu-like symptoms on Friday 2/26/21. As of Sunday, 2/28/21, symptoms continue; maybe slightly diminished.
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| 60 | 2021-02-27 | headache, fever, malaise, cough |
Headache, Low grade fever, cough, loss of appetite, hot flashes, Lost my voice. Didn't feel well Fri...
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Headache, Low grade fever, cough, loss of appetite, hot flashes, Lost my voice. Didn't feel well Friday night, started coughing and feeling unwell. I had a fever in the morning and had lost my voice but wasn't coughing anymore. Today no fever but no voice and I just don't feel well. No appetite today either.
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| 60 | 2021-02-27 | headache |
At 48 hours After vaccines I developed a headache nauseous Hot the following day I was sore all over...
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At 48 hours After vaccines I developed a headache nauseous Hot the following day I was sore all over still having a headache still nauseous my ribs hurt my hand hurt four days today still not well tired weak headache! So sick ! I do not wish to have the second dose! I really thought I was gonna die
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| 60 | 2021-02-27 | influenza like illness, fever |
That evening starting to feel flu like symptoms. Today I feel like I have the stomach flu-body aches...
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That evening starting to feel flu like symptoms. Today I feel like I have the stomach flu-body aches, headache, sore arm, nausea, 102 fever, joint pain
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| 60 | 2021-02-28 | chills, fever |
Pfizer. My right hand was swollen up like a catchers- mit. Very painful in thumb joint at a level ...
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Pfizer. My right hand was swollen up like a catchers- mit. Very painful in thumb joint at a level 10. Was swollen for 5 days, then fever chills, body aches (fever 0f 100.2) Right hand was so painful was intolerable, truly had to wait for it to pass, nothing helped except for soaking in Epsom salt bath, which was short live. Have had arthritis in this thumb but not for approximately 8 years. Entire hand was swollen and not useable.
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| 60 | 2021-02-28 | fatigue, headache | excessive vomiting, nausea, headache, aches, fatigue |
| 60 | 2021-02-28 | headache |
pain in lymphoma area; pain in lymphoma area; Multiple headaches; neck pain; inner ear pressure; jaw...
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pain in lymphoma area; pain in lymphoma area; Multiple headaches; neck pain; inner ear pressure; jaw pain; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247), via an unspecified route of administration in the left arm on 21Jan2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included type 2 diabetes and overweight, and the patient had no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications included lisinopril, metformin, metoprolol, sitagliptin (JANUVIA). The patient did not receive any other vaccine within 4 weeks of the vaccination. On 01Feb2021 at 09:00, the patient experienced multiple headaches, neck pain, pain in lymphoma area, inner ear pressure, jaw pain. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcomes of multiple headaches, neck pain, pain in lymphoma area, inner ear pressure, jaw pain was resolving.
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| 60 | 2021-02-28 | influenza like illness, headache | flu like symptoms, head ache, weakness, body aches |
| 60 | 2021-03-01 | chills |
Vaccine given 2/9/21. On the afternoon of 2/12/21 I began to have joint pains in my right wrist. By ...
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Vaccine given 2/9/21. On the afternoon of 2/12/21 I began to have joint pains in my right wrist. By 2/10/21 in the morning both elbows, knees and wrists were sore. Elbows and right knee felt warm to the touch. Nodules or red spots developed around the joints. I could barely walk or climb in and out of the car, the bed, and had a very difficult time standing up from the toilet or a low chair or couch. No fever, but did have a few chills with teeth chattering at least twice.
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| 60 | 2021-03-01 | fatigue, productive cough |
I started to get mild nausea within about 15 mins. then a chemical taste in my mouth. Later I ...
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I started to get mild nausea within about 15 mins. then a chemical taste in my mouth. Later I was getting some sputum or phlegm coming up,, no cough, on short of breath no nasal discharge. During the night I woke up because the phlegm was much worse and abundant I wanted to sleep so at first was swallowing it, then it was so much that I got up and went to the bathroom. That is when I noticed that the palms of my hands were scarlet red. on both hands and not on the wrists or any where else. by morning it was gone but I did have diarrhea and still a cold mild nausea feeling in my stomach. Yesterday , 3 days later, still had diarrhea and nausea and was tired,,symptoms are not severe, but since these are not typical symptoms for me. I figured they will go away, but also I figured that I should communicate the reaction . I am scheduled for my 2nd shot in 3 weeks,
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| 60 | 2021-03-01 | fatigue |
Seizure: Sunday 2/28 @noon Migraines: 2/28 post seizure & 3/1 & 3/2 Pre-seizure symptoms: 3/1 & 3/2 ...
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Seizure: Sunday 2/28 @noon Migraines: 2/28 post seizure & 3/1 & 3/2 Pre-seizure symptoms: 3/1 & 3/2 ExtremeMuscle&Joint pain, fatigue, Ubrelvy 100mg 2/28 & 3/2, Ibuprofen 800mg, alt w/Tylenol 2-500mg, Rest/sleep most of days, warm showers, heating pads
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| 60 | 2021-03-01 | headache, chills, sweating, fever |
Heart attack; Myocarditis; Chills; didn't check her temperature but is sure she had one/She didn't c...
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Heart attack; Myocarditis; Chills; didn't check her temperature but is sure she had one/She didn't check her temperature but she is sure she had a fever; was soaking wet when she woke up like her fever had broken and then she was fine/She woke up and was very sweaty; achy right side; Headache; This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), via an unspecified route of administration in the right arm, on 06Jan2021 at 18:00 at the age of 60 years, at a single dose for Covid Prevention/COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received the first dose of Covid-19 vaccine (Manufacturer: Pfizer, with Lot Number: EK5730) in the right arm, on 18Dec2020 at the age of 60 years for COVID-19 immunization. The patient reported that 13 days after the last dose of the vaccine, on 19Jan2021, she had a heart attack. She has no heart issues whatsoever. She had diagnostic testing such as a cardiac catherization, echocardiogram, both on 19Jan2021; and a heart MRI with contrast on 20Jan2021. The test results indicated that she had myocarditis caused by a virus. The cardiac catherization and echocardiogram also revealed heart attack because of myocarditis. She did not have any other issues with her heart. The patient asked if they would they let her know if anything comes up as far as information. The patient has recovered with lasting effects. She would be on medication for the next 3 years supposedly. The heart attack was caused by myocarditis which was caused by a virus. There were no other issues with her heart, arteries or anything. These events required a visit to the emergency room. She first went to a hospital in the city and was transferred via ambulance to another hospital in another city on the same day. Patient was hospitalized for the heart attack and myocarditis from 19Jan2021 to 22Jan2021. She had a lot of other symptoms the next day after receiving the vaccine on 07Jan2021. She also experienced chills. She didn't take her temperature but is sure she had one. She was achy on her whole right side and she had a headache. She started having chills at 1:30 PM (13:30) while at an eye doctors appointment. She laid down and was soaking wet when she woke up like her fever had broken and then she was fine. She didn't check her temperature but she is sure she had a fever. She woke up and was very sweaty. The outcome of the events heart attack and myocarditis was recovered with sequelae on Jan2021. The outcome of the remaining events was recovered on 07Jan2021.
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| 60 | 2021-03-01 | headache, fatigue |
SHORTNESS OF BREATH 1.29.21 TO CURRENT AND HAS NOT STOPPED, EXTREMLY TIRED FOR 7 DAY, FAST HEART BEA...
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SHORTNESS OF BREATH 1.29.21 TO CURRENT AND HAS NOT STOPPED, EXTREMLY TIRED FOR 7 DAY, FAST HEART BEAT. DIZZINESS FOR APPROX 4 DAYS, HEADACHE FOR APPROX 4 DAYS
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| 60 | 2021-03-01 | headache |
Pt experienced blurry vision to both eyes and slight headache. Onset approximately 25 minutes after ...
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Pt experienced blurry vision to both eyes and slight headache. Onset approximately 25 minutes after receiving vaccination. Pt did not lose LOC, did not lose vision completely. No problems with gait. Alert and oriented. Episode was transient and all sx's went away after about 30 minutes. After sx's resolved, pt refused transport to hospital for further evaluation, signing CFD refusal form stating able to drive self home.
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| 60 | 2021-03-02 | cough |
Patient felt like she needed to cough, dry throat. Iniital BP 151/83. Final BP 137/88 (pulse 71). Gi...
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Patient felt like she needed to cough, dry throat. Iniital BP 151/83. Final BP 137/88 (pulse 71). Given water.
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| 60 | 2021-03-02 | headache |
continued mild headache; eye strain and sensitivity to bright light; eye strain and sensitivity to b...
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continued mild headache; eye strain and sensitivity to bright light; eye strain and sensitivity to bright light; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EM9810), via an unspecified route of administration in the left arm on 06Feb2021 at 10:15 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension (HTN), obstructive sleep apnoea (OSA), periodic limb movements of sleep (PLMS), arthritis, asthma, allergies to Band-aid adhesive, steristrips and lanolin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, but the patient did receive concomitant medications within 2 weeks of the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247) on 16Jan2021 at 16:30 (at the age of 60-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccinations within 4 weeks prior to the COVID-19 vaccination. On 07Feb2021 at 00:00, the patient experienced continued mild headache, eye strain and sensitivity to bright light. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of continued mild headache, eye strain and sensitivity to bright light was not resolved.
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| 60 | 2021-03-02 | throat pain |
5 minutes after receiving the vaccine, patient became flushed. She also stated that she had a sore t...
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5 minutes after receiving the vaccine, patient became flushed. She also stated that she had a sore throat without SOB or difficulty swallowing. She was able to drink water without difficulty. Her airway was patent and oropharynx was normal on exam. She had no stidor on exam. Patient was advised to seek care at the ED, but she did not.
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| 60 | 2021-03-02 | respiratory tract congestion, fever, headache, chills, fatigue |
Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appet...
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Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appetite, fatigue, could not lift arm.
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| 60 | 2021-03-03 | chills |
At midnight after the shot I developed 99.9, chills, myalgia, severe migraine and all of it lasted 1...
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At midnight after the shot I developed 99.9, chills, myalgia, severe migraine and all of it lasted 16 hours. I reported it to the nurse practitioner but did not want to see her because I knew it would resolve. I am a nurse and expected it would improve on it's own and it did. I did take Tylenol for the symptoms when they began. I work in a clinic.
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| 60 | 2021-03-03 | malaise, chills, fatigue, headache |
SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSE...
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SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSEA, SWOLLEN LYMPH NODES UNDER BOTH ARMS, FEELING UNWELL
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| 60 | 2021-03-04 | chills |
4 hours after vaccine, had the following Reaction : -Big Chills -Nausea -Small amount of swelling o...
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4 hours after vaccine, had the following Reaction : -Big Chills -Nausea -Small amount of swelling on Face, Ankles, & Wrists -Very tired = fatigue / sleep
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| 60 | 2021-03-04 | chills |
I received vaccine. Noted at the 30 minute post wait vaccine site feeling a very slight like it was ...
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I received vaccine. Noted at the 30 minute post wait vaccine site feeling a very slight like it was hard to take a deep breath 15 minutes after receiving the vaccine. I took my pulse. It was 90. I did not tell the medical monitor people. My husband drove me home after the 30 minute watch period was up. At 1:15pm I gave myself an albuterol neb to. Post tx home pulse ox was 95% pulse 96. No n/v, no itching. Breathing felt improved . I did a home peak flow reading which was 240. My personal best baseline is 350. I auscultated my anterior chest. Diminished, clear, no wheezing. I sat calmly. My husband noticed the left side of my face was mildly swollen. Amazing! For him to notice! it was very slight around cheek bone to jawline. I sent him to get otc Benadryl. I took 25 mg po . At 2:20 pm Pam was 300 p02 sat 98% pulse 96. Lips felt tingling, no swelling. Speech clear. Swallowing intact Drank water, low sodium soup. 3:30 pm did another albuterol next. Sat 95% after neb . Pulse 89. 20 minutes post neb peak flow reading 320. Started feeling chills. Temp outside a nice seventy degree day. Wrapped self 6 blankets,winter hoody fleece, heating pad and finally fell asleep. Family watched me sleep. Woke up 7pm. Still felt cold. Had fluids, urinated, breathing ok. Went back to sleep. 11 pm woke up, peak flow 300, did neb, took Benadryl wore my cpap machine and went to bed till today.
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| 60 | 2021-03-04 | cough, body temperature increased |
Pt experienced diarrhea at 0300 today with vomiting. Pt had body ache and feeling weak, Temperature ...
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Pt experienced diarrhea at 0300 today with vomiting. Pt had body ache and feeling weak, Temperature was 101 at 0930 this morning. Pt has minimal coughing at this time. Current temperature is 99.9 The pt denies any SOA prior or currently at this time. The pt was informed to eat small amount of crackers as tolerated and fluids as tolerated. Get plenty of rest. Should sx's worsen or SOA occur, then call for an ambulance for assistance.
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| 60 | 2021-03-04 | fatigue, nasal congestion, headache, chills, cough |
Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on m...
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Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on me, I immediately tasted something weird in my mouth. It was not as metallic tasting as usual. More plasticy. Shot did not hurt. Was told to stay in 30 minutes waiting area.I did. The taste remained in my mouth. I left at 10:34 am feeling OK, except for weird taste. As I drove off the parking lot, I noticed that my mouth and tongue were tingling, with worst of it on my left side. My throat did not seem to be affected, so I continued driving. Some nasal congestion and coughing. The tingling turned into numbness in my mouth and tongue, all the way back to top of throat. I called my primary care doctor at 12:10 pm and left a message. I received a call back at 2:15 pm from nurse. She told me to take Benadryl and have someone take me to Urgent Care right away to get my vitals checked. I did not take Benadryl, as CDC said it could mask anaphylactic reaction. I called a friend and she took me . I noticed that my lymph nodes in my neck were swelling and painful. We arrived at 2:45 pm. My vitals were checked, heart and breathing listened to and was checked briefly for swelling in mouth and throat. There was no swelling. He said he had never heard of this tingling reaction and claimed it is just a side effect and not a serious reaction and that it would probably last a couple of days. He recommended that I watch for new symptoms and take Benadryl. That was $30. We left at 3:10. We left. I noticed that the numbness was spreading to my lips and up the left side of face and I was getting super tired. Also, my mid to lower back started hurting a lot. I took a Benadryl. 4:30 pm still have same numbness. My eyes got super dry and itchy. My head started to hurt. Some coughing. 5:10 pm dry eye and numbness, more swollen lymph nodes and chills. Pain in calves, upper back, same on both sides. 6:38 weirdly, from the bottom of my thumb to halfway up my arm there is pain. Both arms simultaneously. Worse on the left. 8:11 pm after bundling up and using a heating pad, plus extra heat, chills are lessened. Lymph nodes very sore in neck. Eyes are not quite as dry. Everything else is the same. 8:48 pm jaw really aches. Intestinal discomfort. Going to bed. 10:39 pm pain from jaw extended up into left ear. Upper part of throat hurts. March 5, 2021 4:00 am. Body aches have lessened. Left arm sore at shot area. 5:45 am eyes definitely dry, but not nearly as dry as yesterday. Numbness in mouth , tongue and face has lessened, but still uncomfortably present. Definitely worse on the left side. Little bit of tingling on the left, mostly on cheek from chin to ear. Headache gone. Lymph nodes sore and swollen . 7:00 am went on a walk. Noticed some achyness throughout body. Very tired. 10:51 am The tingling and numbness remain in my mouth, tongue and cheek up to my left eye. Very tired. Lymph nodes still swollen and sore.
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| 60 | 2021-03-04 | lethargy |
Pt was observed to drop her phone on the floor. When it was picked up & RN attempted to hand it to ...
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Pt was observed to drop her phone on the floor. When it was picked up & RN attempted to hand it to her, she appeared to be sleeping. She did wake after physical stimulus but was lethargic, confused & stated she "felt dizzy"
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| 60 | 2021-03-04 | throat pain |
Sore throat, and chest feels heavy. Hurts to swallow. No treatment. I am currently monitoring my is...
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Sore throat, and chest feels heavy. Hurts to swallow. No treatment. I am currently monitoring my issue. If symptoms worsen I will go to ER
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| 60 | 2021-03-04 | throat irritation | Scatchy throat, affected voice, swollen tongue |
| 60 | 2021-03-06 | fatigue, malaise |
Four days after vaccination my trunk was covered with a red rash that was slightly itchy. The next d...
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Four days after vaccination my trunk was covered with a red rash that was slightly itchy. The next day it spread partly down my arms and legs. On day 6 I had malaise and fatigue and lessening of rash.
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| 60 | 2021-03-06 | headache | HA, lightheaded. Evaluated by EMS, cleared |
| 60 | 2021-03-07 | chills, fatigue |
Beginning 20 hours after vaccine, became extremely chilled and fatigued followed quickly by pain in ...
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Beginning 20 hours after vaccine, became extremely chilled and fatigued followed quickly by pain in all bones of body - face bones, leg and arm bones, ribs, etc. Thinking became foggy - everything became difficult to do. I went to bed at 7:30 pm on 2/25/2021 - slept fitfully until 6:30 am on 2/26/2021. All symptoms had lessened by 30%-50% during the day on 2/26/2021. By 2/27/2021, I felt pretty much like me again.
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| 60 | 2021-03-07 | fatigue, cough, headache |
I received the shot at 4:30 pm. About an hour after receiving the shot, I felt a little dizzy, and ...
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I received the shot at 4:30 pm. About an hour after receiving the shot, I felt a little dizzy, and my heart started beating faster. My body felt weird. I had a small headache and was very tired and laid down. I fell asleep pretty quickly. I woke up around 2:30 am the following morning, with a greater headache. I took tylenol for the headache. I took another dose of tylenol 4 hours later. I had loose stools, fatigue and my lungs felt heavy (cough) for approx 12 hours. Most symptoms resolved by the following day. A little fatigue and heaviness remains.
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| 60 | 2021-03-07 | fatigue, fever | Extreme fatigue. low grade fever, All major joints were affected. This lasted 24 hours. |
| 60 | 2021-03-07 | headache |
Almost immediate discomfort at injection site, followed by sore shoulder (left) and neck pain as wel...
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Almost immediate discomfort at injection site, followed by sore shoulder (left) and neck pain as well as headache for 24 hours. One week later, severe joint pain for 48 hours.
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| 60 | 2021-03-07 | influenza like illness, fatigue, headache, chills |
Extreme soreness in Left upper arm; chills; headache; tiredness; feeling like I had the flu; extreme...
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Extreme soreness in Left upper arm; chills; headache; tiredness; feeling like I had the flu; extreme weakness; rapid heartrate; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration in the left arm on 29Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy, coronary artery disease (CAD), hypertension (HTN), pulmonary hypertension, sick sinus syndrome, hypothyroidism, hyperlipidemia, osteoporosis, chronic kidney disease (CKD), and diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included alprazolam (XANAX), venlafaxine hydrochloride (EFFEXOR), quetiapine fumarate (SEROQUEL), sertraline hydrochloride (ZOLOFT), isosorbide mononitrate (IMDUR), and metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 02:15, the patient experienced extreme soreness in left upper arm, chills, headache, tiredness, feeling like she had the flu, extreme weakness, and rapid heartrate. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.
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| 60 | 2021-03-07 | malaise |
On the day of the shot, by Noon I could feel the vaccine moving into my throat and my face. My thr...
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On the day of the shot, by Noon I could feel the vaccine moving into my throat and my face. My throat and left cheek started to swell and turn slightly red. I took more Benadryl and called my allergist in the afternoon. They told me I needed to get to the hospital for treatment. At the hospital, they gave me steriods, benadryl and Pepcid in an IV. After allowing this to work, they sent me home with a steriod prescription for 60Mg for the next 5 days. They asked me to follow up with my allergist if I had other issues , they also told me that I would not be able to get the 2nd dose of the vaccine. Over the next several days, I continued to have issues with this redness that had grown over my entire face. I looked like I was totally sunburned. I did not feel well, the redness was very hot, and I struggled with some breathing. I made an appointment on Monday morning with my allergist, and they adjusted my allergy medicine and gave me more asteroids for 5 more days. They advised me to use my nebulizer treatments as needed to remove the heaviness in my chest. This redness and swelling has moved around my body, almost as if I can see where the vaccine is at in my body. It went from my head to my chest/back and right arm. Down to my abdomen, and then down below my knees. In the morning, it is usually in my face and then it moves around during the day. I can feel this fluid moving around in my body because the redness brings swelling/fluid. This last saturday 3/6/2021 was horrible, it was in my right ear and right foot. It was very painful and made me very dizzy. I struggled to walk. Then on Sunday morning, I felt fine all day. Today Monday, it feels like it is in my right foot again, but I feel like It is getting better.
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| 60 | 2021-03-07 | fever | Fever greater than 104° for 24 hours. Syncope for 24 hours following that. |
| 60 | 2021-03-08 | chills, fatigue, fever | Low-grade fever, chills, body weakness, aches, brain fog, fatigue |
| 60 | 2021-03-08 | chills, fever, fatigue | fever, chills, back pain, fatigue, loss of appetite, foggy |
| 60 | 2021-03-08 | headache, chills |
Injection site pain, muscle pain, could not raise arm up high, chills, whole body ached, joints hur...
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Injection site pain, muscle pain, could not raise arm up high, chills, whole body ached, joints hurt, weak, mild consistent headache, nausea, skin sensitivity, feeling like a bad case of the flu for 30 hours. Getting better by Sunday evening. Still not 100% as of Tuesday. Slight headache comes and goes like a sinus infection would feel like.
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| 60 | 2021-03-08 | headache |
High Blood Pressure now am on medication and I have never had High blood pressure nor have I been on...
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High Blood Pressure now am on medication and I have never had High blood pressure nor have I been on BP medication. I have been taking medication for 2 weeks and my BP has maintained high
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| 60 | 2021-03-09 | cough |
acute chest tightness, chest pressure, SOB, severe cough, tachypneic, throat closing feeling hoarse ...
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acute chest tightness, chest pressure, SOB, severe cough, tachypneic, throat closing feeling hoarse voice, presyncope but epipen administered on site of vaccination location to avert syncope or cardiovascular collapse promptly. Symtoms occurred within 10 minutes of vaccine administration . Vaccine given 12:18 pm or 12:25 pm and symptoms within 10 minutes since in ER 12:30 pm but had received epipen en route before ER arrival since medical building was next to ER
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| 60 | 2021-03-09 | headache |
mild headache, sore arm at injection site, mild nausea, mild weakness. sore arm immediately after in...
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mild headache, sore arm at injection site, mild nausea, mild weakness. sore arm immediately after injection lasting 2 days. Headache, nausea and weakness day after vaccination lasting 24 hours.
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| 60 | 2021-03-09 | headache |
Vaccination was a 7:45 am Monday. On Tuesday at mid morning I started showing an allergic reaction....
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Vaccination was a 7:45 am Monday. On Tuesday at mid morning I started showing an allergic reaction. Itchy red spots all over head, ears and neck, some on lower part of body. Swollen lip. Took two benadryl at 1:45 am Wednesday . This helped to ease the itching. Had a headache so on Wednesday morning I took two Tylenol and made a Dr. appt. Also was weak and faintish on Wednesday when I got up. Dr's said to keep taking anti-histamines and report to ER if tongue or throat starts to swell.
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| 60 | 2021-03-09 | headache |
sever headache itching over entire torso both began about an hour after injection. Lasted through th...
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sever headache itching over entire torso both began about an hour after injection. Lasted through the evening and night Took Tylenol
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| 60 | 2021-03-09 | sweating, body temperature increased, fatigue |
Saturday, March 6 felt fine all day with normal activity. Woke up at 7:05 am Sunday, March 7 with d...
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Saturday, March 6 felt fine all day with normal activity. Woke up at 7:05 am Sunday, March 7 with dizziness, nausea and sweats that would last about a minute. Remained sitting still with my eyes closed about 3 hours and then eyes could be open but could not move without the dizziness and subsequent nausea. I did not vomit. My temperature was-low in the morning but climbed just to 99.3 Sunday. By Sunday afternoon, I no longer had the short sweats but remained dizzy and nauseous mostly upon any movement. I went to sleep at 11:00 pm Sunday night with the slight 99 fever. Woke Monday , March 8 much improved from the dizziness and temperature 98.6., but felt extreme tiredness. I did not go tot work Tuesday and rested on the couch most of the day-temperature 98.6.
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| 60 | 2021-03-09 | fever, chills |
On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3...
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On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3, chills, body aches and weakness On day 4 after second dose had severe back pain, painful to walk, despite taking Motrin. Went to doctor and had MRI done. Then by early February started having insomnia, hard time falling asleep and staying asleep . I feel the second dose of vaccine might have caused my immune system to become over active. The back is now ok after rest and physical therapy but the insomnia still persist.
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| 60 | 2021-03-09 | fever, headache, chills |
Fever ranging from 100 to 100.9; Chills; Headache; Soreness at site of injection; This is a spontane...
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Fever ranging from 100 to 100.9; Chills; Headache; Soreness at site of injection; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249), via an unspecified route of administration in left arm, on 05Feb2021 at 12:30 PM, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231) on 13Jan2021 at 01:45 PM for COVID-19 immunization (in left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 06Feb2021 at 02:00 AM, the patient experienced fever ranging from 100 to 100.9 accompanied by chills and moderate headache as well. Fever subsided by the morning of 07Feb2021 and headache was mild by then. The patient also experienced soreness at site of injection on 06Feb2021 at 02:00 AM only if she touches it. No treatment was administered for the adverse events. The patient has not been tested for COVID-19 post vaccination. The patient was recovering from the events.
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| 60 | 2021-03-10 | chills |
Tingling/numbness started in feet and then worked it?s way to the top of my head. The tingling/numb...
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Tingling/numbness started in feet and then worked it?s way to the top of my head. The tingling/numbness lasted about 10 hours and gradually diminished from my feet up to my head. About 2 hours after the tingling/numbness started I felt my blood pressure or blood sugar start to fluctuate up and down for about 2 hours. I stayed in bed for this time period. I felt light-headed and scared. After about two hours, I felt stable enough to get out of bed and ate some food and drank some liquids. The numbing/tingling sensation seemed concentrated around my head for hours. I couldn?t really focus on anything. It felt like when your foot falls asleep. I felt as if I was having a neurological reaction because of the weird tingling numbness sensation. It felt like my nerve endings were firing all over; like having the chills without being cold. Although the biggest event was on 2/28, I felt the tingling ing/numbness in my arms on and off for at least another week. I?m scared to get the 2nd dose.
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| 60 | 2021-03-10 | chills |
1/11 vaccination 1/12 I just had body aches, chills. 2:13 PM i was on my couch, I could hear myself ...
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1/11 vaccination 1/12 I just had body aches, chills. 2:13 PM i was on my couch, I could hear myself having trouble breathing while dreaming. I sat up, elevated, and went back to sleep. SOB that afternoon. I slept and woke up the next day and felt fine, went to work. 1/14 I worked all day. 3:10 I couldn't breath. Was with my neurologist. Pulsox was 79. I went to the ER. Hooked me up to IV, chest xray. Dr. said anxiety was up. After 4.5 hours I was able to go home. symptoms subsided.
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| 60 | 2021-03-10 | cough, fatigue, headache, throat pain | sore throat, headache, very tired, hard to move the left arm, cough occasionally. |
| 60 | 2021-03-10 | fatigue | Joints swollen and moderate fatigue Feels like a Lupus flare |
| 60 | 2021-03-10 | fever, chills |
My Arm Pit and my Breast on my right side of my body became so painful as if I had a major injury or...
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My Arm Pit and my Breast on my right side of my body became so painful as if I had a major injury or surgery. Tylenol and Aspirin could not control the intense pain. The pain was excruciating!! I also had aches, fever, chills and tender lymph nodes in my neck. The excruciating pain last 3-4 days. 7 days later I still have tenderness in my breast and arm pit.
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| 60 | 2021-03-11 | cough | Itching, coughing, wheezing, |
| 60 | 2021-03-11 | fatigue, headache | Headache, vomiting, nausea. No fever, but very tired |
| 60 | 2021-03-11 | fatigue |
Fatigue starting at 20:25 on 1/27/2021. Ended on arising on 1/29/2021 at 0530 Nausea with vomiting...
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Fatigue starting at 20:25 on 1/27/2021. Ended on arising on 1/29/2021 at 0530 Nausea with vomiting starting at 2200 on 1/27/2021. Continued thru the night and early morning hours stopped at approximately 0930 on 1/28/2021 Diarrhea starting after midnight on 1/28/2021 Ended at 0700 on 1/28/2021
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| 60 | 2021-03-11 | fatigue |
Approximately 10 hours after the vaccine, I awoke with pain in all the joints in my body. I took Ibu...
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Approximately 10 hours after the vaccine, I awoke with pain in all the joints in my body. I took Ibuprofen and went back to sleep. When I woke up later I felt better but was tired and achy for the next 24 hours. I continued taking Ibuprofen So adverse event lasted approximately 48 hours
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| 60 | 2021-03-11 | headache |
Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started aro...
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Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started around 1 pm March 8 and subsided by 8 am March 9
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| 60 | 2021-03-11 | fever, fatigue |
Extreme fatigue from 1620 on 1/6 gone when arose at 730 on 1/7 Fever starting at approximately 1900....
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Extreme fatigue from 1620 on 1/6 gone when arose at 730 on 1/7 Fever starting at approximately 1900. Fever broke in the early am approximately 0300 awoke and noted wetness as if had been sweating No fever when arose
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| 60 | 2021-03-13 | chills, fever, headache |
Burning sensation at injection site, felt itching in ears when administered. Felt sore since vaccine...
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Burning sensation at injection site, felt itching in ears when administered. Felt sore since vaccine was administered. Today, 03/14, woke up feeling very sore and around 11:45am I began to feel chills, body aches, headache and fever.
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| 60 | 2021-03-13 | fatigue |
Extreme energy within 30 minutes of injection Followed about 2 hours later by extreme fatigue (slep...
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Extreme energy within 30 minutes of injection Followed about 2 hours later by extreme fatigue (slept over 3 hours between 11am and 3pm) Severe pain at the injection site and muscles surrounding it (approx. 8pm) continuous as of this report (3/14/21 12:45am) Pain in the lower left jaw (approx 9pm) continuous as of this report (3/14/21 12:45am)
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| 60 | 2021-03-13 | headache, chills, fatigue | Chills, headache, nausea, body aches and fatigue |
| 60 | 2021-03-13 | headache, fatigue, malaise, fever, chills |
INJ. PAIN 3/11/2021 TIREDNESS 3/12 &13/2021 HEADACHE 3/11 & 12/ 2021 MUSCLE PAIN 3/11 & 12/2021 C...
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INJ. PAIN 3/11/2021 TIREDNESS 3/12 &13/2021 HEADACHE 3/11 & 12/ 2021 MUSCLE PAIN 3/11 & 12/2021 CHILLS 3/12 & 13/2021 JOINT PAIN 3/11/12/13/2021 FEVER 3/12/13/2021 102.5 & 100.2 FEELING UNWELL 3/12/13/2021 I JUST KEPT TAKING TYLENOL TILL I FELT BETTER. I AM FINE TODAY. 3/14/2021
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| 60 | 2021-03-13 | headache | Severe diahrrea, lightheadedness, headache, legs ached- started around 4:00 pm No treatment |
| 60 | 2021-03-13 | headache |
red rash around injection site soreness at injection site had bump on injection site body aches head...
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red rash around injection site soreness at injection site had bump on injection site body aches headache
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| 60 | 2021-03-13 | headache | Nausea and vomiting, dizziness, stomach upset, no appetite, headache |
| 60 | 2021-03-13 | sweating, headache |
2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:...
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2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:50 am woke to hot sweating and cold lightheaded and dizzy, nauseous and dry heaves. Rash on shot spot and surrounding area. Skin peeling at bandage area. 11:00 am shot area sore. Bandage area still a rash and slight peeling of skin.Dizziness is gone and nausea is gone. No headache
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| 60 | 2021-03-14 | fatigue, fever, chills | Achy, slight fever (100.2), tired, chills. |
| 60 | 2021-03-14 | fatigue |
swollen lymph nodes; tiredness; diarrhea; This is a spontaneous report from a contactable consumer (...
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swollen lymph nodes; tiredness; diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 10Feb2021 09:15 at single dose for COVID-19 immunisation in workplace clinic. The patient's medical history included AFib, hypertension, known allergies: TB test (allergies to medications, food, or other products: TB test). Concomitant medications included apixaban, digoxin, metoprolol, enalapril; the patient received all the drugs within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), in left arm on 20Jan2021 09:15 AM at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On an unspecified date in 2021, the patient experienced swollen lymph nodes, tiredness, diarrhea. The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the events was recovering.
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| 60 | 2021-03-15 | chills, fatigue | Achy, chilly and tired the next day |
| 60 | 2021-03-15 | chills, fever |
15 hours after vaccination sever diarrhea and vomiting, which lasted 8 hours. Chills and shaking. Fe...
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15 hours after vaccination sever diarrhea and vomiting, which lasted 8 hours. Chills and shaking. Fever that climbed to 102.7 and lasted 24 hours. Took acetaminophen. Fever back to normal on 3/16/2021, four days after the vaccination.
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| 60 | 2021-03-15 | fatigue, chills |
experienced chills and body pain on the 3rd day after receiving the 2nd dose vaccine . chills and bo...
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experienced chills and body pain on the 3rd day after receiving the 2nd dose vaccine . chills and body pain lasted for 2 days . on the fifth day felt like black curtain in front of my eyes and felt dizzy. checked my blood pressure was 170/90. Blood pressure went up to 200/100 . went to the hospital emergency and was admitted for observation overnight. CT, MRI , blood work done. BP controlled with medication Nefidefine 60mg. discharge home next day. was still having very light headedness and BP will shoot up to 190/90. physician had to change the medications couple of time. felt very exhausted . could not go to work almost 3 weeks because of the symptoms like lightheadedness. lasted at least 4 weeks to get back to work normal. never experienced this before. I was taking Olmasartan 5mg for blood pressure and my Bp always stated 130/80s
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| 60 | 2021-03-15 | fatigue, headache | Headache, nausea, fatigue |
| 60 | 2021-03-15 | fatigue, malaise, chills |
About 13 hours after receiving vaccine I awoke close to midnight feeling ill. I spent the next 3 hou...
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About 13 hours after receiving vaccine I awoke close to midnight feeling ill. I spent the next 3 hours having bouts of diarrhea every 5 to 10 minutes along with chills and feeling hot and abdominal pain. This morning on the 16 of March I feel okay with some fatigue and sore right shoulder at injection site.
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| 60 | 2021-03-15 | headache |
Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt t...
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Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt taken to vaccine clinic observation area to be closely monitored. Pt placed on gurney and given water to drink. VS stable. Pt report headache 5/10, feeling sensitive to light, and nauseated. While in observation area pt reports feeling what she describes as "feeling weird wavey sensation over entire body, warm head, and cool body." Pt offered but declined to go to ED. explained risks and benefits to pt. Pt states that she drove herself to vaccine clinic. Pt advised that it it would be unsafe to drive herself home and advised to to contact husband for ride home. Pt called her husband to pick her up. After several min pt states stated that she was "feeling a little better" and "headache was also a little better" 3/5 on pain scale but still feeling dizzy and chest feeling a little tight. " Pt states having a history of Asthma. Pt again offered to be treated in ED and accepted. Pt transported to ED by gurney accompanied by three RN's.
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| 60 | 2021-03-15 | throat irritation |
3/12 ? Got vaccine at 1:40 pm and within about 1-2 minutes, I felt a sensation of heat in my throat ...
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3/12 ? Got vaccine at 1:40 pm and within about 1-2 minutes, I felt a sensation of heat in my throat and upper chest. It got a bit worse and then improved over the next few hours. I also experienced a scratchy/itchy sensation in my throat and a slightly itchy feeling on the skin of my neck and upper chest. No wheezing or swelling. Took 25 mg Benadryl at bedtime. 3/13 ? Sensations continued, still fairly mild, but with occasional tingling on lips in addition to other symptoms. Took 25 mg Benadryl at bedtime. 3/14 ? Feeling about the same; still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime. 3/15? Symptoms continue to improve, but I?m still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime.
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| 60 | 2021-03-16 | body temperature increased, dehydration |
The event began with me feeling extremely cold and unable to warm up. It later progressed to needle...
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The event began with me feeling extremely cold and unable to warm up. It later progressed to needle like sensations where ever touched. I do not remember the next week. Per my husband I had a sustained temp of 102 and was difficult to keep hydrated. My O2 sats remained stable. The following week I became unable to drink anything thicker than water. This has improved but continues to this day. My husband is a physician.
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| 60 | 2021-03-16 | chills, fever, headache, fatigue |
Beginning on the second day after the patient first vaccine she began experiencing fever up to 102.5...
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Beginning on the second day after the patient first vaccine she began experiencing fever up to 102.5, body aches, headache, profound fatigue, chills and nausea. She came to my clinic as this is her 9th (ninth) day of experiencing fevers and fatigue. The other symptoms have resolved.
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| 60 | 2021-03-16 | chills | Felt anxious, with chills/tingling in feet. BPs 174/77 (pulse 71), O2 sat 98%. Final BP 134/75. |
| 60 | 2021-03-16 | fatigue, headache | left arm soreness, headache, upset stomach, tired |
| 60 | 2021-03-16 | fatigue, fever, chills |
12 hours post vaccine, began to experience extreme chills, hyperventilation, breathing difficulties,...
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12 hours post vaccine, began to experience extreme chills, hyperventilation, breathing difficulties, and fever of 103. Couldn't talk due to chills without extreme stuttering. Ended up being transported to a local ER for care where I remained for approximately 7 hours. Was given IV fluids and Toporol to control fever. Fever persisted for 72 hours, loss of appetite and extreme fatigue. Now 7-days post 2nd shot and still experiencing fatigue.
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| 60 | 2021-03-16 | fatigue | Extreme fatigue |
| 60 | 2021-03-16 | head discomfort |
As I pulled up for the 15 minute wait period the symptoms started 5 minutes after I received my vacc...
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As I pulled up for the 15 minute wait period the symptoms started 5 minutes after I received my vaccine. A tingling feeling up my left arm to back of my neck. My neck stiffened and then my throat started to close. Not to where I can't swallow but just like when I eat food that I'm allergic too, it closes up. The nurse that was overseeing me was holding the umbrella over my car window with the rainfall. All of a sudden their was lightning & thunder. The nurse threw the umbrella because she was shocked from the lightning. She started to talk to all the other around her and forgot about me. Since I could still swallow I didn't get her attention. When she returned she asked me the time so I had to pull my phone out. She didn't know the time of my 15 minutes and sent me away. As soon as I got out of the parking area but still inside amusement park, I started to feel my cheeks becoming numb and my right eye was blurry. I quickly moved over to the side lane still inside of amusement park and waited. I called my husband and told him that with the heavy rain I didn't feel safe driving with my right eye being blurry. I waiting another 15 minutes before driving home. That evening the blurriness came back, my eye's & forehead was tender to touch but no headache. Only pressure in my head. My symptoms of closed throat, swollen cheeks, pressure in my head and blurriness continued on Friday, March 12th, Saturday, March 13th, Sunday, March 14th and Monday, March 15th. As of today, no other systems other than feeling my body has inflammation.
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| 60 | 2021-03-16 | headache, fatigue, throat pain | Dizzyness, nausea, severe headache, painful arm, sore throat, fatigue. |
| 60 | 2021-03-16 | headache |
03/15/21 @3:30AM awoke with significant headache and vertigo, room spinning around me, could not lay...
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03/15/21 @3:30AM awoke with significant headache and vertigo, room spinning around me, could not lay flat. By about 7:00AM vertigo stopped, had HA, dizziness with loss of balance. Ibuprofen 400mg q3-4 hrs, sudafed 30mg q4 hrs. Continued unchanged x 48 hrs. Today, 03/17/21, HA, dizziness, loss of balance somewhat improved, still taking ibuprofen 400mg every 4-5 hrs . Had covid in January 2021 with HA and vertigo as presenting symptoms.
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| 60 | 2021-03-16 | headache |
Fifteen minutes after vaccination pt c/o lightheadedness; symptoms progressed w moderately severe he...
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Fifteen minutes after vaccination pt c/o lightheadedness; symptoms progressed w moderately severe headache and nausea. She was hemodynamically stable no signs of any allergic reaction. There are concerns her V-P shunt is not working properly. After lying in a recumbent position for 30+ minutes headache worsened. We elected to transport to ER, via ambulance so she was recumbent during transport.
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| 60 | 2021-03-16 | headache |
A few days after the vaccine on that Wednesday I began having pain in the upper shoulder and back ar...
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A few days after the vaccine on that Wednesday I began having pain in the upper shoulder and back area which persisted to a heaviness in my chest going into Thursday. Thursday night I woke up in the middle of the night to the feeling of not being able to breathe. I laid awake for a while but dosed back off and it happened again a little later. It felt as if someone was sitting on my chest which prompted me to go to the ER the next day. Various test were done and I was admitted in the hospital for further observation. After admission I developed a massive headache which lasted from that Friday afternoon until that Sunday. I was released on that Sat and the symptoms seemed to be getting better and by that Sunday evening all symptoms had subsided.
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| 60 | 2021-03-16 | sweating | Hot Flash with Sweats, Followed by fainting, Non-responsive, Elevated blood pressure |
| 60 | 2021-03-16 | malaise, headache, fever |
Just a few hours after receiving my first Vaccine, I started running a fever of 99.9, Got real sick ...
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Just a few hours after receiving my first Vaccine, I started running a fever of 99.9, Got real sick at my stomach, started have Diarrhea, Severe Headache, My arm hurt really bad could not use it for a Day and 1/2. Just felt like I had been run over by a Bulldozer.
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| 60 | 2021-03-17 | body temperature increased, fatigue |
/o sore arm & fatigue since receiving the vaccine on Friday. Deveolped low grade temp on Monday, tak...
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/o sore arm & fatigue since receiving the vaccine on Friday. Deveolped low grade temp on Monday, taking tylenol & ibuprofen PRN, No other complaints at this time. Advised to continue with Tylenol/ibuprofen and contact PCP if symptoms worsen.
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| 60 | 2021-03-17 | body temperature increased | Temperature 103 degrees and weakness |
| 60 | 2021-03-17 | head discomfort |
After about 10 minutes felt head pressure and light headedness. Reclined patient - lightheadedness r...
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After about 10 minutes felt head pressure and light headedness. Reclined patient - lightheadedness resolved; slight nausea when leaving - felt much better
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| 60 | 2021-03-17 | headache |
Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness ...
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Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness and soreness in arms; Heaviness and soreness in arms; has a sore spot only where the COVID vaccine was; This is a spontaneous report from a contactable pharmacist (patient). A 60-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN9581), via an unspecified route of administration on 04Feb2021 at 10:20 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included ongoing multiple sclerosis. There were no concomitant medications. The patient previously received the first dose bnt162b2 (Lot: EL3249) on 14Jan2021 for COVID-19 immunisation and experienced couldn't re stand. The patient experienced could stand, couldn't walk on 05Feb2021, frontal headache, heaviness and soreness in arms on 04Feb2021, swollen lymph nodes in left arm on 05Feb2021, neck ache on 04Feb2021 at 22:00, had a sore spot only where the covid vaccine was in Feb2021. Event details: The patient had the second COVID vaccine on 04Feb2021. Was fine that day. Had heaviness in her arm and little bit of headache. Was fine the day of the shot. 04Feb2021, felt a little heavy in the arm where she got the COVID shot. Received COVID vaccine in left arm. Drove home and was fine. Sat down and watched TV and had a frontal headache. Took Tylenol. By the time she went to bed, around 10:00 PM, her neck was so sore to turn from side to side. On top of her arms where shoulder pads would be is there the heaviness was. Both arms became sore. It was manageable and she took Tylenol. Eventually it went away. Friday morning 05Feb2021 when she got up, got to the point where she got out of bed and couldn't get up. There was no possible way for her to get up. Her husband had to buy her a 3-in-1 potty chair so she could just stand and pivot, seriousness was provided as disabling, could understand hospitalization, but confirmed she never went to the hospital. Could not rest that day or go back to the bathroom. Didn't walk anywhere. Was in a chair that she could sleep in. Husband bought her a potty chair. Was able to use the lift on the lift chair later that afternoon. Definitely debilitating. Sister who was an orthopedist nurse had to help her and secured she wouldn't fall. The patient had swollen lymph nodes only in the left arm on 05Feb2021. At time of reporting the patient had a sore spot only where the COVID vaccine was. It was not red. Only sure up underneath and when it was touched. The outcome of events could stand, couldn't walk, heaviness and soreness in arms was resolved on 06Feb2021, outcome of other events was unknown.; Sender's Comments: Based on available information, due to close temporal association, a possible contribution roe of bnt162b2 to the onset of "unable to walk" cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 60 | 2021-03-17 | headache |
I already alerted you to the rash and itching. I got a headache starting about 30 minutes after the ...
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I already alerted you to the rash and itching. I got a headache starting about 30 minutes after the shot. I started having what looked like bruising all along the veins in my arms and hands. Still have that. I went to the doctor and also found that I had high blood pressure and an elevated heart rate. BP 140/90 and Heart rate 85. My normal heart rate is between 55-60 and my usual blood pressure is 108/70. The doctor gave me a steroid shot. This morning, my blood pressure and heart rate were still high and I still had a headache. Then the headache stopped and I took my blood pressure and it was down to around my usual 108/70 and the heart rate was 60. So hopefully I'm starting to recover from this shot.
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| 60 | 2021-03-17 | fever, chills, fatigue | Soreness, fever, chills, fatigue |
| 60 | 2021-03-17 | fever | Fever 101.7 |
| 60 | 2021-03-18 | body temperature increased, chills |
Mild aches and chills. Temp 100.4 for part of the day. Symptoms started about 7AM and chills and a...
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Mild aches and chills. Temp 100.4 for part of the day. Symptoms started about 7AM and chills and aches were over by 4-5 PM. Temp was 99:4 at bedtime and normal this morning and feel fine today. Only reactive symptoms after 2nd vaccine.
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| 60 | 2021-03-18 | chills | Fast resting heart rate (>100 bpm), chills, difficulty/pain taking deep breath, dizziness |
| 60 | 2021-03-18 | cough |
I started throwing up and had diarrhea by around 10 pm, did that about 4 times, my stomach was so bl...
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I started throwing up and had diarrhea by around 10 pm, did that about 4 times, my stomach was so bloated, it was weird. The next day, couldn?t get out of bed, all I had yesterday was diarrhea and felt like someone kicked me in the ribs. Today I am having a hard time taking a deep breathe or coughing without my ribs hurting so bad. My stomach feels better. Haven?t eaten anything, I am more concerned about under my breast hurt so much when I take a deep breathe or cough. I haven?t gone to doctor because I just wonder if it hurts so much there because if the vomiting
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| 60 | 2021-03-18 | fatigue |
Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pa...
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Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pain on and off; Arrhythmia; This is a spontaneous report from a contactable physician. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on 11Feb2021 09:00 (batch/lot number was not reported) as single dose for COVID-19 immunisation. Medical history included (G60.9) PN - Peripheral neuropathy (SCT42658009), (M79.2) A Neuralgia (SCT16269008), (R55) Syncope (SCT271594007), (I10) HTN - Hypertension (SCT38341003), (R00.0) Tachycardia (SCT3424008), (E16.2) Hypoglycemia (SCT302866003), (R55) Vasovagal symptom (SCT248229009), (M25.50) Joint pain (SCT57676002), (F41.9) Anxiety (SCT48694002), (K21.9) Acid reflux (SCT235595009), and (M06.4) Polyarthritis (SCT416956002); all were current or ongoing. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 12Jan2021 for COVID-19 immunization (product: COVID 19, brand: Pfizer, administration time: 09:00 AM, route: intramuscular, vaccine location: left arm). On 11Feb2021 11:00, the patient experienced dizzy, nausea, vomit, pain on all body, frequent fall, severe fatigue, strange feeling, abdominal pain on and off, and arrhythmia. The AEs resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. There were no treatments given for the events. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID post vaccination. The patient has no known allergies. No other vaccines received within four weeks prior to COVID vaccine. The events were reported as serious and disabling. The patient has not recovered from all the events. Information on the lot/batch number has been requested.; Sender's Comments: Drug causality for suspect drug in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 60 | 2021-03-18 | headache, chills, fever |
Body aches; fever (100.5); chills; nausea; headache; This is a spontaneous report from a contactable...
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Body aches; fever (100.5); chills; nausea; headache; This is a spontaneous report from a contactable consumer, the patient (patient). A 60 -years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration in the left arm on 12Feb2021 at 14:15 as a single dose, for COVID-19 immunization. Historical Vaccine includes BNT162B2, Dose 1, Lot number EL8982, Administered on 22Jan2021 at 14:30 in the right arm. Medical history included Allergy: Egg intolerance. Concomitant medication includes Prempro, and multi vitamin. The facility in which the vaccine was administered No other vaccines were given within 4 weeks. On 13Feb2021 at 13:00 the patient experienced Body aches, fever (100.5), chills, nausea, headache. No treatment was given for the events. Lab data includes Body temperature 100.5 on 13Feb2021. The clinical outcome of the events Body aches, fever (100.5), chills, nausea, headache were not recovered.
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| 60 | 2021-03-18 | headache, fatigue |
Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fat...
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Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fatigue Day 3: unable to lift left arm, headache Day 4: sore arm, 3" oval shaped red spot next to shot spot: swollen, raised, itch Day 5: arm better, red spot still itch Day 6: able to lift arm, less sore, red spot smaller, still itch, shot spot still itch too Day 7: arm almost back to normal, red spot diasppeared Day 8: all 10 toes red, swollen, extremely itch, unbearable especially at night Day 9 - 10: different toes itch more each night Day 11 (3/17): visited urgent care - diagnosed fungal infection Day 11: visited Primary Care Physician : referral to visit Podiatrist Day 13 (3/19): visited Podiatrist - diagnosis COVID Pfizer Vaccine side effect, prescription: Betamethasone
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| 60 | 2021-03-18 | headache |
Date and time adverse event started: 3/18/21 1520 immediately 1707 Caller states about 2 hours ag...
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Date and time adverse event started: 3/18/21 1520 immediately 1707 Caller states about 2 hours ago called was given Pfizer in the Left deltoid. Felt slight pain then when needle withdrawn started bleeding. Pressure was applied for about 45 minutes dressing changed two times. now has a band aid over the area. Area is starting to bruise and the patient is getting a headache. Patient has a grape sized hard knot at the injections site. Patient using ice indirectly for 10 minutes on 10 minutes off. Caller questions if vaccine went into the blood stream will it be effective, or does the vaccine need to be placed in the muscle to have time to replicate to be effective. . Does caller need another first shot.
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| 60 | 2021-03-18 | sweating, chills, fatigue, fever, malaise |
Arm was sore at bedtime. By the morning, I could barely move my right fingers. Very sore and tired ...
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Arm was sore at bedtime. By the morning, I could barely move my right fingers. Very sore and tired the day after. I was incredibly sore everywhere - back,chest, hips, legs, neck... very hard to move. Around 5 PM the day after the vaccination, I became violently ill. Diarrhea, chills, feverish, sweating. etc. This lasted until about 3 AM on the 18th.
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| 60 | 2021-03-19 | chills, headache, fatigue, malaise, fever |
Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, ...
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Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, violent headache, chills fevers ,dry heaves, red and hot arm developed after couple days lasted about six days spread to 4x6 inches got itchy then sore to touch. Became vague and almost disoriented, had to sleep due to overwhelming fatigue w vile headache
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| 60 | 2021-03-19 | chills, headache |
At approximately 2:00 AM I woke up with body aches, a very bad headache, and chills. These symptoms...
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At approximately 2:00 AM I woke up with body aches, a very bad headache, and chills. These symptoms continued for the next twelve (12) hours and disrupted my ability to function normally.
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| 60 | 2021-03-19 | fatigue, headache, throat pain | Body aches, headache, fatugue, sore throat, sore arm |
| 60 | 2021-03-19 | fatigue, headache | Headache, injection site pain, nausea, tiredness, joint pain |
| 60 | 2021-03-19 | fatigue, fever | Fibromyalgia flare and nerve pain, low grade fever, extreme fatigue second day after vaccination |
| 60 | 2021-03-19 | fatigue |
Severe debilitating fatigue that began the day after the vaccine (as expected), but has persisted; f...
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Severe debilitating fatigue that began the day after the vaccine (as expected), but has persisted; fatigue is so severe that I have had to stop working. I am a physician doing telemedicine
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| 60 | 2021-03-19 | fatigue |
swelling where shot was given and could not lift my arm for 2 days. Nausea for 2 days and really ...
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swelling where shot was given and could not lift my arm for 2 days. Nausea for 2 days and really tired.
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| 60 | 2021-03-19 | headache, malaise, fatigue | Fatigue malaise headache nausea on March 19 all day ... fine on March 20 |
| 60 | 2021-03-19 | influenza like illness | Swollen Lymph Nodes under arm where shot was given,; Flue like symptoms - no doctor visits yet |
| 60 | 2021-03-19 | fever, chills, headache | Fever , chills, headache, body ache, nausea |
| 60 | 2021-03-19 | fever | Body aches, fever (100.8 - my regular temp is 97.5, very low energy |
| 60 | 2021-03-20 | chills, body temperature increased, malaise |
I felt fine when I woke up. My left arm was very sore which also was the case after first vaccine. A...
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I felt fine when I woke up. My left arm was very sore which also was the case after first vaccine. Around 10 am I developed chills and just did not feel great. My husband took my temp and the highest it got was 102.6 which is high for me since my baseline is 97.6 or so. I did not have a great appetite and felt very stiff when I moved around. I pushed fluids and took 3 naps Saturday. I have a low grade fever of 99 today but feel much better. Did take 2 naps and slept well last night. Took Advil with each meal and doing so today.
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| 60 | 2021-03-20 | chills, malaise, headache, fever |
Fever (fluctuated between 99 and 102 degrees), chills, achy body, nausea, headache for approximately...
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Fever (fluctuated between 99 and 102 degrees), chills, achy body, nausea, headache for approximately 12-15 hours did not feel well. The next morning (Sunday 3/21) woke up nauseous and had trouble breathing. Went outside for cold air and breathing was OK.
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| 60 | 2021-03-20 | chills | Chills, itching, swelling of lips, itchy eyes, sore joints, |
| 60 | 2021-03-20 | fatigue, headache |
nausea & lightheadedness (10 minutes), diarrhea (one instance), fatigue (2 days), headache (1,5 days...
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nausea & lightheadedness (10 minutes), diarrhea (one instance), fatigue (2 days), headache (1,5 days), sore injection site (1 day)
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| 60 | 2021-03-20 | fever |
Chills, body aches and low-grade fever. Took 1-Tylenol 500 mg and 2-200 mg Ibuprofen. After 6 hours...
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Chills, body aches and low-grade fever. Took 1-Tylenol 500 mg and 2-200 mg Ibuprofen. After 6 hours fever was gone and feeling better.
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| 60 | 2021-03-20 | sinus congestion, fatigue, influenza like illness, headache |
Same symptoms as when I had Covid in November 2020. Extreme fatigue, headache, nausea, sinus congest...
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Same symptoms as when I had Covid in November 2020. Extreme fatigue, headache, nausea, sinus congestion, severe flu-like symptoms. These lasted 48 hours.
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| 60 | 2021-03-20 | throat clearing |
COVID Vaccine clinic. Per chart review, pt received COVID vaccine at 1426. At approximately 1505 p...
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COVID Vaccine clinic. Per chart review, pt received COVID vaccine at 1426. At approximately 1505 pt c/o nausea and ran outside. Pt awake, alert, respirations easy and unlabored, no distress noted. No vomiting occurred. Pt stated history of throat swelling and facial swelling/rash after PCN. 1510: Pt stated nausea resolved. Pt Diabetic and had not eaten lunch. Juice and crackers given, pt tolerated well with no difficulty. Respirations remain easy and unlabored, no distress. 1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences. Pt to triage area via wheelchair by RN. BP 171/80 | Pulse 77 | Resp 17 | LMP 02/01/2013 (LMP Unknown) | SpO2 98% 1523: Pt awake, alert, c/o difficulty breathing. RN called for assistance, attempted to located on site MDs. 1526: No MDs on site, 911 called. BP 184/84 | Pulse 82 | Resp 20 | LMP 02/01/2013 (LMP Unknown) | SpO2 100% 1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now. 1530: Epinephrine given per MD order. 1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN. During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.
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| 60 | 2021-03-21 | chills |
Due to 4 days progressive worsen skin lesion. Lesion as erythema multiform, generalized on hand, for...
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Due to 4 days progressive worsen skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg; Oral ulcer; Chill; Body ache; Joint pain; Joints swelling; Diarrhea; This is a spontaneous report from a contactable other healthcare professional (HCP). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201), via unspecified route of administration in the left arm on 17Feb2021 as single dose for COVID-19 immunization. Medical history included hyperlipidemia. The patient had no known allergies. The patient is not pregnant. There were no vaccine in four weeks. Other medications in two weeks included cholesterol med. The previously received the first dose of BNT162B2 on 26Jan2021 12:00 intramuscular at left arm (lot number: EL9262) for COVID-19 immunization. The patient was seen at urgent care on 04Mar2021 due to 4 days progressive worsened skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg from 28Feb2021 (12:00 AM). Patient presented with chill, body ache, joint pain, joints swelling and diarrhea since second dose of vaccine on 17Feb2021. She also has oral ulcer at the same time when rash started on 28Feb2021. Vital sign was stable, no shortness of breath (SOB) and no chest pain. Events resulted in Doctor or other HCP office/clinic visit. The treatment for the events included Hydroxyzine 25 mg prn. It was unknown if patient had COVID prior vaccination or if COVID tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Erythema multiforme cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 60 | 2021-03-21 | fatigue, headache |
8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscl...
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8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscle soreness. Initially I noticed my knees hurting with radiating pain up into my thighs. My head hurt, particularly at the back of my skull, near my neck. My neck muscles were sore, as were BOTH shoulders - my right shoulder (injection site) was only slightly sorer than my left shoulder. I called a 24/7 nurse associated with insurance company to ask if ibuprofen or tylenol were acceptable treatments for my symptoms. She told me I could take either and alternate if I felt I needed to maximize relief. I noticed the joins in my toes and fingers were hurting. It was frightening to experience tightness in my chest and back muscles. I never felt like my lungs were compromised, there was just a heaviness as the muscles seemed constricted. I felt a slight rise in my heart rate and experienced a few palpitations mostly because I kept pondering how much worse my symptoms could get. I was a little cold, so I decided to go to bed after drinking extra water (also a suggestion from the nurse). I slept for a few hours 10:00 PM - 4:00 AM then got up and called an advise nurse to report that my joint and muscle pain were not subsiding. She encouraged water and more painkiller. As the day wore on, I felt less achy and more shaky/jittery. My thinking was somewhat unclear - I felt a little dizzy, out of balance, off-kilter and brain "foggy." As I write this 36 hours after my injection, my symptoms are subsiding. Where I felt a little chilled during our cool and rainy afternoon, I now feel a wave of heat sort of traveling through my body. It isn't a fever - just an odd sensation that something is still going on.
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| 60 | 2021-03-21 | fatigue |
Extreme fatigue starting next morning Saturday after vaccine. Slept almost continuously until Sunday...
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Extreme fatigue starting next morning Saturday after vaccine. Slept almost continuously until Sunday afternoon.
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| 60 | 2021-03-21 | head discomfort |
After about 20 minutes felt head pressure and lightheadedness, Reclined patient, light headedness re...
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After about 20 minutes felt head pressure and lightheadedness, Reclined patient, light headedness resolved. Slight nausea when leaving felt much better. VS 168/90; 73; 97%SaO2
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| 60 | 2021-03-21 | headache, chills, fever | Headache, site of injection hurt, swollen injection site, slight fever and chills |
| 60 | 2021-03-21 | headache, fatigue |
By eight pm my left arm started hurting. At 2:30 am Sunday morning it was hurting so bad it woke me ...
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By eight pm my left arm started hurting. At 2:30 am Sunday morning it was hurting so bad it woke me up. I could not raise my arm up past 6 inches. My left arm and side down to my waist was hurting. I took some Ibruprofen. Used a heating pad on my shoulder. Finally got back to sleep for a few hours. When I woke around 7:30 am, most of the pain had moved under my arm and to the front of my shoulder. I sat in my hot tub (100 degrees) for an hour and took more Ibruprofen. I was able to raise my arm up about half way. Was very tired. Went back to bed around 10 am and slept until 2:30. Had a headache and fatigue. Napped off and on the rest of the day. Today I can raise my arm all the way up, slowly. It is still painful to do so. The headache and fatigue are minimal.
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| 60 | 2021-03-21 | headache, fatigue |
extreme fatigue, headache, nausea, muscle aches, joint pain, low grade fever, chills, swollen lymph ...
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extreme fatigue, headache, nausea, muscle aches, joint pain, low grade fever, chills, swollen lymph nodes in neck and under arm, treatment was motrin 600 mgs q6hrs from 2/18/21-02/22/21 returned to work on 02/23 lymph nodes still slightly enlarged as of today, 03/22/21
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| 60 | 2021-03-21 | headache, fever, fatigue, chills, malaise |
Swollen lymph nodes under arms and in groin, headache, pain at injection site, tiredness, fever, chi...
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Swollen lymph nodes under arms and in groin, headache, pain at injection site, tiredness, fever, chills, felt unwell
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| 60 | 2021-03-21 | headache, fever |
Fever ~ 101F, started about 18 hours after injection, lasted about 8 hours Headache, started with fe...
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Fever ~ 101F, started about 18 hours after injection, lasted about 8 hours Headache, started with fever, lasted about 12 hours
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| 60 | 2021-03-21 | headache |
3-22-21 11AM TC: PT STATES ON '3-19-21 7PM SHE HAD SWELLING OF HER TONGUE AND RT SIDE OF FACE AND NE...
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3-22-21 11AM TC: PT STATES ON '3-19-21 7PM SHE HAD SWELLING OF HER TONGUE AND RT SIDE OF FACE AND NECK; SHE CALLED HER PCP WHO HAD HER SUE HER EPI PEN - THE SWELLING RESOLVED. ON 3-20-21 SHE ALSO HAD A EARACHE, HEADACHE AND BLOODY NOSE. HAS TAKEN TYLENOL.'
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| 60 | 2021-03-21 | malaise, chills |
03/19/2021 - 4 PM I STARTED TO NOT FEEL WELL. LEFT WORK - WENT HOME , STARTED TO SHAKE REALLY HARD...
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03/19/2021 - 4 PM I STARTED TO NOT FEEL WELL. LEFT WORK - WENT HOME , STARTED TO SHAKE REALLY HARD WITH COLD CHILLS. LAID DOWN WITH TWO BLANKETS AND WAITED FOR THE SHAKING TO STOP...THEN FELL ASLEEP. I AM GUESSING SHAKING WENT ON FOR A GOOD 1/2 HR TO HOUR. i WAS VERY WEAK TO GET UP TO GO THE BATHROOM. MY HUSBAND HELPED ME.
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| 60 | 2021-03-21 | nasal congestion, chills, headache |
Loss of appetite morning after vaccine, headache, body aches, chills, face flushed. Fever started af...
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Loss of appetite morning after vaccine, headache, body aches, chills, face flushed. Fever started afternoon. 99.4. Took Tylenol but it gradually rose to 102.3. Took 3 hours for fever to go down. By 5:30 fever was gone & I was feeling better. Next day I felt great but by three days later I had a fever blister & very sore, dry and stuffy nose which lasted two weeks. And headache as well. I?m thinking because of stuffy nose. I did have Covid last March/April 2020 so I have heard that I would have side effects.
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| 60 | 2021-03-21 | sinus pain, headache, chills | Chills, musculoskeletal pain, headache, sinus pain, nausea, tooth sensitivity |
| 60 | 2021-03-21 | throat clearing, throat irritation |
Complained of itchy throat and trouble clearing throat. BP 186/98, p140, O2 sat-97% Denies shortne...
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Complained of itchy throat and trouble clearing throat. BP 186/98, p140, O2 sat-97% Denies shortness of breath, no dyspnea, no trouble swallowing, no hives or rash. Did not bring her Albuterol with her Repeat BP in 5 minutes- 154/85, p-127, O2 sat-97% Evaluated by Dr. 1343: given Zyrtec 10 mg sublingual, 13:50 pm BP- 146/92, p-118, O2 sat- 97% states decreasing symptoms, no need to clear throat, slight itchiness in throat. denies shortness of breath, no dyspnea, no trouble swallowing, 1400- discharged home with instructions to use inhaler, call 911 or seek immediate care if symptoms return or worsen in any way She will take Claritin or Zyrtec prior to second shot and will also bring Albuterol
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| 60 | 2021-03-22 | cough, sinus congestion, headache, nasopharyngitis |
Patient reported symptoms on Sunday the 14th with a headache, cough, cold symptoms, sinus congestion...
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Patient reported symptoms on Sunday the 14th with a headache, cough, cold symptoms, sinus congestion, stuffy nose, and drainage. Patient is still congested, but other symptoms resolved. On 3/17/21 - Patient was tested and results were given to her on the 18th showing she was positive for Covid19.
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| 60 | 2021-03-22 | fatigue, headache, fever |
March 21 I had fever 101 , fatigue, nausea, body aches, headache that kept me from my daily function...
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March 21 I had fever 101 , fatigue, nausea, body aches, headache that kept me from my daily functions. Reporting app did not ask about that date and I want to report that was a bad day. I did not seek medical treatment. Treated with ibuprofen and rest
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| 60 | 2021-03-22 | headache, body temperature increased | Severe headache 101 temp Nausea Intense pain at injection site Intense body pains |
| 60 | 2021-03-22 | headache, malaise, fatigue |
I started feeling fatigued about 3 hours after vaccination. By evening I felt sickly (How you might...
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I started feeling fatigued about 3 hours after vaccination. By evening I felt sickly (How you might feel at the onset of a cold) and I started getting a bad headache. The headache lasted for 48 hours. It was severe and I had to stay in bed. I am just now starting to feel a little. better
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| 60 | 2021-03-22 | influenza like illness, headache, fatigue |
Flu-like symptoms: headache, fatigue, dizziness, nausea, swollen lymph nodes, sore arm beginning th...
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Flu-like symptoms: headache, fatigue, dizziness, nausea, swollen lymph nodes, sore arm beginning the evening of injection. All symptoms, except sore arm, gone by morning. No treatment given.
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| 60 | 2021-03-22 | fever, headache |
Within 1 hour after receiving vaccine, approx 45 min., Both ears suddenly felt as if I was on a pla...
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Within 1 hour after receiving vaccine, approx 45 min., Both ears suddenly felt as if I was on a plane and was blocked as you would feel by altitude change. I kept trying unblock by swallowing etc. That last 15ish minutes followed by a constant sound in both ears as if someone was rubbing sand paper back and forth in front of each year. That lasted 40-50 minutes. Approximately 32 hours after feel like I have to keep swallowing to unblock my ears. That altitude flucuation again feeling but not as bad as the first encounter. This was related to the vaccine. No doubt in my mine. Never had anything like this before unless on an airplane. Sand paper sound, never. I let my physician know tonight via email. In addition I felt dizzy within 5 minutes of receiving the injection. Subsided within 15 -20 minutes. Felt aloof the remainder of the day. Also arm hurt so bad the next day I had to cancel golf. Low grade fever plus headache
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| 60 | 2021-03-22 | runny nose, nasal congestion, fatigue |
Red swollen eyes, runny nose, congestion, fatigue, and small amount of shortness of breath. Lasted a...
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Red swollen eyes, runny nose, congestion, fatigue, and small amount of shortness of breath. Lasted about two days
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| 60 | 2021-03-23 | body temperature increased |
Felt abnormal and went to bed. Woke up at 9:35am with 101.7 temperature and called into work to advi...
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Felt abnormal and went to bed. Woke up at 9:35am with 101.7 temperature and called into work to advise I will not be coming in. I went back to bed no food no medicine, Most information I read and was aware is that it would be better with sleep. Only to wake up at 8:30pm with a 102.7 had 500 mg acetaminophen went back to bed. Woke up Thursday morning at 9:45am fever free. Friday afternoon I noticed swelling on my left neck area. Just inside my left clavicle. I made a Dr appointment for Monday and Dr. found several Lymph nodes swollen as well as under my left arm pit area. Due to some chest pain she sent me for a chest x-ray.
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| 60 | 2021-03-23 | chills, headache, fever |
20 hours of terrible body aches, headache, chills, nausea. Fever (that got up to 100.2) for 12 hours...
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20 hours of terrible body aches, headache, chills, nausea. Fever (that got up to 100.2) for 12 hours.
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| 60 | 2021-03-23 | fatigue, cough, fever | cough, fever and fatigue |
| 60 | 2021-03-23 | fatigue, lethargy, malaise, headache |
Received the first vac on 3/12 at 8:30 a.m.. I started feeling achy and tired by 4pm. By the next da...
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Received the first vac on 3/12 at 8:30 a.m.. I started feeling achy and tired by 4pm. By the next day, I had diarrhea and stomach upset starting by mid day. Since then, I have had daily diarrhea, lethargy, weakness, off and on headache, body aches (especially joints) and overall feeling of unwell.
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| 60 | 2021-03-23 | fatigue |
I was submitting my events daily on website and two days it tells me my session has expired and won'...
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I was submitting my events daily on website and two days it tells me my session has expired and won't let me report anything. On Sunday night, March 21st, I started with very painful joint and muscle aches with fatigue. The next morning I felt terrible and could barely function, I had a bought with diarrhea that lasted almost the entire day and had no energy. I developed a large lump on my left clavicle area that seemed to be filled with fluid. My knees I had replaced are still very painful today ( 7 days post vaccine). I phoned my Dr. yesterday and they told me to take 1000mg of Tylenol 3 times a day. I am doing this now for the second day with some relief. I feel this is very unusual to feel this way 7 days after the vaccine. On day 1-2 the only symptoms were a sore arm from the vaccine. Saturday was actually a good day with no symptoms, the other symptoms started on Sunday. I feel like my heartbeat is irregular also but my BP is good. I would like to be able to to report daily on v-safe like I was the first few days.
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| 60 | 2021-03-23 | headache, chills, fatigue |
Extreme exhaustion, chills, muscle aches, brain fogginess, headache - all the symptoms I experienced...
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Extreme exhaustion, chills, muscle aches, brain fogginess, headache - all the symptoms I experienced when I had COVID-19 in early November 2020. All symptoms improved within 18 hours except headache, which lasted for 36 hours. Headache was also a lingering effect after all other COVID-19 symptoms subsided when I had the virus, as well.
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| 60 | 2021-03-23 | headache, fatigue |
Symptoms were minor--soreness at injection site for 2 days, loose stool the day after injection, and...
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Symptoms were minor--soreness at injection site for 2 days, loose stool the day after injection, and minor headache and fatigue on the day after injection through the following day (2 days after injection).
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| 60 | 2021-03-23 | headache | Headache, eyes burned, diarrhea |
| 60 | 2021-03-23 | pneumonia |
Began to feel bad one week after receiving injection and made appt with provider, xray showed infi...
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Began to feel bad one week after receiving injection and made appt with provider, xray showed infiltrate, pnuemonia, in right lower lobe, antibiotics prescribed and taken increased shortness of breath at time of visit.
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| 60 | 2021-03-23 | fever, chills, headache, fatigue | Headache, chills, low fever, tired |
| 60 | 2021-03-24 | fatigue |
neurothopy for 1-2 days; bone pain; Exhaustion; This is a spontaneous report from a contactable cons...
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neurothopy for 1-2 days; bone pain; Exhaustion; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via unspecified route of administration on unspecified date at age of 60 years old at single dose for COVID-19 immunisation. Patient had chemotherapy for ovarian cancer in 2020. Concomitant medications were not reported. Patient experienced exhaustion, bone pain, neurothopy for 1-2 days post first vaccine. Event took place after use of product. Outcome of events was unknown. Information on the lot/batch number has been requested.
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| 60 | 2021-03-24 | headache, cough, fever, chills |
this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400m...
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this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400mg ibuprofen before going to bed around 11pm. by 1 am on 3/24 I was running a fever, shivering & my inj arm was very sore/felt heavy. Took 400 more ibuprofen, fever reduced before too long. Also felt slightly nauseous during the night & into the day of 3/24. around 2 pm got a bad headache. more ibuprofen, still felt a little nauceous, tho that subsided in early a.m. 3/25. Also was coughing quite q bit most of 3/24, but that may have been due to allergy stuff. experienced some mild diarrhea on 2 occassions 3/24. Symptoms are fairly well abated by 10a.m. 3/25.
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| 60 | 2021-03-24 | headache |
pt reports having sharp pains in the head lasting about ten seconds, and then going away before rece...
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pt reports having sharp pains in the head lasting about ten seconds, and then going away before receiving the vaccine. but the frequency has increased since getting the vaccine
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| 60 | 2021-03-24 | throat pain, headache |
After coming into the observation post vaccination, the patient told the nurse that she was itchy. T...
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After coming into the observation post vaccination, the patient told the nurse that she was itchy. The nurse assessed her and did not note any hives but did see scratch marks. Soon after, the patient stated she felt hot and had a headache. She quickly noted that her throat had begun to also hurt at that time. EMT's came over to assess her, per the nurses request the EMT's at that time suggested to the patient that she be further evaluated at the hospital. She accepted the transport to the ER.
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| 60 | 2021-03-24 | fever, chills | Fever, 100 F. Chills Nausea Sore Arm |
| 60 | 2021-03-24 | fever, chills |
Body aches and chills at first. On Sunday 3/21, my fever spiked to 103.7. called doctors office. Was...
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Body aches and chills at first. On Sunday 3/21, my fever spiked to 103.7. called doctors office. Was told to take Tylenol for fever and if it didn't drop to the walk in or ER. It finally dropped later that evening. Then the next day 3/22 i have a rash on my arm i received the vaccine in. On 3/24 it was worst. put a call back into the doctors. Said if it continues to get worst to go to the ER. I put ice and cortisone cream on it which helped take the itching away.
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| 60 | 2021-03-24 | fever, chills | Chills, aches and pains, felt like a fever but didn?t register as one. |
| 60 | 2021-03-24 | fever, fatigue |
Day 1 muscle stiffness lower back and slight fever, tired. Day 2 bone, muscle pain moved to right hi...
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Day 1 muscle stiffness lower back and slight fever, tired. Day 2 bone, muscle pain moved to right hip, sore to touch, tired. Day 3 bone, muscle pain moved upper back, tired. Took aspirin. Day 4 bone, muscle pain more extreme, tired. Took aspirin. Day 5 extreme pain in hip and ribs, sore to touch hard to breath, fainted, tired. Took tylenol. Pain went away
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| 60 | 2021-03-25 | chills, fatigue |
Approximately 28 hours after administered: extreme fatigue, mild chills and muscle aches. Chills su...
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Approximately 28 hours after administered: extreme fatigue, mild chills and muscle aches. Chills subsided in 4 hours, muscle aches in 6 hours.
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| 60 | 2021-03-25 | chills, headache |
seven minutes after injection my skin felt flushed and hot around my upper back, neck, shoulders, I ...
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seven minutes after injection my skin felt flushed and hot around my upper back, neck, shoulders, I felt dizzy and then had diarrhea this continued off and on for several hours...in the ER they gave me steroid, saline solution for dehydration and pepcid. I had a headache and chills while in the ER. Went home and felt fine that night other than mild headache.
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| 60 | 2021-03-25 | chills, fever |
gradual onset of diarrhea and fever 2 days after injection for a duration of 4 days. fever of 101, c...
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gradual onset of diarrhea and fever 2 days after injection for a duration of 4 days. fever of 101, chills diarrhea and inflammation under left arm and breast.
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| 60 | 2021-03-25 | chills | Nausea, Vomit/Diarrhea, Chills (very cold head to toes), body/joints ache, stiff throat |
| 60 | 2021-03-25 | dehydration, fatigue, headache | Hallucinations Possibly fever, fatigue & dehydration 1-2 days ago Mild headache |
| 60 | 2021-03-25 | fatigue, body temperature increased | temps up to 103, fatigue |
| 60 | 2021-03-25 | headache | Severe headache, debilitating joint pain throughout body. |
| 60 | 2021-03-25 | headache |
things went black; my blood pressure was alarmed was over 200 checked other arm same called there te...
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things went black; my blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high; severe dizziness; severe headache nausea; weakness; severe headache nausea; This is a spontaneous report from a contactable other healthcare professional (patient). An 60-year-old non-pregnant female patient received bnt162b2 (COVID 19, brand: Pfizer, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Feb2021 11:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included Stent in LAD (Left anterior descending coronary artery). Concomitant medications included losartan potassium, lorazepam (ATIVAN), acetylsalicylic acid (BABY ASPIRIN) and furosemide. It was reported that, within 15-20 minutes went to stand up severe dizziness and things went black started to get severe on 07Feb2021 at 11:15 AM. On 07Feb2021 at 11:15 AM, Headache, nausea Nurse Practitioner that gave shot took her blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high and she could not stand up due to weakness dizziness apparently they called Paremedic/EMT advised in her best interest to be seen in Emergency department. they did not how ever ask if she belonged to a ambulance company which she do so know she have a bill of about 1,500 with ambulance company. was in the ED for about 4 hours till blood pressure can down. was given medication for nauseas, felt like she was hit by a truck. Patient had Cardiac montering/medication. No covid prior to vaccination. No covid tested post vaccination. Outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events assessed as possibly related to the suspect drug BNT162B2______ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 60 | 2021-03-25 | sweating |
The VR has a history of vagal response to immunizations and blood. The VR had the vaccine without i...
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The VR has a history of vagal response to immunizations and blood. The VR had the vaccine without incident and went to the observation area. The VR was then sitting with his wife when he "was thinking of the vaccine" and he became unresponsive. I was called to the site. The VR was pale, cool, and diaphoretic. The VR became responsive and was assisted to the cot where he laid flat. The VR's wife states that this is typical behavior and response for him. An ambulance was called by the paramedics that were on scene in the observation area. The VR refused transport. The VR was given water and candy and was able to ambulate without difficulty. VR remained in the observation area for 40 minutes and then discharg
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| 60 | 2021-03-25 | throat pain, fatigue, malaise |
Initially, mild nausea, immediately (with 15 minutes of administration) . Resolved promptly within 3...
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Initially, mild nausea, immediately (with 15 minutes of administration) . Resolved promptly within 30 minutes of injection. Then, three hours after administration (at approx. 12.30 p.m.), the following symptoms in order of severity: 1. Severe tiredness/fatigue. Lasted 4 hours. Resolved when I took a half hour nap. 2. Sore throat. Still present at 10.30 pm. 3. Swollen lymph nodes (lymphadenopathy). Significant improvement after 4 hours from onset (3 hours after administration). However, still present at 10.30 p.m. 4. Feeling unwell/malaise. Resolved after I took a nap. 5. Dry eyes. I had to remove my contact lenses and put on eyeglasses when I got home at approx. 2pm. 6. Dry mouth. Unresolved, even with drinking a lot of water and tea. Symptoms were fairly severe. I had to leave work and go home to rest. I was unable to drive myself home.
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| 60 | 2021-03-26 | cough, headache, fever, chills |
Day 1..... couldn't sleep that night Day 2.....fever, chills, bad headache, fell asleep at 4pm and s...
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Day 1..... couldn't sleep that night Day 2.....fever, chills, bad headache, fell asleep at 4pm and slept all night with 800 mg Tylenol. Day 3.....fever, Chills, bad headache, cough, diarreha Day 4..... headache, cough diarreha
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| 60 | 2021-03-26 | fatigue, chills, fever |
Within four hours of shot, low grade fever, 101.4, chills, nausea, exhaustion. Asleep by 9:00p.m., s...
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Within four hours of shot, low grade fever, 101.4, chills, nausea, exhaustion. Asleep by 9:00p.m., slept 13 hours, On March 17, woke at 10 am. Nausea, fever, chills gone, but totally exhausted with burning sensation at shot site and soreness in upper right arm. Remained in bed all day, asleep by 6 pm. Remained exhausted through March 23. Any physical activity caused shortness of breath and further tiredness. Exhaustion dissipated by March 24, 2021
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| 60 | 2021-03-26 | fatigue, chills, fever |
soreness in arm. Chills, fever as high as 101.8, body aches, fatigue. Fever continued the entire n...
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soreness in arm. Chills, fever as high as 101.8, body aches, fatigue. Fever continued the entire next day along with fatigue. Today, March 27th, I have woken up feeling better, no fever.
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| 60 | 2021-03-26 | headache, fatigue | Extreme headache (migraine) lasting 48 hours Extreme fatigue lasting 48 hours |
| 60 | 2021-03-26 | influenza like illness, headache |
Approx 8 hours after the first vaccine shot, I felt like I had mild flu like symptoms without a feve...
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Approx 8 hours after the first vaccine shot, I felt like I had mild flu like symptoms without a fever: body aches, and headache
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| 60 | 2021-03-26 | fever, fatigue, headache |
100? Fever, total body aches, nausea, inflammation, some shortness of breath, chest tightening, fati...
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100? Fever, total body aches, nausea, inflammation, some shortness of breath, chest tightening, fatigue, headache.
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| 60 | 2021-03-26 | sneezing, nasopharyngitis, fatigue |
1-After 5 minutes of taking the vaccine I started to sneeze few minutes later it pass. At about 12mi...
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1-After 5 minutes of taking the vaccine I started to sneeze few minutes later it pass. At about 12midnight My arm was sore and in pain and very warm to the touch 2- on Tuesday morning I was very cold and very tired . 3- Around none or so I notice my self cleaning my mouth the left side , it feel like you just where out of the Dentist , like went you anesthesia from the dentist is running out. I have feeling but it almost feel like my drooling like my saliva is out of my mouth and also my left eye felt heavy and at first very watery and the dry . My left side of my mouse feel different and I?m connately cleaning my mouth.
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| 60 | 2021-03-27 | chills, headache | Body/muscle pain and stiffness, headache, chills |
| 60 | 2021-03-27 | chills, nasal congestion, fatigue, fever, respiratory tract congestion, throat pain, cough |
3/25/21 2:00 AM sore throat congestion 3/26/21 3:09 AM. Awoke with chills 101.5 fever, sore throat n...
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3/25/21 2:00 AM sore throat congestion 3/26/21 3:09 AM. Awoke with chills 101.5 fever, sore throat nausea aches cough Continue with very sore throat, fatigue nausea congestion dry cough nasal congestion
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| 60 | 2021-03-27 | malaise, headache, fatigue, chills | Headache muscle pain tiredness nausea chills Overall not feeling well |
| 60 | 2021-03-27 | fever, headache, fatigue, chills |
At 20 hours after vaccine, experienced chills, extreme fatigue, headache, fever fluctuations between...
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At 20 hours after vaccine, experienced chills, extreme fatigue, headache, fever fluctuations between 97.1 and 104.3 degrees for about 24 hours
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| 60 | 2021-03-28 | chills, headache, fatigue |
Swollen Lymph Nodes, chills, headache, nauseous stomach, pain radiating in left boob & left back, an...
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Swollen Lymph Nodes, chills, headache, nauseous stomach, pain radiating in left boob & left back, and tireness
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| 60 | 2021-03-28 | headache, fatigue | Extreme headache for 3 days weak and tired very sore arm at injection site |
| 60 | 2021-03-28 | headache, fever, chills | HA, shivers at night , muscle cramps , mild fever |
| 60 | 2021-03-28 | fever, chills, headache, lethargy |
Heart rate increase Blood Pressure increase Chills Fever Headache Body Ache Tight Chest Lethargy W...
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Heart rate increase Blood Pressure increase Chills Fever Headache Body Ache Tight Chest Lethargy Weakness
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| 60 | 2021-03-28 | sneezing |
The next day I felt it was allergies, sneezing etc. I was told go to take a test took pcr and it cam...
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The next day I felt it was allergies, sneezing etc. I was told go to take a test took pcr and it came back two days later positive for covid. 24 hours after 3nd vaccine. Also have pain in left breast Under arm where shot was given
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| 60 | 2021-03-30 | chills |
she tested positive for Sars-CoV-2 infection; she tested positive for Sars-CoV-2 infection; getting ...
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she tested positive for Sars-CoV-2 infection; she tested positive for Sars-CoV-2 infection; getting sick; got the chills; This is a spontaneous report from a contactable consumer (also mentioned being a Physical Therapist Assistant). A 60-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Batch/lot number: EN6203, Expiry Date: Jun2021, in Pharmacy/Drug Store, via an unspecified route of administration, in left arm on 26Feb2021 at 12:00, at 60 years of age, as single dose for COVID-19 immunization. Medical history included SARS-CoV-2 test positive in Nov2020 (COVID-19 Virus throat swab test was used), also reported as COVID-19 infection in Nov2020 with no symptoms, except a slight sore throat and gingival disorder from an unknown date. On 26Feb2021 the patient had no symptom, saying she felt great. She reported she worked out and was in great shape for her age. She said she was not the typical 60 year old. On 09Mar2021 in the evening the patient felt like she was getting sick and got the chills and she had never had that happen before, and didn't know if her symptoms were from the 2 pills of an herbal supplement she used for periodontal issues to strengthen her gums she had ordered online (she never saw the product in a store) and that she had taken on the same day; moreover she tested positive for SARS-CoV-2 infection on 11Mar2021 with a COVID-19 Virus 24-hour nasal swab test done at her work. The events didn't require visit to Emergency Room or Physician Office. It was reported that the patient was scheduled to receive her second dose of vaccine 19Mar2021 and the patient wanted to know if this is possible with her current diagnosis and how likely it is this is a false positive test for SARS-CoV-2. No treatment was administered for the reported events. At the time of the report the outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 60 | 2021-03-30 | runny nose, malaise |
her arm was extremely sore; unable to move left side of neck/unable to move arm; She felt unwell lik...
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her arm was extremely sore; unable to move left side of neck/unable to move arm; She felt unwell like she had the flu/sick; nose running; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), an unspecified route of administration, administered in left arm on 25Feb2021 (at the age of 60-years-old), as single dose for COVID-19 immunisation. Medical history included lupus from 2018 to an unknown date, Cushing's syndrome from 2018 to an unknown date and ongoing Hashimoto's disease. The patient had also allergies. Concomitant medications included ibuprofen (ADVIL). Patient reported that within 2 minutes of getting the vaccine her nose was running. Two hours later she started to feel unwell. Her nose was still running. She was not sure if this was from the vaccine or because of her allergies. She felt unwell like she had the flu. She was sick and progressively getting worst. She was having reaction to the injection. On 26Feb2021 she woke up around 3:00 am and was unable to move the left side of her neck or her left arm. She still has some neck stiffness. She had small incidences for 3 days after. She felt paralyzed. She was unable to move her arm because it was completely painful. She didn't panic that her arm was extremely sore. She was able to move it. Caller added that she though she had Covid when she got the vaccine and didn't know it. She was sent t an EMS station to be tested. She was given the rapid test on 03Mar2021. Within 15 minutes she was told the result was negative. They sent out another test the same day. On 06Mar2021 she received negative results. She was scheduled to get the second dose on 18Mar2021 at 11:00am. The outcome of events 'she felt unwell like she had the flu/sick' was not recovered, nose running was resolving, unable to move left side of neck was resolved on 28Feb2021, unable to move arm was not resolved, the outcome of other event was unknown.
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| 60 | 2021-04-01 | chills, fever, headache |
Shot 3/3/2021 9:05am, headache started around 7:00pm, overnight also had fever and chills. 3/4-Heada...
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Shot 3/3/2021 9:05am, headache started around 7:00pm, overnight also had fever and chills. 3/4-Headache and fever continued, also had nausea and vomiting. On 3/5/3021, other symptoms resolved, but woke with double vision due to 6th cranial nerve palsy. This is the fourth acute occurrence of the nerve palsy. As of today, 4/2/2021, the double vision is still acutely present.
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| 60 | 2021-04-02 | headache |
Sore left arm at injection site; Tingling feeling on forehead; Slight headache; neck pain; This is a...
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Sore left arm at injection site; Tingling feeling on forehead; Slight headache; neck pain; This is a spontaneous report from a contactable Pharmacist. A 60-years-old female patient received BNT162B2 ( BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247) first dose via an unspecified route of administration, administered in left arm on 18Feb2021 9:15 as single dose for COVID-19 immunization. Vaccination administered facility Workplace clinic. The patient medical history included Osteoporosis; irritable bowl syndrome. The patient concomitant medications included : Citracal; Centrum; Vit D (ergocalciferol); Colace; Evening Primrose (oenothera biennis), ascorbic acid, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dibasic, chromium picolinate, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, magnesium borate, magnesium oxide, manganese sulfate, nickel sulfate, nicotinamide, panax ginseng root, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium metavanadate, sodium molybdate, sodium selenate, stannous chloride, thiamine mononitrate, tocopheryl acetate, zinc oxide (CENTRUM ENERGY). On 18Feb2021 10:00 patient experienced with sore left arm at injection site (vaccination site pain), tingling feeling on forehead, slight headache, and sore neck on left side. The outcome of the event was recovering. Follow-up information was received on (25-MAR-2021): No new medically significant information was received on this case.
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| 60 | 2021-04-03 | fever, headache, malaise |
12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post...
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12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post: malaise; 5th-10th day post: coronary vasospasms, malaise, arrhythmia; took nitroglycerin patches, nitro bid paste; 11th day: met with rheumatologist, started medrol dose pack, improved spasms for a short time, 13th day: afib symptoms and Apple Watch reading noted by patient; 15th day spasms began again and increased symptoms of afib: saw doctor in office for EKG showing afib; met with cardiologist ordered increase in diltiazem and second medrol dose pack; first 48 hrs on second dose pack improved spasms, by 3rd day spasms significantly increased and constant afib w headache, dizziness, malaise. Visited ER, admitted. cardio version. Reduced dilitiazem, reduced ramipril, increased isosorbide. Continued symptoms with waxing and waning of spasms and atrial fibrillation . Although this is a pre-existing chronic condition, Afib without relief is not normal. Spasms without resolution not normal nor have I experienced an episode of this duration ever.
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| 60 | 2021-04-05 | headache, fatigue | Thrush, extreme fatigue daily, severe headaches nightly, still occurring |
| 60 | 2021-04-05 | throat irritation | Became nauseated has itchy throat and chest tightness with in 5 mins of receiving the vaccine |
| 60 | 2021-04-06 | throat irritation |
My throat was itchy in between that half hour my voice started to change; my throat felt worse; I ha...
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My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I still have problem swallowing a little bit; My throat was itchy in between that half hour my voice started to change; my throat felt worse; This is a spontaneous report from a contactable consumer (reporting for herself). A 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included anxiety, depression, neuralgia, heart, blood pressure issue and lot of allergies. Concomitant medication included levothyroxine; atorvastatin calcium (CHOLESTAT [ATORVASTATIN CALCIUM]); pantoprazole; ciprofloxacin hydrochloride, tinidazole (FLOXAZOLE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); lubiprostone (AMITIZA); thioctic acid (ALPHA LIPOIC ACID); baclofen; linezolid (ZENIX [LINEZOLID]); ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]); rosuvastatin calcium (CRESTOR); docusate sodium (STOOL SOFTENER); benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) taken for heart; desvenlafaxine succinate (PRISTIQ) taken for anxiety, depression; citalopram; venlafaxine hydrochloride (EFFEXOR) taken for anxiety; escitalopram oxalate (LEXAPRO); cyclobenzaprine; gabapentin taken for neuralgia; metoprolol taken for heart; amlodipine taken for blood pressure issue; magnesium oxide. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Feb2021 for COVID-19 immunization and experienced pulse rate would not go down. On 15Mar2021, it was reported that they had it done at the hospital, then after 15 minutes, her throat was itchy the may say another half hour in between that half hour, her voice started to change and her throat felt worse. They walk me down to the ER my throat was hurting then slowly they gave me Epi Pen and they injected in an IV with steroids. The have wheezing in her lungs and spent the night in hospital for observation. They did all kind of blood work, when she was placed in ER. The patient reported that she still have problem swallowing a little bit and voice changes after talking. The outcome of the event "still have problem swallowing a little bit" was not recovered while the outcome of the other events was unknown. Information on the lot/batch number has been requested.
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| 60 | 2021-04-09 | chills, headache, fever |
vomiting; diarrhea/Lingering diarrhea into second day; ringing in my left ear. LOUD!; excessive urin...
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vomiting; diarrhea/Lingering diarrhea into second day; ringing in my left ear. LOUD!; excessive urination; eyes feeling like they were popping out; tunnel vision; 104 fever; severe chills and quaking; severe chills and quaking; the worst headache in my life/slight headache on the back of my head, and continued into today; felt like broken shins; hip joints on fire; This is a spontaneous report from a contactable consumer herself (patient). A 60-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Mar2021 (Batch/Lot Number: EN6204) Solution for injection as Single Dose for covid-19 immunisation. Medical history included asthma, mild HP (Hypersensitivity pneumonitis) and I am fat. Concomitant medications included lovastatin, eszopiclone (LUNESTA), lisinopril and gabapentin. The patient previously took first dose of BNT162B2 (EN6198), on Left arm on 27Feb2021 for Covid-19 immunization. On 23Mar2021 02:00 patient experienced 104 fever, severe chills and quaking, the worst headache in my life, what felt like broken shins another friend said she had this as well, hip joints on fire, eyes feeling like they were popping out, vomiting after hours 26, tunnel vision, excessive urination, diarrhea started at hour 28. Lingering diarrhea into second day, slight headache on the back of her head, and continued into today, ringing in her left ear. The patient underwent lab tests and procedures which included body temperature: 104 on 23Mar2021. Patient did not test covid post vaccination. Patient did not have covid prior vaccination. The outcome of all events was recovered with sequelae.
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| 60 | 2021-04-09 | headache |
Sickle cell crisis; She said she was unable to touch her collar bone because of the pain; pain along...
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Sickle cell crisis; She said she was unable to touch her collar bone because of the pain; pain along her heart, collar bone area, and ribs; Hot flash on the left side of her head preceded the headache; Headache; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received first dose of BNT62b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 12Mar2021 (Batch/Lot Number: EN6206) as single dose for covid-19 immunisation. Medical history included sickle cell anaemia diagnosed when she was a baby from an unknown date unknown if ongoing. The patients concomitant medication included unknown injectable medication the patient stated she was given injectable medication for 2 tests, 1 on 23Feb2021 and 1 on 26Feb2021. She said she didn't know the name of the medications given to her and the tests were ordered by her cardiologist. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). The patient experienced sickle cell crisis on 18Mar2021 headache on Mar2021, she said she was unable to touch her collar bone because of the pain on an unspecified date, pain along her heart, collar bone area, and ribs on an unspecified date, hot flash on the left side of her head preceded the headache on an unspecified date. The patient was hospitalized for sickle cell crisis from 19Mar2021 to 20Mar2021. The patient was still had sickle cell crisis pain along her heart, collar bone area, and ribs. She said she was unable to touch her collar bone because of the pain. She said she also had a headache. She clarified the headache started a couple days after she had the COVID-19 Vaccine. She said a hot flash on the left side of her head preceded the headache. She said she still had a headache, and some days her headache was better. She said yesterday (24Mar2021) her headache was so strong. She said the headache was on the left and back side of her head, but particularly strong on the back side of her head. The patient went to the Emergency Room after midnight on 19Mar2021. She said she spent the night at the hospital as an inpatient, and then was discharged by Saturday (20Mar2021) afternoon, around 14:30-15:00. She said she was given Morphine for pain, and was on an IV, and took her regular medicines. She said she did not know the name of the IV fluids that were given to her. The patient underwent lab tests and procedures which included cardiac stress test and electroencephalogram result was unknown. The outcome of event hot flash on the left side of her head preceded the headache was unknown and outcome of all other events was not recovered, Information on the lot/batch number already available. Further information has been requested.
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| 60 | 2021-04-11 | fatigue, headache |
Within 30 minutes I had a headache, fatigue that lasted 2 days. I had small hives on my face startin...
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Within 30 minutes I had a headache, fatigue that lasted 2 days. I had small hives on my face starting day 2 lasting 2 days. I had a lump behind left ear that lasted 5 days. I have had ringing in my ears, louder in the left ear, since the injection, for 2 weeks now. It is quite loud and annoying. I have recovered from all side effects except the ear ringing.
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| 60 | 2021-04-12 | headache |
Systemic: Headache-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional...
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Systemic: Headache-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Patient said she experienced left side numbness, slurred speech, severe neck pain, and a headache. She said she had stroke like symptoms but after being hospitalized for 3 days and having a CT scan performed stroke was ruled out.
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| 60 | 2021-04-14 | headache |
One week after receiving the first vaccine, I developed severe headaches. I got my booster 21 days l...
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One week after receiving the first vaccine, I developed severe headaches. I got my booster 21 days later. One week after receiving the booster, I started having severe headaches, severe neck, back and abdominal pain. I went to the ED the morning of 3/5/21, was admitted to the hospital and release on 3/8/21. It is in the H&P from Health facility.
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| 60 | 2021-04-14 | malaise, headache |
I experienced muscle and joint aches, headache and overall malaise. Approximately 14 days after the...
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I experienced muscle and joint aches, headache and overall malaise. Approximately 14 days after the first vaccine , started having vision deficits in my left eye out of the blue. I experienced a fuzziness and haziness in the vision of the left eye and pain above the left eye brow. Was seen urgently in the eye clinic on 3/29/21 and had a battery of tests - a swollen and inflamed left optic nerve was observed and some deficits to vision and peripheral vision. Had second vaccine on 3/31/21 and eye seemed to get worse. Seen by Optical Nerve Specialist on 4/5/21 and had battery of tests and optic nerve worse. Dr. diagnosed as ischemic optical neuropathy likely due to giant cell artritis (GCA). I had urgent/emergent temporal artery biopsy on 4/6/21 to determine if giant cell artritis. Received results from biopsy on 4/13/21 and negative for GCA. Saw Optical Nerve Specialist on 4/14/21 and diagnosed with ischemic optical neuropathy but cause can not be specified. Optic nerve is still swollen and vision impacted. I am to return to clinic in 8 weeks and see if improvement. I have never had any issue like this in the past.
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| 60 | 2021-04-15 | malaise |
Felt sick with covid like symptoms beginning 4/2, Shortness of breath began 4/3, received negative c...
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Felt sick with covid like symptoms beginning 4/2, Shortness of breath began 4/3, received negative covid test on 4/7, went to ER on 4/12, CT scan showed MASSIVE bilateral Pulmonary embolism, Angiogram of heart showed right side under stress at 50%. 4/13 Surgery - catheterized directed thrombosis to dissolve clots. Discharged from hospital 4/15
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| 60 | 2021-04-18 | fatigue |
appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; enti...
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appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; entire intestinal tract and stomach became hard; extended and felt like it was on fire and was extremely painful; vomiting along with diarrhea; vomiting along with diarrhea; pain and burning in my stomach and back; pain and burning in my stomach and back; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 12:15 (Batch/Lot Number: EP6955) as single dose (at the age of 60-year-old) for COVID-19 immunisation, administered at Pharmacy or Drug Store. Medical history included known allergies: Sulfa drugs, aspirin cordisone. Patient had not COVID prior vaccination. Patient was not pregnant. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, cortisone and experienced drug hypersensitivity. No other vaccine in fourweeks. On 29Mar2021 19:30 the patient experienced she felt tired, sore arm, entire intestinal tract and stomach became hard, extended and felt like it was on fire and was extremely painful, vomiting along with diarrhea, pain and burning in my stomach and back. On 31Mar2021 the patient experienced appendix had ruptured, diagnosed with appendicitis, could barely stand. The patient was hospitalized for appendix had ruptured and diagnosed with appendicitis for 2 days. The events were considered serious as per hospitalization, disability, life threatening. Therapeutic measures were taken as a result of appendix had ruptured and diagnosed with appendicitis: appendectomy. COVID was not tested post vaccination. Course of events was as follows: She had the shot on 29Mar2021 at 12:15, 4 hrs after she felt tired and had sore arm. 7 hours after, her entire intestinal tract and stomach became hard and extended and felt like it was on fire and was extremely painful. 4 hrs later she started vomiting along with diarrhea. The vomiting continued non stop along with the pain and burning in her stomach and back. On 31Mar2021 morning the pain settled into the right lower stomach and became so painful she could barely stand. She went to the ER and was diagnosed with appendicitis. She had surgery that night and found my appendix had ruptured. The OR nurse told he she was the 2nd lady that day who's appendix had ruptured after having their First COVID vaccine and there had been others. She believed this was absolutely the direct result of the vaccine. She queried why were we not warned of this violent side effect of the vaccine. The outcome of events was recovering.
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| 60 | 2021-04-18 | headache, chills |
left side headache, left eye pain, severe vomiting, full body pain, neck pain, chills as of Sunday s...
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left side headache, left eye pain, severe vomiting, full body pain, neck pain, chills as of Sunday some had subsided but not all. tylenol of no use!
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| 60 | 2021-04-18 | fever, cough, chills, malaise, headache |
4/4/ Patient returned to the ED with SOB, cough and home pulse ox readings in the 80's. She was star...
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4/4/ Patient returned to the ED with SOB, cough and home pulse ox readings in the 80's. She was started on O2 at 2L NC and was admitted on IV Remdesivir and Decadron. By 4/8, she was able to be weaned off O2 and completed 4 days of Remdesivir and Decadron therapy. She refused rx to complete 10 day course of Decadron due to concerns regarding hyperglycemia and her diabetes.
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| 60 | 2021-04-20 | malaise |
her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little ...
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her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little tingling; I have a lot of numbness and tingling in my left side; it's still a little tingling; I had 3 days of sheer misery I couldn't use my left side as I am left handed; it made it kind of difficult; I couldn't hold anything in it, if I wanted to put my hand back; I could not even grab my head up to put it off; I have been not feeling that good; shot I went to home I had gastro intestinal problems; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in arm left (reported as "Left shoulder") on 31Mar2021, at the age of 60-year-old (Batch/Lot number was not reported, it was reported that "it says Pfizer and then 8733") as single dose for covid-19 immunisation. Medical history included multiple sclerosis (MS) and she had the GA (gallbladder atony) thing it was awful she mean anything she ate or drank, right to the toilet. Concomitant medications included ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported and Vitamins. Consumer stated, she had the COVID-19 shot last Wednesday 31Mar2021 and she have MS so what it happens was she have got the shot she went to home she had gastro intestinal problems she had she could not get off the toilet for a while and then her MS started to flare, So she have a lot of numbness and tingling in her left side and it's still a little tingling but she had 3 days of sheer misery. She couldn't use her left side as she was left handed so it made it kind of difficult and she live alone. The reporter wanted to know that it was as potential side effects, she was just glad they didn't go full blown affect because they are miserable. When paraphrased the above concern, Consumer stated, No she was starting to get a lot better because she would be really going to say it if it didn't come, because she was not going to stand it but 3 days she couldn't use it at all, she mean she couldn't hold anything in it, if she wanted to put her hand back and probably feel she could not because she was not she could not hold anything she could not even grab her head up to put it off, as she said she had the GA thing it was awful she mean anything she ate or drank, right to the toilet. Consumer stated, No she haven't talked to anybody like any she have been not feeling that good, the first thing she had blown up in because when she had MS it starts to flare she don't she actually want to do is laid down and sleep. For treatment, consumer stated, no treatment, she stayed home, she just rested that's it, it's like her left side is affected her left leg was affected and her arm is affected all the left side is numb and tingly, so she don't like to do anything she don't like to walk anywhere, it's not good. Consumer stated, she just wanted to let us know in case anyone called us with and MS. Date for second shot of COVID-19 Vaccine is "21Apr2021." The outcome of the event "tingling" was recovering; of the other events was unknown. Information about lot/batch number has been requested.
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| 60 | 2021-04-23 | fever, chills |
Chills; body aches; fever; nausea; This is a spontaneous report from a contactable consumer (patient...
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Chills; body aches; fever; nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration in the left arm on 11Feb2021 at 08:45 AM (at the age of 60-year-old) as a single dose for COVID-19 immunization at Workplace clinic. Medical history included allergies to medications, food, or other products was Sulfa drugs. Prior to the vaccination, the patient was diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications received within 2 weeks of vaccination included citalopram at 20 mg. Patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for Covid-19 immunization. On 12Feb2021 at 12:00 AM, on the second day, the patient experienced chills, body aches, nausea and fever. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the chills, body aches, nausea and fever were recovering. No follow-up attempts are Possible. No further information can be obtained.
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| 60 | 2021-04-24 | chills |
possible hearing loss; episodes of elevated tinnitus (pre-existing); vertigo; dizzy; hands felt like...
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possible hearing loss; episodes of elevated tinnitus (pre-existing); vertigo; dizzy; hands felt like vibrating; nauseous; threw up; diarrhea; chills; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 60 years of age), dose 2 via an unspecified route of administration, administered in arm left on 05Apr2021 13:00 (Batch/Lot Number: EP7533) as a single dose for COVID-19 immunisation. Medical history included tinnitus and penicillin allergy, both from an unknown date and unknown if ongoing. Concomitant medications included ciclosporin (RESTASIS) and vitamin d nos (VITAMIN D NOS), both taken for an unspecified indication, start and stop date were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number: EL9629) (at 60 years of age), dose 1 in the left arm on 08Mar2021 13:00 for COVID-19 immunisation. The patient was not pregnant. The patient did not receive any other vaccine in four weeks prior to covid vaccine. The patient had no covid prior to vaccination. The patient has not been covid tested post vaccination. The patient experienced repeated night time episodes of elevated tinnitus (pre-existing), possible hearing loss, vertigo, dizzy, hands felt like vibrating, nauseous, threw up, diarrhea, and chills, all on 05Apr2021 14:00 PM with outcome of recovered/resolved with Sequel. The events resulted to Emergency room/department or urgent care. No treatment received for the events.
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| 60 | 2021-04-24 | pneumonia |
Pneumonia; This is a spontaneous report from a contactable nurse. A 60-year-old female patient recei...
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Pneumonia; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6200) via intramuscular, administered in Arm Right on 19Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient is not pregnant. No other vaccine received in four weeks. Patient experienced pneumonia after first injection on an unspecified date in 2021. Event resulted in Doctor office visit, Emergency room or urgent care, Hospitalization, Life threatening illness. Patient admitted to hospital for 5 days and received treatment. Unknown if patient had COVID prior vaccination. Unknown if COVID tested post vaccination. Outcome of the event was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event pneumonia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified. Linked Report(s) : US-PFIZER INC-2021423487 same patient/product, different dose and event
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| 60 | 2021-04-26 | chills, malaise |
This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old fem...
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This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0158), via an unspecified route of administration, administered in right arm on 08Apr2021 at 16:00 (at the age of 60 years old) at a single dose for COVID-19 immunization. Medical history included overactive immune system, valley fever, Lyme disease, and known allergies to penicillin and morphine. The patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. Concomitant medications included supplements. Patient had no other vaccines in four weeks. On 09Apr2021, patient experienced very sore arm and vertigo. Then 24 hours later, on 10Apr2021, a feeling of dizziness/severe dizziness and nausea that comes and goes - which has been going on for days. It felt like patient was about to pass out. The patient was not able to stand, she can't stand up. Her body suddenly got hot then followed by feeling chills, but no fever. She was feeling so odd and severe brain fog. The patient was feeling so ill. She tried to call Pfizer because she wanted to know how long this will be going on. She didn't know whether to take the second dose. She felt so sick she couldn't drive or work. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was received for the events vertigo, dizziness, nausea, "Not able to stand/can't stand up" and "feeling so ill/feel so sick". The outcome of the events was not recovered.
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| 60 | 2021-04-26 | headache |
her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional ...
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her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional instability; head hurts; nauseous; Disorientated; Dizzy; Slurred speech; Balance impaired; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 30Mar2021 17:30 (Lot Number: EW0150; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. Medical history included depression from 2005 to an unknown date, blood pressure high in 2020 and unknown if ongoing, and high cholesterol in 2020 and unknown if ongoing; stated she was diagnosed with high blood pressure and high cholesterol about a year ago and was on low doses of blood pressure medication and cholesterol medication. There were no concomitant medications. The patient has no prior vaccinations (within 4 weeks). The patient experienced her whole left side, including the left side of her face went numb on 31Mar2021 with outcome of recovering, lost focus on 11Apr2021 with outcome of not recovered, head hurts on 31Mar2021 with outcome of not recovered, nauseous on 31Mar2021 with outcome of not recovered, disorientated on 31Mar2021 with outcome of unknown, dizzy on 31Mar2021 with outcome of not recovered, slurred speech on 31Mar2021 with outcome of recovered in Apr2021, balance impaired on 31Mar2021 with outcome of not recovered, throw up on 10Apr2021 with outcome of recovered on 10Apr2021, emotional instability on 31Mar2021 with outcome of not recovered. The patient received her 1st dose of the Pfizer COVID19 Vaccine on 30Mar2021 and experienced a bucket load of side effects listed with the vaccine. She mentioned that she has lost focus, her head hurts, and so nauseous. She mentioned that half of her face is numb and that she was hospitalized for 24 hours because the doctors thought she had a stroke. She mentioned she has never had a reaction to anything and the doctors told her that this was related to the vaccine. She is asking how long does this side effect last, if the 2nd dose would have more severe side effects than the first, and could she receive her 2nd dose scheduled this Saturday after experiencing this side effects. She mentioned that her doctors recommended that she get vaccinated. She is in distress as she mentioned that this side effects have affected her life and her job. Further clarified, on 31Mar2021 she was disoriented, dizzy, nauseous, and had a massive headache. She said her symptoms were all on the list of possible COVID-19 Vaccine side effects. She said then her (whole) left side, including the left side of her face went numb. She said she called the nurse on the help line, and the nurse told her to call #. She said she didn't call # because she thought it wasn't necessary. She said she went to urgent care. She clarified at the urgent care they flipped out and wheeled her into a back room and hooked her up to a heart monitor, and brain monitor. She said that was around 5:00PM-6:00PM on 31Mar2021. She said she was taken by ambulance from the urgent care to the hospital emergency room. She said she stayed in the hospital overnight. She said she also had slurred speech, couldn't balance, and couldn't track (clarified as focus). She said it was awful. She said they thought she had a stroke because the left side of her face, and her whole left side were numb. She said if she tried to smile, one side of her face didn't work like other side of her face. She said when she was at the hospital, the hospital did all kinds of tests on her. She said she was told she didn't have a stroke, and her symptoms had to be a side effect of the COVID-19 Vaccine shot. She said the doctors at the hospital told her to "tough it out", and wait until her symptoms were done. She said the numbness was gradually going away on the left side of her body. She said the left side of her face was partially numb, and she had parts of left arm that were still numb. She said Thursday, 08Apr2021, was the first day she felt good. She said she was able to focus, and work. She said she felt she had a steady focus, and was not losing her mind. Friday morning (09Apr2021) was "iffy", but she felt she had improved some during the day. She said by Friday night (09Apr2021), she was dizzy, had a headache, was nauseous, and her balance was off. She said on Saturday morning (10Apr2021), she was nauseous, and started throwing up. She said she continued to throw up until Saturday night (10Apr2021). She said she was still nauseous on Saturday night, but was able to have soda crackers. She said she felt like she was standing at a cliff, because she was still nauseous, but not throwing up. She said Sunday morning (11Apr2021) she was not great. She clarified she was still nauseous, had a headache, was constantly dizzy, and lightheaded. She said she didn't throw up, but her focus kept coming and going. She said she felt worse as Sunday night (11Apr2021) came on. She said today (12Apr2021), she was so nauseous, her head hurts, she was dizzy, and couldn't track (focus) well. She clarified she never had a fever with her other symptoms. Caller asked what the hell was going on, and why was it still happening, and how long were her symptoms going to last. She said she was scheduled to get her second COVID-19 Vaccine shot on Saturday (17Apr2021). Caller asked should she get the second COVID-19 Vaccine shot. Reported also had emotional instability from day one (31Mar2021) of her symptoms. Reported she had been resting for a half hour at a time. She said she would feel better for a period of time after resting, so the resting helped. She said she also took Ibuprofen and Tylenol (clarified as generic (place name withheld) Acetaminophen 500mg). She said the Ibuprofen and Acetaminophen helped to keep her headache in the background. Hospital Treatment: She said while she was at the hospital, she was given Aspirin and Tylenol because of her headache. She said the doctors at the hospital didn't change her home medications. The patient underwent lab tests and procedures which included blood test: normal on 01Apr2021, head CT (computerised tomogram): normal on 31Mar2021, echocardiogram: normal on 01Apr2021, tests: unknown results on an unspecified date (the hospital did all kinds of tests on her), MRI brain (magnetic resonance imaging): normal on 31Mar2021, carotid artery ultrasound: normal on 01Apr2021. Therapeutic measures were taken as a result of head hurts (headache). Reporter seriousness for her whole left side, including the left side of her face went numb: hospitalization from 31Mar2021 to 01Apr2021, required a visit to Emergency Room and Physician Office/Urgent Care.
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| 60 | 2021-04-26 | sweating |
Patient had flushing/sweating, rash. Given Benadryl 25 mg PO. Patient stable, released from vaccinat...
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Patient had flushing/sweating, rash. Given Benadryl 25 mg PO. Patient stable, released from vaccination site.
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| 60 | 2021-04-26 | throat pain, headache, chills, fatigue, fever |
I had all this pain at the injection side; tired; headache; chill; throat pain; fever; nausea; swoll...
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I had all this pain at the injection side; tired; headache; chill; throat pain; fever; nausea; swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/expiration date: unknown) via an unspecified route of administration on 23Feb2021 (at age of 60 years) at single dose for COVID-19 immunization. Patient relevant medical history included chronic obstructive pulmonary disease (COPD). Patient concomitant medications were not reported. After receiving covid-19 vaccine patient started running really high temperature and pain at the vaccination side, really tired, headache, chill, throat pain, fever, nausea, Patient said swollen lymph nodes, throat has been sore on unspecified date. Patient stated that run temperature but took Tylenol and it took it down it was high, but I still have the soreness. Patient also mentioned having COVID 19 infection months ago. Treatment received for events was unknown. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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| 60 | 2021-04-27 | fatigue, fever | Muscle aches, fever, sleeplessness, fatigue |
| 60 | 2021-04-27 | headache, fatigue |
Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and s...
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Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Exhaustion; This is a spontaneous report from a contactable other hcp (patient). A 60-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL9262) as SINGLE DOSE in left arm, dose 2 via an unspecified route of administration, administered in Arm Right on 15Feb2021 09:45 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunization. Medical history included arthritis, joint stiffness, back pain, arthralgia and unknown date, Allergic to insect stings. Concomitant medication included acetylsalicylic acid (ASPIRIN); paracetamol (TYLENOL). The patient previously took Augmentin and experienced drug allergy. On 16Feb2021 the patient experienced both times like mini version of covid which patient had a year ago. now right side of my neck hurts and still inflamed, feeling extremely fatigued, headaches, exhaustion (suspected covid-19) The outcome of both times like mini version of covid which I had a year ago, now right side of my neck hurts and still inflamed, feeling extremely fatigued. Headaches, exhaustion was not recovered.; Sender's Comments: The contributory role of the suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL9262) to reported events is probable.
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| 60 | 2021-04-27 | nasopharyngitis, fatigue |
She had a slow infection in her chest; She was breathing fine, but she got out of breath every now a...
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She had a slow infection in her chest; She was breathing fine, but she got out of breath every now and then; her immune system was not too good; no sleeping; She was so tired; she woke up on Thursday (08Apr2021) sick; She had a cold all year long, but normally doesn't have a color from her chest and nose (mucus). She said she now had a color to her chest and nose mucus; Has had a bad cold after the vaccine and an infection in her lungs; She had no energy, and couldn't work; This is a spontaneous report from a contactable consumer, the patient. This 60 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration in the left arm on 07Apr2021 around 12:15 (at the age of 60 years-old) for COVID-19 vaccination. Medical history included smoker since 1976 pack-a-day of cigarettes since 16, quit for 11 months, she went back to smoking, x-rays done in the 1990's and the patient was told that the lower part of her lungs were flat and was told she had chronic obstructive pulmonary disease (COPD) and emphysema at that time. She said her lungs were pretty bad. Family Medical History Relevant to adverse events were not provided. Concomitant medications included ascorbic acid, rosa canna fruit (VITAMIN C PLUS NATURAL ROSE HIPS) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient had a slow infection in her chest on an unspecified date (also reported as her doctor told her she had a little bit of an infection), a bad cold after the vaccine and an infection in her lungs on Apr2021, she woke up on Thursday 08Apr2021 sick, was so tired on 08Apr2021, had no energy and slept for 5 hours, couldn't work on Apr2021, had a cold all year long, but normally clear drainage from her chest and nose, she now had a color to her chest and nose mucus on Apr2021, she was breathing fine, but she got out of breath every now and then on an unspecified date and her immune system was not too good on an unspecified date. She reported that on 11Apr2021 to 13Ap2021 she has been fine, no sleeping. The patient had been told by her doctors that her immune system was not too good, and she should quit smoking. She said her sister was a licensed practical nurse (LPN), and her sister told her that she thought she (the reporter) may have had a cold when she got her first COVID-19 Vaccine. She said she had felt good since Sunday (12Apr2021). She said she felt stronger, but her cold was not better. She said she was breathing fine, but she got out of breath every now and then. The patient reported that she would get a lung infection if she had a bad cold. She said her doctor told her she took way too many antibiotics in the past, and now her body was used to the antibiotics It was also reported that she said she doesn't take antibiotics. She reported that her second COVID-19 Vaccine dose was scheduled for 05May2021, which was 4 weeks after the first COVID-19 Vaccine dose. There were no relevant laboratory tests done. There were no emergency room (ER) or physician office visits. Nature Made Vitamin C 1000mg yesterday (12Apr2021). She said she was taking 1 Nature Made Vitamin C (Lot Number: 2370401, Expiration Date: Feb2024) 1000mg a day. Adverse events following prior vaccinations were not applicable. The clinical outcome of no sleep, chest infection, no energy, couldn't work, out of breath, immune system was not too good was unknown, not recovered for cold, sick, color to her chest and nose mucus and recovering for tired. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 60 | 2021-04-27 | fever, chills, headache |
delirium; chills; fever; headache; body aches; This is a spontaneous report from a non-contactable c...
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delirium; chills; fever; headache; body aches; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 13Apr2021 10:00 (at the age of 60-years-old) as single dose for COVID-19 immunisation. The patient took the first dose on 23Mar2021 at 10:00. The patient's medical history and concomitant medications were not reported. On 13Apr2021 at 22:00, about 12 hours after receiving the 2nd dose, the patient experienced chills, fever, delirium, headache, and body aches. By 35 hours after the dose, symptoms were mostly past. The patient did not have COVID prior vaccination and patient was not tested post vaccination. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 60 | 2021-04-28 | sluggishness |
multiple pulmonary embolisms/Pulmonary embolism and subsegmental pulmonary embolus; felt sluggish di...
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multiple pulmonary embolisms/Pulmonary embolism and subsegmental pulmonary embolus; felt sluggish directly; feeling discomfort in my lungs; pain in my lung/chest area; pain in my lung/chest area/right-sided chest pain under the rib; difficult and extremely painful to breathe/significant shortness of breath/shortness of breath due to extreme pain; blood clots; This is a spontaneous report from a contactable consumer (patient) and physician. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534 and expiration date not provided), via an unspecified route of administration, administered in Arm Left second dose on 07Apr2021 17:00 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant at time of vaccination. The patient's concomitant medications included cetirizine, diphenhydramine, and phenylephrine. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6203), right arm first dose on 10Mar2021 for COVID-19 Immunization. On 07Apr2021 21:30, the patient felt sluggish directly after receiving the second dose. The patient began feeling discomfort in my lungs about 5 hours after the dose. The pain in my lung/chest area grew worse throughout the night to the point where it was difficult and extremely painful to breathe. The patient went to urgent care in the morning, and they ran an EKG, urine analysis, and chest X-ray: all with unknown results. They were concerned it could be something worse along with potential pneumonia, so they sent me to the emergency room. In the emergency room, I received a CT scan where they found multiple pulmonary embolisms (1 large one in my right and multiple in my left lung). The patient stated that she had just had my yearly physical the previous week (Apr2021), with no signs of any health issues. With that, the doctors believed my condition to be related to my 2nd dose, so I was admitted to the hospital. I had to stayed for 2 nights. I am now on blood thinners, other meds (pain medications), and require oxygen during sleep (O2 levels drop too low). I have been referred to lung and hematology specialists. Also, reported that patient experiencing significant shortness of breath and right-sided chest pain under the rib. This persisted for some time until she presented to the emergency department found to have segmental and subsegmental pulmonary embolus. Additionally, the patient experienced blood clots, chest pain, and shortness of breath due to extreme pain. Hypercoagulable work-up pending. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab) with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 60 | 2021-04-30 | fatigue, headache |
anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both,...
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anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both, had severe pain/her right knee joint is in severe pain; she could barely walk and she couldn't bend at all; really weak; had leg aches; she couldn't stay awake/she couldn't sleep again; diarrhea; severe pain at the back of her neck with a headache; severe pain at the back of her neck with a headache; had extreme fatigue; lightheadedness; upper back pain; bloody nose; she couldn't see out of her left eye for about 2 hours; she couldn't breathe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:41 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 60 years). Medical history included ongoing chronic obstructive pulmonary disease, ongoing chronic kidney disease and Positive ANA. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) on 18Mar2021 for covid-19 immunisation and experienced First dose: a little bit of soreness and swelling all on the site. The patient stated that during her second dose last Thursday on 08Apr2021, she had an anaphylactic reaction and she couldn't breathe and long story short she had to go to the emergency room and she was given all kinds of epi shots and treatment and stuff and eventually she had to be kept in the ICU unit. She is not sure why she had such a severe reaction. She wanted to report that since then she has kept track every day on how she has been and she actually thought yesterday was the first day that she had felt better. She had extreme fatigue, lightheadedness, upper back pain and even a bloody nose on 10Apr2021 and also she couldn't see out of her left eye for about 2 hours. Then on 11Apr2021, she had severe pain at the back of her neck with a headache that lasted about 20 minutes and she couldn't move her neck. She had diarrhea and the only temperature she had was on 12Apr2021, it was only 99.5 degrees Fahrenheit, which isn't bad, but she had really bad diarrhea on 12Apr2021 and she took Imodium. She had a headache and slight breathing difficulties and things like that. On 13Apr2021 she had a headache, was really weak, had leg aches, fatigue that was really bad and she couldn't stay awake and her temperature that day was 98.7 degrees Fahrenheit which is normal. Then yesterday, 15Apr2021, she thought she was over all the things and that she was feeling better from the fatigue, nausea (occurred on an unspecified date), lightheadedness but she couldn't sleep again. She didn't sleep since Wednesday morning until last night finally and she only slept for an hour since Wednesday morning. She woke up on 15Apr2021 and had no symptoms except her left and her right hips, both, had severe pain and she could barely walk and she couldn't bend at all. All she could do it take Tylenol and she used a heating pad and the pain was excruciating. She went to bed last night and she did sleep for maybe a total of 2 hours and when she woke up this morning her left hip seemed to be a little better but her right hip is still in severe pain and now her right knee joint is in severe pain too. Other than that, she has no other symptoms just the joint pain. She didn't know it would go on for this long, it has been over a week now and she just wanted to let us know about this. The patient was hospitalized for the event anaphylactic reaction from 08Apr2021 to 08Apr2021. The patient underwent lab tests and procedures which included Blood typing: anti kell antibodies (doctor randomly decided to do a blood typing and they found anti kell antibodies in her blood) on an unspecified date, temperature: 99.5 degrees fahrenheit on 12Apr2021, temperature: 98.7 degrees fahrenheit on 13Apr2021. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, diarrhea and arthralgia. Outcome of the event anaphylactic reaction was recovered with sequelae on 09Apr2021 while outcome of the events nausea, dyspnea, arthralgia, sleep disorder and movement disorder was unknown. Outcome of the event vision impairment was recovered on 10Apr2021 while outcome of the event neck pain was recovered on 11Apr2021. Outcome of the remaining events was recovered on 15Apr2021.
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| 60 | 2021-04-30 | fatigue |
Back disorder; lower back issues; Feeling abnormal; felt fuzzy; Vaccination site pain; sore arm; Diz...
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Back disorder; lower back issues; Feeling abnormal; felt fuzzy; Vaccination site pain; sore arm; Dizzy; Fatigue; Energy decreased; not feeling as much energy as before; Pain upon movement; walk about a block but then starts to hurt; This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program, based on the information received by Pfizer (Manufacturer Control No: 21K-163-3774842-00). Solicited report from a consumer of a 60 year old female with events of heart/atrial flutter, atrial fibrillation, eye surgery and arm surgery and non-serious weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt with humira 40mg/0.4ml (adalimumab). The patient had a relevant medical history of tobacco use/four cigarette sticks per day, seropositive high titer rheumatoid arthritis, fingers swelling, joint pain, joint swelling and lost of blood flow in hands and legs. On unknown dates, the patient experienced eye surgery, arm surgery, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt. In 2020, the patient experienced heart/atrial flutter and atrial fibrillation. In Sep2020, the patient experienced weight gain due to attempting to stop smoking. On 24Feb2021, the heart/atrial flutter and atrial fibrillation resolved. Covid-19 vaccine was also considered suspect. The patient had eye and arm surgery in the past. On 24Feb2021, she underwent pulmonary vein cryoballoon ablation surgery for the atrial fibrillation and atrial flutter. She had a procedure done and went into her heart and froze the nerve endings that were causing the atrial fibrillation, and also fixed the flutter in her heart. The causality as per reporter for this procedure was reported as no reasonable possibility. She still recovering. She discontinued the Humira two weeks before the surgery and took her last injection on 10Feb2021 and was paused it for four weeks, but she started back it on 10Mar2021. She follows up with her surgeon at the end of the month and she hopes this helps got her off of the blood thinners and other medicines, she been on for this. She stated that this was not related Humira. She was advised by her physician to increase the exercise to lose some weight. With her lower back issues, she was hoping that when she got off of the blood thinners, she could do pain shots again and start exercise. She could walk about a block but then she started to hurt. She had been careful with her diet also, cut out the salt also. This had nothing to do with Humira and she did not want to be contacted about this again for this also. She felt fuzzy, it took her most of the morning to get woken up. Her Doctor thinks once she would off of the blood thinners she would be back to normal. Other than that she feels fine. She does not wanted to be contacted about this. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received first dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown. She agreed to have physician contacted. Blood thinner was also considered as co-suspect. Other medical history included abstains from alcohol, contrast dyes allergy manifested by scratch throat, allergy manifested by bowel movements (oral medications for rheumatoid arthritis; up to eight times a day and slept 15 hours per), prevent esophagus damage, heart, low thyroid, and attention-deficit/hyperactivity disorder. The patient's concomitant medications included pantoprazole to prevent esophagus damage, metoprolol for heart, levothyroxine for low thyroid, vortioxetine hydrobromide (TRINTELLIX) for depression, and dexamfetamine sulfate (DEXTROAMPHETAMINE) for attention-deficit/hyperactivity disorder. The patient underwent laboratory tests and procedures which included blood work: everything was fine in Jan2021; chemical stress test and treadmill stress test: confirmed atrial fibrillation and atrial flutter in Sep2020; body weight: gain in Sep2020; and X-ray: confirmed atrial fibrillation in Sep2020. The action taken in response to the events for adalimumab and apixaban was unknown. The patient recovered from atrial flutter and atrial fibrillation on 24Feb2021. Outcome of Feeling abnormal and Pain upon movement was unknown. The patient had not recovered from the remaining events. Change History: On 05Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, suspect drug information, concomitant drug information, past drug information, laboratory/diagnostic procedures and narrative description. The events of "atrial flutter", "atrial fibrillation" and "weight gain due to attempting to stop smoking" were added. On 11Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of "LOWER BACK ISSUES" and "WALK ABOUT A BLOCK BUT THEN STARTS TO HURT" were added. the event of "atrial flutter" was amended to "heart/atrial flutter". On 08Apr2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "felt fuzzy", "got first dosage of covid-19 vaccine and experienced sore arm", "fatigue and dizzy from the blood thinners after surgery" and "still not feeling as much energy as before" were added. Causality for humira 40mg/0.4ml(adalimumab): The reporter's causality for the event(s) of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood THINNERS after surgery unknown onset and fatigue and dizzy from the blood thinners after surgery unknown onset with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of felt fuzzy, still not feeling as much energy as before and walk about a block but then starts to hurt was not provided. Manufacturer opinion is that there is no reasonable possibility that the events of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery unknown onset, fatigue and dizzy from the blood thinners after surgery unknown onset, still not feeling as much energy as before and walk about a block but then starts to hurt are related to humira 40mg/0.4ml(adalimumab). The reporter's assessment of the causal relationship of the events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information , the events of sore arm, fatigue and dizzy could be related to the suspected drug of BNT162B2. The other events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 60 | 2021-04-30 | sinus congestion, throat pain |
Bell's Palsy; I started to have sharp pain behind my ear; sinus congestion; deep sore throat; dry le...
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Bell's Palsy; I started to have sharp pain behind my ear; sinus congestion; deep sore throat; dry left eye; This is a spontaneous report from a contactable other healthcare professional (HCP; patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 27Mar2021 at 16:00 (Lot Number: ER8733, expiry date not reported) at the age of 60-years-old at a single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was facility. The patient received no other vaccine in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. Medical history included penicillin-rash; high cholesterol being treated with Repatha; slightly high blood pressure being treated with lisinopril; cysts in pancreas, thyroid and kidneys-all benign. Concomitant medications included evolocumab (REPATHA) for high cholesterol; lisinopril for slightly high blood pressure; spironolactone for an unspecified indication and testosterone for an unspecified indication, all start and stop dates were not reported. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 27Mar2021, 4 days later on 31Mar2021 20:30 she developed Bell's Palsy. She would like to know if in the clinical trials those who experienced this adverse event was after the first or the second dose of the vaccine. She already reported this adverse event to Safety, online and verbally. She would like to know if Pfizer recommends for people who develops Bell's Palsy after the first dose of the vaccine not to receive the second dose and if there's information about the cases of Bell's Palsy after receiving the vaccine during the vaccination to larger populations. She's also wondering if there is information about how long it takes to resolve. Patient reported that four days after vaccination on 31Mar2021 at 20:30, she started to have sharp pain behind her ear, sinus congestion, deep sore throat, and dry left eye, went to bed, next morning she woke up with Bell's palsy on left side of face (also reported to have occurred on 31Mar2021 20:30). These resulted in a doctor or other healthcare professional office/clinic visit. The patient was treated with high dose prednisone and Valtrex. The outcome of the events was not recovered.; Sender's Comments: Bell's palsy is not uncommon in general population, however the causal association between bell's palsy and the usage of the vaccine BNT162B2 cannot be excluded because of strong temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 60 | 2021-04-30 | throat irritation |
Anaphylactic reaction; it started like a flushed feeling; She felt woozy; she still feels a little t...
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Anaphylactic reaction; it started like a flushed feeling; She felt woozy; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she is just a little uncomfortable, just a little today, not too bad; She adds that she is having a hard time focusing; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8731 and expiry date unknown, Solution for injection), via an unknown route on 12Apr2021 at 15:05 (at the age of 60-years-old) at single dose on left arm for COVID-19 immunization. Relevant medical history included allergies, asthma, she had anaphylaxis in the past to allergies. (Unspecified allergens). The patient added that she had issues for about a year before her surgeon had to do a surgery on her throat. She added she was fortunate because her thyroid was in her airways 14 years ago and her body exploded with allergies and her throat closed a lot. When the doctor did the surgery, the doctor opened her throat up more so that if she had another anaphylaxis it would not result in death. Concomitant medications was not reported. On the same date, after the vaccination the patient had anaphylactic reaction. She stated that happened 62 minutes, it might have been 64 minutes and also stated a few minutes after 60 minutes. The vaccination facility released her after 30 minutes at 15:35 and when she realized something was happening it was 16:10 when the patient realized what it was that she was experiencing. The vaccine facility held onto her for 30 minutes, so she got the vaccine around 15:05 and they watched her for 30 minutes. She believed it was around 65 minutes later that she started noticing something was happening. The patient started like a flushed feeling. She does not know to describe it, it was like she had a drink or something like she felt flush or something over her system like a wave or something. It was like a strong drink or something. She does not drink a lot but it was like woohooo, a wave of something, and then she felt woozy. It was not too bad at first, she was at a bank drive through and she was not driving. The patient was going to pick something up so she stopped for 5 to 10 minutes. She was on the phone with a friend. She felt woozy. The patient asked her husband to buy diphenhydramine (Benadryl). Her husband called back when she got done at the bank, and she was only 10 minutes from her house. The patient had her EpiPen with her. The patient was feeling better and she still feels a little tight in her throat and the way she explained it yesterday was that it was like someone had their finger down her throat, it was uncomfortable. She was just a little uncomfortable, just a little today, not too bad. She added that she was having a hard time focusing. Today, the patient felt tight, scratchy, and hoarse. It was not like it was last night. The patient did not receive any treatment for the events. Outcome of the events were unknown. Description of Product Complaint: Description of complaint: Consumer reporting an AE for the Pfizer COVID 19 vaccine mentions that they told her not to take the flu vaccine because she would get sick. Her flu symptoms would go on for 2-3 months. If she got the flu shot in September or October, she would not feel well through Christmas. Caller adds that she never got the flu again when she stopped the vaccine. Caller does not know manufacturer, NDC, lot or expiration date for the flu vaccine she had that made her sick Caller does not have any information about the Benadryl - and she does not have the bottle that she took that made her sleepy because she added that the only bottle she had was the one that her husband bought yesterday and it was not opened and she had not taken it. Caller added that she had not taken Benadryl in 14 years since before her surgery. Caller adds it might have been 15 years, she would have to remember that. AE identified after call completed. No NDC, lot or expiration date provided for Benadryl caller took 14 to 15 years ago. Follow-up attempts completed. No further information is expected.
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| 60 | 2021-05-02 | sweating, headache |
Patient was working in the traffic area of the parking lot. The patient was exiting the area after t...
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Patient was working in the traffic area of the parking lot. The patient was exiting the area after the 15 min observation period. She reported no symptoms or complications prior to leaving the area and no usual behavior was noted at this time. Patient was accompanied by her husband and son. Near the parking lot the patient was witnessed losing consciousness and falling to the ground. Patient immediately assisted the patient and also called for assistance. I was notified immediately and myself, the paramedics on sight, and NP responded to the patient incident. The patient was diaphoretic and had abnormal vital signs that were repeated multiple times. The set I obtained were 117 heart rate, 99% oxygen on room air, 167/94, 225/112, both taken lying down. Patient complained of severe headache, blurry vision, tinnitus, and dizziness over the past 2 days prior to days. Patient reports having only one medical condition, psoriasis, and takes a cream for it, but also reports she has not seen a doctor in "many years". No stroke symptoms were observed.
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| 60 | 2021-05-06 | dehydration, fatigue, chills, headache, throat pain |
Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eye...
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Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eyes it is swollen; She was having severe diarrhea; having severe dry heaves; vomiting bile; It had dehydrated her/lead to dehydration; Her throat closing up and it being sore from vomiting and dry heaving; couldn't swallow to get any fluids in; Her throat closing up and it being sore from vomiting and dry heaving; she was struggling with having a dry mouth; puffiness; Headache; severe muscles aches/Muscles pain; feeling nauseous; Was a little warm on her arms/ it was warm to the touch; it just looked like a bee sting and it wasn't super sore; sensitive to the touch; It had big red spots; had a little tiredness; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 16Apr2021 at 10:00 (at age of 60 years old, Lot Number: EW0ISO) as single dose for covid-19 immunization. Medical history included she had lupus, sjogren's syndrome. The patient's concomitant medications not reported. The patient previously took Pneumonia Vaccine on 04Mar2021 (Anatomical Location: Left arm); took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 at 10:00 (at age of 60 years old, Lot Number: the lot number starts with ER something and then it ends with a 3) as single dose for covid-19 immunization; took azathioprine for lupus and had allergic reaction; took belimumab (BENLYSTA), subcutaneous from an unspecified date (Lot Number: PV7G; Expiration Date: Jun2023, NDC: 49401-088-01, Number on the side: 0147098) to an unspecified date, self injection once a week for lupus. She gets it through the VA and it is subcutaneous use and the manufacturer is company. she was immunocompromise, she had lupus, so she was off of her medication (BENLYSTA) for a month per the CDC guidelines. She wanted to let Pfizer know that as well. For her first COVID vaccine she was originally scheduled to go 6 to 7 days after she had her pneumonia shot and they told her that she would have to wait 2 weeks before having her COVID shot and she did. Other than that she had followed the guidelines and she had been able to take her regular medications but she had to stop her Benlysta because of her immune system and everything. She had been following through on what the CDC has said. Patient stated that she just did a follow up with her doctor because of what happened after her second Pfizer COVID vaccine and her doctor recommended her to let Pfizer know about the side effects that she was having. On Friday 16Apr2021 she had her shot at 10 AM and it was no big deal, it was a little warm on her arms. She stated that it just looked like a bee sting and it wasn't super sore, it was warm to the touch and sensitive to the touch. It had big red spots and there has really been no change since it began. It looks about the size of a bee sting and it was still there. She had a little tiredness and she was not hungry but when she woke up at 06:40 the next morning (17Apr2021) on Saturday she was having severe dry heaves and vomiting bile and she could not get it under control. It had dehydrated her and she was having severe muscles aches. She had the severe dry heaves and the vomiting that lead to dehydration and then she went to the emergency room and she got replenished and they had given her something for feeling nauseous and eventually she was released 3 to 4 hours later. They gave her pills as well so she was doing well now and she hasn't done anything since she went to the emergency room with the vomiting and feeling nauseous. She went there about 1030 to 1040. Before she went she couldn't stop and she told herself that if it didn't stop on the 5th time then she was going to go to the emergency room and it got really bad so she had to call 911 to come and get her. Then she was having severe diarrhea on Sunday (18Apr2021) and the only way she could stop that was for her husband to pick up antidiarrheal pills. That only went away because of the medicine from the pharmacy. She had the over the counter medicine and she took Imodium. She hasn't been eating a lot so she hasn't had a bowel movement since she took that medication. When she had diarrhea there was no substance, it was very watery. And now today (unspecified date) she was having another reaction that she was seeing and it was just itching on her hands and her feet. She had been continuing to take the Benadryl and something that they gave her in the emergency room and she had taken Tylenol for the little headache that she has had. She had a slight headache and she was still taking Tylenol like they had recommended. This began the same time as she was vomiting on 17Apr2021 when she was going through all of that she had the slight headache. But her biggest concern was during this time when initially on Saturday (17Apr2021), her throat closing up and it being sore from vomiting and dry heaving, she was having the dry heaves her airway closed shut and she couldn't swallow to get any fluids in. Her concern was that the back of her throat was killing her and it was totally closed up so she had to go to the emergency room. She had recognized this because in the past she has had a medication where she had an allergic reaction (she thinks it is the medication that they gave her for lupus because she has been on several different things. She thinks azathioprine but she can't recall exactly but she thinks that might of been the one that did it to her) and it had closed her esophagus up the same way like this. This time it got worse to where she couldn't even swallow water no less a pill. This was on 17Apr2021. When she went to the emergency room they gave her the hydrocortisone to take it down and she actually had felt better while she was waiting for the saline drop. She was able to swallow when her airway was opened again by the time they treated it with the hydrocortisone. Around 16:00 she was better when she left the emergency room that same day 17Apr2021. She doesn't really have a sore throat, it is pretty fine. It seems to be okay she thinks that once the dry heaves and all that stopped it helped to relax that. She was a little raspy from the whole thing and she was struggling with having a dry mouth but that even had been resolved as far as her throat. She had no other reactions than what she explain but she also had a lot of muscles pain but that was to be excepted because it says that on all that she has read. She had had all of the reactions listed except for fever. She had had chills and then when clammy and then was clammy and had chills. She had all of those side effects listed on the sheet and when she went on Saturday following her vaccine to the emergency room most of the side effects were treated in emergency room. They gave her Pepcid, hydrocortisone through her IV and gave her Zofran for the vomiting and they said to keep taking acetaminophen. They gave her cetirizine for allergy or the itching or whatever and they also gave her famotidine which she thinks is Pepcid. Since being off the lupus drug she was getting her symptoms again such as sensitivity to light, inflammation and the dry heaves didn't help so under her eyes it was swollen and she just takes it as it was because she was not on her medication and she had something else injected inside of her. Also, she had Sjogren's disease too so her eyes were already drier than normal and she had had puffiness since 17Apr2021 when she was vomiting. She just wanted to make sure that Pfizer got that information because she didn t see that listed. The only side effect she was related was the swollen glands and she has glands in her throat but she wanted to be sure that Pfizer had that data just in case if it could help someone else. Again, she wants to reiterate that with her first dosage she had no problems. She couldn t even see the mark and all of this is stemming from the second dose of the COVID vaccine. The outcome of the events "Dry heaves, Bilious vomiting, Dehydration, Her throat closing up and it being sore from vomiting and dry heaving, Unable to swallow, Dry mouth, Nauseous" was recovered on 17Apr2021. The outcome of events "Feeling of warmth, Vaccination site pain, Hyperaesthesia, Vaccination site erythema, Tiredness" not recovered. The outcome of the event "Headache" was recovering. The outcome of other events was unknown. No follow up attempts are needed. No further information is expected.
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| 60 | 2021-05-07 | body temperature increased, headache, fatigue, malaise, chills, sleepiness |
body aches; Headache; sleepiness; Fatigue; Chills; body temperature: 97.5-98.7; Ear pain; sense of f...
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body aches; Headache; sleepiness; Fatigue; Chills; body temperature: 97.5-98.7; Ear pain; sense of fullness in ears and lymph nodes; sense of fullness in ears and lymph nodes; I feel pretty awful after this first dose.; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 03Feb2021 17:40 (Batch/Lot Number: EL9269) as single dose at the age of 60-year-old for COVID-19 immunisation, offered at the health system she works for and administered at hospital. Medical history included ongoing acoustic neuroma on 8th cranial nerve left side, on the side she felt the intense ear pain, diagnosed 2007-2008, thyroid cancer from 2004 and thyroid removed, her hormone levels are normal, COVID-19 in Dec2020. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). There were no concomitant medications. The patient experienced I feel pretty awful in Feb2021 with outcome of unknown, ear pain on 03Feb2021 with outcome of not recovered, sense of fullness in ears and lymph nodes on 03Feb2021 with outcome of recovered on 05Feb2021, body aches on 04Feb2021 with outcome of not recovered, headache on 04Feb2021 with outcome of recovering, sleepiness on 04Feb2021 with outcome of not recovered, fatigue on 04Feb2021 with outcome of not recovered, chills on 04Feb2021 with outcome of not recovered, body temperature: 97.5-98.7 on 04Feb2021 with outcome of unknown. The events did not require a visit to Emergency Room or Physician Office. The course of events was as follows: Patient expected that since she just had COVID in Dec2020, she thought her response to the vaccine would not be severe because she already had some immunity from the infection. The evening of the vaccine, on 03Feb2021, she experienced ear pain and a sense of fullness in her ears and lymph nodes. The ear pain was almost immediate after vaccination. On 04Feb2021, the next day, she woke up with a headache. It was an unusual headache. It did not go away with Tylenol. Then about halfway through the day, she developed significant body aches like when she had COVID. She also experienced extreme sleepiness like when she had COVID too. She took Motrin and had to lie down during her work day. The Motrin did help. Then mid morning 04Feb2021, she got a chill. She couldn't get warm enough. She had no fever. She checked multiple times. Her temps ranged from 97.5-98.7 on 04Feb2021. She experienced fatigue. She did not know the seriousness for any of the side effects she experienced. As of 05Feb2021, her headache has improved. She was still experiencing sleepiness and fatigue. The chills she developed mid day. She had not them right now. She has better and worse moments just like when she had COVID. She was worried about the second one. The patient underwent lab tests and procedures which included body temperature: 97.5-98.7 on 04Feb2021, COVID-19: positive in Dec2020. No other relevant tests. Therapeutic measures were taken as a result of headache and sleepiness. A Product Complaint was filed.
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| 60 | 2021-05-07 | headache, cough, fatigue, throat pain |
High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; ...
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High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; Joint and muscle pain; Blurred vision; Persistent cough; My glands started hurting; My ears hurt specially on the right where the shot was given everything is the worse; Sore throat; Jaw pain; my neck under my chin is swollen and painful; my neck under my chin is swollen and painful; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; This is a spontaneous report from a contactable consumer(patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW016) via an unspecified route of administration in right arm on 19Apr2021 at 17:15 as SINGLE DOSE for covid-19 immunization. Patient was 60 years old at the time of vaccination. Medical history included rheumatoid arthritis, COPD, chronic empyema, asthma, chronic bronchitis, gastritis, irritable bowel syndrome, blood pressure high and digestive disorder, all from an unknown date and unknown if ongoing. Concomitant medications included quetiapine fumarate (SEROQUEL), POTASSIUM CHLORIDE, albuterol sulfate (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), FLUNISOLIDE, FLUOXETINE, HYDROCHLOROTHIAZIDE, IPRATROPIN, METOPROLOL, MONTELUKAST, PANTOPRAZOLE, FAMOTIDINE and LOSARTAN, all taken on unspecified date for unknown indication. In Apr20, the patient had high fever of 107.5 degree fahrenheit, dizziness, nausea, headache, fatigue, joint and muscle pain, blurred vision, persistent cough, my glands started hurting, my ears hurt specially on the right where the shot was given everything was the worse, sore throat, jaw pain and neck pain, my neck under my chin is swollen and painful, abscess in my gum and swelling and blisters in my mouth. On unspecified date, the patient underwent lab tests and procedures which included body temperature 107.5 degree F, blood test which she does every year and she had a follow up every 6 months. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 60 | 2021-05-09 | fatigue |
April 1, dark urine April 2, Fatigue, injection site pain dark urine April 3, Extreme fatigue, dark ...
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April 1, dark urine April 2, Fatigue, injection site pain dark urine April 3, Extreme fatigue, dark urine Jaundice went to urgent care, they advised i go to ER as they felt i needed an abdominal scan to see why i had so much bilirubin in my urine. Went to Hospital. CBC showed my hemoglobin was 5.9. Went down to 4.9 before first transfusionhad CT SCan and sonogram.. Was admitted and disagnosed with hemolytic Anemia brought on by Covid Vaccine. had 5 blood transfusions over the course of my 8 day hospital stay. As of 5/06/21 My hemogloblin is 10.3 and has been at this level for past three weeks, I am currently under the care of a hemotologist
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| 60 | 2021-05-13 | throat irritation |
My throat was itchy/my throat felt worse; My throat was itchy in between that half hour my voice sta...
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My throat was itchy/my throat felt worse; My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I am allergic to them/ Severe reactions and had to be hospitalized overnight; had problem swallowing a little bit and voice changes after talking; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Age at Vaccination 60 year), as single dose for covid-19 immunisation. Medical history of the patient included anxiety, depression, nerve pain, ongoing blood pressure (hypertension), change in personality and cardiac disorder. Concomitant medication of the patient included levothyroxine, atorvastatin calcium (cholestat [atorvastatin calcium]), pantoprazole, 1300mg fluconazole (Fluxizol), 81mg aspirin, lubiprostone (Amitiza), alpha lipoic acid, baclofen, linezolid (Zenix [linezolid]), centrum silver, 10mg rosuvastatin calcium (Crestor), 100mg docusate sodium (stool softener), amlodipine and magnesium oxide for blood pressure. Patient was on Benazepril HCTZ for heart, Pristiq for anxiety or depression, citalopram for pain (something to do with pain I can't remember), Effexor for Anxiety, Lexapro, Levaquin, and Sulfa for rashes. Patient got it from her bladder infection. Cyclobenzaprine (I can't remember), Gabapentin, change in personality and nerve pain. Metoprolol for heart. Patient was not taking any of these medications now she got several allergies from them. Patient had a lot of allergies. She was on lot of medications. But it was not what she was taking any these medications on the same, so she was like what was going on. Patient not taking the medication (Unspecified Medication), she was allergic to them, but she was taking other medication. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number, PF12ER6200), via an unspecified route of administration, administered in Arm Left on 22Feb2021 (Age at Vaccination 60 year), as single dose for covid-19 immunisation. On 15Mar2021, the patient had severe reactions and had to be hospitalized overnight. Within mild reaction for 15 minutes and within 40 minutes severe. Patient went to have it done at the hospital they walked her down to the ER they get to give her an epi Pen injection into IV." When again probed for the concern, Patient stated, she had it done at the hospital, they after 15 minutes her throat was itchy they may say another half hour in between that half hour her voice started to change and her throat felt worse they walk her down to the ER her throat was hurting then slowly they gave her Epi Pen and they injected in an IV with steroids. Patient had wheezing in her lungs and she spent the night in hospital for observation. Patient stated that she still had problem swallowing a little bit and voice changes after talking. Patient wanted to know it was like how she supposed to find out what she was allergic. Patient further stated, "Because she want to you know she need an update how was it bad so she want to had to go all this what she was allergic. Event outcome for the events swallowing difficult and for voice alteration it was not recovered and for other events it was unknown. Information about lot/batch number has been requested.
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| 61 | 2020-12-31 | lethargy, malaise, sweating | Lethargic, Diaphoresis, general unwell feeling |
| 61 | 2020-12-31 | fever, headache | Body ache, head ache, fever, nausea, liwer leg muscle spams/cramping |
| 61 | 2021-01-03 | headache, lethargy | Lethargy and headaches for 2 days |
| 61 | 2021-01-03 | influenza like illness, nasal congestion, fever, cough, throat pain |
Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, ...
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Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, Itching all over body, scalp pain and tenderness. 12/28 Began feeling better, mild cough persists. 1/4: Feels as though she has "bad flu" fever of 101 F.
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| 61 | 2021-01-03 | malaise, fatigue | Extreme fatigue, weakness, lightheaded, malaise |
| 61 | 2021-01-03 | respiratory tract congestion |
congestion in the throat and upper lungs; congestion in the throat and upper lungs; This is a sponta...
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congestion in the throat and upper lungs; congestion in the throat and upper lungs; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular on the left arm on 21Dec2020 09:30 at a single dose for COVID-19 immunization. The patient's medical history included herpes 2. The patient was not pregnant. The patient had no known allergies to medications, food, or other products. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 26Dec2020 09:00, the patient experienced congestion in the throat and upper lungs. Oxygen level was 98 and temperature was 97.7. She had a good diet, no dairy, and no Christmas junk food, so for the patient, it was inexplicable. She was also consistent at mask wearing and all the precautions. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were reported as non-serious.; Sender's Comments: Considering the temporal gap between the vaccination and the event onset, the Company considers the event pulmonary congestion is unlikely related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 61 | 2021-01-03 | throat irritation |
About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, ...
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About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, feeling that I would pass out, lightheafdedness, increased heart rate and blood pressure, mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness, very slight throat soft tissue sensation
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| 61 | 2021-01-04 | cough, fever, nasal congestion, malaise, headache, chills |
Headache, fever, chills, cough, congestion, malaise, patient reports she has been "down" since Satur...
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Headache, fever, chills, cough, congestion, malaise, patient reports she has been "down" since Saturday and is still experiencing all of these symptoms overall. Patient has been taking TheraFlu
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| 61 | 2021-01-04 | fatigue, body temperature increased, headache |
VACCINE SAT AT 1:30 PM, SUNDAY 9:00 AM FEELING TIRED NAUSEATED, TEMP UP TO101 THROUGH THE DAY, HEADA...
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VACCINE SAT AT 1:30 PM, SUNDAY 9:00 AM FEELING TIRED NAUSEATED, TEMP UP TO101 THROUGH THE DAY, HEADACHE,PAIN IN LEFT ARM AT INJECTION SITE. TEMP SEEMED TO BREAK THAT EVENING 98.0 . MONDAY INJECTION SITE VERY RED AND RAISED, ITCHY, ABOUT 1 TO 1 1/2 INCHES IN SIZE. TODAY TUESDAY SAME SIZE ITCHY NOT RAISED .
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| 61 | 2021-01-04 | headache | NAUSEA AND HEADACHE |
| 61 | 2021-01-04 | headache |
Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseat...
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Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseated. Continued to have worsening symptoms. Nausea/Vomiting, muscle twitching, severe headache, increased heart rate went to ED on 1/5 at 0100.
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| 61 | 2021-01-04 | fever, chills, headache |
Headache; muscle aches and pains; feels like she is getting a fever; thinks she is having the chills...
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Headache; muscle aches and pains; feels like she is getting a fever; thinks she is having the chills; feeling a little warm/ She is cold, too; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) intramuscular on left arm, near the top (in the muscle), at single dose for vaccination on 29Dec2020 at 12:45 pm at 61-year-old. Medical history included: hay fever allergies, allergic to prochlorperazine maleate (COMPAZINE). Concomitant medication was not reported. No additional vaccines administered on same date of the Pfizer vaccine. On 30Dec2020, the patient stated her headache started about an hour and a half ago. She started having the muscle aches and pains when she woke up this morning. She felt like she was getting a fever, but she was at work and couldn't take her temperature. She was feeling a little warm, she was cold, too. She was having the chills. The patient confirmed all of these symptoms just started happening this morning (30Dec2020). No emergency room nor physician office visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. It was reported as non-serious.
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| 61 | 2021-01-04 | fever, nasopharyngitis, chills |
aches/pains/body aches and pains; hot flashes; a little fever/fever of a little over 100; she was fr...
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aches/pains/body aches and pains; hot flashes; a little fever/fever of a little over 100; she was freezing/chills; cold was worse; couldn't get comfortable; started feeling bad when she went to bed; This is a spontaneous report from a contactable consumer (patient's husband). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 27Dec2020 at 12:45 on Left Upper Arm at single dose for COVID-19 immunization in hospital. No additional vaccines administered on same date of bnt162b2. The patient medical history included she may be a little overweight, but she was not obese. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), levothyroxine sodium (SYNTHROID), lubiprostone (AMITIZA) for stomach. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the flu shot (influenza vaccine) in the past for immunization and got sick once afterward, she was not sure if it was food poisoning or the flu vaccine, she didn't get one this year. Patient's husband reported that patient got the vaccine yesterday (27Dec2020). She felt fine all day but started feeling bad when she went to bed on 27Dec2020. She was experiencing aches, pains hot flashes and a little fever a little over 100. She had a miserable night. She had body aches and pains, hot flashes and a little fever started around one in the morning of 28Dec2020. The fever was a little over one hundred. It looked like she what she got was normal side effects. The reporter didn't know how long approximately and how high her fever could get before he called the doctor. She had started to feel better on 28Dec2020. Then she was down again. She didn't feel great when she went to bed and then was up from 1AM to 2AM until now (28Dec2020). From 1AM or 2AM until 7AM or 8AM of 28Dec2020 it was the worse with bad aches and pains. She couldn't get comfortable. Alternating between fever and chills. Around 8AM to 9AM it started to get less and the aches started to get less. She didn't have a fever and he had checked 4 or 5 times. Around 2:00PM on 28Dec2020 she had the fever of a little over 100. The hot flashes were moderate to severe. The cold was worse and she was freezing in the middle of the night on 28Dec2020. He gave her heating pads and blankets and she was still freezing. Reporter thought the second shot would be worse with reactions. She was concerned about getting the second shot. No event required a visit to Emergency Room or Physician Office. No Investigation Assessment provided. The outcome of the events was unknown. This report was reported as non-serious.
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| 61 | 2021-01-04 | fever |
Patient describes feeling feverish, joint aches in elbows and knees, body aches, red rash at knees a...
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Patient describes feeling feverish, joint aches in elbows and knees, body aches, red rash at knees and elbows and arm pain at injection sites. This is the 2nd dose, patient reports no adverse reactions on the first dose.
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| 61 | 2021-01-05 | fatigue, fever | Low grade temp, body aches, fatigue |
| 61 | 2021-01-05 | headache |
couldn't lift my head off my pillow; severe pain in neck; squeezing on a nerve; had soreness in my a...
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couldn't lift my head off my pillow; severe pain in neck; squeezing on a nerve; had soreness in my arm; This is a spontaneous report from a contactable nurse, the patient. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Dec2020 (at the age of 61 years old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 18Dec2020, the patient experienced soreness in her arm that was gone by the next day. On 23Dec2020, while driving home, she felt severe pain in neck. She almost felt like something went up in her neck and started squeezing on a nerve. It proceeded to get bad so she took muscle relaxants. Christmas day was horrible, she couldn't lift her head off her pillow. The pain came from up head, under her clavicle and down her back. Her pain started getting better, but then next morning it up started again. The only way she's able to get some sleep is to take Flexeril, 800mg of Motrin and applying moist heat. The clinical outcome of severe pain in neck, squeezing on a nerve, couldn't lift her head off her pillow was unknown, and for event had soreness in her arm was recovered on 19Dec2020. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 61 | 2021-01-06 | chills, headache, fever | Fever 101.7 Chills, Body Aches, Generalized Weakness, Head Ache, Diarrhea |
| 61 | 2021-01-06 | chills, fever |
Woke up this morning (the day after receiving the vaccine) with chills, fever of 101.9 & diarrhea. C...
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Woke up this morning (the day after receiving the vaccine) with chills, fever of 101.9 & diarrhea. Called my manager at work. Went back to bed. Around 8am took 2 Tylenol extra strength 225 caplets, 500mg each. 3 hours later temp down to 99.2. My normal is 97.6
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| 61 | 2021-01-06 | cough, productive cough |
worry; frustration; regrets/wishing she would have never taken it; phlegm; can't talk; taking her vo...
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worry; frustration; regrets/wishing she would have never taken it; phlegm; can't talk; taking her voice, she felt like she was losing her voice; scary/"scaring" her; coughing/cough; difficult for her to catch her breath/lost her breath, couldn't catch her breath/couldn't breath; allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284, expiry date 30Apr2021) intramuscular on 29Dec2020 09:16 at 0.3 mL, single for Covid-19 immunization in a hospital. Medical history included diabetic, allergy reactions, blood pressure (abnormal), cholesterol (abnormal); all ongoing, and reaction to dust. Concomitant medications included ongoing amlodipine;hydrochlorothiazide;valsartan for blood pressure, ongoing potassium for unspecified indication, BP pills (unspecified) and has cholesterol medications. The patient informed that yesterday (29Dec2020), she got the COVID vaccine shot at work, received it at 9:16 am and was monitored for 30 minutes post administration. The patient went to work and was holding the babies. The patient worked in transport in the NICU at a hospital. Few hours after the injection, while working in the NICU, she experienced coughing to the point where it was difficult for her to catch her breath. The patient started coughing so bad, she had no control. She mentioned trying to drink water and continued coughing more. The patient lost her breath, couldn't catch her breath, she had to call for the charge nurse (manager), as she couldn't breath and they took her to the ER and consulted at the ER of her facility. The patient informed that she kept coughing and couldn't catch her breath. They made her drink water. The patient has allergies, so she always has an epi pen with her. The patient felt like she had an allergic reaction to the vaccine. The doctor there explained that her symptoms were not related the Covid-19 vaccine she received earlier. The patient specified that the last time she had a similar reaction was at work and was due to dust. The patient explained that she was perfectly fine before receiving the vaccine, laughing, and so what can her symptoms be related to, if it was not the vaccine. The patient was coughing all night, can't get rid of the cough. She has called her doctor. The nurse said just to watch herself for now. The patient informed that she was supposed to go back to work tomorrow and she was afraid to go around the babies. The patient informed that today (30Dec2020), she gargled apple cider vinegar and salt water, and phlegm came out. The patient continued saying that she has still been coughing, can't talk and that it was scary. The patient informed that she was taking her voice, she felt like she was losing her voice. It was "scaring" her. She was unsure if it was the Pfizer vaccine. The patient attempted to reach her HCP and that she cannot be seeing at her clinic due to her cough. The patient mentioned that she won't have access to a respiratory clinic until Tuesday. The patient expressed her concerned about returning to work with babies and asked if she should return to work tomorrow. The patient pursued verbalizing her worry and frustration. The patient asked if she can decide not to get the second dose. The patient voiced her regrets on receiving the first dose of the COVID-19 vaccine. She stated wishing she would have never taken it and that all who have an EpiPen should not receive it. The outcome of the event cough was not recovered, Dyspnoea, Allergy to vaccine, Productive cough, Speech disorder, Aphonia, Nervousness, Anxiety, Frustration tolerance, Depressed mood was unknown.
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| 61 | 2021-01-06 | headache, chills | Headaches, body aches, chills, x 3 days now resolved. |
| 61 | 2021-01-06 | headache, fatigue, chills |
Headache, Myalgia, Arthralgia, Chills, Fatigue, Injection Site Pain Narrative: Adverse reaction last...
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Headache, Myalgia, Arthralgia, Chills, Fatigue, Injection Site Pain Narrative: Adverse reaction lasted 3 days, employee did not report to work on day 3 after vaccine.
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| 61 | 2021-01-06 | headache, fatigue | Patient describes headache and dizziness, also fatigue. |
| 61 | 2021-01-06 | headache |
left fingers felt cold and numb slightly light headed Felt 'goofy' and headache still feeling the s...
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left fingers felt cold and numb slightly light headed Felt 'goofy' and headache still feeling the same today - did register for V-safe
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| 61 | 2021-01-06 | nasopharyngitis, throat pain |
Cold/ cold like symptoms; Sore throat; Congested/ sore throat; Sore arm; I was hurting for a day; Th...
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Cold/ cold like symptoms; Sore throat; Congested/ sore throat; Sore arm; I was hurting for a day; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) intramuscular on left arm at single dose for COVID-19 immunization on 23Dec2020 at 61-year-old. No medical history or concomitant medication. Yesterday (30Dec2020), the patient woke up with a sore throat, it was like getting cold with a sore throat, congested, the patient had cold like symptoms, seemed like the patient was getting a cold. The patient just took decongestant medication. After waking up this morning (31Dec2020) the patient did not have taken anything. The patient got tested for COVID (for antigen not a PCR) yesterday (30Dec2020) and was negative. The patient did not have got any fever, just sore arm a week ago (Dec2020). She was hurting for a day and then she was good, everything good. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.
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| 61 | 2021-01-06 | throat irritation, cough |
Pt stated that she was feeling a tickle in her throat 10 minutes after administration of the vaccine...
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Pt stated that she was feeling a tickle in her throat 10 minutes after administration of the vaccine. Pt stated that her throat is dry and feels a sensation to cough. Pt stated that started feeling swelling of the tongue 30 minutes after administration of the vaccine. Pt was given water and says that it helped relieve itching. Pt was given benadryl 25mg IM and is being monitored. Charge nurse is taking over monitoring and care of patient.
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| 61 | 2021-01-07 | chills, headache | Chills. Nausea. Headache. Body aches. Flushed face |
| 61 | 2021-01-07 | fatigue, fever, chills, cough, malaise |
Chills; dry cough; no appetite; fatigue; pain at injection site; general malaise; general aches; tem...
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Chills; dry cough; no appetite; fatigue; pain at injection site; general malaise; general aches; temperature 102; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer-BioNTech ;lot number: EK9231) intramuscularly at right arm on 02Jan2021 at 07:45 A.M. at a single dose (dose number: 1) for COVID-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19 on 07Dec2020. No known allergies (no allergies to medications, food, or other products) and no other medical history. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medications the patient received within 2 weeks of vaccination were none. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events included chills, temperature 102, general aches, fatigue, pain at injection site, dry cough, general malaise, no appetite. Temperature elevated till 03Jan2021, 6pm. Symptoms similar to what she experienced when diagnosed with covid-19 on 07Dec2020. All events with start date on 02Jan2021 at 06:00 P.M. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Since the vaccination, the patient had not been tested for COVID-19.
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| 61 | 2021-01-07 | fatigue | Arthralgia fatigue Narrative: |
| 61 | 2021-01-07 | fatigue |
1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after...
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1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after receiving the vaccine, at 2 PM started with itching of scalp, arms, legs, rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck. Took 50 mg Benadryl w/ some relief. 630 PM symptoms reoccur, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER at 830 PM
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| 61 | 2021-01-07 | fatigue |
Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet...
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Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) solution for injection via an unspecified route of administration on left arm on 22Dec2020 02:30 at a single dose for Covid-19 immunization. Medical history included CREST Syndrome, type 2 diabetes, osteoarthritis, allergies to Sulfa and Dermabond tape. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergy. The patient took other medications in the last two weeks. On 26Dec2020, the patient experienced average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also, she experienced achiness, and tiredness on 26Dec2020. No treatment received for the events. The patient was not diagnosed with Covid-19 and has not been tested prior to vaccination. Outcome of the events was unknown. No follow-up activities are needed. No further information is expected.
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| 61 | 2021-01-07 | headache, cough, runny nose, nasopharyngitis | SEVERE HEADACHE, MILD DIZZINESS, RUNNY NOSE , EAR ACHE, STOMACH ACHE, COLDS,COUGH |
| 61 | 2021-01-07 | headache, fatigue, chills |
Severe chills /tremors 14 hours following the second injection that lasted uncontrollably for one ho...
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Severe chills /tremors 14 hours following the second injection that lasted uncontrollably for one hour, headaches, fatigue, abdominal pain that cleared 1/7 in the afternoon. The nausea was so bad I could not eat. Vomited only one time. I missed one day of work, slept the whole day, and night, too.
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| 61 | 2021-01-07 | headache |
Headache; Nausea; Vomiting; Diarrhea; I just ache all over; This is a spontaneous report from a cont...
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Headache; Nausea; Vomiting; Diarrhea; I just ache all over; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; Solution for injection; lot number: EJ1685; expiration date: not known), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. Medical history included hypertension. The patient's concomitant medications were not reported. The patient had been feeling fine after her last vaccination when she took it at a hospital on 29Dec2020 until today (01Jan2021), in which she experienced headache, nausea, vomiting, diarrhea, and she just ache all over. The patient stated it was not serious and just wanted to make sure she was not supposed to be doing something. The patient did not receive treatment for these reported events. The outcome of the events was unknown.
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| 61 | 2021-01-07 | headache | Soreness Headache |
| 61 | 2021-01-07 | sweating, chills |
Swollen stiff arm at the site of the injection; Swollen stiff arm at the site of the injection; Naus...
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Swollen stiff arm at the site of the injection; Swollen stiff arm at the site of the injection; Nausea; Diarrhea; shivering; Sweating; Body ache; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: PFL72TRA9899), intramuscular in left arm, on 31Dec2020 at 07:00, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (diagnosed prior to vaccination). There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 31Dec2020 at 8 PM (also reported as after exactly 12 hours; possibly discrepant), the patient experienced swollen stiff arm at the site of the injection, severe episode of nausea, diarrhea, shivering, sweating, and severe body ache. Treatment received for the adverse events included paracetamol (TYLENOL). The events were considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.
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| 61 | 2021-01-07 | sweating, headache |
patient reports fasting high blood sugar >200 12+ hours after vaccination - she is diabetic on oral ...
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patient reports fasting high blood sugar >200 12+ hours after vaccination - she is diabetic on oral metformin and has never had elevated blood sugar >140 with fasting; controlled HgA1C at 6.1%; felt dizzy, nauseated, HA and sweaty as if she may pass out - never passed out
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| 61 | 2021-01-07 | malaise, headache |
Headache Malaise and frequent stools but not considered diarrhea Narrative: She states that she had ...
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Headache Malaise and frequent stools but not considered diarrhea Narrative: She states that she had immediate pain at the injection site. On Saturday at 7AM, she developed malaise and frequent stools but would not classify them as diarrhea as well as a headache. She has never had a fever. Today, she continues to feel weak but reports that she is improving.
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| 61 | 2021-01-07 | malaise, headache | Headache, Myalgia, Arthralgia, decreased appetite, general malaise, some abdominal discomfort |
| 61 | 2021-01-07 | fever, cough, fatigue, respiratory tract congestion | fever 101, arm soreness, body aches, fatigue, nausea, congestion and dry cough |
| 61 | 2021-01-08 | body temperature increased | Day 2 of 1/5/2021 vaccine, temp of 102.4 day 3, temp of 100.5 day 4 temp of 100.5 day5 temp normal |
| 61 | 2021-01-08 | fatigue |
About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left d...
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About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left deltoid muscle felt completely numb; palms slightly flushed, felt as if heart rate slightly elevated, but not tachycardia. No rash, no hives, no difficulty breathing. Acute episode lasted about 20-30 minutes, then just felt a little off for 1.5 hours more, then back to normal. For next 34-48 hours-mild fatigue.
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| 61 | 2021-01-08 | headache |
01/08/21 02:30am on set of headache, 01/08/21 05:15am nausea Headache, called in for work due to thi...
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01/08/21 02:30am on set of headache, 01/08/21 05:15am nausea Headache, called in for work due to this being so bad, 01/08/21 08:54am hip pain/throbbing, took motrin. reported difficulty to bear weight, stayed in bed all day. 01/09/20 01:00pm reports much improved continues with slight pain today, but able to ambulate and function without problems.
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| 61 | 2021-01-08 | fever, chills, headache |
First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next da...
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First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next day. Dose two given on 01/07/21 with onset of shaking chills on 01/08/21 at 2:00am, ensuing fever max 101.7 degrees Fahrenheit, at 4:00 am noticed redness of eyes, face flushed with burning feeling, headache, dizziness, blood pressure of 184/96 and heart rate of 153. This required medical evaluation and treatment with IV fluids and Toradol for resulting headache. Patient also self administered 1000mg oral Tylenol prior to ER evaluation.
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| 61 | 2021-01-08 | fever, fatigue | Low grade fever, fatigue, body aches, arm pain |
| 61 | 2021-01-09 | chills, fever | chills, fever, arm pain |
| 61 | 2021-01-09 | headache, fatigue | Headache, nausea, body aches, joint pain, fatigue. |
| 61 | 2021-01-10 | chills, cough, headache |
Sunday 1/10/2021 at 10:30 am started with chilling then body aches and headache started in the next ...
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Sunday 1/10/2021 at 10:30 am started with chilling then body aches and headache started in the next hour then headache. Chilling better about one hour later. Took ibuprofen at 1:15 pm and relief of aches and headaches in about 30-60 minutes. Had dry cough. Very tired all day.
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| 61 | 2021-01-10 | chills, cough, fever, headache, fatigue |
1-24 hours AFTER vaccination: headache, fatigue, body aches, chills, fever (102) 24-48 hours AFTER v...
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1-24 hours AFTER vaccination: headache, fatigue, body aches, chills, fever (102) 24-48 hours AFTER vaccination: headache, fatigue, cough, GI distress, fever (100) 48-72 hours AFTER vaccination: headache, elevated temperature (99.7)
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| 61 | 2021-01-10 | fatigue, chills, headache | Headache (moderate to severe), chills, fatigue, muscle aches, skin sensitivity |
| 61 | 2021-01-10 | fatigue, headache | SORE ARM,HEADACHE LOWER BACK PAIN FATIGUE |
| 61 | 2021-01-10 | fatigue, headache |
injection site soreness and swelling, sore are with in 1 hour, lasted 48 hours, diarrhea started 13...
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injection site soreness and swelling, sore are with in 1 hour, lasted 48 hours, diarrhea started 13 hours after injection lasted 72 hours. headache started 12 hours after injection lasted 60 hours tiredness started 4 hours after injection lasted 48 hours I only took tylenol
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| 61 | 2021-01-10 | fatigue | Extreme fatigue beginning on the evening of 1/7/2021 lasting through Saturday (1/9/2021) morning. |
| 61 | 2021-01-10 | headache, fatigue, chills |
24 hrs- chills, Headache,LA sore, wheezing, fatigue Took Tylenol 3 times, using Proair inhaler 48 h...
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24 hrs- chills, Headache,LA sore, wheezing, fatigue Took Tylenol 3 times, using Proair inhaler 48 hours- more chills, more wheezing, LA still sore Took Tylenol twice, using inhaler 72 hours- LA still sore, skin red over deltoid and biceps with tenderness, still wheezing, using inhaler throughout day Symptoms somewhat controlled with repeated doses of Tylenol and Proair
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| 61 | 2021-01-10 | headache, malaise |
Euphoria began ~2hours after vaccine lasting ~2.5 hours. Unable to process information, irritabilit...
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Euphoria began ~2hours after vaccine lasting ~2.5 hours. Unable to process information, irritability, anxiousness, generalized not feeling well around 5pm day of; went to bed. Woke up at 10:30pm with headache, took Tylenol. Wednesday didn't feel well in general, left work at noon, went home to bed. Thursday felt better but not baseline self. Friday generalized not feeling well. Saturday went to ER due to feeling much worse generally, SOB. Tests Urine, blood. Everything within normal limits.
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| 61 | 2021-01-10 | headache, fever | Elevated heart rate to 120, fever, shortness of breath, headache |
| 61 | 2021-01-10 | headache, fever | Low grade fever body aches chills headache arm soreness |
| 61 | 2021-01-10 | headache |
Slight headache the night I received the dose, shot site redness and muscle pain for 2 days after r...
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Slight headache the night I received the dose, shot site redness and muscle pain for 2 days after receiving dose
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| 61 | 2021-01-10 | fever, chills |
On 01/10/2021 started feeling Chills then 102.5 fever lasting 2 hours, took 2 Tylenol and fever went...
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On 01/10/2021 started feeling Chills then 102.5 fever lasting 2 hours, took 2 Tylenol and fever went down to normal. Later I realized that I had two swollen lymph nodes on the left side of my neck. Next morning 01/11/2021 at woke up noticed another swollen above the hollow of the clavicle.
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| 61 | 2021-01-10 | fever, fatigue | Diagnosed with COVID-19, Fatigue, Bodyaches(severe), Myalgia, Fever, Diarrhea, GI Discomfort |
| 61 | 2021-01-10 | throat irritation |
30 minutes s/p vaccination developed scratchy throat, no other sx VSS Transported to clinic for obse...
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30 minutes s/p vaccination developed scratchy throat, no other sx VSS Transported to clinic for observation
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| 61 | 2021-01-11 | chills | myalgias, chills, left arm soreness, vertigo |
| 61 | 2021-01-11 | fatigue, malaise |
Soreness and swelling at injection site; Soreness and swelling at injection site; Malaise; feels tir...
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Soreness and swelling at injection site; Soreness and swelling at injection site; Malaise; feels tired; This is a spontaneous report from a Pfizer-sponsored program. A contactable other HCP (Patient) reported for a 61-year-old female patient received the first dose of BNT162b2 (lot: EK92331), intramuscular at left arm on 04Jan2021 (approximately between 18:15-18:30) at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications included supplements. The patient experienced soreness and swelling at injection site, malaise and feels tired on 05Jan2021 08:00. She was scheduled for second dose a day later for COVID vaccine so after the 21 days to get her second dose. Patient is a Dental Hygienist. She received the first dose on 04Jan2021 and is scheduled to receive second dose on 26Jan2021. She should have it scheduled for 25Jan2021. There is no prescriber. She received it at a local hospital through her employer. They did not offer her the 25Jan2020, and said next day is 26 days. They told her there would not be any problem being a day late. She called back with a concern and had evening appointment with the intention of being 3 weeks later. She did it while she had 2 days off work in case she had a reaction. She was told it was not a big deal to get it 1 days later. She asked if she could go to a different location and they told her no, it had to come from the same batch and lot to receive second dose. She is just concerned about doing it a day before she has to go back to work because there are worse side effects with second dose. There is a 4 day grace period from what she read of of 17-21 days and not over 21 days. She is not sure if that is true though. The outcome of the events was not recovered.
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| 61 | 2021-01-11 | headache, fever | Headache, low grade fever |
| 61 | 2021-01-11 | headache, fever | Low grade fever, headache |
| 61 | 2021-01-11 | malaise, headache | Headache, nausea, diarrhea, malaise. Improving. |
| 61 | 2021-01-11 | malaise, fever |
fever; nausea; general feeling of unwell; soreness at site; redness; whole upper arm was swollen aft...
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fever; nausea; general feeling of unwell; soreness at site; redness; whole upper arm was swollen after the injection; This is a spontaneous report from a contactable other HCP (patient, Respiratory Therapist) reported that a 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , Batch/lot number: EJ1685) via an unspecified route of administration on 21Dec2020 around 6:00 PM in left upper arm at 0.3mL single dose for COVID Prevention. The patient's medical history was covid at the end of Apr/May2020 with shortness of breath, seasonal allergies and allergies to "some anitbiotics." The concomitant medications was reported as none, received no other vaccines on the same day as the COVID vaccine. The patient experienced soreness at site, redness and swelling, fever, nausea, general feeling of unwell 3 days. Patient stated, "I had covid at the end of April/May with shortness of breath. I thought I would have less reaction from the vaccine. I know someone who was out of work for a while week after the vaccine." States that she read that the 2nd dose is supposed to have worse side effects than the first. If she had bad side effects from the 1st dose, will the 2nd be worse? Also asking if the side effects are the immune system reacting or just an allergic reaction. Patient was anxious about getting her second COVID shot on 11Jan2021. Patient stated that she had all the side effects listed, for three days. Patient stated that she didn't mind the side effects at the time, she had fever, soreness at the injection site, nausea, and a general feeling of unwell, but Patient stated that she could not work like that. Patient stated that her question was, statistically she has read that the side effects from the second shot are supposed to be worse than the first shot, but she was wondering, if she had bad side effects from the first shot, will her side effects be worse after the second, or will they maybe be lessened because she already had bad side effects. Patient reported that she did fill out the VSafe significant because she had to work on the third day after her shot, which was Christmas Eve, and work, was so busy and she did not feel well. Patient stated that she does have two days scheduled off work after her next injection, but it is the third day that she was worried about because she does not want to work feeling like that. Patient stated that the arm soreness started that same day (21Dec2020). At first, Patient reported that the arm soreness resolved, but then she states that it is still a little sore to the touch. So Patient confirmed that it is ongoing but improved. Patient reportsed that the fever started the day after the injection, 22Dec2020 and it has resolved. Patient reported that the last day she recorded a fever was on 24Dec2020. Patient stated that she woke up on 24Dec2020 and her temperature was normal, so she went to work and she did not feel so well at work, but they were so busy that she barely noticed, and then when the Patient went home that night, she took her temperature and it was 100 degrees Fahrenheit. Patient reported that the nausea started on 22Dec2020, which was mild at times, but then she got to where she did not want to eat. Patient reported that the nausea has resolved but she was not entirely sure when it resolved because she had been so busy at work on 24Dec2020, and it was hard to tell what she was feeling because she was non-stop busy that day. Patient stated that she was nauseous for a full three days, and she remembered that she did not eat much on the 24th either. So Patient stated that her nausea may have resolved on the third day after her injection, but it is unknown to her what day exactly that it resolved. Patient was also experiencing the general feeling of unwell from 22Dec2020 for a few days, but stated that by 25Dec2020 she felt okay. Patient also included that her left arm was also swollen, like her whole upper arm was swollen after the injection in Dec2020. Patient stated that she also experienced redness, there was a like a red mark that was further down her arm than the injection site in Dec2020. The outcome of soreness at site was recovering. Patient confirmed that both the swelling and redness had resolved in Dec2020.The outcome of fever was recovered on 24Dec2020. The outcome of general feeling of unwell and nausea was recovered on 25Dec2020.
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| 61 | 2021-01-11 | fever, chills, headache, fatigue | Fever/chills 104.8, N/V, severe fatigue/weakness, severe headache, body aches |
| 61 | 2021-01-11 | fever, headache | Headache, low grade fever. |
| 61 | 2021-01-11 | respiratory tract congestion, headache, fever | Headache, Body aches, fever, stuffy head developed 12 hours after injection |
| 61 | 2021-01-11 | respiratory tract congestion |
congestion; positive for Covid-19; positive for Covid-19; This is a spontaneous report from a contac...
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congestion; positive for Covid-19; positive for Covid-19; This is a spontaneous report from a contactable healthcare professional (patient). A 61-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiration date not reported), via an unspecified route of administration on left arm on 31Dec2020 at 08:15 at a single dose for Covid-19 immunization/precaution because she works with hospice patients. Medical history included blood pressure (abnormal), diabetes, cholesterol (abnormal), and acid reflux, all are ongoing. The patient has no family medical history. Concomitant medications included amlodipine besilate, benazepril hydrochloride for blood pressure taking about 4-5 years, metformin for diabetes taking about 5 years, rosuvastatin for cholesterol Taking about 5 years, pantoprazole for acid reflux taking 5 years, and vitamin D as supplement taking for 3 years. No previous immunization nor vaccines administered on same date of the suspect drug. The patient was calling about the COVID vaccination, which she received on Thursday, 31Dec2020. Her husband tested positive on Thursday, so she took the test on Thursday after she took the vaccination and they just told her today, 04Jan2021, that she is positive for Covid-19. She wanted to know if that was going to mess up her vaccination in any way and if there are recommendations for second dose. She is a CNA. There was no prescriber. She received it because she works with hospice patients. Test was administered on 31Dec2020. COVID Test resulted on 10:00 04Jan2020 as positive. ER or physician's office required: She just went to get a COVID test when her husband tested and they gave her a azithromycin (Z-PACK) 250 mg because she had congestion. Take two tabs first day and then one daily for 4 more days. She is taking last one today (04Jan2021). Outcome of the events was unknown.; Sender's Comments: A causal association between reported events and BNT162B2 cannot be excluded.
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| 61 | 2021-01-12 | dehydration, chills |
Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and mo...
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Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and moderate to severe abdominal cramping with moderate chills lasting 6 hours. Any fluids taken ran right through me. 4 lb weight loss and muscle cramping from dehydration. 12 hours after symptoms started I was able to take fluids and eat crackers. 24 hours after start felt shaky with mild abdominal soreness but improvement progressed and by 28 hours after start if symptoms felt normal other than I felt like I did 100 sit ups!
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| 61 | 2021-01-12 | fatigue, fever |
Employee reported a fever of 101.1 and fatigue post 24 hours after second covid vaccination. Was res...
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Employee reported a fever of 101.1 and fatigue post 24 hours after second covid vaccination. Was resolved by the next morning with a temp of 96.8.
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| 61 | 2021-01-12 | fatigue, sleepiness, body temperature increased, chills |
Woke with chills & shaking. Temp was only 99.3 oral at that time. Took Motrin 800mg. Significant bod...
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Woke with chills & shaking. Temp was only 99.3 oral at that time. Took Motrin 800mg. Significant body aches & pain. The next day, 1-13-21, Temp 100.4, continued body aches, very tired & sleepy. Sore right arm, body aches from head to toe. Taking Motrin again.
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| 61 | 2021-01-12 | fatigue |
Was premedicated with Medrol, Singulair and Zyrtec 20 minutes after vaccine developed paresthesias o...
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Was premedicated with Medrol, Singulair and Zyrtec 20 minutes after vaccine developed paresthesias of both sides of lower face, lips and face swelling. This resolved in @ 20 minutes. Next day developed excessive fatigue with difficulty talking and a heavy sensation in the chaste with an event of fullness sensation of the right soft palate and tongue.. This became worse on the second day for which needed treatment with Medrol pack and antihistamins.
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| 61 | 2021-01-12 | headache, fever, chills |
Pfizer-BioNTech COVID-19 Vaccine EUA Chills and low grade fever (highest it got was 99.7)- started a...
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Pfizer-BioNTech COVID-19 Vaccine EUA Chills and low grade fever (highest it got was 99.7)- started at 11:00 p.m. on 11/12/21. Not able to sleep in the night, headache started sometime in the night. Fever and chills were gone by morning. Headache resolved about 5:00 p.m. on 1/13/21.
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| 61 | 2021-01-12 | fever, chills, fatigue |
Extreme fatigue, hard chills, fever of 100 for several hours, nausea, generalized weakness. Chills ...
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Extreme fatigue, hard chills, fever of 100 for several hours, nausea, generalized weakness. Chills and extreme fatigue lasted 4 hours. Low grade fever lasted 12 hours.
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| 61 | 2021-01-13 | chills, fatigue, malaise, headache | Moderate to severe fatigue, headache, fever, chills, malaise |
| 61 | 2021-01-13 | fatigue |
At time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed a...
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At time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested for about 45 mins before I felt well enough to drive. All better after about 2 hours.Next day, tired, sweaty, nauseous, lightheaded when standing.
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| 61 | 2021-01-13 | headache, chills, fatigue | Short term memory loss, Severe fatigue, Chills, Mild HA, Depression - lasted 5 hours and was gone. |
| 61 | 2021-01-13 | headache, fever, chills, fatigue |
Pt received vaccine at 0730 on 1/11/2021. She developed fever, chill, body aches and headache at mid...
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Pt received vaccine at 0730 on 1/11/2021. She developed fever, chill, body aches and headache at midnight the same day. The following day shew had a fever a high as 103. She continued to feel fatigued, achy, headache, slightly nauseated and weak. Her symptoms improved over the course of the last 2 days. She is fever free today
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| 61 | 2021-01-13 | headache |
Headache for3 days Nausea for 3 days Muscle weakness for 3 days. Joint pain for 3 days. Red rash at ...
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Headache for3 days Nausea for 3 days Muscle weakness for 3 days. Joint pain for 3 days. Red rash at injection site. Swelling at injection site. Diarrhea for 2 Days
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| 61 | 2021-01-13 | influenza like illness |
About 30 minutes after taking the vaccine, when I was driving home, my face got very hot and red. I ...
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About 30 minutes after taking the vaccine, when I was driving home, my face got very hot and red. I also started feeling lightheaded like I might faint. I pull over into a parking lot and had a family member come get me to drive me home. I was extremely thirsty and drank a lot of water at home. Eventually, my redness went away and my face did not feel as hot. I did feel other more typical symptoms too such as painful arm, and flu like symptoms. I am mainly concerned about the reaction I had when driving home since it was similar to what happens when I take cortisone or Doxycycline. I am needing information as to whether it is safe for me to take my second dose of the covid vaccine.
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| 61 | 2021-01-13 | fever, chills, fatigue, headache |
Fever to 102 F. Chills. Total body aches. Severe headache. Nausea. All began around midnight, 1...
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Fever to 102 F. Chills. Total body aches. Severe headache. Nausea. All began around midnight, 16 hours post-shot. Worsened throughout the night and began to diminish about 8 hours later. After about 12 hours had only slight fever, more manageable headache, was achy all over and fatigued. Back to baseline 36 hours after onset of symptoms.
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| 61 | 2021-01-13 | fever, chills, nasopharyngitis |
chills; body aches; cold; fever; pain at injection site; This is a spontaneous report from a Pfizer-...
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chills; body aches; cold; fever; pain at injection site; This is a spontaneous report from a Pfizer-sponsored Program Pfizer First Connect. A contactable consumer (patient herself) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0140), via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunization. Patient had a history of COVID in Nov2020. Concomitant medication included levothyroxine sodium (SYNTHROID) (for twenty some years), bupropion hydrochloride (WELLBUTRIN) (for about a year), naltrexone (for about a year), all from an unspecified date and ongoing. The patient got the vaccine yesterday (06Jan2021). Patient experienced chills, body aches, cold, fever, and pain at the injection site started at 10 am on 07Jan2021. The fever has went up a little since this morning, but everything else has stayed the same. Her fever was 100.6 degrees Fahrenheit now. Earlier this morning it was 99.3 degrees Fahrenheit. Outcome of events were not recovered.
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| 61 | 2021-01-13 | fever | Fever, muscle weakness, muscle pain |
| 61 | 2021-01-14 | chills, fever, headache, fatigue |
Received Covid vaccine on 01/12/21. Late that afternoon, developed fever, chills, headache, body ac...
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Received Covid vaccine on 01/12/21. Late that afternoon, developed fever, chills, headache, body aches, and fatigue, lasted throughout the day on 01/13/21.
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| 61 | 2021-01-14 | chills |
Chills; Diarrhea; Again today 24 hours later she had abdominal cramping that was almost debilitating...
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Chills; Diarrhea; Again today 24 hours later she had abdominal cramping that was almost debilitating; Abdominal cramps; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the right arm on 07Jan2021 07:00 at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient experienced abdominal cramps on 07Jan2021 13:30, diarrhea and chills for 20 or 30 minutes and then it all went away on 08Jan2021. Again today 24 hours later, she had abdominal cramping that was almost debilitating. Had Covid 19 Test up the nose test, thinks it was PCR that was negative on 06Nov2020. The outcome of events was recovered on 08Jan2021.
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| 61 | 2021-01-14 | fatigue |
Increased fatigue with dizziness. On the 3rd day at around 2130 I walked into my home and woke up on...
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Increased fatigue with dizziness. On the 3rd day at around 2130 I walked into my home and woke up on the floor. EMS was called and I was sent to the emergency room. Bruising to my left eye with a short LOC.
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| 61 | 2021-01-14 | headache, body temperature increased |
Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at inje...
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Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at injection site radiating up and down arm and up into neck ; Body aches especially lower back developed within 24 hours with a severe throbbing type headache and ringing in the ears. Elevation of temperature by 1-2 degrees normal for me runs 97 degrees F and was up to 99 degrees F. Headache intensified with movement(ex. .bending over ,etc) Treated arm soreness and lower back with heat compresses... elevated temp and headache with rest and a lot of water. It is now over 48 hours since vaccination and all symptoms are subsiding but still present with temperature normal for me and no arm soreness. Scheduled day off from work day after vaccination but also a second day due to the severe headache mostly.
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| 61 | 2021-01-14 | headache, fatigue |
DEVELOPED SORE ARM THAT LASTED 1 DAY. ALSO HAD BAD FATIGUE AND HEAD PAIN LASTING UNTIL MORNING OF 1/...
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DEVELOPED SORE ARM THAT LASTED 1 DAY. ALSO HAD BAD FATIGUE AND HEAD PAIN LASTING UNTIL MORNING OF 1/10/21.
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| 61 | 2021-01-14 | headache |
but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; but then...
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but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; Got the vaccine early Friday afternoon and had a sore arm; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the vaccine early Friday (08Jan2021) afternoon and had a sore arm but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever. The patient asked if that normal for side effects to occur 2 days later. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 61 | 2021-01-14 | fever, headache, chills | Feeling cold, headache, chills, tender arm, fever |
| 61 | 2021-01-14 | throat irritation | Felt a little light headed and my throat was scratched |
| 61 | 2021-01-16 | headache, fatigue, fever |
"Pfizer-BioNTech COVID-19 Vaccine EUA", Injection site pain, Severe tiredness, mild headache, muscle...
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"Pfizer-BioNTech COVID-19 Vaccine EUA", Injection site pain, Severe tiredness, mild headache, muscle pain, fever, loss of appetite, HR in lower 90's, pulse OX in low 90's.
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| 61 | 2021-01-16 | fever | Fever of 100.4. Ibuprofen used. Went to bed/slept. Temperature normal (97.3) in am. |
| 61 | 2021-01-17 | body temperature increased |
Received Vaccine on 1/2/2021 at 10AM , at 3PM employee felt itchy, took a nap, and at 8PM she had a ...
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Received Vaccine on 1/2/2021 at 10AM , at 3PM employee felt itchy, took a nap, and at 8PM she had a circular redden skin rash on her arms, legs, and torso. Temperature: 99 degrees. Employee took Tylenol and Claritin for rash, complained of diarrhea, vomiting, and weakness of both knees within 24 hours all symptoms were gone.
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| 61 | 2021-01-17 | chills, fatigue |
i1/13/21 at about 2;45 pm, I had my second Covid vaccination. had pain on site on left arm 1/14/21 ...
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i1/13/21 at about 2;45 pm, I had my second Covid vaccination. had pain on site on left arm 1/14/21 woke up feeling a little tired, went to work. went home early at 1:30 pm, feeling a little chilly. no fever. 1/15/21 in the morning noted pain on Left armpit ( injection site is left arm), pain from left shoulder blade to right shoulder blade. took advil. In the afternoon, about 4:00 pm, noted some swelling and soreness on left armpit. took Advil.. 1/16/21, Called employee health to report this. Advised to take advil and monitor and call pcp if symptoms persists.
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| 61 | 2021-01-17 | chills, headache, chills, fever, headache, fever |
12-14 hours after my second vaccine I had severe chills, body aches, headache, and felt feverish. Th...
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12-14 hours after my second vaccine I had severe chills, body aches, headache, and felt feverish. This was only partially mitigated by acetaminophen and ibuprofen. It lasted until about 42 hours post vaccine.
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| 61 | 2021-01-17 | chills, headache | Headaches, Chills, worst nausea and abdominal pain I?ve ever had in my life, vomiting |
| 61 | 2021-01-17 | headache |
Headache/headache got worse and worse; This is a spontaneous report from a contactable consumer (pat...
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Headache/headache got worse and worse; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (herself and co-worker). This is the first of two reports. A 61-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EJ1686, expiry date: unknown), intramuscular, on 06Jan2021 13:30 at a single dose on left arm for COVID-19 immunization. The vaccine was administered at a hospital. It was also reported that she received the vaccine at a military facility. There were no additional vaccines administered on same date of bnt162b2. Medical history included high blood pressure diagnosed about a month ago (Dec2020) and ongoing, and glaucoma from an unspecified date (diagnosed when she was 15 years old) and ongoing. Concomitant medications included losartan (Manufacturer: Lupin, 50 mg tablet) for high blood pressure, venlafaxine ER (Manufacturer: Aurobindo, 150 mg Prolonged-release capsule) as anti-depressant, latanoprost (Manufacturer: Sandoz, 0.005 %) for glaucoma, and brimonidine tartrate, timolol maleate (COMBIGAN, Manufacturer: Allergan) for glaucoma; all were from unspecified dates and ongoing. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EH9699), intramuscular, on 19Dec2020 at a single dose on left arm for COVID-19 immunization; there was no adverse event following this vaccination. The patient experienced headache on 06Jan2021 at 11:45 am (As reported, pending clarification). The patient reported that she did not have anything with the first dose. She got the second dose of the Pfizer Covid Vaccine on 06Jan2021 at 13:30. She started getting headache at 11:45 am (as reported) but she didn't think much of it. On 07Jan2021, she had a headache and she took two Tylenol and then went to sleep. She woke up around midnight that night and her headache got a little bit worse, so she took two Tylenol again and fell asleep. In the morning of 08Jan2021, around 2:30 am her headache got worse and worse, and she took three Tylenol. Her headache was still there but it was not enough to go to the emergency room or anything. She panicked on Thursday (07Jan2021) since her headache was still there; her headache was still lingering but it was going away. Her headache pain was at 7 out of 10 on an unspecified date. She stated that she was supposed to work at the time of report, but she called out of work due to her headache. Therapeutic measures were taken as a result of the headache and included treatment with Tylenol 500 mg (lot number: DFE3060A, expiration date: Apr2022). The adverse event did not require a visit to Emergency Room or Physician office. Outcome of the event was recovering.
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| 61 | 2021-01-17 | headache | Nausea & Headache |
| 61 | 2021-01-17 | headache | Dizziness and headache on 1/18 |
| 61 | 2021-01-17 | nasopharyngitis, headache |
Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left...
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Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left side of face, joint pain, headache and neck pain. Lasted about 3 hours, shaking stopped but had chills that lasted all night. The next day, no appetite but when she ate something, she vomited. Worse things were shakes, headache and neck pain and vision. . Had vision problems. Eyes were swollen and jittery and hard to focus. The swelling went away but still unable to focus. Everything has gone except vision issue.
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| 61 | 2021-01-18 | body temperature increased |
Pfizer-biotech COVID-19 Vaccine EAU Expected extreme sleepiness, could only stay awake for 20 minute...
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Pfizer-biotech COVID-19 Vaccine EAU Expected extreme sleepiness, could only stay awake for 20 minutes at a time for next 24 hours. O2 saturation went down as low as 91 but mostly was at 93, heart rate 112 on Jan 13, along with a 100.1 oral temp. I did not Check on Jan 12. Morning of Jan 14: 99 oral temp and 95 O2 saturation. By evening temp and O2 were back to normal: 98° and 98%. Jan 17 I experienced some wheezing. I did have COVID with pneumonia Sept 2020.
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| 61 | 2021-01-18 | chills, fatigue, headache, influenza like illness, fever |
Doesn't feel like eating; Fever; Chills/ Chilled; Nausea; Severe Headache/Dull headache/Frontal head...
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Doesn't feel like eating; Fever; Chills/ Chilled; Nausea; Severe Headache/Dull headache/Frontal headache; Fatigue; Body aches; This is a spontaneous report from a contactable Nurse (patient). This 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1686), via intramuscular, on 06Jan2021 (at 14:30) at single dose at left deltoid for COVID-19 immunisation, administered at hospital. Age at vaccination is 61-year-old. Historical vaccine included Diphtheria and Tetanus vaccine (intramuscular, at single dose) on 15Dec2020 for immunization; and Shingles vaccine (intramuscular, at single dose) on 15Dec2020 for varicella immunization. Relevant medical history included usual tenderness. No relevant concomitant medications were provided. On 07Jan2021, she woke up at 2:00 in the morning, she had a high temperature, she was chilled, she had a severe headache, nausea, fatigue, and body aches. She got up and took ibuprofen (ADVIL). She was basically in bed, she had to cancel all her appointments in the morning, she just laid in bed and the following afternoon her fever broke at about 4:30 in the afternoon then she just had a low grade temperature and a dull headache, nausea through the next day, Friday the 08Jan2021. She still has a very dull headache and just not right, kind of like a flu bug. She had no fever; she had not had any fever after Friday afternoon or Saturday. Fever started at 2 in the morning 07Jan2021 and she experienced the chills until after fever broke. Fever went above 102 degrees. She still had a little of the nausea, she just didn't feel like eating. She still had the dull headache. The nausea and headache have improved when compared to how it was on the 07Jan2021. She was back to work now she just has a dull frontal headache. The reporting nurse assessed all the events, except of 'Doesn't feel like eating', serious for disability. She stated she may have had usual tenderness but nothing like this. The patient had recovered from the event fever on 08Jan2021 and from the event 'chills/chilled' on 07Jan2021; the patient was recovering from 'nausea' and 'severe Headache/Dull headache/Frontal headache', while the outcome of the remaining events was unknown.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded due to temporal relationship. It is worth noting that patient had other vaccines not far ago, including Diphtheria and Tetanus vaccine and Shingles vaccine on 15Dec2020 for immunization. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 61 | 2021-01-18 | chills | Chills, swelling, warm to touch , redness on the right arm inject site area and very itching |
| 61 | 2021-01-18 | cough, fatigue, chills, headache, fever |
fatigue; headache; body aches; chills; cough; GI distress; high fever (102); This is a spontaneous r...
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fatigue; headache; body aches; chills; cough; GI distress; high fever (102); This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration in the left arm, on 08Jan2021 at 17:00, at a single dose, for COVID-19 immunization. Relevant medical history included diabetes type 2, high blood pressure, hyperlipidemia, and glaucoma. Concomitant medications included orphenadrine (K-FLEX), empagliflozin (JARDIANCE), losartan, atorvastatin calcium (LIPITOR), and insulin. The previously took metformin and experienced allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient is not pregnant at the time of vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 18:00, the patient experienced fatigue, headache, body aches, chills, cough, gastrointestinal (GI) distress, and high fever (102). The patient did not receive treatment for the events. Outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 61 | 2021-01-18 | fatigue |
itching of scalp, arms, legs; rash; abdominal hives; facial swelling; difficulty swallowing; swellin...
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itching of scalp, arms, legs; rash; abdominal hives; facial swelling; difficulty swallowing; swelling back of neck; inj site very sore; fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK923) , via an unspecified route of administration on 29Dec2020 09:45 at the first single dose at arm left for covid-19 immunisation. Medical history included known allergies: Sulfa. The concomitant drug was unspecified. The patient previously took cipro and experienced drug hypersensitivity. On 29Dec2020, the patient expected side effect of inj site very sore and fatigue for 24 hours. On 06Jan2021 14:00, the patient started with itching of scalp, arms, legs ,rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck, took 50 mg Benadryl w some relief. 630 PM symptoms reoccurred, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of the back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER. The patient received Prednisone 50 mg orally and for the 4 days. The outcome of event inj site very sore and fatigue was recovered on 30Dec2020; the outcome of events was recovered.
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| 61 | 2021-01-18 | headache, fatigue |
DIARRHEA 01/09, 01/10, 01/11, HEADACHE 01/09THRU 01/19 VERY TIRED 01/09 THRU 01/19 NAUSEA 01/09 TH...
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DIARRHEA 01/09, 01/10, 01/11, HEADACHE 01/09THRU 01/19 VERY TIRED 01/09 THRU 01/19 NAUSEA 01/09 THRU 01/19 SORE ARM 01/09 THRU 01/19
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| 61 | 2021-01-18 | headache | itchy rash on bilateral elbows, headache |
| 61 | 2021-01-18 | influenza like illness, cough, headache, fever |
Cough; Headache; Dizzy; Nauseous; Low grade fever; Little Noxious, whole body aches completely aches...
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Cough; Headache; Dizzy; Nauseous; Low grade fever; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231 and expiration date 30Apr2021), via an unspecified route of administration on 07Jan2021 second dose at single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included lisinopril for blood pressure. The patient stated that she took her second dose on 07Jan2021 afternoon and today 08Jan2021 the patient feel really cough "ing" (not clarified), light headache, dizzy. I am having fever "99.4" (not clarified). The patient asked are not they not safe to take Tylenol, is it okay to take Motrin or just have to be Tylenol (treatment)." It was clarified that patient experienced Dizziness, headache, fever, a low grade fever and little Nauseous. Just my whole body aches completely aches my whole body like I have the flu." The patient was treated with Tylenol for the events. The outcome of the events was unknown.
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| 61 | 2021-01-18 | malaise, fatigue | vertigo, fatigue, malaise |
| 61 | 2021-01-18 | throat pain, cough, chills, malaise | chills shakes nausea vomiting cough sob sore throat maliase |
| 61 | 2021-01-18 | fever, fatigue, headache |
24 hours after my 2nd vaccine I had symptoms of severe fatigue and body aches. I had a low grade fev...
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24 hours after my 2nd vaccine I had symptoms of severe fatigue and body aches. I had a low grade fever and headache. The following morning I had pain in my left axilla, low grade fever, headache and body aches. I left work early because of severe fatigue and was out the following day for symptoms due to covid vaccine.
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| 61 | 2021-01-18 | throat irritation |
Systemic: 6 hours after vaccine lost voice, 8 hours after mouth, tongue, throat itching. next morni...
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Systemic: 6 hours after vaccine lost voice, 8 hours after mouth, tongue, throat itching. next morning had face and lip swelling and tingling. self treated with antihistamines. resolved after 3 days.
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| 61 | 2021-01-19 | fatigue, headache |
Joint pain (all joints felt like they were on fire - different than usual arthritis pain - could bar...
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Joint pain (all joints felt like they were on fire - different than usual arthritis pain - could barely walk or hold a cup of water due to pain), significant fatigue (barely able to get out of bed) recurrence, brain fog recurrence, headache , muscle pain, I felt almost like I did when I had COVID - starting to subside now 4 days after vaccination
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| 61 | 2021-01-19 | fatigue, nasal congestion | Tingling in left face check..legs very weak .. congestion..very tired for 4 days |
| 61 | 2021-01-19 | head discomfort, chills, fatigue |
Slightly sore left deltoid, cleared up in a few days. 16 hours after shot, experienced the dramatic...
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Slightly sore left deltoid, cleared up in a few days. 16 hours after shot, experienced the dramatic sensation of tilting while sitting on a couch. Had I been driving, this would likely have caused an accident. This is the first time I have ever experienced this feeling. There were 2 or 3 other episodes of feeling like I was falling. 2 of this happened while lying down. They were sudden sensations that made me gasp. Spent most of 1 week in bed with fatigue, vertigo, and 2 times vomiting. Vomiting occurred day 2 post vaccine. Fatigue was continuous for about a week. At day 16 now, certain movements still illicit vertigo. All vertigo symptoms have lasted under 1 minute. However, some have been back to back, such as after repositioning multiple times in bed. Ears have felt very full for almost 2 weeks. Certain head positions or movements, still illicit sensations of the room moving. There was no specific headache, but my head did not feel good for about 2 weeks. There was no fever, but there was chilling one night, a couple of days after the vaccine. I don't know if getting 2nd vaccine is wise.
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| 61 | 2021-01-19 | headache, body temperature increased | Larm pain, low grade temp to 100.2, mild headache |
| 61 | 2021-01-19 | headache, fatigue, chills, fever |
mild tingling of lips after injection - within 1st hour. Fever- up to 101.6 degrees- noticable aft...
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mild tingling of lips after injection - within 1st hour. Fever- up to 101.6 degrees- noticable after 15 hours of the vaccine Chills- off and on after about 15 hours of vaccine Body aches and pains/ fatigue Headache- severe
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| 61 | 2021-01-19 | headache, fatigue | After getting this vaccine I start feeling dizzy, headache, fatigue, tachycardia and body aches |
| 61 | 2021-01-19 | malaise, chills |
I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a wa...
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I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a warm sensation after the vaccine in my deltoid muscle then felt it go up both my ears, around my head. I then felt the same warm sensation in my abdomen, followed by buzzing of my entire body with light headedness. I could breath, I could talk, but I had an urgency for others around me to know that I wasn?t feeling well and something was not right. I asked my colleagues if someone could take me to the ER for monitoring. They immediately put me in a recliner and elevated my legs. This did not relieve my symptoms and asked to go to the ER. I got to the ER and laid on the stretcher with continued increased buzzing sensation especially in my finger tips and arms. My vital signs were 148/88 and HR 88 (elevated from my normal of 100-120/60-70, HR 60s). The buzzing turned into a sensation in my arms that rumbled erratically. I thought something bad was about to happen and that my blood cells would burst. Then I also felt icy cold in my arms and my gut. Next what happened were teeth chattering shivers. All these symptoms occurred in a matter of minutes. They started an IV, drew blood, gave me Benadryl and ran IV fluids. My vitals did not reflect what I felt inside, but as symptoms let up, my VS returned to normal. As quickly as the symptoms started, they eventually calmed down and I was able to leave the ER in 1.5 hours to go home. I was very scared. The ER doctor thought I had a hyperimmune response to the vaccine.
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| 61 | 2021-01-19 | runny nose, fever, headache, fatigue |
Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours...
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Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours after injection (I took 2 Tylenol and took a 3 hour nap) o Tired o Left Eye twitch o Blurred double vision o Headache o Nauseous ? Side Effects started about 5 - 6 hours after injection (I took 2 Tylenol a Benadryl and used my Ventolin inhalator) o Tired o Watering eyes o Sore tongue o Headache o Nauseous o Heavy feeling in chest ? Side Effects started some time during the night after injection o Muscle cramping in both legs and opposite arm of injection site o Low fever 100.3 Sunday side Effects (I took 2 Tylenol and took a 3-4 hour nap) o Tired o Left Eye twitch o Watering eyes o Sore tongue o Excessive thirst o Swollen neck glands o Nauseous (only after eating) o Muscle cramping in both calves o Blurry vision in the evening o Runny nose Monday side Effects (Went to work) o Tired o Left eye lid twitch o Swollen neck glands o Nauseous o Runny nose o Achy body o Diarrhea Tuesday side Effects (Went to work) o Left eyelid twitch o Swollen neck glands o Runny nose o Sore throat o Diarrhea BLOODY Wednesday side Effects (went to work) o Swollen neck glands o Runny nose o Sore throat Note: I have several Allergies that require me to take an allergy pill every day. I also use an inhaler as needed. My symptoms were not any worse than when I have a bad allergic reaction, I have received shots of Epinephrine for my allergies and did not feel one was necessary.
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| 61 | 2021-01-19 | sneezing, headache, chills, fatigue |
Could not raise right arm above shoulder. Extreme fatigue. Sneezing with first shot. Sneezing, achi...
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Could not raise right arm above shoulder. Extreme fatigue. Sneezing with first shot. Sneezing, aching in joints., headache, chills with second shot.
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| 61 | 2021-01-20 | chills, body temperature increased, lethargy, fatigue |
Around 7:30 PM I arrived home from work and started feeling very lethargic, extremely tired. Around ...
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Around 7:30 PM I arrived home from work and started feeling very lethargic, extremely tired. Around 3 AM I started running a temperature (100.5F) and started with the chills and body aches. I still feel very tired.
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| 61 | 2021-01-20 | chills, body temperature increased |
Approximately 9 hours after vaccination, pain in injection arm became much worse, a pain rating of 6...
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Approximately 9 hours after vaccination, pain in injection arm became much worse, a pain rating of 6 to touch and on abduction. About 11 hours after vaccination, I became increasingly uncomfortable, feeling warm, chills, muscle aches. I could not sleep. 22 hours after vaccination, my temperature was 101 F (did not take it before this time). Temperature waxed on waned from that point (day #2). About 36 hours after the vaccine, my temperature stabilized to normal. 48 hours after the vaccine, I felt better and better with each hour.
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| 61 | 2021-01-20 | chills, headache, fever |
Diarrhea about 6hrs after injection chills fever body aches and dull headache continued for about a...
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Diarrhea about 6hrs after injection chills fever body aches and dull headache continued for about another 24 hrs
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| 61 | 2021-01-20 | chills, fever, headache |
The first thing I had nausea and stomach pain (for 2 days) in the AM and then it went to achy, joint...
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The first thing I had nausea and stomach pain (for 2 days) in the AM and then it went to achy, joint hurting and headache. It was not like I could not work or anything, it was just there. On the 9th day I woke up with fever and chills and a super bad headache and I felt so bad I could not even go seek medical care, I finally went after 3 or 4 days feeling like that. At the walk in clinic they tested me for flu, covid and strep and on the rapid the result was negative but when done the PCR it came back positive (around 12/29/20). I did not have any respiratory issues on this one. I do remember having diarrhea.
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| 61 | 2021-01-20 | chills |
sensitivity to cold; feeling chilled; short of breath (SOB) with minimal exertion; This is spontaneo...
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sensitivity to cold; feeling chilled; short of breath (SOB) with minimal exertion; This is spontaneous report from a non-contactable nurse reported for herself. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular in the left arm on 08Jan2021 12:00 at single dose for Covid-19 immunization in a hospital. Medical history included COPD, hypothyroidism and allergies to penicillin (PCN). The patient was not pregnant. The patient has no COVID prior vaccination. Concomitant medications included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), montelukast sodium (SINGULAIR), oxybutynin, and azelastine; all from unspecified date for unspecified indication. The patient previously took Celebrex and experienced allergies. Historical vaccine included first dose of BNT162B2 intramuscular in the left arm on 20Dec2020 09:15 (61 years old) at single dose for Covid-19 immunization in a hospital. The patient has no other vaccine in four weeks. On 08Jan2021 15:45, the patient experienced sensitivity to cold, or feeling chilled for 48 hours post dose, short of breath (SOB) with minimal exertion for 72 hours post dose. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not COVID tested post vaccination. The patient did not received treatment due to the events. The outcome of the events sensitivity to cold, or feeling chilled, short of breath (SOB) with minimal exertion was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.
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| 61 | 2021-01-20 | fatigue |
felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fati...
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felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right deltoid on 27Dec2020 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), testosterone (MANUFACTURER UNKNOWN); all taken for hormonal treatment from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: some extreme fatigue (non-serious) on 27Dec2020 with outcome of unknown, nausea (non-serious) on 31Dec2020 with outcome of unknown, dizziness/lightheaded (non-serious) on 31Dec2020 with outcome of unknown, vertigo (non-serious) on 31Dec2020 with outcome of unknown, felt very uncomfortable (non-serious) on an unspecified date with outcome of unknown, mental fogginess (non-serious) on an unspecified date with outcome of not recovered. The patient stated she wanted to report her experience with the first dose of the Pfizer Vaccine (COVID Vaccine), which was received on 27Dec2020. The patient stated she experienced some extreme fatigue starting that first day and then about four days later on 31Dec (not clarified), she experienced some nausea, some dizziness that advanced to vertigo and that occurred late at night; at the time she was getting ready for bed time around 22:00, but it just lasted for about one hour. The patient "went to bed just thinking about and staying in bed and then I felt very uncomfortable and I got up and then I went back to bed about at 01:30, that's how I just fell asleep." Then the next day, the patient was not feeling the vertigo, however, she was feeling lightheaded for about two days and then the fatigue continued to 08Jan (not clarified). Then starting on a Saturday, the patient "felt normal myself energetic and positive." The patient was still feeling mental fogginess, " I was getting here." The patient stated that dizziness and vertigo, or the mental fogginess were not listed on her list of possible side effects. The patient even asked her doctor what it would be, and the patient let her know that she received the vaccines. The events did not require any emergency room or physician office visits. The causality assessment from the reporting patient was reported as: "Yes, I believe it did."
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| 61 | 2021-01-20 | malaise, fatigue | Extremely tired dizzy feeling of vomiting upset stomach |
| 61 | 2021-01-20 | fever, chills | Global myalgia, chills, high fever, significant arm pain. Excedrin used. Symptoms mostly resolved. |
| 61 | 2021-01-20 | fever | Day after 2nd vaccine, developed chills, fever of 99.4, and overall body aches |
| 61 | 2021-01-20 | fever | Resident with fever of 102 |
| 61 | 2021-01-21 | chills, fatigue |
I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs fe...
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I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs feeling weak and wobbly. Could not perform my work duties. Progressed to Rigors. Lasted at least 3 hrs in it's severest form. Now, 24 hrs later I still have some hand tremors, and legs are weak. Shoulder, knees, hips achy. I'm very fatigued. Right arm soreness @ injection site. All events were reported. I was sent home from work, had to be driven home. I rested, slept and hydrated the remainder of the day. Did not go to work today.
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| 61 | 2021-01-21 | chills, headache | Itching, headache, chills |
| 61 | 2021-01-21 | chills | Palpitations with elevated heart rate and some chills. |
| 61 | 2021-01-21 | fatigue, headache |
received 2nd pfiser covid vaccine and had body aches, tiredness and headache for 36 hours. started ...
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received 2nd pfiser covid vaccine and had body aches, tiredness and headache for 36 hours. started 12 hours after vaccine
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| 61 | 2021-01-21 | fatigue | Extremely tired and exhausted for about 24 hours. Treatment as sleep and rest |
| 61 | 2021-01-21 | headache |
Headache 8:00pm to current 4:00pm 1-22-21 Nausea 6:00 am 1-22-21 to 3:00 pm Vomiting 8:00 am to 1:30...
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Headache 8:00pm to current 4:00pm 1-22-21 Nausea 6:00 am 1-22-21 to 3:00 pm Vomiting 8:00 am to 1:30 pm. Took zofran
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| 61 | 2021-01-21 | throat pain, headache, body temperature increased |
Had when I woke up at 6 am set on Jan 22, 2021 still ongoing Sore throat, severe headache, nausea, ...
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Had when I woke up at 6 am set on Jan 22, 2021 still ongoing Sore throat, severe headache, nausea, muscle ache, light headness, dizzy. January 22, 2021 temp 100.1 tympanic
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| 61 | 2021-01-21 | fever, headache |
SEVERE HEADACHE, BODY ACHES, LOW GRADE TEMP (99-100) LASTED ABOUT 24 HRS. TOOK EXTRA STRENGTH TYLENO...
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SEVERE HEADACHE, BODY ACHES, LOW GRADE TEMP (99-100) LASTED ABOUT 24 HRS. TOOK EXTRA STRENGTH TYLENOL Q 4 H
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| 61 | 2021-01-22 | body temperature increased, headache | Temperature of 101 degrees, headache |
| 61 | 2021-01-23 | headache | Severe base of neck and frontal head pain. Unable to sleep. Lasted x 2 days; 01-18 & 01-19-21. |
| 61 | 2021-01-24 | body temperature increased, headache | 12 hours after shot Headache, stomach upset, fever 100.6, body aches x 36 hours |
| 61 | 2021-01-24 | lethargy, headache |
Extremely lethargic Swelling in vaccinated arm Pain in vaccinated arm Body aches Headache Congesti...
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Extremely lethargic Swelling in vaccinated arm Pain in vaccinated arm Body aches Headache Congestion
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| 61 | 2021-01-24 | malaise |
Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfor...
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Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfort, disoriented, feeling a sense of impending doom.
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| 61 | 2021-01-24 | fever, chills | Chills. Fever. Nausea. Vomiting. Fainted |
| 61 | 2021-01-25 | cough |
Pfizer-BioNTech COVID-19 Vaccine EUA I went to bed at 8 pm and noticed my arm was sore. I awoke at 1...
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Pfizer-BioNTech COVID-19 Vaccine EUA I went to bed at 8 pm and noticed my arm was sore. I awoke at 11 pm to use the restroom and when I returned to bed I had a cough and SOB. This continued with copious secretions with worsening over time until I was fighting for air at 4:30 am. My husband called the ambulance because he did not feel he could get me to the hospital in time. In the ambulance I was started on 4L of O2. Upon arrival at the ER I was given a breathing treatment and started on the BiPap. I was admitted to the hospital and received 3 more breathing treatments and recovered to be on room air by 11:00 pm. The tests and observations, the doctor reported that there was no other cause than the vaccine.
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| 61 | 2021-01-25 | headache, malaise, sleepiness |
not sure if it is covid; feeling unwell; headache; dizzy; sleep the whole day/ falling asleep; This ...
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not sure if it is covid; feeling unwell; headache; dizzy; sleep the whole day/ falling asleep; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE and also reported as Pfizer Covid vaccine; unknown lot number and expiration date), via an unspecified route of administration on 04Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had the first dose of the Covid vaccine on 04Jan2021. She stated that the first day it was okay but on the second day, she slept the whole day and even when standing up cooking, she was falling asleep and on the third day, she was completely okay. After that day, she was okay until now. She was now feeling unwell, headache (she never gets a headache like this before, a really, really headache) and dizzy (all starting yesterday). She takes Tylenol and will be okay for 8 hours. She further reported that she did not have a fever. She added that on Sunday, she was dizzy and has an on and off headache but not all the time and also for today too. She is not sure if this is a side effect or if it is covid. She inquired if these are side effects or does she need a Covid testing. The outcome of the events was unknown. The following information on the batch/lot number has been requested.
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| 61 | 2021-01-25 | headache, malaise |
No problems with first vaccine. Started having severe head aches 2 days after the vaccine. Back Ache...
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No problems with first vaccine. Started having severe head aches 2 days after the vaccine. Back Ache after 5 days on the right side. Throwing up 6 days after for 3 days. Went to the hospital 10 days later for four days was taken by ambulance because she was to ill to drive.
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| 61 | 2021-01-25 | headache | Headache, nausea |
| 61 | 2021-01-26 | chills, fatigue |
Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, sl...
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Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, slight left arm ache, loss of appetite, insomnia, body/joint aches. I took a couple of Aleve tabs 24 hours after the vaccine and then switched to 500 mg Tylenol 30 hours after the vaccine, with no relief of symptoms from either meds. I've been sleeping (taking 2 hour naps) and called off of work (I work in home health). Today, 1.27.21 I feel better, still having 'hot flashes' and some chills (again, without fever). I feel tired, slept last night for 12 hours (no further insomnia). I am eating, but really have no appetite.
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| 61 | 2021-01-26 | chills, headache |
AT VACCINE SITE R ARM - REDNESS, SLIGHTLY SWOLLEN, TENDER. ALSO C/O H/A SINCE 1500 1/26/21. NOTED CH...
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AT VACCINE SITE R ARM - REDNESS, SLIGHTLY SWOLLEN, TENDER. ALSO C/O H/A SINCE 1500 1/26/21. NOTED CHILLS 1/26/21 PM ALSO
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| 61 | 2021-01-26 | chills, headache | headache, shakiness, chills, lightheadedness |
| 61 | 2021-01-26 | chills, fever |
Chills, low grade fever right away. Next 9 days--severe stomach burning, nausea, unable to hold flu...
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Chills, low grade fever right away. Next 9 days--severe stomach burning, nausea, unable to hold fluids down, "metal taste"--by day 9 went from 103 kg to 92 kg. Slowly got better after this with time and Pepto Bismol.
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| 61 | 2021-01-26 | fatigue, headache | Headache 1st day Day 2/3 severe body aches, muscle and joint pain, fatigue, brain fog, insomnia |
| 61 | 2021-01-26 | sweating, fatigue, chills |
unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffnes...
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unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 61 | 2021-01-26 | sweating |
During 15 min observation after receiving vaccine, patient reported tingling in lips and diaphoresis...
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During 15 min observation after receiving vaccine, patient reported tingling in lips and diaphoresis. Patient was administered diphenhydramine 50 mg PO while in vaccine clinic, rapid response was called and patient was transported to the ED. Patient was administered famotidine 40 mg PO and prednisone 50 mg PO and released from ED 5 hrs later.
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| 61 | 2021-01-26 | fever |
felt cold and chilly; can't move her arm up and down; Fever/ 101.2; body aches; mild pain in arm; Th...
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felt cold and chilly; can't move her arm up and down; Fever/ 101.2; body aches; mild pain in arm; This is a spontaneous report from a contactable consumer report self. This 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL4176), via an unspecified route of administration at left arm on 12Jan2021 14:30 at single dose for covid-19 immunization. Medical history included COVID in Nov2020 (Patient was tested for Covid on 23Nov2020 and found out the 25Nov2020 the result was positive), she just quarantined herself at a hotel (They gave her Benzonatate, but she was also taking Tylenol 500mg and Robitussin DM). Concomitant medications not reported. Patient did not get any other shots or 4 weeks prior. No problems with vaccines in past that she can remember. No additional vaccines administered on same date of the Pfizer suspect. Patient received the Pfizer BioNtech vaccine on 12Jan2021 and after that on 12Jan2021 night she didn't feel anything but mild pain in arm, it was so painful, but not as bad on 13Jan2021 even though she still has it. She can't move her arm up and down. On 13Jan2021 morning at dawn she had a fever and it is now 101.2. Has taken Tylenol 500mg (Lot number: SLA071, UPC number: 30047112, Expiry Date: Aug2024). Patient had body aches started 12Jan2021 at midnight (12:00) that is start date of 13Jan2021. She felt cold and chilly and not sure if it was the weather or her. No Emergency Room or Physician Office visit. The outcome of "felt cold and chilly" was unknown, of else events was not recovered.
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| 61 | 2021-01-27 | body temperature increased, headache, throat pain, fatigue |
A day after getting the vaccine, had fatigue, body ache, headache, fever of 101, sore throat, bitter...
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A day after getting the vaccine, had fatigue, body ache, headache, fever of 101, sore throat, bitter taste, dizziness.
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| 61 | 2021-01-27 | chills, fever, fatigue | FEVER, CHILLS, FATIGUE, NAUSEA; 12HR; TREATED WITH TYLENOL 650MG BID; EFFECTIVE |
| 61 | 2021-01-27 | chills, fever, influenza like illness, fatigue |
FEVER, CHILLS, NAUSEA, FATIGUE, FLU-LIKE SYMPTOMS, TREATED WITH TYLENOL 650MG BID, EFFECTIVE - SYMT...
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FEVER, CHILLS, NAUSEA, FATIGUE, FLU-LIKE SYMPTOMS, TREATED WITH TYLENOL 650MG BID, EFFECTIVE - SYMTPOMS RESOLVED
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| 61 | 2021-01-27 | cough | Cough, body aches, shortness of breath for 10 days |
| 61 | 2021-01-27 | fatigue, sweating |
tired; sweaty; nauseous light headed when standing; rush of hotness through entire body; severe naus...
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tired; sweaty; nauseous light headed when standing; rush of hotness through entire body; severe nausea/nauseous light headed when standing; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Lot number: 3302), via an unspecified route of administration in right arm on 13Jan2021 13:00 at single dose for covid-19 immunization. Medical history was none. Concomitant medication included escitalopram, vitamin d. At the time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested about 45 mins before feeling well enough to drive. All better after about 2 hours. Next day (14Jan2021), tired, sweaty, nauseous light headed when standing. No treatment received. No pregnant at the time of vaccination. The outcome of the events was unknown.
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| 61 | 2021-01-27 | fatigue | extreme fatigue |
| 61 | 2021-01-27 | fatigue |
10 -15 minutes after shot: Swelling of tongue; drainage from nose and back of throat;gourde voice; t...
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10 -15 minutes after shot: Swelling of tongue; drainage from nose and back of throat;gourde voice; trouble swallowing : elevated blood pressure Told nurse 25 minutes later.given benedryl injection Things improved and an hour later tongue began to swell again and blood press increased Paramedics called and they transported me to the ER where I was given an Epi injection and steroids. Monitored for three hours and sent home with prescription for steroids: epi pen; and zyrtec Still experiencing fatigue , headache and lots of drainage off and on
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| 61 | 2021-01-27 | fatigue | fatigue |
| 61 | 2021-01-27 | headache, body temperature increased, fatigue |
A little over 48 hours into my COVID19 shot (Pfizer), I got sick. I was freezing cold, slight headac...
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A little over 48 hours into my COVID19 shot (Pfizer), I got sick. I was freezing cold, slight headache, no appetite, and tired/achy. I slept for 3 hours and woke up a little after 8 p.m. Temperature was 100.5. After calling work and notifying my doctor, I drank a Powerade and went to bed. This morning, I feel almost normal. Slight headache (maybe from lack of food) and my stomach is still a little upset.
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| 61 | 2021-01-27 | headache, chills | Headache Chills Neck hurt Back hurt |
| 61 | 2021-01-27 | headache, fever, chills |
Fever 101; pain in both thigh; chills; nausea; headache; This is a spontaneous report from a contact...
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Fever 101; pain in both thigh; chills; nausea; headache; This is a spontaneous report from a contactable nurse (patient herself). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 13:00 at single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Concomitant medications were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. On 14Jan2021 01:00, the patient experienced fever 101, pain in both thighs, chills, nausea and headache. No treatment was received for the adverse events. Clinical outcome of the events was recovered with sequelae on Jan2021.
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| 61 | 2021-01-27 | headache | immediately following the vaccine she experienced a horrible headache, dizziness, and shakiness |
| 61 | 2021-01-27 | headache |
headaches; achy feeling; nausea; felt hot; This is a spontaneous report from a contactable consumer ...
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headaches; achy feeling; nausea; felt hot; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3249) via an unspecified route of administration in the left arm on 12Jan2021 09:15 AM at a single dose for COVID vaccine. Medical history included rheumatoid arthritis. Concomitant medications included leflunomide, paroxetine, and ergocalciferol (VITAMIN D) (other medications in two weeks). The patient had no other vaccine in four weeks. The patient had known allergies to sulfamethoxazole/trimethoprim (SEPTRA) and mefloquine. It was reported that the patient had 4 days of headaches and achy feeling on 12Jan2021. During her 30-minute wait after the injection, she experienced some nausea and felt hot on 12Jan2021. Treatment was not received for the events. The patient had no COVID prior vaccination. She did not have COVID tested post vaccination. The outcome of the events was recovering.
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| 61 | 2021-01-27 | headache |
Severe headache 15 hours after getting second COVID vaccine. Relieved partially with acetaminophen....
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Severe headache 15 hours after getting second COVID vaccine. Relieved partially with acetaminophen. Dull headache second day. Headaches are very unusual for me.
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| 61 | 2021-01-27 | sweating, throat irritation |
Increased HR, Weakness, Throat Irritation, Diaphoresis. Patient was asked to sit in observation for...
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Increased HR, Weakness, Throat Irritation, Diaphoresis. Patient was asked to sit in observation for 30 min. Hx of allergies. Very anxious, anxiety causing increased HR and Sweating. throat itching/tightness. Legs elevated, 50 mg of Benadryl given.
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| 61 | 2021-01-28 | fatigue |
This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (n...
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This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EL3294 and Expiration Date unknown) via an unspecified route of administration on 11Jan2021 07:15 AM (Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EK5730 and Expiration Date unknown) via an unspecified route of administration on 21Dec2020 03:45 PM (Left arm) at single dose for COVID-19 immunisation.No covid prior vaccination, no covid tested post vaccination and no known allergies.Other medical history included thyroiditis and scleritis The concomitant medications included Levothyroxine, Vitamins, paracetamol (TYLENOL), Pepsid, Melatonin. No other vaccine in four weeks. Patient experienced, fatigue, left under eye bruise, right eye injection, joint swelling, gum bleeding with brushing on 13Jan2021 08:00 AM, resulted in Doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered with unknown treatment.
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| 61 | 2021-01-28 | headache |
Headache/Could not pick my head up; All the muscles in my shoulders and my back were tightened up/mu...
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Headache/Could not pick my head up; All the muscles in my shoulders and my back were tightened up/muscles are still tight and at all the way to my neck; Muscle pain; muscles in my neck are all tied up between my shoulder blades, my shoulders all was shrugging and I could never release the muscles back that is what I felt like.; Could never release the muscles back that is what I felt like/My muscles never acted this way; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Nurse reported that she had severe side effects but not an allergic reaction. She had the vaccine on Thursday (31Dec2020) and by Sunday (02Jan2021), she had a horrible headache, all the muscles in her shoulders and back were tightened up. And all the week long, she kept trying to keep care with hot packs and cold packs and Advil and Maxalt and all kind of things but could not. Yesterday morning (as reported), she lifted nothing heavy, did nothing different at all and she could not pick her head up. Patient had to seek for medical attention just at her doctor's office not at the hospital. She had to have somebody and take care of muscle pain. She still have the muscle pain she do have to go back but they did give a muscle relaxant. Patient reported that she never had a reaction ever like this. Nurse further stated that she didn't do anything as a precursor before the vaccine or after the vaccine. The muscles in her neck were all tied up between her shoulder blades, and her shoulders all was shrugging and could never release the muscles back that was what she felt like. Nurse stated that she just have to take the second shot, that was just the first one. Somebody told her that she have to report it because it took her off the work for two days. And her muscles were still tight and at all the way to my neck and still have headache. She had a shot on 31Dec2020, and symptoms started on the 2nd. Patient reported that she never had such kind of pain before and her muscles never acted this way. She was advised by her healthcare provider that there were side effects and this one she consider severe. She was advised to continue to take the second one. Outcome of the events headache/could not pick my head up and all the muscles in my shoulders and my back were tightened up/muscles are still tight and at all the way to my neck were not recovered; outcome of the rest of events was unknown. Information on the Lot/Batch number has been requested.
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| 61 | 2021-01-28 | fever, chills |
Fever, chills, weakness, body ache, dizziness didn't get out of bed for over 24 hours. Took Tylenol ...
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Fever, chills, weakness, body ache, dizziness didn't get out of bed for over 24 hours. Took Tylenol for relief. still feeling weak. can't stand up long without feeling dizzy.
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| 61 | 2021-01-29 | chills | Numbness around my mouth, chills, and nausea |
| 61 | 2021-01-29 | headache, fatigue |
alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves ...
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alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves over the next week. Also fatique,, muscle and joint pain. for 6 days also had sever headace, numbness in face and lips, spasm of left eyebrow. Mised wek of work, ended up in Emergency room. Had negative covid test. sent home. Was fatiques and dizzy and brain fog for next three weeks. Took a month to feel rigtht.
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| 61 | 2021-01-30 | chills, headache | Bad headache Tight chest Shortness of breath Chills |
| 61 | 2021-01-30 | headache |
Metallic taste in her mouth. Violent shaking for 11.5 hours and pulled muscles in her stomach and b...
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Metallic taste in her mouth. Violent shaking for 11.5 hours and pulled muscles in her stomach and back. Injection site hot. Fingers on that side were white Dizziness. H/A. Vomiting
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| 61 | 2021-01-30 | headache |
12 hr after vaccine, sore arm, a little achy. 15 hrs after vaccine (11 pm) and through the night, fe...
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12 hr after vaccine, sore arm, a little achy. 15 hrs after vaccine (11 pm) and through the night, felt very cold and had difficulty getting warm, headache, all body achy, unable to get into any comfortable position and very limited sleep. By 24 hr after vaccine and continuing until 40 hr after, nausea most of day, severe muscle pains, headache, difficulty moving from pain and general weakness, head swimming sensation. felt like skin crawling sensation all over. By 48 hrs, much less headache and nausea, able to eat, still had skin crawling sensation and achy but able to walk around a bit, not able to go outside. By 58 hr after (at time of report), just weak all over feeling, head fuzzy but better. Treatment: ondansetron x 2 doses (at 24 hr and 20 hr), Nurtec x 2 doses at 15 hr and 20 hr), Acetaminophen 8 hr x 2 doses (at 36 hr and 48 hrs)
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| 61 | 2021-01-31 | chills, fatigue, fever |
exhaustion; Chills; feeling feverish; aching left arm at injection site; This is a spontaneous repor...
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exhaustion; Chills; feeling feverish; aching left arm at injection site; This is a spontaneous report from a contactable other health professional (HCP). A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular on 10Jan2021 at 15:30 on her left arm at a single dose for COVID-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing and known penicillin (PCN) allergy. There were no concomitant medications. The patient previously took erythromycin and clindamycin and experienced allergies. The patient received the first dose of BNT162B2 (lot number: EH9899), intramuscularly on left arm on 20Dec2020 at 03:30 PM. The patient experienced chills, feeling feverish, aching left arm at injection site and exhaustion on 15Jan2021 at 16:45. On 16Jan2021, consumer stated, "I recently had the COVID vaccine and it was last Sunday. Is that possible to have a reaction 5 days out?" There was no treatment received for the events. The outcome of the events was not recovered.
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| 61 | 2021-01-31 | chills | Chills & Vomiting |
| 61 | 2021-01-31 | headache, fatigue |
Severe sudden diarrhea, headache, weakness, taste of smoke with burning sensation. Today unable to...
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Severe sudden diarrhea, headache, weakness, taste of smoke with burning sensation. Today unable to do anything, very tired.
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| 61 | 2021-01-31 | headache, malaise, chills | Headache, Chills, Nausea, Diarrhea, Malaise |
| 61 | 2021-01-31 | headache, fever |
Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness...
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Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness in arm, headache, and fever of 99.4 at about 2:30am on 1/18/2021. Side effects persisted all day on 1/18/2021 but relieved with acetaminophen 325mg every 6 hours. All side effects resolved by morning of 1/19/2021. Around 4:30pm on 1/19/21 started having pain in left axilla which was due to swollen lymph node. The pain and swelling progressed over the evening and pain radiated to chest, throughout left arm, and shoulder. All of these side effects continued all day on 1/20/21 but started getting better around 6pm. All side effects resolved by morning of 1/21/2021.
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| 61 | 2021-01-31 | headache, sinus congestion, nasopharyngitis, malaise, body temperature increased, fatigue |
(This is a duplicate entry. I mistakenly entered that patient received the Moderna vaccine, but she ...
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(This is a duplicate entry. I mistakenly entered that patient received the Moderna vaccine, but she in fact received the Pfizer.) I got the 2nd dose of the Pfizer vaccine late last Wednesday afternoon (1/20). Before the 2nd dose, I premedicated (as instructed by my medical office) with Benadryl 50mg and Pepcid 20mg (for the histamine blocking effect) since I had terrible itching for about 36 hrs after the 1st dose; but the itching didn't begin-after the 1st dose-until about 8hrs after the shot & became intense 2 more hrs later. I had itching the night of the 2nd dose that kept me awake part of the night but was FAR less intense than after the 1st dose. I came to work Thurs not feeling ill--just cold and tired all day (I attributed to the cold weather and not sleeping well). Thurs about noon I began feeling ill--like I was coming down with the flu; I went home after my shift and found my temp to be 100.4. Shortly thereafter it was 100.9. I thought it would pass by morning so I just showered, drank fluids, took Tylenol and slept. By 0200ish Fri 1/22 I still had a fever of 100.9 (even with Tylenol on board), a bad headache, sinus congestion, and significant neck and back pain so I called out for work. I continued to treat the fever and by noon Fri the fever finally had resolved-along with the head, neck and back pain. I've been fine since.
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| 61 | 2021-01-31 | headache | headache in the frontal lobe nausea diarrhea dizzy |
| 61 | 2021-01-31 | headache |
Patient's reaction(s) noted during COVID vaccine observation period: At 1700, patient had left obs...
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Patient's reaction(s) noted during COVID vaccine observation period: At 1700, patient had left observation area, gotten to car, drove away but returned because she was experiencing nausea and headache. Patient was seated, used wet cloth to forehead and back of neck. VS: B/P 127/86, HR 98, O2 sat 98%, Temp 98.0. At 1715 VS: B/P 124/76, HR 88, O2 sat 98%, temp 98.1. At 1730 VS: B/P 121/91, Hr 86, O2 sat 98%,. Still c/o headache, refused tylenol. Nausea still present but slightly improved. Reassured by staff and husband and taking sips of Sprite 1745 B/P 118/64, HR 85, )2 sat 98%, nausea improving still has H/A, states these symptoms have occurred in past with other events. 1800 B/P 117/69, HR 89, O2 sat 98%. Was walked out to car, denies lightheadedness or shortness of breath. States other symptoms are improving. Disposition: Declined going to ED. Left to go home with no further concerns.
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| 61 | 2021-01-31 | headache |
Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Other- CHEST TIGHTNESS,TROUBLE BREATHI...
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Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Other- CHEST TIGHTNESS,TROUBLE BREATHING-Medium
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| 61 | 2021-02-01 | chills, headache, fever |
very sore Painful arm at injection site; Started chilling; ran a fever between 102- 103 degrees; hea...
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very sore Painful arm at injection site; Started chilling; ran a fever between 102- 103 degrees; headache; felt nauseous; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration in left arm on 18Jan2021 10:00 at first single dose for COVID-19 immunization. Medical history included high blood pressure (BP) on medication, known allergies: Penicillin (PCN), levaquin, covid-19 on 18Nov2020. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient had a very sore painful arm at injection site, no redness, started chilling and ran a fever between 102- 103 degrees during the night and into the next day. Had headache felt nauseous. Events start date/time: 19Jan2021 02:00 AM. By 6 pm the next day the patient started to feel a little better. The patient tested positive for covid 19 in 18Nov2020. Covid was not tested post vaccination. No treatment was received for the events. Outcome of the events was recovering.
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| 61 | 2021-02-01 | headache, fever, chills |
Slight fever/ her temperature usually runs 97 and currently is 99.4; joint pain because her hips hur...
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Slight fever/ her temperature usually runs 97 and currently is 99.4; joint pain because her hips hurt/ her hips were really sore; Chills; Arm pain; Headache/ pain at the base of the head/ pain in her head; Neck pain; Shoulder pain; pain everywhere; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ16R6), intramuscular in the left arm on 17Jan2021 09:30 at single dose for COVID-19 prophylaxis. The patient medical history was not reported. There were no concomitant medications. The historical vaccine included the first dose of BNT162B2 on 26Dec2020 at her 60-year-old for COVID-19 prophylaxis. The patient was a physical therapist (non- Healthcare Professional), she received the second dose and was having almost every side effects. She experienced arm pain started night around 17Jan2021 17:00; headache, pain at the base of the head, neck pain, shoulder pain, pain everywhere on 17Jan2021; chills that she couldn't get rid of on 17Jan2021 19:00; slight fever, and overall feeling tough, joint pain because her hips hurt on 18Jan2021. At 17:00-19:00 on 17Jan2021 and stated that she could not tolerate her head being upright. She stated that she went to bed at 19:00. Pain in her head, neck, and shoulders is a little better because she can actually sit up now and hold her head up. She said that her temperature usually ran 97 and currently was 99.4. She said that she did not take her temperature on 17Jan2021 and did not get up until 13:00 and stated that she took it when she got up on18Jan2021. She noticed joint pain when she got up on 18Jan2021, her hips were really sore. Chills started at night, when she went to bed she had the chills around 19:00 17Jan2021. The outcome of pain in her head, neck, and shoulders was recovering, of the other events was not recovered.
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| 61 | 2021-02-01 | headache | Head ache. |
| 61 | 2021-02-01 | fever, chills, headache |
lost 22lbs; teeth hurting; can't eat; sores in mouth; cold chills; Headache/it's mainly in the back ...
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lost 22lbs; teeth hurting; can't eat; sores in mouth; cold chills; Headache/it's mainly in the back of her head; Diarrhea; Throwing up/threw up 4 times; low grade temp of 100; This is Spontaneous report from a contactable consumer reporting for self. A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration in Right arm on 14Jan2021 10:00 at single dose for covid-19 immunisation. Patient received 1st dose of bnt162b2 on 24Dec2020, Lot number: EL0140; She only had a little aches with the first dose. States that she has had Covid before. There were no concomitant medications. She got the 2nd covid vaccine and felt like she got Covid all over again, diarrhea, throwing up, cold chills, and headaches started on 15Jan2021 at around 2:00AM, low grade temp of 100 on 15Jan2021, then she got sores in her mouth and now her teeth hurt. States that maybe it's from the fever. States that she can't eat because it hurts. She lost 22lbs because she couldn't eat. She has been gargling with half warm water and half peroxide. States that she threw up 4 times, but she doesn't even remember how many times she had diarrhea. After she was done throwing up she finally sat down and took her temperature, so it was probably around 4:00-5:00 AM. States that she still has a headache; it's mainly in the back of her head. Outcome of event diarrhea, throwing up, low grade temp of 100, chills was recovered, of headache was recovering, of can't eat and lost 22lbs was unknown, of others was not recovered.
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| 61 | 2021-02-01 | sluggishness, headache, sneezing, fever, chills |
sluggish and wanting to sleep all day; Sneezing; stuffy head; Low grade fever; Chills; bad headache;...
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sluggish and wanting to sleep all day; Sneezing; stuffy head; Low grade fever; Chills; bad headache; arm hurts; The initial case was missing the following minimum criteria- No Adverse Effect. Upon receipt of follow-up information on 19Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided - "has not received information card "), via an unspecified route of administration on 17Jan2021 at single dose on the left arm for COVID-19 immunization (reported as "Why was the patient taking Covid-19 vaccine (Verbatim): works in a group home "). Medical history included ongoing heart murmur since 2019. There were no concomitant medications. There were no investigation assessment. The patient experienced low-grade fever, chills and a bad headache on 17Jan2021. Patient was sluggish and wanting to sleep all day on 18Jan2021. Patient took Tylenol for a headache. It did not work so she took sumatriptan. The patient was also sneezing on 18Jan2021. Patient reported that she sweated the fever out. She had chills at night. The headache was lingering off and on but was mild. She sneezed all day on Monday (18Jan2021). She has not sneezed yet today but she has a stuffy head on 18Jan2021. Patient clarified that she took Acetaminophen Rapid Pain Relief instead of Tylenol. She took two 500mg tablets (UPC: 3225152303, Lot: 91670159AA, Expiry: Aug2022). Patient also reported that her arm hurts on 17Jan2021. She was unable to provide the Lot number. She will receive the information card after she receives the second dose. She had a picture of the card but it was not very clear. Outcome of the events arm hurts, headache, stuffy head was recovering (also reported as ongoing), for chills, low grade fever was recovered on 18Jan2021, for sluggish and wanting to sleep all day was recovered on 19Jan2021 while for other event was unknown. Information about batch/lot number has been requested.
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| 61 | 2021-02-01 | throat irritation, headache, cough |
Mild headache, scratchy throat, dry cough. BP 140's/80's, pulse 82, 100% O2 sat. Given Benadryl 50 m...
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Mild headache, scratchy throat, dry cough. BP 140's/80's, pulse 82, 100% O2 sat. Given Benadryl 50 mg.
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| 61 | 2021-02-02 | chills | Migraine headache chills and joint pain |
| 61 | 2021-02-02 | fatigue |
FATIGUE, SORENESS AT INJECTION SITE, MUSCLE ACHES, DIZZINESS, LIGHT HEADEDNESS, MUSCLE AND BODY ACHE...
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FATIGUE, SORENESS AT INJECTION SITE, MUSCLE ACHES, DIZZINESS, LIGHT HEADEDNESS, MUSCLE AND BODY ACHES
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| 61 | 2021-02-02 | headache, fever | Left gland/ Lymph node in armpit very swollen and painful. Headache and Fever |
| 61 | 2021-02-02 | headache |
She wore sunglasses in her house because the light bothered her eyes; Eyes felt dry; Loss of vision ...
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She wore sunglasses in her house because the light bothered her eyes; Eyes felt dry; Loss of vision in right eye; Hole in her retina; Bad headache for 3 days; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported similar events for 2 patients. This is 1st of 2 report. A 61-year-old female consumer (patient) received 2nd dose of BNT162B2 (Covid Vaccine, lot number: EL1248) on 06Jan2021 at single dose in the right arm for COVID-19 immunisation. Medical history was not reported. Concomitant drug included Multivitamin, Vitamin C, Vitamin D Zinc all from Mar2020 and ongoing. Historical Vaccine was 1st dose of BNT162B2 (Batch/lot number: EK5730) on 18Dec2020 in the right arm. Patient got COVID vaccine and a few hours later or the next day she started getting a hole in her retina and started losing her site in right eye. she went to the doctor as she has a hole in her retina. Again, this may be totally unrelated but she wanted to call and get this reported. She is going to see a retinal specialist this afternoon. After she had her COVID vaccine she had a bad headache for 3 days. She wore sunglasses in her house because the light bothered her eyes. She noticed this on 16Jan2021 because she was looking at paperwork and her eyes felt dry. She blinked a few times and had opened one eye alone, and she noticed that her left eye was fine but the vision in her right was not. This could have been going on longer. She just never closes only one eye. When both are open, her vision is normal. She saw the eye doctor yesterday, and that is when they said she had a hole in her retina. They said she will have to have surgery to close the hole. She knows she is at the right age for this to spontaneously happen, but just in case it is related, she wanted to report it. Outcome of the event Loss of vision in right eye was Not Recovered, for headache was recovered, for other events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046804 same reporter, AE and drug, different patient
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| 61 | 2021-02-02 | headache | severe headache muscle weakness muscle pain |
| 61 | 2021-02-03 | fatigue, chills, headache |
Diarrhea; Chills; Slight headache; Very body tired; This is a spontaneous report from a contactable ...
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Diarrhea; Chills; Slight headache; Very body tired; This is a spontaneous report from a contactable other HCP reported for herself that a 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: p9231), via an unspecified route of administration at the age of 61-years, on 22Jan2021 17:00 (05:00 PM) at single dose in left arm for COVID-19 immunization, in hospital. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had slight headache on 23Jan2021 and was very body tired. On 24Jan2021 10:00 AM, she had diarrhea and chills. No treatment received for the adverse events. The events were considered as non-serious. Outcome of the events was recovering/resolving. Since the vaccination, the patient has not been tested for COVID-19.
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| 61 | 2021-02-03 | headache |
Headaches, dizziness, loose stool, upper body pain, 8/10 for 15 minutes (Felt like a heart attack an...
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Headaches, dizziness, loose stool, upper body pain, 8/10 for 15 minutes (Felt like a heart attack and then gone completely after 10 minutes)
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| 61 | 2021-02-03 | headache |
61-year-old female presents the ED for evaluation of lightheadedness. Patient reports shortly after...
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61-year-old female presents the ED for evaluation of lightheadedness. Patient reports shortly after receiving first dose of Covid vaccine, began to feel lightheadedness 15 minutes later. Patient reports that she started off with a right-sided headache, and when she went to stand up took 2-3 steps forward and fell lightheaded, and and sat back in her chair. Denies loss of consciousness, chest pain, shortness of breath. Denies alleviating or exacerbating factors. Patient reports that they taken her blood pressure after symptoms, was found to be elevated, 200/100 systolic. Patient denies previous history of blood pressure medications. Denies previous reactions to vaccines
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| 61 | 2021-02-03 | sleepiness, throat irritation |
12:54 pm Pt reported feeling cold & feeling of throat closing. Pt calm & talkative through situation...
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12:54 pm Pt reported feeling cold & feeling of throat closing. Pt calm & talkative through situation. Interpreter RN assisted with interpreting. Another RN assessed pt, negative wheezing &/or stridor, pt accepted bottle of water ingested/tolerated sips of water. Pt ambulated with RN w/o issue to have IM Benadryl 50 mg Right gluteus. Pt tolerated well. Pt prior hx allergies to PCN & NSAID?s w/side effects of laryngeal edema. 12:55 pm called over to pt, RN for 61 yo F with hx of laryngeal edema with PCN & NSAID?s. Pt states her throat feels scratchy, primary Spanish speaking w/interpreter at side. Assess pt no ins/exp wheezing. No stridor, no SOB on O/A 98% O2 sat, HR 67, with 90 SBP palp. Pt also, hx of anxiety. Pt given bottle of water with sips occasional clearing throat. No mouth/oral swelling visualized, however pt is requesting Benadryl. Pt does not have Benadryl on her & discussed with option of IM injection if pt feels she needs it. Pt not flushing, talking with staff & continues with no stridor. Pt again states she would like to have Benadryl. 1300 Per standing order with pt?s stated feels like her throat is having swelling/itching Benadryl 50 mg IM R gluteal with band aid applied. 1305 Per adm ALS called for f/u, pt continues with no distress, no stridor, no ins/exp wheezing. Pt sips on water & is talking with staff without distress. 1308 ALS on scene with update status, PMH & allergies with Benadryl 50 mg given @ 1300 IM, HR 67, O2 sat 98% RH, B/P 161/80 RA. Pt not in distress & is stating she feels much better, no throat swelling, just feels sleepy. Pt has husband in personal vehicle to assist pt home. Pt denies need for transport. 1323 Pt sitting in chair, calm & no distress, cont. to re-assess. 1330 Pt tolerated well & cleared for discharge to home with husband. Pt I/S to f/u with PCP if needed. Any SOB, increased anxiety d/t possible reaction, call 911 & will be re-evaluated. Pt consents to go home with husband driving.
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| 61 | 2021-02-04 | chills, sweating |
I experienced muscle aches the spread across my entire back starting at about 8 PM on 2/4/21. At 2:3...
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I experienced muscle aches the spread across my entire back starting at about 8 PM on 2/4/21. At 2:30 AM on 2/5/21, I passed out three times after rising from the toilet, resulting in a split lip. I was covered with sweat the third time I "came to" and soon got the chills.
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| 61 | 2021-02-04 | chills | BODY ACHES, CHILLS, JOINT PAIN, ARM SORENESS |
| 61 | 2021-02-04 | fatigue |
Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, diz...
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Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, dizziness, chest pressure, and profound weakness. Brought to Emergency Department by crisis RN where she remains achy with weakness, fatigue and had no energy. Pt reports "feeling tired" and "my speech is slower". On exam, slight R facial droop noted, tongue noted to be leaning towards the right, pronator drift noted in R arm. Code Brain activated with real time audio video interaction. MRI completed with normal results. Symptoms resolved. Stroke team ok with discharge to home with f/u with PCP.
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| 61 | 2021-02-04 | headache, fatigue |
feeling tired but also edgy; edgy/ nervous; anxious; unable to focus; headaches; blood pressure was ...
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feeling tired but also edgy; edgy/ nervous; anxious; unable to focus; headaches; blood pressure was much higher than normal; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284) via an unspecified route of administration on the left arm on 11Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and back pain. Concomitant medication included levothyroxine sodium (SYNTHROID), ibuprofen and ergocalciferol (VIT D). The patient previously received 1st dose of BNT162B2 on 20Dec2020 for COVID-19 immunization (left arm, lot number: EH9899). After receiving second dose on 11Jan2021 the patient was feeling tired but also edgy, nervous, anxious, unable to focus, some headaches. Discovered 18Jan2021 that blood pressure was much higher than normal and associated with the way I was feeling. Had to go to primary care to have medication prescribed. The events resulted to a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. Patient was not pregnant. No known allergies. The facility where the vaccine was administered was in a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19 (Nasal swab), on 13Jan2021 and 16Jan2021 both test results were negative. Outcome of the events was not recovered.
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| 61 | 2021-02-04 | headache |
Difficulty swallowing, tongue swelling, headache, Epi pen 0.3mg, 25 mg Benadryl Improvement in tong...
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Difficulty swallowing, tongue swelling, headache, Epi pen 0.3mg, 25 mg Benadryl Improvement in tongue swelling
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| 61 | 2021-02-04 | nasal congestion, fatigue, headache |
Mild headache that evening, arm slightly sore during the night and the next day. Frontal headache a...
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Mild headache that evening, arm slightly sore during the night and the next day. Frontal headache and muscle aches the next day on 1/22/21. Some fatigue and nasal congestion that next day as well. Some fatigue and headache on 1/23/21. Took Tylenol once on 1/22 and 1/23.
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| 61 | 2021-02-04 | throat pain, cough, fever, headache, fatigue, chills, nasal congestion |
sore throat; had chills; hot with a slight fever; hot with a slight fever; dizzy; tired/slept all da...
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sore throat; had chills; hot with a slight fever; hot with a slight fever; dizzy; tired/slept all day; congestion; severe headache; severe cough; achy/was in such pain all over; This is a spontaneous report from a contactable healthcare professional (patient). A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249, expiration date unspecified), intramuscular on 18Jan2021 12:00 at single dose (left arm) for COVID-19 immunization. Medical history included slight hypertension and allergies to penicillin. The patient was not pregnant at the time of vaccination. Concomitant medication included losartan. The patient took first dose of bnt162b2 on 28Dec2020, at 10:00 (lot EL1284) at left arm for COVID-19 immunization. When the patient went to bed that night about 10 hours after the shot, I was just achy on 18Jan2021, at 22:30. When she got up at 02:30, she was in such pain all over and had chills and was hot with a slight fever, was dizzy, and tired on 19Jan2021. When she woke up later and had to call off, she had all of that (worsening), plus congestion and severe headache on 19Jan2021. The patient slept all day, but developed a severe cough by that night and she took nighttime cold medication to sleep and when she woke up on Wednesday, she took the daytime ones. The patient reported that she still have achiness, was tired, and a sore throat and some cough on Thursday, 21Jan2021. The patient received therapy for the event severe cough; and patient did not received treatment for the rest of events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was recovering.
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| 61 | 2021-02-04 | fever, chills |
Symptoms - ? Patient reports at approximately 02:00 she woke up with body aches, chills and fever (T...
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Symptoms - ? Patient reports at approximately 02:00 she woke up with body aches, chills and fever (Tmax 102.1), Tylenol taken at 05:00, at time of call temp 101. Patient denies COVID-19 exposure without proper PPE and denies travel. Patient next scheduled to work tmw morning. Last day of work and shift - ?Tuesday (2/2) Home remedies? - Tylenol at 05:00 Any improvement? - mild Recommendation? Patient educated to continue to monitor symptoms at home and to take ibuprofen and Tylenol as directed in Medical Directive and to increase fluid intake. Patient educated to manage her symptoms and to adhere to the Workplace Policy. Patient verbalized back understanding and denied further questions at this time.
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| 61 | 2021-02-04 | fever, chills |
Symptoms - ?Patient reports at approximately 02:00 she woke up with body aches, chills and fever (Tm...
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Symptoms - ?Patient reports at approximately 02:00 she woke up with body aches, chills and fever (Tmax 102.1), Tylenol taken at 05:00, at time of call temp 101. Patient denies COVID-19 exposure without proper PPE and denies travel. Patient next scheduled to work tmw morning. Last day of work and shift - ?Tuesday (2/2) Home remedies? - Tylenol at 05:00 Any improvement? - mild Recommendation? Patient educated to continue to monitor symptoms at home and to take ibuprofen and Tylenol as directed in the paperwork and to increase fluid intake. Patient educated to manage her symptoms and to adhere to the Illness in the Workplace Policy. Patient verbalized back understanding and denied further questions at this time.
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| 61 | 2021-02-04 | fever |
had been running a temperature of 99.5 to 101; This is a spontaneous report from a contactable consu...
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had been running a temperature of 99.5 to 101; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female non-pregnant patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL 3249 and expiry date unknown) via unspecified route of administration at the left arm on 11Jan2021 at single dose for Covid-19 immunization. The patient medical history was not reported. The patient has no covid prior vaccination. Concomitant medication included losartan and vitamin; both from unspecified date for unspecified indication. The patient previously took vancomycin and Keftab; both experienced allergies. The patient had no other vaccine in four weeks. The patient had been running a temperature of 99.5 to 101 since Monday 11Jan2021 during the night (also reported as 11Jan2021 12:00 AM). The patient was not covid tested post vaccination. The patient did not receive treatment due to the event. The outcome of the event had been running a temperature of 99.5 to 101 was not recovered.
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| 61 | 2021-02-05 | fatigue, headache, body temperature increased |
Dizziness started about 5 minutes after shot. Nurse had me lay down. Better after 20 minutes. Bad he...
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Dizziness started about 5 minutes after shot. Nurse had me lay down. Better after 20 minutes. Bad headache started while driving home. Took Tylenol but 24 hours later still have headache. Arm hurts at injection site. Very tired. slept 14 hours and still tired. Temp has been around 99.5 when I've been awake enough to take it.
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| 61 | 2021-02-06 | malaise, chills, fatigue |
I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty ba...
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I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty bad symptoms on first dose by all info i have found. The actual shot was given by another facility than listed previously. I recieved the first dose of Pfizer at Health Dept . No other location information was provided by them. When i got the shot, a blood vein and possibly a nerve was hit. The nurse did everything properly i think to correct and notify other RN. It caused immediate pain in left fingers and arm felt heavy. That continued for days, but not too bad and injection site itself really was not very sore. My concern was how sick I felt starting within 6 hours of the injection and how long it lasted. I had pretty much instant nausea- no vomiting- mild but persistant, severe fatigue and general overall uneasy/sick feeling. Joint pain started within the 6 hours, along with a few odd pains in neck and right abdomen. Was extremely chilled for hours, pretty bad tension /tight feeling headache, jittery feeling and foggy. I took a 500mg Tylenol about 8 hours after the shot, and it helped to relieve most symptoms to a degree that was nagging, but tolerable. I pretty much went through this for about the next 3 days and off/on to the 5th day
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| 61 | 2021-02-07 | chills, sleepiness | chills, body ache, sleepy |
| 61 | 2021-02-07 | fatigue, chills, headache |
Pt stated -Onset 12-16 hours post injection of shills, headache, body ache, joint pain and fatigue. ...
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Pt stated -Onset 12-16 hours post injection of shills, headache, body ache, joint pain and fatigue. The symptoms lasted a day and resolved.
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| 61 | 2021-02-07 | fatigue, fever |
facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no it...
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facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no itching. Didn't notice until I left the vaccine site and was on the way home in car because covered by mask. Note I am a very fair skin, freckled red haired woman. I was very, very nervous and had gotten myself to the point of tears. Perhaps the flushing was from that. Have had similar flushing when drinking red wine. Swelling in lymph node in supraclavicular area on same side as shot. Has happened with Flu shot once. Slight fever for a short period of time and fatigue. I continue to have slight shortness of breath from having covid on. 4/3/20. Nothing different.
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| 61 | 2021-02-07 | fatigue | Sore arm. Nausea. Fatigue |
| 61 | 2021-02-07 | head discomfort |
Tingling upper and lower extremities, tingling left lower lip and cheek, weird feeling in head. Symp...
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Tingling upper and lower extremities, tingling left lower lip and cheek, weird feeling in head. Symptoms started February 1 at 6 PM were intermittent until 6 AM February 4. No symptoms until 6 AM February 6, again they were intermittent. Virtual visit with nurse practitioner at MD office February 6 at 11 AM. No symptoms since 6 AM on February 6.
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| 61 | 2021-02-07 | headache, fatigue |
She had significant fatigue the day after the injection along with a sore arm and intermittent heada...
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She had significant fatigue the day after the injection along with a sore arm and intermittent headache. Starting about 72 hours after the vaccine she noticed a swollen lymph node at the base of her neck on the side of the injection. The lymph node, sore arm and intermittent headache are still present.
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| 61 | 2021-02-07 | headache, runny nose, fever, cough, fatigue, chills |
Body aches; fever(100.1); chills; runny nose; cough; headache; fatigue; neck pain; head congestion; ...
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Body aches; fever(100.1); chills; runny nose; cough; headache; fatigue; neck pain; head congestion; This is a spontaneous report from a contactable nurse reporting for herself. A 61-year-old female patient (non-pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9261), via an unspecified route of administration on 20Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included Irritable Bowel Syndrome with Constipation (IBSC), anxiety, allergies, Known allergies: sulfa. Historical vaccine included 1st dose of BNT162B2 (lot: EL1284) on 28Dec2020 at 14:00 via intramuscular at single dose on right arm for COVID-19 Immunization. Concomitant medication included celecoxib (CELEXA [CELECOXIB]), montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), lisdexamfetamine mesilate (VYVANSE) and linaclotide (LINZESS). The patient experienced body aches, fever (100.1), chills, runny nose, cough, headache, fatigue, neck pain and head congestion, all on 21Jan2021 at 14:45 with outcome of resolving.No treatment was received for the events. This case was reported as non-serious.
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| 61 | 2021-02-08 | fatigue, body temperature increased |
On 2/5 am felt dizzy and nauseated. On 2/6 am felt dizzy and nauseated On 2/7 had child, abdominal ...
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On 2/5 am felt dizzy and nauseated. On 2/6 am felt dizzy and nauseated On 2/7 had child, abdominal cramping and pain , Temp 99.3 On 2/8 stomach uncomfortable, fatigue and muscle aches. 2/9 feel tired
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| 61 | 2021-02-08 | fever, chills | Chills, fever up to 101.2 F, body aches, and nausea, lasting 40 hours. |
| 61 | 2021-02-08 | sinus congestion | Rapid heart beat, high blood pressure, sinuses blocked, and anxiety. |
| 61 | 2021-02-09 | cough | coughing 50 mg benadryl po given walked out to her car unescorted |
| 61 | 2021-02-09 | headache, influenza like illness |
I had flu like symptoms headache and dizziness with both doses. The symptoms of the first dose stopp...
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I had flu like symptoms headache and dizziness with both doses. The symptoms of the first dose stopped at day 3. After the second dose, 3 weeks later, the symptoms appeared later but held on to day 5 or 6, except the more extreme dizziness which I still have. It is worse on some days and there is some nausea in the mornings with headache. I have never had vertigo but this is what I imagine it to be.
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| 61 | 2021-02-09 | headache |
splitting headaches; chronic nausea; Vomiting is explosive and unpredictable; metallic taste in mout...
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splitting headaches; chronic nausea; Vomiting is explosive and unpredictable; metallic taste in mouth for 3 days.; This is a spontaneous report from a contactable other hcp, the patient. This 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730), dose number 1, via an unspecified route of administration in the right arm on 29Dec2020 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunization. Medical history included type 1 diabetes mellitus from 1974 to an unknown date (T1DM dx 1974) and aortic valve replacement from 1990 and unknown if ongoing (AVR 1990 and 1992). Concomitant medication included insulin (INSULIN), simvastatin (SIMVASTATIN) and lisinopril (LISINOPRIL). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 31Dec2020, the patient experienced metallic taste in mouth for 3 days. On 07Jan2021 at 13:00, the patient experienced splitting headaches, chronic nausea began and vomiting which was explosive and unpredictable. No therapeutic measures were taken as a result of the events. The clinical outcomes of the metallic taste in mouth for 3 days, splitting headaches, vomiting and chronic nausea were not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 61 | 2021-02-09 | headache |
Headache; cramps; Woke up feeling terrible; Over all body ache; Like no energy; This is a spontaneou...
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Headache; cramps; Woke up feeling terrible; Over all body ache; Like no energy; This is a spontaneous report from contactable Pharmacist (patient). A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)Lot number EL1284, expiration date 30Apr2021, Intramuscular on 13Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient previously received first dose of BNT162B2 on unknown date. The patient received her second dose of the Pfizer vaccine a week ago on Wednesday, '2 days ago' (not clarified), so it's 9 days ago and she was wondering if she could still have, she felt fine for over a week and then yesterday (22Jan2021) she woke up feeling terrible, just over all body ache, 'cramps' (voice feeble not clarified further) like no energy and she was wondering that. She was getting a headache now from this conversation. She did take Acetaminophen yesterday and she was ready to take it now, that's a bad headache. The outcome of all events was unknown.
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| 61 | 2021-02-09 | headache |
Headache began immediately after vaccine administration, B/P 180/118, Denies chest pain, SOB, prurit...
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Headache began immediately after vaccine administration, B/P 180/118, Denies chest pain, SOB, pruritus, rash, blurred vision, recommended transport by EMS but patient declined
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| 61 | 2021-02-09 | malaise, headache |
30 minutes after injection: severe headache, general feeling of illness. Following day in the mornin...
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30 minutes after injection: severe headache, general feeling of illness. Following day in the morning, headache, left arm in extreme pain, facial numbness, disorientation, inability to talk, confusion, difficulty breathing
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| 61 | 2021-02-10 | fatigue, chills, malaise, fever, cough |
Injection Site Pain, tiredness, headache severe, muscle pain, chills, joint pain, fever, nausea, fee...
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Injection Site Pain, tiredness, headache severe, muscle pain, chills, joint pain, fever, nausea, feeling unwell, cough
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| 61 | 2021-02-10 | headache, chills | Chills, body aches, headache, stomach ache Duration = 60 hours |
| 61 | 2021-02-10 | fever, chills, headache | ELEVATED TEMP OF 101, CHILLS ACHES, HEADACHE, WEAKNESS |
| 61 | 2021-02-14 | chills, fatigue, headache |
Severe all arm pain for short period of time, chills, headache, fatigue, swollen lymph nodes and con...
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Severe all arm pain for short period of time, chills, headache, fatigue, swollen lymph nodes and continuing nausea.
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| 61 | 2021-02-14 | chills, fever |
I am a teacher, so thankful to have received my vaccines. 40 years ago, as a young teacher I had a ...
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I am a teacher, so thankful to have received my vaccines. 40 years ago, as a young teacher I had a bad reaction to a flu shot and I have never had another one. I didn't think this vaccine would be similar. I am not someone who gets very sick often and I don't miss days of teaching for illness. Note that my first vaccine on 1/21 had no effects. I did not even get a sore arm. I even sort of bragged about it. The 2nd vaccine on 2/11 seemed fine until I woke up the following morning feeling like I had been hit by a truck. I yawned for 3 hours straight, but still made it to school and worked and taught 6 online classes. I took an ibuprofen that morning because I was feeling so odd. By 3:00 I was driving home (40 minute drive) and I cried uncontrollably the whole way home while my hands and feet were shaking. Not normal for me. When home I went almost immediately to bed. I had a slight temperature and was dizzy. I thought I had the chills but it didn't feel like any chills I have had before. Usually my teeth would chatter and I would feel hot and cold at the same time. The hottest temperature I had was 100.5. But by 9 I started shaking so profusely that I couldn't pick up the thermometer any more, I couldn't use my phone, or take a sip of water. I stumbled to the bathroom holding onto things all the way. My husband was not home, or I imagine he would have called 911 at that point. I kept shaking a lot through the night and kept praying that it wouldn't happen to my heart. I fell asleep eventually and dreamed of fish flopping inside me and my neighbors coming over to to see why the bed was knocking against the wall. Saturday morning I woke up and all the shaking had stopped, but I found I was too weak to get up much. Today is Monday and I mostly feel normal, except a little dizzy when I move and the top of my head is tender to the touch.
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| 61 | 2021-02-14 | chills |
On Thursday,1/21, I felt fine and was working. At 1530, I began having rigors and SOB and called 91...
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On Thursday,1/21, I felt fine and was working. At 1530, I began having rigors and SOB and called 911. At the ED my temp was 103.
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| 61 | 2021-02-14 | fatigue, fever, headache, chills | Fever, Chills, Severe Muscle Cramps, Headache, Extreme Fatigue, Dizziness, Inflammation |
| 61 | 2021-02-14 | headache, head discomfort |
Severe migraine headache with pain behind eyes with uncontrolled tearing, ringing in head, pain and ...
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Severe migraine headache with pain behind eyes with uncontrolled tearing, ringing in head, pain and pressure lasting about 12 hours. No treatment. Dull headache with numb forehead lasting several days. Took Advil for 3 days Wheezing and shortness of breath lasting 6 hours and the same symptoms the following day lasting about 6 hours. No treatment Did call the doctor with my reaction and concerns for second dose recommendation.
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| 61 | 2021-02-14 | fever |
2nd COVID-19 vaccination on 02-11-2021. NO symptoms with 1st vaccination. I woke up to a fever of ...
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2nd COVID-19 vaccination on 02-11-2021. NO symptoms with 1st vaccination. I woke up to a fever of 99.8 on 02-12-2021, which gradually escalated to 102 within 2 hours. It remained at 102 for most of day. Finally came down to 101.1 by around 6:00PM. My normal body temperature is low- around 97.6. I also had an odd sensation at the back of my throat- cannot really describe it- sometimes hurt to swallow- but not consistently. Only felt that symptom the day of 02-12-2021. The next morning, my temperature was 99.2. Eventually returning to normal around 3:00 PM that afternoon. I did not take any OTC medications during the course of recovery.
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| 61 | 2021-02-16 | headache, fatigue, fever |
Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101...
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Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101 - 2 days headache - 5 days nausea - still have diarrhea - 6 days Sore and stinging left arm (received vaccine), sore upper and lower back and neck. Felt like I was kicked in those areas - still have Fatigue - 6 days, lessening Toes bright red at the top and are painful, areas on bottom of toe as well - still have
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| 61 | 2021-02-16 | fever, headache, chills |
Sore arm started about 6 hours after the vaccination and lasting about 24 hours. Fever, chills, sev...
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Sore arm started about 6 hours after the vaccination and lasting about 24 hours. Fever, chills, severe body aches, severe headache lasting about 9 hours starting at midnight following the vaccination.
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| 61 | 2021-02-16 | throat irritation |
I received my first dose at 9:50am on February 3, 2021. Approximately 15 minutes after the first vac...
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I received my first dose at 9:50am on February 3, 2021. Approximately 15 minutes after the first vaccine dose was given (10:05am) I began to get an itchy throat along with an allergic type cough. The cough went away in about an hour but I still had the itchy throat off and on throughout the afternoon. I called my Primary Care provider and she recommended I take 25mg of Benadryl every 6 hours and to call 911 if my symptoms got worse. I took the recommended doses at 5:10pm and 11:15pm that day and all symptoms resolved. I had no symptoms the following day and did not take any Benadryl the following day. I would like to note that I was sent outside the building immediately after the vaccine to wait for the 15 minutes because they could only have 20 people in the room, so there was essentially no monitoring if my symptoms would have gotten worse. We drove to the ER and just sat in the parking lot to be sure the symptoms were not progressing. I am still waiting to see if it is recommended that I receive the second dose of the vaccine. At my provider's recommendation, I am seeing an allergist tomorrow to further discuss.
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| 61 | 2021-02-17 | influenza like illness |
This is a spontaneous report from a non-contactable consumer. A 61-year-old female patient (not preg...
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This is a spontaneous report from a non-contactable consumer. A 61-year-old female patient (not pregnant, age at vaccination reported as 61-years-old) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration (left arm), on 02Feb2021, at single dose, for covid-19 immunization. Medical history included sulfa allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), for covid-19 immunization. The patient felt flu like symptoms the day after the second vaccination dose on 03Feb2021. Symptoms have resolved on the second day after vaccination. The patient recovered from the adverse event on 04Feb2021. No treatment was received for the adverse event. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination. No follow-up attempts are possible; information about the lot/batch number cannot be obtained.
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| 61 | 2021-02-18 | chills, fever |
Over a 3 day period, I had chills, fever, entire body aches (I could barely move), nausea, EXTREME l...
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Over a 3 day period, I had chills, fever, entire body aches (I could barely move), nausea, EXTREME labored breathing. Symptoms were more severe than the actual covid virus I had.
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| 61 | 2021-02-18 | headache, throat pain |
Thursday February 4th I had Severe Headache, Earache, low grade temp, sore throat then by the Tuesda...
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Thursday February 4th I had Severe Headache, Earache, low grade temp, sore throat then by the Tuesday the 9th I noticed drooping to the right side of my face. Went to the ER and was told it was bells palsy
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| 61 | 2021-02-18 | fever |
Around 1 am on 1/29/2021, hot flashes, fever 99, & a little bit nauseas this lasted 48hrs. My legs f...
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Around 1 am on 1/29/2021, hot flashes, fever 99, & a little bit nauseas this lasted 48hrs. My legs felt weak & shaky legs and fuzzy head. I feel with no energy. This symptoms are still going on.
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| 61 | 2021-02-21 | body temperature increased, chills, fatigue |
2/10/21: Woke up with chills, no fever @5:15am, back to sleep, Temp 99.3F at 10:05am, Tylenol at 10...
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2/10/21: Woke up with chills, no fever @5:15am, back to sleep, Temp 99.3F at 10:05am, Tylenol at 10:50am, Temp 100.3F at 5:15pm Temp 101.3F at 9:10pm and took tylenol and regular medications, Temp 100.6F at 10:55pm and went to sleep. 2/11/21: woke up with temp 98.7 at 10:00am, had body aches, red and feverish area where vaccine was given in upper left arm. The red, itchy and feverish area about 3 inches x 2 inches on upper left arm lasted about 5 days, also got a lump under left arm that lasted about 6 days and all of these went away by 2/17/21. But I've had more fatigue, and shortness of breath since this 2nd vaccine. Misses my doctor appointment on 2.17/21 due to the winter storm, not going anywhere , we were having all last week.
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| 61 | 2021-02-21 | headache |
patient reported: Mild headache after the vaccine, Headache resolved after 1-2 d After 2 days of va...
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patient reported: Mild headache after the vaccine, Headache resolved after 1-2 d After 2 days of vaccine she started feeling right leg heaviness (whole leg) , she was dragging when she walks But no visible swelling, pain, redness per patient, She states at that time she was able to stand and move leg fine but only when she walks she needed to drag No facial weakness , upper extremities symptoms . Had slurry speech intermittent for 1 week after vaccine (Currently none) Lasted for 2 weeks, then resolved completely. after that no symptoms at all. Now Waking fine, no facial weakness, no extremities weakness She did not call us at that time as she thought it is side effect of covid vaccine and thought it would go away. When she went for covid vaccine #2, they said she needs to contact primary care physician due to some symptoms after first vaccine,. then she called us for an advise. by the time she called, no symptoms of neurology. MRI brain: did not show any abnormalities Discussed with local Infectious disease specialist: not sure those were vaccine related or not, recommended to report.
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| 61 | 2021-02-22 | chills, headache, malaise | Severe dizziness, severe headaches, chills, muscle aches, malaise |
| 61 | 2021-02-22 | chills, upper-airway cough syndrome, throat pain, headache |
Right side upper arm ache spread to right side of neck and into headache at back and top of skull. ...
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Right side upper arm ache spread to right side of neck and into headache at back and top of skull. Persisted through night and spread down into right side of neck to left arm ache. Throat became red and right, then left side of tonsil became pus filled. Chills but no fever. Fatigue every day. Took 2-3 hour naps every couple of days and slept 8-10 hours through the nights. Headache off and on for 10 days. Throat remained red, becoming most sore late afternoons, voice hoarse. On and off drippy nose. On the 13th day I felt normal energy level in the morning but today, my 15th day at nearly 3pm, my normal energy is waning and throat becoming sore again.
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| 61 | 2021-02-22 | headache, chills, fatigue | nausea, vomiting, headache, tired, chills, pain in injection site |
| 61 | 2021-02-23 | fatigue, dehydration |
Extreme lower stomach pain; Could not move for 3 days; dehydration; fatigue; speech issues; This is ...
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Extreme lower stomach pain; Could not move for 3 days; dehydration; fatigue; speech issues; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location/vaccination location: arm left) on 29Jan2021 13:30 at SINGLE DOSE for COVID-19 immunisation. Medical history included bad back, penicillin allergy, and covid prior vaccination all from unknown dates and unknown if ongoing. The patient has not had other vaccine in four weeks. Patient was not pregnant. Concomitant medication included oxycodone hydrochloride (OXYCONTIN). The patient experienced extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues (all events assessed as serious - disability) all on 05Feb2021 17:00. Patient's clinical course is as follows: One week after the shot, patient had extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues then continued for 2 more days. No treatment was provided for the events. It was reported that patient was COVID tested post vaccination. The patient underwent lab tests and procedures which included nasal swab with result of negative on 20Jan2021. Facility type vaccine was reported as nursing home. Outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 61 | 2021-02-23 | headache, cough |
Covid 19 Vaccine screening questionnaire reviewed , administered Covid vaccine; patient developed co...
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Covid 19 Vaccine screening questionnaire reviewed , administered Covid vaccine; patient developed coughing spells, non productive after 2-3 minutes after the vaccine administration, she states she felt like fainting. Lung sound checked - no wheezing. Pulse Oximetry checked 96%. Observed for 30 mins in the field. Intermittent coughing still noted. Pulse oximetry remained 96%, no shortness of breath or difficulty breathing. After 3 0 mins, patient continue to cough , states she feels tickles in her throat that makes her cough and she has a headache. Patient given Benadryl 25 mg p.o. and monitored for 30 mins. Patient felt better after 25 mins of observation and minimal coughing , pulse oximetry @ 96-98% denies SOB or difficulty breathing . Patient sent home with husband and advised to rest at home and call 911 if she develops SOB or difficulty breathing. Followed up call over the phone at 5: 00 PM , patient states she fell asleep when she went home and no cough , no SOB or difficulty breathing.
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| 61 | 2021-02-23 | headache |
Received first COVID vaccination at 3:50pm and 5-10 minutes later began to experience pain and throb...
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Received first COVID vaccination at 3:50pm and 5-10 minutes later began to experience pain and throbbing in jaw and lower molars. pain began moving forward. tongue began to tingle and mouth went numb. Glands were swollen and pain was experienced in both ears, under both eyes and cheek bones. Also experienced pain in the top and back of head.
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| 61 | 2021-02-23 | headache | 1. Facial numbness 2. Nausea 3. Pain in back of neck 4. Headache |
| 61 | 2021-02-24 | fatigue, influenza like illness |
Had my 2nd vaccine 1/28/21. On 2/3/28, I has rashes, redness & itchiness upper chest. On 2/5/21, My ...
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Had my 2nd vaccine 1/28/21. On 2/3/28, I has rashes, redness & itchiness upper chest. On 2/5/21, My lymph nodes right neck is swollen, also painful mass around 2x3cm below right clavicle near the sternum. I also have flu-like symptoms, body weakness especially lower extremities. Rashes and itchiness upper chest still present. 2/9/21 : Lymph node swelling of right neck & below right scapula still present. Rashes & itchiness upper chest still present but controlled with hydroxyzine tablet. Flu-like symptoms still present. 2/11/21: Rashes & itchiness minimal, less medication needed. Lymph node swelling less, still gets tired easily. 2/19/21: lymph node below right clavicle bigger for 1 day. No more lymph node swelling right neck. Still gets tired easily. 2/24/2021: Lymph node below right clavicle 1x1 in size, not painful.
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| 61 | 2021-02-25 | headache | Headache, bodyaches, dizziness, oral temp 99.0F |
| 61 | 2021-02-25 | throat pain, chills, fever |
chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helpe...
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chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helped. Limited range of motion noted on L arm, could not lift arm ROM more than 30 degrees 12 hours after vaccine still had chills, and fever. Then started to itching on both hands, noticed and uncontrollable itching. Took Benadryl 25mg and feel asleep. hives and itching was gone by the time she woke up. Severe fever and body aches 22 hours after vaccine administration. Temperature was 101.8. Throat felt "sore, with some little difficulty swallowing", took Tylenol 1200mg and Vit C 2000mg and Vit D 10,000 IU and Zinc 100mg. Today, 48 hours after vaccine administration, having systemic hives, and eyes are puffy and swollen, R eye more than left, upper lid is swollen. Took Claritin 10mg and Famotidine 20mg. Hives are better but not fully resolved, but itching is persistent. Still discomfort noted in swallowing.
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| 61 | 2021-02-26 | fatigue, headache, body temperature increased | Headache, slight elevated temperature, tired |
| 61 | 2021-02-26 | fever, fatigue, chills, headache | Extreme chills, fever, body aches, headace, extreme fitigue, swelling and pain at injection site |
| 61 | 2021-02-27 | chills |
Had chills, nausea and ringing in the head/ears about 4 hours after the first shot. The chills and n...
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Had chills, nausea and ringing in the head/ears about 4 hours after the first shot. The chills and nausea stopped by the next morning. But the ringing in my head/ears is still going on. It?s driving me crazy. It?s a high pitch buzzing sound that never stops. At times I feel dizzy and nauseous because of it.
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| 61 | 2021-02-27 | nasopharyngitis, fatigue, headache | cold symptoms, headache, sore arm, fatigue |
| 61 | 2021-02-27 | runny nose, head discomfort, headache |
Pain at the injection site was typical for vaccination and was essentially gone by the next day. Hea...
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Pain at the injection site was typical for vaccination and was essentially gone by the next day. Headache started within one hour after vaccination and was severe 4 hours after vaccination. Next day morning I woke up with all my face swollen, runny nose, headache, stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year and dizziness. Face edema and runny nose subsided 3 days after injection. Stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year persists 7 days after injection. Dizziness and foggy head became worth 7 days after injection.
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| 61 | 2021-02-28 | headache |
Nothing too horrible... Nasseau periods, and diarrhea for 2 days, slight headache. I took some pept...
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Nothing too horrible... Nasseau periods, and diarrhea for 2 days, slight headache. I took some pepto bismol today. Hope it helps. I am still not sure if these are due to the vaccine or not?
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| 61 | 2021-02-28 | fever, headache, chills |
arm/joint pain, vomiting chills low grade fever overnight, headache. Severe pain in shoulders, hips ...
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arm/joint pain, vomiting chills low grade fever overnight, headache. Severe pain in shoulders, hips and lower back lasted 3 days. lymph nodes in armpits very sore. headache lasted 2 days. vomiting lasted 8 hrs. fever(99-101) lasted 2 days. had 3 minor breathing incidents which was alleviated by using rescue inhaler(albuterol) Called in to Health Service and messaged primary care, was advised to take advil, tylenol, lots fluids and get tested for COVID19.
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| 61 | 2021-02-28 | fever |
Localized rash; High fever; Nausea; Vomiting; Dizziness; Rapid heart rate; it was after the shot, if...
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Localized rash; High fever; Nausea; Vomiting; Dizziness; Rapid heart rate; it was after the shot, if she pressed where the injection was it is still a little sore; She called in sick last week; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiration date not provided), via an unspecified route of administration in the right arm on 19Jan2021 13:30 at a single dose for COVID-19 vaccination. Medical history included Blood pressure high diagnosed a couple years ago. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) for COVID-19 immunization on 29Dec2020 and unspecified flu shot last fall, she thinks in Sep or Oct2020, but she has never had problems with those. Concomitant medications included unspecified medications. The patient called and said she had reaction to the Pfizer COVID-19 vaccine 12 hours after her second dose and wanted to report it. She said also this past weekend, on Sunday, on 24Jan2021, she started to develop a localized rash that has like a border to it. She added that she got her second dose of the COVID-19 vaccine on 19Jan2021 at about 01:30 PM in her right arm. She said that she woke up the next morning, 20Jan2021 at 03:00 AM with a high fever, nausea, vomiting, dizziness, and rapid heart rate. She said that the high fever that started the temperature she took was 103 initially, she says she took paracetamol (TYLENOL) and it came down to 101, and the next day it was probably 100 most of the day, then it broke that evening. She said the Tylenol, the dose was the extra strength, unknown if it was 500 mg, they were capsules. She says she normally doesn't keep it around, the in-house nurse suggested it so she went and got a sample thing and took a couple doses, she doesn't have it with her as she is at work and is not at home. She said that the nausea and vomiting subsided after the first day or second day, she had the on and off fever and slept most of the day both days. She said that she doesn't have a fever now. She said that she doesn't have her exact heart rate from when she was having the rapid heart rate, she just felt it in her chest. She added that the only reason she said anything was because she called in sick last week on an unspecified date in Jan2021. She said that the rash started developing after that and it is now probably the size of a 16 oz or 60 oz cup, unable to clarify number with caller, she said that it is definitely big but it doesn't bother her, though she is concerned it is there. She clarified that it is a couple inches in diameter and kind of looks like the state of (State Name), on her injection arm which was her right arm. She said her arm is not sore now, it was after the shot on an unspecified date in Jan2021, if she pressed where the injection was it is still a little sore. She said that the hospital said to report it. She said she also has a concern if she should she get another shot if they decide this is needed for more than two vaccinations. She said that she knows they are still gathering information at this point, so she thought she should better turn in, hopefully there will be solution later on. The outcome of the events localized rash, dizziness, heart rate increased and sickness was unknown. The outcome of the events fever, nausea and vomiting was recovered on an unspecified date in Jan2021 while the outcome of the event vaccination site pain is recovering.
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| 61 | 2021-02-28 | sleepiness | Rash, itchy around neck, hot, weak, drowsy, evaluated by EMS-transported to nearest ER |
| 61 | 2021-03-01 | chills, fatigue, headache, fever, sinus congestion |
Chills and headache beginning 10 pm of the day of injection, followed by fever, nausea, body aches, ...
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Chills and headache beginning 10 pm of the day of injection, followed by fever, nausea, body aches, sinus congestion soon thereafter and extreme fatigue. Aleve (2 tablets) at 7 am the next morning with little, if any, relief but perhaps prevented it from becoming worse and another at 2:30 am on Monday morning (the second day). Slept, although not always well, for the better part of 32 hours, with less than 3 hours of being awake and up, trying to eat little. Was able to make it through a nine hour shift on Monday, still with no appetite and a bit off (attributed to not being truly rested despite 32 hours in bed).
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| 61 | 2021-03-01 | fatigue, throat pain, chills |
on 01/14.21, The patient had the chills and fatigue. On 1/17/21, The patient developed severe right ...
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on 01/14.21, The patient had the chills and fatigue. On 1/17/21, The patient developed severe right ear pain and right sore throat. On 1/19/21, developed multiple painful sores on the right side of the hard palate. On 1/20/21, the ulcers in the month got worse. Started on Valtrex. On 1/24/21, the patient felt better but the pain and sore throat returned on the 1/26/21.
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| 61 | 2021-03-01 | fatigue, fever, headache, chills |
Fever, chills, body aches, nausea, pain at injection site, extreme fatigue, headache. Also on 2/8 ha...
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Fever, chills, body aches, nausea, pain at injection site, extreme fatigue, headache. Also on 2/8 had a Shingles rash for which I consulted a dr and was treated
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| 61 | 2021-03-01 | fatigue |
I woke and I felt exhausted - like I would have to resign from work that day - that's how exhausted ...
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I woke and I felt exhausted - like I would have to resign from work that day - that's how exhausted I was. At 6:00 pm, I felt like I had energy. And from then on - I felt like my body had been reset - like I had more energy. (Until the second dose of the vaccine.)
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| 61 | 2021-03-01 | headache, fatigue |
Moderate fatigue - unresolved mild headache - unresolved diarrhea - resolved 2/19/2021 joint pain - ...
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Moderate fatigue - unresolved mild headache - unresolved diarrhea - resolved 2/19/2021 joint pain - resolved 2/22/21 increased blood pressure - resolved 2/19/2021 swollen eye lids and upper checks - resolved 2/22/2021
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| 61 | 2021-03-02 | chills, headache, fever |
pt states that she developed a head ache, chills, fever and sore arm. Pt took Advil to alleviate the...
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pt states that she developed a head ache, chills, fever and sore arm. Pt took Advil to alleviate the pain and her reaction lasted around 24 hours . The symptoms had subsided by 2 PM the next day.
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| 61 | 2021-03-02 | chills, fever |
Fever 102.1; Chills; achy; This is a spontaneous report from two contactable healthcare professional...
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Fever 102.1; Chills; achy; This is a spontaneous report from two contactable healthcare professionals. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) at the age of 61 years, intramuscular on the left arm on 27Jan2021 16:15 at a single dose for COVID-19 immunization. Medical history included high blood pressure, COVID-19 and allergies to quinolones. The patient's concomitant medications were not reported. The patient is not pregnant. The patient previously took celecoxib (CELEBREX) and experienced allergies. The patient experienced fever 102.1, chills and achy on 28Jan2021 08:00. The patient did not received any treatment for the events. The outcome of the events was not recovered.
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| 61 | 2021-03-02 | fatigue, headache |
mild persistent headache all symptoms are mild flush...
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mild persistent headache all symptoms are mild flushed face tired lack of appetite/ food tastes different rash
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| 61 | 2021-03-02 | fatigue |
As soon as injection I got a horrible taste in my mouth then wi seconds my heart rate increased then...
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As soon as injection I got a horrible taste in my mouth then wi seconds my heart rate increased then some shortness of breath, that lasted less then a minute approx 5 minutes later a bad headache started then I felt extremely tired the headache lasted about 5 minutes the tired about 15. Nothing was needed everything got better on its own.
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| 61 | 2021-03-02 | headache |
First headache, vertigo, dizziness, nausea, neck tension, left arm weakness. Progressed in the cours...
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First headache, vertigo, dizziness, nausea, neck tension, left arm weakness. Progressed in the course of several weeks to both legs weakness, and then the right arm, tension in the jaw and the face (altered facial sensation). Poor balance. Symptoms continue getting worse. Unable to work.
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| 61 | 2021-03-02 | headache |
Pt received vaccine and was being monitored following receipt. After ~30 minutes, developed right si...
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Pt received vaccine and was being monitored following receipt. After ~30 minutes, developed right sided chest pressure with shortness of breath. Used her inhaler, which helped with shortness of breath. EMS was called and patient was transported to the ED where she also endorsed a headache. EKG showed some ST depression with T-wave inversion that was not present in 2008. Patient was monitored for a few hours - had 2 negative troponins and repeat EKG and was discharged home.
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| 61 | 2021-03-02 | headache | Severe headache and body pain |
| 61 | 2021-03-03 | chills |
Patient had moderate reaction to COVID-19 first dose vaccination. Tachycardia, lightheadedness, chil...
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Patient had moderate reaction to COVID-19 first dose vaccination. Tachycardia, lightheadedness, chills, throat discomfort. Patient had improvement with water, O2 and juice. Patient left in wheelchair after 90 minutes of observation with resolution of tachycardia and throat discomfort.. States she had similar reactions to influenza vaccine in past, but did not last that long. We discussed ER evaluation at which patient elected to go home as she had driver and wanted to go home. Patient instructed Benadryl, rest and fluids day of event. 911/ER if worsening symptoms. Patient in agreement to plan.
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| 61 | 2021-03-04 | cough, headache |
still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 wen...
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still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 went to get covid test but due to blood in my nose received antibody test which was neg; bad headache; winded; vomited; diaherra; coughing/cough; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; This is a spontaneous report from a contactable other hcp (patient). A 61-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiry date not reported), via an unspecified route of administration on the left arm on 20Jan2021 18:45 at single dose for COVID-19 immunization. Medical history included diabetes mellitus and high BP from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, losartan potassium and sodium fluoride (CREST CAVITY PROTECTION). The patient previously took septra and experienced allergies. The patient reported that on 21Jan2021, they woke up and brushed their teeth then at 6:40am blood with large clots gushed from their right (rt) nostril. The patient went to ER and stopped bleeding after 2 hrs. On 22Jan2021, the patient woke up with bad headache, winded, vomited, diaherra (as reported), coughing. On 23Jan2021, they went to get covid test but due to blood in their nose, they received antibody test which was negative. On 24Jan2021, the patient was still feeling bad with all the above symptoms. Then on 25Jan2021, they went to ENT doctor who cauterized their nose and stated that since antibody was negative to take the maderna vaccine since they have no antibody in their system, the Pfizer vaccine did not work. From 26Jan2021 to 13Feb2021, the patient felt same started feeling better 14Feb2021 but still have sore muscles in their shoulders and cough. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 23Jan2021. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of epistaxis and clot blood which include the doctor cauterized their nose. The patient recovered with sequel from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the epistaxis and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including CBC and coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 61 | 2021-03-04 | headache, fever |
Slurred Speech, fever, aches, feet and hand swelling, confusion, headache, memory loss - mostly reso...
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Slurred Speech, fever, aches, feet and hand swelling, confusion, headache, memory loss - mostly resolved some memory issues and headache still 2 days later
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| 61 | 2021-03-05 | runny nose, cough |
Immediately after I got the shot, My nose started running and. Lips felt big and tingling. ( MD d...
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Immediately after I got the shot, My nose started running and. Lips felt big and tingling. ( MD did not see visible swelling). And roof of mouth was numb, throat felt like it was closing up, Started getting hoarse, chest tightening. MD gave me 25mg Benadryl and after 30 minutes starting relaxing, Coughing up phlegm. My left arm was very sore and swollen like a lemon... Today. My lip feels kind of burning (like pre herpes outbreak). and roof of my my mouth is still numb. I noticed that I lost sense of taste completely!
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| 61 | 2021-03-05 | throat irritation, headache, cough | Coughing, itchy throat, headache. BP 150/92, pulse 68. Given Benadryl 25 mg PO. |
| 61 | 2021-03-06 | headache, fatigue, chills | Chills, fatigue, nausea, body aches, headache |
| 61 | 2021-03-07 | fatigue, sleepiness | TIRED, DROWSY. EVALUATED BY EMS- CLEARED |
| 61 | 2021-03-07 | headache, fever |
arm soreness at injection site (both vaccines); fever <100.6F x 24 hours; delayed headache x 3 days;...
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arm soreness at injection site (both vaccines); fever <100.6F x 24 hours; delayed headache x 3 days; enlarged left breast lymph nodes; This is a spontaneous report from a contactable health care professional (patient) reported for herself. A 61-year-old non-pregnant female patient (Patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL0140, expiry date: unknown) via an Intramuscular on 28Dec2020 at 12:00 PM (at the age of 61-years-old) on Left arm at single dose and second dose (lot number; EL0142, expiry date: unknown) via an intramuscular route on 19Jan2021, at 08:30 AM on left arm at single dose; both for COVID-19 immunization. Medical history included hypothyroidism and hyperlipidemia. Patient received unspecified concomitant medications (Other medications the patient received within 2 weeks of vaccination (unspecified)). Patient had no Allergies to medications, food, or other products. On an unknown date, the patient had arm soreness at injection site (both vaccines); on 20Jan2021, at 05:00 am, patient had fever less than 100.6 F x 24 hours, delayed headache x 3 days for 3 days, enlarged left breast lymph nodes (routine mammogram/sonogram was 2 days post injecting on left arm). No treatment was received for the adverse events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 25Jan2021, patient underwent nasal swab (SARS-COV-2-BY-NAAT) test and resulted as negative. Seriousness of the events was reported as non-serious. Outcome of the events was recovered on an unknown date in Jan2021.
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| 61 | 2021-03-07 | headache | Seven hours of nausea and vomiting. Also head ache. |
| 61 | 2021-03-07 | fever, fatigue, chills |
Exhausted; Chills; Aches; Fever 100.8; Nausea; This is a spontaneous report from a contactable nurse...
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Exhausted; Chills; Aches; Fever 100.8; Nausea; This is a spontaneous report from a contactable nurse (patient). This 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN5318) via an unspecified route of administration in the left arm on 26Jan2021 at 14:00 (at the age of 61-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included hypertension and Hashimoto's disease; the patient was allergic to sulfa and penicillin. Concomitant medications included enalapril, sertraline, lansoprazole (PREVACID) and rosuvastatin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140) on 05Jan2021 at 12:15 in the left arm. On 26Jan2021 at 15:00, the patient experienced exhausted, chills, aches, fever 100.8 and nausea. All the events were considered as non-serious. Corrective treatments taken as a result of the events included paracetamol (TYLENOL) and she went to bed-slept for 14 hours straight. The patient recovered from the events on an unspecified date. The patient had not COVID-19 prior to vaccination and she was not tested for COVID-19 post vaccination.
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| 61 | 2021-03-08 | chills, fever, headache |
Day after 2nd vaccine had aching in all joints, chills with low fever, headache lasting 24-48 hours....
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Day after 2nd vaccine had aching in all joints, chills with low fever, headache lasting 24-48 hours. Hip pain continues worsening with walking and standing over time. Hips started to ache after first vaccine but didn't realize it was attributed to vaccine. Started taking fish oil and Glucosamine tabs for joints. Hip pain after 2nd vaccine increased and continues today. Went to Internal Medicine clinic to be seen on 1/25/2021. Xrays, UA, ANA, CBC and CMP were done. Xrays show mild degenerative changes to hips bilaterally. ANA elevated at 2.1. Everything else within normal limits. Physician then added RA, C- Reactive Protein and Sedrate, all coming back WNL. Will be making appointment with Rheumatoidologist.
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| 61 | 2021-03-08 | headache | nausea, headache |
| 61 | 2021-03-08 | throat pain, fatigue |
Tongue swelled and then went numb - like novacaine had been shot into it, throat swelling by 6 PM, t...
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Tongue swelled and then went numb - like novacaine had been shot into it, throat swelling by 6 PM, took a big swig of Benadryl, went to Fire station, transported by ambulance to ER, blood pressure got way too low on ambulance ride, difficulty breathing/taking air in, IV applied - hospital by 6:30 PM, breathing still difficult, blood pressure better until it dropped again, IV given and monitored. Stable and discharged around midnight. Friday - Tuesday - very tired, heavy arms and legs, sore throat and tongue, limited to soft, bland. foods.
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| 61 | 2021-03-08 | fever, chills, fatigue, headache |
Tiredness, fatigue, headache, nausea, chills, fever. Starting about 9:PM on 02/27/21 continuing all ...
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Tiredness, fatigue, headache, nausea, chills, fever. Starting about 9:PM on 02/27/21 continuing all the next day 02/28/21. Still had a slight headache on 03/01/21.
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| 61 | 2021-03-08 | throat clearing |
Rapid heartbeat, flushing, tingling of whole body like an adrenaline rush, felt like my blood was on...
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Rapid heartbeat, flushing, tingling of whole body like an adrenaline rush, felt like my blood was on fire. Hoarse voice and constant clearing of throat due to production of phlegm in throat. Tingling lips and tongue. This continued all day until I took 10 mg of prednisone. Within 3 hours, all symptoms were gone. Slept well all night. The next day (Wednesday) I felt fine. Slept fine Wednesday night. Thursday morning, all of the above symptoms returned. I took 5 mg prednisone, which didn?t alleviate symptoms so I took an additional 5 mg. I also took 2 Benadryl. Symptoms went away. Slept well Thursday night. Friday morning they returned. I had a doctor?s appointment scheduled (new patient visit) which I canceled as the office told me to go to the ER at the hospital where I got my shot. By the time I got to the ER, my symptoms had subsided. The ER doctor gave me 60 mg of prednisone, 1 famotidine, Benadryl.
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| 61 | 2021-03-09 | chills, headache, fatigue | Sore arm and neck muscles, headache, chills, and fatigue |
| 61 | 2021-03-09 | headache |
1.5 days after vaccine, lost sense of taste and most smells. I had a bad headache that day and slig...
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1.5 days after vaccine, lost sense of taste and most smells. I had a bad headache that day and slightly less on Saturday. I was told to get a covid test which I did Saturday morning. I received the results of negative on Sunday the 6th. Today is the 10th, one week after the vaccine, and still no taste. I met by phone with my Dr. , and she said to report it as a side effect to the vaccine.
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| 61 | 2021-03-09 | headache |
Headache; Arm sore; This is a spontaneous report from a contactable consumer (patient). This consume...
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Headache; Arm sore; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (reporter and reporter's husband). This is the first of two reports. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9269 and expiry date: unknown),via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunization. Medical history included diabetic and high blood pressure. Concomitant medication included metformin and, hydrochlorothiazide, losartan potassium (HYZAAR). Patient got the vaccine on 04Feb2021, last Thursday and the effects have not been bad, it was just arm sore on the same day. She did not have any headache but yesterday on 06Feb20021, she had a headache. No treatment was received for the events. The second dose was scheduled on 25Feb2021. Outcome of the events was recovered on Feb2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021174383 same reporter, vaccine, different patient and event
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| 61 | 2021-03-10 | chills, headache, fever |
Begin 4 days after first vaccine on 3/9/2021- First significant increase in thirst; Extreme chills ...
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Begin 4 days after first vaccine on 3/9/2021- First significant increase in thirst; Extreme chills and fever rapidly spiking to 101.5; decrease to about 100 after a few hours and held steady through early morning; decreasing to my normal (97''s) next day; Significant headache from below forward head to left and right side of neck (eustachian tubes and mandibles and lymph nodes) eye pain; vomiting (limited); leg muscle pain/. No injection site reaction 3/11 feel great
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| 61 | 2021-03-10 | headache |
I am on infusion for severe psoriatic arthritis, and was doing well. Two days after injection it was...
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I am on infusion for severe psoriatic arthritis, and was doing well. Two days after injection it was as if the effects of my infusions were cancelled. Extreme widespread stiffness, pain, joint swelling and heat, muscle weakness and pain. I also had swollen lower lip and have had an increase in headaches and nausea. Two weeks after the injection I awoke with my right arm swollen, hard, and itchy. The arm and my lips have resolved, but I am still having all the other problems. I have reported these symptoms to both my primary doctor and my rheumatologist.
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| 61 | 2021-03-10 | headache |
Slight headache and moderate arm pain ; both arm pain and headache gone by next morning; this is fo...
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Slight headache and moderate arm pain ; both arm pain and headache gone by next morning; this is for reporting purposes only; no care needed; all side effects abated in a reasonable time period.
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| 61 | 2021-03-10 | sweating, fatigue |
I had hallucinations. I thought it was vivid dreams but I could not wake myself. I even went to bath...
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I had hallucinations. I thought it was vivid dreams but I could not wake myself. I even went to bathroom three times during the night and could not stop them while getting up and walking to bathroom. I would sit up in bed and even get out of bed but they would not stop. I?ve never had this happen ever in my life. I was crying out and sweating. I have also had severe fatigue, even much more than what I experience with CFS.
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| 61 | 2021-03-10 | fever, fatigue |
After 1st dose : Fatigue/tiredness/lack of energy for 1 day. After 2nd dose: Fever of 101 - 102.6...
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After 1st dose : Fatigue/tiredness/lack of energy for 1 day. After 2nd dose: Fever of 101 - 102.6 for 3 days. Hips achy. I have a total knee replacement of my R knee. That became warm to touch, painful and very stiff. The knee surgery was 3 years ago. I was prescribed MOBIC for the knee by my surgeon when I reported the issue.
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| 61 | 2021-03-10 | throat irritation |
Patient received first Pfizer COVID vaccine and in observation area started complaining of scratchy ...
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Patient received first Pfizer COVID vaccine and in observation area started complaining of scratchy throat. Exam was normal. Calm patient, clear lungs, strong pulse. No rash. Gave positive answers to all questions, such as do you itch 'a little,' do you have trouble breathing 'a little.' I suspect anxiety. Given Benadryl and continued monitoring. All symptoms resolved. Observed total of 45 minutes and discharged home. Ok for next vaccine.
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| 61 | 2021-03-11 | chills, malaise, headache, fatigue |
Monday 3/08/21 after work, I was very tired and achy. I went to bed and slept 10 hours. When I eat I...
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Monday 3/08/21 after work, I was very tired and achy. I went to bed and slept 10 hours. When I eat I had diarrhea. On Tuesday, no appetite. Ate very little - crackers, and some chicken noodle soup. I had headache and chills on Tuesday evening, Wednesday and Thursday. I didn't feel well at all. Lightheaded Thursday morning, another diarrhea after a small breakfast. Called my doctor, suggested a covid test. Had a rapid covid test. It was negative. Teleconference call with my doctor on Thursday at 3pm. Nose bleed Friday morning 11:00am.
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| 61 | 2021-03-11 | chills, fever, headache | Shaking chills, high fever, severe body aches, nausea, diarrhea, vomiting, massive headache |
| 61 | 2021-03-11 | headache, fatigue, chills |
February 25, 2021 approximately 9:30 am: Approximately 5 minutes after receiving vaccine had a stro...
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February 25, 2021 approximately 9:30 am: Approximately 5 minutes after receiving vaccine had a strong medicine taste in throat. Lasted 45 minutes - 1 hour. Approximately 9:55 am slight feeling of throat closing, which lasted about 45 minutes. Approximately 10:00 am headache, which lasted until approximately 4:00 pm, February 26, 2021. Arm soreness evening of February 25, 2021 lasted approximately 2 weeks. February 26, 2021 approximately 6:00 am diarrhea, headache, chills, legs aching, and fatigue, which lasted until until approximately 4:00 pm.
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| 61 | 2021-03-11 | headache |
I got my shot on March 5 and on March 9 I woke-up with super bad headache and vomited many times the...
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I got my shot on March 5 and on March 9 I woke-up with super bad headache and vomited many times the morning of the 9th. My headache pain was an 8 out of 10 from March 9 to March 11 and remained super nauseous. I got some anti nauseous medicine from the doctor. On March 12, I woke-up perfectly well. This headache and nauseousness felt like my usual reaction to soybean ingestion. I normally have a delayed reaction when I ingest soy bean. Normally, if I ingest soybean, i react 7-12 hours later. I am positive that I did not have any soybean before or after my vaccination.
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| 61 | 2021-03-11 | sweating |
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo...
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Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
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| 61 | 2021-03-11 | fever, headache, chills |
Chills, severe body aches - 11pm thru the next day, nausea - 230 am, and vomiting - 6am until 9pm,...
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Chills, severe body aches - 11pm thru the next day, nausea - 230 am, and vomiting - 6am until 9pm, fever - 530pm-939pm , headache and extreme fatigue - all day and into the next day (3/7)
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| 61 | 2021-03-11 | throat irritation |
Shortly after receiving vaccine, patient began to experience shortness of breath and throat itching/...
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Shortly after receiving vaccine, patient began to experience shortness of breath and throat itching/tightness.
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| 61 | 2021-03-12 | chills |
Received Pfizer vaccine at the Hospital on March 12, 2021 at 10:05 a.m. No reaction at that time. O...
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Received Pfizer vaccine at the Hospital on March 12, 2021 at 10:05 a.m. No reaction at that time. One hour later my ears and scalp began to itch. I had chills and severe nausea. Severe stomach cramping. Rash covering arms, legs, scalp, back and shoulders, Hives across chest and down both arms. Swelling and hives on palms of hands. Difficulty breathing. Symptoms began one hour after vaccine and continued to worsen. Was treated at Center for allergic reaction. Was given Benedryl and Famotadine, then released.
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| 61 | 2021-03-12 | cough | within one minute, cough, wheezing, SOB resolved with inhaler. no EPI pen necessary |
| 61 | 2021-03-12 | fever, headache, fatigue | Dark, granular diarrhea w unusual, intense odor Fever Fatigue Headache |
| 61 | 2021-03-12 | fever |
Metallic taste in mouth that subsided the next morning. Sore arm for 3 days Slightly feverish on and...
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Metallic taste in mouth that subsided the next morning. Sore arm for 3 days Slightly feverish on and off for the first 2 days All of the above were relatively mild
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| 61 | 2021-03-13 | chills, headache, fever | Low grade fever, chills, body aches, intense headache , excruciating eye pain and my hair hurt |
| 61 | 2021-03-13 | fatigue, chills, headache |
Around 12;00pm on 3/13 , I felt muscle aches through back, shoulders, neck. Sore at site of vaccin...
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Around 12;00pm on 3/13 , I felt muscle aches through back, shoulders, neck. Sore at site of vaccine and Headache. I felt tired and rested around 1:00p.m. Took 1 extra Strength Tylenol. Then started getting chills. Felt like I had swollen lymph node on ride side of throat when swallowing and had some pain going up into my ride ear. These symptoms lasted all evening. I didn't feel like eating dinner so rested and took 2 extra strength Tylenol at 9:00 p.m. and went to bed. Woke up early in morning with bad headache so I took another 2 extra strength Tylenol around 6:00am. I finally started feeling better around 9:00am.
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| 61 | 2021-03-13 | headache, chills, fever, fatigue |
Everyday since vaccination fever of 99.5 (no higher ), chills, headache, extreme tiredness (sleeping...
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Everyday since vaccination fever of 99.5 (no higher ), chills, headache, extreme tiredness (sleeping 15-18 hours per day)
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| 61 | 2021-03-13 | headache | mild headache mild rash on the chest |
| 61 | 2021-03-13 | fever | 102 fever, severe left arm pain, weakness |
| 61 | 2021-03-14 | chills |
8 days after vaccine, developed burning sensation of skin which has changed locations in upper and l...
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8 days after vaccine, developed burning sensation of skin which has changed locations in upper and lower extremities. Lasts hours at a time and changes location. Also developed diarrhea, vomiting, body aches, chills 8 days after the vaccine.
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| 61 | 2021-03-14 | fatigue, chills, headache, malaise, fever |
Pfizer-BioNTech COVID-19 Vaccine EUA. injection site pain, tiredness, headache, muscle pain, chills...
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Pfizer-BioNTech COVID-19 Vaccine EUA. injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell
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| 61 | 2021-03-14 | fatigue, chills |
Tacycardia and shortness of breath, followed by chills. Duration of 10 minutes until resolved. Subs...
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Tacycardia and shortness of breath, followed by chills. Duration of 10 minutes until resolved. Subsequent abdominal pain with mild diarrhea and then extreme fatigue for 5 hours. Similar to a food allergy reaction
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| 61 | 2021-03-14 | headache, fatigue, chills |
9:00 p.m extremely tired, no energy, head ache body aches. Cold chills then hot. Weak thru Monday 3...
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9:00 p.m extremely tired, no energy, head ache body aches. Cold chills then hot. Weak thru Monday 3/15/2021 feeling better , just still feeling tired.
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| 61 | 2021-03-14 | headache, fever, chills |
Had severe headache, chills, fever, whole body aches, joint pain, swollen arm, very hard lump and ho...
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Had severe headache, chills, fever, whole body aches, joint pain, swollen arm, very hard lump and hot at injection site. All this started the day after injection .so severe that it felt like I had covid AGAIN! Couldnt eat or hardly get out of bed the day after shot and the second day after the shot I still felt the same but was able to eat . The third day after shot, my fever went away and most of the body aches except I still have the headache and my arm is still hot, and swollen. Just have been taking tylenol this whole time and cold wash cloth for fever and swelling.
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| 61 | 2021-03-14 | headache, sleepiness, fever, fatigue |
Friday evening I was tired and slept a lot. When I woke up on saturday I had pain in my muscles and ...
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Friday evening I was tired and slept a lot. When I woke up on saturday I had pain in my muscles and neck and in my shoulders. I was not hungry and I had a fever(101.2). I slept until 1pm and I started getting nauseous. I never got up off the couch saturday. Pain in left arm/shoulder blade went away around 5pm Saturday. I still had a slight fever and headache saturday evening. Sunday I felt better but I still had a slight fever and headache but felt generally much better. Monday I had no fever no headache, and a little aching in my right arm at the injection site.
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| 61 | 2021-03-14 | sweating |
Patient became sweaty, unresponsive, and felt dizzy. Patient was given orange juice and had her plac...
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Patient became sweaty, unresponsive, and felt dizzy. Patient was given orange juice and had her place her head between her legs to increase blood flow. EMS was called.
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| 61 | 2021-03-14 | fever, fatigue, influenza like illness, headache, chills |
Sore left upper arm by 5pm, 3-13-21. Very tired, muscular aches whole body, chills/feverish, headach...
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Sore left upper arm by 5pm, 3-13-21. Very tired, muscular aches whole body, chills/feverish, headache overnight to present, nausea. abdominal cramping and diarrhea x 2 days. Feels like 'the flu'.
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| 61 | 2021-03-14 | sluggishness |
Constriction of throat followed by heaviness in chest, followed by a headache. Had distress but was ...
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Constriction of throat followed by heaviness in chest, followed by a headache. Had distress but was afraid to say something. hands tingling fingers both hands. NOT hyperventilating. Oriented but sluggish to respond to questions. initially elevated bp then hypotensive. after leaving vaccine clinic throat felt like a golf ball and went to ER to seek treatment. DX- allergic reaction and given IV Benadryl, Pepcid and solumedrol.
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| 61 | 2021-03-15 | chills |
nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; ...
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nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.
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| 61 | 2021-03-15 | fatigue |
She also experienced shortness of breath/out of breath; heart out of sync; new heart rhythm abnormal...
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She also experienced shortness of breath/out of breath; heart out of sync; new heart rhythm abnormality; she has heart rhythm problem (premature atrial contraction); feeling exhausted; This is a spontaneous report from a contactable Nurse (patient). A 61 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3249), via an unspecified route of administration on 19Jan2021 (at the age of 61 -years-old), single dose for COVID-19 immunization. Medical history included covid infection over a year ago. The patient had no concomitant medicines were not reported. The patient She had flare ups when she took Hep b vaccine before and did not get the 2 remaining doses because of the reaction. She has had so many vaccines over the years and had her flu shot every year. Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 19Jan2021. Consulted the doctor 01Feb and told she has heart rhythm problem (premature atrial contraction). She also experienced shortness of breath. Not sure if it is vaccine related or due to her age. She will have the 2nd dose on 09Feb2021. Stated that she was feeling exhausted (29Jan2021) and out of breath. Stated that the doctor told her that her heart rhythm out of sync. Stated that in Dec she had her heart checked and it was okay. Stated that her other Covid is due to be given 09Feb. Does not know if the vaccine is contributing to her heart rate's bivalvular rhythm. Stated that she had Covid infection over a year ago. Stated that she is worried that the vaccine caused an abnormal rhythm to her heart. Stated that she has a new heart rhythm abnormality. Stated that she had all of her lab work done on 11Jan2021 and it was okay. Stated that on 27Jan-28Jan that she tried to pick up a watermelon and was short of breath for no reason. Stated that it happened a couple of times. Stated with her rhythm being out of sync that it feels like her heart is failing. The outcome of the event dyspnea was recovered, heart disorder and fatigue was not recovered, other events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported arrhythmia cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 61 | 2021-03-15 | headache, fatigue |
Swelling/pain in Left deltoid at injection site; Mild frontal headache; Fatigue 4 hours after vaccin...
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Swelling/pain in Left deltoid at injection site; Mild frontal headache; Fatigue 4 hours after vaccine Mild frontal headache; Swelling/pain in Left deltoid at injection site; This is a spontaneous report from a contactable nurse (patient). A 61-year-old non-pregnant female patient received BNT162B2 (solution for injection; lot number: EL9264) in left arm, via an unspecified route of administration on 09Feb2021 09:30 am at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included osteopenia, mild depression. The patient had no known drug allergies. The patient concomitant medications included citalopram, ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+). The patient was not diagnosed with covid-19 before vaccination and covid was not tested post vaccination. The patient experienced Swelling/ pain Left deltoid at injection site, fatigue 4 hours after vaccine, mild frontal headache on 09Feb2021 13:00. The patient did not receive treatment for the events. Outcome of vaccination site swelling and pain was recovered on an unspecified date of 2021 and rest of the events was unknown.
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| 61 | 2021-03-15 | pneumonia, lethargy |
Fluid buildup in lungs. Than pneumonia set in.; Fluid buildup in lungs. Than pneumonia set in.; Weak...
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Fluid buildup in lungs. Than pneumonia set in.; Fluid buildup in lungs. Than pneumonia set in.; Weakness; lethargic; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 13Feb2021 (Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) taken for an unspecified indication, start and stop date were not reported. The patient experienced fluid buildup in lungs. than pneumonia set in, weakness and lethargic on 15Feb2021. Therapeutic measures were taken as a result of all the events which includes Medicine and breathing treatments. Outcome of the events was recovering.
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| 61 | 2021-03-16 | chills, fatigue |
Within 10 min I started feeling dizzy, kind of loopy. I didn't think anything of it. I Waited 15 mi...
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Within 10 min I started feeling dizzy, kind of loopy. I didn't think anything of it. I Waited 15 min, got in my car, and felt the need to defecate. Went back in the store, completed, got in my car to drive home. Started to feel even dizzier but kept driving. Felt like maybe I was having a little bit of a strain swallowing but was breathing fine. I took 2 puffs of my Albuterol. Still felt unnatural and anxious. Got home and started to feel a little better within 15 minutes. The arm is sore, not too much of a bother, body aches. Chills for a few hours. Got up and went about my day. Tired and anxious.
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| 61 | 2021-03-16 | headache |
[Vaccinated at another site] -- 24 hrs after first COVID dose, she had several days of dyspnea, trem...
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[Vaccinated at another site] -- 24 hrs after first COVID dose, she had several days of dyspnea, tremors, headache, tachycardia, and hypertension, all without fever.
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| 61 | 2021-03-16 | malaise |
woke up with nausea 36 hours after getting the shot. After vomiting I was able to go back to sleep...
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woke up with nausea 36 hours after getting the shot. After vomiting I was able to go back to sleep. The entire next day I didn't feel well. Weak, slightly nauseous. All the symptoms lasted approximately 24 hours then I was back to normal. In case it matters. I believe I had Covid last February but it was prior to public knowledge and test availability.
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| 61 | 2021-03-17 | chills, headache, fatigue | Headache, chills, muscle soreness, pain at injection site, tired - still lingering |
| 61 | 2021-03-17 | headache | 3/17 Headache -- heart racing -- contact doctor's office and took some meds |
| 61 | 2021-03-17 | headache |
Pt states that 5min after vaccination she developed a headache, her nose was tingling about an hour ...
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Pt states that 5min after vaccination she developed a headache, her nose was tingling about an hour later, she took tylenol and currently 4-5h later her lip is tingling.
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| 61 | 2021-03-18 | chills, headache, fever |
I had significant chills (causing strong body shaking) starting 3 hours after the shot, followed by ...
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I had significant chills (causing strong body shaking) starting 3 hours after the shot, followed by 36 hours of intermittent fever combined with chills, fever was high but not measured. I was very weak and at times was unable to get out of bed or stand. I had significant joint and overall body pain, at times unable to stand up straight. As this subsided about 36 hours I remained quite weak. On the night of 16 March I was woken up at 1 am with a very severe headache. I took Tylenol and 5 hours later still had the headache - it subsided after about 8 hours. I additionally had stomach cramping but no vomiting or diarrhea, and had no bowel movements until the episode cleared up. During the 4 days that this occurred I tried to keep well hydrated but still had quite concentrated strong urine. I took Tylenol periodically throughout the 4 days, not starting until after the injection was administered. I still feel a little loss of balance/brain fog and have recurring headaches (not migranes).
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| 61 | 2021-03-18 | chills, fever | Fever, chills, muscle aches |
| 61 | 2021-03-18 | fatigue, chills, headache |
Immeditely after my first shot on March 7 I felt fine (except some mild soreness at injection site)...
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Immeditely after my first shot on March 7 I felt fine (except some mild soreness at injection site). A full week later, on March 14, I had some mild chills, fatigue, headache, and a red itchy rash. The rash was located on my right inner forearm, my left inner thigh, my lower back and hip area, and my ears. No rash on injextion site arm. I took benadryl and used a topical 1% hydrocortisone cream, and the rash eventually subsided after 5 days.
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| 61 | 2021-03-18 | headache, fever |
Sore arm started within 5 minutes and better after 2 days. Headache & low grade fever within 2 hours...
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Sore arm started within 5 minutes and better after 2 days. Headache & low grade fever within 2 hours and lasted 2 days.
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| 61 | 2021-03-18 | fever |
1. Started Mar 8: Swollen lymph nodes on the right side behind the ear and at the root of sculp. ...
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1. Started Mar 8: Swollen lymph nodes on the right side behind the ear and at the root of sculp. Painful, in 4 days started fading away, in 6 days no pain , in 9 days completely gone. 2. started Mar 9: High Blood pressure - 167/97; was taken Amlodipine ( 2*2.5 mg); in 4 days it stabilized. 3. started Mar 14: Fever, treated with Tylenol taking every 6-8 hours. on Mar 19 temp is normal. 4. on Mar 18 Dr. took blood and urine tests. No sings of any abnormality. Came to conclusion - should be vaccine side-effect, report to.
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| 61 | 2021-03-18 | fever |
fever; This is a spontaneous report from a contactable other health professional. A 61-year-old fema...
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fever; This is a spontaneous report from a contactable other health professional. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) at the age of 61 years old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported stopping medication on 10Feb2021 due to receiving COVID-19 vaccination on 12Feb2021 and then resuming therapy on 15Feb2021. Patient reported fever for 2 days after vaccination on 14Feb2021. The outcome of the event was unknown. Information about lot/batch number has been requested.
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| 61 | 2021-03-19 | chills, headache, fever |
I woke up at 2:30am morning of March 19, 2021 with fever, chills, severe headache, throbbing arm pai...
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I woke up at 2:30am morning of March 19, 2021 with fever, chills, severe headache, throbbing arm pain in left arm from shoulder to elbow (injection was in left arm), and nausea. Got up to try to get Tylenol tablets, but returned to bed because I was unsteady on my feet & didn't feel like I should try to go downstairs to get the Tylenol or a thermometer to take my temperature. But my husband said I was warm to touch when he brought me extra blankets to help mitigate persistent chills I was having t/o the night. Symptoms continued until morning of March 20, 2021 and gradually lessened by evening. Stayed in bed all of March 19th and took Tylenol 650mg every 6 hours to lessen bad headache. Ate a few saltine crackers to lessen nausea symptoms & drank ice water. Had a small nosebleed evening of Mar 19th that resolved with pressure to the bridge of my nose. Today (Mar 20th), I have residual light headache that goes away with Tylenol, but no fever, chills, nosebleeds or arm pain.
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| 61 | 2021-03-19 | chills | Body aches Naseau and vomiting Chills Arm soreness |
| 61 | 2021-03-19 | headache, fatigue, influenza like illness |
I have been sick for 9 days and today I have a terrible headache to accompany the flu like symptoms....
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I have been sick for 9 days and today I have a terrible headache to accompany the flu like symptoms. Everything hurts I am nauseous and exhausted my body feels really heavy
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| 61 | 2021-03-19 | throat pain, headache, fatigue, cough |
Around 7 hours after the shot the left side of my neck hurt a little along with a little sore throat...
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Around 7 hours after the shot the left side of my neck hurt a little along with a little sore throat. That evening, I was really tired with body aches. That night I had deep body aches and vomited. I also had a slight headache and coughing. The worst part was the extreme body aches. I felt like I had been hit by a truck. On Saturday (shot was on Thursday), I?m better but my body is sore and I don?t have much energy.
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| 61 | 2021-03-19 | productive cough, cough |
Pt c/o Right chest tightness, and phlegm in her throat, coughing. Her VS (BP/HR, SBP @ 140-170'a) VS...
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Pt c/o Right chest tightness, and phlegm in her throat, coughing. Her VS (BP/HR, SBP @ 140-170'a) VS stable all throughout, sat 100% the whole time. Called Dr., ordered to give Benadryl 25 mg po and Albuterol 2 puffs inhaler. Her symptoms got better, but continued. Called 911 since she's still coughing and continue to have the 'phleghm' like symptoms in her throat.' 911 assessed her and pt refused to go to ER for further treatment, she signed the paper. Sent her home with her husband, and instructed her to call 911 if her symptoms get worst.
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| 61 | 2021-03-20 | chills, headache |
Severe headache; chills; muscle aches; arm and neck pain; arm and neck pain; This is a spontaneous r...
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Severe headache; chills; muscle aches; arm and neck pain; arm and neck pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN9581), via an unspecified route of administration, on 10Feb2021, 04:00PM as single dose in the right arm for COVID-19 immunization at Hospital. Medical history included gastroparesis, gastroesophageal reflux disease (GERD), memory loss. Allergies to medications, food, or other products was reported as yes. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient had been diagnosed with COVID-19. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced severe headache, chills, muscle aches, arm and neck pain on 11Feb2021 12:00 PM. No treatment received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected
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| 61 | 2021-03-20 | chills, fever, fatigue | Fatigue, fever, chills and arm soreness for 24 hours |
| 61 | 2021-03-20 | chills |
1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, starte...
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1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, started to shiver, jaw rattling, immediately had hot tea and wrapped in blanket. 3. Nosebleed, very unusual for me, 7 am. 4. Nosebleed, severe tinnitus, nausea, had to get out of bed and get to restroom, immediate bowel movement, severe dizziness vertigo getting back to bed. Slight tinnitus day after while writing report. Still have low nausea. 5. Sore arm for 4-5 days.
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| 61 | 2021-03-20 | chills | Severe chills and body aches |
| 61 | 2021-03-20 | headache, chills, fever |
Chills; Fever; Pounding headache; Swollen lymph nodes on left side; This is a spontaneous report fro...
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Chills; Fever; Pounding headache; Swollen lymph nodes on left side; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 09:45 AM (Batch/Lot Number: EL3247), at the age of 61-year-old at the time of vaccination, as SINGLE DOSE for covid-19 immunisation . Medical history included chronic lymphocytic leukaemia (CLL) and former breast cancer. Concomitant medication included tamoxifen 20 mg taken for an unspecified indication, start and stop date were not reported. The patient received dose 1 of vaccine on 15Jan2021 01:00 PM at left arm, lot number: EL1283. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. On 05Feb2021 22:00, the patient experienced chills, fever, pounding headache, swollen lymph nodes on left side. The outcome of the events was recovered. The patient took Tylenol as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19.
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| 61 | 2021-03-20 | headache, cough, fatigue, fever |
Fever as high as 100.7, muscle aches, headache severe, fatigue moderate to severe, Three asthma att...
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Fever as high as 100.7, muscle aches, headache severe, fatigue moderate to severe, Three asthma attacks. One was severe taking 2 hours to resolve. Worse on 3/20 than today on 3/21. I?ve taken 2 Tylenol and used my rescue inhaler 4 times. The inhaler improves my breathing, but I don?t feel normal yet. Oxygen saturation between 93-96%. If still experiencing symptoms will call PCP and/or go to urgent care. If I?m still coughing I will have to reschedule a hematologist appointment.
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| 61 | 2021-03-20 | headache, fatigue, fever | Headache, shoulder and neck soreness, low grade fever-24 hours. Just tired today |
| 61 | 2021-03-20 | headache |
Patient received the Covid-19 vaccine. She reports symptoms of sudden onset itching throughout entir...
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Patient received the Covid-19 vaccine. She reports symptoms of sudden onset itching throughout entire body 5 minutes post-injection along with sudden onset severe headache. Vaccine injection time 1715, symptom onset at 1720. Vitals: @1720: BP 148/94, HR 79, O2 98 @1725: BP 148/83, HR 80, O2 99 (PO benadryl 50mg given at this time) @1730: BP147/80, HR 70, O2 96 @1735: BP 148/82, HR 71, O2 99 @1745: 149/92, HR 74, O2 98 @1755: BP 148/71, HR 73, O2 97 @1805: patient ambulated to restroom. Patient stated that "symptoms aren't improving at all after benadryl -- I think I should go to the emergency room. Wait until I get back from the bathroom to call 911." @1814: Patient returned from restroom, 911 called @1820: EMS arrived, care handed off to EMS @1825: EMS transported patient to ER
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| 61 | 2021-03-20 | headache |
Ears-ringing, and headaches started after about a week of second vaccine. Still occurring off and on...
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Ears-ringing, and headaches started after about a week of second vaccine. Still occurring off and on 20 days after vaccine. Not continual and some days worse than others.
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| 61 | 2021-03-20 | fever, fatigue, headache |
Fever of 100.5 Severe headache Severe body aches Some nausea All lasting about 18 hours Fatigue c...
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Fever of 100.5 Severe headache Severe body aches Some nausea All lasting about 18 hours Fatigue continuing past that
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| 61 | 2021-03-21 | chills, fatigue, malaise |
Around noon the following day I started feeling achy and tired. My eyes burn and I have chills. Ju...
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Around noon the following day I started feeling achy and tired. My eyes burn and I have chills. Just feel like I'm coming down with something.
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| 61 | 2021-03-21 | chills, fever, fatigue |
16.5 hrs after injection stomach cramping and diarrhea every 2 hrs x 3. 24 hrs after injection chill...
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16.5 hrs after injection stomach cramping and diarrhea every 2 hrs x 3. 24 hrs after injection chills, fever (99.1), joint pain, fatigue.
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| 61 | 2021-03-21 | chills |
Sore arm at injection site with both shots. With the second shot only: Next day @ Approximately 7:00...
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Sore arm at injection site with both shots. With the second shot only: Next day @ Approximately 7:00 am started feeling dizzy. Approximately noon stated feeling chills and general body aches. 6:00 pm took ibuprofen and slept until 6:00 am next day . All symptoms then gone
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| 61 | 2021-03-21 | chills |
States tenderness to top of left rib below arm pit that started around 2/24/21 and went to PCP on 3/...
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States tenderness to top of left rib below arm pit that started around 2/24/21 and went to PCP on 3/3/21 for evaluation. Reports bloodwork ordered. States she has been getting progressively worse with complaints of bilateral hip pain and discomfort to upper and lower back. Reports she had chills on 3/19/21 but no fever and has been in contact "daily" with PCP.
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| 61 | 2021-03-21 | headache, fever, chills, fatigue |
Fever, chills, headache, fatigue, body aches. Fever of 102.5 lasted for about 10 hours until I fina...
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Fever, chills, headache, fatigue, body aches. Fever of 102.5 lasted for about 10 hours until I finally took Tylenol. My headache continued for about 24 hours. I felt like I had Covid all over again but in total it only lasted 24 hours.
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| 61 | 2021-03-21 | headache |
Headache started approximately 12 hours after receiving vaccine , lasted all night - took 2 Tylenol ...
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Headache started approximately 12 hours after receiving vaccine , lasted all night - took 2 Tylenol 325 mg caplets and headache was gone within a couple of hours. Also arm was quite sore first night but much better 2nd night.
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| 61 | 2021-03-21 | sweating, chills |
Face Swelling, lips swelling, felt like inside of mouth was thickening. Called doctors office and s...
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Face Swelling, lips swelling, felt like inside of mouth was thickening. Called doctors office and spoke to oncall doctor. He recommended to take antihistamine. On way home -stopped at gas station and got Benadryl. Took Benadryl twice Saturday and Sunday. Had cold chills and sweating Sunday night. Stomach pain and diarrhea Monday.
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| 61 | 2021-03-21 | sweating, headache, chills |
COULD NOT LIFT ARM, DIZZINESS WHEN LYING DOWN, SEVERE VOMITING, DIARRHEA, HEADACHE, SWEATS, CH...
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COULD NOT LIFT ARM, DIZZINESS WHEN LYING DOWN, SEVERE VOMITING, DIARRHEA, HEADACHE, SWEATS, CHILLS,
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| 61 | 2021-03-21 | fever, chills, headache |
On 3/19/2021 around 4:00 I started with body aches, headache, fever, and chilling. I continued with...
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On 3/19/2021 around 4:00 I started with body aches, headache, fever, and chilling. I continued with that during the night and on 3/20/2021 I still had the body aches and felt weak. On 3/21/2021 I noticed that I had a rash developing in places. On 3/22/2021 I woke at 5:00 a.m. covered with a rash over my entire body that itched. I took Benadryl and that is when I went to the ER.
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| 61 | 2021-03-22 | fatigue, chills |
Pfizer-BioNTECH Covid-19 Vaccine EUA Upper arm ?shoulder pain. Shaking chills, Body aches. Started a...
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Pfizer-BioNTECH Covid-19 Vaccine EUA Upper arm ?shoulder pain. Shaking chills, Body aches. Started at 1 a.m. on 3/23/2021. Tylenol 1000mg taken at 5a.m . Chills and muscle aches lasted until 12 noon. Deeling tired and very mild muscle aches continue. Tylenol 1000 mg taken at 4pm.
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| 61 | 2021-03-22 | fatigue, respiratory tract congestion, headache | Headache, tired and a strong feeling of congestion at forehead. |
| 61 | 2021-03-22 | headache |
Immediately: headache, left eye pain, nausea, cold sensation and felt ?weird? but thought it was nor...
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Immediately: headache, left eye pain, nausea, cold sensation and felt ?weird? but thought it was normal and thought I might feel flying for a bit but that it would wear off so I did not report feeling anything at the clinic. I left the clinic and got in the car to drive home and felt a weird feeling in my throat reminiscent of my esophageal spasm and then it felt like someone had their hand on my throat squeezing my throat and felt like I needed to take deep breaths to expand my lungs. Within a minute or two at most, my lips, tip of my tongue, tip of my nose and face beside my lips and under my cheeks started to tingle and go numb. My insides felt swollen. I had a doctors appointment and went there after picking my son up at home. I reported my feeling to my doctor who prescribed a steroid for 3 days and told me to also take Benadryl or Claritin, which I did. However, today is day 4 after my vaccine and today is the first day my insides don?t hurt.
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| 61 | 2021-03-22 | fever, lethargy, sleepiness |
I woke up about 3am with a fever and freezing to death. I was very lethargic. As the days progressed...
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I woke up about 3am with a fever and freezing to death. I was very lethargic. As the days progressed, I became very weak and wanted to sleep all of the time. I lost my appetite, taste and smell. I was tested for COVID on 1/12 and found out I was positive the next day. I was out of work for 2 weeks and returned to work on 1/25/21. I got an infusion on 1/20 so I can't get my 2nd dose until 90 days after that date.
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| 61 | 2021-03-22 | fever, throat pain, headache, chills |
Pfizer-BioNTech Covid 19 vaccine The night of the vaccine March 11th , I had fever of 100.8, chills,...
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Pfizer-BioNTech Covid 19 vaccine The night of the vaccine March 11th , I had fever of 100.8, chills, headache, muscle aches, sore throat, joint pain that lasted until Tuesday morning, March 16th. I had no symptoms on Tuesday & Wednesday, but developed hives on my ankles Thursday afternoon exactly one week after the Covid 19 vaccine. When I got up Friday morning I was covered in hives on my legs, arms and abdomen. The whelps were raised and itchy and appeared to be spreading. I went to my HCP and they administered an intramuscular steroid shot and advised me to take Benadryl as needed
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| 61 | 2021-03-22 | fever |
Low fever (100 F), pain at injection site, nausea and dizziness. It lasted about 12 hours. I took a...
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Low fever (100 F), pain at injection site, nausea and dizziness. It lasted about 12 hours. I took a Tylenol when nausea subsided (in the afternoon).
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| 61 | 2021-03-23 | fatigue |
I had swollen and very, very painful - the muscle on top of my shoulder (Trapezius) on the right sid...
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I had swollen and very, very painful - the muscle on top of my shoulder (Trapezius) on the right side and I took Advil late at night time because it was so painful I couldn't sleep. My arm was not sore but that muscle was. That seemed to calm it down (Advil). The next morning, I was very swollen under my right armpit - I figured it was my lymph node. It was uncomfortable and very noticeable - quite swollen for three days. It took about a week to go back to normal. I also had abnormal fatigue and that took longer to resolve - that took about two weeks to be resolved.
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| 61 | 2021-03-23 | fatigue | dizziness, fatigue, severe stomach cramps and diarrhea, muscle aches 8 days running |
| 61 | 2021-03-23 | headache |
started with slight headache early in the morning. I attributed this to pollen and allergies. It l...
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started with slight headache early in the morning. I attributed this to pollen and allergies. It last most of day. Then at 4:30 my head began to pound. I felt dizzy and extremely nauseous. This lasted about 4 hours and then I felt much better.
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| 61 | 2021-03-23 | headache |
BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; ...
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BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; if she moves her head quickly, she can feel like she will have a headache, hangover; could not walk; Trouble walking; Funny taste in mouth; Pain/ felt achy; tingling sensation from head to her to spine/ hands tingling/ it was also in her abdomen area and in her leg; Back pain; Could hardly move; could not stand up; autoimmune response; delayed allergic reaction; tweaky muscle/ pulled a muscle in her back; pain at the top of her head down to her hip; pain at the top of her head down to her hip; having trouble holding her urine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration in the left arm, on 05Mar2021 1:45 PM at a single dose for COVID-19 immunization. The patient did not receive any vaccines within 4 weeks prior to receiving the BNT162B2. Medical history included allergic reaction, autoimmune disease, brain barrier fever, epilepsy, encephalitis and meningitis. She had epilepsy as a child. She gets epilepsy when she gets sick. The last 4 times she got sick she had a seizure. The last seizure was 1 year ago (in 2020). She may have had COVID, but she got really sick and had a seizure. She is not sure if it was COVID or not. If it was the flu, she does not want that again. She had ataxia and ended up in hospital two times but did not stay. Prior to this, she did not go to hospital for 30 years. She was unable to walk, her gait was real bad. The neurological disorder messed her up for a while. Concomitant medications were not reported. It was reported that the patient received the PFIZER-BIONTECH COVID19 VACCINE first dose and experienced autoimmune response. After the vaccine, she had pain and tingling sensation from head to her to spine (05Mar2021), BP dropped to 70/40 (06Mar2021), seizures (06Mar2021), and delayed allergic reaction (Mar2021). She wanted to know if she should take the second dose or not. She also wanted to know if that would be considered the anaphylactic reaction. It was also reported that the patient experienced funny taste in mouth, back pain, hands tingling on 05Mar2021. The patient further explained that when she got the shot, she had a funny taste in her mouth. It started immediately after she got the vaccine and it lasted 30 minutes. She mentioned this to the people at the facility, but they said she was crazy and no one else has mentioned this. She thought they would be interested, but they did not care. About 20 minutes later she had a tingly sensation. It was in the back of her head that developed into a stingy, painful, heat, funny type feeling. It was all the way down to her back. She later further explained the back of her head was tingling (05Mar2021). Like were the cerebellum is to spine. This sensation is still there, but better. After she felt this feeling her back then started hurting. She bent over and her back went out. She felt achy. She already had what she called a tweaky muscle (05Mar2021). She had pulled a muscle in her back, but it was nothing that had caused a problem. After getting the COVID vaccine it triggered an immune response in her body. She started to have pain at the top of her head down to her hip (05Mar2021). She bent over and she could not stand up (05Mar2021). Her husband had to help her put her pants on and sit down due to this. She started to have horrible back pain (05Mar2021). She could hardly move (05Mar2021). She was having trouble walking (05Mar2021). She was having trouble holding her urine (05Mar2021). On Saturday evening (06Mar2021), her blood pressure started dropping and she later had a seizure. After the seizure occurred it seems like everything got better and she did not have any trouble since. It was very scary. She mentioned she was in the bathroom and there was a tub full of water. She had a hard time already getting to the bathroom. She was in a lot of pain. The amount of pain she had she thinks affected her blood pressure. She had pain in the back, middle of her back. It started at her head, back of head, down her spine, came down to her back and hips. She was hurting a lot and having a terribly hard time getting around. She could hardly walk. She was going to the bathroom because she felt like she had to go. Her husband was helping her sit on the toilet. When she stood up it was like her blood pressure dropped, she almost went headfirst in the tub full of water, but her husband caught her, laid her down, and had a seizure. This was a very unnerving feeling. The seizure did not last more than a minute, maybe two at the very most. The seizure occurred probably around 6PM or 7PM. It did not last long at all. She woke up on the floor. She had been sitting and she thought she had fallen off the toilet. However, her husband had to remind her that a few things happened in between. She almost fell in the bathtub and she has glass doors. She mentioned she felt as clarified and confirmed sped up. She did fall into a cabinet and is bruised up from that seizure (06Mar2021). She is sore from the pain from that. Still inflamed (06Mar2021) possibly due to the seizure. Like she has ruminants of what occurred to back of head, cerebellum. Before she had the seizure, her blood pressure had started dropping. It started dropping in the evening around 5PM or 5:30PM. Mentioned she is a little confused about the time onset because she was hurting so much and bad all day. She does not take any pain medication. She has an autoimmune disease and it is difficult for her to take medications. On top of that, if she wanted to take an Aspirin she was told she should not take one. She was informed she was trying to promote an auto-immune response to the vaccine. As the day ran on, she was in a lot of pain. She had been in pain since Friday and was trying to deal with that. The patient further stated her blood pressure is back, no illness. After the seizure her blood pressure went back to normal and at this time it is perfectly fine. The back pain she experienced went from the brain down to her backbone. The pain is gone. It started to go away after the seizure and by Sunday 07Mar2021 it was totally gone. At first it was like she could not walk (05Mar2021). It was like she/her back was on fire (05Mar2021). The patient also mentioned if she moves her head quickly, she can feel like she will have a headache, hangover. She feels it in her back. She feels like she is near recovery, and this is a feeling she does not thing will stay. She further went on to say her hip where she fell is a different story. However, this is associated to a fall and not a vaccine. She was having this problem when she had the vaccine, but the vaccine caused it to be more and extra aggravating. She later added, when she first got home along with head tingling her hands were tingling as well. When her brain and hands were going through this tingling sensation, she started to notice the back trouble and it was also in her abdomen area and in her legs causing trouble walking (05Mar2021). The events did not require a visit to the emergency room or physician office. Outcome of the events trouble walking, could not walk, tingling sensation and hangover was recovering. Outcome of BP dropped to 70/40 was recovered on Mar2021. Outcome of seizures recovered on 06Mar2021. Outcome of funny taste in mouth was recovered on 05Mar2021. Outcome of back pain was recovered on 07Mar2021. Outcome of bruised up was not recovered. Outcome of the remaining events was unknown. The patient provided an unrelated causality between the vaccine and event fall. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information, the event Fall is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.
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| 61 | 2021-03-23 | fever |
Fainting, fever, chills, nausea. Had repeated fainting spells the morning after the day I was vacci...
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Fainting, fever, chills, nausea. Had repeated fainting spells the morning after the day I was vaccinated. Felt better the next day, still had slight fever. By Wednesday (third day after vaccine day), felt fine. The reason I am reporting this is the fainting episodes. I do not see that online as a listed common side effect of the vaccine.
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| 61 | 2021-03-24 | chills, fatigue, headache |
Huge bruise with a knot. Warm to touchArm pain to the point I couldn?t lay on it. Side effect symp...
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Huge bruise with a knot. Warm to touchArm pain to the point I couldn?t lay on it. Side effect symptoms started 3 days after injection on 03/24/2021. Headache, chills, fatigue, atypical chest pain.
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| 61 | 2021-03-24 | chills, headache, fever | Headache, body aches, joint pain, fever and excessive chills. |
| 61 | 2021-03-24 | fatigue, chills, fever, headache | Injection site pain, tiredness, headache, chills, joint pain, fever |
| 61 | 2021-03-24 | fatigue |
minimal chronic portal inflammation ( lymphs, rare eos, some neutrophils, no plasma cells seen); ext...
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minimal chronic portal inflammation ( lymphs, rare eos, some neutrophils, no plasma cells seen); extensive cholestasis; symptoms of mild decrease appetite; some fatigue; This is a spontaneous report from a contactable Physician. A 61-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 19Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included hemiparesis, hypertension, hyperlipidemia, recurrent UTI. Concomitant medications included AMLODIPINE BESILATE, calcium carbonate, colecalciferol (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]) for UTI, cefalexin KEFLEX [CEFALEXIN] and nitrofurantoin for UTI. The patient received first dose of BNT162B2 on 29Dec2020. On 02Feb2021 the patient experienced minimal chronic portal inflammation, symptoms of mild decrease appetite, some fatigue and extensive cholestasis. Serologic workup was notable only for ASMA 1:160, including extensive viral and immune workup Liver performed on 24Feb2021: extensive cholestasis, normal reticulin and trichrome stains, minimal chronic portal inflammation; no lobular or interface activity. The patient underwent Sars Cov2 test on 22Feb2021 which resulted negative. At the time of the reporting the patient was recovering from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Hepatitis, cholestasis and other events due to temporal relationship . Additional information is needed to better assess the case, including complete medical history, diagnostics including liver function tests/hepatic enzymes prior to subject drug therapy and during subject drug therapy, abdominal ultrasound, CT/MRI of abdomen, viral hepatitis serology, serum bilirubin, serum alkaline phosphatase, counteractive treatment measures and concomitant medications. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 61 | 2021-03-24 | headache, fatigue, sweating |
Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tigh...
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Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tightening of chest every so often; acid reflux; hot flashes; sweating; stomach aches; upper abdominal pain radiating to back; severe fatigue; Dizzy/dizziness; stomach feels odd; Headaches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6198), via an unspecified route of administration, administered in upper left arm on 25Feb2021 9:00 (at the age of 61-year-old) as single dose for virus (COVID-19 immunisation). Medical history included chronic pain, pancreatitis, allergic to medications, old injury in her right arm, menopause and an ongoing mass in parotid lobe discovered in 2019 with CT scan. MRI performed in Mar2020 and CT scan in Oct2020. She stated that they are just watching it because it has not changed. Well defined borders are present, caller stated that doctor was unconcerned. Her mother had heart disease. Ongoing concomitant medications included ibuprofen for chronic pain and gabapentin from 2019 for chronic pain. The patient also took unspecified medication for pancreatitis. She has taken all kinds of stuff after pancreatitis but they do not work. The patient got deadly ill from the flu shot. Unsure of onset age, vaccine/brand name, or vaccination date. She stated that it was before 2003, possibly in the late 1990's or early 2000's. The patient had no history of all previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. On unspecified date the patient experienced diabetes; on 25Feb2021, the patient experienced dizzy, stomach feels odd, hot flashes, severe fatigue, sweating, stomach aches, acid reflux, upper abdominal pain radiating to back; on 26Feb2021 she experienced tightening of chest every so often; and in Feb2021, she had headache. It was further reported as follows: The patient stated that she took the Pfizer shot, clarified that she received the Covid-19 vaccine, on 25Feb2021, not quite 2 weeks ago. She stated that she had a little bit of a reaction after receiving the vaccination while there, so they were monitoring her. She has been experiencing hot flashes, sweating, and stomach aches for 2 days. She cannot get rid of hot flashes and that she has not had a hot flash in 2 years. She states that she has been down for 2 days with fatigue, that it's really bad. She is inquiring if the side effects that she is experiencing are common side effects and if it is ok to get 2nd shot. Her second vaccine is scheduled for 17Mar2021. She stated that she wanted to take the time to make a report as she is allergic to medications. While inquiring about dates of vaccines and side effects, she stated that she was experiencing tightening of chest every so often. She stated that she only had a few days of stomach pain and she has not stopped eating. She is unable to concentrate (unspecified date) and she has been experiencing headaches, experiencing them twice in 2 weeks. She also reported that she has been having upper abdominal pain radiating to her back. This concerns her, every time she gets it, it scares her. She had pancreatitis when she was 36. It is a nightmare thought. Does this sound like maybe she is possibly starting Diabetes? She reported that this shot has triggered everything. She has an old injury in her right arm. Her arm is killing her, her hands are swelled up, she has acid reflux again, she felt terrible. She stated that the dizziness not as strong as it was at the beginning. The fatigue it comes and goes and that she has spurts where she is energetic. She stated that it's more on than off. She is no longer having stomach aches. She compared the pain to pains of constipation. She also stated that she was constipated after receiving the vaccine on unspecified date. She had nausea at the beginning. The tightening of chest happened off and on, the last day that she experienced tightening of chest was on Sunday. For acid reflux, she is taking Zegerid as treatment, 20mg 20 mg capsules by mouth once daily as needed. She started this on 02Mar2021. She experienced upper abdominal pain yesterday and some this morning, but it was mostly in her back this morning. Her Sweating is off and on. She experienced headache just a couple of times but that she has not had one in a while. She stated that they lasted only an hour or two, and that she does not usually get headaches. She suggested that these may be due to sinuses and weather change. She has been taking Ibuprofen twice a day as treatment. But she normally takes Ibuprofen for chronic pain. Supposed to be 3 times a day but she does not want to take that much. She stated that all of this could also be stress related and that this could also be menopause. The patient recovered from stomach aches on 02Mar2021. The outcome of the events dizzy, sweating, tightening of chest every so often, upper abdominal pain radiating to back, headache was recovering; the outcome of stomach feels odd, hot flashes, severe fatigue, acid reflux was not recovered. The outcome of the remaining events was unknown.
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| 61 | 2021-03-24 | headache, fatigue |
Directly after getting the shot I was sleeping harder than I ever have for about 14 days then on Mar...
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Directly after getting the shot I was sleeping harder than I ever have for about 14 days then on March 4 woke up after a very deep sleep tired the next day the same thing March 5 woke up extremely fatigued March 6 same thing woke up extremely fatigued and after going for a short bike ride started getting an intense headache, set up got very dizzy, then proceeded to throw up harder than I ever have and so debilitatingly that I had to call the paramedics and they took me to the emergency room. The ER doc at first said that this could not be an adverse effect 14 days later of the first Covid shot, but then he said he didn?t know, for the next nine days I did not leave my house I was so exhausted. I am an athlete and exercise every day have tons of energy all day long and have never felt this way before. I then met with my regular Doctor Who ordered tests of different varieties everything came back normal and to this day which is now March 25 I have extreme fatigue and I can barely work. Like I said above I am an athlete I run five days a week ride my bike two days a week and swim generally two or three days a week and work as a teacher and I can barely do any of that.
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| 61 | 2021-03-24 | sweating |
Low BP 74/40, low heart rate- 40, sweating, dizzy, gave ice pack on back of neck and under arms, too...
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Low BP 74/40, low heart rate- 40, sweating, dizzy, gave ice pack on back of neck and under arms, took vitals after 10 min again HR 53- BP 82/43, RR 16 96% drank water, 14:55 not dizzy, sitting up, BP 133/82, no sweating, HR 50, RR 16, 99%, 15:00 took to car gave water for way home
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| 61 | 2021-03-24 | sweating |
On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 10...
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On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 102. On 3/22/21 and continue to have swelling in my left armpit (Lymph node area), spasms in my left shoulder blade and surrounding soft tissue adjacent to my left armpit and neck area. I have experienced soreness in that arm/shoulder but not at the injection site - overall bicep and clavicle area. I have been able to alleviate symptoms to a degree by taking a tylenol once or twice a day but the pain is limiting some of my daily activities to a degree.
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| 61 | 2021-03-24 | fever | Fever of 101.7 |
| 61 | 2021-03-24 | throat irritation |
Patient came in received second dose Pfizer vaccine at 3:00pm and reported she had burning sensation...
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Patient came in received second dose Pfizer vaccine at 3:00pm and reported she had burning sensation in top of mouth, throat, chest area at 15:03. Patient stated this reaction had also occured after first dose and lasted 3 days. Patient vitals were 99% O2, pulse 82, BP 122/82, Resp. 18 at time of reaction. Patient has no s/s of shortness of breath, n/v, dizziness, swelling, hives. Patient was given 25mg of PO diphenhydramine and monitored for 30minutes. No increase in symptoms. Patient left with symptoms starting to resolved. Patient educated by provider on site to take famotidine and continue diphenhydramine PO as needed every 4-6 hours. If s/s increase to report to the emergency department.
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| 61 | 2021-03-25 | cough |
Pasting clinicians note below: Patient is 61 year old female with hx of anaphylaxis presenting for C...
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Pasting clinicians note below: Patient is 61 year old female with hx of anaphylaxis presenting for Covid-19 vaccine, Dose #1. She developed itching in there throat within 30 minute waiting period. She was taken to Rapid Response Room. Symptoms progressed from itchy throat, to congestion in throat/upper chest, clearing her throat, watery eyes. Then dry cough. No nausea, no vomiting, no light headed feeling. No facial swelling No hives. OBJECTIVE: Vitals - 154/97, 105, 100%RA Neck - Supraclavicular mild retractions, end inspiratory stridor CV: tachy, regular, no murmur pulm - diminished breathe sounds throughout, no wheezing. Speaking full sentences. Assessment/ Plan: Anaphylaxis to Covid-19 Vaccine: - emergency responders - epi 0.3 mg IM administered to L mid outer thigh at 9:35 am by me - epi 0.3 mg IM administered to R mid outer thigh at 9:41 am because symptoms not subsiding by me -benadryl 50 mg IM x 1 L deltoid by RN 9:45 am - Itching in throat subsided but still retracting and clearing throat so albuterol 3 puffs given at 9:50 am Vitals stable entire time (see midas report) EMS arrived to transport to local hospital.
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| 61 | 2021-03-25 | fatigue | Fatigue |
| 61 | 2021-03-25 | fatigue |
Sore arm for about 3 days. Then a week later I suddenly got cold hands, legs, stiff neck, swollen he...
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Sore arm for about 3 days. Then a week later I suddenly got cold hands, legs, stiff neck, swollen head, dizzy, multiple bowel movements, week leg muscles, tired. Lasted about 1 hour for initial wave, then was tired and out of commission for about 3 hours afterwards.
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| 61 | 2021-03-25 | headache, fatigue |
(1) Headache started shortly after injection, mild at first, then moderate, went away 48 hours later...
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(1) Headache started shortly after injection, mild at first, then moderate, went away 48 hours later (2) Extreme fatigue started 4 hours after injection, improved somewhat 24 hours later, mostly gone 48 hours after injection (3) Tinnitus first noticed 8 hours after injection, mild or intermittent for the next 5 days, then became more noticeable and persistent; has been persistent and nonstop since then. (It has been one week since the injection.)
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| 61 | 2021-03-25 | headache | woke up spinning, light headed, slight headache. |
| 61 | 2021-03-25 | headache |
Had a sudden pounding headache & a super loud buzzing in my ears. The headache lessened & the ear bu...
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Had a sudden pounding headache & a super loud buzzing in my ears. The headache lessened & the ear buzzing went down a little bit, but ear buzzing is still pretty loud. The loud ear buzzing has not gotten any better 23 days later!!! My ears are still buzzing now. I am wondering will my 2nd dose of Pfizer Covid vaccine due on 04/01/2021 make my ear buzzing worse?
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| 61 | 2021-03-25 | sweating, chills, fatigue |
Began with waves of prickly hot sweats, light headed dizziness, cold chills, nausea. Got progressive...
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Began with waves of prickly hot sweats, light headed dizziness, cold chills, nausea. Got progressively worse-was at dentist, sent home, could not walk unaided (dizzy). Threw up in car on way home. Spent evening with these sympyoms gradually decreasing in strength, very fatigued, took effort yo breathe. Also soreness of arm. Next day: very fatigued, sore arm, but test of symptoms passed (little nausea, but not bad)
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| 61 | 2021-03-25 | fever, headache, fatigue, chills | Pfizer-BioNTech Covid-19 Vaccine EUA. Tiredness Chills Fever sore arm headache |
| 61 | 2021-03-26 | chills, fever |
Tinnitus moderate to severe onset about 24 hours after vaccination. High pitched ringing both ears....
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Tinnitus moderate to severe onset about 24 hours after vaccination. High pitched ringing both ears. Occurred with a low grade fever, chills, and muscle aches. One alleve (naproxen sodium) pill to address symptoms did not impact tinnitus.
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| 61 | 2021-03-26 | fatigue, malaise, chills, headache | Headache Body Ache Tiredness Chills General not feeling well |
| 61 | 2021-03-26 | headache, chills, lethargy, fatigue, sleepiness |
Pfizer-BioNTech COVID-19 Vaccine EUA The area received vaccination was sore, about two hours later b...
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Pfizer-BioNTech COVID-19 Vaccine EUA The area received vaccination was sore, about two hours later became drowsy, had to leave work and go home, woke up around 5 p.m. body ached on left and right side, took Aleve for pain.. Overnight had chills, headache, next morning, took Aleve for pain. Whole body ached for about a week, headaches, lethargic, tiredness. About week and half later only ache in right arm, sore like I sprained it, still tender today.
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| 61 | 2021-03-26 | headache |
Swelling of throat and neck pain, shortness of breath, headache progressed for 1 hour after shot. We...
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Swelling of throat and neck pain, shortness of breath, headache progressed for 1 hour after shot. Went to ER at Hospital. Took 25 mg Benedryl, declined prednisone, but left ER 2 hrs later with prescription for epipen and prednisone. Took Zytec at home and slept. Symptoms were gone next day.
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| 61 | 2021-03-26 | headache |
weak, cold, throwing up, hot flashes, dizziness, head hurt, sweating in sleep, diarrhea , body pain,...
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weak, cold, throwing up, hot flashes, dizziness, head hurt, sweating in sleep, diarrhea , body pain, nausea
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| 61 | 2021-03-26 | headache |
3/23 mild headache 3/24 mild headache 3/25 mild headache 3/26 rash started, in patches, right arm, t...
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3/23 mild headache 3/24 mild headache 3/25 mild headache 3/26 rash started, in patches, right arm, trunk, under hair on head, and partially down back of neck.Severe itchiness. Took OTC benadryl, two tablets, no relief. 3/27 rash continues, itches more in evening
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| 61 | 2021-03-26 | throat irritation | dizziness and scratchy throat, patient waited extra time and left after improvement. |
| 61 | 2021-03-27 | chills, fever, headache, fatigue |
Injection site pain and redness, tiredness, splitting headache, muscle ache, chills, joint pain, in...
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Injection site pain and redness, tiredness, splitting headache, muscle ache, chills, joint pain, intermittent fever, loss of appetite
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| 61 | 2021-03-27 | chills |
3/11-3/12/21 - heart palpitations, start of flu symptoms 3/13-3/18/21 - heart palpitations and high ...
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3/11-3/12/21 - heart palpitations, start of flu symptoms 3/13-3/18/21 - heart palpitations and high heart rate, blood pressure high and low, chills, weak, diarrhea, nausea, headache 3/19-3/23/21 - heart issues better, still had flu symptoms Propanolol and Alprazolam for heart palpitations. ER visit 3/16 - recv IV's, all labs normal. PCP visit 3/23.
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| 61 | 2021-03-27 | fatigue |
total of 4 days tired/weak, and right arm sore (from thursday through sunday) early saturday morning...
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total of 4 days tired/weak, and right arm sore (from thursday through sunday) early saturday morning had 4 hours of hallucinations, nausea and extreme vomiting, dizzyness ,loss of appetite slept for 12 hours on saturday and sunday after the 4 hrs of events listed above. still weak after feeling better on sunday afternoon
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| 61 | 2021-03-27 | headache, chills, fever, fatigue |
Chills, fever 101.6F, headache, fatigue, nausea, diarrhea. Today she states she is feeling a little ...
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Chills, fever 101.6F, headache, fatigue, nausea, diarrhea. Today she states she is feeling a little better but is still a little nauseated and fatigued. She states she's been taking Tylenol off and on.
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| 61 | 2021-03-27 | headache | Both arms feeling like on fire. Headache, body aches, stomach ache, throat feels tight |
| 61 | 2021-03-27 | fever | Pain Lymph node inflammation Fever Aching Resolution after 3 days |
| 61 | 2021-03-29 | chills |
Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt li...
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Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt like fire ants; chills; no energy; tightness in chest; This is a spontaneous report from a consumer reported for herself. An 61-year-old female non- pregnant is unknown female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198), via an unspecified route of administration on Left arm on 02Feb2021 17:45 at single dose for covid-19 immunisation. Medical history included COVID-19, Congested Heart disease, and Penicillin allergy. The patient's concomitant medications were not reported. The patient experienced Hit with heaviness limbs pain in joints whelps all over body arms legs stomach back groin felt like fire ants chills no energy tightness in chest on 22Feb2021. Received Inhalers for breathing and steroids. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events was "Recovering".
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| 61 | 2021-03-30 | chills, sweating |
violent heavying, sweating for 2 hours; pain in chest; diarrhea; chills; sore; This is a spontaneous...
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violent heavying, sweating for 2 hours; pain in chest; diarrhea; chills; sore; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 06Mar2021 14:00 as a single dose (at the age of 61-years-old) for covid-19 immunisation. The patient had known allergies to flu shot, contrast dye, aspirin and codeine. She had a major reaction to flu shot so was scared to have this. She took Pepcid and Zyrtec 3 days prior and 1 week following. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. There were no other vaccine in four weeks. There were other medications in two weeks. The patient received the first shot, day 1 and 2 was fine. On day 3 (09Mar2021 11:00), diarrhea started, day 4 (10Mar2021) - violent heavying, sweating for 2 hours then pain in chest. The patient thought she was having a heart attack. After many test it was not her heart, then more test that would not cause these issues. The physician determined it was the vaccine. On Mar2021, she still feel chills and very sore. The patient was scared to get her second dose. It was unknown if the patient received treatment for the reported events. The reported events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not tested post vaccination. The outcome of the events was unknown. Information on the lot/ batch number has been requested.
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| 61 | 2021-03-30 | fatigue, chills, fever, headache |
Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appet...
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Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appetite; Nausea; Sore arm at injection site (minor); Swollen lymph gland under left arm; Dizzy; This is a spontaneous report received from a contactable nurse (reported for herself). A 61-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection and Lot number: EL3246), intramuscularly to left arm on 12Jan2021 10:00 at a single dose for COVID-19 Immunization. Patient medical history was reported as none. Patient concomitant medications included calcium, ergocalciferol (VITAMIN D), multivitamin and probiotic. The patient previously took BNT162B2 (Comirnaty, Lot number: EJ1685) vaccination, intramuscularly to left arm on 22Dec2020 for COVID-19 immunization. On 12Jan2021 22:00, 12 hours after the second dose of vaccination the patient experienced with fatigue, fever (101.6), chills, shakes, muscle pain, joint pain, headache, foggy head, loss of appetite, nausea, sore arm at injection site (minor), swollen lymph gland under left arm. patient was on bed and felt dizzy after fever broke for about 24 hours. Seriousness was reported as non-serious. Patient received on advil at night for treatment of events. The outcome of events was recovered on an unspecified date. No follow-up attempts are possible, No further information available
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| 61 | 2021-03-30 | sweating |
Left side got tight including brain/ brain was not cooperating with the eyes/ Brain shaking; Profuse...
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Left side got tight including brain/ brain was not cooperating with the eyes/ Brain shaking; Profuse sweating; Never had low blood sugar before/Blood sugar crashed; Left side got tight; This is a spontaneous report from a contactable other hcp (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 08:45 am (Batch/Lot Number: EN6203) at age of 61-years-old as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes. No pregnant. No Covid prior vaccination. No Covid tested post vaccination. No Known allergies. No other vaccine in four weeks. Concomitant medication included semaglutide (OZEMPIC), metformin (METFORMIN), lisinopril (LISINOPRIL), all empagliflozin, linagliptin (GLYXAMBI) taken for an unspecified indication, start and stop date were not reported. The patient experienced left side got tight including brain/ brain was not cooperating with the eyes/ brain shaking, profuse sweating, never had low blood sugar before/ blood sugar crashed on 03Mar2021 09:30. Adverse event: Left side got tight including brain. After maybe 20 minutes while she was driving back. Blood sugar crashed and brain was not cooperating with the eyes. Brain shaking. Profuse sweating. Ate something when she got to work and started improving. Never had low blood sugar before. No treatment for events. The patient underwent lab tests and procedures which included blood glucose: low/crashed on 03Mar2021 09:30. The event outcome recovered in Mar2021.
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| 61 | 2021-03-30 | productive cough, throat irritation, malaise, headache |
Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and ...
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Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.
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| 61 | 2021-03-30 | fever, headache, chills |
chills; injection site pain; headache; muscle pain; fever/tiny fever; impacted lymph nodes/lymph nod...
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chills; injection site pain; headache; muscle pain; fever/tiny fever; impacted lymph nodes/lymph nodes are impacted a little bit; nausea/feeling nauseous; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6206) via an unspecified route of administration, administered in Arm Left (left shoulder), at the age of 61-year-old, on 03Mar2021 19:00, as SINGLE DOSE for covid-19 immunisation. The patient medical history was overweight, diagnosed COVID last Apr2020 she had it for 17 days and had every symptoms. The patient tried to give antibodies for many months and she was told she had two different kinds of antibodies which prevented her from doing that. The patient has long hauler symptoms which are nerve pain in her thighs and mouth. The patient's concomitant included an unspecified medication (she takes something but not relevant). The patient did not receive any vaccine within 4 weeks prior. The patient previously received shingles vaccine on 14Feb2020 and tetanus shot on an unspecified date (years ago) both given for immunization and her arm hurt/ pain at the injection site (if she touches it, it hurts). On 03Mar2021 at 7PM, after receiving first dose, she felt blah described as she developed injection site pain which is dissipating but still there, headache, muscle pain, tiny fever, impacted lymph nodes, nausea/ feeling nauseous which she didn't have before. The patient can get up and walk around. On 04Mar2021, the patient had chills in the afternoon. It was just a little fever. The patient took Tylenol and Advil in the afternoon and it helped it go away. The patient took one of each. It was reported that the COVID headache is like none other and she had the headache again. For the COVID headache if you take things it doesn't make it go away. When the patient said she had the headache again she meant she had the same headache that she had in April. The events did not require ER or physician office visit. Outcome of injection site pain was not recovered while it was unknown for the other events. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.
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| 61 | 2021-03-30 | throat irritation |
Patient was given vaccine at 10:45am - Patient reported scratchy throat at 10:48am - at 10:50am we g...
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Patient was given vaccine at 10:45am - Patient reported scratchy throat at 10:48am - at 10:50am we gave 50mg of Diphenhydramine orally, patient condition worsened, she described her throat starting to swell up, and had noticeable difficulty breathing and shortness of breath. We administered Epinephrine at 10:55am and within 5 seconds patient reported improvement. Patient remained stable until EMS arrived about 5-10 minutes later. Patient was advised to be taken to the hospital for monitoring and agreed. She remained stable and reported an "itchy back" upon exit.
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| 61 | 2021-03-31 | headache, lethargy |
received second dose of vaccine on 3/30. On 3/31 presents via EMS due to altered mental status and v...
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received second dose of vaccine on 3/30. On 3/31 presents via EMS due to altered mental status and vomiting. EMS reports that she was found sitting in her van lethargic and actively vomiting. When EMS arrived they noticed that the patient had her fingers in her throat trying to induce vomiting. EMS reports EKG in sinus rhythm with HR 84, BP 178/106, and O2 sat 99% on RA. EMS did not notice focal weakness. Pt c/o HA and is noted on arrival to not be moving her LUE. I spoke with her daughter, who said she spoke to the pt on the phone at 10:45 am today and that she seemed normal at that time. She reports the pt does not have h/o cancer or heart disease and is unaware of any pt medication allergies. She reportedly received her COVID vaccine yesterday.
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| 61 | 2021-03-31 | malaise |
felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quen...
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felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quenching, it was kind of weird; body jerking; feeling weird/felt like she was not herself/ she felt her body was trying to fight off something; heaviness in her legs; felt pain in her face; flinching; This is a spontaneous report from a contactable consumer(patient). The 61-year-old female patient received first dose BNT162b2, via an unspecified route of administration on 04Mar2021 (Lot Number: EN6205) as single dose for CIVID-19 immunization. Medical history included blood pressure issues from 2010 and ongoing, ongoing sinus issues which was diagnosed in 1973 or 1974, hypoglycaemia, reaction to tetanus shot several years ago. The patient's concomitant medications were not reported. She received postnasal drip started on 02 Mar2021 or 03 Mar2021 before the vaccine. She got the first Covid shot on 04 Mar2021. She wait 30 minutes because had reaction to tetanus shot several years ago. She had flinching, jerking and feeling weird 10 minutes after vaccine on 04 Mar2021. She and husband in holding area waiting. One time jerk so bad felt that she felt she had to lay down. She felt like she was not herself like she was out of body like there and she was not (AS REPORTED). She had a weird feeling after vaccine, she felt her body was trying to fight off something, felt like little bit out of body feeling, felt like she was going to hit the floor on unknown date. She felt lightheadness on 04 Mar2021. They checked her pulse and there was nothing with her heart rate. She does not know if it was an anxiety attack or not. She was nervous about getting the vaccine because it was so new. She felt this way for four days. On the fourth day that she felt she was coming around and on the fifth she felt herself. She has other underlying health issues and does not want the virus. She had heaviness in her legs, felt a pain in her face both on 04 Mar2021. The doctor wanted to rule out if she was having a stroke. She went to the ER, the ER kicked her out and did not find them. Her BP was 130/60 on 09Mar2021. They did blood work and an EKG(Electrocardiogram). They ruled out stroke. The doctor stated that the allergies could have made her feel dizzy but did not know about the twitching and jerking. She has lightheadness and dizziness because of other health reasons like sinuses, blood pressure and low blood sugar which these were before the vaccine. She had the normal EKG on 09 Mar 2021. There was unknown treatment received for events. Outcome of heaviness in her legs was recovered on 06Mar2021, of felt pain in her face, feeling weird, Dizziness was recovered on 07Mar2021, flinching, jerking was recovered on 04Mar2021, of felt like I was going to hit the floor was unknown. Case was assessed as serious.
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| 61 | 2021-04-06 | fever |
Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs ac...
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Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; temp of 101.6; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 01Mar2021 17:15 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included end stage renal disease (ESRD), high blood pressure and pulmonary hypertension; all from an unknown date and unknown if ongoing. The patient has no COVID prior vaccination and not tested to COVID post vaccination. There was no other vaccine in four weeks. Concomitant medications (reported as Other medications in two weeks) included clonidine (CLONIDINE), macitentan (OPSUMIT), minoxidil (MINOXIDIL), carvedilol (CARVEDILOL), and tadalafil (ADCIRCA); all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (lot number: unknown) first dose on 22Jan2021 at 02:45 PM right arm for covid-19 immunization. The patient also previously took Hydralazine and experienced allergies. It was reported that on 01Mar2021 08:00 PM the patient went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs., acting stiff and unusual behavior. The patient's daughter took the patient and had a temp of 101.6 was sent home Tuesday morning. The events resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered with sequalae (reported as with lasting effects). No treatment was given for the events. Information on the lot/batch number has been requested.
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| 61 | 2021-04-07 | sleepiness, fatigue |
The first day she felt severe fatigue within hours. Went to bed and slept all day and all night. The...
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The first day she felt severe fatigue within hours. Went to bed and slept all day and all night. The next day woke up disoriented and weak. Called dr and dr recommended her call the ambulence. Went to ER and admitted to hospital. They said she had an infection and got on antibiotics. In the hospital 2-3 days and dismissed. Continue to have weakness and severe fatigue. Had 3 "MS hug"- muscles severely contract during this time- has to take muscle relaxer.
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| 61 | 2021-04-08 | cough | racing heartbeat, breathlessness, coughing, nausea |
| 61 | 2021-04-10 | headache |
I experienced a slight headache sore arm and elevated blood pressure after the shot. My blood press...
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I experienced a slight headache sore arm and elevated blood pressure after the shot. My blood pressure is usually very well controlled. On Monday the 29th, at about 3:30 pm, I started to slur my words. At first we blamed it on the Novocaiine earlier in the day, but I had been talking fine after it and had had it many, many times before and it was worn off. We called my doctor's office after my right arm and leg became very heavy and awkward. They told me to go to the nearest hospital. When I got there, I presented ass a full stroke. I was very hard to understand and my mouth drooped and I had very little use of my right arm and leg. They ran tests, but could not give me the medication because I was already on Eliquis. They thought they saw a small clot very high up. I was hospitalized over the next four days and improved my speech dramatically after a bad headache on March 30. The doctors go back and forth to whether it was a Acute Ischemic Stroke, which is what my paperwork says and a complex migraine. I do not experience migraines or anything like this ever before. I did not have a real headache on the 29th. Since my symptoms, right arm and leg difficulties are still here, my Doctor believes it was a stroke. I have an appointment with a Neurologist and I have to have another MRI. I am going to Physical Therapy. My Doctor told me to fill this out, she thinks it may be from the vaccine.
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| 61 | 2021-04-11 | throat irritation |
Patient received her second Pfizer covid vaccine on Tuesday 4/6/21. She said she had been doing yard...
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Patient received her second Pfizer covid vaccine on Tuesday 4/6/21. She said she had been doing yard work before she came to get her vaccine. After she received her vaccine she felt fine. On Tuesday night she started to feel some itchiness. She said the itchiness got worse over the next two days. She talked to her husband and he advised her to take Benadryl so she took two Benadryl. On Wednesday she had some soreness at her injection site. Very early Thursday morning she noticed a golf ball sized knot in her armpit. She said it was sore and if she rubbed it, it felt like it was pushing into her breast. She said it felt like pressure going all the way to her breast bone and along her esophagus. She ended up calling EMS and her blood pressure was up to 181/107 and had a high heart rate. She said she never had any hives but did have some throat, tongue, and lip swelling and said that her throat felt raw. The EMS gave her 2 nitroglycerin tablets and 5 aspirin. She spent Friday and Saturday in the hospital. She said the hospital did all kinds of cardiac tests on her and everything can back clear besides a leaky heart valve. She said she is feeling much better now and that the hospital was not sure if it was a reaction to the vaccine, something else, or a combination of things that caused it.
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| 61 | 2021-04-13 | chills, cough, fatigue |
Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills...
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Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange. No fever. Second not as severe as the first. Body aches, muscle pain, dizziness, chills, nausea, painful injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black): susp tibial artery occlusion lt . Heparin. Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.
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| 61 | 2021-04-14 | cough, headache |
At approx. 9:22 AM on 4/2/21, I began having problems swallowing my saliva and felt my throat begin ...
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At approx. 9:22 AM on 4/2/21, I began having problems swallowing my saliva and felt my throat begin to close. I also began having problems breathing, began coughing and choking, chest pain, and dizziness. The nursing staff at Hospital immediately got a wheelchair and rushed me next door to the ER. The nurses had called ahead so that the ER doctors were ready to assist me. I was given Epinephrine, steroids, nubilizer treatments, Bendryl, IV fluids and oxygen. After some time I began feeling a little better but then the reaction restarted and treatments had to be re-administered several times. It was quite frightening. I also had a severe headache and tightness of the chest . The ER doctor believed that I should be admitted which was done on 4/2/21 and was kept thru 4/4/21.
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| 61 | 2021-04-16 | cough, throat pain, fatigue |
test positive for COVID 19; test positive for COVID 19; coughing; Muscle aches; Fatigue; Sore throat...
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test positive for COVID 19; test positive for COVID 19; coughing; Muscle aches; Fatigue; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 16Jan2021 10:30 as single dose for covid-19 immunisation. Medical history included high blood pressure, migraines, inflammatory arthritis, penicillin allergy. Concomitant medications included eszopiclone (LUNESTA) (MANUFACTURER UNKNOWN); valsartan (MANUFACTURER UNKNOWN); sumatriptan succinate (IMITREX) (MANUFACTURER UNKNOWN). On 8Feb2021, the patient experienced coughing, muscle aches, fatigue, sore throat. On 23Feb2021, the patient experienced test positive for covid 19. There was no direct adverse reaction from the vaccine, but I did test positive for COVID 19 on 23Feb2021 (yesterday) with symptoms of coughing, muscle aches, fatigue and sore throat. The patient underwent lab tests which included sars-cov-2 test: negative on 19Feb2021 and sars-cov-2 test: positive on 23Feb2021. The patient did not receive any treatment for the events. The clinical outcomes of the coughing, muscle aches, fatigue, sore throat, test positive for covid 19. No follow-up attempts are possible.
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| 61 | 2021-04-17 | chills, sneezing, productive cough, fever, nasopharyngitis |
This is a spontaneous report from received from contactable consumer. A 61-year-old female patient r...
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This is a spontaneous report from received from contactable consumer. A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7534), via an unspecified route of administration on 24Mar2021 via an unspecified route of administration in top of left arm as single dose for covid-19 immunization. Medical history included Salpingo-oophorectomy (resection to remove an ovary and fallopian tube) in Mar2016 and an operation in 2016 for diverticulitis. Concomitant medications were not reported. There were no allergies to medications, food, or other products. No known allergies. No, she says this is her first vaccine, she has never even had the flu vaccine. Caller clarifies she is talking about the Pfizer BioNTech vaccine. Later in the call clarified as the COVID-19 vaccination. She is calling to report that she contracted COVID. She says she is so discouraged, she did everything right and she ended up getting COVID, she was shot in the arm, her family forced her to get it, 7 days later she was sick, so sick Wednesday(31Mar2021)/Thursday(01Apr2021), positive on Saturday (03Apr2021). She says she is been googling this, it has only been only 6 months, less than 6 months in. On 30 Mar2021, patient had experienced ill, Sneezing, coughing, choking, coughing up phlegm, Fever, Chills and aches. Patient says she did not get her second shot, she is supposed to go for it on 14Apr2021 but she suspects she had to get tested before she gets the vaccine. She says she does not know what to do. She says she is isolating herself and has her own bathroom. She says her card has a patient number and an ISS number. She says she is got this vaccine for society to get this vaccine rolling so we can be whatever the word is, for social status, to be in the cool club. Patient says she had no tests since she does not have a primary. The adverse event was not resulted in emergency room. The patient was resolving from the event COVID. At the time of reporting the outcome of the events were unknown. Additional information has been requested.
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| 61 | 2021-04-17 | chills |
My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super water...
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My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super watery bowel movement then went into clay like and drier consistency but still dark (I never had stool this dark).; I was dry/ I needed water; room seemed like it was so much further away, my stairs the spindles were larger in size, it was if I was high on something/feeling of peace, calm/high feeling; I was whistling in my breathing/ I had a loud whistle; feeling my eyes and hearing were sharp/ my eyes were changed eventually; had my eyes dilated; felt I like I was getting hemorrhoids/I woke up feeling like I had too much sugar; black stool; constipation; Chills; wanted to vomit; I got shaky; scares; There's a feeling of hardness in my lower abdomen and heart area (Belch); There's a feeling of hardness in my lower abdomen and heart area (Belch); reversed my beta blockers (it keeps it in the 50s) it went to 79; My energy was so much more.; The next day I gained 3.2 pounds then the next day lost 3 pounds; My injection site for the first 2 weeks,I had an itch/ extreme itch; injection site for the first 2 week/there's pain there on touch (no throbbing pain); My tooth broke; movement under my skin/shingles feeling; My skin is extremely dry; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. It was reported that the patient vision wasn't as good. She also had glasses to read (eyeglass wearer and ongoing) and behind her eyes they were dry one (left) mostly. Concomitant medications included unspecified beta blockers. On 11Mar2021, she got chills on the same day. Right as she got the shot, she wanted to vomit also and got shaky. On 12Mar2021, she woke up with whistling in her breathing for a few minutes then it was done. At the same moment, her eyes were changed eventually. She had mucus in my eyes as her vision wasn't as good and behind her eyes, they were dry one eye (left). So, watching TV wasn't as good and became bothersome. She later noticed, the black in here eye was taken up most of her eye (as if her eyes were dilated). Her eyes and hearing were sharp also now sharp as she was reading better (without my read glasses) and had to turn down the volume in her TV. She also felt like she was getting hemorrhoids for a few days but then it went away. She also had black stool, then constipation (harder stool) eventually went the day right after the shot (12Mar2021). Then around 5pm, she had feeling like she had too much sugar and was dry which she needed water. Once she sat down, her living room door seemed like it was so much further away, stairs the spindles were larger in size, it was if she was high on something. It was different nothing but this injection. She was also experiencing a feeling of peace and calm. As if nothing was wrong, no stress (stressing about something) she couldn't even think of- everything was gone, a calming effect. It was high feeling. The next day (13Mar2021), she had a super watery bowel movement then went into clay like and drier consistency but still dark (she never had stool this dark). In Mar2021, she also stated that there was a movement under her skin like a pre-herpes or a pre-shingles. She mentioned that she knew herpes and the movement under her skin was shingles feeling. Her skin was also extremely dry. On 17Mar2021 (a week after the injection), she woke up to my heart spasm. It was beating real fast (beating like right under her skin), no pain and heart attack but more than a heart flutter. She didn't know whether it was going to beat or stop. She also woke up with a loud whistle (louder than before) out of a dream. She stated that during the day she doesn't get the stressed, but in her dream, it was magnified and woke up in a violent vicious fury. She had 3 nights of this (uncalm coming into my dreams viciously, morbidly gross) started on 14Mar2021. The heart spasms come as a few seconds and goes away but that's happened twice which it scares her. She also stated that there was feeling of hardness in her lower abdomen and heart area (belch) in Mar2021. The injection almost reversed her beta blockers (which keep it in the 50s) it went to 79 (same as it was before she started taking beta blockers) but her blood pressure was normal 121/something (that was a good thing). She also mentioned that her energy was so much more while other people woke up early, cleaning up -would get sleepy and a little tired. But this (injection) gave her energy. Her injection site for the first 2 weeks also had an itch, that would come up (not constant) almost like a yeast infection which had an extreme itch. There's pain was there on touch (no throbbing pain) it took over a week before it was gone. She also mentioned that the chills were off and on for 4 days. The vaccine also did something to her weight as she was expecting to lose weight, but she didn't. One day, she gained 3.2 pounds then the next day lost 3 pounds. Her tooth also broke (but no pain in her tooth) even she had a sensation of her teeth being weak which she could feel it. Her tooth broke eating a tortilla chip and that's weird. She wanted to know if other people had called in with the symptoms that she had experienced. The patient recovered from breath sounds abnormal and constipation on 12Mar2021; cardiospasm, chills and vaccination site pain in Mar2021 while the remaining events were unknown. No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.
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| 61 | 2021-04-17 | fatigue | Extreme weakness & Fatique Dizziness Fainting Death 04/09/2021 |
| 61 | 2021-04-17 | fever, headache, cough |
dizziness; headache; fever; stomach cramps; migraine; no appetite; dry cough; fainting; stomachache;...
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dizziness; headache; fever; stomach cramps; migraine; no appetite; dry cough; fainting; stomachache; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 61-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 61 years old, administered in arm left on 23Mar2021 19:15 (Lot Number: EN6207) at single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, arthrosis, osteoporosis, due to arthritis the patient couldn't eat pork because her joints get swollen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included etanercept (ENBREL); methotrexate sodium (METHOTREXAAT). The patient experienced fainting, stomachache, stomach cramps, migraine, no appetite, dry cough on 24Mar2021 15:30, dizziness, headache, fever on 25Mar2021. The patient stopped using Enbrel and taking Methotrexate a few days prior Pfizer's vaccine. Next day on 24Mar2021, the patient had stomachache, 3rd day (25Mar2021) started with dizziness, headache and fever. Symptoms kept going after 10 days. 5 days later the patient went to the hospital and was prescribed something for stomach cramps and migraine. But the fever continued. 3 days later doctor prescribed an antibiotic since she didn't know the reason of the fever. During the course of the fever the patient had been taking Tylenol on daily basis. Fever came and went and the patient had no appetite and keep with fainting. Doctor ordered lung rx but the patient couldn't do it. 10 days later the patient had dry cough (event onset date was also reported as 24Mar2021, 15:30). The same symptoms remained. The patient did not receive treatment for all events (except fever). Events resulted in Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. The outcome of the all events was reported as not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
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| 61 | 2021-04-18 | fatigue |
having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, lef...
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having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, left leg weakness; trouble walking/stumbling; speech problems; slurred speech; fatigue; injection site pain; nausea; pain in my left hip; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8727), via an unspecified route of administration, administered in left arm on 29Mar2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included chronic fatigue syndrome, fibromyalgia, sulfa allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced immediate fatigue, injection site pain, nausea, along with pain in her left hip the day after her first Covid vaccine on 30Mar2021 05:00 (Tuesday). The injection site pain resolved after a few days, but she continued to be exhausted and nauseous all week. On 02Apr2021 (Friday), she began to experience numbness on my entire left side, left arm and hand weakness, left leg weakness, trouble walking, speech problems, having to really think about her words (her daughter-in-law was typing this as she could not), slurred speech, stumbling. Her family was concerned she was having a stroke on 02Apr2021 05:00, but have no drooping in her face. She was so scared that she will not be getting her second vaccine. She have not gone to a doctor, as she do not have insurance. The symptoms were continuing. No treatment was received for the adverse events. The outcome of the event 'injection site pain' was recovered; the events fatigue and nausea was not recovered; and unknown for the rest of the events. Events were reported as non-serious. Information on lot/batch number was available. Additional information has been requested.
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| 61 | 2021-04-18 | malaise, headache |
tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light a...
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tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light and sound sensitivity/head pounding; light and sound sensitivity; light and sound sensitivity; nausea; lightheadedness; My arm was sore; Felt absolutely terrible; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 01Apr2021 13:30 (1:30 pm) as single dose for COVID-19 immunization in a clinic. Medical history included autoimmune hypothyroidism, gastrooesophageal reflux disease and don't tolerate NSAIDs but not allergic all from an unknown date. Concomitant medications included levothyroxine; esomeprazole magnesium (NEXIUM); cetirizine hydrochloride (ZYRTEC ALLERGY); gabapentin; and estradiol (ESTROGEL) all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromicin and experienced drug intolerance but not allergic on an unspecified date. The patient previously received the first dose of bnt162b2 (lot number: EN6204) on 11Mar2021 1:30 pm administered in left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination. On 01Apr2021, it was reported that the patient experienced tachycardia (avg. 125 bpm), dry mouth, low sodium, low potassium, excruciating headache/head pounding, light and sound sensitivity, nausea, lightheadedness, arm was sore, and felt absolutely terrible. The patient was hospitalized for tachycardia (avg. 125 bpm) for 1 day. The events required physician office and emergency room visit. the patient was treated with IV saline, IV anti-nausea, and IV morphine. The patient underwent lab tests and procedures which included blood potassium: low, blood sodium: low, and heart rate: 125 bpm - tachycardia all on 01Apr2021. The outcome of the events was recovered.
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| 61 | 2021-04-21 | headache |
After the vaccination, I experienced pain and tingling/numbness in upper arm radiating to under the ...
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After the vaccination, I experienced pain and tingling/numbness in upper arm radiating to under the arm. Throughout the day and into the night I had pain, redness, itching and swelling at injection site. The next day (21st) a hard lump developed under the skin where I had the injection. I also had a headache and muscle aches. I didn't take any medication for the pain and discomfort as I was told it was beneficial to let the reactions occur without drug interaction or interference.
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| 61 | 2021-04-24 | headache, fatigue |
Mild headache and moderate fatigue exacerbated with activity; Mild headache and moderate fatigue exa...
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Mild headache and moderate fatigue exacerbated with activity; Mild headache and moderate fatigue exacerbated with activity; This is a spontaneous report received from a contactable nurse (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via unspecified route of administration in left arm on 12Feb2021, (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient was non-pregnant at the time of vaccination. The patient medical history included stage 1 hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had been tested for COVID-19, undergone Nasal Swab on 21Feb2021 and resulted in negative. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient concomitant medication included multivitamin. The patient previously took Keflex and experienced allergy. On 13Feb2021, the patient experienced mild headache and moderate fatigue exacerbated with activity. The patient visited physician office for the events. The patient did not receive treatment for the events. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) in left arm on 09Mar2021 for COVID-19 immunisation. The seriousness of the events was reported as disability. The outcome of the events was not resolved. Information on Lot/Batch number was available. Additional information has been requested.
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| 61 | 2021-04-24 | headache |
Bell's Palsy; Persistent headache; This is a spontaneous report from a contactable consumer (patient...
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Bell's Palsy; Persistent headache; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 12:00 (at the age of 61years) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on 06Mar2021 12:00 (at the age of 61years) for Covid-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. It was reported that the patient experienced Bell's Palsy 10 days later. It was further reported that the patient had a persistent headache from date of second vaccine to now (pending clarification), including onset of Bell's Palsy. The onset date of adverse events was 07Apr2021 (11:00 AM) (as reported). The adverse events resulted in Emergency room/department or urgent care. The patient was treated with steroids and anti-viral. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. Information on the lot/batch number has been requested.
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| 61 | 2021-04-24 | headache |
felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Heada...
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felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Headache; nausea; could not sleep for 6 days; Heart Racing; Body shaking; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6208), via an unspecified route of administration, administered in arm right on 12Mar2021 09:30 (at the age of 61-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma, blood pressure and cholesterol; all from an unknown date. The patient had known allergies. No covid prior vaccination. No other vaccines in four weeks. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR); chlorphenamine maleate, phenylpropanolamine hydrochloride (NASAMEX); simvastatine; ibuprofen; losartan; and furosemide (FUROSE); all were taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 10:00, the patient experienced chest pain, rapid heartbeat, high blood pressure, dizziness, felt like she was going to faint and couldn't walk so dizzy. Her heart raced/heart racing for 5 days, headache, nausea and could not sleep for 6 days and body shaking. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events. Double the dose of losartan for blood pressure. Not tested covid post vaccination. The outcome of the events was recovered.
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| 61 | 2021-04-24 | headache |
Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headach...
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Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headaches. It has been 36 days now and the headaches are still there but not as severe. The ear ringing tho; It is extremely irritating; Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headaches. It has been 36 days now and the headaches are still there but not as severe. The ear ringing tho; This is a spontaneous report from a contactable consumer (patient). This 61- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: ER8733), via an unspecified route of administration, on 01Mar2021 at 12:00 AM (at the age of 61-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was reported as "other" and anatomically located on the left arm. Historical vaccine included: bnt162b2 (COMIRNATY, Solution for injection, Lot number EL9265,) dose 1 on 08Feb2021, for covid-19 immunization. No allergies to medications, food, or other products. The medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021, she experienced Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headaches. It has been 36 days now and the headaches are still there but not as severe. The ear ringing thou is still present 24/7. It is extremely irritating and there is nothing i can do to make it better. Treatment was not received for the adverse event. The clinical outcome of the events was not recovered. On 05Apr2021, the patient was tested for COVID-19 via Nasal Swab since having the vaccine, with a negative result. No follow-up attempts are possible. No further information is expected.
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| 61 | 2021-04-27 | headache, fatigue, chills, fever |
Tiredness; Chills; Fever; Doesn't feel good, weak; Lymph node swollen, hurts, can't touch it; Nauseo...
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Tiredness; Chills; Fever; Doesn't feel good, weak; Lymph node swollen, hurts, can't touch it; Nauseous; Headache; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old female patient received the second dose of BNT162B2 (COMIRNATY Formulation: Solution for injection) via unspecified route of administration as a SINGLE DOSE on 07Apr2021 02:35PM for COVID-19 immunization. The patient had no relevant medical history and family history. Patient received historical vaccine of first dose BNT162B2 (COMIRNATY) via unspecified route of administration in left arm on 17Mar2021 02:35 PM for COVID-19 immunization. Medical history and concomitant medication was not reported. No family history. Patient reported as does not think her medications had anything to do with the events. she takes all the same medications and didn't have any events with the first vaccine. On 07Apr2021 at 14:35 after second vaccine she got headache right after that and still ongoing. On 08Apr2021 lymph node under arm swollen hurts and she can't touch it and still ongoing, she was nauseous around 5 or 6 in evening. On 08Apr2021 2:00 AM she had chills, tiredness, doesn't feel good weak and fever was 100.5 then it went higher and lower. Second shot on Wednesday and she really sick was 25 percent better today. No Prior Vaccinations (within 4 weeks). The outcome of event recovered for Chills, Fever on 09Apr2021, Nauseous on 08Apr0221 and not recovered for Tiredness, Headache, Doesn't feel good, weak, Lymph node swollen, hurts, can't touch it. No follow-up attempts are needed. No further information is expected.
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| 61 | 2021-04-27 | throat pain, fatigue, body temperature increased |
I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pai...
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I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.
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| 61 | 2021-04-28 | fatigue, headache, fever | Fever, muscle ache, headache, extreme fatigue |
| 61 | 2021-04-28 | fever | Fever. Temp increased from 95.7f to 100.7f. Fever broke after 15 hours. |
| 61 | 2021-04-30 | malaise, fatigue |
severe vertigo; fall down on the floor; nausea; horrible spinning; vomited; dizzy; generalized weakn...
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severe vertigo; fall down on the floor; nausea; horrible spinning; vomited; dizzy; generalized weakness; brain fog; a little tired; a little off; Fatigue; sore arm; couldn't eat; couldn't open her eyes; nystagmus; couldn't walk at all without help; This is a spontaneous report from a contactable consumer, reporting for herself. A 61-year-old female patient received the second dose of the bnt162b2 (BNT162B2; Lot Number: EN6208; Expiration Date: Jun2021), via an unspecified route of administration in the right arm on 19Mar2021 at 13:30 at a single dose for covid-19 immunisation. Medical history included ongoing celiac disease diagnosed in 2012 and has been gluten free ever since, allergies, and anxiety. Concomitant medications included zolpidem tartrate (AMBIEN) taken for sleep; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergies; alprazolam (MANUFACTURER UNKNOWN) taken for anxiety; vitamin d nos (MANUFACTURER UNKNOWN) taken for immune system health; and magnesium (MANUFACTURER UNKNOWN) taken for health. The patient previously received the first dose of the bnt162b2 (Lot number: EN6203) at 61 years of age on 26Feb2021 between 5:15PM and 5:30PM in the left arm at a single dose for covid-19 immunization and the flu vaccine (INFLUENZA) for immunization 15 years ago and experienced arm was sore. There were no other prior vaccinations within 4 weeks. On 19Mar2021, the patient experienced sore arm. On 21Mar2021, the patient experienced a little off, fatigue, brain fog, a little tired. On 31Mar2021, the patient experienced severe vertigo, fall down on the floor, nausea, vomited, horrible spinning, generalized weakness. In 2021, the patient experienced couldn't open her eyes, couldn't eat, nystagmus, could not walk at all without help. On an unknown date, the patient experienced dizzy. The events, severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning, required emergency room and physician office (video) visits. The patient was hospitalized for severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning from 31Mar2021 to 02Apr2021. The clinical course was as follows: the patient received the second dose on 19Mar2021 and she didn't really have any bad side effects, a sore arm, and a little tired on the second day, maybe a little off but was fine. 12 days later she was vacuuming and had severe vertigo, she was down on the floor, just horrible spinning, horrible nausea and laid on floor and vomited all day. Her doctor told her to go to the ER. They did all kinds of tests with unknown results on an unknown date and she could not open her eyes for 2 days, she was so violently spinning with vertigo, they gave her fluids. She went in on Wednesday and by Friday she was a little better, she could open her eyes, still had spinning and vertigo. It was like nystagmus, her eyes were, she just really couldn't open her eyes for the doctor, had generalized weakness and couldn't walk at all without help in the hospital. The only time she moved from one position was to go to the bathroom with assistance. In the ER, she could not get up out of bed the first night they were trying all ways of catharizing her. She could not even get out of the bed with the help, they had to carry her to the CAT scan with negative result on 31Mar2021. She had slightly improved but still had vertigo and she was not vomiting anymore, that was only the first couple days. She was sent home with medications for dizziness and nausea but they didn't do anything. Two weeks later she was still dizzy, had vertigo, it was way better than it was, she can open the windows a little bit but she was basically in a dark room for like the first week and a half. Not violent like it was the first couple of days. The events were further described as: she was a little sore on 19Mar2021, 20Mar2021, 21Mar2021, and maybe the 22Mar2021 her arm was still sore. She clarified the sore arm pretty much ended on the 22Mar2021. She was surprised she felt fine on 19Mar2021 and 20Mar2021 and on the evening of 21Mar2021, in the middle of the night between 20Mar2021 and 21Mar2021 she felt a little off and a little more tired. On 21Mar2021, she didn't feel great, fatigued and brain fog but was fine after that. She began feeling a little off and a little tired early morning on the 21Mar2021. That was pretty much gone by the 22Mar2021. The feeling tired and a little off and the brain fog and fatigue went away 22Mar2021. She vomited constantly, started suddenly and violently and was incapable of moving, all she did was vomit and lay on the floor. It was a complete 360, she was fine vacuuming a minute before and then suddenly got dizzy and went down and could never get up. She had to be taken from upstairs in her house and transported to the hospital. She was not really experiencing the nausea now, she was not completely herself but she can eat, she couldn't eat for the first couple of days and was on IV fluids and once she got out of the hospital was able to eat a little and now eating almost normally. It took a week to eat normally and she couldn't eat holiday dinner on 04Apr2021. From 31Mar2021 to 10Apr2021, every day the nausea has slightly been improving. She was not quite herself and still has vertigo and was making herself eat her meals. She vomited 30 times and in the hospital they gave her an IV to stop that and never vomited in hospital, maybe once in the ER. She confirmed the 31Mar2021 was the last time she vomited. She had not recovered completely from nausea. She used be running around all the time, she would walk 10 miles per week to exercise, yesterday she had a mammogram scheduled and she was just so wiped out for doing something for the first time and had to lie down for the whole rest of the day. She was hospitalized from 31Mar2021 until the evening of 02Apr2021 when they let her out. She was given medication for nausea and dizziness didn't do anything. She was given ondasetron (ZOFRAN), 4 mg and meclizine. Because of her weakness, the patient was checked to see if there was any brain bleed or brain stem problems that would explain the vertigo and did not find anything. The tests were negative for any brain problems on an unknown date. Lab data included: blood levels: low on vitamin d (probably because she was not absorbing nutrients as well) on an unknown date, endoscopy: unknown results on an unknown date, and MRI: negative on 01Apr2021. Therapeutic measures were taken as a result of severe vertigo, fall down on the floor, nausea, horrible spinning, vomited, and dizzy. The clinical outcome of the events, severe vertigo, nausea, generalized weakness, could not open her eyes, nystagmus, could not walk at all without help, was recovering. The clinical outcome of the events, fall down on the floor, horrible spinning, dizzy, was unknown. The clinical outcome of the events, a little off, fatigue, sore arm, brain fog, and a little tired, was recovered on 22Mar2021. The clinical outcome of the event, vomited, was recovered on 31Mar2021. The clinical outcome of the event, could not eat, was recovered in 2021. No follow-up attempts are needed. No further information is expected.
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| 61 | 2021-05-03 | fever |
Every time she bends over, if her head gets below her shoulders to pick something up she will black ...
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Every time she bends over, if her head gets below her shoulders to pick something up she will black out; fever; everything in her body ached; vertigo; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 26Mar2021 10:00 (Batch/Lot Number: ER8733; Expiration Date: Jul2021) as single dose at age of 61-year-old for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis. Concomitant medications included methotrexate; hydroxychloroquine. Adverse event following prior vaccinations violently ill from flu shot, ended up in urgent care, 20 years. The patient experienced every time she bends over, if her head gets below her shoulders to pick something up she will black out, fever, everything in her body ached, vertigo on an unspecified date in 2021. Clinical course: The first Covid 19 vaccine she ran a fever and everything in her body ached. Every time she bends over, if her head gets below her shoulders to pick something up she will black out. She reports she has blacked out in the shower and blacked out from leaning off the sofa to pet her dog. She almost went into her coffee table trying to pet her dog. This lasted for about 5 days after she received her first Covid 19 vaccine. After about 5 days it cleared up and went away. She called the facility that gave her the Covid 19 vaccine, a drive thru facility and they told her she had vertigo. She knows she didn't have vertigo because she didn't have these problems until after she received the Covid 19 vaccines. Outcome of event black out was recovered in 2021, and outcome of other events was unknown.
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| 61 | 2021-05-05 | headache, throat pain, runny nose, cough |
Patient received COVID vaccines 1/29/2021 and 1/8/2021. On 5/2/2021 developed body aches, cough, he...
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Patient received COVID vaccines 1/29/2021 and 1/8/2021. On 5/2/2021 developed body aches, cough, headache, rhinorrhea, sore throat. Tested positive for COVID.
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| 61 | 2021-05-05 | nasal congestion, runny nose, chills, cough, fatigue, headache |
Cough; Shortness of Breath; Fatigue, Chills, Muscle or Body Aches, Headaches, New loss of taste or s...
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Cough; Shortness of Breath; Fatigue, Chills, Muscle or Body Aches, Headaches, New loss of taste or smell, Congestion or Runny Nose, Diarrhea; Vomiting. Prednisone (DELTASONE) 10 mg tablet; Take 2 tablets (20 mg total) by mouth 2 (two) times a day for 4 days-Azithromycin (ZITHROMAX) 250 mg tablet; z pack. 500 mg day one 250 mg day 2-5. -Albuterol HFA (PROVENTIL;VENTOLIN) 90 mcg/actuation inhaler; Inhale 2 puffs every 6 (six) hours as needed for wheezing for up to 7 days.
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| 61 | 2021-05-06 | headache |
Headache. Denies c/p, swelling, itching. Extended observation. BPs 173/88 (HR 89), 181/87 (HR 86), O...
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Headache. Denies c/p, swelling, itching. Extended observation. BPs 173/88 (HR 89), 181/87 (HR 86), O2 100%. Stable gait w/one person assist. Stable and released.
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| 61 | 2021-05-07 | fatigue, headache, fever, sweating |
Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the bac...
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Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the back kind of by the lungs; She has been sick; Her mental status was also affected; What scared her was not feeling like she was getting enough oxygen; Nausea; Body pain/flu-like body pain in her muscles over her shoulders; Out of it; Pain in her back where her lungs are; Problems breathing/Her breathing still almost feels labored; Hot and cold sweats; Dizzy; Shaky; Weak; Tired; Headache; Anxious; Fever; Itchy; Arm hurt; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 61-year-old female patient received first dose BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (Batch/Lot Number: TW0151) as SINGLE DOSE for covid-19 immunization. Medical history included cancer, pneumonia, pain in her lungs, smoker and arthritis. The patient's concomitant medications were not reported. The patient experienced what scared her was not feeling like she was getting enough oxygen on an unspecified date, problems breathing/her breathing still almost feels labored on 11Apr2021, arm hurt on 09Apr2021, pain in her back where her lungs are on 11Apr2021, hot and cold sweats on 10Apr2021, dizzy on 10Apr2021, shaky on 10Apr2021, nausea on 13Apr2021, body pain/flu-like body pain in her muscles over her shoulders on 11Apr2021, out of it on 11Apr2021, weak on 10Apr2021, tired on 10Apr2021, headache on 10Apr2021, anxious on 10Apr2021, fever on 10Apr2021, itchy on 09Apr2021, feeling like maybe there is something wrong with her spleen on an unspecified date, the pain is in the left side of the back kind of by the lungs on an unspecified date, she has been sick on an unspecified date, her mental status was also affected on an unspecified date. Patient had the first dose of the Covid Vaccine on 09Apr2021 and gradually her arm hurt, she had hot sweats, she felt dizzy, was shaky, had nausea, and had body pain. The one thing she is concerned about was she had pain in her back where her lungs are and she was having problems breathing. She has a little bit of that still. She has also been out of it. Her breathing still almost feels labored, and this past weekend she thought she would go to the emergency room. Her main concern is this awful pain in her back while she was having problems breathing and getting enough oxygen. She felt weak, dizzy, and shaky. She got scared. She has been sick, she had cancer a long time ago. What scared her was not feeling like she was getting enough oxygen. The pain is in the left side of the back kind of by the lungs. It goes directly from the front to the back. On Monday it started feeling better. Today it is so much better. She will feel like she is not getting enough oxygen or giving a full breath and then this in her back. She remembers having pneumonia years ago and having pain in her lungs. That's why she knows the pain is in the back of her lungs. She has to say she is a smoker. She slowed down and couldn't smoke this week or during that. She kind of quit, that's her reality now. The pain comes and goes throughout the day but it is not as bad. She didn't have this shortness of breath and other things until a couple days after she got the vaccine. It gradually came up on her. She was not having trouble breathing, it was more slightly labored. It was not profound, just there. Sometimes when she is speaking after a while she gets tired and will have to take a moment and take a deep breath. It is so much better. She called her primary care physician and was anxious, and all he said was she would feel effects for 2 weeks. He wasn't very helpful. Her arm hurt the day that she had the shot. Even today there are little bits of pain but very light. 09Apr2021 through 11Apr2021 was when everything really hit. It was hard to lift up her arm. It was a little pain, it was no big deal. She would have the AC on and blast it when she had the hot and cold sweats. She was using napkins because she was sweating profusely. It felt like she obviously had a reaction to the vaccine. It's normal she guesses. She didn't expect it for the first dose. The 11th, 12th, 13th, and 14th it was really bad. Her whole body was sweating and would get wet. She'd be hot and then cold. She was anxious because she was having problems breathing. She still gets a little bit of hot and cold sweats, but nothing compared to what she went through. As the days go on she is slowly getting better. She was dizzy not just during the day, at night she couldn't sleep because of it. She has gradually gotten better. Yesterday she tried to do some gardening but felt so weak she had to come back inside. When she gets up she feels weak and a little bit of lack of air. She has labored breathing. She was real itchy. The shakiness, dizziness, and anxiety all came on and were horrible. She doesn't know if the nausea was because she couldn't eat and had to take her regular medication. It was very light nausea. She had flu-like body pain in her muscles over her shoulders. Her headache was major too during all of this. The headache is something that comes and goes still. It is a weird kind of headache. She had a fever and got like flu all over body pain. She doesn't know how to explain how she felt out of it. She doesn't know if it was the fact she was so sick. She had a feeling of did she do that. She couldn't make decisions. She would need to take the garbage out and go back to the garbage and think what did she come here for. Her mental status was also affected. The weakness gradually got really bad, and she still hasn't recovered from it. She still feels weak and tired when trying to do things. She was tired the day after she got the vaccine. The first day she thought it was nothing and she was fine. Gradually it got real bad when she was sick. She didn't feel that flu-ish feeling but was weak and tired. She got dizzy and she had the brain fog thing. She was having really bad headaches during the same time. The weakness and tiredness go hand in hand. She takes a mineral for her thoracic spine, but she takes that more for elderly arthritis. She doesn't have any conditions that she thinks played a role. She has been feeling like maybe there is something wrong with her spleen. Took Tylenol for her fever. Mentioned fever would go away and come back. The patient underwent lab tests and procedures which included body temperature: 102, 99 and 100.1 (unit unspecified) all on unspecified dates. Therapeutic measures were taken as a result of fever and itchy. Outcome of the event problems breathing/her breathing still almost feels labored, arm hurt, pain in her back where her lungs are, hot and cold sweats, dizzy, out of it and headache was recovering. Outcome of the event fever was recovered on 13Apr2021, itchy was recovered with sequelae on 14Apr2021, body pain/flu-like body pain in her muscles over her shoulders was recovered on 16Apr2021, nausea was recovered on 16Apr2021, shaky was recovered on 19Apr2021. Outcome of the event weak and tired was not recovered. Outcome of all the other events was unknown.
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| 61 | 2021-05-07 | headache |
Very late diagnosing as shingles; Headache at work after vaccine; then got more severe along with le...
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Very late diagnosing as shingles; Headache at work after vaccine; then got more severe along with leg very sensitive and burning feeling; then got more severe along with leg very sensitive and burning feeling; severe stomach pain; This is a spontaneous report from a contactable other HCP (patient). A 61-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 28Jan2021 09:00 (at 61 years old), single dose for covid-19 immunisation. Medical history included concussion, endometriosis, all from an unknown date. Concomitant medications included estradiol; progesterone. No other vaccine in four weeks. On 28Jan2021 09:00, patient experienced Headache at work after vaccine , then got more severe along with leg very sensitive and burning feeling, better then 5 nights very severe stomach pain-Dr appt and ER to get sonogram, CT-Very late diagnosing as shingles. The outcome of the events was not recovered. Treatment of adverse events was CT, Sonogram. No covid prior vaccination. Not covid tested post vaccination. No Known allergies. Information about lot/ batch number has been requested; Sender's Comments: Based on known disease pathophysiology, the event herpes zoster is assessed as not related to suspect vaccine BNT162B2.
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| 61 | 2021-05-07 | throat irritation |
itchy throat; an allergic type cough; This is a spontaneous report from a contactable other HCP. A...
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itchy throat; an allergic type cough; This is a spontaneous report from a contactable other HCP. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL 9265) on 03Feb2021 at 09:45 at single dose via an unspecified route of administration on right arm for COVID-19 immunization .Relevant medical history included asthma, supraventricular tachycardia, Premature ventricular contractions and seasonal and drug allergy. Concomitant medications included atenolol, loratadine (CLARITIN [LORATADINE]), acetylsalicylic acid (ASPIRIN 81), magnesium. Approximately 15 minutes after the vaccine patient began to develop an itchy throat with an allergic type cough that lasted about an hour. The cough subsided but the itchy throat continued through the day. Patient took 25 mg Benadryl twice (every 6 hrs) at the advice of her doctor and that stopped the symptoms. The next day patient did not presented itchy throat or cough and did not need to take any more Benadryl. The patient recovered from the events on an unspecified date.
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| 61 | 2021-05-13 | malaise |
1st and 2nd dose- swollen glands; injection site pain in right arm; 2nd dose- shingles/shingles blis...
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1st and 2nd dose- swollen glands; injection site pain in right arm; 2nd dose- shingles/shingles blisters; felt quite ill/not feeling well; second dose- extreme pain in left hand/sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 08Mar2021 (Batch/Lot Number: EN6208) (at the age of 61-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included breast cancer (2-time breast cancer survivor), had lymph nodes removed, and has low thyroid. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for low thyroid from an unspecified start date and ongoing; ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+) taken for an unspecified indication from an unspecified start date and ongoing; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication from an unspecified start date and ongoing; famotidine (PEPCIDAC) taken for an unspecified indication from an unspecified start date and ongoing; esomeprazole sodium (NEXIUM) taken for an unspecified indication from an unspecified start date and ongoing. Patient previously took shingles vaccine on an unknown date (reported as number of years ago) for immunization, flu shots on an unknown date for immunization and also previously took the 1st dose of BNT162B2 (Batch/lot number: EN6200) (at the age of 61-years-old) on 15Feb2021, intramuscular administered in the right arm for COVID-19 immunisation, and experienced injection site pain in right arm, sore arm and swollen gland. Patient stated having what was considered typical, like a sore arm and did have some swollen glands with the first and second dose. It was also reported that after 1st and 2nd dose, there was injection site pain in right arm. After second dose she developed shingles, or what was later found out to be shingles, she had extreme pain in her hand. She thought it was injured or something, it was very painful. She got shingles blisters on her hand, and then also got some on her arm, the opposite arm as the injection. Her dermatologist and internist verified it was shingles. Her internist said it may have been triggered by the vaccine. She clarified it started in the palm of her hand and then traveled up her arm on the opposite side of the vaccine, she got the vaccine in the right arm and the shingles in the left arm. She felt quite ill as a result of the shingles. Her dermatologist put on Valtrex, three times a day. It helped with the spread; it stopped spreading. Her dermatologist was not associating it with the vaccine, and she was not sure she was either. After not feeling well for several days she told internist and he was confident that the vaccine was what caused the shingles. She doesn't remember for sure the event extreme pain in left hand, but it was within a few days after the 2nd dose. The swollen glands started within 24 hours, as well as, the sore arm. It wasn't anything she didn't expect. Like with the flu shot maybe a little worse, but it wasn't severe. Her sore arm was not ongoing. It recovered completely by the next day. Swollen glands came back when the shingles first happened, but they initially began within 24 to 48 hours, for both doses. After the second dose she took two extra strength Tylenol again on the first night again; she just took it once after the 2nd dose. Pain in the hand was 98 to 95 percent better. Her doctor did whole blood work up (unknown results) just to see her white count (unknown results) to rule out something else. The blisters were too small for the dermatologist to scrape and get a biopsy. She did not get the most current 2 dose vaccine for shingles, she only got one dose and that was a number of years ago, she was going to get it but then COVID happened. The outcome of event herpes zoster and pain in extremity was resolving while for other events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
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| 62 | 2020-12-31 | sweating |
REACTION OCCURED 8 MINUTES AFTER VACCINE, CHEST TIGHTNESS, FLUSHED AND DIAPHORETIC, 97.9, 165/83, 77...
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REACTION OCCURED 8 MINUTES AFTER VACCINE, CHEST TIGHTNESS, FLUSHED AND DIAPHORETIC, 97.9, 165/83, 77. 25MG BENADRYL GIVEN.
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| 62 | 2021-01-01 | fatigue |
Severe left upper extremity pain and fatigue for two days after that I took two Tylenol?s and all t...
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Severe left upper extremity pain and fatigue for two days after that I took two Tylenol?s and all the symptoms subsided
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| 62 | 2021-01-01 | headache | Headache |
| 62 | 2021-01-02 | chills, throat pain, influenza like illness, cough |
9 DAYS POST VACCINATION EXPERIENCED SORE THROAT, MILD DRY COUGH, CHILLS W/O FEVER, GENERALIZED FLU L...
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9 DAYS POST VACCINATION EXPERIENCED SORE THROAT, MILD DRY COUGH, CHILLS W/O FEVER, GENERALIZED FLU LIKE MUSCLE ACHES.
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| 62 | 2021-01-02 | malaise, fatigue, fever, headache |
Approximately 12 hours after injection, sudden onset headache, went to bed and woke a couple hours l...
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Approximately 12 hours after injection, sudden onset headache, went to bed and woke a couple hours later with severe back pain, neck pain, deep muscle ache in legs, low grade fever. 24 hours after injection, some decrease in pain with Tylenol, diarrhea, fatigue, general malaise. Loss of taste, loss of appetite . 48 hours post injection- subsiding muscle aches, other symptoms on going, 72 hours post to present, diarrhea, loss of appetite
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| 62 | 2021-01-03 | headache, fatigue, nasal congestion |
Arm was sore for about three days. On 12/21 evening, had headache, some lightheadedness and severe ...
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Arm was sore for about three days. On 12/21 evening, had headache, some lightheadedness and severe back muscle ache. On 12/22, had stomach upset, extreme fatigue, nasal congestion. On 12/24, had diarrhea. Fatigue continued until at least 12/29.
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| 62 | 2021-01-04 | chills, fatigue | fatigue chills arm soreness |
| 62 | 2021-01-04 | fatigue, headache | Severe headache from 12/30 0400 to 1/3/21, extreme fatigue, and excessive thirst |
| 62 | 2021-01-04 | fatigue, fever, chills, headache |
Persistent vomiting from 3am to about noon on Monday. Fever of 38.4 ' C. Headache, chills, fatigue....
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Persistent vomiting from 3am to about noon on Monday. Fever of 38.4 ' C. Headache, chills, fatigue. Slept most of the day. Took acetaminophen when able to drink. Drank ginger tea and ate dry toast in the evening. Tuesday, HA controlled with Acetaminophen and Ibuprofen. Able to eat and increase fluids. Consulted with my PCP who suggested I enter my information. Feeling stronger as time passes. I believe another nights sleep will help.
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| 62 | 2021-01-04 | headache |
By 1400 had low grade HA, by 1600 more severe. Managed with Tylenol. 1800 no appetite, and nauseat...
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By 1400 had low grade HA, by 1600 more severe. Managed with Tylenol. 1800 no appetite, and nauseated. Continued through night.
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| 62 | 2021-01-04 | headache |
Had gotten a headache within 1/2 hour of getting the injection. Within 2 hours after receiving the i...
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Had gotten a headache within 1/2 hour of getting the injection. Within 2 hours after receiving the injection my arms started to itch and upper back areas. Within 4 hours I noticed rash like redness with tiny little spots/bumps all up and down both arms and the itching was getting worse with both arms and upper back areas. This went away by Friday evening. I had the headache until the following Monday evening.
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| 62 | 2021-01-04 | headache | Headache, dizziness, earache |
| 62 | 2021-01-04 | influenza like illness |
6 to 7 minutes after vaccine felt flu like symptoms then could taste medicine. Breathing seemed to ...
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6 to 7 minutes after vaccine felt flu like symptoms then could taste medicine. Breathing seemed to slow down, blood pressure went to 140/90 and always have low blood pressure then tongue felt numb. I work at a hospital so they took me to the ER
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| 62 | 2021-01-04 | fever, chills, fatigue, headache, malaise |
fast heart beat; it was like she didn't feel good; low grade fever; nausea; headaches; chills; sore ...
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fast heart beat; it was like she didn't feel good; low grade fever; nausea; headaches; chills; sore arm /arm soreness; tired; felt like she had a flu; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history included Diabetes, allergies, heart (Heart disorder). Concomitant medications included irbesartan (AVAPRO) for heart, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for allergies, metoprolol for heart, metformin for Diabetes, all were ongoing. The patient (Hospital scheduler/employee) had been experiencing side effects of the vaccine. She took the vaccine on 18Dec2020 and still experiencing nausea, headaches, and chills. She asked how long she would experience these side effects and if she needed to take anything. Patient reported she was exposed to someone who had COVID, her son's girlfriend had direct exposure to COVID and wanted to know how it would affect her. The patient further stated she was a hospital scheduler, she had the Pfizer Covid vaccine on 18Dec2020. She had a sore arm/arm soreness and was tired immediately after (18Dec2020), stated by Saturday 19Dec2020, she started having a low-grade fever, chills, headache, nausea, and still had the soreness in the arm. This went on for 2-3 days. Patient stated that up until now, she still had nauseous feeling that happened intermittently around early morning or mid-day, the chills were midday to early evening, it was like she didn't feel good, had to leave early from work. The fever only lasted a couple of days. She also had one isolated episode of fast heart rate that woke her up in the early hours of Sunday 20Dec2020. Caller stated she expected some of these effects to only last a couple of days but wanted to know if this was normal. She tried working 2 days last week and by mid-day she was just really tired, like she was about to get the flu, she felt like she had a flu just with no respiratory symptoms (De2020). She knew of one other coworker who was experiencing similar symptoms. No patient identifiers were provided, no further information provided. Patient did have history of allergies from when she was a child and was on medication, she was on over the counter medication Zyrtec for years, she didn't know if there could be a conflict between them. She received her vaccine part of the hospital. She also called because her son and his girlfriend live in her house and his girlfriend was exposed to someone who tested positive for Covid, she wanted to know how this may affect her since she had the vaccine. Investigation assessment was no. The outcome of the event "sore arm /arm soreness" was recovered in Dec2020, of "low grade fever" was recovered on 21Dec2020, of the events "tired", "nausea", "headache" and "chills" was not recovered, of the other events was unknown. Information about Lot/Batch number has been requested.
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| 62 | 2021-01-04 | fever, headache, chills | Chills, headache, fever, achey |
| 62 | 2021-01-04 | throat irritation |
Five minutes after vaccine patient had itchiness around eyes, itchy throat and mild shortness of bre...
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Five minutes after vaccine patient had itchiness around eyes, itchy throat and mild shortness of breath. Later, patient reported swelling around eyes and lips.
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| 62 | 2021-01-05 | chills, fever, fatigue |
1/2/21- 1/5/21 Fever, chils, arthralgias, swollen throat, nausea, BLURRY VISION, RED eyes, white no...
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1/2/21- 1/5/21 Fever, chils, arthralgias, swollen throat, nausea, BLURRY VISION, RED eyes, white noise in ears, fatigue lacinating pain ankles, knees ,wrist and finger joints; pain along nerves and vessels fingers with right fourth DIP ulnar side small vessel bleed hematoma 4 cm x 4cm swelling; NO trauma sedenatry Saw Urgent care 1/4/21 -with negative covid 19, strep and flu tests said was repsonse to vaccine Saw primary 1/5/21 Dr hopsital, said probably had covid before and was repsonse to vaccine. 1/6/21; all fingers still swollen no pain most other symptoms improving but TIRED
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| 62 | 2021-01-05 | chills, fever, malaise, fatigue |
I got my shot on the 19th and that evening it was like a light switch and I was so tired I went to s...
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I got my shot on the 19th and that evening it was like a light switch and I was so tired I went to sleep at 730pm I had severe chills and fever and had to go to bed. The next day I still wasn't feeling well and I was called in to get covid tested and I went to the ER on the 21st and took a rapid covid test that was positive. I was stable and had good oxygenation and was discharged. I have fever nausea vomiting I also had problems with O2 stat i was in the 80s and realized I was having respiratory failure so I was admitted on the 27th and I've been here ever since. I had kinetic storm and infusions my O2 stats were bad and I was sent to the covid unit and put on high flow oxygen and negative for a PE, I'm still on the covid unit but I feel much better today
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| 62 | 2021-01-05 | headache, chills, throat pain, fever | Fever,body aches,chills,heada he body aches,light sensitivity,,sore throatpain at site |
| 62 | 2021-01-05 | headache | Headache for 7 days then resolved |
| 62 | 2021-01-05 | sleepiness, fatigue, headache, malaise, chills |
Feeling unwell; Headache; Tiredness; Muscle pain; Chills; Nausea; Injection site pain; had been asle...
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Feeling unwell; Headache; Tiredness; Muscle pain; Chills; Nausea; Injection site pain; had been asleep most of the whole day; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: Arp2021), via an unspecified route of administration on 30Dec2020 at single dose at right arm for Covid virus. Medical history included blood thinner treatment. Concomitant medication included ongoing apixaban (ELIQUIS) for blood thinner treatment. The patient previously took coumadin, warfarin. Patient received the Covid-19 vaccine yesterday. She had been asleep most of the whole day (Dec2020). She had injection site pain, headache, tiredness, muscle pain and chills. She thought she was going to work but that didn't work. She was currently taking Eliquis. She had been on coumadin and warfarin before. She looked at the different medications that needed to be reported. She would also call her physician and make her aware. The start date for "Injection site pain" was 30Dec2020. The start dates for headache, tiredness, muscle pain and chills all were 31Dec2020. The patient also experienced nausea, feeling unwell on 31Dec2020. Investigation assessment was no. The outcome of the event "Injection site pain" was not recovered. The outcome of the other events was unknown.
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| 62 | 2021-01-06 | cough | CoughWheeze |
| 62 | 2021-01-06 | fever, chills | chills, fever, joint pain, muscle aches |
| 62 | 2021-01-06 | fever, headache | Patient report HA and fever. Treatment include Tylenol . |
| 62 | 2021-01-07 | chills, fever | chills, fever, muscle ache, joint pain |
| 62 | 2021-01-07 | fatigue, headache, chills | Chills, headache, muscle pain, tiredness, and nausea. |
| 62 | 2021-01-07 | fatigue, headache, malaise |
Fine pin point rash and itching noted 45 minutes after shot given. Rash noted to neck,spine,hips,upp...
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Fine pin point rash and itching noted 45 minutes after shot given. Rash noted to neck,spine,hips,upper back,upper chest and bend of both arms.Benadryl 25 mg OTC 1/6/21 and 1/7/21.Itching. Itching decreasing 1/8/21. Having copious side effects also of injection site pain,tiredness,headache,joint and muscle pain,nausea,lymphadenopathy and feeling unwell.1/6/21,1/7/21 but feeing better when tylenol 500mg ing system to relieve aches and pains
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| 62 | 2021-01-07 | fatigue, headache |
Pfizer-BioTech COVID-19 Vaccine EUA 24 hrs post vaccination I started feeling fatigued, muscle and h...
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Pfizer-BioTech COVID-19 Vaccine EUA 24 hrs post vaccination I started feeling fatigued, muscle and headaches which seemed to move around my body for about 24 hrs. At one point it seemed to settle into my hand. Knuckles swelled arthritis like. When walking up stairs I had significant muscle weakness in my legs and exertional dyspnea. Eyes felt "feverish" but had no fever. The next morning while trying to do a routine workout the same thing happened. It was a significant change to my normal condition. The dyspnea was the most concerning. The body aches settled into my lower back. Fatigue was moderate-moderately severe. As the day went on things waxed and waned. By the end of 72 hrs. most symptoms subsided. Friday 01/08/2021 I had a completely normal workout, no exertional dyspnea, fatigue subsided, no body aches. Back to normal. I would consider the symptoms to have been Moderate+.
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| 62 | 2021-01-07 | fatigue, headache |
Back pain; Muscles felt really tightened up and stiff when getting out of bed and throughout the day...
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Back pain; Muscles felt really tightened up and stiff when getting out of bed and throughout the day (worst complaint); slight nausea/nausea; slight fatigue; slight headache; slightly stiff neck; right arm pain; The muscles knot up under her rib cage/muscle tightness; This is a spontaneous report from a contactable other health care professional. A 62-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), intramuscularly in the left arm on 29Dec2020 at 06:30 at a single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis from an unknown date and unknown if ongoing. Concomitant medications included ergocalciferol (VIT D), levothyroxine (MANUFACTURER UNKNOWN); both taken for an unspecified indication from an unspecified date to an unspecified date. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced allergy from an unspecified date to an unspecified date, influenza vaccine (FLU VACCINE) for an immunization on an unspecified date (received within two weeks of vaccination). The patient experienced the following events and outcomes: muscles felt really tightened up and stiff when getting out of bed and throughout the day (worst complaint) (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight nausea/nausea (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight fatigue (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight headache (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slightly stiff neck (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, right arm pain (non-serious) on 30Dec2020 with outcome of unknown, back pain (non-serious) on 31Dec2020 with outcome of unknown, the muscles knot up under her rib cage/muscle tightness (non-serious) in Dec2020 with outcome of unknown. The patient received the COVID-19 vaccine on 29Dec2020 at work, and she had been experiencing adverse events since. The worst side effect she was experiencing was muscle tightness. At the time of the report, the patient got up at 09:00, and her "back was killing her." The patient was achy. The patient would tighten up really tight under both rib cages, and it made her nauseous. The patient had been taking ibuprofen (ADVIL) and ibuprofen (MANUFACTURER UNKNOWN since she received the vaccination. The patient received the vaccine in her left arm, but her right arm hurt the next day. The next day after that (30Dec2020) she woke up and the right side of her back around the kidney area hurt. It was the right side lumbar. The next morning after that, "her entire back was killing her down the middle of her spine. From her head all the way down." Since then, it came and went. The patient could not say if it was persisting, improving or worsening for any of the symptoms. "It just grabs her." The day before the report, the patient thought she was doing better. The patient cleaned the house, and then sat down to eat. The past two nights, it had "hit her really hard during supper time." Both of her sides of her back would tighten up; "tense up like waiting for an impact before a wreck." The patient's back would seize up. The patient could not get comfortable; and would start pacing. Then, she would try to lay down. Last night, it took a half an hour to loosen back up. "It knots up like crazy. It was bad enough, she thought she was going to pass out." The patient did not know if it was the combination of eating supper or what. The patient thought if she got up that maybe she would feel better. The patient started pacing around. The patient went outside because she thought maybe fresh air would help. When it would tighten up under her rib cage, it made her nauseous. The patient did not know if it was a "vagus nerve thing or what." The patient was close to throwing up. The muscles knot up under her rib cage. The patient's back felt like she fell off a horse. It was weird to her that her left arm never bothered her. "Nothing stays the same." Sometimes it was her entire arm or part of the arm that hurt. Like on top of her forearm. The patient thought she was doing good and then it would come back. When she moved her arm upward, she felt it. The patient said she could deal with the arm pain. It was the knotting up pains that were the worst. The patient tried calling an institute (name withheld) because it happened while eating dinner the other night. The institute (name withheld) "nurse was useless." The pain was across her sacroiliac area. The patient had been "living on Advil and ibuprofen for her back pain." The patient had been taking them together. The patient worked nights, and she was planning on going to work the night before the report, but she had to text her boss and tell her she could not come in. The patient was in good health; had perfect blood pressure and her sugar was normal. The patient was not diabetic. The patient's labs were always normal. The patient was really dreading that second shot. "The flu shot kicked her butt for a couple of days, but this was way worse." The patient started reading up on the COVID vaccine, and it said usually younger people had severe side effects. That old people have less of a response. The patient did not know why she was experiencing such side effects. At the time of the report, it was day 7 or 8, and she was still feeling bad. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
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| 62 | 2021-01-07 | fatigue, fever | body aches, low grad temp, nausea that led to one episode of dry heave vomiting, weakness & fatigue |
| 62 | 2021-01-07 | headache, chills, fever | Fever 100.6 F , chill, headache, pain |
| 62 | 2021-01-07 | headache, chills | Headache, Myalgia chills |
| 62 | 2021-01-07 | headache, fatigue, chills |
At 12 hrs after injection vomiting and severe chills for an hour. 15 hrs after injection severe bod...
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At 12 hrs after injection vomiting and severe chills for an hour. 15 hrs after injection severe body aches for an hour. 18 hrs after injection was mild-moderate headache and moderate tiredness and confusion for another 4-6 hrs.
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| 62 | 2021-01-07 | headache |
46 hours after receiving vaccine, experiencing twinges of moderate to severe headache and/or ear pai...
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46 hours after receiving vaccine, experiencing twinges of moderate to severe headache and/or ear pain left side, similar to symptom experienced when I contracted Covid in Mar2020; 46 hours after receiving vaccine, experiencing twinges of moderate to severe headache and/or ear pain left side, similar to symptom experienced when I contracted Covid in Mar2020; This is a spontaneous report from a contactable healthcare professional, the patient. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK5730) solution for injection in the left arm on 30Dec2020 at 13:15 (at the age of 62-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included COVID-19 in Mar2020. Concomitant medications included atorvastatin, colecalciferol (VITAMIN D) and cetirizine. The patient no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19 in Mar2020. On 01Jan2021 at 10:30 (about 46 hours after receiving vaccine), the patient experienced twinges of moderate to severe headache and/or ear pain left side, similar to symptom experienced when I contracted Covid in Mar2020. No treatment was provided for the events ear pain and headache. The outcome of the events ear pain and headache was unknown. Since the vaccination, the patient has not been tested for COVID-19.
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| 62 | 2021-01-07 | malaise, headache, sleepiness |
10:23pm felt a slight headache and nausea. Left work at 10:43pm since didn't feel good. While on r...
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10:23pm felt a slight headache and nausea. Left work at 10:43pm since didn't feel good. While on road, my tongue started to tingle and then my lips started to tingle and both sides of face felt numb. This started around 10:50pm? Went to bed and woke up Sat with same tongue, lip tingleling and face numbness. Lips felt very swollen. Felt that way throughout the weekend. On Monday, went back to work place injection area and requested someone talk to me. Nurse practioner came out and spoke to me, asked about balance of facial features, no problem breathing or swallowing and gave me 25mg benadryl to take 3 times a day. Did nothing but make me sleepy. She calls me Tue am and told me to make an appt with PCP. Made phone appt for Wed. Dr calls me Wed am and gives me presciption for 60mg Prednisone to take for a week (at this time symptoms are the same). the first 3 days taking Prednisone the intensity of tingleling seems to lessen day by day. But on 4th day, the symptoms stopped lessening. Finished the meds anyway. Last 3 days, i've also had that mild headache back in addition to the numbness from face traveling up to my ears. Past few days the tingling in tongue isn't confined to just the edges of the tongue. It started with the first 1/4 of whole tongue and is today tingleling in the front half of whole tongue. One good thing so far is the past few days, my lips feel way less swollen and tingleling is lessening. So, riding this out, hoping it will end sometime this year. Will not be getting the second shot. Just so you know.
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| 62 | 2021-01-07 | throat pain, cough |
Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore th...
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Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Weakness/generalized weakness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162b2 (Pfizer, Lot number: 5730), via an unspecified route of administration at right arm at 22Dec2020 21:00 at single dose for covid-19 immunization. Medical history included Mayonaise allergies. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergies. At 31Dec2020 06:00, the patient experienced Weakness, nausea, occasional dry cough, generalized weakness, neck and lower back soreness, and sore throat which has now dissipated. Tested Positive for COVID-19 on 02Jan2021 (also reported as 01Jan2021, pending clarification). The covid test type post vaccination was Nasal Swab, Covid test name post vaccination was COVID-19 PCR ROCHE c6800(NTX), RNA SARS CoV2 TGT1, PAN SARS RNA TGT2. No treatment received for events. The events result in Emergency room/department or urgent care. The patient was not pregnant. The outcome of the events were nor recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.
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| 62 | 2021-01-07 | fever, headache |
Patient 00037022 DOB 03-21-1958 received 2nd dose Pfizer lot EL1284 on 1-6-2021 in left arm. She ha...
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Patient 00037022 DOB 03-21-1958 received 2nd dose Pfizer lot EL1284 on 1-6-2021 in left arm. She has not had history of reaction before. Starting from midnight that night she has fever between 100.6-101.2, body aches and stiff neck. She also has swollen left arm pit, head ache, Pruritus breathing. She has a history of afib and last night she had two runs of it and took metoprolol.
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| 62 | 2021-01-08 | chills | Myalgia, NauseaVomiting, chills |
| 62 | 2021-01-08 | headache, chills, fever | Fever, chills, muscle aches, headache |
| 62 | 2021-01-08 | headache, chills |
Confusion, Headache, Myalgia, fatigue, chills Narrative: Felt "loopy" with sharp vision initially....
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Confusion, Headache, Myalgia, fatigue, chills Narrative: Felt "loopy" with sharp vision initially. Over 3 day period developed varying degrees of chills, headache, muscle aches. Fatigue on first day.
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| 62 | 2021-01-08 | fever, chills, fatigue | High fever, fatigued, chills |
| 62 | 2021-01-09 | chills, fever |
Fever 100.4 at 0100 am Chills, Body aches Took Motrin two hours later still chills and body aches To...
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Fever 100.4 at 0100 am Chills, Body aches Took Motrin two hours later still chills and body aches Took Tylenol. Two hours later , fever gone and chills stopped, body aches a little. Not much!!
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| 62 | 2021-01-09 | chills |
About 13 hours after injection I started having extreme chills and shaking. Took 2 Ibuprofen and the...
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About 13 hours after injection I started having extreme chills and shaking. Took 2 Ibuprofen and the chills subsided during the night and then had mild/moderate body aches for about another 12 hours. About 48 hours after the injection the top half of my arm is currently slightly swollen, red and hot to the touch.
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| 62 | 2021-01-09 | throat pain, headache, chills, fatigue |
Early morning Friday 01/08/21, moderate pain at injection site, PO Tylenol 1000mg, @ 0615, heading i...
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Early morning Friday 01/08/21, moderate pain at injection site, PO Tylenol 1000mg, @ 0615, heading into work. Then @ 1030 feeling tired, neck & shoulder pain, chills, headache, right ear pain, slight sore throat, PO Motrin, 400mg moderate relief. Total of 30 hrs of recurring symptoms, alternating Tylenol & Motrin throughout. Started to feel better Saturday afternoon 4-4:30p
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| 62 | 2021-01-09 | fever, chills | Fever, chills, nausea, vomiting, dizziness, generalized ache for 24 hours. Tylenol, Zoran, Pepcid |
| 62 | 2021-01-10 | chills, fatigue, fever |
Eight hours after vaccine I developed terrible chills fever, terrible myalgia and weakness . The ...
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Eight hours after vaccine I developed terrible chills fever, terrible myalgia and weakness . The pain was terrible as was the fatigue and fever . I used Ibuprofen. 48 hours later I felt almost completely normal- no pain etc . Then 56 hours later resumption of chills fever for 4 hours . At 64 hours and after ibuprofen feeling better
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| 62 | 2021-01-10 | chills |
Starting on 01/09/2021 at 02:00am woke up nauseous and hot. Body aches especially r arm with tinglin...
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Starting on 01/09/2021 at 02:00am woke up nauseous and hot. Body aches especially r arm with tingling in r hand, dizziness and chills throughout the day They would come and go. Late afternoon, Biceps went into spasms all fingers aching. After nap at 06:00 woke up and all symptoms gone. On 01/10/2021, woke up with tingling and burning from bilateral knees to toes. Lasted 2 hours and then gone. In afternoon 1 episode of dizziness and hot flashes followed by chills. 01/11/2021 Slight headaches. No bodyaches or other symptoms.
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| 62 | 2021-01-10 | fatigue, sweating, chills, headache |
Excessive sweating, body aches intense,chills,fatigue,headaches stating after falling asleep and inc...
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Excessive sweating, body aches intense,chills,fatigue,headaches stating after falling asleep and increase all night and throughout the day.
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| 62 | 2021-01-10 | headache, chills | chill, headache |
| 62 | 2021-01-10 | headache, sinus headache |
ON 12/31/20 AT 1PM, DEVELOPED SORENESS AT INJECTION SIGHT, GREATER THAN NOTICED WITH OTHER VACCINATI...
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ON 12/31/20 AT 1PM, DEVELOPED SORENESS AT INJECTION SIGHT, GREATER THAN NOTICED WITH OTHER VACCINATIONS. LASTED 48-72 HOURS. ALSO HAD HEADACHE, WHICH WAS PRESUMED TO BE SINUS HEADACHE, BUT DID NOT RESPOND TO SINUS MEDICATION. HEADACHE CONTINUED THRU 1/1/21 WITH NAUSEA ALSO NOTED. SYMPTOMS SUBSIDED BY 1/2/21
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| 62 | 2021-01-10 | headache |
Arm pain @ injection site, able to sleep on right side; relieved with Ibuprofen. Headache, mild, nex...
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Arm pain @ injection site, able to sleep on right side; relieved with Ibuprofen. Headache, mild, next afternoon, relieved with Ibuprofen.
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| 62 | 2021-01-10 | headache |
On 1/6/21, I received the initial COVID vaccination. Later that evening, I started to experience pai...
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On 1/6/21, I received the initial COVID vaccination. Later that evening, I started to experience pain, swelling and redness at the injection site (right arm). I also had a severe headache with nausea. I was directed to get a COVID test, at the hospital on 1/7/21. I continued to experience these side effects of the vaccine for the next 2 days.
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| 62 | 2021-01-10 | headache |
Body aches and headache the morning following vaccination. Headache continued next day, but lesser. ...
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Body aches and headache the morning following vaccination. Headache continued next day, but lesser. Relieved by Ibuprofen both days.
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| 62 | 2021-01-10 | fever, cough, chills |
shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever...
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shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever for 4 days, horrible chills that were just debilitating; ached everywhere/ severe aches; site soreness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administration at left upper arm on 18Dec2020 at single dose for COVID-19 immunization. Medical history included auto immune problems, diabetes, thyroid condition, all ongoing since age 28; pemphigusvulgarism since Sep2020 and ongoing. No concomitant medications. Patient is a frontline worker. She received the vaccine on 18Dec2020 at (Name) where she works. 9 days later she got very ill. she didn't know if it's unrelated. She wanted to know if there is anything she need to be watching out for in order to get her second vaccine on Friday. She was so sick and she did have some autoimmune problems. She was really healthy. On 26Dec2020, she had a 103 degree fever for 4 days, horrible chills that were just debilitating. She was just shaking. She ached everywhere, she had severe aches since 26Dec2020. She got tested for Covid and it was negative on 28Dec2020, she had no cough and no vomit. She stayed in bed and drank lots of fluids and toughed it out. By New Year's Day (reported as 30Dec2020) her fever broke but she was so weak and didn't work. She was back at work now. Also, she experienced site soreness from the injection since 19Dec2020. She did have a cough or any shortness of breath. She felt awful. She had recovered. She was just a little nervous because everything she read said the reaction was more severe with second injection. She planned on getting the second shot. She would have a repeat Covid test on 07Jan2020. Reporter seriousness for fever 103: Medically significant. Reporter seriousness for severe aches: Medically significant. Reporter considered the causality of the event site soreness was related with bnt162b2, of the events fever 103 and severe aches was unknown. The outcome of the event fever was recovered on 30Dec2020, of event ache was recovered on 31Dec2020, of event chills was recovering, of event vaccination site pain was recovered on an unspecified date in Dec2020, of events cough and shortness of breath was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fever, pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 62 | 2021-01-10 | fever, headache | Headache Fever, resolved after 24 hrs |
| 62 | 2021-01-10 | runny nose |
Red rash and itching in 4 inch circumference around injection site that lasted 4 days. Sudden onset...
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Red rash and itching in 4 inch circumference around injection site that lasted 4 days. Sudden onset of runny nose and itching of eyes.
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| 62 | 2021-01-11 | body temperature increased | Swollen lips, increased heart rate, temp at 101 |
| 62 | 2021-01-11 | chills, headache, nasopharyngitis |
About 10:30 pm, 1/11/21, became very cold teeth chattering headache, sharp pains in muscles then ach...
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About 10:30 pm, 1/11/21, became very cold teeth chattering headache, sharp pains in muscles then aches, uncomfortable to touch skin. Took 2 acetaminophen, lots of blankets, able to sleep. No fever, woke up with same symptoms but milder.
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| 62 | 2021-01-11 | chills, headache |
Chills, dizzy (nearly fainted), headache and joint (hip) pain. All symptoms manifested approximately...
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Chills, dizzy (nearly fainted), headache and joint (hip) pain. All symptoms manifested approximately 21 hours after injection
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| 62 | 2021-01-11 | headache, chills | Chills, Headache, Nausea, Body Aches |
| 62 | 2021-01-11 | headache, cough |
A chest x-ray showed some inflammation on the lungs; Slight pain in her arms after taking the vaccin...
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A chest x-ray showed some inflammation on the lungs; Slight pain in her arms after taking the vaccine; Bad headache; She started to develop a cough after the injection that did not improve and had worsened by the end of the second week; This is a spontaneous report from a contactable Nurse (reporting for herself). A 62-year-old female patient started received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, batch/lot no. and expiry date: unknown), via an unspecified route of administration on 18Dec2020 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. As reported, patient asked, "should I get the second injection of the COVID-19 vaccine since I have this cough that will not go away?." This female nurse, who was also the patient, reported receiving her first injection of the PFIZER COVID-19 VACCINE on 18Dec2020. She started to develop a cough after the injection that did not improve and had worsened by the end of the second week. Treatment has included cetirizine (ZYRTEC), dextromethorphan (ROBITUSSIN),Guaifenesin (MUCINEX) and albuterol inhaler. A chest x-ray showed some inflammation on the lungs and she was given a steroid inhaler, which has helped. She has received two COVID-19 tests at different time intervals, and both were negative. She was scheduled to receive the second COVID-19 vaccination on Friday but was uncertain if she should receive it given her cough was not improving. She had a bad cough, and other symptoms just before her injection (pending clarification). But her general practitioner (GP) put her in a steroid inhaler. She talked to her GP but can't give her complete advice as to whether she can still take the 2nd dose or not due to her situation. She said she had very slight pain in her arms after taking the vaccine, and felt a really bad headache on 18Dec2020. She would like to know if she still needs to continue the 2nd dose of vaccine or not since she still has a cough. Patient asked if there was any guidance on getting a second dose and what if test was a false positive and she really did have COVID-19?. Outcome of the event "She started to develop a cough after the injection that did not improve and had worsened by the end of the second week" was not recovered while "A chest x-ray showed some inflammation on the lungs", Slight pain in her arms and Bad headache were unknown. Information on the Batch/Lot number has been requested.
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| 62 | 2021-01-11 | headache |
2nd dose- Headache, bodyaches pain at injection site and bruising; symptoms lasted for 24hrs then re...
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2nd dose- Headache, bodyaches pain at injection site and bruising; symptoms lasted for 24hrs then resolved. Pain and tenderness persist at injection site. 1st dose - no reported adverse events
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| 62 | 2021-01-11 | lethargy, fatigue, headache |
approximately 2 hours after my vaccination, I started with a very severe headache and felt extremel...
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approximately 2 hours after my vaccination, I started with a very severe headache and felt extremely tired. I had difficulty staying awake. I slept about 2 hours. When I woke up my headache was gone and I was no longer tired. I went to bed and slept well until a headache woke me up the next morning however it was not as severe as the previous night. I was a bit lethargic but not too bad. My headache continued until the evening of 1.11.21 however I was not lethargic and was able to work. Today is 11.12.21 and I feel fine. I had no injection site discomfort to speak of.
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| 62 | 2021-01-11 | malaise, headache |
Nausea; Diarrhea; Jitteriness; foggy head or brain; she can't concentrate /she didn't pay it any att...
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Nausea; Diarrhea; Jitteriness; foggy head or brain; she can't concentrate /she didn't pay it any attention; sleeping a lot; sick; Headache; body aches; This is a spontaneous report from a contactable nurse. A 62-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 05Jan2021 08:15 at single dose for COVID-19 immunisation. Anatomical location of administration of vaccine was right deltoid. Medical history was not reported. The patient previously took omeprazole (PRILOSEC) and experienced drug hypersensitivity and lip swelling. Concomitant medication included atorvastatin (LIPITOR). The patient experienced headache on Jan2021, body aches on Jan2021, nausea on 06Jan2021, diarrhea on Jan2021, jitteriness on Jan2021, foggy head or brain on Jan2021, sleeping a lot on Jan2021, sick on Jan2021, she can't concentrate /she didn't pay it any attention on Jan2021. The outcome of headache and she can't concentrate /she didn't pay it any attention was recovering, of pain, jitteriness, foggy head or brain was not recovered, of sleeping a lot and sick was unknown. Nausea, and diarrhea recovered on 07Jan2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events headache, pain, nausea, diarrhea, feeling jittery, feeling abnormal, disturbance in attention and hypersomnia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 62 | 2021-01-11 | malaise |
Atrial fibrillation; Was not feeling well; Warm sensation in chest; This is a spontaneous report fro...
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Atrial fibrillation; Was not feeling well; Warm sensation in chest; This is a spontaneous report from a contactable nurse (patient). This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EJ 1685), intramuscular, on 21Dec2020 at 09:30 PM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 62-years-old. The patient received also varicella zoster vaccine RGE (CHO) (SHINGRIX) on 19Nov2020. Medical history included gastrooesophageal reflux disease (GERD) and high cholesterol. Concomitant medications included omeprazole, colestyramine (QUESTRAN), and vitamins. On 22Dec2020, the patient was not feeling well intermittently starting the day after the injection with warm sensation in chest that would go away until 31Dec2020 when the warm sensation of chest would not go away. The patient was sent for EKG that showed atrial fibrillation that she is now being treated for. The events resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. Outcome of the events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported atrial fibrillation and the administration of COVID 19 vaccine, BNT162B2. More information regarding the clinical course, the patient's underlying concurrent medical condition are required for the Company to make a more meaningful causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, Agency, as appropriate.
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| 62 | 2021-01-11 | respiratory tract congestion, fatigue, cough, throat clearing |
some congestion that just came on; her arm was really aching after the injection; she started coughi...
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some congestion that just came on; her arm was really aching after the injection; she started coughing; voice was hoarse; light wheeze; soles of her feet were hurting; pressure in bilateral groin; aching all over; very tired; balance issues; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231) intramuscularly in left upper arm on 05Jan2021 at single dose for covid-19 immunisation. The patient got her Covid vaccine yesterday (05Jan2021) around 11 or 11:30 am in her left upper arm. She had bilateral breast cancer and had lymph nodes removed in each arm but more removed from her Right, so she got the vaccine in the left arm. She also had some skin cancers removed, one would not heal properly on her left arm and formed a blister, and her dermatologist popped it and put a band aid on it. The vaccine was given 3 inches above it. The patient's concomitant medications were not reported. The patient experienced pressure in bilateral groin, aching all over, very tired and balance issues on 05Jan2021; light wheeze on 06Jan2021. Seriousness for these events was medically significant. The patient stated she had some congestion that just came on. She felt fine yesterday (05Jan2021) right after getting the vaccine, that at work she did notice that there was something different feeling in the left side of her groin. She was not in direct patient care. She noticed on her left side in the groin, something felt different, then yesterday evening (05Jan2021) after work she was really tired in the evening, aching all over last night, even the soles of her feet were hurting, woke up like her balance was off, she would walk one way and go another, states it is not like an orthostatic issue, that she knows what that feels like. She stated that in her inguinal area she could feel pressure, bilaterally. Her arm was really aching after the injection. Her breathing, heard a light wheezing, was clearing her voice, and then she started coughing, voice was hoarse. The outcome of events pressure in bilateral groin, very tired and light wheeze was not recovered; of events aching all over and balance issues was recovering; of other events was unknown.; Sender's Comments: The reported events bilateral groin, aching all over, very tired, balance issues and light wheeze were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 62 | 2021-01-11 | runny nose, throat irritation, runny nose, throat irritation |
During administration of vaccine pt became dizzy and faint. Pt was able to go to the observation are...
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During administration of vaccine pt became dizzy and faint. Pt was able to go to the observation area, waited approximately 15 mins and then reported chest tightness, dizziness, rash and itching on her arms, fast heart rate, watery eyes, runny nose, and throat irritant. Vitals were obtained and pt was requested to wait another 15 mins for monitoring. During monitoring period, patient became to complain of increased throat irritation and new tongue swelling. Response team was contacted. During reassessment patient's symptoms decreased. Team decided patient was stable and did not require transport to the ED. Patient was monitored for another 15-20 minutes with symptoms resolving. Patient was advised to discuss reaction with her PCP prior to getting second dose of the vaccine.
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| 62 | 2021-01-12 | body temperature increased |
Tight sensation in her throat, tongue felt tingling. Temp increased to 99, blood pressure increased...
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Tight sensation in her throat, tongue felt tingling. Temp increased to 99, blood pressure increased to 179/99
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| 62 | 2021-01-12 | fatigue, chills |
1st 24 hrs just arm soreness, 2nd 24 hrs itching and fatigue, 48 hrs, anaphylaxis, hives, rash, itch...
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1st 24 hrs just arm soreness, 2nd 24 hrs itching and fatigue, 48 hrs, anaphylaxis, hives, rash, itching, lymph swelling, chills
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| 62 | 2021-01-12 | headache, chills, fever | Fever. Chills. Headache. All my joints hurt. |
| 62 | 2021-01-12 | headache, fatigue |
Day after receiving vaccine: fatigue, fever, headache, body aches, shortness of breath, Two days af...
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Day after receiving vaccine: fatigue, fever, headache, body aches, shortness of breath, Two days after receiving vaccine: extreme fatigue, racing pulse, high blood pressure
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| 62 | 2021-01-12 | headache, fever, fatigue, chills | Chills, fever, severe muscle aches, headache, fatigue |
| 62 | 2021-01-12 | headache | Dizziness, Headache, Palpitations, HYPERtension, anxiety and stated SOB Narrative: |
| 62 | 2021-01-13 | chills, fatigue, malaise |
was afraid; she was nervous; vomiting; Fatigue; felt chills/chill became a bone chill, and she was f...
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was afraid; she was nervous; vomiting; Fatigue; felt chills/chill became a bone chill, and she was freezing; felt chills/chill became a bone chill, and she was freezing; randomly felt miserable/she felt like her body was purging/feeling "blah"; she wasn't really eating; Feeling sick; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730), via an unspecified route of administration in her right upper arm on 22Dec2020 16:00 at single dose for COVID-19 immunization. Vaccination Facility Type is hospital and which was not a facility. Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing and it was maybe 10 years ago that she was diagnosed, and she was treated for her diabetes. There were no concomitant medications. There was no history of all previous immunization with the Pfizer vaccine (within 4 weeks) or additional vaccines administered on Same Date of the Pfizer Suspect. The patient received the first dose of the COVID-19 vaccine 22Dec2020 and is due for her second dose this upcoming Tuesday, 12Jan2021. She asked if it would be safe to receive the second dose at a different time, due to personal plans. She said after she received the first dose of the COVID-19 Vaccine on 22Dec2020, she was feeling sick in Dec2020. She said she had vomiting, chills, and randomly felt miserable, fatigue from 23Dec2020. She said she was nervous about getting the second dose of the COVID-19 Vaccine on Tuesday, 12Jan2021. She said she had plans around that time period and she was afraid she was going to be sick after she receives the second COVID-19 Vaccine dose. She asked if the second COVID-19 Vaccine dose had to be administered in the timeframe that was scheduled. The patient reported she felt chilled when she woke up the next morning, 23Dec2020. She said at first she thought she felt chilled because it was cold outside. She said after she arrived at work on 23Dec2020, the chill became a bone chill, and she was freezing. She said she realized the chill was not a normal cold feeling. She said by mid-morning on 23Dec2020, she began to vomit, and went home and went to bed. She said she got sick 2 more times that day. She said she went to work on Thursday, 24Dec2020, and randomly got sick. She said she wasn't really eating at that point (Dec2020), so it was not like she got sick before or after she ate something. She said she continued to get randomly sick through holiday, 25Dec2020. She said she felt like her body was purging. She said she was feeling "blah", but she was not bedridden or out of commission. She said she had no fever that she knew of. She said her symptoms resolved right after holiday, clarifying she started to feel like herself, saying she felt good. The patient declined any treatment and reported she didn't think her symptoms were that severe, though her family wanted her to go to the doctor. There was nothing had changed in her routine prior to receiving the first dose of the COVID-19 Vaccine. Reported she had blood work every 4 months, and her last blood work was probably done in Oct2020 or Nov2020. The events did not require a visit to emergency room or physician office. The outcome of the event feeling sick, she wasn't really eating, were resolved in Dec2020, outcome of fatigue, felt chills/chill became a bone chill, and she was freezing were resolved on 23Dec2020, outcome of vomiting, randomly felt miserable/she felt like her body was purging/feeling "blah" were resolved on 25Dec2020, outcome of fear and nervous were unknown.
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| 62 | 2021-01-13 | chills, headache, fatigue | nausea, HA, chills , fatigue after second shot |
| 62 | 2021-01-13 | fatigue, chills, headache |
Knot in arm, very sore arm, severe headache, fatigue, chills, fever, nauseous all on first night af...
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Knot in arm, very sore arm, severe headache, fatigue, chills, fever, nauseous all on first night after shot. All gone by next morning with the exception of the headache, which is not as severe now.
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| 62 | 2021-01-13 | fatigue, headache | I had to leave work as I was achy, fatigued and had a headache |
| 62 | 2021-01-13 | fatigue | Soreness of the site then was sick 6 days later positive for COVID -19. Fatage |
| 62 | 2021-01-13 | headache, fatigue, throat pain, chills | Sore Throat , Fatigue, Chills, Pain at the injection site, headache |
| 62 | 2021-01-13 | headache, throat pain, fever, chills | Soreness at the injection site. Chills, sore throat. slight fever. headache |
| 62 | 2021-01-13 | throat pain, fever, headache | Soreness in the arm , sore throat Mild fever, Pain at the injection site. Headache that |
| 62 | 2021-01-13 | fever, headache, fatigue, chills |
Body aches; fever; chills; diarrhea; headache; joint pain; nausea; fatigue; This is a spontaneous re...
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Body aches; fever; chills; diarrhea; headache; joint pain; nausea; fatigue; This is a spontaneous report from a contactable other HCP (patient). This 62--year-old female HCP reported for herself received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via intramuscular route of administration, on 07Jan2021at 02:00 PM (at the age of 62 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included chronic Fatigue. The patient have known allergies to Sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included liothyronine sodium (T3), levothyroxine sodium (T4), progesterone, estradiol, estriol (BIESTROGEN), testosterone, colecalciferol (VITAMIN D), calcium, zinc sulfate (XINC), ascorbic acid (Vitamin C), magnesium. The patient previously received the first dose of BNT162B2 (lot number/expiration date: unknown) on 17Dec2020 at 10:30 AM (at the age of 62 years old) as a single dose in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 10:00 PM, after the second dose, the patient experienced body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue. No treatment was received for the events body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue. The outcome of the events body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 62 | 2021-01-14 | body temperature increased, chills |
She said she received her First Covid vaccine on 12/22/2020. She said on 1/4/2021 she worked that e...
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She said she received her First Covid vaccine on 12/22/2020. She said on 1/4/2021 she worked that evening and started having severe pain in calf of her left leg no redness ,no heat, just hurt to work 1/8/2021 She had surgery on her left leg. 2nd Covid Vaccine received on 1/12/2021 She said she had PT on her right leg with severe pain in her left calf She said she did not have any therapy on her left leg. Two ? three hours later she developed chills, temp 100.1 took temp again later is was 99. She had ultrasound that showed a large blood clot She said the PA told her the blood clot could be from receiving the Covid vaccine
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| 62 | 2021-01-14 | chills, fatigue | Soreness with swelling and heat at injections site. Chills, Body Aches & Fatigue lasting 48hrs. |
| 62 | 2021-01-14 | chills, headache, cough | body aches, chills, cough, headache, nausea--soreness/swelling left armpit |
| 62 | 2021-01-14 | chills, headache, fatigue | Patient describes chills, body aches, headache and fatigue. |
| 62 | 2021-01-14 | chills |
2nd dose next day had nausea in am since subsided. chills muscle aches and swelling soreness at arm ...
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2nd dose next day had nausea in am since subsided. chills muscle aches and swelling soreness at arm site present @ this time.
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| 62 | 2021-01-14 | cough, chills, headache | Body aches, chills, cough, headache, nausea, soreness and swelling of L arm pit. |
| 62 | 2021-01-14 | fatigue, chills, fever |
On the evening of the vaccine day, recipient woke up with Fever, Chills, Body aches, and Fatigue. Ca...
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On the evening of the vaccine day, recipient woke up with Fever, Chills, Body aches, and Fatigue. Called off of work.
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| 62 | 2021-01-14 | fatigue | Fatigue, body aches, nausea. Resolved. |
| 62 | 2021-01-14 | headache, chills |
Reported left arm injection site pain, dull headache, chills and a rapid hear rate. Went to ED due t...
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Reported left arm injection site pain, dull headache, chills and a rapid hear rate. Went to ED due to heart rate.
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| 62 | 2021-01-14 | headache, fever, chills |
chills; fever; intense body pain all over; headache; nausea; This is a spontaneous report from a con...
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chills; fever; intense body pain all over; headache; nausea; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on 05Jan2021 17:30 in right arm at single dose for COVID-19 immunization. Medical history included hypopituitarism from an unknown date and unknown if ongoing. The patient received first dose of BNT162B2 (lot number: EJ1685), on 18Dec2020 10:45 in left arm at single dose. Concomitant medication included second dose of varicella zoster vaccine rge (cho) (SHINGRIX) for immunization, hydrocortisone acetate (CORTEF), levothyroxine sodium (SYNTHROID), desmopressin acetate (DDAVP), simvastatin, estrogens conjugated, medroxyprogesterone acetate (PREMPRO) and losartan potassium (LO). On 06Jan2021 08:00, the patient experienced chills, fever, intense body pain all over, headache and nausea. No treatment was given to the patient for the events. The patient recovered from the events in Jan2021. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient received SHINGRIX within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 62 | 2021-01-14 | headache, sinus congestion, fatigue, nasal congestion, upper-airway cough syndrome, chills, throat irritation |
Advised received first covid vaccine 12/21/2020 w/o issues. Received 2nd Pfizer vaccine on 1/11/21. ...
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Advised received first covid vaccine 12/21/2020 w/o issues. Received 2nd Pfizer vaccine on 1/11/21. Within minutes her tongue was tingling with sensation of feeling full-felt funny. 30 min later had frontal/jaw headache. 60 min later chills with goose bumps all over while working (works as resp technician at NMCP). While walking to car, her upper arm and front of thighs hurt as if exercised too much. Self treated with Advil and tylenol. --- Next day 1/12 0100am awoke with severe bilateral shoulder joint pain extending to shoulder blades, stabbing abdominal/stomach pain, nausea, urge to vomit. she returned to sleep but awoke 6am with nausea and severe diarrhea and fatigue. She c/o nasal congetion, sinus fullness and severe post nasal drip x 24 hours. S/s persisted and left work early now with severe bilateral ankle pain. She was off Wed/Thursday. Wed 1/13 her shoulder pains eased but now with severe back pain. Wed evening noted tongue swelling sensation again (has pictures) and took oral benadryl and ice chips. She went to sleep. Thursday 1/14 bilateral knee pain/joint with increased nausea again - treated with zofran. Friday 1/15 returned to work, pain in knees made gait wobbly = treated with advil. Notified ID MD and director on tongue swelling and constantly trying to clear throat = sent to ER where treated with oral decadron and M Toradol for pain. She was sent home with prednisone dose pack and compazine. Recommended f/u with HCP for further testing to r/o possibility of a mast cell disorder of familial hypertrytassemia due to her history of multiple allergies/insect allergies--
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| 62 | 2021-01-14 | headache | Severe headache lasting over 34 hours |
| 62 | 2021-01-14 | fever, chills, malaise |
As per Emergency Dept note of 23 Dec 2020: "Syncope, related to getting the vaccine. Normal ECG, no...
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As per Emergency Dept note of 23 Dec 2020: "Syncope, related to getting the vaccine. Normal ECG, no evidence of arrhythmia, normal H/H, no evidence of ACS, CHF clinically. Normal nonfocal exam. Symptoms resolved. Home with reassurance." As per follow-up note of 04 Jan 2021: "62yo female s/p first dose of Pfizer-BioNTech vaccine on 12/23/2020 who experienced syncope, hypertension (200/100) within minutes after receiving the vaccine. She was then transported to the ED where she was given IV fluids, anti-emetic and discharged a few hours later. She reports the onset of fever, chills, anorexia, malaise, and emesis 4 hours after receiving the vaccine. The malaise, chills and anorexia persisted for 4 days at which point she started feeling better. COVID test was reportedly negative. She wants to decline 2nd dose of vaccine."
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| 62 | 2021-01-14 | fever, headache |
Second dose of Pfizer vaccine was administered too early, at day 15. Individual is reporting muscle...
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Second dose of Pfizer vaccine was administered too early, at day 15. Individual is reporting muscle pain, fever, and headache
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| 62 | 2021-01-14 | fever | "100.1 fever by that night, aches, pains" |
| 62 | 2021-01-15 | headache, fever |
Jan 12, 11:30am - Dizziness, headache, muscle aches, weakness, cold feeling, flushed. Temperature = ...
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Jan 12, 11:30am - Dizziness, headache, muscle aches, weakness, cold feeling, flushed. Temperature = 102.4 F. Had to leave work. Slept for 18 hours, Symptoms continued for 48 hours.
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| 62 | 2021-01-16 | malaise, fatigue, headache |
Left sided facial numbness mildly affecting left lip, cheek and area around left eye. Lasted le...
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Left sided facial numbness mildly affecting left lip, cheek and area around left eye. Lasted less than an hour. Continued symptoms 48 hours after vaccine are moderate persistent headache, moderate fatigue. Feeling of not well. taking tylenol.
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| 62 | 2021-01-16 | respiratory tract congestion, fatigue, chills, fever, headache |
chills, fever over 102, terrible headache, body aches, sore arm, loss of appetite, nausea, severe fa...
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chills, fever over 102, terrible headache, body aches, sore arm, loss of appetite, nausea, severe fatigue, congestion
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| 62 | 2021-01-17 | chills, fatigue, headache, fever |
ON 1/7; CHILLS, LOW GRADE FEVER (100F), BODY ACHES, HEADACHE, AND FATIGUE X 14 HRS. TOOK ADVIL - 2 T...
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ON 1/7; CHILLS, LOW GRADE FEVER (100F), BODY ACHES, HEADACHE, AND FATIGUE X 14 HRS. TOOK ADVIL - 2 TABS AND REST.
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| 62 | 2021-01-17 | fatigue, body temperature increased, sneezing |
At 8:00-8:45 - started sneezing uncontrollably -it lasted until I went to bed - for about an hour - ...
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At 8:00-8:45 - started sneezing uncontrollably -it lasted until I went to bed - for about an hour - couldn't stop; about 8:30 I felt like I had hit a wall. Totally exhausted. Went to bed. 1:00 am woke up with a temp of 99.8. My baseline temp is 96. It lasted about 24 hours. I had temp and fatigue until 24 hours later - Friday morning. Went to work on Friday morning - so I felt better. So about 30 some hours of symptoms. Did not treat symptoms.
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| 62 | 2021-01-17 | fatigue, headache, fever |
PT received second injection on 1/13/2021 and had significant side effects following the second vacc...
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PT received second injection on 1/13/2021 and had significant side effects following the second vaccine. 24 - 48 hours of low grade fever, severe nausea, headache, fatigue and body aches.
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| 62 | 2021-01-17 | headache, chills |
Had second injection 10 am on 1/16/21 . Woke up at 1:30 am during night on 1/17 with rigors, took ...
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Had second injection 10 am on 1/16/21 . Woke up at 1:30 am during night on 1/17 with rigors, took tylenol, temp in am 99.6. Had headache next day, Ok with tylenol. Woke up in am of 1/18/21, itchy all over. Looked in mirror and had hives over right side of torso in back, and on chest and abdominal area in front. Very itchy. No shortness of breath. O2 sat 96%. Took 10 mg of Atarax I had at home for allergy itching. Called our Occupational Health office, instructed to call back if worsens or unresolves in next 24 hours.
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| 62 | 2021-01-17 | headache, fever, chills, fatigue |
EVENING OF 12/28/20, DEVELOPED HEADACHE, FEVER, CHILLS, BODY ACHES, FATIGUE, AND INJECTION SITE PAIN...
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EVENING OF 12/28/20, DEVELOPED HEADACHE, FEVER, CHILLS, BODY ACHES, FATIGUE, AND INJECTION SITE PAIN. RESOLVED BY 12/30/20.
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| 62 | 2021-01-17 | headache, fever |
Pfizer-BioNTech COVID-19 Vaccine EUA: soreness in left arm at shot injection site started around 8:0...
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Pfizer-BioNTech COVID-19 Vaccine EUA: soreness in left arm at shot injection site started around 8:00pm (shot was at 215pm). Upon awakening 1/19 at 6:00am, arm continued to be sore and I had fever registering at 102.5. I took two Tylenol then and again at 3:00pm. Headache appeared around 9:00am and was gone by 7:00pm. Temp began to decrease at 10am, to 101.1 and was 99.3 at 2:30pm. Sunday morning woke up with no soreness in arm or fever/headache.
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| 62 | 2021-01-17 | headache |
12/21/20 - SYMPTOMS STARTED ONE HOUR AFTER RECEIVING THE VACCINE. DIZZINESS, HEADACHES FOR 24 HRS. P...
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12/21/20 - SYMPTOMS STARTED ONE HOUR AFTER RECEIVING THE VACCINE. DIZZINESS, HEADACHES FOR 24 HRS. PAIN ON INJECTION SITE. TOOK TYLENOL.
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| 62 | 2021-01-17 | nasopharyngitis |
Feel like , I have a cold or allergies, Lower back pain, Abdominal Pain One Knee was shaking right a...
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Feel like , I have a cold or allergies, Lower back pain, Abdominal Pain One Knee was shaking right after vaccine Full body pain daily mostly in the lower back
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| 62 | 2021-01-17 | fever, fatigue |
I started running a low grade temp about 9 pm on 1/6/2021. Woke in a.m. (early) with 100.9 temp and ...
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I started running a low grade temp about 9 pm on 1/6/2021. Woke in a.m. (early) with 100.9 temp and swollen lymph nodes under my arm and along the side of my breast and a tingly right hand. Fever broke early am on friday (1/8/2021). I was very fatigued and tired and still had a very tingly hand on 8th. Tingly slowly got better and I didn't notice it anymore on Wednesday ,13th. Fatigue was better by Sunday the 1/9th. I felt pretty much back to normal by 11th except for my hand. No treatment.
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| 62 | 2021-01-17 | fever |
I had my first vaccination on 1/11/21 at HD. The reaction was typical- significantly sore red inflam...
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I had my first vaccination on 1/11/21 at HD. The reaction was typical- significantly sore red inflammed arm over deltoid muscle that resolved after 3 days. Second dose given 21 days later- some swelling and soreness, low grade fever. Then 3 days later, I awoke, turned in bed and experienced an intense shearing pain in my neck and arm. The pain was the worst ever felt, and was not improved with NSAIDS, Acetaminophen, Hydrocodone, or Tramadol. I went to an urgent care center on 1/16 where a tentative diagnosis of sprained neck was made. The sypmptoms continue with slight improvement with steroids, and a muscle relaxant. I am concerned because I understand that covid itself can impact the nervous system considerably. I am awaiting improvement in symptoms and if none seen then I will see my primary care MD
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| 62 | 2021-01-17 | throat irritation | Swelling, itching, in the throat. One hive |
| 62 | 2021-01-18 | chills, cough |
fever(99), and chills,, stomach upset and diarrhea--also reporting a new cough that developed after ...
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fever(99), and chills,, stomach upset and diarrhea--also reporting a new cough that developed after the vaccine HX of Multiple Sclerosis
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| 62 | 2021-01-18 | chills, fever |
Once i received the 2nd dose- My arm swollen for 3 days - continue to be red as thought rash going...
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Once i received the 2nd dose- My arm swollen for 3 days - continue to be red as thought rash going over the top half of arm around the injected area. chills , body aches, fever. stayed in bed the next 3 days. 4 day sweating, and low grade fever , fatigue very weak.
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| 62 | 2021-01-18 | fatigue | Body aches, fatigue, left arm soreness |
| 62 | 2021-01-18 | headache | Severe headache joint pain about 12-14 hts |
| 62 | 2021-01-18 | malaise, fatigue, fever, chills, headache |
Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling ...
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Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling in chest. No sob. Early on 1/8/21 in the AM, had 2 runs afib, that responded to metoprolol. She reported the afib to her cardiologists. Called again on 1/19/21 to report continued fevers, fatigue, body aches, nausea, and chills that caused her to call off on 1/17/21. Ordered COVID-19 PCR.
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| 62 | 2021-01-18 | fever, headache |
Pfizer -BioNTech Covid-19 Vaccine EUA After the vaccine I developed headache, low grade fever, muscl...
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Pfizer -BioNTech Covid-19 Vaccine EUA After the vaccine I developed headache, low grade fever, muscle ache, stiffness and nausea. This felt positive for the first 3 days until the symptoms did not leave and remained for 9 days post vaccination.
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| 62 | 2021-01-19 | chills, throat pain, headache, fatigue |
Headache, dizziness, swollen glands chin/throat sore throat and chills. Extreme fatigue. Covid tes...
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Headache, dizziness, swollen glands chin/throat sore throat and chills. Extreme fatigue. Covid test and ruled out.
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| 62 | 2021-01-19 | headache, fatigue, fever, malaise, chills |
Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling ...
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Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling in chest. No sob. Early on 1/8/21 in the AM, had 2 runs afib, that responded to metoprolol. She reported the afib to her cardiologists. Called again on 1/19/21 to report continued fevers, fatigue, body aches, nausea, and chills that caused her to call off on 1/17/21. Ordered COVID-19 PCR.
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| 62 | 2021-01-20 | chills | Chills. Bodyaches |
| 62 | 2021-01-20 | fatigue, headache |
2 hours after receiving the COVID vaccine, I experienced the following: light headedness, dizziness...
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2 hours after receiving the COVID vaccine, I experienced the following: light headedness, dizziness, severe headache, rapid heart rate, high blood pressure, tightness in chest and fatigue
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| 62 | 2021-01-20 | headache, fatigue | Fatigue, headache. Resolved. |
| 62 | 2021-01-20 | headache, fever |
fever of 100.5; severe muscle and joint aches for about 24 hours; severe muscle and joint aches for ...
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fever of 100.5; severe muscle and joint aches for about 24 hours; severe muscle and joint aches for about 24 hours; severe headache; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: E11283), via an unspecified route of administration on 07Jan2021 06:30 at a single dose for covid-19 immunization. The patient's medical history included osteoarthritis from an unknown date and unknown if ongoing. Concomitant medication included aciclovir sodium (ACYCLOVIR [ACICLOVIR SODIUM]), famotidine (FAMOTIDINE), hydroxychloroquine (HYDROXYCHLOROQUINE), escitalopram oxalate (LEXAPRO), rosuvastatin calcium (ROSUVAST) , cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took cipro [ciprofloxacin hydrochloride monohydrate] and experienced drug hypersensitivity, vioxx and experienced drug hypersensitivity, ees and experienced drug hypersensitivity. On 07Jan2021 at 18:30, 12 hours after the injection, the patient experienced fever of 100.5 with severe muscle and joint aches for about 24 hours. Then the fever subsided and had severe headache for 24 hours. All the events recovered in Jan2021.
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| 62 | 2021-01-20 | headache |
30 minutes after being vaccinated with Pfizer vaccine (second dose) in her right arm, employee devel...
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30 minutes after being vaccinated with Pfizer vaccine (second dose) in her right arm, employee developed itching and red splotching (not elevated) on her left arm. She had no difficulty breathing, no swelling and said she "felt fine" except for the itching. She took Allegra about 1:30 pm. We recommended she call her husband to come and take her home and to go to ER if symptoms progressed. She declined. At about 3:00 pm redness was improving on upper arm but had spread down to the palm of her hand. Again she stated she felt fine. Patient drove home on her own about 4 pm but agreed to text Nursing Supervisor when she got home. She reported at about 7 pm that she was greatly improved. Follow up today (1/21) itching/redness is gone but does have body aches and headache. Her only known past allergy is to Sulfa drugs. No issues with first dose. Let employee know that if there is ever a reason for another covid vaccine that she would have to have it done in the care of a doctor's office.
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| 62 | 2021-01-20 | headache | headache treated with advil |
| 62 | 2021-01-20 | headache | headache - treated with advil |
| 62 | 2021-01-20 | headache | headache |
| 62 | 2021-01-20 | headache |
Since shortly after the injection she has experienced a low grade headache over her eyes and on the ...
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Since shortly after the injection she has experienced a low grade headache over her eyes and on the top of her head, similar to a sinus headache.
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| 62 | 2021-01-20 | throat clearing |
Felt itchy and shaky after vaccine. Left after 30 min. She later developed hives and was seen at E...
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Felt itchy and shaky after vaccine. Left after 30 min. She later developed hives and was seen at ED. Per ED notes, approx 1 hour after vaccine, she developed mild erythematous rash over upper chest/ collarbone region. Slightly itchy. She took benadryl PO x 1 with resolution of itching and rash within 1-2 hours. Patient has noted she is needing to clear her throat more often, feeling like it is "a little mucousy". She does not have a frank cough. She denies SOB, chest pain, difficulty breathing, stridor, wheezing or nasal congestion. She does not feel her mouth, lips, face or tongue are swollen. She has no difficulty swallowing. She denies abdominal pain, vomiting, and diarrhea. Denies myalgias, headaches, chills or fevers at this time. Discussed can use additional antihistamine as needed for further rash. Does not need epi IM at this time. Reviewed common side effects for 2nd vaccine to expect in next 24 hours. Reviewed elevated BP and asked to recheck at PCP or next medical visit to monitor for possible hypertension
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| 62 | 2021-01-21 | fatigue, sleepiness |
Extreme fatigue-unable to function-head congestion lasted approximately 48 hours slept approximately...
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Extreme fatigue-unable to function-head congestion lasted approximately 48 hours slept approximately 36 of those hours
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| 62 | 2021-01-21 | fatigue | HAD FATIGUE AND NAUSEA |
| 62 | 2021-01-21 | throat pain, throat irritation, fatigue |
A little over 12 hours after receiving my 2nd dose at 8:42 am, I woke up at approximately 11:15 pm t...
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A little over 12 hours after receiving my 2nd dose at 8:42 am, I woke up at approximately 11:15 pm to find that my tongue and throat were swelling. I immediately took 1 25mg benadryl and went to the Emergency Room (ER). After many questions and examination of my mouth. I was given another benadryl, prednisone, and famotidine. I waited and was observed for approximately 2.5 hours in the ER. At that time it was obvious that the medication was effective and I was comfortable leaving the ER to return home. I had prescriptions for more prednisone and famotidine to take for 5 days. On Wednesday, I felt well enough to go to work at my school, though I did light duty. On Thursday, I was also at school and also attended a physical therapy session and exercise class. I talked at length with my PT about my experience and she could tell that I was feeling good (presumably from the prednisone) and cautioned me about not overdoing things during exercise. I felt like my tongue was beginning to swell and the PT mentioned that my words sounded a bit funny (she was the only one to comment on this). I then went to dinner at my daughters house and began to feel tired from the benadryl. Upon arriving home and getting ready for bed, my husband and I both noticed how flushed my chest and face had become during the day. My throat and tongue were still somewhat swollen and my throat was beginning to hurt. During the day on Thursday, I had registered with the local Covid information website and had received an email stating that I should feel free to call the triage phone number if I needed. At approximately 9:45 pm I called and talked with a nurse who urged me to return to the ER because of the flushing and continued swelling. In the ER I was seen by a different doctor who was concerned not so much about the swelling, but about the white streaks in my throat and had me swabbed for strep throat. That test was negative. He said he had read my chart from Tuesday night and felt that the medication that had been prescribed was appropriate and that he didn't feel anything needed to be changed. He asked about how bad my throat felt and wrote a prescription for Magic Mouthwash and I asked for an EpiPen, which he also prescribed. We arrived home at approximately 12:00 am, but it was still difficult to lie down and sleep. I had already decided that I would not go to school on Friday and stay home and rest. I needed to pick up my prescriptions when the pharmacy opened and I ran a few other errands while I was out, but returned home and slept most of the afternoon. I have not been very energetic this evening, but decided that I wanted to get this form filled out. At approximately 10:00 PM on Friday evening, I hope that I am able to sleep better than I have the last several nights.
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| 62 | 2021-01-22 | chills, fever | Insomnia, body aches, chills, low grade fever. I was okay by noon on Thursday. |
| 62 | 2021-01-22 | fever | SEVERE abdominal pain, fever, nausea, |
| 62 | 2021-01-23 | fever, chills |
Starting on the 16th of Jan I became very sick to my stomach.This lasted the the AM on the 18th no o...
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Starting on the 16th of Jan I became very sick to my stomach.This lasted the the AM on the 18th no other syptoms present. I left work at 8:00am on the 18th with no fever ( I checked three times during the midnight shift ) I went home to bed and woke up at 6:00pm with 100.8 fever ( I never run a fever ) had fever chills and joint pain in the upper body no respiratory issues .Within 48 hours the fever was gone as well as the chills but I continued to be sick to my stomach for another two days.I wanted to report this delayed reaction because of my underlying HIV and given the fact no individuals with HIV were included in the initial study. I tested negative with the nasal swab test on the 20th.
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| 62 | 2021-01-24 | body temperature increased |
BP at 179/99; Tongue felt tingly; felt a tight sensation in her throat; Temp elevated at 99; This is...
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BP at 179/99; Tongue felt tingly; felt a tight sensation in her throat; Temp elevated at 99; This is a spontaneous report from a contactable other HCP. A 62-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EZ9231), intramuscular in left arm on 13Jan2021 10:15 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. The patient had no covid-19 prior to vaccination. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unknown date COVID-19 immunization. On 13Jan2021 10:15, the patient experienced tongue felt tingly, felt a tight sensation in her throat, temp elevated at 99, BP at 179/99, and HR 62. No hives, no wheezing, and no angioedema. The events recovered on an unknown date in Jan2021. The patient received Benadryl 50 mg as treatment and had ice pack behind neck, laid down for 30 mins. The patient was not tested for COVID-19 post vaccination. Information about batch/lot number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event blood pressure increased cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 62 | 2021-01-24 | chills, headache, fatigue |
arm soreness, joint pain, chills, fatigue x 48 hours headache start at same time but has gotten wo...
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arm soreness, joint pain, chills, fatigue x 48 hours headache start at same time but has gotten worse on day 3 post vaccine and not relieved by acetaminophen
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| 62 | 2021-01-24 | chills, headache |
Systemic: Rash (other than injection site), Systemic: Chills, Systemic: Generalized Body Aches , Sys...
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Systemic: Rash (other than injection site), Systemic: Chills, Systemic: Generalized Body Aches , Systemic: Headache.
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| 62 | 2021-01-24 | chills, sleepiness, fatigue |
Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulenc...
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Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulence; Chills; Joint pain; Lower GI symptoms; she is also feeling cold; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: GL3248 (Caller said that the G may be an E.)), via an unspecified route of administration in the left arm on 07Jan2021 at second single dose for working with cancer patients. Medical history included ongoing diabetic and ongoing hyperthyroidism, both diagnosed about 6 years ago and were under control. There were no concomitant medications. Historical vaccine included BNT162B2 on 18Dec2020 for working with cancer patients (First dose, lot number: EJ1685, injection in the left arm). On 11Jan2021 the patient had chills, joint pain, and lower GI symptoms. Her lower GI symptoms included diarrhea. Then caller clarified that it was not diarrhea but the urge to go. The stools were solid. She also had lots of flatulence. She was also wiped out of energy, around like 2 PM on 11Jan2021 she went up a flight of stairs and was so exhausted. The patient is a nurse. She was in her office that day and had to literally lay on the floor because she was so wiped out of energy. She left work early and went to bed. Then the next day 12Jan2021, she was unable to get out of bed the whole day. She is so sleepy and has no energy. She went to bed last night at 08:30, but is still so sleepy. Today she is feeling better, but still had lower GI symptoms. She was also feeling cold, which she normally is always hot. She was having to put 5 blankets on her. Outcome of the event chills was recovered on 12Jan2021, of events joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed was recovering, of events flatulence and feeling cold was unknown. The reporter considered the event chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed as serious (disability) and related to BNT162B2.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed and the administration of the COVID 19 vaccine, BNT162B2, given the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 62 | 2021-01-24 | headache, fatigue |
Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; ...
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Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; Swelling; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included ibuprofen and paracetamol (TYLENOL). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: Ek5730, expiry date not reported) in the right arm on 18Dec2020 15:00 at single dose for COVID-19 immunisation. On 08Jan2021 at 18:00, the patient experienced brain fog, headache, muscle spasm at injection site, severe fatigue, joint pain, driving difficult and swelling. It was unknown if treatment was received for the adverse events. Clinical outcome of the events was not recovered.
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| 62 | 2021-01-24 | headache | Diarrhea, headache, and body aches next day, 1/15/21. |
| 62 | 2021-01-24 | headache | neck pain that ran up to head |
| 62 | 2021-01-24 | sweating |
joint pain; bad back spasms in the middle of the back radiating up through right should to right arm...
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joint pain; bad back spasms in the middle of the back radiating up through right should to right arm; Sweating; arm pain; she couldn't do anything with her right hand. She "couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing".; arm shoulder blade rib cage are sore; arm shoulder blade rib cage are sore; This is a spontaneous report from a contactable consumer (patient, healthcare tech in the ER). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Jan2021 at single dose for COVID-19 immunization. Medical history included spondylosis. Concomitant medications were not reported. patient calls today to report symptoms following administration of the covid vaccine. Caller reports that she got the vaccine on Friday. Reports that on Saturday she started to have joint pain everywhere on Sunday she felt a little better. Reports that on Monday she got up and had really bad back spasms in the middle of the back radiating up through right should to right arm. She went to work, only worked for 2 hours and then checked into the ED. They did an EKG because she was sweating and was with arm pain. They did X-rays and gave her steroids and gave her a pain shot stating it didn't do anything, states they put her on steroids to come home with, muscle relaxers to stop spams. Reports that on Monday night she couldn't do anything with her right hand. She couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing. The spasms won't stop, everything; arm shoulder blade rib cage was sore. Went back to the ER on Tuesday, they did a thoracic and cervical MRI, nothing looked different or wrong. they told her to stay on steroids and keep taking muscle relaxers, with ibuprofen and Tylenol. She also asks, what should her do, and if her history of spondylosis triggering this reaction. Patient was recovering from joint pain, was not recovered from bad back spasms in the middle of the back radiating up through right should to right arm and arm shoulder blade rib cage are sore. Outcome of the events was unknown. Identification of the case safety report serious was No. Information on the Lot/Batch number has been requested.
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| 62 | 2021-01-24 | malaise |
Nearing 24 hours after receiving my second vaccine, I began to feel ill, similar to an intestinal f...
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Nearing 24 hours after receiving my second vaccine, I began to feel ill, similar to an intestinal flu coming on, weak and dizzy. I felt that way for approximately 20 minutes and went lie down but began to feel more dizzy and then very nauseated. I then vomited several times and afterward began to feel steadily better. The whole even was approximately 2 hour before I felt back to normal.
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| 62 | 2021-01-24 | fever, sneezing, malaise, headache, fatigue, cough |
1/14 am. General malaise and fever shortn of breath, cough sneezing body?s aches joint pain ongoing...
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1/14 am. General malaise and fever shortn of breath, cough sneezing body?s aches joint pain ongoing for last 10 days Still low grade fever 99.8 and cough headache body aches weakness fatigue short of breath
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| 62 | 2021-01-24 | throat clearing |
Patient c/o shortness of breath and "throat closing up"after receiving Covid vaccine at 10:00am.. O...
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Patient c/o shortness of breath and "throat closing up"after receiving Covid vaccine at 10:00am.. O2 started at 4l/min via n/c at 10:10am. , BP taken and advised to administer her Epi pen that she had with her due to allergy to Gelatin, administered Left thigh by patient.at 10:15am. 911 called at 10:20am. BP 152/93 HR 80 at 10:25am, 154/105 HR 75 at 10:27am, 148/92 HR 75 at 10:30 when departed to Medical Center. 02 sat remained at 99%. Skin warm and dry and remained alert through out process.
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| 62 | 2021-01-25 | chills, fever, headache, fatigue |
Fever; Chills; Headache; Body aches; Extreme fatigue; This is a spontaneous report from a contactabl...
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Fever; Chills; Headache; Body aches; Extreme fatigue; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283; expiry date: unknown) via an unspecified route of administration, on 12Jan2021 at 10:00 in the left arm, at a single dose, for COVID-19 immunization. Relevant medical history included rheumatoid arthritis, allergic rhinitis, sulfonamide allergy, and allergy to capsicum. Concomitant medications included adalimumab (HUMIRA), hydroxychloroquine, leflunomide and other unspecified medications. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FL0140; expiry date: unknown) on 22Dec2020 at 15:00 in the left arm, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 12Jan2021, at 23:00 (on the same day after the injection), the patient experienced fever, chills, headache, body aches, and extreme fatigue. The patient did not receive treatment for the events. The patient was recovering from the events. The patient has not been tested for COVID-19 since vaccination.
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| 62 | 2021-01-25 | fatigue, cough, runny nose, fever, chills, lethargy |
runny nose; slight cough; Lethargy; very tired; no appetite; Severe body aches; chills; fever; my ly...
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runny nose; slight cough; Lethargy; very tired; no appetite; Severe body aches; chills; fever; my lymph nodes under my injection arm became swollen and sore; my lymph nodes under my injection arm became swollen and sore; This is a spontaneous report from a contactable other HCP (patient). A 62-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: 0140) intramuscular in right arm on 11Jan2021 15:30 at single dose for COVID-19 immunization. She received the first dose of BNT162B2 (lot number: 0140) intramuscular in left arm on 21Dec2020 16:15 for COVID-19 immunization. Medical history included Sulfa and PCN allergy. There was no other medical history. There was no concomitant medications. There were no other medications in two weeks, no other vaccine in four weeks. The patient experienced severe body aches, chills, and fever starting approximately 8-10 hours after vaccine on 11Jan2021. These symptoms were accompanied by a runny nose and slight cough on 12Jan2021 08:00. Lethargy, very tired, no appetite also on 12Jan2021 08:00. Symptoms resolved with Tylenol, Nyquil, and one day of deep sleep. On the second day (Jan2021), her lymph nodes under her injection arm became swollen and sore. Patient is not pregnant. Events were recovered on Jan2021.
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| 62 | 2021-01-25 | fatigue | ON 1/20/21 DEVELOPED FATIGUE, CONFUSION, AND VOMITING. FOLLOWED UP WITH PCP. |
| 62 | 2021-01-25 | headache, fatigue, cough, fever |
HA; Fatigue; DOE; Chest pressure; Fever 100.2; Sudden coughing spell; This is a spontaneous report f...
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HA; Fatigue; DOE; Chest pressure; Fever 100.2; Sudden coughing spell; This is a spontaneous report from a contactable Nurse (patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number=EL3248) on 12Jan2021 18:00 at SINGLE DOSE on Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Medical history included essential hypertension (Essential HTN), cardiac output (PLR). Concomitant medication received within 2 weeks of vaccination included lisinopril. The patient previously received first dose of BNT162B2 (Lot number=EL1284) on 23Dec2020 07:00 PM at SINGLE DOSE on Left arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Headache (HA), Fatigue, Dyspnea on effort (DOE), chest pressure, fever 100.2, sudden coughing spell that lasted hours during the night on 13Jan2021 06:30 AM. The outcome was Recovering. No treatment received for the adverse events. All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 62 | 2021-01-25 | fever, chills |
Fever; Chills; This is a spontaneous report from a contactable pharmacist. A 62-year-old female pati...
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Fever; Chills; This is a spontaneous report from a contactable pharmacist. A 62-year-old female patient (reporter's sister) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunization. Medical history included virus 3-4 weeks ago in 2020 prior to getting the vaccine. The patient's concomitant medications were not reported. The patient had the virus 3-4 weeks ago and received the vaccine yesterday (11Jan2021). She experienced fever and chills for a short time after the vaccine. The reporter wanted to know "Is that more prominent after you have had the virus? Are we getting reports of patients who had Covid 19 prior to getting the vaccine having more side effects? If since his sister got those reactions, can she be more contagious." The outcome of events was unknown. Information on the lot/batch number has been requested.
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| 62 | 2021-01-26 | body temperature increased, headache, fatigue |
Woke up at 5am 1/26/21 with Headache, body aches, ax temp 100.4. Left arm pain with enlarged lymph ...
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Woke up at 5am 1/26/21 with Headache, body aches, ax temp 100.4. Left arm pain with enlarged lymph nodes left axillary area. Fatigued. Headache became debilitating around noon. Extra strength Tylenol decreased temperature and body aches but did not help with headache. Fatigued all day. 1/27/21 10amFatigued, headache, body aches gone.
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| 62 | 2021-01-26 | headache, chills, fever |
body pain/ Soreness; Headache; Fever up to 101.7; Shivers; This is a spontaneous report from a conta...
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body pain/ Soreness; Headache; Fever up to 101.7; Shivers; This is a spontaneous report from a contactable consumer (patient's husband). A 62-year-old female patient received first dose BNT162B2 of (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246, expiration date: Apr2021), via an unspecified route of administration on left arm on 14Jan2021 10:00 at SINGLE DOSE for COVID-19 immunization (patient is a medical worker). There were no medical history and concomitant medication. The patient noticed about 21:00 on 14Jan2021, she was having body pain and a headache. The patient's husband took her upstairs and took her temperature and she had a fever and then she got the shivers which went on for quite a while. The hot bath seemed to help. She has had no other treatment. The patient's husband stated that his wife and he both got inoculated at the local hospital. He was fine but his wife has a fever up to 101.7 and he was asking if she take ibuprofen as she has a roaring headache and she was sore. The patient has been taking baths to relieve the soreness. No prior vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer vaccine. No event required a visit to physician or emergency room. There were currently no vaccines available for the second dose, but she is planning to get the second dose 31Jan2021. The outcome of the event Shivers was recovered on 14Jan2021 and the outcome of the other events were not recovered.
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| 62 | 2021-01-26 | headache, nasopharyngitis, cough, nasal congestion |
pt states she woke up next after vax she woke up with cold symptoms, ie; stuffy nose, coughing, body...
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pt states she woke up next after vax she woke up with cold symptoms, ie; stuffy nose, coughing, body aches and headache. Pt states she has intermittent dizziness.
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| 62 | 2021-01-26 | headache, fever, fatigue |
Had 2nd shot on Tuesday 1/19 at 1500. Went to bed felt a little nausea, woke at 0300 1/20 with runs....
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Had 2nd shot on Tuesday 1/19 at 1500. Went to bed felt a little nausea, woke at 0300 1/20 with runs. Finally back to bed to continue with violent shakes. fever, aches and head aches lasting until late Thursday afternoon. Exhausted feeling still remaining through Saturday. Felt myself on Sunday 1/24
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| 62 | 2021-01-27 | fatigue, chills, body temperature increased |
Very sore arm at injection site, aching joints, 101 degree temperature with chills starting at hour ...
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Very sore arm at injection site, aching joints, 101 degree temperature with chills starting at hour 12 and ending at hour 23 post shot and fatigue the entire next day. 48 hours after vaccine all symptoms are gone.
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| 62 | 2021-01-27 | fatigue, headache |
approx. 15-20 min after vaccine admin, pt c/o "ha, fatigue", evaluation by EMT, vs 158/86 100, spo2 ...
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approx. 15-20 min after vaccine admin, pt c/o "ha, fatigue", evaluation by EMT, vs 158/86 100, spo2 97, p=101, pt reports that this bp is "normal for her", she remained alert aned oriented, progressed to feeling "flushed from head to waist", at 5:05 pm, pt feels that these s/s r/t "very busy all day,this is the first time I have sat down all day", bp 168/95, 103, spo2 96, cool pack applied to back of neck, pt reports increase in feeling , "flushed", 1720- pt c/o "my neck feels swollen, my jaw hurts", denies shortness of breath, or chest pain, no hives observed on head, or abd, pt agrees to more advanced eval at ER, husband notified, 1730, pt experiences dry heaves, no emesis, bp 179/109, Ambulance called to transport to ER, IV initiated by EMT, 1740, pt to stretcher, with ambulance crew, report given, pt continues to deny shortness of breath, and chest pain, she remains alert and oriented.
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| 62 | 2021-01-27 | fever, chills, malaise, headache |
migraines; arm is sore where the injection; she could hear like blood going through her, and if she ...
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migraines; arm is sore where the injection; she could hear like blood going through her, and if she moved it got faster and faster; Chills; muscle aches; not feeling well; Headache; fever; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (BNT162B2, manufacture: Pfizer), via an unspecified route of administration on 21Dec2020 by injection once to right arm (Lot Number: EJ1685) at SINGLE DOSE, via an unspecified route of administration on 11Jan2021 (Lot Number: EL3302) at SINGLE DOSE for covid-19 immunization (reported as healthcare worker, medical receptionist). Medical history included Other Conditions No. There were no concomitant medications. The patient experienced fever on 11Jan2021, headache on 12Jan2021, chills on 12Jan2021 23:30 , muscle aches on 12Jan2021 06:00, not feeling well on 12Jan2021 , migraines and arm is sore where the injection on an unspecified date. The caller had her second vaccine (later clarified as COVID vaccine) on 11Jan2021, and had the same symptoms as on the first one. They were not as bad, and she thought the first one was pretty bad. She previously reported her symptoms with the first vaccine. Symptoms with the second were fever, headache, chills, of course, and muscle aches, her arm weighs a ton, and not feeling well. Fever was noted when she was sleeping, it is now 99.6, but it was was 103. Headache was noted in the early morning, it was not a normal headache, it was the worst thing, and she is prone to migraines, but this was not even like that, she could hear like blood going through her, and if she moved it got faster and faster, one time, she stood still and it was like ahhh! Chills started about 11:30 last night, they went away this morning, about 11AM. Muscle aches started at 6AM yesterday, and are finally gone, as of probably about 9AM, they are fine now, just her arm is sore where the injection was. Not feeling well started yesterday and is getting better. First dose was 21Dec2020, she previously provided lot EJ1685, confirms both were Pfizer vaccines. The outcome of the event fever, not feeling well was recovering, headache recovered on 13Jan2021, chills recovered on 13Jan2021 11:00, muscle aches recovered on 13Jan2021 09:00. No follow-up attempts possible. No further information expected.
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| 62 | 2021-01-28 | fatigue, headache | very bad muscle aches, tired, headache. |
| 62 | 2021-01-28 | headache, chills |
When she woke up at 1/28/21 had the general body aches, headache, and chills. Then today that has r...
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When she woke up at 1/28/21 had the general body aches, headache, and chills. Then today that has resolved, but is having a stabbing, throbbing head pain in one spot. Had been taking regular Tylenol but took Tylenol with Codeine as it is limiting her to what she can do. Had trouble sleeping last night due to it. Just hoping that it goes away.
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| 62 | 2021-01-28 | headache, fatigue |
Headache, HYPERtension, FATIGUE Narrative: PATIENT HOSPITALIZED OVERNOC w/HTN urgency. patient late...
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Headache, HYPERtension, FATIGUE Narrative: PATIENT HOSPITALIZED OVERNOC w/HTN urgency. patient later seen by PCP endorsing improvement of symptoms. pt further endorsed feeling lightheaded with vaccination # 1. pt also with c/o increased burping.
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| 62 | 2021-01-28 | malaise | shaking, dizziness, felt bad right after injection |
| 62 | 2021-01-28 | fever, chills |
Chills; fever; This is a spontaneous report from a contactable nurse (patient). A 62-year-old femal...
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Chills; fever; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date unknown) via an unspecified route of administration in the right arm on 07Jan2021 at 8:30 AM at a single dose for for COVID-19 immunization. The patient medical history was not reported. The patient has not had COVID prior to vaccination. Concomitant medications included doxycycline, lisinopril, thyroid, ubidecarenone (COQ10 [UBIDECARENONE]) on unspecified dates for unspecified indications. The patient previously took EES (erythromycin ethylsuccinate) and experienced allergies, and previously received the first dose of BNT162B2 on 17Dec2020 for COVID-19 immunization. The patient had no other vaccines in four weeks. 07Jan2021 at 20:00, the patient experienced chills and fever. It was reported that patient missed three days of work. It was unknown if treatment was received for the adverse events. The outcome of events was recovered on unspecified date in Jan2021.
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| 62 | 2021-01-28 | fever, malaise, headache, chills | headache, chills, fever 101, malaise |
| 62 | 2021-01-29 | fatigue, headache, chills, fever | injection side pain, tiredness, headache, muscle pain, chills, joint pain, fever |
| 62 | 2021-01-29 | throat irritation |
Patient is a 60-year-old female with past medical history of HTN, SLE presents emergency department ...
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Patient is a 60-year-old female with past medical history of HTN, SLE presents emergency department with throat itching after receiving the COVID-19 vaccination. Patient states that she previously had allergic reaction to contrast dye in the past and is having a similar sensation in her throat. She admits to nausea but denies any voice changes, difficulty swallowing, wheezing, rash. Patient denies requiring admission recommendation from allergic reaction past. Patient received Allegra prior to receiving the vaccination. This is her first dose of the vaccination.
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| 62 | 2021-01-30 | fatigue, nasal congestion, fever |
Early afternoon - Tiredness- 7-8 pm Fever of 99; Muscle/joint aches/pains; Upset stomach; stuff nose...
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Early afternoon - Tiredness- 7-8 pm Fever of 99; Muscle/joint aches/pains; Upset stomach; stuff nose Later in evening - hives Next morning - swollen lip on left side (had derm filler on 1/21/2021) Took Tylenol and Benadryl
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| 62 | 2021-01-30 | headache, chills | Chills with uncontrollable shivering, headache, body aches and joint pain |
| 62 | 2021-01-31 | chills, fatigue, headache, influenza like illness |
(Friday)Immediately after the injection-dizziness, vertigo, tunnel vision, blurred vision, pin point...
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(Friday)Immediately after the injection-dizziness, vertigo, tunnel vision, blurred vision, pin point pupils, unable to talk, headache, facial and lip numbness, numbness traveled down the right side of my body (side of injection) trembles, weak legs, very weak all over. EMTs were called but I didn't go to the hospital. My son picked me up and took me home because I was unable to drive. On the way I experienced loss of vision and speech for about 5 minutes. When I got home, my legs were so shaky that I had to have help walking. I started getting severe chills that took 3 hours to get warm (2 heavy blankets, space heater, and heating pad). I was very fatigued and felt bad the rest of the day. (Saturday)The next day I had flu-like symptoms; headache, joint aches, chills, nausea, extreme fatigue. Sunday was better but still had to rest most of the day because when I would stay up for over 30 minutes, the symptoms would return. Monday- stomach cramps, headache, fatigue but went to work (30 minutes late due to stomach) and left 30 minutes early.
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| 62 | 2021-01-31 | fatigue | Systemic: Anaphylaxis-Severe, Systemic: Exhaustion, Systemic: Nausea |
| 62 | 2021-01-31 | headache, fatigue |
Pain swelling redness at injection site. Dizziness, Body Aches. headache stomach distress, tired...
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Pain swelling redness at injection site. Dizziness, Body Aches. headache stomach distress, tiredness
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| 62 | 2021-01-31 | headache | Body aches and Headache |
| 62 | 2021-01-31 | fever, chills, headache | chills, aching, headache, slightly nauseous, low grade fever |
| 62 | 2021-01-31 | fever, sleepiness |
On the day following the vaccination, I had fever 100.3 and when I took a nap in the afternoon I had...
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On the day following the vaccination, I had fever 100.3 and when I took a nap in the afternoon I had nightmares and had difficulty waking up. It felt as though I had been drugged.
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| 62 | 2021-01-31 | throat irritation |
I had to get cleared by a allergist prior to getting the vaccine due to my prior history allergy his...
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I had to get cleared by a allergist prior to getting the vaccine due to my prior history allergy history. I was advised by the allergist to take Allegra an hour before receiving the vaccine. About 10 minutes after receiving the vaccine, I started to throat my started to feel dry and tickling, it felt like it swelling starting from the left side to the center, I started having difficulties swallowing my salvia and any fluid. My blood pressure was checked and it was elevated. I started to have difficulty breathing. They transferred me over to the ER. They gave me IV medicines Benadryl, Prednisone, Pepcid (I think). After 6 hours I was able to go home. Everything went back to normal besides the pain in the left arm at injection site. I had a telemedicine visit today with my primary care physician to follow up.
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| 62 | 2021-02-01 | chills, headache |
Second vaccine given on 1/28/21. Got sick later that evening with pain & soreness at the injection s...
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Second vaccine given on 1/28/21. Got sick later that evening with pain & soreness at the injection site. Along with a severe headache, nausea, and chills. The symptoms lingered over the next couple of days. Contacted Employee Heath and manger the following day. Stayed out of work on 1/29/21.
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| 62 | 2021-02-01 | chills |
racing pounding heart rate 110-126 (normal is 60); racing pounding heart rate 110-126 (normal is 60)...
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racing pounding heart rate 110-126 (normal is 60); racing pounding heart rate 110-126 (normal is 60); Very weak; chills; whole body achiness; This is a spontaneous report from a non-contactable nurse (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK4176) via an unspecified route of administration on the left arm on 18Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included coronavirus and allergies: sensitive to milk protein and gluten sensitivity. Concomitant medication included St John's Wort, colecalciferol (VITAMIN D [COLECALCIFEROL]), calcium carbonate (TUMS [CALCIUM CARBONATE]) and multivitamin. The patient previously took casein and experienced allergies. On 19Jan2021 05:00 AM, the patient experienced racing pounding heart rate 110-126 (normal is 60), very weak, chills, whole body achiness. Work the night shift, 11p-7a and symptoms started around 5am. No treatment was received for the events. Patient was not pregnant. The facility where the vaccine was administered was in a Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 62 | 2021-02-01 | fatigue | Dizziness, Increase Blood Pressure, Fainting, Fatigue, |
| 62 | 2021-02-01 | fever, influenza like illness |
Nausea, fever , aches and pains all over , flu like symptoms , Rash from chin to chest , itchy . st...
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Nausea, fever , aches and pains all over , flu like symptoms , Rash from chin to chest , itchy . still have itchy neck chin to chest.
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| 62 | 2021-02-01 | fever | fever and facial swelling |
| 62 | 2021-02-02 | fatigue, headache |
Within 15 minutes of receiving the injection, I began with a tingling sensation in my lower lip. Wit...
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Within 15 minutes of receiving the injection, I began with a tingling sensation in my lower lip. Within 3 minutes, the same sensation began in my upper lip. The tingling became more intense and then my lips began to swell. My BP was taken and was 170/100. I was given 25 mg of Benadryl orally and closely monitored for approximately 1 hour. The tingling in the lips and the swelling subsided within 45 minutes to an hour and my BP dropped to 140/82 when I left to go home. The following day, I began to experience fatigue and a headache. The fatigue and headache (which was only slightly relieved with 1000mg. of Acetominophen) lasted for 3 days and then all symptoms completely subsided.
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| 62 | 2021-02-02 | sweating, headache |
Patient had some flushing, sweating and headache. Patient also had generalized itching over entire b...
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Patient had some flushing, sweating and headache. Patient also had generalized itching over entire body. no rash noted.
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| 62 | 2021-02-03 | headache, malaise, fatigue, sinusitis, chills |
chills day 1 and 2; tiredness; headache; muscle pain; joint pain; feeling unwell; dizziness; weaknes...
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chills day 1 and 2; tiredness; headache; muscle pain; joint pain; feeling unwell; dizziness; weakness; sleeplessness; sinus unable to drain, feels like sinus infection but no fever; This is a spontaneous report from a contactable health care professional (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283) in the hospital, via intramuscular route of adminsitration on 08Jan2021 at 15:00 at a single dose on the left arm for COVID-19 immunization. Medical history included Diabetes, High blood pressure, Osteoporosis, Hyperlipidemia, GERD, Diverticulosis and allergies to soaps, shampoos and lotions all from an unknown date and unknown if ongoing. Concomitant medication included metformin (manufacturer unknown), losartan (manufacturer unknown), ezetimibe (manufacturer unknown), esomeprazole (manufacturer unknown), dulaglutide (TRULICITY) , hctz (manufacturer unknown), denosumab (PROLIA), Alive multi vitamin (as reported), vitamin d3 (manufacturer unknown), ascorbic acid, colecalciferol, copper gluconate, cyanocobalamin, durapatite, folic acid, glucosamine hydrochloride, magnesium oxide, manganese sulfate, phytomenadione, sodium borate decahydrate, zinc amino acid chelate (BONE UP), alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME) and curcuma longa rhizome (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]). The patient had no other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination. It was reported that the patient had chills day 1 and 2, tiredness, headache, muscle pain, joint pain, feeling unwell, dizziness, weakness, sleeplessness and sinus unable to drain, feels like sinus infection but no fever all on 08Jan2021 at 19:00. The patient took Advil, Mucinex and Walphed as treatment for the events. The outcome of the events was not recovered. The patient has not been tested for COVID-19 post vaccination.
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| 62 | 2021-02-03 | headache, runny nose, fatigue, throat pain |
Dizziness; nausea; headache; constant eye and nose drain; constant eye and nose drain; burning eye a...
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Dizziness; nausea; headache; constant eye and nose drain; constant eye and nose drain; burning eye and nose; burning eye and nose; weakness; tiredness; sore lips and throat; sore lips and throat; sore on tongue; chest tightness; This is a spontaneous report from a contactable consumer reporting for herself. A 62-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 14Jan2021 11:30 for Covid-19 immunisation, administered at hospital. Medical history included hypertension, high cholesterol, diabetes mellitus, allergies penicillin. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included atenolol (manufacturer unknown), losartan (manufacturer unknown), atorvastatin (manufacturer unknown), hydrochlorothiazid (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 07:00 the patient experienced dizziness, nausea, headache, constant eye and nose drain, burning eye and nose, weakness, tiredness, sore lips and throat, sore on tongue, chest tightness. The patient underwent lab tests and procedures which included Sars-cov-2 nasal swab test: negative on 19Jan2021. The outcome of all events was not recovered as all ongoing now for 1 week. The events were considered non serious. Information on the lot/batch number has been requested.
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| 62 | 2021-02-03 | headache |
Patient with headache, muscle aches, nausea. then developed palpitations and dull constant nonexert...
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Patient with headache, muscle aches, nausea. then developed palpitations and dull constant nonexertional chest ache for several hours resolved with fluids and Tylenol/motrin.
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| 62 | 2021-02-03 | headache |
headache; Itchy; prickly skin all over body; This is a spontaneous report from a contactable consume...
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headache; Itchy; prickly skin all over body; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: unknown), via an unspecified route of administration on the right arm on 10Jan2021 at 09:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK5730 on 20Dec2020 at 09:00 AM on the right arm for COVID-19 immunization, and Benadryl. The patient took Benadryl before the second dose and throughout the day, and it somewhat helped with the constant skin irritation. On 10Jan2021, the patient experienced headache, itchy and prickly skin all over her body. No admission to hospital involved and no treatment was received. The events resolved on an unspecified date in 2021.
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| 62 | 2021-02-03 | fever, fatigue, headache |
101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; severe headac...
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101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; severe headache with light sensitivity for days 1-5; muscle cramps; joint pain; nausea; extreme fatigue lasting several days.; This is a spontaneous report from a contactable Other Health Professional (HCP) (patient). A 62-year-old female patient (pregnant: No) received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: EL0140), via unspecified route of administration on left arm on 12Jan2021 at 10:00 AM at single dose for covid-19 immunisation. The relevant medical history included Rheumatoid Arthritis, Asthma, Hypertension, Multiple allergies, Peripheral Neuropathy, degenerative disc disease, known allergies: Sulfa drugs; Tetracycline; Nsaids; Aspirin; Ioxinol; multiple pollens & molds; capsicum, peppers, black tea, black cohosh, and more. Concomitant medications included valsartan (DIOVAN), adalimumab (HUMIRA), leflunomide, hydroxychloroquine phosphate (PLAQUENIL), montelukast sodium (SINGULAIR) and levocetirizine dihydrochloride (XYZAL). The patient previously received first dose of BNT162B2 at the age of 61 years old on 22Dec2020 (first dose, Lot number: EL1283, 03:00 PM, Left arm) for covid-19 immunisation. The patient experienced 101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; muscle cramps, joint pain, nausea, and extreme fatigue lasting several days on 12Jan2021 at 04:00 PM. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering.
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| 62 | 2021-02-03 | fever | PER MD: HIGH FEVER, TACHYCARDIA, HALUCINATIONS, CHANGE IN MENTAL STATUS |
| 62 | 2021-02-04 | headache | soreness in arm, headache |
| 62 | 2021-02-04 | headache | soreness in arm, bad headache, nausea, itching on head, face and upper body. |
| 62 | 2021-02-04 | productive cough, cough |
Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible...
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Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible flu. I'm wearing diapers because of uncontrollable diarrhea. I can't leave my sofa to walk over to my desk because I'll be so out of breath. I have a cough that produces a pink or gold Phelm I have dry mouth. I have no appetite I'm so weak and have lost 15 pounds. Don't know what to do. My next Covid is shot is feb 11 Called employer on 2/3/21 but hung up. Tried calling multiple times to follow up. In triage she stated she had a COVID test scheduled and had spoken with her PCP. COVID test through PCP: 2/4/21 She passed away the night of 2/4/21
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| 62 | 2021-02-04 | fever, headache |
Got injection Friday at 12 noon, Saturday morning woke up with fever 101.2, diarrhea x 12 hours, hea...
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Got injection Friday at 12 noon, Saturday morning woke up with fever 101.2, diarrhea x 12 hours, headache x 3 days (frontal) on Sunday developed a baseball size red, hard and warm to touch raised area around injection site. This lasted for 3 days
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| 62 | 2021-02-04 | throat irritation |
Pt stated she felt like she had a "tickle" in her throat. She was given a bottle of water. She felt...
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Pt stated she felt like she had a "tickle" in her throat. She was given a bottle of water. She felt as though that was helpful. She denied itchiness, shortness of breath, dizziness, lightheadedness, tachypnea, dysphagia, facial, tongue or lip swelling. She denies feeling like her throat is closing. No visible rash or urticaria noted.
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| 62 | 2021-02-05 | chills, sinus headache, fever |
Came on fast and furious Horrible Chills lasting about 3 hours, threw up about 20 times, sinus heada...
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Came on fast and furious Horrible Chills lasting about 3 hours, threw up about 20 times, sinus headache for a couple of days, low grade fever for about 12 hours , achy all over felt like pin pricks up and down my body to the bottoms of my feet. At one point my air passage felt blocked possibly by something that I threw up.. had trouble regaining my breath. I was surprised at how fast and furious this came on.
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| 62 | 2021-02-05 | malaise, fatigue, headache |
Body Aches, headache, nausea, dizzy ness, feeling unwell, fatigue Pfizer-BioNTech COVID-19 Vaccine E...
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Body Aches, headache, nausea, dizzy ness, feeling unwell, fatigue Pfizer-BioNTech COVID-19 Vaccine EUA
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| 62 | 2021-02-05 | fever, fatigue | Fever x 3 days Weakness, fatigued, achy Urinary Incontinence day 1 Brain fog |
| 62 | 2021-02-05 | fever | fever the day after the vaccine op to 100° Fahrenheit |
| 62 | 2021-02-06 | throat irritation |
SENSATION OF BURNING OF TONGUE, LIPDS, THROAT AND NOSE WITH PAIN. EXAM FAIRLY BENIGN, NO OBVIOUS AB...
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SENSATION OF BURNING OF TONGUE, LIPDS, THROAT AND NOSE WITH PAIN. EXAM FAIRLY BENIGN, NO OBVIOUS ABNORMALITIES OTHER THAN MILD GLOSSITIS. TREATED WITH ANTIFUNGAL AND ANALGESICS
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| 62 | 2021-02-07 | chills, fatigue, headache, fever | Headache, Fever chills times four days, mouth sores, swollen lymph nodes, joint pain, fatigue. |
| 62 | 2021-02-07 | fatigue, chills, headache |
Sore arm and mild chills 5 hours after injection. Moderate chills, fatigue, headache, sore arm 20 hr...
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Sore arm and mild chills 5 hours after injection. Moderate chills, fatigue, headache, sore arm 20 hrs after injection. Went to bed and slept 2 hrs, started feeling better 26-36 hours after injection. Completely recovered by 48 hrs.
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| 62 | 2021-02-07 | headache |
Patient developed headache within 24 hours of the vaccination. The headache has persisted. She the...
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Patient developed headache within 24 hours of the vaccination. The headache has persisted. She then developed a mild erythema, mild edema, and pruritus of the palms of both hands 3 days after the vaccination. Also has pruritus of both feet but no erythema. No vesicles, ulcerations, or papules have developed.
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| 62 | 2021-02-07 | lethargy | lethargic underarm itchy 20 minutes after injection underarm on left side developed a rash |
| 62 | 2021-02-08 | cough |
On 1/8/2021 2 days after I received the Covid vaccine I started to have SOB and coughing. I started ...
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On 1/8/2021 2 days after I received the Covid vaccine I started to have SOB and coughing. I started to used my inhalers and it would give some relief but I was using it more than normal. I had not had asthma attack for more than a year. My asthma is very controlled that I don't use any inhalers whether daily or as needed. I went to work as usual since at that time my symptoms weren't getting worse but also not getting better. On 1/19/21, I was feeling more out of breath and having more dry hacking cough that when I called EH I was told to do the Covid testing. That same day I called my Asthma doctor and did a video call and was prescribed Breo inhaler, spiriva inhaler, xoponex nebulizer treatment and xoponex rescue inhaler. I couldn't go to work because of my shortness of breath and coughing. The treatment didn't work. On Tuesday 1/26/21, I called my asthma doctor again and another video call was made. She changed my inhaler to symbicort, still continue spirirva inhaler and nebulizer treatment. I also contacted my primary doctor who asked that I schedule an appointment with him so he can see me. On 1/28/21, I saw my primary doctor who did blood works to see if I have any blood clot and to see how my heart was doing. I was given phenergan with codeine to help with my coughing and it did help me to go to sleep. My blood works came out negative and he ordered CAT scan of my chest since I can't get rid of my SOB and coughing. I had the CAT scan on 2/3/21. He called me the next day and I was told that I had mucous plugging. He told me to go home and he prescribed Duoneb nebulizer treatment 4x a day and spiriva inhalers 2x a day. I started to get rid of the mucous that I had and started to breath better. It took 4 days of 4x a day nebulizer treatment and inhalers before I started to feel
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| 62 | 2021-02-08 | fatigue |
I was sitting in my sofa watching television and felt this odd dizziness overcome my head. I felt na...
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I was sitting in my sofa watching television and felt this odd dizziness overcome my head. I felt nauseated and hot. I closed my eyes for a few minutes and when I hope Ed the the intense dizziness subsided. I still feel a little dizzy, very tired and switch from feeling hot to very cold.
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| 62 | 2021-02-08 | fatigue |
heart rate of 160; severe nausea; arm soreness; muscle soreness in left arm; general fatigue; This i...
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heart rate of 160; severe nausea; arm soreness; muscle soreness in left arm; general fatigue; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 21Jan2021 13:00 at single dose in left arm for COVID-19 immunisation. Patient age at time of vaccination was 62 years. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) administered on 30Dec2020 at 01:00PM and the patient said she did not have a reaction after the first vaccine. The patient received no concomitant medications. She stated that she had no other recent vaccinations or new medications. One thing that may be important is that she did do a 7 day detox that ended the Sunday before her second vaccine dose, so her body was pretty much having no impurities in it, and she has been eating clean since then, maybe having something foreign put into her body set it off after detox. The patient experienced arm soreness and general fatigue on 21Jan2021, and on 22Jan2021 at 01:00 she experienced severe nausea and heart rate of 160 (which was reported serious as medically significant). Patient reported that after her second dose of the COVID-19 vaccine she had a significant side effect that didn't happen until 10-12 hours after getting the vaccine. She did not have a reaction after the first vaccine. After the second injection her arm was sore, and she had general fatigue. She had the second dose injected Thursday at around 01:00PM, then at one in the morning her heart rate was 160, and she had severe nausea. She was that way until 08:00AM. Her heart rate was 120 probably by 09:00AM, then came down to 100, she has never had anything like that before. Her arm soreness was a deep muscle soreness to her left arm. The fatigue was a couple hours later after she got the second dose of the vaccine. The nausea started at 01:00AM, and lasted until six to eight, she did no treatment, and it improved and is still gone now. For her heart rate of 160, she had no treatment, though she probably should have gone to the hospital, but it came down. She usually runs a heart rate of 60-70, it went back to normal Friday, probably in the afternoon on the 22nd, about 12 hours after that started. The patient stated that she feels this is medically significant for her heart rate to be that high. She had contacted her primary care physician (PCP), but they didn't call her back for 4-5 hours, by then she was fine. She doesn't think that this was treated well by her PCP, and that they should have done an electrocardiogram (EKG) and follow up labs, she is changing her PCP as a result of this. She is concerned about the people who will be getting their second dose, she has been helping with these, they have patients that are over 100, they wouldn't survive that rapid heartbeat. The outcome of arm soreness/muscle soreness and fatigue was unknown.; Sender's Comments: The reported event of heart rate increased was likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 62 | 2021-02-08 | headache, influenza like illness |
Pain at injection site; mild headache, body aches, nausea, (flu like symptoms). 400mg ibuprofen twic...
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Pain at injection site; mild headache, body aches, nausea, (flu like symptoms). 400mg ibuprofen twice 6 hours apart. Symptoms last 24 hours
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| 62 | 2021-02-09 | chills, fatigue, headache |
Moderate to severe fatigue; moderate nausea; slight joint pain; Vomiting; Dose 1 administration date...
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Moderate to severe fatigue; moderate nausea; slight joint pain; Vomiting; Dose 1 administration date 21Dec2020, Dose 2 administration date 07Jan2021; severe underarm pain; moderate chills; shaking; severe migraine-like headache; This is a spontaneous report from a contactable other health professional reporting for herself. A 62-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EK4176), via an unspecified route of administration on 07Jan2021 10:30 AM at single dose in Right arm for COVID-19 immunisation. Medical history included IV dye allergy and Allergy when on antibiotics from an unknown date. Concomitant medication included acetylsalicylic acid (ALKA SELTZER) received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL0140) on 21Dec2020 10:30 AM in Right arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced vomiting 12 hours after second injection on 07Jan2021 at 10:30 PM, then severe underarm pain and moderate chills and shaking 14 hours after, then severe migraine-like headache and slight chills 22-26 hours after. Moderate to severe fatigue, moderate nausea, slight joint pain for another 2 days, on 10Jan2021. Third day after injection was slight nausea and moderate fatigue. Fourth to sixth day after injection was slight fatigue. Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the adverse event. The outcome of events was recovered. The case was reported as non-serious.
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| 62 | 2021-02-10 | chills, nasal congestion |
1st shot 1/13/21, 2nd shot 2/3/21 0830 am 1st dose pfizer # EK 9231, 2nd dose pfizer# EL8982 shiver...
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1st shot 1/13/21, 2nd shot 2/3/21 0830 am 1st dose pfizer # EK 9231, 2nd dose pfizer# EL8982 shivers, heart pounding, bp 153/86 elevated for her, congestion
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| 62 | 2021-02-10 | chills, fever | Fever Chills Body Aches |
| 62 | 2021-02-10 | fatigue, chills, fever, headache | Chills, Fever, Fatigue, slight headache, loss of appetite It only lasted one day |
| 62 | 2021-02-10 | sweating, chills |
collapse and passed out; Woke up at midnight with severe leg cramps; I turned white as a ghost and s...
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collapse and passed out; Woke up at midnight with severe leg cramps; I turned white as a ghost and sweats; I turned white as a ghost and sweats; Got the chills after sweating; This is a spontaneous report from a contactable 62-year-old female consumer reported for herself that she received 1st dose of bnt162b2 (BNT162B2; lot number EL9261) on 26Jan2021 04:30 PM at left arm for COVID-19 immunization in Public Health Clinic. Medical history and concomitant drugs was none. The patient woke up at midnight with severe leg cramps, tried walking it out, collapse and passed out (according to husband). He stated that the patient turned white as a ghost and sweats. After coming too, drank electrolytes and water. The patient got the chills after sweating. It took a while for her to warm up and go back to sleep. Event start time was reported as 27Jan2021. The outcome of the event was resolved.
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| 62 | 2021-02-10 | malaise, headache |
woke up not feeling good; a few hours later headache and dizzy; dizziness increased; driving and ha...
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woke up not feeling good; a few hours later headache and dizzy; dizziness increased; driving and hard to keep eyes open; feeling overall sick and getting very hot; threw up quickly three times water only nothing in my stomach. Got home and went to bed and slept for a few hours. Woke up and felt better. Headache and fatique so rested the day; next day felt better with headache and rested. Third-day slight headache but felt much better.
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| 62 | 2021-02-11 | headache, chills |
Injection site soreness and dark red circle for 3 weeks Severe chills 4 days Dizziness Headache Naus...
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Injection site soreness and dark red circle for 3 weeks Severe chills 4 days Dizziness Headache Nausea
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| 62 | 2021-02-11 | headache |
Severe body aches, headache, pain under arms, pain at injection site and could not lift arm for 26 h...
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Severe body aches, headache, pain under arms, pain at injection site and could not lift arm for 26 hours
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| 62 | 2021-02-14 | headache, chills, fatigue | Extreme fatigue, chills, headache, joint and muscle aches, nausea. |
| 62 | 2021-02-14 | headache, fatigue, fever | headache, fever, fatigue, diarrhea, |
| 62 | 2021-02-14 | headache |
pain at site of injection at 24 hours post injection. Nausea, diarrhea, headache 24 through 48 hours...
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pain at site of injection at 24 hours post injection. Nausea, diarrhea, headache 24 through 48 hours post injection.
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| 62 | 2021-02-15 | influenza like illness, fever, head discomfort |
Developed typical flu symptoms but developed severe incapacitating migraine/nausea/photofobia/vertig...
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Developed typical flu symptoms but developed severe incapacitating migraine/nausea/photofobia/vertigo. Felt feverish but no temp. Severity so bad almost went to ER. Took Imitrex x2 with chest tightness occurring after 2nd dose. Lasted x3 days then pressure on right side of head eye for a month. Elected not to do 2nd shot due to above s/s.
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| 62 | 2021-02-16 | headache, sweating |
Swollen lt. arm, severe body aches and pain, headache, excessive sweating for 14 hrs. Missed work o...
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Swollen lt. arm, severe body aches and pain, headache, excessive sweating for 14 hrs. Missed work on 1/27/2021. 8 hrs.
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| 62 | 2021-02-17 | headache, fever |
The site got worse through Thursday and was red, hot; Weakness; woke up with 100.5 degrees temperatu...
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The site got worse through Thursday and was red, hot; Weakness; woke up with 100.5 degrees temperature; Difficulty remembering things; Vomiting; Headache 10/10; developed a red area below injection site/The site got worse through Thursday and was red, hot; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular in right deltoid on 24Jan2021 at a single dose for prevention (COVID-19 immunization). Medical history included Low immunoglobulin/compromised immune status/Low immunoglobulin diagnosed 8 years ago, hereditary angioedema from 2010, asthma diagnosed in her 20's, Allergic to Thermarisol, diagnosed allergies, respiratory illness, and endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (LOT number: EJ1686) in right deltoid on 03Jan2021 for covid-19 immunization, and flu shot on Sep2020 without adverse event. She got second injection on 24Jan2021. On 25Jan2021, she woke up with 100.5 degrees temperature and could not stop vomiting. She had to go to the ER. They gave her Zofran, IV and also Toradol because she had a number 10 headache. She continued with low grade temperature throughout week from 99.5-100.5 degrees Fahrenheit, and by Tuesday morning, she developed a red area below injection site. By Thursday, there was a red area growth to 13 cm x 15.5 cm on the injection site. She could not remember her email address and said her brain was not thinking. This started after the vaccine that she began having difficulty remember things. She never had a headache that bad. It improved but she has a lingering headache still. She continued to have a temperature from Monday to Saturday. Currently, she does not have an elevated temperature. Difficulty remembering things was reported as just irritating, but significant. The site got worse through Thursday and was red, hot and ended up measuring 13 cm x 15.5 cm. Regarding weakness, she could walk but medics had to help support from her seat to the ambulance. The outcome of the events red and hot injection site was not recovered; the outcome of the events vomiting, headache, weakness was recovering. The outcome of difficulty remembering things was unknown. The outcome of high temperature was recovered on an unknown date. The events was assessed as medically significant.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events and the use of BNT162B2 cannot be excluded. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
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| 62 | 2021-02-18 | headache, fatigue, fever |
Fever, headache, dizziness, muscle and join pain/aches - at time severe, hives, nauseous/stomach ach...
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Fever, headache, dizziness, muscle and join pain/aches - at time severe, hives, nauseous/stomach ache similar to indigestion, loss of appetite, injection site pain, fatigue
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| 62 | 2021-02-18 | fever, headache, chills, fatigue, sneezing, runny nose |
I woke up with runny nose and constant sneezing, muscle aches and pains. Fever 103 and chills and un...
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I woke up with runny nose and constant sneezing, muscle aches and pains. Fever 103 and chills and uncontrollable vomiting. Suspects cerebral edema because of head ache and vomiting. Took 8 mg of dexmetholzone and Zofran. Neither were helpful. I took a shot of emetrex in case of a migraine. Vomiting has stopped but fatigue and weakness persists.
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| 62 | 2021-02-18 | throat irritation |
Took 2 benedryl prior to vaccine. Vaccine rec'd at 4:30 pm woke up at 2 am with hives and severe itc...
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Took 2 benedryl prior to vaccine. Vaccine rec'd at 4:30 pm woke up at 2 am with hives and severe itching on arms, throat and upper torso along with scratchy throat. Hives reappeared for two days afterwards. Should I get the second dose?
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| 62 | 2021-02-21 | headache |
RECEIVED 1ST DOSE OF PFIZER COVID 19 VACCINE ON 02/13/21. ON 02/22/21 WENT TO PROVIDER WITH COMPLAIN...
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RECEIVED 1ST DOSE OF PFIZER COVID 19 VACCINE ON 02/13/21. ON 02/22/21 WENT TO PROVIDER WITH COMPLAINT OF SEVERE HEADACHE AND WAS INSTRUCTED TO GO TO ER. ON 02/22/21 WENT TO ER WITH COMPLAINT OF SEVERE HEADACHE. DISCHARGE TO HOME SELF CARE IN REGARD TO FOLLOW UP WITH PCP FOR FURTHER EVALUATION SINCE DID NOT AGREE TO CT SCAN.
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| 62 | 2021-02-21 | sweating |
01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Calle...
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01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Called dr and had a Telemed call with NP on Tues. 01/26. Predisone and Benadryl was prescribed. Thurs. 01/28 Call to let them know that it wasn?t working. I went into the office for one shot of Solumedrol. This help and they were gone. They gave me second dose of Predisone to take in case it came back and to continue the Benadryl. 02/8 Second vaccine. Hives began that night: arms, torso, thighs, hair. Call the Dr. on 02/10 and suggested I go to an allergist. Went to allergist on 02/11 she said to only take one Predisone, Allegra one am and one at noon, then take zertek at nighttime. The Predisone created a major brain fog, I had to stop. Saw the allergist on 2/18, she agreed to get off the Predisone. 02/11 I passed out in the am and when I woke up with vomit running down my face. Still suffering with hives this entire time. 02/17 my face, lips, tongue started to swell and I had chest pain for 90 minutes. My feel swelled and I have hives so bad on my feet I could not walk or put on shoes. 02/20 Woke up with sweat on my chest. My hands were so swollen I had to have my wedding ring was cut off . 02/21 I went to the Urgent Care and received a shot of Solumedrol. They said this should last me for a few days. 02/21 woke up 3 time throughout the night soaked in sweat.
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| 62 | 2021-02-21 | throat pain |
The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teet...
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The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; pain in neck; pain in left shoulder; The shortness of breath lasted over; My lips were tingly; I could feel the end of my nose. My throat was closing/throat closing a little bit; I had pain in my arm; my muscles ached.; The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; anaphylaxis; allergic reaction to the first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN5318), via an unspecified route of administration on 22Jan2021 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included drug allergies from an unknown date. There were no concomitant medications. The patient experienced anaphylaxis on an unspecified date in 2021. The patient had a little bit of an allergic reaction to the first dose of the Pfizer COVID 19 vaccine in 2021, it was not severe enough to use an Epipen. The shortness of breath from 22Jan2021 18:00 lasted over a week. Her lips were tingly from 22Jan2021 14:30, she could feel the end of her nose. Her throat was closing from 22Jan2021 14:30. She had pain in her arm from 22Jan2021 11:00, and her muscles ached from an unspecified date in 2021, the left side of her face, ear, throat and teeth hurt (facial pain from an unspecified date in 2021, ear pain from 22Jan2021 23:00, throat pain from an unspecified date in 2021, tooth pain from 22Jan2021 23:00), pain in left shoulder from 22Jan2021 20:30, pain in neck from 22Jan2021 23:00. She did have to take Benadryl for treatment of shortness of breath. She felt better after 1.5 weeks. The outcome of events anaphylaxis, allergic reaction, muscles ached, Facial pain, Throat pain was unknown, outcome of event pain in arm was resolving, outcome of event tooth pain was resolved on 23Jan2021, outcome of shortness of breath was resolved on 01Feb2021, outcome of other events was resolved on 24Jan2021.
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| 62 | 2021-02-22 | fatigue, headache |
Soreness at injection site and fatigue within several hours; headache next morning with slight dizzi...
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Soreness at injection site and fatigue within several hours; headache next morning with slight dizziness
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| 62 | 2021-02-22 | sweating, headache, fatigue, fever, chills | Fever (103+), vomiting, chills, headache, nausea, sweating, fatigue for 36+ hours. |
| 62 | 2021-02-23 | influenza like illness, headache | severe headache, general flu-like symptoms started 4 hours after vaccine and lasted 36 hours |
| 62 | 2021-02-23 | fever, headache |
2/3/21: c/o Fever, headache and vomiting; 2/3/21 at 7am: Fever escalated; 2/4/21: Temp: 104; admit...
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2/3/21: c/o Fever, headache and vomiting; 2/3/21 at 7am: Fever escalated; 2/4/21: Temp: 104; admitted to hospital; Dx: HSV-1, Encephalitis; Tx: Acyclovir IV TID x 3 weeks, completes tx on 2/25/21 Admitted total of 6 days 2/10/21: discharged home, continues to have difficulty with computation of numbers and naming objects
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| 62 | 2021-02-24 | fatigue |
persistant nausea/nausea become much worse on day 4; fatigue; slight appetite loss; unable to eat no...
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persistant nausea/nausea become much worse on day 4; fatigue; slight appetite loss; unable to eat normally; lost much weight; This is a spontaneous report from a contactable consumer reported for herself. A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EM980) , on 04Feb2021 at 16:00 (at 62 years) at single dose in left arm for covid-19 immunisation . Medical history included glucose intolerance. Patient was not pregnant.Concomitant medication included atenolol and calcium/ergocalciferol (CALCIUM/VITAMIN D). The patient previously took sulfamethoxazole/trimethoprim (BACTRIM) and experienced allergy. On 08Feb2021 at 08:00 (as reported) the patient experienced persistent nausea, fatigue, slight appetite loss, unable to eat normally and lost much weight, all non serious. Events were described as follows: patient had persistent nausea. The first few days she had the expected side effects of fatigue and slight appetite loss. The fatigue resolved on the second day, but the nausea become much worse on day 4. She had been unable to eat normally since then and had lost much weight that she cannot afford to lose. She kept hoping that it will go away, but it was 8 days after her shot and she still had nausea (as reported). Anti nausea medicine was administered, no treatment given for the other events. Patient recovered from fatigue in Feb2021; outcome of the other events was not recovered.
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| 62 | 2021-02-24 | influenza like illness |
I have chronic left lower quadrant pain/inflammation due to prior abdominal surgeries. My doctors ha...
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I have chronic left lower quadrant pain/inflammation due to prior abdominal surgeries. My doctors have told me it is scar tissue/adhesions. I have flare ups periodically. This has been going on for more than 15 years. I have not had a major flare up in more than 2 years. I received the second dose on 2.10. I had mild flu like symptoms in the next 24 hrs. On 2/16 I began to feel like I was going to have a flare up. The pain progressed to constant. It was the worst flare up of this left lower quadrant pain I have had in YEARS! I had to call my MD and ask for pain medications. I was nauseous as well. The pain slowly began to subside and by 2/23 I was back to normal. The ONLY thing different in my life has been the vaccine.
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| 62 | 2021-02-24 | fever | low grade fever first 2 days, continued off and on nausea, dizziness and confusion |
| 62 | 2021-02-25 | headache |
body ache, head ache, nausea, diarrhea, weakness, muscle pain, moving body pain, food intolerance, t...
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body ache, head ache, nausea, diarrhea, weakness, muscle pain, moving body pain, food intolerance, thirst, shaking, feeling of crawling out of body. Lasted 3 1/2 days. Last 2 days shaking and crawling out of body feeling was not present. Diarrhea only day 1. Nausea lasted 1 1/2 days. Day 4 no adverse effects remained. Not certain if the above was related to vaccine but timing seemed to match.
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| 62 | 2021-02-26 | sweating |
For about 20 minutes I experienced severe belly pains, profuse sweating and cold and clamminess, my ...
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For about 20 minutes I experienced severe belly pains, profuse sweating and cold and clamminess, my temperature dropped to 93 degrees. When I finished with these symptoms my temperature climbed back up to 97.7. I have been having intermittent belly pains since then but they are nothing like they were last night and they are getting more mild and far between as I write this.
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| 62 | 2021-02-27 | nasal congestion, throat irritation, sneezing |
Sneezed. Nose got stuffy. Throat felt irritated, but didn't close up. Was irritated all day. Sam...
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Sneezed. Nose got stuffy. Throat felt irritated, but didn't close up. Was irritated all day. Same as when I have allergic reaction to certain foods.
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| 62 | 2021-02-27 | fever, chills, headache | Chills, fever, nausea, vomiting, and severe headache |
| 62 | 2021-02-27 | fever |
Sore arm, nausea, with in an hour of vaccine. fever 100.6 started couple hours later treated with...
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Sore arm, nausea, with in an hour of vaccine. fever 100.6 started couple hours later treated with Tylenol
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| 62 | 2021-02-28 | fatigue, headache |
Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoar...
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Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoarseness, severe fatigue, headache, brain fog for first 20 hrs, then intermittent eyelid and face swelling, hoarseness, fatigue and brain fog for the next 3 days, followed by mast cell activation symptoms of fatigue, puritis, and mild racing heart in the evening for the last two days. For the past 3 years I have been medication free and virtually symptom free. The symptoms of the last few days are consistent with those I had during the years when my MCAD was active. I am concerned that the vaccine has reactivated the hyper-sensitivity of my mast cells.
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| 62 | 2021-02-28 | fatigue, fever |
4 inch area at injection site hard, red, hot. Extreme fatigue. Slight fever. Muscle and bone ache. R...
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4 inch area at injection site hard, red, hot. Extreme fatigue. Slight fever. Muscle and bone ache. Rash and itch on abdomen. Itch at injection site. Symptoms slowly decreasing over time, but not yet gone.
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| 62 | 2021-02-28 | headache, malaise, sweating, chills |
mild headache at waking up and during the day on and off sweats on and off chills on and off feelin...
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mild headache at waking up and during the day on and off sweats on and off chills on and off feeling unwell as if I will get a flu or heavy cold
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| 62 | 2021-02-28 | sleepiness |
nightmares; difficulty waking up; This is a spontaneous report from a contactable pharmacist (patien...
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nightmares; difficulty waking up; This is a spontaneous report from a contactable pharmacist (patient). A 62-year-old non-pregnant female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8292), via an unspecified route of administration in the right arm on 27Jan2021 07:15 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) on 09Jan2021 04:45 PM in the left arm for covid-19 immunisation. The patient experienced nightmares and difficulty waking up on 28Jan2021 14:00 with outcome of recovered in 2021. This was very unusual for patient. Events assessed as non-serious. No treatment was received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications that patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.
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| 62 | 2021-03-01 | fatigue |
Double vision Dizzy Elevated Blood Pressure Light sensitivity Fatigue Symptoms lasted for 10 hours,...
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Double vision Dizzy Elevated Blood Pressure Light sensitivity Fatigue Symptoms lasted for 10 hours, monitored BP, monitored other symptoms (short naps, kept eyes closed as much as possible, minimal light
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| 62 | 2021-03-01 | headache, fever, chills |
On day 11 post 2nd vaccination, developed chills, severe headache, fever as high as 100.2. Able to r...
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On day 11 post 2nd vaccination, developed chills, severe headache, fever as high as 100.2. Able to reduce fever with ice packs but fever returned after 8 hours. Had fever from 2/12/21 to 2/18/21. Headache persisted and did not resolve until 2/22/21. Poor appetite and ackward taste in mouth. On 2/16/21, had Rapid Antigen Covid test, results NEGATIVE. Thought symptoms may have been sinus infection, but usual remedies not effective. Headache was like nothing ever experienced before. Symptoms felt very different. Had Covid test on 1/25/21 prior to 2nd vaccination, NEGATIVE. Self isolated after vaccination and worked from home so low risk of exposure. Was not tested for influenza.
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| 62 | 2021-03-02 | fever, headache, lethargy |
Body aches; Puttered around the house, then lost energy around noon; headache upon waking; felt like...
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Body aches; Puttered around the house, then lost energy around noon; headache upon waking; felt like I had a hangover; Lethargic all day; Fever 99.5-100.2; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received second dose of BNT162B2 (lot number: El9265), via an unspecified route of administration on 29Jan2021 13:00 at single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included levothyroxine sodium (UNITHROID). The patient previously took first dose of BNT162B2 (lot number: El324) at the age of 62 year-old on 08Jan2021 13:00 in the left arm and experienced minor injection site soreness. On 30Jan2021 07:00, the patient experienced headache upon waking Saturday morning and felt like she had a hangover. She felt lethargic all day. She had fever 99.5-100.2 from 7pm- 9pm on Saturday night. She experienced body aches on Sunday morning, 31Jan2021. Puttered around the house, then lost energy around noon. She felt ok but not back to normal energy level yet. Stated she is going to work tomorrow. The patient was not pregnant at the time of vaccination. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 99.5-100.2 on 30Jan2021. The outcome of the events was recovered in Jan2021.
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| 62 | 2021-03-03 | chills, fever |
0430 AM WOKE WITH BURNING FEELING AND CHILLS. AT 0730 TEMP DONE SEVERAL TIMES. 104.9 ORALLY. CALL...
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0430 AM WOKE WITH BURNING FEELING AND CHILLS. AT 0730 TEMP DONE SEVERAL TIMES. 104.9 ORALLY. CALLS MADE TO CLINIC AND PCP. I REFUSED TO GO TO EMERGENCY DEPT (HOSPITAL WAS TOTALLY FULL AND SOME). ALL DAY FEVER, NEVER BROKE. SAT. 102-103 SUN. WOKE FEELING FINE.
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| 62 | 2021-03-03 | cough |
Within an hour, I started getting a dry throat and had a dry cough for a few days. A little breathin...
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Within an hour, I started getting a dry throat and had a dry cough for a few days. A little breathing problem - it was almost like my reaction to bees that I had before - where my throat was closing up but that was just for about an hour. The second day, I had also (three days) of really bad diarrhea.
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| 62 | 2021-03-03 | fatigue, headache |
Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm coul...
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Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm couldnt sleep ..suicidal thoughts/OCD negative thoughts,very depressed... got up at 6pm. Next day woke up with headache started to clean tired and depressed. Dizzy and tripping over my feet. Next day woke up with headache started to clean got very tense and lightheaded and weak. Had to sit. Husband took blood pressure and it was 70/50. took again diff arm same. Sat for 1/2 hr went to 100/74. Feeling weak all day. Very confused no memory. Went to bed took Seroquel to calm down and sleep. Add note: I have been depressed for a while but the drop in blood pressure, drop in mood(bad) and weakness and dizziness happened after shot. Im afraid to take the 2nd one because of how it affected my mood. and blood pressure.
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| 62 | 2021-03-03 | headache, chills, fever, influenza like illness, throat irritation |
WITHIN MINUTES OF THE SHOT, FELT LIGHTHEADED & DIZZY. AFTER 40 MINUTES, EXPERIENCED LIP TINGLING, IT...
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WITHIN MINUTES OF THE SHOT, FELT LIGHTHEADED & DIZZY. AFTER 40 MINUTES, EXPERIENCED LIP TINGLING, ITCHY/SCRATCHY THROAT, ITCHY SKIN, A COUPLE OF STRAY HIVES. ALL OF THESE SYMPTOMS WERE MILD, AND PASSED AFTER A COUPLE OF HOURS. THE NEXT DAY HAD A VERY BAD HEADACHE. ABOUT 18 HOURS AFTER THE SHOT BECAME ILL WITH FLU-LIKE SYMPTOMS. HEADACHE, CHILLS, MUSCLE ACHES, LOW GRADE FEVER, CHEST TIGHTNESS/PRESSURE, HEAD & CHEST CONGESTION. ALL RESOLVED JUST ABOUT 48 HOURS AFTER THE SHOT.
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| 62 | 2021-03-03 | headache, chills, fever | Chills, slight fever, back ache - lower and upper back, headache |
| 62 | 2021-03-03 | headache |
On or around December 22, I noticed pain in my left forehead as though someone had hit me with a bas...
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On or around December 22, I noticed pain in my left forehead as though someone had hit me with a baseball. The next week around the 29th, it got very noticeable - pain to the touch but no swelling. It continued. Between the first dose and second dose I didn't recover, it just stayed.
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| 62 | 2021-03-03 | headache |
About the 11th or 12th, I noticed that the pain in my forehead- felt like little mice going up my h...
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About the 11th or 12th, I noticed that the pain in my forehead- felt like little mice going up my hairline into my scalp (no more into my forehead) - then over the course of the next week it moved further back onto my head. At about 05:00 am 1/21/2021, I was feeling my hairline right by the forehead and I thought I might have a lump there (there wasn't a lump there just felt like one) and I pressed on it a little bit and all of a sudden it exploded with pain and that pain lasted 23 hours. I went to regular doctor on 13th and he said it wasn't shingles and didn't know what it was. I went again on the 22nd - and she made a quick call to neurologist who said to go to ER. I wasn't in excruciating pain at this time. They diagnosed me with Trigeminal Neuralgia (1-22-2021). They gave me migraine medicine - a shot - and a prescription for anti-convulsant - Carbamazepine 200 mg twice daily.
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| 62 | 2021-03-03 | throat pain | blue/purple/black tongue and sore throat |
| 62 | 2021-03-04 | fatigue |
I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day...
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I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day 10 after the vaccine and my mast cell reactivity symptoms have increased by the day--internal and external swelling, flushing, pruritis, wheezing, tightness in chest, as well as pain and pressure in arm pits, groin, and ears. By late afternoon I am severely fatigued, weak, and foggy-headed. These symptoms are consistent with those I experienced during the twenty years when my mast cell disease was unstable. Through identification of my triggers and avoidance of the same, I have been symptom and medication free for the past three years--until taking the Covid-19 vaccine. It appears that the vaccine has reactivated an excessive degranulation response in my mast cells and that response is getting worse as my body responds to the vaccine. I realize that the percentage of persons who suffer from a condition like mine is small, but I would have appreciated having the information that I am submitting to you when I was weighing the pros and cons of vaccination. I know from the twenty years of navigating this disease that there is nothing that can be done at this point other than taking various H1 and H2 blockers. This vaccine appears to be undoing the hard-won level of stability achieved through years of careful lifestyle management.
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| 62 | 2021-03-04 | headache |
62 year old female complained of a headache after receiving vaccine. Onsite EMS was called vritals ...
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62 year old female complained of a headache after receiving vaccine. Onsite EMS was called vritals BP 166/98 100%O2 HR 98. She refused further eval and care.
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| 62 | 2021-03-04 | fever, fatigue, headache |
Developed the following approx 15-17 hours after injection: Low grade fever 100.2 Muscle and joint a...
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Developed the following approx 15-17 hours after injection: Low grade fever 100.2 Muscle and joint ache Fatigue Headache Took two Tylenol which brought fever down and slept. Took two more Tylenol at bedtime and felt normal the following morning.
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| 62 | 2021-03-05 | chills, headache |
On day 10 I woke with achey shoulders, neck and hands. Later in day had mild chills and overall ache...
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On day 10 I woke with achey shoulders, neck and hands. Later in day had mild chills and overall aches and by evening had 101.5 temp and flushing of face along with mild headache. Tylenol taken along with warm shower and early bed. Woke in am with mild headache, loss of appetite. Felt better by 11am and after a cup of tea. By afternoon I felt 100% back to normal. No rashes or even a sore arm post vaccination in the days prior to this event on day 10.
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| 62 | 2021-03-05 | fatigue, headache, throat pain |
15-20 after vaccine was administered I felt very confused and couldn't remember where I put my card,...
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15-20 after vaccine was administered I felt very confused and couldn't remember where I put my card, my pocketbook, felt pretty disoriented. I remember someone telling me to sit down and eat something. (I had already had lunch and a snack). That evening I started to have a bad headache. Thursday morning I had a very difficult time getting up and was extremely fatigued; felt hot. I felt exhausted all day and looked pretty tired and pale. Friday morning still tired, had some bouts of energy, but they didn't last long. Body aches were worse and I also had some stomach discomfort Saturday felt like I had a sore throat, felt weak, and still pretty tired. I had some problems catching my breath when climbing stair and and at one point felt hot and clammy. Headache was better.
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| 62 | 2021-03-05 | fatigue | Vomiting, dizziness, stabbing lower stomach pain, exhaustion, diarrhea. |
| 62 | 2021-03-06 | fatigue, fever, headache | First day rash/ hives and headaches with fatigue Continue to aches, fever, headaches and nauseated |
| 62 | 2021-03-06 | headache, fever, malaise | fever of 103 but went down with tylenol, headaches and overall feeling ill. |
| 62 | 2021-03-06 | malaise |
pt. presented to the ED at hospital with SOB, that didn't resolve with inhaler, and generally not fe...
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pt. presented to the ED at hospital with SOB, that didn't resolve with inhaler, and generally not feeling well. ED note attributed to the COVID vaccine
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| 62 | 2021-03-07 | fatigue, headache, chills |
Saturday evening injection sight started hurting. Woke up Sunday morning to nausea, dizziness, chil...
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Saturday evening injection sight started hurting. Woke up Sunday morning to nausea, dizziness, chills, muscle and joint pain, headache, tiredness
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| 62 | 2021-03-07 | fatigue |
Rapid heart beat; jitteriness; fatigue; sore arm; This is a spontaneous report from a contactable he...
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Rapid heart beat; jitteriness; fatigue; sore arm; This is a spontaneous report from a contactable health care professional (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6201), via an unspecified route of administration on 05Feb2021 at 08:15 on the left arm at a single dose for COVID-19 immunization. Medical history included sleep apnea from an unknown date and unknown if ongoing and meningioma removal on an unspecified date, 3 years ago. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced rapid heart beat, jitteriness, fatigue and sore arm on 05Feb2021 at 10:00. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.
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| 62 | 2021-03-07 | fatigue |
About 7-8 hours after Vaccine (1st dose), I developed severe arm pain and could not lift my arm and ...
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About 7-8 hours after Vaccine (1st dose), I developed severe arm pain and could not lift my arm and noticed numbness/tingling in my right little finger. I went to bed and woke up at around 2:30 AM, I had very hot, stabbing, shooting pain running up and down my arm into my neck and upper shoulder. I also had pain running down my arm. This pain was a 9/10 and lasted for 3-4 hours non stop. I was up most of the night and considered going to the ED. The following day, I still had numbness/tingling in my right little finger. I was able to move my arm a little more but not enough. The numbness/tingling took 3-4 days to go away and the arm soreness took 5-6 days to go away. I received the shot from a Pharmacy Intern. I do have shoulder problems but this was not normal. I am a RN. I am very thin, weighing around 107 lbs. I wondered about the technique used or the length of the needle, or the possibility that I was allergic to something in the vaccine. I was also very, very tired for 2-3 days. I do have a sore arm after the flu vaccine but not like this. I will not be receiving the second vaccine, even though I am immunocompromised. I did call my MD office but did not go in.
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| 62 | 2021-03-07 | influenza like illness | Vomiting, and other flu-like symptoms |
| 62 | 2021-03-07 | lethargy |
8:00 am 3/3/2021 had severe muscle and joint aches. Area of injection was red all around in large ar...
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8:00 am 3/3/2021 had severe muscle and joint aches. Area of injection was red all around in large area and warm to rich. Was lethargic.
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| 62 | 2021-03-07 | throat irritation | itchy all over body and throat rash on chest and arms |
| 62 | 2021-03-08 | chills, fatigue |
Little chill; tired; felt like I have no energy/ My body feels so weak; slight pain on left arm/ my ...
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Little chill; tired; felt like I have no energy/ My body feels so weak; slight pain on left arm/ my hand started to pain a lot; I couldn't even touch my own self it was so sensitive; may be I'm inflamed; nausea; severe pain/ my waist my back is so painful; My body feels so weak; my fingers and hand; It triggered the shingles pain in my back; It triggered the shingles pain in my back; had no appetite, I didn't eat; She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiration date: May2021), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. Medical history included shingles which she contracted in 2019, about one and a half years ago, it was a shingles on her back and lower back which she stated were the worst place for shingles has attacked, it left her with severe pain in both legs; diabetes; and high blood pressure. Concomitant medications included losartan, atenolol (a beta-blocker), and metformin for diabetes. The patient took the vaccine on 22Jan2021 and after about 2-4 days (Jan2021), she had a little chill and got very tired. She had to take care of herself. She was very tired not realizing it was the shot she took. She also felt like she has no energy. The patient was working from home but a lot of times, she was lying on the couch. Over the weekend (Jan2021), she had a slight pain on left arm. About a week or 8-10 days later (2021), she got very tired and couldn't even sit up. Her body was not itself. She started to feel like a bus rolling over her, like somebody took a baseball bat and beat her really bad. The patient uses her arm a lot and her hand started to feel a lot of pain. She couldn't even touch herself; it was so sensitive. She took paracetamol (TYLENOL) but it didn't work. She had celecoxib (CELEBREX) an anti-inflammatory, she thought she was maybe inflamed, but it didn't work. She had some diclofenac cream, she rubbed it, but it didn't work. The patient had shingles about a year and a half ago which was very bad. She just felt weak and didn't feel like herself anymore. She had a little bit of nausea and her whole body was really terrible. When she had the shingles, it left her with severe pain in both legs. She saw a neurologist and told her that she would have to take pregabalin (LYRICA) and it would go away. So, when she had severe pain last week, she took pregabalin but it didn't help. The patient took half of acetaminophen, oxycodone (PERCOCET) as she was not the person who takes pills, but it didn't work. Her body was so severe on Friday, it was not going away, the pain was there 24 hours. The patient has been experiencing this for 8-10 days now. She took one PERCOCET on Friday and had a slight relief and didn't took anything again. She kept rubbing the diclofenac cream, but it was not much of a relief. This morning, she has to work, she was sitting so she took PERCOCET. She is getting her second shot on Friday, 12Feb2021. She asked how she will feel after the second dose if she felt that way after the first dose, if the first shot was adequate, and if she should take the second dose. She stated that she didn't want to take the second dose. Her body felt so weak including her fingers and hand. It triggered the shingles pain in her back and felt like she was beaten up by someone. She has to lie down for the pain in her back. She also mentioned that she couldn't sit for so long as her waist and back were so painful. She was lying on a heating pad and ice and nothing was working. She even has a hard time getting up. She thought what happened was it triggered the shingles pain in her back and also left her with a problem under her feet. The shingles left her with some kind of damage when she took the shot. It was really bad. Her son was a physician and was concerned because last week, it got so bad, she didn't come out, she was in bed and bedridden from Friday to Sunday. She had no appetite, she didn't eat. The only thing that the patient had was diabetes and high blood pressure, but it was under control. She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit, but before my pressure was like 120 something, over 68 or 72 it was always around the 60s and 70s. Since she was having this, it was a little high. The outcome of the events was unknown.
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| 62 | 2021-03-08 | chills, headache, fatigue |
Pfizer-BioNTech COVID-19 Vaccine EUA - injection site pain & swelling & redness, tiredness, monster ...
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Pfizer-BioNTech COVID-19 Vaccine EUA - injection site pain & swelling & redness, tiredness, monster of a headache, chills but no fever, another red, itchy, blotchy, painful area, about the size of a man's wallet, just below injections site (but, not connected to injection site redness).
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| 62 | 2021-03-08 | fatigue |
Significant joint pain; fatigue; left arm pain. - Joint pain lasted 3 weeks from 12/27/2021 - 1/19/...
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Significant joint pain; fatigue; left arm pain. - Joint pain lasted 3 weeks from 12/27/2021 - 1/19/2021; Called Dr. - telemed visit - 1/18/2021. I had not recovered from the adverse symptoms of first dose before getting second dose. I had the second dose on January 19, 2021 - had joint pain but I did so much easier than this first dose.
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| 62 | 2021-03-08 | headache, fatigue, fever |
The first reaction - 15 minutes after the vaccine - I felt really dizzy and loopy. She told me, I th...
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The first reaction - 15 minutes after the vaccine - I felt really dizzy and loopy. She told me, I think you better sit back down. I felt better after sitting there for 30 minutes after. I didn't get dizzy again. I finished my workday. Next morning, I woke up with a fever 100.8 (about). I woke up with sore muscles - I tend to get sore muscles easily but I felt more sore than normal and I had a headache. Fever stopped after 24 hours. Note: I also get dizzy really easily - and so it isn't difficult for something to make me dizzy. I also felt really tired. And over the weekend, I felt nauseated (not initially but over the weekend.) And that lasted until about midday Monday (over the weekend) to be getting better . I took Tylenol and I rested. That helped with the symptoms.
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| 62 | 2021-03-08 | headache, fatigue |
Within minutes after receiving shot I became completely dizzy, lightheaded and started to faint. EMT...
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Within minutes after receiving shot I became completely dizzy, lightheaded and started to faint. EMT came to my aid and took vitals all looked OK. I stayed in place until I felt better about 30 minutes. For the rest of that day and the next day I was extremely tired, a little nauseous, and kind of out of it. The third day I had very sore left arm at site and very sore and tender lymph notes on left side of Arm and trunk. Six days after the shot I came suddenly down with a massive headache and diarrhea. Al has since resolved and I am on day eight.
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| 62 | 2021-03-08 | sweating |
Presented with weakness, generalized, and mild sweating. per patient " I typically get weak and swe...
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Presented with weakness, generalized, and mild sweating. per patient " I typically get weak and sweaty when I stand prolonged periods of time." patient states symptoms pre vaccination and continued after vaccine." patients symptoms improved after sitting in chair, no other symptoms.
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| 62 | 2021-03-08 | malaise, headache, fatigue | excessive fatigue, headaches, joint pain, loss of appetite, feeling unwell |
| 62 | 2021-03-08 | sneezing |
Next day repeated sneezing all day every 5 minutes 2 sneezes; This is a spontaneous report from a co...
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Next day repeated sneezing all day every 5 minutes 2 sneezes; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration, in the right arm on 05Feb2021 at 10:00 AM (at the age of 62-years) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included liraglutide (VICTOZA), metformin, lisinopril, bupropion hydrochloride (WELLBUTRIN), rosuvastatin calcium (COLESTRAX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Feb2021, the next day after vaccination, at 2:30 PM, the patient had repeated sneezing all day every 5 minutes 2 sneezes. No treatment was given. The clinical outcome of the sneezing was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 62 | 2021-03-09 | chills |
Three (3) days after receiving my second shot, I began to feel nauseous. Shortly after, diarrhea be...
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Three (3) days after receiving my second shot, I began to feel nauseous. Shortly after, diarrhea began and lasted for 24 hours. Then, I began to have the chills and a migraine-like headache. The migraine is still continuing past 24 hours.
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| 62 | 2021-03-09 | fever, chills, headache |
fever; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 62-ye...
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fever; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (brand=Pfizer), lot no. El3428, via an unspecified route of administration (right arm) on 03Feb2021 16:00 at a single dose for COVID-19 immunization. Medical history included acid reflux and known allergies to erythromycin and azithromycin (ZITHROMAX). No covid prior to vaccination. Concomitant medication included lansoprazole. The patient previously first dose of BNT162B2 (brand=Pfizer) for COVID-19 immunization on 15Jan2021 03:15 PM (lot no. El3428, right arm). No other vaccine in four weeks. On 04Feb2021 09:00 AM, the patient had fever and chills and headache on Thursday and Friday after her vaccine. No treatment received for the events. No covid test post vaccination. The patient recovered from all events on 05Feb2021.
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| 62 | 2021-03-10 | chills |
Approximately 39 hours after immunization I woke with abdominal cramping. Upon standing I became li...
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Approximately 39 hours after immunization I woke with abdominal cramping. Upon standing I became light- headed and fell. My legs and arms turned red and warm and started itching. Itching subsided in an hour but redness remained for several hours. After itching stopped chills started and lasted several hours . By 7am symptoms were gone except for redness.
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| 62 | 2021-03-10 | fatigue |
I lost muscle control while playing tennis for about 5 minutes. After that I felt very tired, queez...
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I lost muscle control while playing tennis for about 5 minutes. After that I felt very tired, queezy, dizzy for about two days.
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| 62 | 2021-03-10 | headache, chills, fever | Fever (101) Swelling, pain under arm that was vaccinated, lymph nodes Body chills Headache |
| 62 | 2021-03-10 | headache |
Headache increasing in severity to worse ever felt from Day 8th, February 17th through February 19t...
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Headache increasing in severity to worse ever felt from Day 8th, February 17th through February 19th. Some relief with Aleve and Tylenol, Having minor to moderate headaches on and off since, relieved by OTC, combination of OTC anti inflammatory or Tylenol.
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| 62 | 2021-03-10 | nasal congestion |
Patient received her second dose of vaccine at 6:40 PM. After the minute observation period, she le...
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Patient received her second dose of vaccine at 6:40 PM. After the minute observation period, she left the facility en route to her home. When she got to her car, she felt that the base of her tongue was swollen. She returned back to the vaccination center. At 7:05 PM, she was assessed by the post vaccine RN. BP 155/98, HR 103. O2 Sat 98% RA. She continues to verbalize that she feels minor swelling of tongue and "congested" nostrils. 7:15 PM BP 174/112 HR 103 O2 - 97% RA. Patient was also assessed by pharmacy. Epi-pen was not administered. Patient's symptoms were not improving. EMS called to transport patient to hospital for adverse reaction and increased blood pressure. BP 165/102 HR 103. Patient transported to hospital via stretcher.
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| 62 | 2021-03-10 | runny nose, influenza like illness, malaise, fever, chills, headache |
Dramatic flu symptoms. Extreme chills freezing cold extremities, fever, aches insomnia nose dischar...
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Dramatic flu symptoms. Extreme chills freezing cold extremities, fever, aches insomnia nose discharge, loose stools, headache, light nausea but did not vomit. Still not feeling well. Symptoms have decreased and can now sit in a chair as apposed to lying in bed.
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| 62 | 2021-03-10 | throat irritation, throat pain |
8:58AM: Vaccine administered 9:10AM: Reported tingling in fingers of right hand 9:19AM: Reported ti...
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8:58AM: Vaccine administered 9:10AM: Reported tingling in fingers of right hand 9:19AM: Reported tingling in fingers of right hand and burning of throat. CRNP notified and came to assess patient. Patient reported tingling in fingers of right hand but rest of right upper extremity felt fine. Having "upset stomach" and "throat soreness" which patient states she did not have prior to vaccine. She then stated her throat was burning. Able to drink water. Denied difficulty breathing or shortness of breath. Patient listed her allergies of Morphine and Percocet causing itching and scopolamine patch causing delirium. She reports taking all her prescribed medications this morning as well as 2 Tylenol. 9:29AM: Benadryl 25mg PO administered and patient continued to be monitored in observation area 9:44AM: CRNP reassessed patient and she stated she feels better and her throat was only sore and no longer burning 9:58 AM: CRNP reassessed. Patient states she is still feeling okay and would like to leave. MA walked with patient outside where patient got a taxi and was staying at her daughters house the rest of the day so she would not be by herself.
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| 62 | 2021-03-11 | body temperature increased, chills |
Exactly 12 hrs after second injection I had 103 temperature, severe shakes and chills. Both knees an...
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Exactly 12 hrs after second injection I had 103 temperature, severe shakes and chills. Both knees and arms at the elbows swelled and the elbow and Lymph nodes on my right inner elbow are still swollen. I am just now able to grip anything with my Left hand. I had both vaccines in my right arm. I am predominantly left handed. This has affected my work asin which I am still working full time.
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| 62 | 2021-03-11 | cough, headache |
Shortness of breath; joint pain in hands; Headache; coughing with extreme pain and described a feeli...
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Shortness of breath; joint pain in hands; Headache; coughing with extreme pain and described a feeling of bugs crawling in her lungs, bugs front and back/ painful cough; itching; This is a spontaneous report from a contactable nurse. This case was also received from Pfizer sponsored program. A 62-year-old female patient received the 2nd dose (at the age of 62-years-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# not provided), via an unspecified route of administration in Feb2021 at SINGLE DOSE for COVID-19 immunization. Medical history included lung and back problems (back pain). It was reported that the patient normally took an inhaler (not steroid inhaler because she didn't want to interfere with immune response), and other things. The patient previously took prednisone which started at 40mg for 2 days, 30 for 2 days, 20 for 2 days then goes down to zero for back pain (stopped taking 4 days before the second dose of the vaccine). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot# not provided) on 29Jan2021 (at the age of 62-years-old) for COVID-19 immunization. The patient's 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE was administered a week ago (Feb2021) Friday. It was reported that she got very ill initially which she said joint pain in hands and headache noted in Feb2021 (Saturday) which wasn't so bad. On Saturday afternoon, she reported shortness of breath, coughing with extreme pain (painful cough) and described a feeling of bugs crawling in her lungs, bugs front and back, and itching, and no one else reported it. The patient kept sleeping and waking up, thinking she was alright, but the coughing and lasted until Sunday evening, it was a very painful cough, and a creeping sensation in lungs front and back. She missed work on Monday. The events (joint pain in hands, headache, shortness of breath, coughing with extreme pain (painful cough) and itching) were medically significant as she was unable to go to work. It was also mentioned that since the patient stopped taking the Prednisone 4 days before the second dose of the vaccine. The patient had an exacerbation of pain (it came back). The patient was also wondering when can she start the inhaler and steroid for the back as she has lung and back problems. Outcome of the events were unknown. Information on lot number/batch number has been requested.; Sender's Comments: Based on data provided, the reported events are assessed as possibly related to BNT162B2. This case will be reviewed upon receipt of further information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 62 | 2021-03-11 | fatigue, fever, headache | fever (100.4), headache, fatigue, nausea, gastric pain |
| 62 | 2021-03-12 | fatigue |
I received the 1st Covid vaccine dose on March 8 . Minor tenderness and fatigue 1st 2 days. Then on ...
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I received the 1st Covid vaccine dose on March 8 . Minor tenderness and fatigue 1st 2 days. Then on March 11 and still today, March 13, I have had tingliness on my face and chin and nausea. It seems to be getting worse and not better. I have been taking Benedryl. Is this normal or what should I do?
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| 62 | 2021-03-12 | headache, chills, fever | Fever, aches, headache, nausea, chills |
| 62 | 2021-03-13 | body temperature increased, chills, fatigue, headache |
After receiving my first Pfizer vaccine on 2.24.21 at 4:45 p.m., I felt well. I woke the next morni...
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After receiving my first Pfizer vaccine on 2.24.21 at 4:45 p.m., I felt well. I woke the next morning 2/25/21, and felt fatigue, arm was tender but not sore. Earlier that morning, I had an aura, but no migraine materialized. Around 10 a.m., I began to have chills, more fatigued, and sore muscles. Left work at 3 p.m. Arrived home, went to bed with temperature of 101.2. Took Tylenol. Friday, Fever was gone, felt fatigued, arm still tender, and had a headache. Took Tylenol. Did not go to work on 2/26/21. Saturday, 2/27/21, woke at 4 a.m., right arm where vaccinated was very sore, armpit very sore, and right breast very sore. Placed cool compresses on my breast, arm pit and arm where vaccine was given. Took Tylenol. Still fatigues, achy, with sore shoulder muscles. Sunday, 2/28/21, Vaccine arm still sore, with some soreness still in right breast area. Took Tylenol. 3/1/21, called Dr. Still a bit achy and arm still tender
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| 62 | 2021-03-13 | fatigue, headache |
The night of the injection, I had severe pain in my neck, back of my head and right arm. The pain w...
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The night of the injection, I had severe pain in my neck, back of my head and right arm. The pain was so severe that I could not move my head or arm all night. I took Advil but could not sleep from the pain. When I did manage to sleep, I would have horrible dreams. By morning, I was feeling better but still sore from my neck and arm. I felt very tired and rested the entire next day. Pain has not returned. It was very scary.
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| 62 | 2021-03-13 | fatigue, fever | Fever 101.9, fatigue |
| 62 | 2021-03-13 | headache, respiratory tract congestion, malaise |
Headache first 30 min, malaise 6-7 hrs after , joints shoulders and hands/fingers x48 hrs moderate /...
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Headache first 30 min, malaise 6-7 hrs after , joints shoulders and hands/fingers x48 hrs moderate /severe then lessening, Swollen Armpit lymph node 3 in x 4 in for 48 hrs then getting smaller . Severe to moderate pain . Congested all days , needed Inhaler first 24 hrs , benedryl and decongestant , naproxen and Tylenol needed all days
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| 62 | 2021-03-13 | influenza like illness, throat pain |
2 weeks after receiving the 2nd dose, do you feel loved left neck had an apathy and sore throat, ha...
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2 weeks after receiving the 2nd dose, do you feel loved left neck had an apathy and sore throat, had pharyngitis laryngitis was seen by knee urgent care hand emergency room hand tested negative for Covid and strep. Developed left vocal cord paralysis and constant flu like symptoms that have lasted for six weeks. My vocal cords will mean to me injected need to paralysis
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| 62 | 2021-03-14 | fatigue |
A. 2-4 hours post dose: tiredness (may have been unrelated and due to lack of sleep and activity tha...
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A. 2-4 hours post dose: tiredness (may have been unrelated and due to lack of sleep and activity that day) B. Some buzzing in ears, and increased tinnitus (pre-existing) off and on up to ~ 24 hours post C. 4 hours post dose to current (24 hours post): Soreness in arm, at/around injection site, typical of other vaccinations (minimized bruising and soreness by rubbing arm during 15 min wait time to disperse serum and reduce bruising/ soreness); soreness increasing overnight ? feels much like exercise muscle soreness, still tender to touch at site at 30 hours post inoculation.
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| 62 | 2021-03-14 | fatigue |
On day 3 after the injection, I started experiencing heart palpitations. That lasted for about an ho...
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On day 3 after the injection, I started experiencing heart palpitations. That lasted for about an hour and didn't happen again until the next evening, around 5pm. That episode lasted for hours, and I finally went to bed at 9pm due to being so tired. The palpitations stopped sometime in the night. The next afternoon, I decided to lay down for a bit as I was still feeling quite a lot of fatigue and SOME body aches since the day after the injection. When I laid down, palpitations started again within just a few minutes. I got up, and they stopped in a few minutes. Since that last episode, I have only had the occasional "flip-flop" in my heart. I've never had palpitations prior to this, (beta blocker is for a too fast heart rate with no palpitations)so thought it might be a reaction. I'm scheduled for the 2nd dose on 3/27 and want to make sure it is safe for me to get that. Contacted my Doctor's office this morning, but haven't heard back as yet.
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| 62 | 2021-03-14 | fatigue |
Client received first COVID vaccine on 03/05/2021 about 1100 am, reaction noticed on 03/07/21 early...
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Client received first COVID vaccine on 03/05/2021 about 1100 am, reaction noticed on 03/07/21 early in the day, exact time not known. Client report vaccine given in left arm (deltoid), reaction on top of left shoulder. Reaction is a lump, the size of "2 big marshmallows" on top of her shoulder, with left sided neck pain and fatigue. No redness, pain or restriction with movement at reaction site. Client has applied ice and taken Tylenol for reaction. Client has an appointment with PCP tomorrow, 03/16/21.
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| 62 | 2021-03-14 | headache, chills |
The day after the vax (Friday) All day my arm hurt so badly I could hardly raise it up. Around 7:30...
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The day after the vax (Friday) All day my arm hurt so badly I could hardly raise it up. Around 7:30pm, I got nauseous, a really bad headache and had really bad chills. I got two heating pads out, one for my arm and one to warm me up. It lasted ?til about 3am and then it was over. My arm is still a little tender, but otherwise I am back to "my normal".
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| 62 | 2021-03-14 | headache, sweating, fever |
Serious swelling and tenderness in arm pit and side, upper back, lymph nodes in neck and back of sk...
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Serious swelling and tenderness in arm pit and side, upper back, lymph nodes in neck and back of skull. upper chest and back of neck with horrible headache, Fever of 101.4, chills but major sweating. Ear aches in both ears from headache. Stomach upset for 4 days and couldn't eat. Body aches. Sleeplessness. Very light headed couldn't think for 4 days.
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| 62 | 2021-03-14 | influenza like illness, chills, fever | flu like symptoms the next day, low grade fever, body aches, chills |
| 62 | 2021-03-14 | fever, fatigue, headache |
A couple of days after at 10:30 PM I had a fever of 101.5 with a headache in the front on top of my ...
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A couple of days after at 10:30 PM I had a fever of 101.5 with a headache in the front on top of my forehead. I stayed home from work the next day and my fever was 100.0. Tylenol helped. I felt tired but better. It became difficult to breath. It felt like I had chest pains especially on exertion. It improved if I sat down. It lasted aa week. My doctor sent me for a chest x-ray and blood tests. I had contracted Covid-19 on the third week after my first dose of the vaccine. Positive test results on 01/11/2021.
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| 62 | 2021-03-14 | fever | Fever, 101.5, rash on legs arms, muscle aches |
| 62 | 2021-03-15 | chills, body temperature increased | Slight arm soreness initially. 12 hours later developed nausea, chills, body aches, temp of 100.5. |
| 62 | 2021-03-15 | fatigue, chills, cough |
Difficulty breathing, fast heartbeat, tongue numbness, dizziness, edginess, chest heaviness starting...
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Difficulty breathing, fast heartbeat, tongue numbness, dizziness, edginess, chest heaviness starting within 1/2 hour. I am four days into symptoms. I still have some chest heaviness and still having asthma issues which includes coughing. I also had side effects of sore arm, chills, fatigue. Did not seek treatment. I had no idea how long this would last. I wish I would have read the paperwork for severe allergic reaction, but I didn't. I would have gone to the ER. I have suffered with this since Saturday.
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| 62 | 2021-03-15 | fatigue |
At about 1:15 PM, 6 hours after receiving the first dose of the vaccine, I experienced an episode of...
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At about 1:15 PM, 6 hours after receiving the first dose of the vaccine, I experienced an episode of Raynauds phenomenon in my left hand, 2nd through 5th finger. It took 20 minutes of active warming (rubbing, external heat) to resolve this episode. Then 20 minutes later I had another episode of Raynauds, more severe with bilateral hand involvement, fingers 2-5 on both hands. The second episode took 15-18 minutes of active warming to resolve. After these two episodes I started feeling very fatigued which I had not felt prior to the episodes.
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| 62 | 2021-03-15 | headache, head discomfort |
Got the vaccine, and a few minutes or so she felt like a funny sensation up around/left side of her ...
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Got the vaccine, and a few minutes or so she felt like a funny sensation up around/left side of her head, like something was crawling inside her head, like something bulging. Throbbing type pressure sensation. She did not say anything at the time, and went home. She went home and still felt the feeling on her head. She did also notice that her hot flashes got a little worse than usual. Had a sore arm for a couple of days. When she laid down at night she could feel that sensation/throbbing in her head a little more. She put a ice compress on it but could feel it a little bit, not as bad as it was as of today 3/16/21. She called the pharmacy on Wednesday 3/10/21 who advised her to go see her PCP. She went to the UC last Friday 3/12/21 as she could not see her PCP. They checked her scalp and did not see any rashes or anything, and advised her to take Motrin intermittently with Ibuprofen. She also told her to check back if she continued to have problems, but she decided to see her regular PCP.
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| 62 | 2021-03-15 | headache, fever, chills |
These started 31 hours after injection. Chills, Headache, low grade fever of 99.9 body aches, sore ...
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These started 31 hours after injection. Chills, Headache, low grade fever of 99.9 body aches, sore arm. On 3 rd day after vaccine, injection site became red, hot to the touch and swollen. A separate area from the injection site also became red, swollen and hot to the touch. 4 th day, injection site and random site became more swollen and began to grow together with intense itching. Still hot to the touch and red.
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| 62 | 2021-03-15 | headache |
Reported chest pain, shortness and of breath, and headache. Transferred to the ED. Symptoms resolved...
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Reported chest pain, shortness and of breath, and headache. Transferred to the ED. Symptoms resolved. Followed up with PCP.
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| 62 | 2021-03-15 | fever, chills, fatigue | Muscle & body aches, slight fever, chills, mild stomach upset, exhaustion |
| 62 | 2021-03-16 | chills, fatigue | Injection site soreness Tiredness Chills |
| 62 | 2021-03-16 | fatigue |
Person administering hit a vein and blood was dripping down. Sore arm, lump and dark bruise 1.5? ac...
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Person administering hit a vein and blood was dripping down. Sore arm, lump and dark bruise 1.5? across at injection site. Fatigue and body aches beginning 4 days after vaccination.
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| 62 | 2021-03-16 | fatigue |
Myriad of symptoms first dose 12/16/21 runny nose, fatigue, sore throat, chills, and diarrhea -ne...
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Myriad of symptoms first dose 12/16/21 runny nose, fatigue, sore throat, chills, and diarrhea -negative Covid test day 8 Only one symptom second dose 1/5/21 only severe body aches Beginning March 3, 2021 onset of severe joint arthralgia in wrists, hands, elbows, shoulders, knees, and feet. This is along with fatigue and inability to walk or move without pain. This has exacerbated my carpal tunnel to becoming unbearable as well. This is totally NEW and NEVER had this before. If I had to describe the pain it is like inflammation similar to description of Rheumatoid Arthritis. NSAIDS are barely helpful and contraindicated as I have GERD with Barrett's esophagus. I have heard this reaction has been reported with post vaccination patients.
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| 62 | 2021-03-17 | chills, headache | Chills, dizziness, brain fog, headache |
| 62 | 2021-03-17 | chills, malaise |
Was sick for 1-1/2 days. Injection site sore for days. Had chills, just a general feeling of sick t...
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Was sick for 1-1/2 days. Injection site sore for days. Had chills, just a general feeling of sick to my stomach.
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| 62 | 2021-03-17 | chills | 3 hours of chills and intense back pain. |
| 62 | 2021-03-17 | fatigue, influenza like illness, respiratory tract congestion, fever, productive cough, headache |
Fever as high as 103 same day as vaccine, lasting for about 4 days. Headaches, "flu-like" symptoms, ...
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Fever as high as 103 same day as vaccine, lasting for about 4 days. Headaches, "flu-like" symptoms, congestion & fatigue. Coughing up green colored phlegm. Taking aleve as needed. Diagnosed with bronchitis by PCP on 3/8/2021, prescribed amoxcillin. Followed up with PCP again on 3/12/2021 and was told that her chest xray and labs were "negative". Symptoms improving today.
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| 62 | 2021-03-17 | malaise |
I had chest pressure and chest pain. 160/100 - blood pressure when I checked it. I just didn't feel ...
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I had chest pressure and chest pain. 160/100 - blood pressure when I checked it. I just didn't feel good. I went to my doctor - they increased my blood pressure med dosage. Next day, I saw a cardiologist (16th) and he had another medication: Hydroclorothyrozide - HCTZ - 12.5 mg daily. Eventually they had to increase the HCTZ about two weeks ago and now my blood pressure is normal.
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| 62 | 2021-03-17 | fever |
tested positive for Rheumatoid Arthritis; body aches; muscle pain; joint pain; nerve pain; fingertip...
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tested positive for Rheumatoid Arthritis; body aches; muscle pain; joint pain; nerve pain; fingertips and toes were very painful-burning sensation; fingertips and toes were very painful-burning sensation; Underarm pain-throbbing; skin hurt when applying lotion; Low grade fever 99.9; This is a spontaneous report from a contactable other healthcare professional (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262), intramuscularly at right arm on 29Jan2021 11:00 at single dose for COVID-19 immunization at workplace clinic. The patient's medical history included autoimmune disorder, kidney disease, angina, and high blood pressure. There were other medications that the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Known allergies: Simvastatin, Tramadol, Codeine. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), at the age of 62-year-old, intramuscularly at right arm on 09Jan2021 13:15 at single dose for COVID-19 immunization at workplace clinic. It was reported that on the 2nd day after the vaccine (30Jan2021 13:00) patient started having body aches, muscle pain, joint pain, nerve pain. Her fingertips and toes were very painful-burning sensation. Also reported underarm pain-throbbing. Her skin hurt when applying lotion. Had low grade fever 99.9. Treatment was received for the above mentioned events: Tylenol 500mg, 2 Caps Q6h. Patient was recovering from the above mentioned events. She do have an autoimmune disorder: her Rheumatologist is checking for Psoriatic arthritis. She had tested positive for Rheumatoid Arthritis (unknown outcome). No treatment for this condition at this time. The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 or not prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 62 | 2021-03-18 | body temperature increased |
Patient was found in house by EMS with agonal respirations. Patient was intubated on scene and broug...
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Patient was found in house by EMS with agonal respirations. Patient was intubated on scene and brought to ER. At ER, patient presented with a HR of 55, BP of 80/43, O2 of 99%, and a rectal temperature of 107.3F. Further work-up revealed thrombocytopenia with a platelet count of 63, WBC of 13.7, and an elevated lactate of 2.2. Imaging shows a kidney stone obstruction of the right ureter. Diagnosis of sepsis was made with patient admitted to the hospital. Repeat rectal temp after acetaminophen suppository and external cooling continues to be 107. Care is ongoing at time of this report.
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| 62 | 2021-03-18 | chills, fatigue |
I had arm pain, aches, tired and vomited a few time. I felt weird all over. I had pain in my upper a...
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I had arm pain, aches, tired and vomited a few time. I felt weird all over. I had pain in my upper abdomen, legs and lower back. Chills and anxiety. On 2/8, I had a tele visit with my doctor. I took Tylenol as instructed to make sure that I didn't develop a fever. My doctor said that it could be from the vaccine. My left leg and foot were swollen on 2/13, so I called my doctor again and he sent me for a Doppler to check for a blood clot. I saw him on 2/15 in person. I have lower back pain and weakness in my legs at times, but it doesn't prevent me from doing anything. They feel heavy, especially if I walk for an extended period of time.
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| 62 | 2021-03-18 | chills, fever, sleepiness |
Chills; fever; soreness; sleepy; This is a spontaneous report received from a contactable consumer (...
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Chills; fever; soreness; sleepy; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date unknown), via an unspecified route of administration in the left arm, on 28Jan2021 08:00, as single dose, for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication included vitamins. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient experienced chills, fever, soreness, and was sleepy on 28Jan2021 (reported as 03:30 AM, pending clarification). No treatment was given for the events. The outcome of the events was not resolved. The reporter assessed the events as non-serious.
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| 62 | 2021-03-18 | fatigue, headache |
Extreme headache. Could not lift head off of pillow. Light bothered me and made headache worse. So t...
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Extreme headache. Could not lift head off of pillow. Light bothered me and made headache worse. So tired could hardly stay awake.
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| 62 | 2021-03-18 | fatigue, throat pain | sore throat, dizziness, right eye pain, diarrhea, leg pain, fatigue, soreness at site area |
| 62 | 2021-03-18 | fatigue, throat irritation, runny nose, fever |
First DaY immediately after the shot: Strong itching around mouth; 40 minutes later: runny nose; st...
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First DaY immediately after the shot: Strong itching around mouth; 40 minutes later: runny nose; strong sense of back of throat and esophagus burning; sensation in lungs like...pulsing slight burn--If you can imagines a sparkler (yep, the kind from the 4th of July) being in your lungs that is only a little painful, more like a wiggle, than a painful sensation, that would describe it. 2nd day: really tired by 4PM, feeling feverish. Very tired . Tired enough that I accidentally left the house for a job interview wearing one white sock and one black sock. Which isn't normal for me. 3rd day: muscle aches. 4th days feels like a really mild virus. This is not me but another person from my former job said she had spontaneous canker sores from the Pfizer shot.
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| 62 | 2021-03-18 | headache, fatigue |
About 6 hours after I got it, I felt tired. The next day, my arm was sore and my eyelids were swolle...
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About 6 hours after I got it, I felt tired. The next day, my arm was sore and my eyelids were swollen every day for about 5 days. I had aches and pain all over, itchiness, headache, joint pain over the next week. Around the 22nd, it stopped. It took almost 10 days for me to feel somewhat normal.
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| 62 | 2021-03-18 | headache, fever, fatigue |
About 30 minutes after vaccine, started to have a hard time breathing, short of breath & "chest fe...
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About 30 minutes after vaccine, started to have a hard time breathing, short of breath & "chest felt heavy" while at work at desk. Called an ED response- taken to ED was monitored for 4 hours, then released to home. That evening experienced fatigue, headache, muscle/body aches, feverish, which continued on 1/19 ,1/20, 1/ 21. felt better on 1/22/21 afternoon.
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| 62 | 2021-03-18 | sweating |
Sudden onset one hour after vaccine of severe irritable bowel. Became diaphoretic, bradycardic and ...
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Sudden onset one hour after vaccine of severe irritable bowel. Became diaphoretic, bradycardic and hypotensive and extreme abd pain. Was taken to the Emergency Room by coworker (I work in the hospital)
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| 62 | 2021-03-18 | fever, fatigue, headache |
Swelling of the arm at the injection site, including soreness, and headache, fatigue, muscle ache, j...
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Swelling of the arm at the injection site, including soreness, and headache, fatigue, muscle ache, joint pain, slight fever - felt like I had the flu. Started overnight after the shot and lasted the entire next day. Treated with rest, hydration and Tylenol. Symptoms were gone by the following morning.
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| 62 | 2021-03-18 | fever, fatigue | Fever Achy Fatigue Lasted about 36 hrs |
| 62 | 2021-03-18 | fever, headache, fatigue | Sore left arm Exhaustion Fever Headache |
| 62 | 2021-03-18 | fever | FEVER,NAUSEA,BODY ACHES AND JOINT PAIN |
| 62 | 2021-03-19 | headache | tingling in legs, nausea, headache, pressure in chest, back pain |
| 62 | 2021-03-20 | chills, malaise, headache, fatigue | Malaise, fatigue, muscle aches, chills, sore skin, headache |
| 62 | 2021-03-20 | headache, fever, fatigue | Slight fever. Headache,tiredness,diarrhea,injection site pain. |
| 62 | 2021-03-20 | headache |
woke 8am on 3/17 with dull headache . 12 noon headache became worse. Took Acetaminophen 500 mg 1p...
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woke 8am on 3/17 with dull headache . 12 noon headache became worse. Took Acetaminophen 500 mg 1pm broke out in cold sweat and became nauseated. 1:30 began vomiting. Remained nauseated, cold sweats off and on, multiple episodes of vomiting until 5pm
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| 62 | 2021-03-21 | chills | Chills, nausea, aches, sore arm |
| 62 | 2021-03-21 | lethargy, headache |
Sever body aches including to touch skin throughout body. Sever pain shooting through body and musc...
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Sever body aches including to touch skin throughout body. Sever pain shooting through body and muscle. Severe headache and lethargy. Swollen painful lymph node under left arm pit that continues...
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| 62 | 2021-03-21 | fever, fatigue, sweating, chills |
high fever x 2 days, low grade fever x 1 day, fatigue, body aches, severe chills, shaking, brain fog...
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high fever x 2 days, low grade fever x 1 day, fatigue, body aches, severe chills, shaking, brain fog x 4 days , injection site reaction - swelling and redness in entire L arm x 3 days, hot flashes with intense sweating.
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| 62 | 2021-03-21 | fever, fatigue | Very sore arm, fever and fatigue |
| 62 | 2021-03-21 | fever |
cellulitis; lymphadenitis; Fever 103; Still swollen from groin area down to knee; This is a spontane...
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cellulitis; lymphadenitis; Fever 103; Still swollen from groin area down to knee; This is a spontaneous report from a contactable other HCP (patient). This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: not reported), via an unspecified route of administration in the left arm on 26Feb2021 at 12:00 PM at a single dose for COVID-19 immunization. Medical history was unknown. Concomitant medications were none. The patient was not pregnant. The patient had no other vaccine in four weeks or other medications in two weeks. The patient experienced fever 103 white posture on knee that turned into cellulitis and lymphadenitis. The patient had IV antibiotics twice within 5 days of vaccine as treatment for events. The patient still had swollen from groin area down to knee. AE resulted in emergency room/department or urgent care. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the events was not recovered. Information on the batch/lot number has been requested.; Sender's Comments: The event cellulitis is assessed as unrelated to BNT162B2 based on the information provided. The event onset date is not reported, therefore the drug-event temporal relationship is not clear. In addition, the BNT162B2 vaccine was administered in the arm but the reported cellulitis was at knee area. It is very unlikely that the cellulitis was related to BNT162B2.
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| 62 | 2021-03-21 | throat irritation |
complained of tingling in legs and itchy throat approximately 10 minutes after injection. Monitored...
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complained of tingling in legs and itchy throat approximately 10 minutes after injection. Monitored in observation area and when symptoms didn't resolve after 30 minutes, transferred to triage 1 for observation and evaluation. 1330-BP 186/82, p-118, O2 sats- 98% Declined a Zyrtec 1337 BP 156/72, p-60, O2 sat-99%, no further tingling in legs. No scratchiness in throat. Denies difficulty swallowing, no shortness of breath, no swelling in mouth, lips or tongue. Evaluated by Dr., Patient released to home. Reviewed symptoms to seek care for- shortness of breath, trouble swallowing, difficulty breathing
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| 62 | 2021-03-22 | chills, headache, throat pain |
Woke up with bad headache in back of head. Throat was hurting & swollen. Chills, achy muscles all o...
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Woke up with bad headache in back of head. Throat was hurting & swollen. Chills, achy muscles all over. Knee joint hurting bad. Not hungry. Slept a lot after taking Tylenol. Next day by 12:00 pm, I felt better.
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| 62 | 2021-03-22 | fatigue, chills | Low fever, body aches/chills, exhaustion, sore arm |
| 62 | 2021-03-22 | fatigue, malaise, sweating |
3/20/21: Sudden fatigue, body aches, malaise, sweating lasting throughout the day. 3/21/21 previous...
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3/20/21: Sudden fatigue, body aches, malaise, sweating lasting throughout the day. 3/21/21 previous day's symptoms improved with some lingering fatigue but increasing manic symptoms, including perseveration, inability to focus, paranoia, manic anxiety, inability to make decisions, racing thoughts lasting throughout the day but clearing by the morning of 3/22/21. SYMPTOMS VERY SIMILAR TO ADVERSE REACTION TO CANNABIS
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| 62 | 2021-03-22 | fatigue |
Date and time adverse event started: pt was vaccinated on 3/11/21, she felt fatigued from 3/12-3/17,...
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Date and time adverse event started: pt was vaccinated on 3/11/21, she felt fatigued from 3/12-3/17, on later developed nausea and dizziness on 3/19 until today. recommended to call pmd in am for possible evaluation. symptoms could be from other medical conditions.
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| 62 | 2021-03-22 | fatigue |
extreme fatigue and whole body muscle ache. This person previously tested positive on 12/31/2020. S...
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extreme fatigue and whole body muscle ache. This person previously tested positive on 12/31/2020. She recovered and was having no symptoms. She received the vaccine upon the recommendation of her physician as she was recently diagnosed with cancer. With in 24 hours she reports that she was completely incapacitated with extreme fatigue and muscle pain "from her toes to her head". Injection occurred 3/6/21. Symptom onset 3/7/21. Date of contact by a case investigator was 3/22/21. Symptoms were still present and acute on 3/22/21.
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| 62 | 2021-03-22 | headache |
Headache at 5 pm, then severe difficulty swallowing and breathing and HBP started at 7:00 pm, went t...
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Headache at 5 pm, then severe difficulty swallowing and breathing and HBP started at 7:00 pm, went to ER, release at 2 am still having symptoms, not as severe. After 48 hours all symptoms gone.
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| 62 | 2021-03-22 | fever, cough, fatigue |
Patient developed fever (15 days after vaccination) that persisted for about 2 months, also develope...
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Patient developed fever (15 days after vaccination) that persisted for about 2 months, also developed cough, and anorexia as well as fatigue.
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| 62 | 2021-03-22 | fever |
62 years old female called to report an adverse reaction after she received her first Pfizer dose on...
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62 years old female called to report an adverse reaction after she received her first Pfizer dose on 03/18/2021 @1330. patient report that on 03/20/2021 @1030 she developed dizziness, lost balance, fever and shaking. patient denies any allergies. patient reported that she is taking Lyrica, Lamictal for facial nerve pain. and amitriptyline to help her sleep. patient was instructed to drink plenty of water and keeping hydrated to help with the dizziness, patient was instructed to take tylenol to help with the fever. patient was instructed to seek medical attention if the symptoms got worse.
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| 62 | 2021-03-23 | body temperature increased |
No serious side effects after first dose. no fever, no tiredness. minimal site pain, very slight b...
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No serious side effects after first dose. no fever, no tiredness. minimal site pain, very slight bump at injection site. gone within 24 hours. Second dose small side effects; very slight bump at injection site, pain upon firm pressure on 3 inch area surrounding lasting for 38-45 hours . about 21 hours after waking the next morning, had eye pain, dryness, gritty feeling, used eye drops with minimum success on relief. after 25 hours eyes feel hot, apply cool compress to closed eyelids, tried eye drops again, some relief. 27 hours started a small temperature of 99.7 - 100.1 for 2.5-3 hours, laid down to rest, improved although eyes were still a little irritated, dry, gritty, not hot. went to sleep, no further symptoms.
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| 62 | 2021-03-23 | fatigue | Left shoulder pain Excessive tiredness not usually experienced (slept 11 hours on 2nd night) |
| 62 | 2021-03-23 | headache, chills, fatigue |
Occasional mild headache, occasional mild chills, a bit of gas, mild muscle aches, occasional hot fl...
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Occasional mild headache, occasional mild chills, a bit of gas, mild muscle aches, occasional hot flashes (more intense than usual) and occasional fatigue (usually starting around mid-afternoon) and lasting for three days, starting about 24 hours after second dose. No fever.
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| 62 | 2021-03-23 | headache, fatigue |
I have a complex history of anaphylactic reactions to many allergens. Immediate reaction to Pfizer ...
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I have a complex history of anaphylactic reactions to many allergens. Immediate reaction to Pfizer vaccine #1--flushed/hot, strong metallic taste, chemical smell, tachycardia (156-158), nausea, some chest discomfort and dizziness. BP 158/85 (my normal is 100/60). O2 sats 98%. I did not feel anxious until heart rate would not come down to baseline. Clinic staff monitored me and did not treat. Allowed heart rate to decrease over time. Took over 20 minutes to get below 120. At 35 minutes, it was below 100. Stayed at clinic for one hour and released. Still had metallic taste (over 3 days now), loss taste, loss of appetite, headache, and fatigue.
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| 62 | 2021-03-23 | fever, headache | Sore arm Fever 102 F Headache |
| 62 | 2021-03-23 | throat irritation, lethargy |
Within 30 min of shot, starting feeling itchy tongue and throat. Drank water and within a few minut...
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Within 30 min of shot, starting feeling itchy tongue and throat. Drank water and within a few minutes got a full body heat flush and starting shaking all over. Heart beating fast and having some pain in chest. Drove to her work place and was assessed by MD and RN on staff. BP was 220/120, pulse over 100. She took a Claritin and was monitored in the work place. She became lethargic and chest pain continued so she went to the closest Emergency Room.
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| 62 | 2021-03-24 | chills, headache, fever | Headaches, Chills, and 102 temp. |
| 62 | 2021-03-24 | chills, sweating |
2nd vaccine rec'd on 03/20/21. On 03/21/21 still a lot of soreness in left upper arm. On 03/22 PM, n...
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2nd vaccine rec'd on 03/20/21. On 03/21/21 still a lot of soreness in left upper arm. On 03/22 PM, noticed the armpit lymph nodes swollen and slightly sore to the touch. Symptoms same on 03/23. On 03/24/21, noticed a red rash on outer part of upper arm to the elbow. Sweats and chills in PM and 2 fever blisters appearing on moth on left side. Morning of 03/25/21, rash worsens, sweats and chills continue. Toward afternoon, lightheadedness and trembling in hands. Felt better after lunch, some lightheadedness, still.
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| 62 | 2021-03-24 | fatigue, headache |
Within 15-minutes of vaccination, the patient reported dizziness. EMS evaluated the patient on-site....
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Within 15-minutes of vaccination, the patient reported dizziness. EMS evaluated the patient on-site. The patient was hypertensive (175/97) with a FSBG of 152 mg/dl. EKG demonstrated NSR, rate 86bpm, no ST elevation. EMS transported the patient toEmergency Department for further evaluation. In the ED, the patient reported dizziness, lightheadedness, near-syncope, aching headache, generalized fatigue, and weakness. Physician administered 25mg PO Meclizine. Upon reevaluation, the patient reported improvement and was discharged with diagnoses of Vaccine reaction and Dizziness.
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| 62 | 2021-03-24 | fatigue |
ON 3/12/2021 I received vaccine at 12:15 pm. After it was administered I waited 15 minutes to see i...
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ON 3/12/2021 I received vaccine at 12:15 pm. After it was administered I waited 15 minutes to see if I got an reaction to it. I was fine until about 3:00pm in the afternoon that I started to feel fatigue, body aches, also had chest pains on left side and in shoulder. pain stayed rest of the night. subsided on Saturday and returned on Sunday. Went to Hospital Sunday Night qround 7:00pm to get heart check out.
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| 62 | 2021-03-24 | fatigue |
I was VERY T ...
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I was VERY T i ???????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? ?? ?? ?? SORRY about the above I'm not sure what happen tried to delete it but couldn't! I woke up Sunday 14th at 7:30AM feeling really tired. had coffee & could barely stay awake. by 8:30AM I went back to bed woke up 11AM ish had lunch could hardly keep my eyes open went back to bed & slept the afternoon away. got up 5PM ish had coffee & supper still very tired I went back to bed. woke up around 10AM had something to drink & bathroom then went back to bed & slept to morning. On Monday the 15th. & Tuesday the 16th. was pretty much the same as the 14th. On the 17th. woke up at 8:45AM FEELING GREAT! No other problem but being very tired!
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| 62 | 2021-03-24 | headache |
Initially light headed and sever headache. The next day, developed severe skin burning sensation al...
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Initially light headed and sever headache. The next day, developed severe skin burning sensation all over body, including inside of mouth. This pain has increased as the days went on. This pain is severe, and continues into now 10 days. Dizziness and stomach upset has increased. Ringing in the ears and increased sensitivity to sound. Also experiencing weak and shakiness.
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| 62 | 2021-03-24 | headache |
Severe nausea for 5 days. Dizzy. Headaches. Severe pain all the way down my right arm to my finger t...
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Severe nausea for 5 days. Dizzy. Headaches. Severe pain all the way down my right arm to my finger tips, hand cramping off and on for 2 days. Not able to eat. Had to start taking Zofran on 4th day to be able to start slowly getting soft food in system.
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| 62 | 2021-03-24 | nasal congestion |
rash; hives; swollen face; congestion; This is a spontaneous report from a contactable consumer (pat...
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rash; hives; swollen face; congestion; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an specified route administered in Arm Left on 14Feb2021 10:30 AM at single dose, second dose via an unspecified route of administration, administered in Arm Left on 07Mar2021 (Batch/Lot Number: ENG199) as SINGLE DOSE for covid-19 immunisation. Medical history included avn (left hip and both knees replaced), Known allergies: Bee stings, Cats. No covid prior vaccination. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT). No other vaccine in four weeks. The patient experienced Slight reaction from first shot: Rash, hives, swollen face, congestion. 10Mar2021 10:00 PM, the patient experienced same events after the second dose, resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient hospitalized for 1 day. The patient tested Covid post vaccination on 11Mar2021: Nasal Swab with Negative result. The outcome was recovering.
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| 62 | 2021-03-24 | fever |
Felt the vaccine immediately in arm, Got a funny taste in my mouth, Started feeling dizzy before I s...
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Felt the vaccine immediately in arm, Got a funny taste in my mouth, Started feeling dizzy before I stood up, Moved to a different chair from injection chair location. Passed out. Never vomited but become very nauseated. These symptoms all occurred within five minutes of the injection. Ran low grade fever all day on March 24 (day after).
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| 62 | 2021-03-25 | chills, headache, fever |
On 3/25 I had a sore arm with firmness around the injection site. Today I woke up very early with f...
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On 3/25 I had a sore arm with firmness around the injection site. Today I woke up very early with fever and chills and feeling pretty ill. Urinated and crawled into bed and put electric blanket on high until I felt warm. Got up about 7:00 and took my temperature and it was about 100. Then it varied between 99 and 102.5 all day. Had blurred vision and body aches and bad headache and nausea. .Took Tylenol or hydrocodone which helped with keeping temp closer to 100 but I?d fall asleep and forget to take Tylenol and it would go back to 102. I didn?t have anyone to drive me that I felt comfortable enough to risk exposure in case it was an actual illness and not the vaccine. I considered calling an ambulance but decided to wait and see if I could get my temp under control. This evening I?m at 100 again (I just took it again) but thought my fever had broken as I didn?t feel I was radiating heat like I felt when it was 102. My normal temp is usually around 97. I haven?t taken anything Tylenol or hydrocodone since about 3:00 but I will take just plain Tylenol now.
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| 62 | 2021-03-25 | fatigue, chills, sweating |
Severe chills/sweats, extreme fatigue, disrupted sleep, no appetite, shaky for 6 days but appear to ...
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Severe chills/sweats, extreme fatigue, disrupted sleep, no appetite, shaky for 6 days but appear to be lessening now
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| 62 | 2021-03-25 | malaise |
Rheumatoid arthritis; little stiffness in her arm; she was not feeling very"/just felt little off; l...
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Rheumatoid arthritis; little stiffness in her arm; she was not feeling very"/just felt little off; little pain in her left arm where the vaccination was given; pain in her elbow; seems like her left arm was swollen; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (lot number: EN6202 and expiration date: 30Jun2021) as 0.3 mL, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Vaccine last Friday (05Mar2021) and on an unknown date, she had little stiffness in her arm and she was "not feeling very" (incomplete sentence), you know she was just felt little off but other than that, not too bad. The patient also had a little pain in her left arm where the vaccination was given and some stiffness on unknown date. Since then, she had pain in her elbow on left arm and today (10Mar2021), the pain was pretty persistent and seems like her left arm was swollen. The patient also stated "I guess I should say, I have rheumatoid arthritis" (pending clarification)". The patient received treatment for the events, stated "The only thing I took in this morning is Tylenol." Outcome of the events was unknown.
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| 62 | 2021-03-25 | throat irritation |
Pt experienced lip numbness and tongue "thickness" between 5 and 10 minutes post-vaccine administrat...
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Pt experienced lip numbness and tongue "thickness" between 5 and 10 minutes post-vaccine administration. She was brought to Observation are, vital signs checked and symptoms monitored. 1 dose antihistamine given at 1205pm. She then felt itchiness in throat and ears. 2nd dose po antihistamine given with complete relief of sx's at 1235pm.
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| 62 | 2021-03-25 | throat irritation | ITCHY THROAT. EVALUATED BY EMS-CLEARED |
| 62 | 2021-03-26 | fatigue, headache, fever |
I developed Mononucleosis six weeks after my second dose of the Pfizer vaccine. Fever, severe night ...
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I developed Mononucleosis six weeks after my second dose of the Pfizer vaccine. Fever, severe night sweats, severe fatigue, loss of appetite, head aches, and blisters on my skin. I have not been exposed to Mononucleosis that I know of and have been isolated from the public because my husband had not been vaccinated yet. Mononucleosis has a 4-6 week incubation period which is when I took my second vaccine shot
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| 62 | 2021-03-26 | fatigue, headache |
Constant headache Body on fire Fatigue Nausea Dizziness Pain and muscle ache Anxiety High blood pr...
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Constant headache Body on fire Fatigue Nausea Dizziness Pain and muscle ache Anxiety High blood pressure
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| 62 | 2021-03-26 | fatigue | Acute fatigue, muscle and joint pains that lasted about 24 hours. Required only extended bedrest. |
| 62 | 2021-03-26 | headache |
Heart palpitations for 3 hours (11:30-2:30), dizziness, slight headache that morning, soreness at in...
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Heart palpitations for 3 hours (11:30-2:30), dizziness, slight headache that morning, soreness at injection site. I left work early and went home to lay down. I took 2 aspirin. I slept for 20 minutes and woke up feeling better. My doctors office was closed since this happened on a Friday. I consulted with a friend that is a RN and she advised going to emergency room. I have horrible health insurance so I didn?t want to pay 650.00 to go to emergency room. I?m not sure I want to get the second shot since I have heard that adverse reactions increase with the second shot.
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| 62 | 2021-03-26 | sweating, chills |
Started w/slight dizziness next day that increased during day. At 3 am awaken from sleep w/extreme v...
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Started w/slight dizziness next day that increased during day. At 3 am awaken from sleep w/extreme vertigo/non- stopped vomiting for a few hours. Zofran from doctor stopped vomiting. Excessive sweating chills and hot flashes But no fever. Could not walk on own for 24 hours. Still experiencing dizziness if stand up or bend over too fast. Ringing in ears.
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| 62 | 2021-03-26 | sweating |
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tig...
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Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: carries APIS tablets which she uses if feels like have an anaphylactic episode. Waited an hour and left with no complications
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| 62 | 2021-03-26 | influenza like illness, chills, fatigue, headache |
Once I?d gone to bed on 3/25 about 10:30 pm. I woke up later that night feeling uncomfortable and re...
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Once I?d gone to bed on 3/25 about 10:30 pm. I woke up later that night feeling uncomfortable and restless. Had cold chills and headache when I woke up the next day I was extremely tired and felt like I had flu like symptoms The following day(Saturday) I felt like normal again myself again
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| 62 | 2021-03-26 | lethargy, fatigue |
Pain in neck, especially, has increased over the past couple of days. Very tired, aching, lethargic,...
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Pain in neck, especially, has increased over the past couple of days. Very tired, aching, lethargic, don't want to be bothered. Loss of appetite started today. Feel pressure in chest, but no cough to speak of.
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| 62 | 2021-03-26 | fever, chills | Fever, chills, aching joints |
| 62 | 2021-03-26 | sleepiness, fatigue |
Pfizer-BioNTech COVID-19 Vaccine EUA. Dizziness starting approx. 1 hour after shot; extreme fatigue ...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Dizziness starting approx. 1 hour after shot; extreme fatigue and sleepiness occurred approx. 5 hours after shot. It is now 14-1/2 hours after the shot and I am still dizzy. I fell asleep for 3 hours. I'm still tired but not falling asleep at the wheel. Pain at injection site started approx. 7 hours after shot and still hurts.
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| 62 | 2021-03-27 | fatigue, chills | Vertigo, Chills, Fatigue, Body Aches, Tinnitus |
| 62 | 2021-03-27 | fatigue, malaise, headache, chills, sweating |
1st dose I had soreness in left arm and a stomach nausea the next day. 2nd dose I had at 2:00 p.m. ...
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1st dose I had soreness in left arm and a stomach nausea the next day. 2nd dose I had at 2:00 p.m. on 3/26/21. Woke up the next morning at 4:00 a.m. with pain in my arm and basically feeling terrible. I had pain in the arm, soreness under arm, achy and severe joint pain all over, headache over my eyes, extreme fatigue, chills on and off, a few instances of sweating, Generally felt really sick. Appetite decreased. The next night woke up in the middle of the night sweating, then later in the night with chills. Aching and pain in joints was miserable. By noon on 3/28/21 was feeling a lot better, still tired and arm just sore. Stomach still a little off.
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| 62 | 2021-03-27 | headache, chills, malaise |
pain at injection site. nausea, chills, headache, joint aches, general unwell feeling. This starte...
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pain at injection site. nausea, chills, headache, joint aches, general unwell feeling. This started during the afternoon after receiving injection in the morning-Friday. This continued all the next day-Saturday. All was resolved by the following morning-Sunday.
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| 62 | 2021-03-28 | fatigue, headache |
Second day tired and head ache 3rd and 4th day i felt good Friday tired and tight chest, continued...
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Second day tired and head ache 3rd and 4th day i felt good Friday tired and tight chest, continued on Saturday Woke up sunday after sleeping 14 hours straight tight chest and head ache continues Monday headache and tight chest and pain onleft side of upper chest.
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| 62 | 2021-03-28 | fever |
Head , neck sinus, Whole body flu like muscle pain lasting ten days. High fever on tenth day. Unbea...
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Head , neck sinus, Whole body flu like muscle pain lasting ten days. High fever on tenth day. Unbearable pain. Took covid test was negative. Daily nausea and farting all day.
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| 62 | 2021-03-29 | body temperature increased |
diarrhea w/ bright red blood; Severe stomach cramping; extreme nausea; back cramps; temp range 97.4 ...
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diarrhea w/ bright red blood; Severe stomach cramping; extreme nausea; back cramps; temp range 97.4 - 99.4; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 10Mar2021 09:30 (lot number: EN6204) as single dose for COVID-19 immunisation. The patient's medical history included high blood pressure, migraines, and thyroid disorder. The patient's concomitant medications included cyclobenzaprine, levothyroxine, telmisartan (TELMI), and topiramate (TROKENDI XR). The patient previously took erythromycin and morniflumate (FLOMAX) and experienced allergies to both. The patient experienced severe stomach cramping, diarrhea with bright red blood, extreme nausea, back cramps, temperature range 97.4 - 99.4, so sick and she had to lay on bathroom floor throughout night on 10Mar2021 20:00. There was no other vaccine in four weeks. The patient was not pregnant at the time of report. Prior to vaccination, patient has no COVID and patient was not tested for COVID post vaccination. The vaccination facility type was Health Department. The outcome of the events were recovering.
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| 62 | 2021-03-30 | chills, fever |
Left arm did not have any feeings when I woke up in middle of the night; Chills; Fever 101.0; Body a...
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Left arm did not have any feeings when I woke up in middle of the night; Chills; Fever 101.0; Body aches in both knees; Sore right arm; This is a spontaneous report from a contactable consumer (Patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6206), via an unspecified route of administration in the right arm on 10Mar2021 at 09:15 for COVID-19 immunization. The patient was not pregnant. Medical history included Hypertension. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EI9267) in right arm on 19Feb2021 for COVID-19 immunization. The patient received other medication in two weeks. On 11Mar2021 at 03:00 AM, the patient experienced chills, fever 101.0, left arm did not have feelings at night, body aches in both knees and sore right arm. The patient did not receive any treatments for the events. The clinical outcome of chills, fever 101.0, left arm did not have feelings at night, body aches in both knees and sore right arm was recovering. No follow-up attempts are possible. No further information is expected.
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| 62 | 2021-03-30 | fatigue, headache, runny nose |
After receiving the first shot, developed a headache on right side; later that evening had a runny n...
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After receiving the first shot, developed a headache on right side; later that evening had a runny nose; Nausea; Diarrhea; Loss of appetite; Sleep loss; Achy; Overall exhaustion; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6203, on 03Mar2021 11:00 at single dose in left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient had no Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. After receiving the first shot, the patient developed a headache on right side on 03Mar2021 11:00, later that evening had a runny nose, nausea, diarrhea, loss of appetite, sleep loss, achy and overall exhaustion. This lasted for 7 days. Treatment received for headache and achy included Tylenol on day 3. The outcome of all events was resolving.
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| 62 | 2021-03-30 | influenza like illness |
I had the normal flu like symptoms for 2-3 days; whole upper left quadrant of my body. This includes...
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I had the normal flu like symptoms for 2-3 days; whole upper left quadrant of my body. This includes the chest area around where my heart is. It is very painful; my neck arm and shoulder were killing me; my neck arm and shoulder were killing me; whole upper left quadrant of my body. This includes the chest area around where my heart is. It is very painful; This is a spontaneous report from a contactable consumer. A 62-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: was not reported), via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 18:45 (at the age of 62 years old) as SINGLE DOSE for covid-19 immunization. The facility in which the vacation was given was a Pharmacy or Drug Store. Medical history included hypertension, blood cholesterol increased and covid-19 (prior to vaccination). The patient has no known allergies. Concomitant medications included lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN). No other vaccines were given within 4 weeks. Prior to vaccination, the patient 'was' diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 04Mar2021 at 00:00, The patient experienced flu like symptoms for 2-3 days, Pain chest, Neck pain, Arm pain and Pain. No Treatment was given. The clinical course was as follows patient had the normal flu like symptoms for 2-3 days. Then noticed that her neck arm and shoulder were killing me. Now it is the whole upper left quadrant of her body. This includes the chest area around where my heart is. It is very painful and I do cry out with a pain sound if I move a certain way. No treatment was given for the events. The clinical outcome of the event was not recovered. Information on the lot/batch number has been requested.
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| 62 | 2021-03-30 | fever, headache, chills |
Muscle ache; headache; chills; temp of 99.3; This is a spontaneous report from a contactable 62-year...
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Muscle ache; headache; chills; temp of 99.3; This is a spontaneous report from a contactable 62-year-old non- pregnant female consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 08Feb2021 14:45, at single dose in right arm for covid-19 immunization. The patient medical history included migraines. The patient had no known allergies. Historical vaccine included bnt162b2 (product: Covid-19, brand=Pfizer, lot unknown-False, administration date-18Jan2021, administration time-02:45 PM, vaccine location-right arm, dose number=1). The patient took the vaccine at workplace clinic. Concomitant medications were not reported. On 08Feb2021 at 23:45, the patient experienced muscle ache, headache, chills, and temperature of 99.3. The patient did not take any treatment for the events. The outcome of the events was recovered on an unknown date. Information about lot/batch number has been requested.
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| 62 | 2021-04-05 | headache |
patient had headache within the first 15 minutes after administration and was found to be positive f...
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patient had headache within the first 15 minutes after administration and was found to be positive for dural venous sinus thrombosis with unknown etiology
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| 62 | 2021-04-06 | headache |
On 2nd day after 2nd vaccine, I felt bad and began to have headaches. On about day 8, I began to hav...
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On 2nd day after 2nd vaccine, I felt bad and began to have headaches. On about day 8, I began to have ear ringing along with headaches. It has been 36 days now. The headaches are still present but somedays not as severe. The ear ringing is 24/7 now and extremely annoying. Nothing I do will make it better.
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| 62 | 2021-04-09 | headache, fever |
fever; feeling out of body experience; diarrhea; in tears from intensity of the sensation; visual pi...
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fever; feeling out of body experience; diarrhea; in tears from intensity of the sensation; visual pictures that were kind of ridiculous and seeing things; Severe headaches; Heard a lot of noises in head; body hurting severely where she couldn't walk; body hurting severely where she couldn't walk; no appetite; nauseas; This is a spontaneous report from a contactable healthcare professional (patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6205) via an unspecified route of administration, administered in Arm Left, at the age of 62-year-old, on 18Mar2021, as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from Oct2020. The patient's concomitant medications were not reported. The patient previously received flu shot as immunization and did not get any reactions and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6205) on 28Feb2021, single dose for covid-19 immunisation and experienced very achy, some fever, some diarrhea, one episode and a big headache, difficulty Sleeping, and intense sensations. The patient experienced severe side effects/ bad reactions three weeks after receiving the second dose of vaccine. The patient experienced visual pictures that were kind of ridiculous and seeing things (medically significant) on 19Mar2021 with outcome of recovered on 21Mar2021, severe headaches (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, heard a lot of noises in head (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, body hurting severely where she couldn't walk (non-serious) on 18Mar2021 with outcome of recovered on 21Mar2021, fever (non-serious) on an unspecified date with outcome of recovered on 21Mar2021, diarrhea (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, in tears from intensity of the sensation second half of the day after receiving Pfizer Covid Vaccine (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, no appetite (non-serious) on 18Mar2021 with outcome of unknown, nauseas (non-serious) on 18Mar2021 with outcome of unknown, feeling out of body experience (non-serious) on an unspecified date with outcome of unknown. The diarrhea was reported as much more intense. The patient doesn't know how else to describe it, except it was very intense and severe. No appetite and nauseas which lasted 2-3 days, it's almost like feeling out of body experience. The events did not require a visit to Emergency room or Physician office. The patient did not receive vaccination within 4 weeks prior vaccination. No relevant tests performed.; Sender's Comments: Based on the close temporal relationship, the association between the event "seeing thingis" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 62 | 2021-04-09 | malaise |
I thought that I had kidney stone; aches and pain/Pain in my right side was very severe/Body ache; F...
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I thought that I had kidney stone; aches and pain/Pain in my right side was very severe/Body ache; Foggy brain; When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy; almost passed out; can't even focus; I was not feeling well; They did gave me Cyclobenzaprine, Prednisone and Hydrocodone and I took them for two days and then I just stopped because it was just making it worse and then I was foggy and couldn't event get up; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot Number: EN6206) as SINGLE DOSE for COVID-19 immunisation; cyclobenzaprine, prednisone and hydrocodone; all via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose for an unspecified indication. Medical history included COVID-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient stated, "First, I had COVID back in early December and then on 12Mar2021, I got my first vaccine and I have lot of aches and pain and very foggy brain. I was just with the 'chiropractor' and he was just with me and I stood up and we were talking and I just got super dizzy and almost passed out, I just don't know. I missed, I can't even focus." When clarified the concern, the patient stated, "When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy and almost passed out, luckily there was a chair to catch me. So, my concern is, do I get the second vaccine if I already had COVID, should I didn't had this first vaccine since I already tested positive? When I had COVID, I was very cloudy in the brain. I don't know if this is a part of side effect, I am trying to find out if I can get the second vaccine." The patient experienced kidney stone. The lab data is clear, upon checking, the blood and urine samples. CAT scan has been done and the report is clear. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 62 | 2021-04-10 | chills |
2 days after i received the vaccine had difficulty breathing shortness of breath and on 5 and 6 days...
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2 days after i received the vaccine had difficulty breathing shortness of breath and on 5 and 6 days also then had chills hand tremors loss of appetite nausea this continued for 2 more months. I went to Urgent care and on March 26 then found a clot in my right lung. I am on warfin now and none of these symptoms did I have prior to the vaccine. I had 5 covid tests to see if I had COVID but all the tests were negative.
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| 62 | 2021-04-11 | malaise |
Began feeling unwell, had urinary urgency, and was itching shortly after 2nd dose of Pfizer COVID-19...
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Began feeling unwell, had urinary urgency, and was itching shortly after 2nd dose of Pfizer COVID-19, then found obtunded due to pulmonary embolus resulting in death within 24 hours of receiving 2nd dose
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| 62 | 2021-04-13 | headache |
Slight headache that day (4/1). The next day (4/2), weakness in left leg and arm. On 4/3 went to ER...
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Slight headache that day (4/1). The next day (4/2), weakness in left leg and arm. On 4/3 went to ER, admitted to NeuroScience ICU. Diagnosed with small blood clot and small bleed in brain--- dural venous sinus thrombosis. The neurology team said this was very unusual and very rare in this part of brain--where the blood flows back to the heart from the brain. They did alot of tests on every part of my body looking for the cause and found nothing. They think it was vacine induced and repoted it to the CDC. Left leg and arm weakness remains with no changes yet. Now taking blood thinner and doing physical therapy
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| 62 | 2021-04-15 | fatigue |
fluid like blister on roof of mouth, red dots on skin, extreme fatigue and worsening of arthritis sy...
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fluid like blister on roof of mouth, red dots on skin, extreme fatigue and worsening of arthritis symptoms and GERD
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| 62 | 2021-04-15 | headache, cough |
Pfizer-BioNTech COVID-19 Vaccine EUA: six days after immunization patient presents with shortness of...
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Pfizer-BioNTech COVID-19 Vaccine EUA: six days after immunization patient presents with shortness of breath, myalgias, cough, headache, and chest pain. Hospitalized with acute hypoxemic respiratory failure secondary to COVID-19 infection: administered steroids, antivirals, and anticoagulation. Patient currently hospitalized.
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| 62 | 2021-04-15 | pneumonia |
Patient presented complaining of worsening SOB over the past 3 days. She reports leg swelling, as we...
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Patient presented complaining of worsening SOB over the past 3 days. She reports leg swelling, as well. Patient was found to have a heart failure exacerbation and critically high potassium, prompting admission to the hospital. Patient received calcium gluconate, insulin, dextrose, and Kayexalate.
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| 62 | 2021-04-16 | fever |
* On 4/2/21 - Fever 103.2, Fatigue, No appetite, Dizziness. * On 4/5/21 - Severe chest pain. Went t...
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* On 4/2/21 - Fever 103.2, Fatigue, No appetite, Dizziness. * On 4/5/21 - Severe chest pain. Went to ER. Transferred to clinic in. Admitted to clinic on 4/5/21: - Test: Ultrasound, Xray, Lab Tests, Electrocardiogram - Outcome: Pericardial enhancement adjacent to the left ventricle with no effusion - Treatment: Motrin 400 mg/4 times a day, Protonix 40mg/day to protect stomach
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| 62 | 2021-04-17 | nasopharyngitis |
passed out twice; Intense, rapid and irregular heartbeat (prolonged); intense pain in various organs...
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passed out twice; Intense, rapid and irregular heartbeat (prolonged); intense pain in various organs and muscles (some short and some long duration); rash; cold; night sweat; no energy; intense dreams first night; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EP6955) via an unspecified route of administration, administered in arm left on 30Mar2021 13:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included zolpidem tartrate (AMBIEN). The patient was healthy. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient received the first dose of BNT162B2 (Lot number: EN6199) in the left arm on 11Mar2021 11:00 AM at the age of 62-year-old for COVID-19 immunisation. The patient experienced passed out twice, intense, rapid and irregular heartbeat (prolonged), intense pain in various organs and muscles (some short and some long duration), rash, cold, night sweat, no energy, intense dreams first night; all on 30Mar2021 with outcome of not recovered. Doctor appointment was scheduled. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether treatment received for the events.
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| 62 | 2021-04-17 | fever, fatigue |
After initial two days of side effects of temp and fatigue, nausea, continued side effects of extrem...
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After initial two days of side effects of temp and fatigue, nausea, continued side effects of extreme fatigue, nausea low grade temp for ten days, fatigue got worse; resulting in extreme shortness of breath. i went to the emergency room where i was diagnosed with AFIB. I spent 6 days in hospital. No previous condition of AFIB. An exam and physical in July did not reveal any health issues.
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| 62 | 2021-04-17 | fever, headache, throat pain |
eyes rolled back/passed out; my throat area under my jaw line started to hurt; my left leg was achy ...
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eyes rolled back/passed out; my throat area under my jaw line started to hurt; my left leg was achy and tingly; my left leg was achy and tingly; headache; nauseated; weak; fever; just didn't feel good; sick; became rigid; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer-BioNTech, lot unknown=true, lot unknown reason=unable to locate or read the details) via an unspecified route of administration in right arm on 26Mar2021 11:45 (62-year-old at vaccination date) at a single dose for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy (HCM), a bruit, ventricularomegaly, gastrointestinal (GI) issues, many female issues (before she got a hysterectomy), cancer activity, hepatitis C (Hep C), COVID-19 since 18Mar2021 (diagnosed as extremely positive, remained sick until 25Mar2021), and allergies to medications, food, or other products included Motion sickness meds. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was reported as yes but unspecified. About 25 minutes after the vaccine, her throat area under her jaw line started to hurt, her left leg was achy and tingly, and she was started to get a bad headache. She became nauseated and weak. She made it home, took paracetamol (TYLENOL), and got in bed. Saturday her headache was on steroids, she had fever, and just didn't feel good. Later that day, she was so sick she went to the bathroom and she guessed she passed out. Basically, her husband said he found her on the floor after he heard a thump. He asked me what was his name. He said she responded correctly, but then her eyes rolled back, she became rigid, and he called 911. she knew 2 sets of paramedics arrived w/ambulances. They monitored her vitals and stayed until she was normal. They were willing to take her to the hospital, but offered other options for her husband and she to consider. They suggested she see her Primary care doctor (she did on 29Mar2021). Her doctor believed she should not take the 2nd dose of the vaccine. Adverse event start date was 26Mar2021 at 12:30 pm. AE resulted in doctor or other healthcare professional office/clinic visit. It was reported no treatment received for the adverse event. The outcome of event was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 62 | 2021-04-18 | fatigue, headache |
Adverse reaction: Sudden severe shortness of breath when I exerted myself, severe constant headache ...
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Adverse reaction: Sudden severe shortness of breath when I exerted myself, severe constant headache that tylenol couldn't dull, fatigue and weakness, weak shoulders could keep them raised for more than a few seconds, swelling of abdomen, rapid fluid retention, lack of appetite, chest felt constricted, nose bleeds, black sticky stools Treatment: 2 units of blood, ferrouse sulfate IV, saline IV, protonix IV, endoscopy Outcome:health back to normal, after blood transfusion, will continue to take pantoprazole for six weeks and Iron Note: used to have ulcers years ago due to H. Pylori bacterium suspect Pfizer mRNA vaccine interacted with H. Pylori antibodies as has been found in other patients with H. Pylori.
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| 62 | 2021-04-19 | malaise, fatigue |
Information obtained from the Hospital. Began to not feel well the next day, SOB, diarrhea and fatig...
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Information obtained from the Hospital. Began to not feel well the next day, SOB, diarrhea and fatigue. Was admitted to hospital on 4/9/21, diagnosed with COVID, placed on a vent and died on 4/19/21.
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| 62 | 2021-04-23 | fatigue, headache |
Tiredness; Headache; Muscle ache; This is a spontaneous report from a contactable consumer (patient)...
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Tiredness; Headache; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6201), via an unspecified route of administration in left arm on 11Feb2021 at 17:45 as single dose for COVID-19 immunization. The medical history of patient was included asthma, high blood pressure, obesity, allergies from Penicillin. Patient did not receive any other vaccine in four weeks. The concomitant medications of patient included triamterene, trazodone, citalopram and potassium (Other medications in two weeks). On 12Feb2021 at 06:00 AM, patient experienced tiredness, headache, muscle ache. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient did not receive any treatment. The outcome of event was recovering.
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| 62 | 2021-04-23 | headache, fatigue |
-Patient died unexpectedly on Thursday, April 22, 2021 at her home (found unresponsive by spouse) -N...
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-Patient died unexpectedly on Thursday, April 22, 2021 at her home (found unresponsive by spouse) -No reactions were observed at the pharmacy (within 15 min waiting period) following either covid-19 vaccine (1st dose administered 8am on 3/26/21 -Left Deltoid) -When asked (4-16-21) how she tolerated the 1st dose, Patient reported minor side effects (mild Headache, tiredness) but had no reservations about receiving the 2nd dose. No additional information.
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| 62 | 2021-04-24 | dehydration, sweating, chills |
cold and hot; gum were bleeding after second dose; felt like she was going to die after second dose;...
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cold and hot; gum were bleeding after second dose; felt like she was going to die after second dose; cold sores on lips after second dose; threw up after second dose; soreness after second dose; dizzy and weak after second dose; dizzy and weak after second dose; chills after second dose; sweating after second dose; dry heaving after second dose; nauseated after second dose; dehydrated after second dose; hasn't eaten for 5 days after second dose; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FR8737and expiry date was not provided), via an unspecified route of administration, in left arm, on 07Apr2021, as a single dose (at the age of 62-years) for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, solution for injection, lot number: EN6201 and expiry date was unknown), via an unspecified route of administration, in left upper arm, on 05Mar2021, as a single dose for COVID-19 immunization. The patient arm hurt after first dose (began immediately and lasted for about 4 days) which was resolved on 09Mar2021. Patient second dose was scheduled on 27Mar2021, but she did not get it till 07Apr2021. It was reported that on 08Apr2021, patient had such an awful reaction to the second dose of the vaccine. She started to get dizzy and weak, chills, everything was a blur, sweating, could not drink threw up if she tried dry heave went back to sleep and slept for 48 hours had just chills the whole time. She was in bed sleeping trying to drink, getting up to go to the bathroom and feeling like she was going to die for the next three days. She was nauseated and is still nauseated and could not drive. She took Tylenol an antiemetic at urgent care that stopped. She took Zofran with the saline solution infusion and she went home and slept. She was dehydrated and had soreness all over. On 09Apr2021, she could not roll over and had a sore on her left butt cheek that was still there cold sores on lips. She thought the sore on her left butt cheek came from laying in bed so much, and it was not in any other space but that one spot almost like she would have gotten the shot there, but she didn't. On 10Apr2021, patient felt like she was going to die, and went to urgent care and asked if they could give her fluids. They gave her fluids and Zofran and that helped a lot. This one shocked the hell out her, she thinks it was her gums that started to bleed on 11Apr2021. She had the best oral hygiene and went to the dentist all the time. She was flosses like crazy. She started to drink a ton of water and has not seen it since. She cannot guess what the reason was. On 11Apr2021, she could function a little and had chills again last night and sweating. She did not have a fever. She ate chicken noodle soup water and a little bit of ginger ale. She started to feel better, but not 100% better not even 90%, not even 80%, but was heading towards the right direction. Patient also hasn't eaten for 5 days after second dose. She experienced cold and hot. She was not complaining at all and she has been sick for days and cannot eat and will throw up but will gain it right back. The dizziness and weakness were subsided. She feels like she is getting beat up but is recovering. Patient thought that vaccine pulled out with a syringe and that's the problem everyone gets the same dose. Patient's weight was 136 or 138 lbs. Outcome of the events nauseated after second dose was resolved on 10Apr2021, and dizzy and weak after second dose was resolved on an unknown date in Apr 2021, and for the events chills and sweating it was recovering, and for all other events, it was unknown.
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| 62 | 2021-04-24 | fever, chills, fatigue |
She was shaking, she thought she was having a seizure with how bad she was shaking; She was shaking,...
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She was shaking, she thought she was having a seizure with how bad she was shaking; She was shaking, she thought she was having a seizure with how bad she was shaking; Chills; Fever; sore hands and wrists; sore hands and wrists; totally exhausted; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 15:00 (Lot Number: EPT533) as single dose for covid-19 immunisation. The patient previously took flu shot. Medical history included diabeticc, thyroid is done, real bad psoriasis, high blood pressure, triglycerides, cholesterol , anxiety, to replenish potassium. Concomitant medications included metoprolol taken for hypertension; acetylsalicylic acid (ASPIRIN (E.C.)); citalopram taken for anxiety; amlodipine taken for blood pressure; hydrochlorothiazide; fenofibrate taken for blood triglycerides; atorvastatin taken for blood cholesterol; losartan potassium to replenish potassium; colecalciferol (VITAMIN D3); metformin taken for diabetes mellitus; levothyroxine; hydroxyzine; guselkumab (TREMFYA) taken for psoriasis,. The patient was shaking, she thought she was having a seizure with how bad she was shaking, chills, fever, sore hands and wrists, totally exhausted, diarrhea on 01Apr2021. The outcome of events chills, Wrist pain, Pain in hand was recovered on 05Apr2021; The outcome of event Fever and Diarrhea was recovered on 06Apr2021; outcome of other events was recovering.
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| 62 | 2021-04-26 | headache |
had a stroke after getting the Pfizer vaccine; weakness left arm and left leg; Headache; Dural venou...
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had a stroke after getting the Pfizer vaccine; weakness left arm and left leg; Headache; Dural venous sinus thrombosis; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 62-years of age) dose 2 via an unspecified route of administration, administered in arm right on 01Apr2021 10:20 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation (to not get Covid). Medical history included ongoing multiple sclerosis which was diagnosed back in the early 90's and the doctors saw no new reasons on any part of the MRI of the brain, neck, and spine, there were no new lesion and she has had no problems for 30 years; and she had sinus pressure. There were no concomitant medications. Historical vaccine included BNT162B2 (Batch/lot number: EN6208) dose 1 in her left arm on 11Mar2021 (at 61 years of age) for COVID-19 immunisation. It was reported that the patient had a stroke after getting the Pfizer vaccine. She stated that she was in the ICU for 3 days. They tested every part of her body and couldn't find a reason. She added that she had a clot in her brain with a small bleed and they told her it was highly unusual to happen in that part of the brain. It was stated that it was where the blood goes from the brain to the heart. She mentioned that it was a dural venous sinus thrombosis. She was in the neuroscience ICU for 3 days and her left leg and left arm are still weak and she will start PT. She wanted to talk about reporting and let us know this was happening and that the neuroscience team reported it to the CDC online while she was in the hospital. She wanted to talk about her concerns and see if we are seeing this with other people. She added that she was tested, and they found nothing. She mentioned that she got the vaccine in a Thursday morning and by Friday she had weakness in her left arm and left leg and a headache. She added that there was a high probability that it was related, that it was a new vaccine and it was hard to say it definitely happened from that but it was a high probability. She had other questions, she has heard from other people with other vaccines and people with Covid experience blood clots. She stated that she was wondering what if it was with the vaccine that is reacting to what it thinks is Covid, or is it the body's response. She was wondering if Pfizer comes out with a booster with the variant, should she not take the booster. She stated that it could have killed her if they had not caught the blood clot in her brain and had she not gone to the ER it could have killed her and she was concerned about taking a booster. She provided that she had the Pfizer vaccine on 01Apr2021 in the morning and had a headache that same day and who knows when on Friday morning she had weakness in her left leg and left arm, so within 24 hours. She provided that she went to the ER Saturday 03Apr2021, that she wasn't sure about it and you don't go running for everything. Stated she was admitted 03Apr2021 and was discharged 05Apr2021 or 06Apr2021. She clarified that her headache was totally gone, that she had sinus pressure that was not related and had it as a constant in her life, it was normal for her and happens with changes with the weather. The patient was hospitalized for had a stroke after getting the pfizer vaccine (cerebrovascular accident) from 03Apr2021 to 06Apr2021. The patient underwent lab tests and procedures which included blood work constantly, CAT scan of her torso, several CAT scans of her brain, had MRI's and CAT scans constantly, brain MRI, MRV of the brain all on an unknown date with unknown results. The events resulted from Emergency Room Visit. The outcome of headache was recovered on an unknown date while not recovered for weakness left arm and left leg. The outcome of other events was unknown. Information on the lot/batch number has been requested.
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| 62 | 2021-04-27 | cough |
I can't walk around anywhere; I have allergies too; It was bad, getting hard to breathe.; she got li...
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I can't walk around anywhere; I have allergies too; It was bad, getting hard to breathe.; she got like double the amount of symptoms that she had experienced following the first dose of Pfizer-BioNTech Covid-19 Vaccine.; she can't talk, it's closing up her throat,; she can't talk, it's closing up her throat,; taste sodium in my mouth constantly; coughing; got home and I've been sick ever since.; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021) via an unspecified route of administration administered on right arm on 07Apr2021 at 13:30 (at the age of 62-year-old) as SINGLE DOSE for covid-19 immunization. Medical history included ongoing Allergies with This was under control, ongoing asthma with This was under control, meniere's disease from 1989 and ongoing with This was under control, have 2 broken knees. Patient knows how to control this condition, she didn't need Prednisone prior to onset of these adverse events, Low immune system with She has an immune deficiency so her immune system very low, like 300., Respiratory illness, Genetic/chromosomal abnormalities, Endocrine abnormalities with endocrine abnormalities (including diabetes) and obesity. Family Medical History Relevant to AE reported as None. History of all previous immunization with the Pfizer vaccine considered as suspect reported as Both doses of product documented in Pfizer Suspect Vaccine and Vaccination fields. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as None. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207; Expiry date: 31Jul2021) via an unspecified route of administration to the right arm on 13Mar2021 at 13:30 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine other than dose 1 of 2 of the Pfizer-BioNTech Covid-19 Vaccine. Regarding concomitant products and other medical conditions patient reported none other than just her inhalers which doses of had to be increased in response to symptoms after first and second doses of Pfizer-BioNTech Covid-19 Vaccine. Concomitant medication included tiotropium bromide (SPIRIVA) taken as Dose increased to twice in the morning daily for an unspecified indication from an unspecified start date and ongoing, (Lot number: 0014678, ; Expiration Date: Jan20230); fluticasone propionate, salmeterol xinafoate (ADVAIR) 500 taken as Dose increased from once daily to twice daily an unspecified indication from an unspecified start date and ongoing; azelastine hydrochloride (Lot Number: 3N2E, Expiration Date: Feb2022), fluticasone propionate (DYMISTA) taken for an unspecified indication from an unspecified start date and ongoing (Lot number: GA00510, Expiration date: May2022); prednisone (PREDNISONE) taken for an unspecified indication with quantity of 27, Dose: 3-20mg daily for 7 days, then 2-20mg daily for 2 days, then 1-20mg daily for 3 days and Ongoing therapy. She also used a nose spray that didn't work so they switched her back to Dymista nose spray. Consumer stated that she received both doses of Pfizer's COVID vaccine and had reactions to both of them. Consumer stated that, "The second dose was even worse. They put her on Prednisone. She did not know if she should be tested again or not? She was sitting up but she could not walk around anywhere. She had 2 broken knees. She could not walk anywhere. After the second dose, they had to bring her to the hospital because she couldn't even walk to her car. She got home and she had been sick ever since. She had allergies too. She could not do anything. she had a hard time breathing. she was hesitant to get the 2nd one, but everybody said to get it. Her IgG level was down to 300 something. She was also tapering off of prednisone and she did not want to be tapering off it because it was worked well for her. She could tell by her breathing that it was helped her. She could taste sodium in her mouth constantly since she had got the vaccination." Second dose completed her prescribed therapy. Dates for Symptoms From 15Mar2021 to Ongoing Reported seriousness for Symptoms reported as Unspecified and the Symptoms was reported as worsened. Patient's doctor dropped her last week, told her she didn't know what to do with her, and that this was too stressful. Onset of symptoms following first dose of Pfizer-BioNTech Covid-19 Vaccine was on 17Mar2021. She couldn't breathe very well when she went in for the first dose of Pfizer-BioNTech Covid-19 Vaccine. She was ok the first day after the first dose of Pfizer-BioNTech Covid-19 Vaccine, seemed ok, arm didn't hurt; but then had onset of symptoms. She has been in bed the whole time since onset of symptoms, was in bed for over 2 weeks. She slept for 2 days straight, only got up for water and the bathroom. It was bad, getting hard to breathe. She had to use her emergency inhaler. The Pfizer-BioNTech Covid-19 Vaccine messed up her Meniere's disease. Doctor started patient on Prednisone for these symptoms, and Prednisone is really the only thing that clears up Meniere's disease because her ears was full and she could not get up. Prednisone helped her and I relayed in her 'rescue' inhalers (treatment) because she did 2 in the morning, two inhalers anyway when she started to feel better, she got her second one and it made her worst. She did not eat anything salty or anything, the barometric pressure was not bad. It was really funny because she had just finished everything and it was a few days before she had to go get her second dose of Pfizer-BioNTech Covid-19 Vaccine shot. She was just starting to feel normal, at least normal for her, she could get up normal and drive. They gave her the second shot of Pfizer-BioNTech and it was like a double. She clarified as she got like double the amount of symptoms that she had experienced following the first dose of Pfizer-BioNTech Covid-19 Vaccine. She is tasting sodium in her mouth from the Pfizer-BioNTech Covid-19 Vaccine. She can't have much sodium which struck up the Meniere's disease really bad the second day after the second dose of the Pfizer-BioNTech Covid-19 Vaccine; her allergies in her head went bonkers. She could not talk, it was closing up her throat, she was coughing every time she eats or dinks, and she's having a "really bad" adverse reaction to the Pfizer COVID-19 vaccine after the second dose. They had to take her out of the hospital to her car in a wheelchair "right after" getting the second shot. She could not get more than 1000 mg of sodium a day, she tastes it in her mouth constantly, she could not get rid of it and it was "going through her system". She wanted to know what to do, since her doctor told her to contact Pfizer. She wanted to know what part of the vaccine is doing that, she assures it is sodium, because sodium is in her mouth 24/7 and she could not get it out, she could not have that much sodium in her body. It was still getting really hard to breathe. She is still taking the Prednisone she was initially prescribed and started on for the symptoms that started after her first dose of Pfizer-BioNTech Covid-19 Vaccine. She is tapering off of Prednisone, and she shouldn't be tapering off, she thinks she needs to be Prednisone for some more days, maybe 3 more days, then she would be ok. It was prescribed as a 7-day burst of Prednisone. She mentioned that the only Prednisone that works on her is the Actavis manufactured Prednisone; her pharmacy orders it for her because they know that. She called the emergency room Saturday when she was really bad. They said they had a line there and it was going to be at least a 4 hour wait. With patient's low immune system, Meniere's disease and that she could hardly breathe she did not go to the emergency room because she could catch something and die while waiting. She decided she would just stay at home and rest. She has not had any Physician's office visit relative to event; she has a telephone appointment tomorrow to see if the doctor is going to be her doctor. She had to cancel her appointment with the doctor today because if she has something she doesn't want to spread it, she feels worse now and with the Meniere's she is tasting sodium in her mouth constantly from the Pfizer-BioNTech Covid-19 Vaccine, she does not eat a lot of salt. The flu shot takes her a couple of days, then she is right back up and Vaccination Last dose on Oct2020. Consumer stated that she has 'Meniere's' disease (History) and it made her worse. The patient underwent lab tests and procedures which included IgG level: 300. Reporter stated the seriousness for the events was Unspecified. Seriousness of event Meniere's disease aggravated was medically significant. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 62 | 2021-04-27 | malaise, chills, headache, influenza like illness |
My partner felt pain overnight. Then, felt flu like symptoms- plus chills- the next day and night. T...
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My partner felt pain overnight. Then, felt flu like symptoms- plus chills- the next day and night. The following morning at 7:00 am, Patient said that she felt real sick. She also, complained of having a real bad Headache, Not long after that, she felt like throwing up. She tried to throw up. Except, nothing came out and she felt very nauseous because of the vaccine. When she came call to bed, I offered to make her some breakfast to help her feel better. Unfortunately, she felt, too, I'll to try and eat an food because of the way she felt. So, I laid next to her with the hope that all would be well. Because, the pharmacist who administered the second dose. Assured my partner, that it was normal to feel flu like symptoms the next day. So, we never doubted what the pharmacist advised. All of sudden, she suffered a cardiac arrest in my presence and died in front of me.
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| 62 | 2021-04-30 | chills |
felt low blood pressure; weak; confused; When fell hit self on head, lip, nose, and eye; When fell h...
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felt low blood pressure; weak; confused; When fell hit self on head, lip, nose, and eye; When fell hit self on head; bruises on face; had burst lip; diarrhea; leg pain; fainted; seizure; felt hot; chills/shaking.; This is a spontaneous report from a contactable consumer (patient herself). This 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration in the left arm, on 13Apr2021 at 21:00 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EP6775 MS 389) administered via an unknown route in the left arm on 17Mar2021 (at 10:00 AM) for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included gastritis and anxiety. Past drug history included allergy to mirtazapine (REMERON). Relevant concomitant medications included diazepam (VALIUM), vitamins and probiotics. On 13Apr2021 at 23:00 the patient had chills / shaking. On 14Apr2021 at 02:00 AM, she felt hot. She went to bathroom, felt low blood pressure, weak, and fainted. Woke up, felt disoriented, not know where she was, confused. When fell hit self on head, lip, nose, and eye. She suffered various bruises on face. May have had seizure, had burst lip and felt was biting. Then suffered diarrhea that day. She also experienced leg pain. She went to the doctor on 16Apr2021. On unknown date, blood work up was done and results were not provided. The patient was recovering from the events. Information on the lot/batch number has been requested.
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| 62 | 2021-04-30 | fatigue, headache |
tired; headache; This is a spontaneous report from a contactable consumer. A 62-year-old female pati...
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tired; headache; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 05Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 62 years). Medical history included fibromyalgia. Concomitant medication included etanercept (ENBREL). The patient experienced tired and headache on 05Apr2021 12:00. The patient's hospitalization was prolonged as a result tired and headache on an unspecified date. The patient underwent lab tests and procedures which included Nasal Swab: unknown on 13Apr2021. Patient is not pregnant. Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 62 | 2021-04-30 | malaise |
blood pressure (BP) was usually 110/70 however 8 hours after shot BP was 145/85; really bad vertigo ...
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blood pressure (BP) was usually 110/70 however 8 hours after shot BP was 145/85; really bad vertigo and dizziness; really bad vertigo and dizziness; facial palsy; vision in her right eye got fuzzy; face got numb on the right side; hot electrical nerve zinging entire right arm, right shoulder blade and right calf; sore arm; feel sick; hangover; vomiting; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the right arm on 16Apr2021 11:15 (Batch/Lot Number: EW0162) as single dose (at the age of 62-years-old) for COVID-19 immunisation. Medical history included anaphylaxis: carries an epi pen, and has allergies to wasps. The patient also took unspecified dietary supplements. The patient had no other vaccine in four weeks. The patient got her first vaccine dose on 16Apr2021 and reported having a history of anaphylaxis and carried an epi pen. She stayed at the vaccination facility for an hour and a half and she got facial palsy and her vision in her right eye got fuzzy. Then her face got numb on the right side. It took 4 hours for it to go away but by dinner she felt ok. She added that immediately after the shot (16Apr2021), she experienced hot electrical nerve zinging entire right arm, right shoulder blade and right calf that lasted 30 minutes; blurry vision right eye started 15 minutes after shot, recurred off and on for 6 hours; facial palsy on right side that started about 30 minutes after shot that lasted 4 1/2 hours; vertigo/dizziness that started 7 hours after the shot; and blood pressure (BP) was usually 110/70 however 8 hours after shot BP was 145/85. She filed a report online when her symptoms began to subside. A couple hours later, she began to feel sick again and went to bed. When she walked to her mailbox, she was feeling ok but when she bent over to get the mail, that made it all worse. She woke up feeling as if she had a hangover and reported vomiting right away after getting out of bed. She had really bad vertigo and dizziness. She also had a sore arm (unspecified which arm) and stated that she was "experiencing everything on the freaking list." The patient wanted to know if this was normal and asked if she should get the second dose. She was advised that if she had a severe allergic reaction after a previous dose of the vaccine, she should not get the Pfizer-BioNTech Covid-19 vaccine. She also wanted to know if her symptoms got worse over the weekend and wanted to know what were the signs if she should go to the hospital. The patient did not receive any treatment for the adverse effects. The patient did not have COVID prior to vaccination and was not COVID tested post vaccination. The patient recovered from hot electrical nerve zinging entire right arm, right shoulder blade and right calf 16Apr2021 11:45; face got numb on the right side on 16Apr2021 15:15 and facial palsy on 16Apr2021 16:15. The outcome of the remaining events was unknown.
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| 62 | 2021-04-30 | malaise |
My nasal passages, throat, and bronchial tubes started to swell up; feeling faint; general malaise; ...
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My nasal passages, throat, and bronchial tubes started to swell up; feeling faint; general malaise; My nasal passages, throat, and bronchial tubes started to swell up; My nasal passages, throat, and bronchial tubes started to swell up; brain fog; This is a spontaneous report from a non-contactable consumer (patient). A 62-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 08Apr2021 14:00 (Batch/Lot Number: ER8729) (at the age of 62-years-old) as single dose for covid-19 immunization. Medical history included known allergies: penicillin from an unknown date. The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2, dose 1, administered in arm left on 18Mar2021 01:45 P.M. (Batch/Lot Number: ER2613) (at the age of 62-years-old) for covid-19 immunization. The patient did not get COVID prior vaccination and did not receive COVID test post vaccination. About five minutes (as reported) after the patient received the shot, she started feeling faint on 08Apr2021 02:15 P.M. Her nasal passages, throat, and bronchial tubes started to swell up on 08Apr2021 02:15 P.M. Taking a decongestant when she got home helped that. For a few days she had congestion and brain fog along with general malaise. Treatment received included she took decongestants. The outcome of the events was resolved in Apr2021. No follow-up attempts are possible. No further information is expected.
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| 62 | 2021-05-03 | fever, sleepiness |
She felt like she would pass out if she didn't feel the black out sensation coming on; fever; dizzy;...
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She felt like she would pass out if she didn't feel the black out sensation coming on; fever; dizzy; body aches; She felt like she was on a boat/ she was not feeling right; had soreness in her arm; has zero energy; She fell asleep in her sunroom and got up around 3:00PM; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0158; Expiration Date: Jul2021, NDC not known), via an unspecified route of administration, administered in right arm on 16Apr2021 at 10:00AM (at the age of 62-year-old) at single dose for prevent Covid 19, she wanted to feel safe traveling. No additional administered vaccines administered on same date with the Pfizer vaccine considered as suspect. Medical history included ongoing rheumatoid arthritis and prior to receiving her Covid 19 vaccines she reached out to her rheumatologist to see if she would be ok getting the Covid 19 vaccine while taking her medications, her rheumatologist told her she would be ok to receive the Covid 19 vaccine. Ongoing concomitant medications included methotrexate injection and hydroxychloroquine. No prior vaccinations within 4 weeks. The patient previously was made to get a flu vaccine for work about 20 years before for immunization, the flu vaccine made her violently ill, she ended up having to go to an Urgent Care, she had to call her mother to come get her, she could not even get out of bed, she had to stay home a week from work because she was sick; she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Mar2021 (at the age of 61-year-old) at single dose for COVID-19 immunization and experienced fever, everything in her body ached, every time she bended over, if her head got below her shoulders to pick something up she would black out and vertigo. When she received her second Covid 19 vaccine her symptoms started again on 16Apr2021. She felt like she would pass out if she didn't feel the black out sensation coming on. She didn't know how long she blacks out for. She tried to grab a hold of something, for example, she was in the shower shaving her legs and she reached down to shave her legs and she could feel herself starting to pass out. She had a ledge or seat in her shower and she grabbed the shower wall and lowered herself to a sitting position on that ledge in her shower. The feeling passed and she tried to shave the other leg and the same thing happened again. When she's sitting on her sofa and she bended down to the floor to pet her small dog, all of a sudden she could feel herself moving forward like she was going to fall forward. Her husband grabbed her arm and pulled her to an upright position and asked her if she was ok. She reported her normal body temperature was 96.9 degrees Fahrenheit on an unspecified date. She was not someone who ran 98.6 degrees Fahrenheit. She reported her temperature had been about 98.8-98.9 degrees Fahrenheit on an unspecified date and that to her was a fever. She was still running a fever. She reported she had been afraid to drive because she was afraid she would pass out. She knew she did not have vertigo. She did a have a yearly check up with her primary care doctor and she was going to talk to her doctor about what's happening. She received her Covid 19 vaccine with her husband at about 10:00AM. Shortly after when she and her husband were driving home, she told her husband she was dizzy on 16Apr2021. She felt like she was on a boat. Even if she looked up or bent over was when she got dizzy. Her fever started right away after her vaccines on 16Apr2021. She also had soreness in her arm and everything in her body aches on 16Apr2021. She had zero energy on 16Apr2021. She was still feeling this way now. She fell asleep in her sunroom and got up around 3:00PM on 16Apr2021. Not any adverse events required a visit to Emergency Room nor Physician Office. The outcome of the event fell asleep was unknown, outcome of the other events was not recovered.
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| 62 | 2021-05-04 | malaise, fatigue |
Left jaw is swollen so huge and it's just hard and now it's going into my lip; Lower lip is numb and...
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Left jaw is swollen so huge and it's just hard and now it's going into my lip; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; short of breath/I can't breath; am still not well, Bad condition here; am still not well, Bad condition here; dizziness; tired; deltoid starts swelling; lost feeling in my mouth; Left jaw is swollen so huge and it's just hard and now it's going into my lip; my stomach was upset; my jaw was sore; The initial case was missing the following minimum criteria: ICH-unspecified product. Upon receipt of follow-up information on 22Mar2021, this case now contains all required information to be considered valid. A 62-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL3302) via an unspecified route of administration on 11Mar2021 in left arm at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. As per the context, it was reported that consumer stated, I took the vaccine (Unspecified Vaccine) the first dose on Thursday and right now my left side, they gave it into my left arm and my left jaw is swollen so huge and it's just hard and just like really hard and now it's going into my lip, my lower lip is numb and it's going down into my throat and up in my ear and it's very painful; she was in severe pain. Consumer stated, I took the vaccine 11Mar2021 and next day i.e. on 12Mar2021 I get up and my jaw was sore and then my stomach was upset and then as the day started on my jaw started swelling really big. I took it on 11Mar2021 and I am still not well, Bad condition here, I have lost feeling in my mouth and I can't breath either. It was the first vaccine and this is the very last I am not taking again. Consumer stated, I had a trip to the emergency room. Regarding lab data, consumer stated, No, they documented how swollen was my jaw was, I didn't know I was short of breath until I start back exercising and then I can't breath in there. Consumer stated, Well I just wanted to know how long this is going to last then because I have lost feeling in my mouth. Consumer stated, I got a vaccine back in March and I called Pfizer then because I had, my deltoid starts swelling and I had to go to the emergency room because that's what the paper says if you have facial swelling. So now my deltoid is still swelling, it will go down some and it will start swelling again, I have got numbness in my lips and my chin, dizziness and it hurts. So, I just wanted to know what you can do for that and along with that if it's normal. Consumer stated, Well I have been on hold for an hour, just to get this number, can't you just type the information in have them contact me. When tried to probe for further questions, Consumer stated, I have already documented and I just need to talk to somebody that know what to do to get my job back, like it was. Consumer stated, I went to the emergency room, the paper that they gave it to me vaccine was (name withheld), it's a drive through and they vaccinated it was the first vaccine I got, and I did not go back and get another one because I haven't recovered from that one yet. My face is out swelling up, my lips numb, my cheeks numb and numb. I am just tired and dizzy. The outcome for the events swelling face, lip swelling, hypoaesthesia oral, pharyngeal hypoaesthesia, hypoaesthesia, pain, general physical health deterioration, malaise, abdominal discomfort, pain in jaw,sensory loss, swelling, dizziness and fatigue were not reported and for the event deltoid starts swelling it was reported as not recovered/not resolved. Information about batch/lot number had been requested.
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| 62 | 2021-05-05 | cough, fatigue |
Patient received COVID-19 vaccine on 1/28 and 1/6/2021. On 4/25 patient developed cough, back pain,...
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Patient received COVID-19 vaccine on 1/28 and 1/6/2021. On 4/25 patient developed cough, back pain, and weakness/fatigue. Tested positive for COVID. Treated with monoclonal antibodies.
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| 62 | 2021-05-06 | chills |
vomiting; chest pain; stomach pain; nausea; chills; body ache; stomach pain more intense; acute panc...
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vomiting; chest pain; stomach pain; nausea; chills; body ache; stomach pain more intense; acute pancreatitis; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER2613, second dose) solution for injection intramuscular in the left arm on 23Mar2021 at 09:00 (at the age of 62-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included ARMD (age-related macular degeneration), high blood pressure, and anxiety. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and AREDS vitamins. The patient had no known allergies. Historical vaccine included BNT162B2 (first dose, lot EN6202) for COVID-19 vaccination on 02Mar2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Mar2021 at 07:00, the patient experienced stomach pain, nausea, chills, and body ache. On 26Mar2021, the patient experienced vomiting and chest pain. In Mar2021, the patient experienced acute pancreatitis and stomach pain more intense. The events resulted in emergency room/department or urgent care visit and hospitalization for 10 days in 2021. Lab test in Mar2021 included CT scan: revealed acute pancreatitis. Treatment for the events included antibiotics, fluids, and oxygen. The outcome of the events was recovered in 2021. Since the vaccination, the patient has not been tested for COVID-19.
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| 62 | 2021-05-07 | chills |
Dizzy; Weak; Non-stop vomiting for 8 hours; Nausea; Loose stools; Body Aches; Chills, no fever; Too ...
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Dizzy; Weak; Non-stop vomiting for 8 hours; Nausea; Loose stools; Body Aches; Chills, no fever; Too sick to call Pfizer yesterday about symptoms; Has a ton of mucous discharge; This is a spontaneous report from a contactable Nurse. A 62-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: JR8729), via an unspecified route of administration, administered in Deltoid Left on 21Apr2021 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 62 years). The patient's medical history was not reported. There were no concomitant medications. The patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN6207) on 31Mar2021 for covid-19 immunisation and experienced Sore Arm after first vaccine (Age at vaccination: 62 years). The patient also had a historical vaccine of Flu vaccine on 16Oct2020 for immunisation and experienced Local Reaction; Redness at injection site (Age at vaccination: 61 years). The patient experienced non-stop vomiting for 8 hours on 22Apr2021 02:30, nausea, loose stools, body aches, chills, no fever and too sick to call Pfizer yesterday about symptoms on 22Apr2021, dizzy and weak on 23Apr2021. The patient also stated that she has a ton of mucous discharge on Apr2021. The events were considered as medically significant by the reporter. Outcome of the event vomiting was recovered on 22Apr2021, outcome of the events body aches and chills was recovering while outcome of the events mucous discharge and sickness was unknown. Outcome of the remaining events was not recovered.; Sender's Comments: There is a reasonable possibility that the events vomiting, nausea, diarrhea, and chills were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 62 | 2021-05-07 | fatigue, nasopharyngitis |
I can't hear out of one ear,; I feel like I have a really bad cold; I'm very tired; I feel really si...
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I can't hear out of one ear,; I feel like I have a really bad cold; I'm very tired; I feel really sick; and I'm concerned that I may have covid now; This is a spontaneous report from a contactable consumer(Patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. She had her first dose of the Pfizer BioNTech covid vaccine and concerned that she may have covid now. Since getting the shot she feels like having a really bad cold, can't hear out of one ear, she is very tired and feel really sick. She is not sure if these are side effects of getting the vaccine or if she has covid. The outcome of all the events was unknown. Information about lot/batch number has been requested.
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| 62 | 2021-05-07 | fatigue, fever |
Fever up to 100 (degree) Farenheit; Tiredness; Feeling weak; This is a spontaneous report from a con...
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Fever up to 100 (degree) Farenheit; Tiredness; Feeling weak; This is a spontaneous report from a contactable physician reporting for herself. This 62-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number EN5318, intramuscularly on the left arm on 03Feb2021 at 11:00 AM (at the age of 62-year old) at single dose for COVID-19 immunization outside a church. Relevant medical history was none. Historical vaccination included first dose of the same vaccine intramuscularly in the left arm on 13Jan2021 at single dose for COVID-19 immunization. Family history included an aunt died from encephalomyelitis disseminate in 1975. Concomitant medication included cyanocobalamin (VIT B12) from 2019 and ongoing orally. On 04Feb2021 at 06:00 AM the patient experienced fever up to 100 degree Farenheit, tiredness and feeling weak. On 02Feb2021 the patient had a PCR test for COVID with negative result. On 03Feb2021 at 3 PM the patient received metamizole (NOVAMISULFON) 1 tablet orally to treat an unspecified event. Treatment for the above events was reported as "No". The patient recovered from the events. The patient commented "Expected side effect of vaccine, personally easy to react to vaccines with fever". Follow-up attempts are completed. No further information is expected.
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| 62 | 2021-05-10 | fatigue |
Major joint pain and inflammation in knees and ankles Major tiredness. Did not wake up on May 7. M...
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Major joint pain and inflammation in knees and ankles Major tiredness. Did not wake up on May 7. My husband had to call 911 as my Blood sugar dropped to a low of 17 I almost died
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| 62 | 2021-05-11 | headache |
To check if it was blood clot; Intermittent long-lasting palpitations; Lymph discomfort in one leg; ...
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To check if it was blood clot; Intermittent long-lasting palpitations; Lymph discomfort in one leg; Severe pain of bones in chest; Joint pains; Severe shooting intermittent head pain; Cold sweat; Felt like she was going to faint; COVID arm popped out; Severe nerve pain behind ear same side as vaccine; Exacerbated back pain; Bad menstrual cramps; This is spontaneous report from contactable consumer (patient). A non-pregnant 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8727), via an unspecified route of administration in left arm, on 31Mar2021 at 01:00 PM (13:00), as first dose, single, for COVID-19 immunization. The patient's medical history included fibromyalgia, complex regional pain syndrome (CRPS), lymphedema (previously resolved), mild asthma, osteoporosis, herniated discs, allergies, and menopause. The patient's concomitant medications included unspecified vitamins. The patient had no other vaccine in four weeks (however, it was also reported that other vaccine was administered in same date, 31Mar2021; pending clarification). The patient was not diagnosed with COVID-19 prior vaccination. On 03Apr2021 at 02:00 AM, the patient experienced intermittent long-lasting palpitations, lymph discomfort in one leg for which they went to check if it was blood clot. On 03Apr2021 at 02:00 AM, the patient also had severe pain of bones in chest, joint pains, severe shooting intermittent head pain, cold sweat, felt like she was going to faint, COVID arm popped out (nite 8; as reported), severe nerve pain behind ear same side as vaccine, exacerbated back pain, and bad menstrual cramps for 2 mornings 11 years post-menopause. The adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment was received for the adverse events. The events were considered non-serious. The patient has not been tested for COVID-19 post-vaccination. The patient had not recovered from the events. No follow-up attempts are needed. No further information is expected.
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| 62 | 2021-05-12 | headache |
having faint spells; blood pressure is a little bit higher than normal; Feeling kind of funny; had s...
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having faint spells; blood pressure is a little bit higher than normal; Feeling kind of funny; had severe headache; This is a spontaneous report from a contactable healthcare professional, the patient. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8727, second dose) solution for injection intramuscular in the left arm on 25Mar2021 (at the age of 62-years-old) as a single dose for COVID-19 vaccination. Medical history included thyroid disease (diagnosed with probably 20-21 years ago) and blood pressure increased (takes blood pressure medicine). Concomitant medication included hydrochlorothiazide for blood pressure increased began taking this 4 or 5 years ago. Historical vaccine included BNT162B2 (first dose, lot EN6200) for COVID-19 vaccination on 04Mar2021 with no adverse effect reported. On 25Mar2021, the patient was feeling kind of funny and had a severe headache. In Apr2021, the patient had faint spells and blood pressure was a little bit higher than normal at 137/80 which began after the second dose Pfizer Covid Vaccine. The patient stated she never felt like fainting before in her life. Her blood pressure was never over 150 and can't keep blood pressure under 130 for some reason. The outcome of the events feeling kind of funny and headache was unknown. The outcome of the events faint spells and blood pressure was a little bit higher was not recovered. Information on batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event faint spells and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-01-01 | throat irritation |
Approximately 1 hours after injection, I felt an unusual feeling at base of throat. It progressively...
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Approximately 1 hours after injection, I felt an unusual feeling at base of throat. It progressively got worse and I felt throat swelling and my voice was effected. No itchy throat like my anaphylaxis reaction to shellfish only swelling. I mildly panicked and wanted to take Benadryl. About 1/2 hour later by the time I got home reaction was over. No repeat of symptoms ever again.
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| 63 | 2021-01-04 | body temperature increased, fatigue |
significant fatigue; temperature was taken when waking up - 101F orally; she slept more; localized i...
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significant fatigue; temperature was taken when waking up - 101F orally; she slept more; localized injection site pain and redness; localized injection site pain and redness; This is a spontaneous report from a contactable nurse (patient). This 63-year-old female Nurse reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via intramuscular at right arm on 17Dec2020 08:30 PM at single dose for COVID-19 immunization. Facility type of vaccine was hospital. Medical history included shingles in Jun2020 after illness that mimicked COVID-19 but all tests came back negative - was sick for 3 weeks; no other chronic health conditions; severe beef/pork allergy - anaphylaxis. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medications were not reported. No other vaccine in four weeks. On 18Dec2020 02:00 PM, patient experienced significant fatigue; she slept for 1 hour and temperature was taken when waking up - 101F orally; she slept more; she had localized injection site pain and redness for 3-5 days. No treatment was received for events. It was reported as non-serious. Outcome of events was recovered in Dec2020.
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| 63 | 2021-01-04 | chills, fever |
6-7 hours after the vaccine she developed arm pain, fever and chills. About an hour later she start...
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6-7 hours after the vaccine she developed arm pain, fever and chills. About an hour later she started to have abdominal pain which worsened over the course of the day to excruciating. She went to the Emergency Room where a CT scan revealed a perforation of her sigmoid colon and had a resection of the area of the colon and a diverting colostomy surgery done the evening of 1/3/2021.
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| 63 | 2021-01-04 | fever, chills, headache | Fever of 99.7 on 12/30/2020 Fever of 100.3 on 12/31/2020 Debilitating headache Chills |
| 63 | 2021-01-05 | headache, body temperature increased | Temperature 101, headache, ears hurt, body aches , nauseated |
| 63 | 2021-01-05 | fever |
low grade fever/fever; 100 degrees Fahrenheit/99.2 degrees Fahrenheit/99.8 degrees Fahrenheit; This ...
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low grade fever/fever; 100 degrees Fahrenheit/99.2 degrees Fahrenheit/99.8 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) at the public health department via unspecified route of administration at right arm on 28Dec2020 12:30 as single dose to prevent getting the Covid virus. Medical history included medication allergies (allergic to like 3 to 4 medications), allergic to sulfur/sulfa, allergic to penicillin, allergic to "-mycins", allergic to dye (for a CT scan). The patient informed that she was given the Pfizer shot, clarified to Pfizer-BioNTech COVID-19 vaccine on Monday (verified to be the 28th). The patient informed that since then she has had a low grade fever and the patient would like to talk to someone to see if that was normal, since it was still not gone. The patient got her first dose of the vaccine injected into her right arm around 12:30 PM Monday (28Dec2020), and her fever started Monday night and got to 100 degrees Fahrenheit and since then she has been running 99.2 degrees Fahrenheit (Dec2020), it was 99.8 degrees Fahrenheit now (30Dec2020). The patient stated "it didn't say on the vaccine card, but the sheet they gave with it says it is the Pfizer-BioNTech COVID-19 vaccine. All that is on there is the date she got it, 18Nov2020 and the healthcare girl put her initials on it" (unable to clarify discrepancy between the dates provided as caller continued speaking). The patient informed that she was supposed to have turned around on the 18th to get the second shot (unable to clarify statement and the caller may have meant that she was supposed to get the second dose of the shot on 18Jan2021, and misread the card as she seemed to have difficulty reading the nurse's handwriting on it). The reporter informed that the LOT number was written with an E and then either a V or a K, it looks like a V but the girl put a leg on there so maybe it was a K then 9231, or EV or 9231 or 9731. The outcome of the event "pyrexia" was not recovered.
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| 63 | 2021-01-06 | body temperature increased, malaise, fatigue |
This is a self report: two days after the vaccine I developed severe heart burn ( something I have ...
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This is a self report: two days after the vaccine I developed severe heart burn ( something I have never experienced). Several over the counter medication were used without relief. . The heart burn was followed by a horrible gastric disturbance. I experienced abdominal pain, cramping and rectal pain. During this time my temperature remand between 100.0 - 101.0 with fatigue and malaise. I have also noticed several welts on my body. I?m typically a very health person and have never experienced any of these experiences before.
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| 63 | 2021-01-06 | chills, body temperature increased |
Temp of 102 with chills and body aches and pains, incision site of left ORIF became red and inflamed...
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Temp of 102 with chills and body aches and pains, incision site of left ORIF became red and inflamed and I had to go to the emergency room where I was given doxycycline b.i.d. for seven days.
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| 63 | 2021-01-06 | chills, fatigue, fever |
Within 8 hours of vaccine receipt, I began to experience left-sided tinnitus. During the first vacci...
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Within 8 hours of vaccine receipt, I began to experience left-sided tinnitus. During the first vaccination; I experienced muscle soreness at the site of injection; mild fatigue the next day (12/14/2020). After the second vaccine, I experienced increased muscle pain, with decreased ROM of the left shoulder due to pain. Within 12 hours, I experienced diffuse myalgias. After 16 hours, I experienced a fever (101F) with chills (resolved within 24 hours). There was significant fatigue the first 36 hours after the second vaccine administration. I took two doses of Tylenol on the first day. No rash.
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| 63 | 2021-01-06 | cough, fatigue, headache, chills |
Headache, Myalgia, CoughWheeze, Syncope, Fatigued, chills, night sweats, mild shortness of breath, c...
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Headache, Myalgia, CoughWheeze, Syncope, Fatigued, chills, night sweats, mild shortness of breath, cough. Takes coumadin for protein s deficiency. Tested + for COVID on 1/4/21 Narrative: Fatigued, chills, night sweats, mild shortness of breath, cough. Takes coumadin for protein s deficiency, sees hematology. Currently taking prn tylenol, scheduled to see hematology. Tested positive for COVID on 1/4/21.
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| 63 | 2021-01-06 | headache, fatigue, throat pain | Headache, NauseaVomiting, Sore throat,fatigue Narrative: |
| 63 | 2021-01-06 | headache, fever, fatigue |
Extreme fatigue, low grade temp for 2.5 days, intermittent headaches that shifted and moved to diffe...
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Extreme fatigue, low grade temp for 2.5 days, intermittent headaches that shifted and moved to different areas and intensity
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| 63 | 2021-01-06 | headache |
Headache tingling hands and lips, tongue felt thick/swollen Narrative: 12/30 given vaccine in the E...
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Headache tingling hands and lips, tongue felt thick/swollen Narrative: 12/30 given vaccine in the ED due to a shellfish allergy for which she carries an epipen. Pt experienced mild symptoms c/w allergic reaction after receiving Pfizer COVID vaccine #1. Symptoms included tingling lips and sensation of swollen tongue. She was given Diphenhydramine 50mg PO. Condition did not progress and her symptoms resolved within about one hour of oral Diphenhydramine. She was observed for 3 hours and discharged to home with prescriptions for an epipen and benadryl. Employee states - "15 min after the vaccination my hands got tingly on the palms. 5-10 min after that the front of my lips were tingly then my tongue felt thick. I also got a headache They gave me benadryl pills in the ED and within 10 min tingling on my lips went away and my tongue felt normal. My headache also went away." She was discharged from the ED back to work and reports no other symptoms.
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| 63 | 2021-01-07 | head discomfort, headache |
20 mins after receiving vaccine, sensation of "wave" through brain with almost loss of consciousness...
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20 mins after receiving vaccine, sensation of "wave" through brain with almost loss of consciousness. BP 151/93, 10 minutes later BP 130/83. Severe Dizziness and intense anxiety attacks commenced within 24 hours and lasted for 7-8 days. These were accompanied by sensation of pressure in brain and headache. Treatment with hydroxyzine 25mg once or twice a day reduced intensity of anxiety attacks but did nothing to help with the dizziness. Headaches were intermittent during this period. Almost all dizziness subsided by day 12 post vaccine. Headaches subsided by day 5.
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| 63 | 2021-01-07 | headache |
24 hours after receiving the first dose of covid vaccine, I started having a really bad headache tha...
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24 hours after receiving the first dose of covid vaccine, I started having a really bad headache that I could not get rid of even with taking 1000mg of tylenol
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| 63 | 2021-01-07 | headache | headache |
| 63 | 2021-01-07 | headache |
Headache, Myalgia, Arthralgia & NauseaVomiting Narrative: Is taking Ibuprofen/ Advil, also took Zof...
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Headache, Myalgia, Arthralgia & NauseaVomiting Narrative: Is taking Ibuprofen/ Advil, also took Zofran for nausea. Body aches are 10/10, sometimes improve down to 8/10.
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| 63 | 2021-01-07 | headache |
Urinary tract infection; Injection site soreness/ Injection site pain; Achy; Headache; Sore on the i...
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Urinary tract infection; Injection site soreness/ Injection site pain; Achy; Headache; Sore on the injection arm; Her arm was stiff feeling; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL0140), intramuscular on 18Dec2020 15:00 at single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The transferring agent stated that she has a caller on the line that received the first dose of the Covid-19 vaccine on 18Dec2020. She is supposed to get the second dose tomorrow 06Jan2021. She developed a urinary tract infection over new years and was put on antibiotics. She wanted to know if she could get the second dose while on antibiotics. The transferring agent stated that the caller reported that she started feeling achy and had a headache, but did not think it was related to the shot. She stated that she had injection site pain and was sore on the injection arm. She had the shot late in the afternoon around 15:00 on 18Dec2020. She said that she was sore later on that evening at the injection site and her arm was stiff feeling the next day, but it was resolved by the day after. She said that the headache came and went. She treated it with Tylenol. She said that she did not feel real good most of the day on Saturday 19Dec2020, but by Sunday she was back to normal again. The outcome of the event Urinary tract infection was unknown while the outcome of the other events was resolved on 20Dec2020.
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| 63 | 2021-01-07 | fever, headache, chills |
Her temp got up to, she think it was to '38.7'; Muscle ache but at the injection site for sure; Neck...
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Her temp got up to, she think it was to '38.7'; Muscle ache but at the injection site for sure; Neck pain; Chills; headache; This is a spontaneous report from a contactable nurse (patient). This 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK4176), via an unspecified route of administration, on 02Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 63-years-old. Medical history was none. Concomitant medications were unknown. Nurse stated she got her shot yesterday in the morning on 02Jan2021. So, she had had just muscle ache but at the injection site for sure and headache, neck pain and then last night starting around 6 O'clock fever and chills. Her temp got up to, she think it was to 38.7 (not clarified further) was when she finally tried to get out of bed to take it. So, she is taking Tylenol a 1000 mg around the clock every 6 hours. The patient is feeling much better but she doesn't want to go through another night like that. Outcome was unknown. For the reporting nurse fever and chills were related to the vaccine.
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| 63 | 2021-01-07 | fever, headache | fever, muscle aches,headache |
| 63 | 2021-01-08 | headache, fever, chills |
Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taki...
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Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taking about 15 seconds to complete injection. Injection was painful. Within 1 hour I could not raise my arm more than 30 degrees without severe pain. Diminished ROM and pain at night is ongoing. Within 4 hours, I had a low grade fever with chills, headache and myalgia that persisted for 12 hours then respoved. I am awaiting an appointment with my primary care physician and will know then if more treatment will be recommended. Incident Report filed at the hospital.
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| 63 | 2021-01-08 | fever, chills, headache |
Chills, body aches, headache, fever. Took OTC Tylenol for fever. Naproxen for body aches. Lasted ab...
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Chills, body aches, headache, fever. Took OTC Tylenol for fever. Naproxen for body aches. Lasted about 12 hours
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| 63 | 2021-01-09 | fatigue, chills, fever, sweating |
chills, fever, sweating and tired started at 5:00 pm the night after receiving the vaccine, in the m...
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chills, fever, sweating and tired started at 5:00 pm the night after receiving the vaccine, in the morning felt much better
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| 63 | 2021-01-09 | headache, fatigue |
Hard, pounding tachycardia, with dizziness, nausea, headache, occurred about 5 minutes after vaccine...
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Hard, pounding tachycardia, with dizziness, nausea, headache, occurred about 5 minutes after vaccine was administered. The tachycardia resolved without medical intervention within 2 minutes. The remainder of the symptoms remained the rest of the day, along with profound fatigue and intermittent self limited tachycardia. The headache was managed with Tylenol. I slept most of the day and through the night. The following day, I had a headache, which was mild. Fatigue remained. I also noted intermittent tachycardia with mild exertion, self limited, less than 1 minute. Mild soreness at injection site.
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| 63 | 2021-01-10 | cough, fever | weakness, fever, cough |
| 63 | 2021-01-10 | fatigue | Extreme fatigue/weakness body aches, especially hips |
| 63 | 2021-01-10 | throat pain, cough, runny nose | I had a sore throat, runny nose, and coughing. Happened four days after my vaccine. |
| 63 | 2021-01-10 | fever |
severe achiness and shaking and fever to 104 F on 1/3/21. Unable to work for two days. Question is ...
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severe achiness and shaking and fever to 104 F on 1/3/21. Unable to work for two days. Question is - should I get the #2 dose in light of the robust antibody response to #1. Could it be even worse?? Any information on this?
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| 63 | 2021-01-11 | chills, headache |
patient developed aches, chills and headache 12 hours post vaccine. Symptoms resolved within 24-48 ...
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patient developed aches, chills and headache 12 hours post vaccine. Symptoms resolved within 24-48 hours
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| 63 | 2021-01-11 | headache |
I felt ok right after the injection but about 2 hours later I started experiencing a pressure headac...
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I felt ok right after the injection but about 2 hours later I started experiencing a pressure headache, gradually felt very poorly and took a nap for a few hours. Upon waking I felt ok but after walk; weakness; felt very poorly; This is a spontaneous report from a contactable other health care professional. A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EL1284), intramuscular on 04Jan2021 11:45 at single dose at left arm for COVID-19 immunization. Medical history included hypothyroidism, psoriasis. Concomitant medications included etanercept (ENBREL), and levothyroxine. The patient felt okay right after the injection but about 2 hours later, on 04Jan2021 14:30, she started experiencing a pressure headache, gradually felt very poorly and took a nap for a few hours. Upon waking the patient felt okay but after walking around the house for about 20 minutes, the headache started up again and the same awful feeling of weakness so she laid down and took another 2 hours nap. When the patient woke up the second time she felt as though nothing had happened, was feeling fine. So the patient would say the side effects lasted for about 5 hours. The outcome of the events was recovered on 04Jan2021 17:00.
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| 63 | 2021-01-11 | fever, malaise |
Large Erythematous area at injection site. Tender and bruising noted Low grade fever. General not fe...
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Large Erythematous area at injection site. Tender and bruising noted Low grade fever. General not feeling well
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| 63 | 2021-01-11 | runny nose, headache, fever |
After receiving second covid vaccine, injection site is red with a circle larger than 2 inches (4 by...
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After receiving second covid vaccine, injection site is red with a circle larger than 2 inches (4 by 6 inches). Symptoms include runny nose, headache, fever and are ongoing since vaccine. Have not visited healthcare professional yet.
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| 63 | 2021-01-12 | body temperature increased, headache, fatigue |
temp of 101.8 at 11:00pm on 1/11/2021. Woke up at 4:00am on 1/12/2021 with muscle cramps in both leg...
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temp of 101.8 at 11:00pm on 1/11/2021. Woke up at 4:00am on 1/12/2021 with muscle cramps in both legs; aching all over and headache and body aches ; fatigue and extreme muscle tenderness in left arm (site of injection) Temp remained at above 100.0 even with Tylenol and headache and body aches until 9:00pm. Woke up on 1/13/2021 with only symptoms being sore arm; slight headache and muscle tightness in neck.
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| 63 | 2021-01-12 | body temperature increased |
up a lot during the night after vaccination, lots of body ache, temp 100.2 dizziness during the d...
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up a lot during the night after vaccination, lots of body ache, temp 100.2 dizziness during the day on 1/12
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| 63 | 2021-01-12 | chills, body temperature increased | Temp 101.4 body aches chills |
| 63 | 2021-01-12 | chills, headache, fever |
Muscle soreness, injection site pain/swelling, tongue numbness, fever, headache and violent tremors ...
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Muscle soreness, injection site pain/swelling, tongue numbness, fever, headache and violent tremors to all extremities (for about 10 mins) and chills the night after getting the vaccine. tongue numbness happens to her at baseline at times, this has subsided The tremors started after stretching her arms, they stopped shaking after about 10 mins after she laid in bed. Temp was about 100-101.2 through the night Has not taken any medications for this.
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| 63 | 2021-01-12 | headache |
Starting on 1/8 she began having headaches and weakness in her legs. On 1/9 the headache got worse, ...
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Starting on 1/8 she began having headaches and weakness in her legs. On 1/9 the headache got worse, she had a COVID test which was negative. On 1/11 she had vomiting for hours after taking Tylenol. On 1/13 she still has a headache, but also SOB and body aches
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| 63 | 2021-01-12 | malaise, chills | Chills, malaise, dizziness, diarrhea, nausea |
| 63 | 2021-01-12 | throat pain, headache | Baseline tinnitus got much louder, headaches, intermittent nausea, sore throat |
| 63 | 2021-01-12 | sleepiness, fatigue |
Extreme fatigue. Had to sleep. Slept 2 hour nap, 9 hour night, then two more two hour naps. (6-7 ...
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Extreme fatigue. Had to sleep. Slept 2 hour nap, 9 hour night, then two more two hour naps. (6-7 hours is normal sleep time for me) Groggy and dizzy during that same time when awake. Resolved within 32 hours.
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| 63 | 2021-01-13 | chills, headache |
Chills; headache; nausea; diarrhea; muscle and joint pain; muscle and joint pain; strange coffee tas...
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Chills; headache; nausea; diarrhea; muscle and joint pain; muscle and joint pain; strange coffee taste; This is a spontaneous report from a contactable Nurse (patient). A 63-year old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 05Jan2021 14:30 on right arm at a single dose for COVID-19 immunization. The patient known allergy included Penicillin allergy and other medical history included Diabetes 2, Hypertension, Reynauds and obesity. There is no other vaccine in the four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications in two weeks included losaeten, metformin, hydrochlorthiazide, duloxetine hydrochloride (CYMBALTA). The patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Dec2020 14:30 on left arm at a single dose for COVID-19 immunization. The patient experienced chills, headache, nausea, diarrhea, muscle and joint pain, strange coffee taste on 06Jan2021 02:00 and result in doctor or other healthcare professional office/clinic visit. No treatment received for these adverse events. The patient did covid test post vaccination via Nasal Swab on 07Jan2021 and result negative. The outcome of the events was not recovered. Information on lot/batch number has been requested.
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| 63 | 2021-01-13 | chills, fever |
chills; fever up to 102; diarrhea; This is a spontaneous report from a contactable other healthcare ...
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chills; fever up to 102; diarrhea; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: ek5730, expiration date: unknown), intramuscularly on the right arm on 18Dec2020 at 16:15 at a single dose for COVID-19 immunization administered at the hospital. The patient's medical history and concomitant medications were not reported. The patient previously took codeine, for which she had known allergies. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Dec2020 at 19:00, the patient experienced chills, fever up to 102, and diarrhea. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of chills, fever up to 102, and diarrhea as she talked to her family physician. The patient recovered from all the events on an unspecified date.
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| 63 | 2021-01-13 | fatigue, chills, fever, headache |
Fever of 100.1, chills, body aches (Lower half of body only), headache, extreme fatigue. Missed work...
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Fever of 100.1, chills, body aches (Lower half of body only), headache, extreme fatigue. Missed work. Started at 4 am, about 18 hrs after vaccine given. Lasted 24 hrs.
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| 63 | 2021-01-13 | headache, fever |
Developed fever and headache then later developed hives, itching, and bruising. Already taking Zyrte...
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Developed fever and headache then later developed hives, itching, and bruising. Already taking Zyrtec daily. Began taking famotidine daily. Required Benadryl on 1/11/21 but still has hives as of 1/11/21.
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| 63 | 2021-01-13 | headache |
Initially muscle soreness at injection site. At 12 hours headache began. During the night body aches...
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Initially muscle soreness at injection site. At 12 hours headache began. During the night body aches and restless sleep, bad dreams. Next day headache, significant fatigue and body aches. Emotional feelings like I wanted to fry ( I am not a crier). 2 Nd night restless sleep, bad dreams, headache. Next day brain fog and significant dizziness and vertigo.
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| 63 | 2021-01-14 | chills, fever |
mid-grade fever with a temperature of 100.4 degrees F. The temperature peaked 101.4 degrees F last n...
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mid-grade fever with a temperature of 100.4 degrees F. The temperature peaked 101.4 degrees F last night.; Chills; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), via an unspecified route of administration in the left arm on 28Dec2020 11:45 at a single dose for COVID-19 immunization. The patient's medical history included asthma, sulfur/sulfameds allergies, and iodine dye allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included estradiol (ESTROGEN), progesterone, colecalciferol (VITAMIN D), allergy shots, and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jan2021 18:00, the patient experienced chills and were continuing today. She was experiencing a mid-grade fever with a temperature of 100.4 degrees Fahrenheit on 04Jan2021. The temperature peaked 101.4 degrees Fahrenheit last night (07Jan2021). The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included rapid nasal pharyngeal COVID test which showed unknown results on 07Jan2021. Outcome of the events was not recovered. The events were considered non-serious by the reporter.
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| 63 | 2021-01-14 | chills, fever |
within 24 hours vaccination shots, I had intermittent low grade fever, constant chills, and mild VER...
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within 24 hours vaccination shots, I had intermittent low grade fever, constant chills, and mild VERTIGO (that was the worst). Re the Vertigo, I didn't fall but experienced it whenever moving. I was bumping into walls and was dizzy whenever I moved position (e.g. sitting to standing & vice versus). These symptoms lasted 5-7 days after they began (both shots).
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| 63 | 2021-01-14 | headache, fever, chills | Fever, chills, headache, body aches, nausea, generalized weakness |
| 63 | 2021-01-14 | fever, headache, malaise |
malaise; headache; low grade fever; dizziness; overall body aches; This is a spontaneous report from...
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malaise; headache; low grade fever; dizziness; overall body aches; This is a spontaneous report from a contactable other healthcare professional (patient). A 63-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided as unable to locate or read the details), intramuscularly on 08Jan2021 at 10:30 AM on Left arm at single dose for COVID-19 immunization in hospital. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided) intramuscularly on 18Dec2020 at 10:15 AM on Left arm at single dose for COVID-19 immunization at age of 63-year-old. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced malaise, headache, low grade fever, dizziness, overall body aches on 08Jan2021 at 19:00. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No. Information on the Lot/batch number has been requested.
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| 63 | 2021-01-15 | headache |
Pounding headache, heart racing to over 145 bps, chest burning and tightness and hard to breath. I w...
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Pounding headache, heart racing to over 145 bps, chest burning and tightness and hard to breath. I was taken to the Emergency Room at Hospital immediately. Reaction occurred within 30 minutes of the injection. An EKG was administered. I was prescribed prednisone and Benadryl. I was diagnosed with Anaphylaxis.
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| 63 | 2021-01-16 | malaise |
2.5 hours after receiving vaccine, I started getting dizzy and vomiting. I vomited 6 or 7 times. I w...
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2.5 hours after receiving vaccine, I started getting dizzy and vomiting. I vomited 6 or 7 times. I was so dizzy I couldn't open my eyes without getting sick. We called ER and explained that we thought I was having a reaction to the vaccine, and their response was they had never heard of that type of reaction. I was sick all night, called my primary Dr in the am and they told me to go to ER. We had to call ambulance to take me there because I was so sick and couldn't open my eyes without having to vomit. Room spun in circles. My arrival at ER, they did MRI, EKG, blood work. My blood pressure was very high, so they connected me to a heart monitor. I had low Magnesium due to vomiting so much. I was treated with Valium and anti-vert medication and fluids. I stayed overnight in hospital- had PT Jan 13th for DX of Vertigo. Then referred to Outpatient PT for Vertigo. Dr's felt it was a "coincident" that I got Vertigo shortly after vaccine, and strongly felt it was not related. . Today is Jan 17th, and I am still dizzy, but feeling better. I have an appointment with my primary Jan 18th and not sure if I should take the 2nd dose. That is the question.
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| 63 | 2021-01-16 | fever, chills, headache | Low grade fever, chills, body aches, headache, nausea |
| 63 | 2021-01-17 | cough |
12/22 Vaccine 12/23 ER. Admitted to hospital for 7 days. Dr stated was due to fluid. Radiology state...
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12/22 Vaccine 12/23 ER. Admitted to hospital for 7 days. Dr stated was due to fluid. Radiology stated no fluid present. Couldn't breath. Pulmonologist put on 2nd inhaler. Coughing a lot. Not able to walk more then 6 steps without stopping to catch breath. *Has had 2nd vaccination on 1/13/2020
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| 63 | 2021-01-17 | fatigue, fever |
Fatigue; low grade fever; reddening on her face on the nasal labial area or smile line area; a very ...
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Fatigue; low grade fever; reddening on her face on the nasal labial area or smile line area; a very sore left arm for a day; a very sore left arm for a day and swelled up a little; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on the left arm on 19Dec2020 16:15 at SINGLE DOSE for COVID-19 immunization at the hospital. It was reported that the patient was menopausal. Ongoing medical histories included gastrooesophageal reflux disease (GERD), iron deficiency (reported as iron supplementation), sinus disorder, hypersensitivity; and hair disorder, nail disorder and immune system disorder (reported as help with hair and nail and immune system). Ongoing concomitant medications included fexofenadine hydrochloride (ALLEGRA) since unknown date (reported as taking for a year) for sinus and allergies, calcium (CALCIUM) since unknown date (reported as taking for a year) for menopause, famotidine (FAMOTIDINE) since unknown date (reported as taking for a year) for GERD, cyanocobalamin (VITAMIN B12) since unknown date (reported as taking for a year) to help with hair and nail and immune system, colecalciferol (VITAMIN D 3) since unknown date (reported as taking for a year or two) for menopause and multivitamin since unknown date (taking for 5 years at least). The patient received the first dose of the Pfizer COVID 19 vaccine on 19Dec2020 at 1615PM in the left arm. She then reported of a very sore left arm for a day and it swelled up a little on that same day. She then felt some fatigue a little the next day (20Dec2020) on Sunday but it didn't prevent her from going to work. On 20Dec2020 to 21Dec2020 (Sunday to Monday), she noticed a low-grade fever for a maybe 12 hours but she couldn't find a thermometer and doesn't know her temperature. She also developed a reddening on her face on the nasal labial area or smile line area but not very pronounced on 20Dec2020 (noticed it for about 8 to 12 hours). All of her symptoms resolved by the 21Dec2020. The events does require a visit to physician office or emergency room (ER).
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| 63 | 2021-01-17 | fever, headache, chills |
1/6 THROUGH 1/10: SEVERE HEADACHE, NAUSEA, CHILLS (OVERWHELMING), JOINT PAIN, FEVER (100), MUSCLE AC...
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1/6 THROUGH 1/10: SEVERE HEADACHE, NAUSEA, CHILLS (OVERWHELMING), JOINT PAIN, FEVER (100), MUSCLE ACHES. TOOK TYLENOL.
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| 63 | 2021-01-17 | fever, malaise |
fever 99.4; muscle and bone aches; muscle and bone aches; wasn't feeling good; This is a spontaneous...
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fever 99.4; muscle and bone aches; muscle and bone aches; wasn't feeling good; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248 and expiry date: unknown), via an unspecified route of administration on 09Jan2021 15:50 at a single dose for COVID-19 immunization. Medical history included menopausal, GERD, sinus disorder, and allergies. Concomitant medications included colecalciferol (VITAMIN D 3) taking for a year or two for menopausal, cyanocobalamin (VITAMIN B12) taking for a year to help with hair, nail, and immune system, calcium taking for a year for supplementation and menopausal, famotidine taking for a year for GERD, fexofenadine hydrochloride (ALLEGRA) taking for a year for sinus and alllergies, and unspecified multivitamin taking for 5 years at least for iron supplementation. The patient received the first dose of bnt162b2 (lot number: EJ1685) on 19Dec2020 at 16:15PM in the left arm. She had a very sore left arm for a day and it swelled up a little. She felt some fatigue a little the next day on 20Dec2020 Sunday but it didn't prevent her from going to work. 20Dec2020 to 21Dec2020 (Sunday to Monday), she noticed a low grade fever for maybe 12 hours but she couldn't find a thermometer and did not know her temperature. She developed a reddening on her face, but it was not very pronounced, on the nasal labial area or smile line area. It was more pronounced on the first dose, she noticed it for about 8 to 12 hours Sunday 20Dec2020. All of her symptoms resolved by 21Dec2020. She received the second dose 9Jan2021 at 15:50PM in the left arm. She noticed nothing right away but maybe 6 hours later, her left arm was very sore. She had more of a fever which she measured at 99.4 Fahrenheit on 10Jan2021. Her normal is 97.1 to 97.5 Fahrenheit which she knew because she had to get screened at work. This time, after the second dose, she also noticed she had bone and muscle aches but was all short lived on 10Jan2021. She went to church and wasn't feeling good from about 10:00AM to about 19:00PM. She did treat the fever and muscle/bone aches with Tylenol extra strength rapid relief 500mg each. She took two by mouth once 3 hours before the vaccine and again once during the night and once yesterday 10Jan2021 afternoon for a total of three times and it did help. She also rested on Sunday 10Jan2021 afternoon, took extra fluids so by the time she had to go to work she felt normal. The vaccine was not administered at military facility. No additional vaccines were administered on same date of bnt162b2. The adverse events did not require a visit to the physician's office or ER. There were no prior vaccinations (within 4 weeks). The patient had no family medical history relevant to the adverse events. Outcome of the event wasn't feeling good was unknown and of the other events was recovered on 10Jan2021.
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| 63 | 2021-01-18 | chills, headache, fever |
fever 102 F; headache; chills; body aches; This is a spontaneous report from a contactable Nurse rep...
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fever 102 F; headache; chills; body aches; This is a spontaneous report from a contactable Nurse reported for herself. A 63-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 22Dec2020 14:30 and the second dose single dose (lot number=EK9231) on 09Jan2021 19:15 for COVID-19 immunization. Vaccine location=Left arm, dose number 1 and dose number 2. Facility-type-vaccine: Hospital. Medical history included asthma. The patient's concomitant medications were not reported. On 10Jan2021 at 14:00 the patient experienced headache with outcome of not recovered, fever 102 °F with outcome of not recovered, chills with outcome of not recovered and body aches with outcome of not recovered. The action taken was not applicable. Tylenol was received as therapeutic measures for fever.; Sender's Comments: Based on a compatible temporal association and known product safety profile, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-01-18 | fatigue, fever, headache | Fever, fatigue, joint pain, dizziness, headache |
| 63 | 2021-01-18 | fatigue |
fatigue; This is a spontaneous report from a contactable consumer reported a 63-years-old female pa...
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fatigue; This is a spontaneous report from a contactable consumer reported a 63-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 29Dec2020 at a single dose for Covid-19 immunization. Medical history included ongoing chronic fatigue and Epstein Barr. The patient's concomitant medications were not reported. The patient works in a nursing home, she received her first vaccine on 29Dec2020, she said since then has had fatigue. Inquiring if this is normal and if anyone else has reported this and asking if others have reported. She is due for second dose 19Jan2021. Outcome of the event was unknown. Information on the Lot/Batch number has been requested.
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| 63 | 2021-01-18 | headache, fatigue, body temperature increased |
Aching, HA and temp of 101.8, fatigue beginning night of 1/15. On 1/16, was fatigued, had swelling ...
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Aching, HA and temp of 101.8, fatigue beginning night of 1/15. On 1/16, was fatigued, had swelling of hands and face. Now resolved.
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| 63 | 2021-01-18 | headache, fever, chills |
from 1201 am to 0515 am on 1/7/21--headache, neck pain, cold hands/feet, chills, nausea, low grade f...
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from 1201 am to 0515 am on 1/7/21--headache, neck pain, cold hands/feet, chills, nausea, low grade fever (99 degrees) treatment taken at 0515 am --1 dramamine, 2 tylenol 0800 am- headache, temp 98.3 0915 am- headache treatment- 1 advil pm 0815 pm- temp 99, chills treatment- tylenol 3 days post vaccine- headache, nausea (treatment advil pm, dramamine) 6 days post vaccine- headache, nausea (treatment advil pm, dramamine) 9 days post vaccine--headache, nausea (treatment advil pm, dramamine)
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| 63 | 2021-01-18 | headache |
10:00am - Vaccine given. 10:15am - client reported experiencing nausea & headache (pain scale: 8/10)...
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10:00am - Vaccine given. 10:15am - client reported experiencing nausea & headache (pain scale: 8/10). BP - 172/85mmHg; Pulse - 94). 10:18am - BP - 176/93mmHg; Pulse - 104 10:20am - BP - 186/93mmHg; Pulse - 105, client reports the pain and nausea symptoms are the same. Client taken to an exam room and placed lying down on her left side, head slightly elevated. Client reported feeling a bit cold, covered with disposable gowns for warmth. Temperature taken at 10:34am - Temperature: 37 degrees Celsius. 10:43am - BP 130/60mmHg, Pulse - 92. Client reported that feelings of nausea is gone, however is still experiencing slight headache 4/10 pain scale. 10:57am - BP 124/64mmHg; Pulse - 88 10:59am - BP 174/89mmHg; Pulse - 99. Client reports that she feels a sharp pain on her abdominal area by the belly button (6/10). Also reports a mid-back pain (9/10 pain scale). 11:10am - BP 162/86mmHg; Pulse - 101 11:15am - BP 147/78mmHg; Pulse - 89. Client reports abdominal pain at 5/10, mid-back pain 8/10. 11:25am - BP 155/82mmHg; Pulse - 90. Client reports abdominal pain is aching at 5/10 pain scale, mid-back pain 7/10 pain scale.
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| 63 | 2021-01-18 | malaise |
Injection was administered very high on left arm(at joint level). It felt like a nail went in, and t...
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Injection was administered very high on left arm(at joint level). It felt like a nail went in, and then she pushed in the medicine. Just the injection process alone made me feel ill. So I waited the 15 minutes before I left, until I felt safe to drive. At noon the meds started affecting me, which is what I expected. I've continued to experience arm pain, weakness, armpit swelling and tenderness, arm not wanting to work and posturing. This is day four and its just starting to feel like its coming back "online." Monday I reported to Colleague Health, who advised me to contact my physician, who I consulted via phone this morning. Physician requested I fill out Adverse Event form.
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| 63 | 2021-01-18 | fever, headache, fatigue, chills | Fever (100.2 degrees), fatigue, headache, joint pain, chills |
| 63 | 2021-01-19 | chills, fever, headache |
12 hrs after vaccine headache,nausea,achy,sore arm 24 hrs after vaccine fever 100.2, bad chills,hea...
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12 hrs after vaccine headache,nausea,achy,sore arm 24 hrs after vaccine fever 100.2, bad chills,headache,body aches,very sore arm 36 hrs after vaccine swollen lymph nodes under rt arm, temp 99.8
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| 63 | 2021-01-19 | fatigue, chills, fever |
Chills and fever (38.8 centigrade) starting 10 hours after injection. Also body aches, joint pain, f...
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Chills and fever (38.8 centigrade) starting 10 hours after injection. Also body aches, joint pain, fatigue. Lasted 36 hours
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| 63 | 2021-01-19 | fatigue, headache | dizziness, faitgue, headache, feeling tightness in throat |
| 63 | 2021-01-19 | fatigue |
redness, itching swelling, warmth at site, muscle aches, fatigue evaluated by MD, tx with pepcid, Ty...
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redness, itching swelling, warmth at site, muscle aches, fatigue evaluated by MD, tx with pepcid, Tylenol, Claritin,Zyrtec began 01/19/2021 with mild relief
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| 63 | 2021-01-19 | malaise, fever, chills |
first night had chills, and didn't feel well, got off sofa and crawled into bed. had chills. around ...
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first night had chills, and didn't feel well, got off sofa and crawled into bed. had chills. around 9:00 pm. took Tylenol and around 4:30Am still has chills and ran fever of 103.1 and took more Tylenol. woke up about 6:30Am and felt better. chills were gone but still didn't feel well. Called Dr. but have not heard back. currently 3:00 pm starting to feel chilled again.
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| 63 | 2021-01-19 | throat pain, headache |
Muscle pain throughout torso; Sore throat; Head ache that comes and goes; This is a spontaneous repo...
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Muscle pain throughout torso; Sore throat; Head ache that comes and goes; This is a spontaneous report from a contactable consumer reporting for herself. A 63-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL3246), via an unspecified route of administration, on 06Jan2021 at 12:00 AM, at single dose, for COVID-19 immunisation. Medical history included allergy to some antibiotics. Concomitant medications were not reported. Patient did not have COVID-19 prior to vaccination. The patient experienced muscle pain throughout torso, sore throat and head ache that comes and goes all on 09Jan2021 at 07:00 PM with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab): negative on 07Jan2021.
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| 63 | 2021-01-19 | fever, chills, fatigue, malaise |
1/15 FELT TIRED DURING THE DAY, CHILLS AND NOT FEELING WELL. STARTED APPRX 6PM. CHILLS, FATIGUE AND ...
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1/15 FELT TIRED DURING THE DAY, CHILLS AND NOT FEELING WELL. STARTED APPRX 6PM. CHILLS, FATIGUE AND LOW GRADE FEVER (100.1) STARTED IN THE EVENING OF TH 15TH, CHILLS AND FEVER WERE GONE IN THE MORNING, FATIGUE AND NOT FEELING WELL LAST ALL DAY SATURDAY. WOKE UP FEELING FINE ON SUNDAY THE 17TH. TOOK A TYLENOL ON SATURDAY.
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| 63 | 2021-01-19 | fever, headache | felt warm, slight fever, headache, very sore arm. Dizzy. |
| 63 | 2021-01-20 | chills |
itching across shoulders /back of neck; nausea; body aches; chills; She felt like there was a tight ...
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itching across shoulders /back of neck; nausea; body aches; chills; She felt like there was a tight band around chest.; sense the she couldn't get a good breath; pulse of 101-129; she had tinnitus, and she noticed that both injections made that worse; This is a spontaneous report from a contactable nurse. A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK4176/expiration date) dose number 2 intramuscularly on 08Jan2021 11:45 at a single dose on the left arm for COVID-19 immunization. The patient received the vaccine in a hospital. Medical history included severe allergic reaction to pecans and tinnitus. Historical vaccine included BNT162B2 on 18Dec2020 (dose number 1, intramuscularly on the left arm) for COVID-19 immunization. The patient experienced tinnitus, sinus infection, and stuffy head after the first dose. No other vaccines were administered within 4 weeks and no other medications were taken within 2 weeks. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post-vaccination. On 08Jan2021, after the 2nd dose, the patient experienced itching across shoulders/back of neck and sl nausea. She took Benadryl which relieved the itching. She went to bed and had onset of body aches, chills, and sense the she couldn't get a good breath. She felt like there was a tight band around chest. Her O2 Sat was 95% - 98%, with pulse of 101-129, T max was 101.8. The symptoms were lasting about 6 hours. In the morning, the patient took Aleve and Benadryl. Most symptoms were alleviated. She took those meds scheduled for 48 hrs. She noticed that if she tried to push past scheduled time, the itching started to return, so she just kept the meds scheduled for 48 hours. No other symptoms after that. She added that she had tinnitus, and she noticed that both injections made that worse. It was not yet subsiding since last injection. The patient also received Tylenol for the events. The outcome of the events was recovered in Jan2021.
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| 63 | 2021-01-20 | fatigue, sinus congestion, runny nose, malaise, cough, sneezing |
Coughing/cough has worsened; Tiredness; Sinus congestion; Runny nose; Dizzy; Didn't feel well; Sneez...
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Coughing/cough has worsened; Tiredness; Sinus congestion; Runny nose; Dizzy; Didn't feel well; Sneezing; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246; Expiration date was not reported) on 09Jan2021 (11:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at a clinic (not a military facility). Medical history included ongoing rhinosinusitis from 2019; ongoing allergy multiple; bronchitis from Mar2020; upper respiratory tract infection from Mar2020; sleep apnea; bipolar depression; and post-traumatic stress disorder (PTSD). There were no concomitant medications. On 09Jan2021 (06:00), the patient had sinus congestion and runny nose. On 09Jan2021, the patient was dizzy. On 10Jan2021, the patient was coughing, and then cough was reported to have worsened; and had tiredness. In Jan2021, the patient did not feel well; and was sneezing. The patient had used a nose rinse with an alcohol rub, and took and Epsom salt bath, and had some soup as treatment for the sinus congestion and runny nose. The patient had two COVID-19 virus tests on unspecified dates, and both were labeled as inconclusive. The outcome of the events was not recovered for 'sinus congestion', 'runny nose' and 'cough/cough has worsened'; and was unknown for 'dizzy', 'tiredness', 'did not feel well' and 'sneezing'.
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| 63 | 2021-01-20 | fatigue |
severe cramps/bunch of spasms with legs and arms; quick stools; Wake up probably about an hour, hour...
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severe cramps/bunch of spasms with legs and arms; quick stools; Wake up probably about an hour, hour and a half then I still feel tired I ended up going back to sleep for another 4 hours; almost like pin pricking; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included blood pressure, thyroid disorder and hormone level abnormal. Previous vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685) via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation, with no side effects. The concomitant medications was reported Levothyroxine at 5 ug 1x/day for thyroid; atenolol, chlorthalidone (ATENOLOL AND CHLORTHALIDONE) 50/ 25 for Blood pressure; estradiol (ESTRACE) at once a day For hormones. blood pressure management. Patient had second shot on Friday (08Jan2021), she was fine until about 09Jan2021 2:30 in the morning then patient woke up with severe cramps and quick stools, she had about 4 dumps throughout the day she was trying to work and then by 4:30, 5 O'clock patient was having enough drinking water and a whole lot of fluids, stools along with a lot of severe cramping, so she ended up calling in today for work which was definitely not her. Then patient went ahead and she have slept 'many parts of today' (not clarified), she slept like, wake up probably about an hour, hour and a half then she still feel tired ended up going back to sleep for another 4 hours. Patient worked only 3, 3 and a half hours a day because of her health, she had 7 or 8 round so don't normally sleep long but she was healthy. 'Problem is' (voice feeble), now that patient had gotten herself a little more relaxed patient was having a bunch of spasms with legs and arms and almost like pin pricking, so said just to call and let you know she tried but couldn't do it online." Treatment was received for events, took the Tylenol 500 (unit not probed) 1 tablet, took that at 4 O'clock.. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.
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| 63 | 2021-01-20 | headache, chills, fatigue |
Chills-blankets and heater. 5 hours Headache-slept, 8 + hours fatigue-slept and felt run down 2 da...
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Chills-blankets and heater. 5 hours Headache-slept, 8 + hours fatigue-slept and felt run down 2 days
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| 63 | 2021-01-20 | headache | Pain at injection site, headache, chills muscle aches, joint pain, restless |
| 63 | 2021-01-20 | fever, chills | Fever, chills, body aches, nausea/vomiting |
| 63 | 2021-01-21 | chills, fever | Fever, body aches, chills, nausea |
| 63 | 2021-01-21 | cough, runny nose |
I was okay during the 30 minute observation period, and was discharged. Between 1 and 1:30 am, abou...
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I was okay during the 30 minute observation period, and was discharged. Between 1 and 1:30 am, about 15 hours after receiving the vaccine, I woke up from my sleep suddenly, with an acute episode of chest tightness, cough, severe running nose and lacrimation. I did not have hives or lip/throat itching or swelling. I felt a little warm in the face. I took Ventolin inhaler two puffs twice 30 minutes apart + Aller-flo nasal sprays. I began to feel a bit better and then took Benadryl 25 mgms (because of my history of Angioedema) around 2:30 am. I feel better now, which is 12 hours after onset of episode, but had to take Ventolin inhaler this morning for a bit of chest tightness. I do not have a history of asthma, but have had seasonal allergies in past years. But if this is seasonal allergy, it is very unusual, since I have never had an acute episode like this without any early milder symptoms. And I haven't needed Ventolin in a couple of years. I am now concerned about taking the second dose.
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| 63 | 2021-01-21 | fatigue, chills, headache |
As I was sitting at my computer and suddenly I could barely keep my eyes open, I was so tired I coul...
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As I was sitting at my computer and suddenly I could barely keep my eyes open, I was so tired I couldn't lift my arms and once I closed my eyes, I could not muster the strength to open them. I felt like I was going to faint and then I got nauseated and I knew I was going to throw up. With my husband's help, I did manage to get to the bathroom (about 6 steps away). I threw up and immediately sat down in the nearest chair. I threw up a second time into a vessel after that. I then got a massive headache and chills. I could barely walk with assistance up the stairs to go to bed. I have never been more fatigued. After going to bed, I slept all night and woke the next day still fatigued, but nothing like the night before. I was able to work, even though I felt really tired. I did not have much of an appetite all day and two days later, I still feel fatigued.
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| 63 | 2021-01-21 | fatigue, headache |
hives covering entire body including soft palate, headache, body aches, stiff joints, fatigue Depo ...
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hives covering entire body including soft palate, headache, body aches, stiff joints, fatigue Depo medrol injection, Prednisone 20 mg/day X 4 days; Zyrtec X 12 days, Benadryl X 12 days
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| 63 | 2021-01-21 | headache | Nausea, headache, body aches |
| 63 | 2021-01-21 | fever, headache, fatigue, sleepiness, chills |
Body aches, very sore injection site, tired feeling, nausea, slight headache. I had the chills, cou...
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Body aches, very sore injection site, tired feeling, nausea, slight headache. I had the chills, couldn?t get warm. Got worse during the night. Couldn?t go to work the next day due to body aches, arm soreness, extreme tiredness. Slept almost all day 1-19-21. Spiked low grade fever during the night. Worked 1-20-21, but extremely sleepy. Injection site got hot and red. Slept 12 hours that night. Went to work 1-21-21 feeling good, just still a little arm soreness.
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| 63 | 2021-01-21 | fever |
respiratory distress; fever; anxiety developed requiring oxygen; Passed away; This is a spontaneous ...
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respiratory distress; fever; anxiety developed requiring oxygen; Passed away; This is a spontaneous report via a Pfizer-sponsored program from a non-contactable consumer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. Medical history included anaphylactic reaction (broad), neuroleptic malignant syndrome (broad), anticholinergic syndrome (broad), acute central respiratory depression (broad), hypersensitivity (broad), respiratory failure (narrow), drug reaction with eosinophilia and systemic symptoms (broad), hypoglycaemia (broad), COVID-19 (broad) and chronic obstructive pulmonary disease (COPD); all from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium and lorazepam (ATIVAN). Within 24 hours of receiving the vaccine, the patient experienced fever, respiratory distress, and anxiety developed requiring oxygen, morphine and lorazepam (ATIVAN). The patient passed away on the evening of 26Dec2020. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: negative on an unspecified date. The outcome of the event death was fatal, while of the other events was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Passed a
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| 63 | 2021-01-22 | chills |
Chills for 3 hours and than abnormal gait which got so bad that became unable to walk for 10 hours w...
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Chills for 3 hours and than abnormal gait which got so bad that became unable to walk for 10 hours without falling down. At first had to hang on to things to walk and than unable to stand or sit up- felt like I was being pushed backwards. Emesis all day
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| 63 | 2021-01-22 | headache, fatigue |
Evening of both doses I had nausea which went away overnight, (also had very strange dreams with fre...
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Evening of both doses I had nausea which went away overnight, (also had very strange dreams with frequent waking up which might have had nothing to do with the vaccine). Second dose nausea the first night, extreme fatigue the second day which was gone by day 3. Headache from day after vaccine until today (5 days later) with more severe headache and dizziness today, but not bad enough to make me not be able to function.
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| 63 | 2021-01-23 | chills, headache, fever |
Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taki...
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Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taking about 15 seconds to complete injection. Injection was painful. Within 1 hour I could not raise my arm more than 30 degrees without severe pain. Diminished ROM and pain at night is ongoing. Within 4 hours, I had a low grade fever with chills, headache and myalgia that persisted for 12 hours then respoved. Incident Report filed at the hospital. MRI done on 1/20/2021-saw Doctor on 1/22/2021 who diagnosed adhesive capsulitis.
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| 63 | 2021-01-23 | chills, fever |
Pfizer-BioNTech Covid-19 Vaccine EUA First developed body aches, chills around 6 pm, 1/18/21. C...
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Pfizer-BioNTech Covid-19 Vaccine EUA First developed body aches, chills around 6 pm, 1/18/21. Chills continued overnight and when I took my temp in the morning, it was significant at 101.1. Fever finally broke around 7pm, 1/19/21. Felt completely normal the following morning
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| 63 | 2021-01-23 | headache, fever, chills, fatigue |
I am submitting this report because I did not download the app until day three post vaccination. The...
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I am submitting this report because I did not download the app until day three post vaccination. The app would not allow me to report my vaccine reaction retroactively to include the previous days. Twelve hours post vaccination: slight chills without fever, severe headache, nausea and fatigue Twenty four hours post vaccination: severe headache, moderate nausea and fatigue Forty eight hours post vaccination: moderate headache, mild nausea and fatigue Seventy two hours post vaccination: symptoms resolved (*Correction: I believe I may have recorded the date for vaccine #1 incorrectly on the form I previously submitted regarding a reaction to my second vaccination. When asked if I had received any previous vaccinations within the past 4 weeks, the correct date for my first Covid-19 vaccination should read 12/28/2020, 10:00 am)
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| 63 | 2021-01-24 | chills, fatigue, headache, malaise |
Injection site pain, tiredness, headache , muscle pain, chill, joint pain, nausea, feeling unwell, s...
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Injection site pain, tiredness, headache , muscle pain, chill, joint pain, nausea, feeling unwell, swollen lymph nodes, difficulty breathing, swelling of face, fast hearbeat, bad rash , dizziness and weakness, intestinal pain. All symptoms lasted 18 days. Was given prescription medication for symptoms by primary care doctor.
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| 63 | 2021-01-24 | fatigue | Achy all over and fatigue. Better every day. |
| 63 | 2021-01-24 | fatigue | body aches and fatigue. better every day |
| 63 | 2021-01-24 | headache, fatigue, throat pain |
right arm sore, 3 days later right arm and hand starting swelling and developed rash with itching, ...
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right arm sore, 3 days later right arm and hand starting swelling and developed rash with itching, also left hand swelled, with rash and itching. Next day woke up with sore throat and headache, and fatigue. went to primary care doctor was put on prednisone, symptoms lasted for 10 days.
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| 63 | 2021-01-24 | headache, lethargy, nasal congestion, chills |
Extreme bone pain, joint pain, hand pain, skin tenderness, headache, nasal stuffiness, chills. Extr...
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Extreme bone pain, joint pain, hand pain, skin tenderness, headache, nasal stuffiness, chills. Extreme pain lasted from 0140- 0500, but continued with the skin tenderness, chills, headache and joint pain. Took Tylenol. Got up once and thought I would pass out. Started resting some around 7am. Drank plenty of fluids. Drained all day. Saturday morning headache, nasal congestion, joint pain, hard to get out of bed. Drained all day. Sunday feeling better, but lethargic. Monday back to work.
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| 63 | 2021-01-24 | headache |
lost muscle capacity of her arm/cannot lift a gallon of milk in the fridge/Right arm lost muscle cap...
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lost muscle capacity of her arm/cannot lift a gallon of milk in the fridge/Right arm lost muscle capacity; headache; terrible pain in her right elbow; joint discomfort; feeling achy in her right arm and all over; feeling achy in her right arm and all over; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL1284), via an unspecified route of administration on 06Jan2021 14:30 at single dose for covid-19 immunisation. Medical history included hypothyroidism, cholesterol. Concomitant medication included levothyroxine, atorvastatin. Patient on the line calling about the COVID 19 Vaccine on Wednesday in her right arm. Her right arm lost muscle capacity, she cannot lift, she cannot even lift a gallon of milk in the fridge. This has improved, but she still cannot use it normally. Thursday she was feeling achy; Friday she had a headache. Later that day she had the most terrible pain in her right elbow. It was excruciating pain. The next morning pain subsided. However, she does not have her full arm strength back yet. She confirmed she is a HCP. She also added, she works at the hospital. It is like a centralized monitoring system where she watches monitors connected to the care unit and since she has background as a HCP she alerts the nurses when there is an issue. She clarified her right arm lost muscle capacity was noticed on Friday 08Jan2021. She got the vaccine on 06Jan2021 and was able to drive home and it was fine. The next day, 07Jan2021 she was achy, like flu like, with joint discomfort that she normally does not have even though she is getting older. She was feeling achy in her right arm and all over. The achiness all over resolved Thursday or Friday. She confirmed she has recovered completely. On Friday 08Jan2021 she had a headache that would just not go away. The headache was not in the front, back, or above eyes so she knows it was not sinuses. The headache lasted all day. Stated by the next morning the headache was gone. Her head is fine. She confirmed she has recovered completely. She later added, even though she is getting older and forgets things. No additional details provided. She was supposed to go to work on Friday, but she was not quite miserable, but she just could not bring herself to go into work. She called out because of the headache and the arm pain had started to kick in. The outcome of the event Muscle weakness upper limb was resolving, joint discomfort was unknown, while the outcome of the other events was resolved in Jan2021.
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| 63 | 2021-01-24 | fever, runny nose, headache |
Nausea 2 days, headache 3 days, aches 5 days, fever one day (100.2), sniffles with clear drainage, r...
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Nausea 2 days, headache 3 days, aches 5 days, fever one day (100.2), sniffles with clear drainage, rash over right eye across inter canthus to lower lid, redness inner right eye, and slight rash right nose.
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| 63 | 2021-01-24 | upper-airway cough syndrome, fever, malaise, cough, headache, respiratory tract congestion |
Had received my first dose of vaccine on 12/18 with some adverse reactions that had gotten better. O...
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Had received my first dose of vaccine on 12/18 with some adverse reactions that had gotten better. On 12/31/20 begin to develop drainage, light cough, not feeling all that good. Got up next morning with deeper cough, congestion and slight headache. Went to urgent care clinic as have problem in winter with chronic cough and bronchitis so thought this was the problem. I was tested for COVID and strep of which I was positive for both. As am a healthcare worker was placed in quarantine .and given antibiotic for strep. I did not then or at any time have a sore throat. Ran slight fever a couple of days of 99.8 and was sleeping a lot but never got any worse. Returned to work on 1-11-21. Continue to have a cough at times but this is nothing I haven't experienced before. I did not receive my second dose of vaccine that was scheduled on 01/08/21 as I was still in quarantine .
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| 63 | 2021-01-25 | fatigue, headache, chills | headache, body ache, chills, fatigue, sore arm, Nausea |
| 63 | 2021-01-25 | fatigue |
Arm pain at site; Fatigue; Nausea; Body aches; This is a spontaneous report from a contactable nurse...
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Arm pain at site; Fatigue; Nausea; Body aches; This is a spontaneous report from a contactable nurse reported for herself. This 63-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Et1685) intramuscular on 11Jan2021 13:15 at single dose for an COVID-19 immunization. Medical history included high blood pressure. Concomitant medication included atenolol Atenolol, Losartan, Calcium, plantago ovata (METAMUCIL), bifidobacterium lactis (PROBIOTIC). Patient received the first dose of BNT162B2 intramuscular in left arm on 21Dec2020 03:30 PM. No other vaccine in four weeks. On 12Jan2021, the patient experienced Arm pain at site, Fatigue, Nausea, Body aches. No treatment received. The outcome of events was not recovered.
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| 63 | 2021-01-25 | influenza like illness, cough, upper-airway cough syndrome, runny nose |
lost a lot of weight, but still plump; tightness in chest; Upper chest tightness with post nasal dri...
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lost a lot of weight, but still plump; tightness in chest; Upper chest tightness with post nasal drip, like the flu; got Covid virus/ Covid PCR testing: positive; got Covid virus/ Covid PCR testing: positive; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EJ1685) via an unspecified route of administration on left arm on 24Dec2020 11:00 at single dose for COVID-19 immunisation. Medical history included ongoing asthma, ongoing allergies. She was asthmatic and believed that the virus would have affected her differently if she didn't get the vaccine. If she was to catch the virus and didn't have the vaccine she may not have come out of it. The patient's concomitant medications were not reported. The patient denied getting any other vaccines that day or 4 weeks prior. No problems with vaccines in past. Received the COVID vaccine at her workplace. The patient got COVID virus on 07Jan2021. It was also reported that the patient lost a lot of weight, but still plump, coughing, tightness in chest, upper chest tightness with post nasal drip, like the flu, body aches, all on an unspecified date. Emergency room visit needed for the events (body aches, runny nose). The patient underwent lab tests and procedures which included Covid PCR testing: negative on 04Jan2021, positive on 07Jan2021, rapid COVID testing: negative on 01Jan2021. The outcome of the event (got COVID virus) was not recovered, of other remain events was unknown. Clinical course: The patient received the first dose of BNT162B2 on 24Dec2020, and a couple weeks later she got the COVID virus (07Jan2021). Mentioned she lost a lot of weight, but still plump. Probably be in the hospital now. Still had some coughing, tightness in chest, but it's not as bad. Upper chest tightness with post nasal drip, like the flu, runny nose in throat that goes down into the lungs and when it goes down she coughs and hacks to get rid of it. Went to the doctor office on the 01Jan2021 and did a rapid test and it was negative. Then on 04Jan2021 she did another PCR Covid test and it was negative. On 07Jan2021 she had symptoms and was insistent on getting another test since having body aches, runny nose. Got the re-test and it came back positive when she went to the emergency room. Got the PCR test. The patient thought that the way they were testing is how it's spreading. Did the testing on the 04Jan2021 and they used a swab bigger than a cue tip, it was huge and couldn't get far up enough instead of the tiny ones. On the 07Jan2021 at her job, emergency room, they had the tiny ones and was able to go further up and that's when she tested positive. Mentioned using salbutamol (ALBUTEROL) nebulizer, over the counter cough syrup, prescription azelastine hydrochloride;fluticasone propionate (DYMISTA) nasal spray, and pseudoephedrine hydrochloride (SUDAFED). When has the dry cough she uses the ALBUTEROL nebulizer with the machine and vials at home and that slows down the coughing a lot and the other stuff with the lungs. Not taking any steroids. Using SUDAFED to stop the runny nose from post nasal drip from going into lungs.
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| 63 | 2021-01-25 | fever, chills | GI issues , fever to 99.6, achy everywhere, chills |
| 63 | 2021-01-25 | fever |
Soreness at injection site for 72 hours.; Low grade fever 99.6 orally on day 3.; GI upset for 3 days...
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Soreness at injection site for 72 hours.; Low grade fever 99.6 orally on day 3.; GI upset for 3 days; Migraine headache on day 6.; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) via an unspecified route of administration in the right arm, on 30Dec2020 at 11:00 A.M., at a single dose, for COVID-19 immunization. Relevant medical history included high blood pressure (BP), seasonal allergies, migraine, asthma, right sided hearing loss. The patient was taking unspecified concomitant medications. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 01Jan2021, at 8:00 A.M., the patient experienced soreness at injection site for 72 hours. On day 3, the patient had low grade fever 99.6. On an unspecified date in Jan2021, the patient had gastrointestinal (GI) upset for 3 days. On day 6, the patient experienced migraine headache. The patient did not receive therapy for the events. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.
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| 63 | 2021-01-25 | sinusitis |
sinus infection; stuffy head; I do have tinnitus, and noticed that both injections made that worse; ...
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sinus infection; stuffy head; I do have tinnitus, and noticed that both injections made that worse; This is a spontaneous report from a contactable nurse (patient). A 63-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), intramuscular on the left arm, on 18Dec2020 at 11:30 at a single dose for Covid-19 immunization. Medical history included at one time a severe allergic reaction to pecans have since eaten small amts without problems and tinnitus. The patient has no Covid prior to vaccination. The patient is not pregnant. The patient's concomitant medications were not reported. No other vaccines in four weeks and no other medication in two weeks. In Dec2020, the patient stated that she does have tinnitus, and noticed that both injections made that worse, it is not yet subsiding since last injection the only other signs and symptoms (s/s) she had from the 1st injection, second day after, about 2 hrs of feeling like she had a sinus infection, stuffy head, wanted to go to bed and rest. The patient was treated with naproxen sodium (ALEVE), paracetamol (TYLENOL), and diphenhydramine hydrochloride (BENADRYL) for the events. The patient was not Covid tested post vaccination. The outcome of the event of tinnitus was not recovered, while other events were unknown. Information on lot/batch number has been requested.
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| 63 | 2021-01-25 | sneezing, nasal congestion, runny nose |
Cold like symptoms such as runny nose, stuffy nose, sneezing,,,,, severe back pain. Cold symptoms...
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Cold like symptoms such as runny nose, stuffy nose, sneezing,,,,, severe back pain. Cold symptoms were done morning of the 26th and back pain lessened by that afternoon.
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| 63 | 2021-01-26 | chills, headache, body temperature increased |
428801 - Number given on Vaccination log - that day of the Vaccination dose 2. (Patient stated short...
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428801 - Number given on Vaccination log - that day of the Vaccination dose 2. (Patient stated shortness of breath was another symptom that she had from COVID and is continuing somewhat especially when I was a mask for work - but had not put it in the first report). Chills on Friday morning in the middle of night; woke up and my temp was 101.3 and I was feeling bad all day; had headache and went back to bed. Still have pain in hip/knee and joints and those pains got really bad after the vaccine - increased. Doctor vist told me to use Ibuprofen to 3 times a day for that pain. Shortness of breath continues from Covid symptoms and so does the hip/joint pain - it has decreased.
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| 63 | 2021-01-26 | fatigue, chills, fever, headache |
: 01.25.21, 1st day of vaccination Both sides of neck, lots of pain along with hard time turning...
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: 01.25.21, 1st day of vaccination Both sides of neck, lots of pain along with hard time turning neck with stiffness . 2nd day Chills, headache. Joints are in pain along with other body pain, nausea. Now, fever 99.1. 3rd day is today, 01.27.21, voice is affected, fatigued body is very achy.
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| 63 | 2021-01-26 | headache, chills | Sudden onset of chills and shakes for about 6 hours, headache, stomach distress, muscle aches, |
| 63 | 2021-01-26 | fever, chills |
Fever, chills, unaware of surrounding, delirium- time frame from approximately 11:15 am to 4:30pm . ...
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Fever, chills, unaware of surrounding, delirium- time frame from approximately 11:15 am to 4:30pm . She was by herself, discovered after a phone call to check on her
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| 63 | 2021-01-26 | fever, cough, fatigue, sweating, headache, throat pain |
About 5:30 or so and I was going to go to lunch at work - I felt like a heartburn and I was looking ...
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About 5:30 or so and I was going to go to lunch at work - I felt like a heartburn and I was looking for a tums. I didn't have any. I asked a coworker because my chest felt like I had heartburn. It was really bad. Protonic - a coworker gave it to me to see if that would help. And I took it. Diaphoretic - sweating - coworker noticed that I was sweating. I had pain in my jaw. I thought I was showing signs of a heart attack. A doctor came over and we told her what was happening with me. He recommended that I should be seen right away. Next thing I know, nurse is wheeling me down to ER in wheelchair as my chest pains weren't going away but ER told me I had to go through triage and wait. Finally got seen and I had an EKG - which was good. CDU unit - was admitted to and checked Troponin levels and did blood work. Everything came back fine. My EKG was being monitored all night. At one point I was feeling something and they gave me a dose of Nitro. It gave me a headache. There all night and then I did a stress test in the morning. And I was released that day. That was my day off so I was off all work. I went back to the work the day after. My granddaughter came to stay with me over Christmas and she started having symptoms of COVID. She wasn't feeling well. /She tested positive.Symptoms for COVID began for me on December 26th and was tested for COVID on December 27th - cough; sore throat; headache, fever, not got chills or lose my taste or smell (until after those symptoms were finished); belching - lots; diarrhea; upset; nausea. Extremely tired and muscles aches, joint pain - settled in my lower back and my hip. I still struggle with those joint pain and tiredness today. They put me off work until January 12 2021. I was scheduled to get the dose 2 at 9th but didn't get it that day because of COVID illness.
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| 63 | 2021-01-26 | fever, fatigue, chills |
shaking chills; temp of 101.4 at 2:00 pm; sudden onset extreme fatigue; This is a spontaneous report...
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shaking chills; temp of 101.4 at 2:00 pm; sudden onset extreme fatigue; This is a spontaneous report from a contactable Nurse reported for herself. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), Intramuscular at Left arm on 13Jan2021 10:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at clinic. Medical history included chronic cerebrospinal fluid leakage (CSF) Leak, intraductal papillary mucinous neoplasm (IPMN) pancreatic lesion, chronic thyroiditis with large nodule, mitral valve prolapse, osteoporosis, multiple breast fibroadenomas, timalleolar fracture, ankle, and prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included lansoprazole, tramadol, potassium citrate, ASA and "Vi". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sudden onset extreme fatigue at 1:00 pm on 14Jan2021 followed by shaking chills and temperature of 101.4 at 2:00 pm. No treatment received for the events. Since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was unknown.
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| 63 | 2021-01-27 | fatigue, fever, chills | Extreme fatigue - throughout the entire day Chills began late afternoon Low Grade Fever 99.7 |
| 63 | 2021-01-27 | fatigue |
Patient received her vaccine on Thursday, 1/21/21. From then until Saturday afternoon she had been ...
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Patient received her vaccine on Thursday, 1/21/21. From then until Saturday afternoon she had been experiencing extreme fatigue. On Sat. around 5:00 PM she was standing at her flat-top stove cooking dinner. A wave of very extreme fatigue came over her, so she leaned over to turn off the burner. When she did this, she passed out leaning forward with her hand on the burner and touching the frying pan. When she came to, she went to the couch and laid down - not realizing for 10 minutes that her hand and right breast were burned. The resulting injuries lead to her having to see her PCP on Monday, and then a General Surgeon on Weds 1/27/21. Injuries sustained include a second degree burn on her right breast, On the right arm, laterally above the wrist is a small superficial partially healed burn. On the dorsal aspect of the right fifth finger there is a longitudinal burn that goes from the MCP joint to almost the tip of the finger. She has limited range of motion due to discomfort and swelling. The blister encompasses the entire dorsal lateral aspect of the finger. The fourth right finger has a less extensive blistered area on the PIP joint. The burn on the fifth finger is deep second degree.
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| 63 | 2021-01-27 | fever, chills, fatigue | Extreme fatigue Fever 99.7 Chills |
| 63 | 2021-01-27 | fever |
fever, nausea, vomiting, severe body aches severe left arm pain, all symptoms worse that 1st dose. F...
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fever, nausea, vomiting, severe body aches severe left arm pain, all symptoms worse that 1st dose. Fever persisted from 1/7/21 to 1/10/21. Seen in ER 1/9/21 with T 101.9 again & workup (-) for bacterial infection /sepsis , COVID neg, flu neg.
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| 63 | 2021-01-27 | respiratory tract congestion, fever | sick with a fever, body aches, congestion, diarrhea |
| 63 | 2021-01-28 | fatigue, headache, throat pain |
starting on 1/19: headache; burning behind eyes and sore throat; x 3 days which have now resolved -...
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starting on 1/19: headache; burning behind eyes and sore throat; x 3 days which have now resolved - now dizzy when standing; fatigue - arms feels heavy when taking shower; pale; remains very weak and tired; dizzy - feels like anemia - tried to work last night but broke out in cold sweat and pale so sent home from work last night - sxs are not worsening
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| 63 | 2021-01-28 | head discomfort |
Chest "fullness" going up to neck and head. BP 141/82 Pulse 83 O2 98% R 18 Assessed by APN at time...
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Chest "fullness" going up to neck and head. BP 141/82 Pulse 83 O2 98% R 18 Assessed by APN at time of incident. Pt declined ER. Will follow up with PCP
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| 63 | 2021-01-28 | headache, fatigue |
dysuria, abdominal, pelvic, left flank, upper and lower back pain. bladder spasms, urinary frequency...
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dysuria, abdominal, pelvic, left flank, upper and lower back pain. bladder spasms, urinary frequency, headache, vision changes, loss of appetite, dysphagia and fatigue
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| 63 | 2021-01-28 | headache, sweating |
8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest...
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8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest; tightness bilateral flank area; HA; body aches; diaphoresis; hot feeling; numbness tingling of head; numbness tingling of head/tingling in jaw and over the top of my head; pressure in the back of my neck; blurred vision; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in right arm on 14Jan2021 10:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. Medical history included HTN, GERD, constipation, ocular migraine, osteoarthritis in sacroiliac joints, small fiber neuropathy, glucose intolerance, steatotic liver, CTS (Carpal tunnel syndrome). Concomitant medication included losartan (LOSARTAN), furosemide sodium (LASIX [FUROSEMIDE SODIUM]), and spironolactone (SPIRONOL). The patient previously received the first dose of bnt162b2 on 24Dec2020 10:00 AM for COVID-19 immunization. On 14Jan2021 11:00, the patient experienced tightness in chest tin which the patient took benadryl 25 mg with improvement, tightness bilateral flank area, HA, body aches, diaphoresis, hot feeling, numbness tingling of head, pressure in the back of my neck, and blurred vision. On 15Jan2021, the patient had an 8/10 chest pain radiating into left arm subsided after 10 mins, tingling in jaw and over the top of head, chest tightness and tightness in both flanks most of day 2. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect BNT162B2 administration to the event chest pain cannot be excluded. The status of medical history including HTN, GERD, constipation, migraine and osteoarthritis in sacroiliac joints would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-01-28 | headache | severe Headache, Axillary swelling and pain |
| 63 | 2021-01-28 | nasal congestion, productive cough, fever, chills |
heaviness in chest with right flank pain; lots of phlegm; Pulse oximeter 89%; difficulty breathing h...
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heaviness in chest with right flank pain; lots of phlegm; Pulse oximeter 89%; difficulty breathing heaviness in chest/Shortness of breath; difficulty breathing heaviness in chest/ heaviness in chest with right flank pain; Chills; Sensitive skin; Super Thirsty; Fever 100.7/Low grade fever 99.9/ Low grade fever 99.0; Joint Pain; Congestion; Right arm injection site severe pain; This is a spontaneous report from a contactable other healthcare professional (Patient). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration on 06Jan2021 10:30 at single dose in Right arm for COVID-19 immunization. Medical history included hypertension. Concomitant medication included benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL/HCTZ, 10-12.5 MG Tablet), ascorbic acid, biotin, boron, calcium, calcium pantothenate, chlorine, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine hydrochloride, tocopherol, vanadium, zinc (CENTRUM SILVER). The patient previously took codeine and experienced allergy. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination. The patient did not have covid-19 tested post vaccination. On 06Jan2021 20:00, the patient experienced Fever 100.7, Joint Pain, Congestion, Right arm injection site severe pain. On 07Jan2021, the patient experienced Chills, Fever 100.7, Sensitive skin, Super Thirsty. On 08Jan2021, the patient had Temperature 98.8, No Chills, Thirsty. On 09Jan2021, the patient was Some relief, no fever, no chills, no joint pain. On 10Jan2021, the patient experienced low grade fever 99.9, Pulse oximeter 89%, difficulty breathing heaviness in chest. On 11Jan2021, oxygen was 92%, Low grade fever 99.0. On 12Jan2021, vital signs stable no fever 97.7, oxygen 96%. On 13Jan2021, Vital Signs stable. On 14Jan2021, the patient experienced Shortness of breath, heaviness in chest with right flank pain, lots of phlegm, Temperature 98.0, Oximeter 96%. Coricidin HBP taken to relieve Congestion. Therapeutic measures were taken as a result of all reported events. The outcome of event chills was recovered on 08Jan2021, outcome of event Fever (event onset date: 06Jan2021 20:00) was recovered on 09Jan2021, outcome of event Low grade fever (event onset date: 10Jan2021) was recovered on 12Jan2021, outcome of event Joint Pain was recovered in Jan2021. The outcome of the other events was recovering.
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| 63 | 2021-01-28 | fever, chills, fatigue, headache |
Severe chills, painful glands especially under L arm, fever (low grade, never over 100.5), muscle ac...
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Severe chills, painful glands especially under L arm, fever (low grade, never over 100.5), muscle aches and weakness, joint pain, severe head ache, nausea, extreme fatigue and slight confusion. Started about 11 hourse post injection and symptoms lasted 20 hours. Acetaminophen and increased water intake. Intermittent bedrest. Missed a day of work. Then suddenly everything cleared and I was wide awake and clear headed, just a little weak in muscles.
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| 63 | 2021-01-28 | fever, chills, fatigue |
Intermittent fever; chills; body aches; tiredness; pain and swelling in a axilla area of left arm; p...
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Intermittent fever; chills; body aches; tiredness; pain and swelling in a axilla area of left arm; pain and swelling in a axilla area of left arm; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration in left arm on 12Jan2021 at 07:00 at single dose for COVID-19 immunization. Medical history included hypertension and ventricular septal defect. The patient was not pregnant. Patient has no COVID-19 prior to vaccination. Concomitant medications included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]), docusate sodium (COLACE), losartan, omeprazole and montelukast sodium (SINGULAIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685), via an unspecified route of administration in left arm on 22Dec2020 at 2PM for COVID-19 immunization. On 12Jan2021 at 11:30 PM, the patient experienced intermittent fever and chills, body aches, tiredness, and pain and swelling in the axilla area of left arm. Patient has not tested for COVID-19 post vaccination. The outcome of the events was recovering.
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| 63 | 2021-01-29 | fever |
Pt received her 2nd dose of the pfizer vaccination on 1/29/2021 and 5 hours later, developed a fever...
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Pt received her 2nd dose of the pfizer vaccination on 1/29/2021 and 5 hours later, developed a fever of 102F, muscle aches and had a syncopal episode.
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| 63 | 2021-01-29 | runny nose, fever, headache, fatigue |
Late evening after shot felt like was getting a cold, runny nose, tired. Next day had fever, high o...
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Late evening after shot felt like was getting a cold, runny nose, tired. Next day had fever, high of 100.0 F, joint pain, headache, fatigue. Lasted about 24 hours, improved by second day after shot with minor fatigue for another day, by 3rd day felt normal.
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| 63 | 2021-01-30 | chills, headache, fever | Chills, fever, headache. Symptoms started 10 hours after injection and lasted 36 hours |
| 63 | 2021-01-30 | chills, headache | mild headache, chills, nausea, muscle and body aches |
| 63 | 2021-01-31 | body temperature increased, headache |
The time of my COVID 2nd vaccine was around 12:58 pm on 01/30/21. I started noticing blurred visions...
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The time of my COVID 2nd vaccine was around 12:58 pm on 01/30/21. I started noticing blurred visions and some tingling at the injection site about 30 minutes after vaccine. Around 9:00 pm I started feeling weak and muscle aches all over, so went to bed. Around 2:00 am on 1/31/21 I woke up in pain all over my body muscle ache, headache, and difficulty walking. Took temperature 99 and my average temp is 97.9. I took one extra strength Tylenol. On 01/31/21 I just felt bad all day felt like COVID symptoms but no breathing difficulties just bad headache all day, weakness, entire left side my body left arm, left side chest, left leg hurt worse than right side. I?ve just treated with extra strength Tylenol and rest. Last night temperature was still 99, but sleep through the night. Today, February 1 still weak, ache all over, mild headache, and some pain on my left side body. I have not sought emergency treatment as if the date/time of report. I?m a healthcare worker taking today and tomorrow off work to recover.
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| 63 | 2021-01-31 | chills |
Pfizer-BioNTech COVID 19 vaccine EUA- 7.5 hours after vaccine severe chills for 4 hours. Severe mus...
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Pfizer-BioNTech COVID 19 vaccine EUA- 7.5 hours after vaccine severe chills for 4 hours. Severe muscle aches for 22.5 hours.
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| 63 | 2021-01-31 | headache, chills, fever |
2:30 AM 1/30/21 chills, skin sensitive to touch, fever, extreme headaches, dizziness, nausea, redne...
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2:30 AM 1/30/21 chills, skin sensitive to touch, fever, extreme headaches, dizziness, nausea, redness at site of injection
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| 63 | 2021-01-31 | headache | Headache and Body aches |
| 63 | 2021-01-31 | fever, chills | Fever up to 100 degrees, chills, body aches, lasting 3 days. |
| 63 | 2021-01-31 | fever, headache, fatigue, chills |
Beginning 24 hours post vaccine I had Fever, headache, body aches, chills for 24 hours. For 36 hours...
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Beginning 24 hours post vaccine I had Fever, headache, body aches, chills for 24 hours. For 36 hours fatigue. All resolved at 48 hours when mild asthma began.
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| 63 | 2021-01-31 | fever |
Starting 12 hours after the injection she had a fever of 101.5 degrees F lasting over 20 hours. She ...
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Starting 12 hours after the injection she had a fever of 101.5 degrees F lasting over 20 hours. She also experienced severe body aches, flank pain, bilateral groin and axillary nodal pain.
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| 63 | 2021-02-01 | fatigue, headache | Nausea and HA one hour after Pfizer vaccine. Fatigue and aches 6 hours to 36 hours. |
| 63 | 2021-02-01 | head discomfort, fatigue, headache |
Loss of taste; Tightening in the jaw; Tightening is on the side where the forehead is and the front ...
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Loss of taste; Tightening in the jaw; Tightening is on the side where the forehead is and the front like on the two sides is the pressure on the side of the head; just thinking of a headache; I have been feeling lot of fatigue; crying; This is a spontaneous report from a contactable consumer. This consumer reported for herself that the 63-year-old female patient received first dose of bnt162b2 (Unspecified Shot), via unknown route of administration on 15Jan2021 at single dose for covid-19 immunisation (to make sure because I am a caregiver). Medical history included Sjoegren's syndrome and had like chronic fatigue but "that is not a real thing". Concomitant medications included buspirone hydrochloride (BUSPAR) and other medications that she just take a half every other day, it is a small amount. She take 5 mg every other day. She was really taking much. The consumer had lab work, may be not sure 2 to 3 weeks, she has been feeling lot of fatigue. Actually, she did do lab work, it was just like lot of blood work. The consumer stated, "I am having some loss of taste and tightening in the jaw and that was immediately. Tightening is still there and the taste loss seems to happen like a day later. Tightening is on the side where the forehead is and the front like on the two sides is the pressure on the side of the head. I guess, just thinking of a headache. I guess, I had headache and crying, it is just nerve-racking." The events started from 15Jan2021 with outcome of not recovered. Treatment received included Advil. Information on the batch number/lot number has been requested.
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| 63 | 2021-02-01 | headache, fatigue | Moderate muscle aches, fatigue, headache and nausea |
| 63 | 2021-02-02 | headache, fatigue, malaise | not feeling well, headache, fatigue |
| 63 | 2021-02-02 | headache |
Mild headache in left upper corner of head. started day of shot and is continuing through the next d...
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Mild headache in left upper corner of head. started day of shot and is continuing through the next day atleast.
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| 63 | 2021-02-02 | throat irritation |
Patient states she had a little bit of itchy throat, itchy nose. No swelling or hives noted. Refused...
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Patient states she had a little bit of itchy throat, itchy nose. No swelling or hives noted. Refused EMS.
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| 63 | 2021-02-03 | chills, headache, fever |
delirious dreams; extreme chills; so cold that it felt like burning ice cubes on skin, could not get...
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delirious dreams; extreme chills; so cold that it felt like burning ice cubes on skin, could not get warm even with multiple blankets; severe body aches; severe headache; fever of 101; nausea; thirsty; Symptoms began to abate today (almost 48 hours later) but still fet some foggy thinking; This is a spontaneous report from a contactable other health care professional (patient) and a contactable consumer. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELIZ83), via an unspecified route of administration at arm left on 19Jan2021 at single dose for COVID-19 immunization. The patient medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at arm left on 29Dec2020 at 9:30 at single dose for COVID-19 immunization. On Jan2021, the patient reported that 15 hours after second dose, he experienced extreme chills, so cold that it felt like burning ice cubes on his skin, he couldn't get warm even with multiple blankets, severe body aches, fever of 101 F, severe headache, delirious dreams, nausea, thirsty and feel some foggy thinking. The patient outcome of the event was recovering.
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| 63 | 2021-02-03 | chills, headache |
8:20 pm - Patient received Pfizer COVID-19 dose 2 vaccine at 3:41 pm. Came in to c/o severe headache...
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8:20 pm - Patient received Pfizer COVID-19 dose 2 vaccine at 3:41 pm. Came in to c/o severe headache, dizzy, vomiting, and chills. BP high initial 176/81 P: 76, 97.7, O2: 99%. Patient has hx of HTN ans took medicine in the am. IMT called 8:25 pm, assessed vitals retaken (BP: 189/84; P:82 right arm; BP: 188/86, P: 82 left arm, and transported via wheelchair to Emergency Center for evaluation.
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| 63 | 2021-02-03 | fatigue, chills, headache |
1st day nausea, next day rapid heart rate, sore arm, headache, nausea 3rd day - sore arm, headache,...
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1st day nausea, next day rapid heart rate, sore arm, headache, nausea 3rd day - sore arm, headache,nausea,chills 4th day - headache, chills and feeling hot, nausea,skin rash , itching, tired,aches 5th day - headache,chills and feeling hot, nausea,rash and uncontrollable itching, tired.
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| 63 | 2021-02-03 | headache, fever | FEVER, BODY ACHES, HEADACHE. |
| 63 | 2021-02-03 | headache, upper-airway cough syndrome, sinusitis, sinus congestion, throat pain, malaise, fatigue |
sinus infection; she had Covid exposure; sinus symptoms, like ear fullness- sinus stuff; sinus sympt...
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sinus infection; she had Covid exposure; sinus symptoms, like ear fullness- sinus stuff; sinus symptoms, like ear fullness- sinus stuff; post-nasal drip; not feeling well; really bad headache; Sore throat; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received bnt162b2 (BNT162B2 reported PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date: unknown), intramuscular left deltoid on 06Jan2021 15:15 at a single dose for covid-19 immunization. Medical history included chronic sinusitis, and allergies to mold and pigweed. She was taking shots up to June but stopped. There were no concomitant medications. The patient did not have prior vaccination within the last 4 weeks. The reporter stated that she had fatigue, a sore throat, and "a really bad headache". She further reported that received her shot 2 weeks ago in a hospital and everything has been fine, however on Sunday (17Jan2021), she started having some fatigue. On Monday (18Jan2021), she started getting a slight sore throat and yesterday (19Jan2021), she has had mild, vague symptoms but she ended up with a really bad headache last night along with a sore throat. She is a school nurse and she has had possible exposure to a student that was positive for COVID. She feels like she has very vague, normal sinus-like symptoms. She added that she had Covid exposure on an unspecified date, as she is a school nurse and had contact with a Covid-positive patient. She stated that the contact with a known-positive Covid patient since receiving her first vaccine. She mentioned that she does have chronic sinusitis, so the sore throat is post-nasal drip, and a headache. However, this headache is worse than the headache she has had in the past. She hasn't had any sinus symptoms for the past 5 months, but she was thinking about getting a COVID test to rule this out. She explained that she is due for her second vaccine one week from today and wanted to know can she still get the second COVID vaccine if she was not feeling well on an unspecified date. She was trying to determine if she does have COVID. She inquired if getting the vaccine automatically turn a COVID test positive if she has already received the first COVID vaccine. The she states on Sunday, her symptoms were very vague. It's mostly just been Monday and Tuesday. Her throat right now is better. The patient stated she did V-safe and did fine with that. She further explained that she was just experiencing sinus symptoms on an unspecified date, like ear fullness- sinus stuff that she normally gets. She doesn't feel like it's a reaction to the vaccine and she doesn't think she is having adverse reactions. She has gone through 12 days without having any symptoms, she doesn't think it's a reaction. She stated she either has been exposed to COVID or she is getting a sinus infection. She just started having these symptoms. It's not abnormal for her, but this time since she is getting the second vaccine, she wanted to know can she go ahead and still get the vaccine if she is still having any residual symptoms. The patient clarified that she got a COVID test (non-rapid test) this morning (20Jan2021) but she has not yet received her results. She mentioned that she has her own regimen, so she doesn't have to take antibiotics. The events did not require an emergency room or physician office. The outcome of the events of the events was unknown.; Sender's Comments: Based on the available information and known product safety profile, the events fatigue, headache and malaise were possibly related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). All other reported events are assessed as Unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
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| 63 | 2021-02-03 | headache |
Headache; vascular rash on toes; This is a spontaneous report from a contactable consumer (patient)....
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Headache; vascular rash on toes; This is a spontaneous report from a contactable consumer (patient). A 63 year-old female patient received first dose of BNT162B2 (lot number: 3246), via an unspecified route of administration on 16Jan2021 14:30 at single dose in the left arm for COVID-19 immunization. Medical history included chronic lymphocytic leukaemia from an unknown date. The patient has no known allergies. Concomitant medication included metformin extended release. On 16Jan2021, the patient experienced headache and vascular rash on toes. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any treatment for the events. The patient underwent lab tests and procedures which included PCR and nasal swab: both unknown results on 20Jan2021. The outcome of the events was not recovered.
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| 63 | 2021-02-03 | headache |
Numb feeling from head all the way to nose; Headache; This is a spontaneous report from a contactabl...
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Numb feeling from head all the way to nose; Headache; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration, injection in upper left arm, on 20Jan2021 at 10:45 at single dose for COVID-19 immunization; administered in a clinic, like the county clinic. The patient's medical history included ongoing over weight (stated she is 100 pounds over weight), ongoing slight heart disease, ongoing thyroid issue, ongoing blood pressure, and feeling like claustrophobic with the mask. The patient previously received swine flu shot in 1976 and experienced odd headache, and received flu shot two months ago (Nov2020). She mentioned that in 1976 she was in the military and had the Swine Flu Shot. The president made it mandatory they get it because they were afraid there was going to be an attack and they all had to get this vaccine. After getting this vaccine she had an odd headache. She also had a headache after getting the COVID 19 Vaccine, but it was not as bad. She had a little headache with the numbness after she got the COVID 19 Vaccine. While in the military when she got the Swine Flu shot they administered it with an air gun. She does not have any details to provide a lot/exp/NDC. They were just hurrying up to administer because afraid of possible biologic attack. She mentioned a lot of people have had bad reactions to the swine flu shot, but no additional details provided. Concomitant medication included metoprolol and ongoing lisinopril; both for blood pressure. There were no additional vaccines administered on same date of BNT162B2, and there were no prior vaccinations within 4 weeks. The patient experienced numb feeling from head all the way to nose on 20Jan2021 10:46, and headache on 20Jan2021. The patient called to report minor adverse reactions that occurred after getting the vaccine. She did not want her HCP contacted because she wants to ensure she gets the second shot. She clarified the reaction was odd. She had her face mask on when she got the shot. Normally she has the feeling like claustrophobic with the mask on which also occurred after she got the shot. After she got the vaccine, she also started to feel numb from her head all the way to her nose. It lasted 45 minutes. She started to feel this numb feeling 1 minute after getting the vaccine. She could tell something was not right. She thought at first it was the face mask, but after she took the mask off after waiting the 15 minutes under observation, she still had the numb feeling as it had not gone away yet. She could touch her face and could feel the numb feeling. The numb feeling was like getting a tooth filled, not that bad, but something like that. The outcome of the event numb feeling from head all the way to nose was recovered on 20Jan2021 at 11:31, and the outcome of the event headache was unknown. She mentioned she has some friends who have passed away from COVID and who were hospitalized from COVID. That is why she is so grateful for the vaccine and putting it out there.
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| 63 | 2021-02-03 | malaise, fatigue, fever, headache |
Aches and pains; Fatigue; Fever/My temperature was 99 which "generally" (not clarified) my temperatu...
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Aches and pains; Fatigue; Fever/My temperature was 99 which "generally" (not clarified) my temperature is usually 97; Arm was extremely painful; Joint pain; Headache; Could not work today because I was not feeling good; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot), via an unspecified route of administration, on 13Jan2021 (at the age of 63-years-old) as a single dose for COVID-19 vaccination. Medical history includes heart disorder. Concomitant medication included: Simvastatin, Atenolol, and medicine for my "heart". The patient reported that she received the first dose on 23Dec2021 and stated she had no reaction. On an unspecified date, the patient stated "I could not work today because I was not feeling good from the vaccine. I got it on the 13th I had off some work yesterday so I had a temperature aches and pains, fatigue and I had to call out last night. Today I am running still very slight fever, aches and pains - so it is improving." The first day, I was fine. I got it at the end of the day. The second day my arm was not red or anything but it was extremely painful, joint pain, headache, fatigue and my temperature was 99 (my temperature is usually 97). Today the temperature is lower and that does not hurt as much." The clinical outcome of the events malaise, aches and pain, fatigue, pyrexia, pain in arm, joint pain, and headache was unknown. No follow-up attempts are possible. No further information is expected.
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| 63 | 2021-02-03 | fever, fatigue, headache | Body aches, fatigue, headache, feverish; lasted about 40 hours; felt like I had COVID again |
| 63 | 2021-02-04 | chills, headache, fatigue |
Soreness and swelling at site of injection 4 hrs after injection Chills one day after vaccine Jo...
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Soreness and swelling at site of injection 4 hrs after injection Chills one day after vaccine Joint pain one day after vaccine Fatigue one day after vaccine Foggy, light headed feeling one day after vaccine Headache and fatigue day 2 after vaccine
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| 63 | 2021-02-05 | headache |
its been 7 days now and am just getting sicker from then shot itching has increased and now have hem...
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its been 7 days now and am just getting sicker from then shot itching has increased and now have hematomas on my body. lungs fill heavy and headaches gotten more painful and i fell like my brain is not right. and diarrhea with pain in lower abdomen . I do not think i should be getting the second shot. I do not have a doctor and cant afford to go to er. I send you information of the first 5 days but do not have that report number.
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| 63 | 2021-02-05 | malaise, fatigue |
Dose 1 and 2 usual adverse events. Sore arm, achey, tired and crappy. But after dose 2 after 24 hour...
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Dose 1 and 2 usual adverse events. Sore arm, achey, tired and crappy. But after dose 2 after 24 hours I began to notice itching. My back, neck, legs, arms. Begins once my zyrtec wears off around 7:30 pm I always take and antihistamine to keep my nose clear for better sleep. All nighttime meds are take at 8- 8:30 pm. Must take ativan to control anxiety and help get to sleep
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| 63 | 2021-02-05 | fever, headache |
Injection site pain started 6 hours after shot. 18 hrs after shot total body aches, fever, headache ...
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Injection site pain started 6 hours after shot. 18 hrs after shot total body aches, fever, headache lasting 16 hrs.
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| 63 | 2021-02-06 | headache, body temperature increased | Thick Tongue, itching face, head, arms legs, increased temperature, headache, muscle pain |
| 63 | 2021-02-07 | chills, headache |
I had pain at the injection site initially and it increased on day 2. Also on day 2, I saw a small r...
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I had pain at the injection site initially and it increased on day 2. Also on day 2, I saw a small rash after showering. The muscle pain has de erased, but the injection site is very tender and the rash has spread down my arm about 2-3 inches. Today, day 5, the rash is slightly itchy. On day 2, I had chills, body aches, joint pain and a headache. All symptoms were gone within 48 hours with the exception of the headache. The headache lasted until day 5.
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| 63 | 2021-02-07 | cough |
Got covid 4 days after vaccine, severe cough, loss of taste, smell, aches, pain especially in my lef...
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Got covid 4 days after vaccine, severe cough, loss of taste, smell, aches, pain especially in my left side of neck. Went to E.R due to muscle spasms, taking motrin, tylenol. Still have severe neck pain.
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| 63 | 2021-02-08 | headache |
Severe head pain started at about 4 am on 1/29 and progressively got worse. By 7 am it led to nausea...
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Severe head pain started at about 4 am on 1/29 and progressively got worse. By 7 am it led to nausea, vomiting, and incapacitating pain. I would rate this a 10 out of 10 on pain scale. My Dr. was contacted and I was prescribed Zofran for nausea and Imitrex for the migraine about 11 am. The medications eased the symptoms to a manageable level. I have no current history of migraines, and have had two subsequent migraines, but not as severe.
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| 63 | 2021-02-08 | fever, chills, fatigue |
Experienced severe cold chills whereas my body felt like pins and needles all over including body ac...
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Experienced severe cold chills whereas my body felt like pins and needles all over including body aches and fatigue. Woke up with night gown damp, so I probably had a low grade fever.
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| 63 | 2021-02-08 | fever | COVID-19 arm, rash, redness, itchiness at injection site. Fever x 3 days. |
| 63 | 2021-02-09 | headache, malaise |
left ear ringing; bad headache; nauseous; no energy; I don't feel well; This is a spontaneous report...
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left ear ringing; bad headache; nauseous; no energy; I don't feel well; This is a spontaneous report from a contactable other healthcare professional (patient). A 63-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Elo142), via an unspecified route of administration into the left arm on 14Jan2021 14:30 at a single dose for covid-19 immunisation. Medical history was reported as none. Patient was not pregnant. Concomitant medication included calcium (CALCIUM), vitamin d3 (VITAMIN D3) and monascus purpureus (RED YEAST RICE). On 14Jan2021, patient experienced bad headache, was nauseous, had no energy and was not feeling well. On 15Jan2021, patient also experienced left ear ringing. The patient received no treatment for the events reported. Outcome of events was recovering.
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| 63 | 2021-02-09 | headache, fever, fatigue | Low grade fever, headache, muscle spasms, fatigue, aches and stiff muscles |
| 63 | 2021-02-09 | fever, fatigue, chills |
Muscle ache; Chills; Fever; was cold; Joint ache; Tired; Sick; could not sleep all night, she was up...
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Muscle ache; Chills; Fever; was cold; Joint ache; Tired; Sick; could not sleep all night, she was up half the night; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: F19262), via an unspecified route of administration at her arm on 23Jan2021 at 0.3 mg (as reported) single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that that she and her 94 year old mother got the COVID-19 vaccine at a drive thru, and her mother did great. After the vaccine she had muscle aches, chills, fever, and was cold. She had side effects that lasted 30 hours, starting that night. She was chilling so bad, she would like to know if they think it was safe for her to get the second dose of the vaccine, they said it was worse for the second. She said she could not hardly work she was so sick after the first dose. She stated that she was really cold, and really sick, and all day, she just could not sleep all night, she was up half the night because she was so cold and just feeling sick. She had joint pain, she had it all. She started taking Aleve on Sunday and she started to get better. The night after she got the vaccine she got her heater and was sitting beside it. She felt tired the whole next day. Her symptoms came quicker than that, she took the Aleve the next day. The outcome of events muscle aches, chills, fever, joint ache was recovered. The outcome of other events was unknown.
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| 63 | 2021-02-09 | throat irritation |
Patient is a 63 y/o female with itchiness to her back of her throat, tongue tingling and having trou...
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Patient is a 63 y/o female with itchiness to her back of her throat, tongue tingling and having trouble swallowing.
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| 63 | 2021-02-10 | fatigue, headache, chills |
The temperature that the Pharmacist recorded was not correct/transport the covid 19 vaccines had a t...
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The temperature that the Pharmacist recorded was not correct/transport the covid 19 vaccines had a temperature of 31 to 33 degrees F; The temperature that the Pharmacist recorded was not correct/transport the covid 19 vaccines had a temperature of 31 to 33 degrees F; improper technique; bruising after the first shot because of improper technique; felt hot at the injection site; swelling; tiredness/tired; arm pain; headache; chills; This is a spontaneous report from a contactable pharmacist (patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EJ1686, expiry date not reported), intramuscular on 02Jan2021 17:00 at a single dose in the left arm for COVID-19 immunization. Medical history included hypertension, known allergies to latex and has covid-19, all from unknown dates and unknown if ongoing. The patient was not pregnant at the time of the vaccination. Concomitant medications included hydrochlorothiazide, potassium chloride, and calcium citrate (CITRACAL). The patient had no other vaccine in four weeks. Patient stated that a cooler used to transport the covid 19 vaccines had a temperature of 31 to 33 degrees F and she was concerned about the vaccines on the bottom of the shipper that were next to the dry ice in the shipper (date unspecified). Patient wanted temperature excursion data for the covid 19 vaccine and stated in Jan2021 she felt hot at the injection site, swelling, tired, arm pain and had bruising after the first shot because of improper technique (02Jan2021 17:00). Patient reported on the first dose having only arm pain, chills, and tiredness, and headache in Jan2021. Patient also stated that the first dose was much better tolerated. Patient stated some of her pharmacist friends have had the same effects from the vaccine. Patient wanted to verify that the vaccine in the syringe is good for 6 hours and that she read Moderna is effective for 1 year and Pfizer is good for 6 to 12 months. She does not think her vaccination of covid 19 was valid because she thinks the temperature that the pharmacist recorded was not correct. Patient wanted to know if she should get tested to see if the vaccine worked. Patient stated that Pfizer is too complex and has too many pieces and states they need to give more information about how to use the thermal shipper. The patient had Covid test post vaccination as nasal swab on (BioReference COVID-19 Nasopharynx) on 26Jan2021 with results as pending. No treatments received felt hot at the injection site, swelling, tired, arm pain, had bruising after the first shot, chills and headache. The patient did recover from the events felt hot at the injection site, swelling, tired, arm pain, had bruising after the first shot, chills and headache on an unspecified date in Jan2021.
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| 63 | 2021-02-10 | headache |
Arm a little sore below injection site. Mild start of a headache for two days but never kicked in. W...
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Arm a little sore below injection site. Mild start of a headache for two days but never kicked in. Weird taste in my mouth 2 hours after shot that only lasted 2 hours.
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| 63 | 2021-02-10 | fever, nasal congestion, headache |
Contracted Covid on 18Jan; Contracted Covid on 18Jan; Nasal congestion; Fever; Headache; Body aches;...
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Contracted Covid on 18Jan; Contracted Covid on 18Jan; Nasal congestion; Fever; Headache; Body aches; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for herself that a 63 years old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL0142 and Expiration Date 31Mar2021) via an unspecified route of administration on 14Jan2021 around 8:30am-8:45am (vaccine location: left upper arm) at single dose for COVID-19 immunisation. The patient's ongoing medical history included compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, Allergic to sulfa when she was a child, seasonal allergies, graves disease in 2014, which was been in remission for the last few years. Other medical history included high cholesterol. Family history included Her mother has Type II Diabetes; she has some unknown cancers in her family; no further information to provide. There was none other prior vaccinations (within 4 weeks). The concomitant medications were reported as ongoing atorvastatin at 40mg taken once daily for High cholesterol (Taken for a long time, at least 10 years).The day after she got the Pfizer COVID- 19 Vaccine she was around someone who had traveled who she did not realize had not quarantined and had seen relatives who were positive for COVID. Patient was contracted Covid on 18Jan2021 (possibly overnight while sleeping or early morning) and had Mild symptoms. First started with nasal congestion; then developed fever; headache; and body aches. Events has improved, she has gotten much better; just been having a fever on and off and nasal congestion but getting better every day; still just having a little bit of symptoms. She was diagnosed with COVID after that administration. She is not saying the vaccine gave her COVID. She called to ask if she should still get the second dose of Pfizer COVID-19 Vaccine as scheduled for 04Feb2021 with this diagnosis. Rapid COVID test (nasal swab) on 21Jan2021 and Positive for COVID. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
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| 63 | 2021-02-11 | headache |
Pfizer BioNTech COVID-19 Vaccine EUA left armpit lymph node swelling injection site pain headache na...
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Pfizer BioNTech COVID-19 Vaccine EUA left armpit lymph node swelling injection site pain headache nausea joint pain
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| 63 | 2021-02-14 | fatigue |
strange feeling and some pain began on left side of neck, left ear and went up my whole neck to my f...
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strange feeling and some pain began on left side of neck, left ear and went up my whole neck to my face. Unsure what the feeling was then realized it felt numb and swollen. tongue felt thick. kinda of like after being numb at dentist office. I also felt kind of tired. I was afraid my throat was going to close up but it didn't. after 1 hour the feeling began to fade. and then went away.
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| 63 | 2021-02-14 | headache | Severe Headache, body aches |
| 63 | 2021-02-14 | sweating, fatigue, headache, chills |
Extreme tiredness; blurred vision and mental fog; heaviness in the chest; difficulty breathing; mild...
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Extreme tiredness; blurred vision and mental fog; heaviness in the chest; difficulty breathing; mild headache; pain in my toes feeling like they were broken; chills; sweating. Lasted from 3-7 pm although 4-7 I was in a sound sleep but aware of the symptoms I was feeling. It was a very unusual feeling of unconscious then conscious delirium feeling.
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| 63 | 2021-02-15 | chills, headache |
Within in an hour of receiving the vaccine, under the injection about 2-3 inches below the site, the...
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Within in an hour of receiving the vaccine, under the injection about 2-3 inches below the site, the muscle group was sore. The next morning I was dizzy, lightheaded, mild headache, nausea, chills. It went all throughout the day. I just drank some clear liquids and ate some soup. When I woke up the next day about 36 hours after receiving the vaccine I had low energy, nauseous, and lightheaded . By that night my arm started feeling weird, it had a tinging feeling, I went to look at it the mirror and there was a red area and bumps but it was lower under the injection site. It seemed to get worse, swelling and more rash so I took Loratadine 10 MG (antihistamine). I went to bed and when I woke up this morning the rash was gone but the soreness is still there and the tinging feeling in my arm is still there. It feels like when your arm falls asleep. I tried to called my doctor but their phones are down and I will try reach back out this afternoon.
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| 63 | 2021-02-15 | fatigue, chills, headache | site pain, next day body aches, joint pain, headache, chills, no fever. tiredness. for two days |
| 63 | 2021-02-15 | fever |
My body was stiff and sore all over, for about 3 days ran fever 100.7 couldnt go to work 24 hours ,...
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My body was stiff and sore all over, for about 3 days ran fever 100.7 couldnt go to work 24 hours , and chest pains for 5 days and unable to lay on side while sleeping chest was enflamed, shortness of breath
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| 63 | 2021-02-15 | throat irritation, headache, throat clearing |
Patient started with itching all over. Redness and hives on chest. "Itchy throat" with frequent clea...
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Patient started with itching all over. Redness and hives on chest. "Itchy throat" with frequent clearing of throat observed. Bilateral breath sounds were clear and equal. No angioedema noted. Vital sings were monitored. Pulse was 98-99% on room air. Later felt a headache and felt jittery. Benadryl 50 mg PO was administered. Within 20 minutes of Benadryl symptoms improved. Prior to discharge the patient was no longer clearing her throat. Patient states she felt better. Husband reports chest and hive are basically gone. Patient remained alert and oriented x4 the entire visit. Reviewed to continue with over the counter Benadryl and take per directions on bottle. Husband reported he would stop and get Pepcid to take with Benadryl. Patient ambulates out of clinic without problems. 4:28 pm 161/88 89 16 97% 4:36 pm 149/82 79 17 99%. 4:43 pm 142/66 71 17 99%. 5:00 pm 124/ 83 72 15 98%.
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| 63 | 2021-02-17 | chills, throat pain, fever |
tongue was swollen and swore feeling in the back of mouth/tongue sensation continued with swollen fe...
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tongue was swollen and swore feeling in the back of mouth/tongue sensation continued with swollen feeling; tongue was swollen and sore feeling in the back of mouth/tongue sensation continued with swollen feeling; difficulty swallowing; sore throat sensation; no appetite; severe abdominal pains; diarrhea; mild heart palpitations; developed fever of 101 Fahrenheit; chills; back pain; Could not Sleep; This is a spontaneous report from a non-contactable consumer reported for herself. A 63-year-old female patient (not pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3247, via an unspecified route of administration on 22Jan2021 09:00 at single dose in left arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was in hospital. Medical history included Hashimoto Disease; Moderate Metro Valve Prolapse; known allergies: food Intolerances (Gluten, Eggs, Diary, Soy, Corn). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ciclosporin (RESTASIS), calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D), ascorbic acid (VITAMIN C), ubidecarenone (COQ-10). The patient previously received the first dose of bnt162b2 with lot number: L0140 on 30Dec2020 10:30 AM in left arm for covid-19 immunisation, ciprofloxacin (CIPRO) and experienced drug allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 (Friday Evening) post injection, she could not sleep. On 23Jan2021 (Saturday) severe abdominal pains post breakfast; breakfast was gluten free bread with vegan scrambled eggs and coffee w/ oat milk. Continued diarrhea for about 1 hour; mild heart palpitations, developed fever of 101 Fahrenheit; mild chills and back pain. On 24Jan2021 (Sunday) - still with fever 99.8; no appetite. On 25Jan2021 (Monday) - tongue was swollen and sore feeling in the back of mouth; difficulty swallowing; sore throat sensation; pain of swelling caused it hard anything; remained home from work, did not see medical doctor. From 25Jan2021 to 28Jan2021 tongue sensation continued with swollen feeling, each day getting slightly better by 28Jan2021 (Thursday) feeling normal. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered in Jan2021. The reporter considered the case as non-serious. No follow-up attempts are possible. No further information is expected.
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| 63 | 2021-02-17 | chills |
very bad chills; This is a spontaneous report from a contactable consumer (patient). A 63-year-old f...
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very bad chills; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 29Jan2021 14:45 at a single dose for COVID-19 immunisation. Medical history included diabetes, cancer and sleep apnea. Concomitant medications were not reported (received within 2 weeks of vaccination). It was reported that 24 hours after getting the shot (30Jan2021 03:00 PM), she had a very bad chills, they lasted at least an hour. 12 hours after that, she got the chills again and 12 hours after that, the same thing. She took acetaminophen (TYLENOL) and that seems to help. Event was reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Outcome of the event was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 63 | 2021-02-17 | headache |
This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 01:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included benazepril, atorvastatin calcium (LIPITOR), and ubidecarenone (COQ 10). On 02Feb2021 01:15, after 5 minutes getting the vaccine on her left arm, it started to get numb and her back and left leg. She had a headache and nausea. The nurse at the clinic took her to a room to rest and applied ice pack on her left arm. She stayed in the room for 2 hours. At night, her heart rate was rapid and she could not sleep. Next day, she had muscles sore and headache. Therapeutic measure was taken as a result of numbness in the left arm,. No treatment was received for the other events. Clinical outcome of the events was recovered with sequelae. Information on the lot/batch number has been requested.
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| 63 | 2021-02-17 | fever, chills |
This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EK9231, intramuscularly into the left arm on 05Jan2021 at single dose for covid-19 vaccination. Medical history included in Dec2020 around 23Dec2020 she tested positive for Covid-19. There were no concomitant medications. Patient said that because of the time of her retirement, she went to the VA and got the vaccination the first week of Jan2021. She said that with the first vaccination she said that she had chills, fever, and her arm hurt real bad. She said that her symptoms came on during the night. She mentioned she had experienced some side effects which went away after a few days. She had herself tested last 06Jan2021 (also reported as 07Jan2021, pending for clarification) for Covid-19 antibodies which turned out positive and PCR which turned out negative. The outcome of the event "Covid antibodies which turned out positive" was unknown, while outcome of other events was recovered in Jan2021.
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| 63 | 2021-02-18 | fatigue |
Within 1.5 hours of vaccine #1: Eye pain (both), itching without visible rash (left buttock only), ...
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Within 1.5 hours of vaccine #1: Eye pain (both), itching without visible rash (left buttock only), thumb pain, brief leg "heaviness" (both) and fatigue, brief RLQ pain, increased tinnitus. The next evening: low back and neck (bone?) pain while attempting to sleep, out of character to usual back pain. By day 3 post injection, left nose tingling similar to onset of cold sore, which included left side of mouth the next day. By 7 days post injection, entire mouth area felt tingly similar to Novocaine wearing off. This lasted 3 days. Now improved. (took B-12 p.o.) Other brief episodes of chest discomfort, gum irritation, and anxiety. Vaccine #2 scheduled for 2/19/2021
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| 63 | 2021-02-18 | fever, headache, chills | Fever, chills, body pain, headache, nausea, loss of appetite, dizzy for 1 week. |
| 63 | 2021-02-18 | fever |
First vaccine shot - No adverse events. Second vaccine shot - on the next evening (02/18/21), I had...
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First vaccine shot - No adverse events. Second vaccine shot - on the next evening (02/18/21), I had a very slight fever lasting just a couple of hours. Later in the evening, I had swelling and pain under my left arm pit lymph node. The pain continues as of this writing. The pain is dull in nature and more sensitive to the touch.
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| 63 | 2021-02-19 | chills |
24 hours after vaccine, developed: Chills - unable to get warm Rash on left arm, middle, chest, stom...
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24 hours after vaccine, developed: Chills - unable to get warm Rash on left arm, middle, chest, stomach, and back One lymph node enlarged under left arm - size of a golf ball, lasted 2 days
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| 63 | 2021-02-21 | chills, malaise |
I developed chills on Friday, February 19, 2021 in the afternoon. Chills continued through Saturday,...
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I developed chills on Friday, February 19, 2021 in the afternoon. Chills continued through Saturday, February 20, 2021. Did not feel well on Sunday, February 22nd and today, February 22nd, I woke up with a nice dose of shingles on my face. Went to see the nurse practitioner at Dr office. Not sure if this is a coincidence or a result of the vaccine.
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| 63 | 2021-02-21 | fever |
nausea, sharp abdominal pains, flushing, fever to 100.9 degrees F beginning the morning after secon...
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nausea, sharp abdominal pains, flushing, fever to 100.9 degrees F beginning the morning after second immunization (approx. 18 hours post) and lasting approx. 12 hours, some residual abdominal pain and nausea for an additional day
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| 63 | 2021-02-22 | chills |
Trigeminal Neuralgia; Nausea; Chills; Body aches; Lightheadedness; Trigeminal nerve disorder; This i...
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Trigeminal Neuralgia; Nausea; Chills; Body aches; Lightheadedness; Trigeminal nerve disorder; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot: EL1284/expiration date not provided) via intramuscular route of administration, in left arm, on 19Jan2021 (at the age of 63 years old) as a single dose for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included losartan, amlodipine, metoprolol, esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL0140/expiration date not provided) on 29Dec2020 (at the age of 63 years old) as a single dose in the left arm for COVID-19 immunization. On 20Jan2021, the patient experienced nausea, chills, body aches, lightheadedness, trigeminal nerve disorder. On 22Jan2021, the patient was diagnosed with trigeminal neuralgia. The events resulted in a physician office visit and Emergency Room visit. The seriousness criteria was disabling/incapacitating. The facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been not been tested for COVID-19. Treatment received for the events included steroids, anti-convulsant and pain relievers. The outcome of the events was not recovered. Follow-up (08Feb2021): New information from a contactable nurse (patient) includes: new event (trigeminal neuralgia), event details, seriousness criteria, treatment received and events outcome.; Sender's Comments: Based on the plausible temporal association and considering lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported events, nausea, chills, body aches, lightheadedness, trigeminal nerve disorder, Trigeminal Neuralgia and the administration of the COVID-19 vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 63 | 2021-02-22 | fever |
2/9 NEXT DAY IN AM 99.7 FEVER; SORE ARM MUSCLE TO MOVE ARM. 2/10 DAY TWO 48 HRS 3-6:00PM TIGHT BU...
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2/9 NEXT DAY IN AM 99.7 FEVER; SORE ARM MUSCLE TO MOVE ARM. 2/10 DAY TWO 48 HRS 3-6:00PM TIGHT BURNING CENTER CHEST PAIN TOOK TYLENOL; WATER. 2/11 DAY 3 - TIGHT BURNING CHEST PAIN INTERMITTENT ALL DAY - TOOK TYLENOL; HYDRATED WITH WATER. 2/12 DAY 4 - NO DISCOMFORT; GOT COVID TEST TO RULE OUT - NEGATIVE. 2/13 DAY 5 TIGHT CHEST PAIN 1:00PM TOOK TYLENOL SUBSIDED ONE HOUR. 8:00PM BLOODY NOSE 30 MINUTES. OK THERE AFTER.
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| 63 | 2021-02-23 | fatigue |
Vision - brightly colored light flashes at edge of vision, left eye at 11:20 am, 10 minutes later a...
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Vision - brightly colored light flashes at edge of vision, left eye at 11:20 am, 10 minutes later also added blurred vision left eye. Both symptoms gone by 1:40 pm with no residual effects from the side effect afterwards. Fatigue for remainder of the day. No treatment other than rest in a chair until vision returned to normal.
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| 63 | 2021-02-24 | chills, fatigue, headache, body temperature increased |
Chills, 102°, headache, body aches, extreme fatigue and injection site pain Symptoms began within...
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Chills, 102°, headache, body aches, extreme fatigue and injection site pain Symptoms began within 45 minutes lasted 48 hrs , treated with Tylenol. Unable to get out of bed.
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| 63 | 2021-02-24 | headache | Lasting effects are increased heart rate, itching, hematomas, head pain, chest pain and heavy lungs |
| 63 | 2021-02-24 | malaise, body temperature increased |
I had a minimally sore injection sight the morning I had the vaccine. As the day went on I began to ...
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I had a minimally sore injection sight the morning I had the vaccine. As the day went on I began to feel joint pain in my back. Around 2:00pm I began to feel chills. Around 5:00pm I registered a temperature of 99.1. My usual temperature is 96.7. I then had trouble staying asleep, had intense joint pain in my back, hands, and feet, which I treated with Tylenol around 11:00pm. I experienced heavy night sweats where I woke up at 5:15 am being soaked. The symptoms I felt overnight felt just like what I had when I was sick with Covid 19 in December 2020. My temperature had returned to normal by 6:00 am.
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| 63 | 2021-02-24 | fever, fatigue |
FELT LIKE I HAD COVID AGIAN . BODY PAIN ,FEVER , GI UPSET . SHORT OF BREATH ,FATIGUE LASTED FOR...
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FELT LIKE I HAD COVID AGIAN . BODY PAIN ,FEVER , GI UPSET . SHORT OF BREATH ,FATIGUE LASTED FOR 4 DAYS
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| 63 | 2021-02-25 | body temperature increased, sweating |
got dizzy; felt queasy; Temp was lightly elevated; Sore injection site; Could not sleep, very uncomf...
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got dizzy; felt queasy; Temp was lightly elevated; Sore injection site; Could not sleep, very uncomfortable.; Got hot and sweaty about 3 1/2 hours after shot.; Got hot and sweaty about 3 1/2 hours after shot.; administration_date=26Jan2021; other vaccine date = 26Jan2021; administration_date=26Jan2021; other vaccine date = 26Jan2021; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unknown route of administration on left arm (L shoulder/Arm) on 26Jan2021 at 09:00 AM at the age of 63 years old at a single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included RA (Rheumatoid arthritis), Penicillin allergy and covid-19 (The patient was diagnosed with COVID-19 prior to vaccination). Concomitant medications included leflunomide (ARAVA) at 20mg, once a day, daily vitamins and mesalamine 1/day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Also reported administration date 26Jan2021; other vaccine date 26Jan2021. On 26Jan2021 09:00, the patient experienced sore injection site (shot was given very high on L shoulder/Arm). Felt like a sharp pain when given. Got hot and sweaty about 3 and an half hours after shot. Could not sleep, very uncomfortable. Next morning (on 27Jan2021), the patient was getting ready to eat breakfast and got dizzy and felt queasy. Temp was lightly elevated. Taking Tylenol to help control soreness. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events administration_date=26Jan2021; other vaccine date = 26Jan2021 was unknown and patient was recovering from all other events. Information on the lot/batch number has been requested.
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| 63 | 2021-02-25 | chills |
anxious; chills; No appetite; metallic taste in her mouth/ had a burnt taste in her mouth; burning s...
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anxious; chills; No appetite; metallic taste in her mouth/ had a burnt taste in her mouth; burning sensation in her whole torso; fast heart rate; This is a spontaneous report from a contactable consumer reported for self and a contactable consumer (husband). This 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 09:00 on Arm left via Intramuscular at single dose (Lot # EL3247) for covid-19 immunisation. Medical history included allergic to penicillin when she was a kid. She said that her lips swelled up. No other products. Since receiving the vaccine, she's had a burnt taste in her mouth on 20Jan2021 and also reported that she had a burning sensation in her whole torso that lasted 2-3 mins after she received vaccine on 20Jan2021 and her heart rate was racing but resolved after a few minutes. She had a metallic taste in her mouth. It made her very anxious and she was having a fast heart rate on 20Jan2021. She got panicky because of the metallic taste. She clarified that the burning sensation she felt was a burning in her whole torso on 20Jan2021 and it was extremely hot like a chemical went into her body that was burning her guts. She said that the burning sensation only lasted 2-3 minutes and was gone. She said that she got scared and her heart was racing a little bit on 20Jan2021. Her heart racing resolved that same day after a little bit. She clarified that she has like a burnt taste in her mouth. She said that it is the roof of her mouth and her tongue that taste like this. The burnt taste is still ongoing. She said that she tried to call the physician, but has not heard back yet. She said that she had chills and no appetite that day on 20Jan2021, but it was gone by the next day 21Jan2021. Outcome of the event metallic taste in her mouth/ had a burnt taste in her mouth was not recovered. Outcome of the event burning sensation, fast heart rate was recovered on 20Jan2021. Outcome of the events chills and no appetite was recovered on 21Jan2021. Outcome of other event was unknown.
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| 63 | 2021-02-25 | headache |
general aching joint pain, headache, spine pain not muscle pain felt like back was broken started ar...
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general aching joint pain, headache, spine pain not muscle pain felt like back was broken started around midnight lasted untill late evening. left thigh pain like someone was doing a vein stripping. nausea no vomiting. Felt bad for 2 days. reddness on left arm not at shot site with left arm pain for 2 days. reddness in lt arm still there 02-26-2021.Red raised area warm no drainage.
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| 63 | 2021-02-25 | fever, chills, fatigue, malaise |
Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb; Cold sensation in...
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Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb; Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb/Arm still has this sensation (like sleep, cold, numb feeling); Arm still has this sensation (like sleep, cold, numb feeling); Fever 102 degrees Fahrenheight; Feeling sick; Chills; Shakes; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date: Mar2021), intramuscularly on the left arm on 07Jan2021 (09:00) at a single dose for COVID-19 immunization at the school/student health clinic (not a military facility). Medical history included ongoing rheumatoid arthritis diagnosed about 5 years ago; ongoing high blood pressure diagnosed a couple of years ago, and ongoing Grave's disease diagnosed about 30-32 years ago. Concomitant medications included ongoing hydroxychloroquine phosphate (PLAQUENIL) for rheumatoid arthritis; and levothyroxine sodium (SYNTHROID) for Grave's disease. On 07Jan2021, the patient had cold sensation in the arm, tingly sensation down in her arm like her arm was cold/numb; arm still had the sensation (like sleep, cold and numb feeling); had fever with body temperature of 102 degrees Fahrenheit; was feeling sick; had chills; shakes; and fatigue. The outcome of the events was not recovered for 'cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb' and 'arm still had the sensation (like sleep, cold and numb feeling)'; was recovered on 09Jan2021 for 'fever with body temperature of 102 degrees Fahrenheit', 'chills', 'shakes' and 'fatigue'; and was recovered in Jan2021 for 'feeling sick'. The patient was asking if these same symptoms should be expected after the second dose, and if it would be okay to get the second dose of vaccination.
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| 63 | 2021-02-25 | throat irritation |
(2/25/2021) PATIENT REPORTS TO OFF-SITE COVID-19 VACCINE CLINIC. PATIENT FILLS OUT VACCINE CHECKLIST...
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(2/25/2021) PATIENT REPORTS TO OFF-SITE COVID-19 VACCINE CLINIC. PATIENT FILLS OUT VACCINE CHECKLIST AND IT IS NOTED THAT PATIENT HAS PREVIOUS ISSUES WITH FLU SHOT WITH A HISTORY OF TORUBLE BREATHING. TEACHING IS PROVIDED WITH PATIENT REGARDING POSSIBLE SIMILAR REACTIONS WITH COVID-19 VACCINE AND THAT SHE SHOULD STAY AT LEAST 30 MINUTES AFTER VACCINATION IF SHE WISHES TO PROCEED. PATIENT CONSENT TO PROCEED WITH COVID-19 VACCINATION. VACCINE IS GIVEN AT 1000 INTO RIGHT ARM AND PATIENT IS ASKED TO STAY FOR OBSERVATION. AT 1030 PATIENT REPORTS TO THIS NURSE ITCHING AND HIVES. PATIENT IS OBSERVED TO HAVE HIVES COVERING BILATERAL ARMS AND CHEST. PATIENT DENIES BREATHING TROUBLE AT THIS TIME. EMERGENCY REACTION KIT IS BROUGHT TO PATIENT?S TABLE. AT 1032 ON CALL PROVIDER IS NOTIFIED OF REACTION AND ORDERS ARE GIVEN FOR BENADRYL 50MG IM. THIS IS GIVEN AT 1034 RN INTO GUTEAL AND PATIENT IS OBSERVED AND VS OBTAINED. AT 1040 PATIENT STATES HER THROAT FEELS ?SCRATCHY? AND ?TIGHT.? IT IS RECOMMENDED TO PATIENT SHE SHOULD BE SEEN IN THE EMERGENCY ROOM. PATIENT AGREES TO THIS IF SHE IS ABLE TO DRIVE HERSELF. PATIENT IS FOLLOWED IN HER VEHICLE TO EMERGENCY ROOM FROM OFF-SITE CLINIC (APPROX. 8 BLOCKS). ON CALL PROVIDER IS NOTIFIED AND HOSPITAL EMERGENCY ROOM IS GIVEN REPORT FROM THIS NURSE. UPON ARRIVAL TO ER PATIENT IS SEEN PER MD. PATIENT REPORTS SYMPTOMS OF CHEST PRESSURE, DYSPNEA, LIGHT HEADEDNESS, ABDOMINAL PAIN, RASH, REDNESS, WARTHM AND ITCHING. PATIENT IS GIVEN 0.4 MG SUBCU ADRENALINE AND 40 MG PREDNISONE ORALLY. PATIENT IS OBSERVED IN EMERGENCY ROOM x 1 HOUR. PATIENT REPORTS SHE IS STARTING TO FEEL BETTER. PATIENT IS DISCHARGED TO AT 1206 FROM EMERGENCY ROOM.
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| 63 | 2021-02-26 | chills | Cold chills, diarrhea, vomiting, shortness of breath, muscle soreness, light headed |
| 63 | 2021-02-26 | influenza like illness, headache, body temperature increased, throat pain, malaise |
Starting a couple hours after vaccination, I began to feel unwell, overall poorly, nothing specific....
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Starting a couple hours after vaccination, I began to feel unwell, overall poorly, nothing specific. Went to be early at 9:30 and awoke at one a.m.on February 26 with splitting headache. Could not get back to sleep well and felt terrible all that day with headache, nausea, and foggy thinking, not funcional after about 2:30 p.m. Took Ibuprofen at 3 p.m., called doctor and went to ER at Medical Center. Was seen at ER a few hours later. Slept some in waiting room. Had sore throat, the worst splitting migraine type headache ever, and was extremely foggy headed, couldn't process thoughts, eyes had difficulty focusing, nausea. My temperature was a little high for me, I am normally low and it was 99. My blood pressure is usually low and it was 105/59, pulse was 82 and respiration was 16 with 96 % Oxygen Saturation. They did tests and had an ophthalmoligist give me an exam also. They said I could go home with the same meds they were giving me in the hospital since they were working to alleviate my painful headache, 600 mg of ibuprofen, reglan and benadryl. Before I left they gave me the potassium chloride. I am continuing my medications today, two days after my vaccine.
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| 63 | 2021-02-28 | headache, chills |
Rash on lower left leg and foot and burning sensation on saying. Patient is affected by CRPS 2. Chi...
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Rash on lower left leg and foot and burning sensation on saying. Patient is affected by CRPS 2. Chills aches and pains and headache the latter lasted three days
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| 63 | 2021-02-28 | fever, fatigue |
Low grade fever (100.3) after one week with progressive weakness, fatigue and swallowing dysfunction...
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Low grade fever (100.3) after one week with progressive weakness, fatigue and swallowing dysfunction analogous to exacerbation of her autoimmune disease (LUPUS) which had been in remission (on medication) for 5 years.
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| 63 | 2021-02-28 | fever |
tingling sensation left skull; fever 101.8; Mild left arm soreness; This is a spontaneous report fro...
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tingling sensation left skull; fever 101.8; Mild left arm soreness; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiry date: 31May2021), via intramuscular route of administration in the left arm on 15Jan2021 10:05 at a single dose for COVID-19 immunization. Medical history included open cholecystectomy in 1990, hypertension, and sleep apnoea (CPAP). The patient's concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22 Dec2020 and experienced fever, nausea, vomiting, diarrhea, metallic taste in mouth, Loss of taste/smell, minimal soreness at the site of injection, strange sensation of tingling in her skull, chills, dry mouth, feels like she has no saliva, tongue felt a little bit too dry, extremely tired, thirst, and altered taste. The patient experienced mild left arm soreness on 15Jan2021 and fever 101.8 on 16Jan2021 23:00. Patient took ibuprofen 400mg and ondansetron (ZOFRAN) 4mg. The patient also experienced tingling sensation left skull continues as described. The patient had no cough, sore throat, stuffy or runny nose. She had no shortness of breath, no nausea vomiting or diarrhea, and no loss of taste/smell or metallic taste in mouth. The patient underwent lab tests and procedures which included body temp: 99.7 on 15Jan2021 18:00, 101.8 on 16Jan2021 11 PM, 99.5 on 16Jan20213 PM, 99.8 on 16Jan2021 10 PM, 99.5 on 17Jan2021 9:00, 99.8 on 17Jan2021 8 PM, 100 on 17Jan2021 10 PM, 99.4 on 18Jan2021 07:00, 99.7 on 19Jan2021 16:00, 98.6 on 20Jan2021 11 AM. Outcome of tingling sensation left skull was not recovered, of remaining events was unknown.
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| 63 | 2021-03-01 | fatigue |
This is the 2nd time since my 2nd shot my throat neck glands are big and sore & thyroid is swelled u...
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This is the 2nd time since my 2nd shot my throat neck glands are big and sore & thyroid is swelled up & sore difficult to swallow. Extreme long lasting exhaustion. Body is weak & sore muscles & joints. I have not been ok since my 2nd shot. I had a hard marble lymph node in my neck after the 2nd shot too.
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| 63 | 2021-03-02 | chills, fever | Bruising and pain at palm up to mid-arm. Swollen arm. 24 hours Fever and chills. 4 hours |
| 63 | 2021-03-02 | cough, fatigue, headache, malaise, fever |
COVID shots Shot Feb 1, 2021 Day one of shot fatigue Day two of shot thigh cramps Day three of shot ...
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COVID shots Shot Feb 1, 2021 Day one of shot fatigue Day two of shot thigh cramps Day three of shot nausea Day four of shot back and joint pain Day five of shot sick feeling aching all over. Muscle and joint pain and fatigue. Chest pressure, cough, Hoarse voice Day six of shot headache fatigue pain through right eye. 2/5Temp 96.6, 98.6, 1:00pm SPO% 93% Resting heart rate 90 6:30pm SPO% 89%-91% Resting heart rate 102 Tylenol 100 mg 9:00am, 3:30pm TEMP 4:30pm 99.7* Symptoms of the freezing chest and cough as well as headache and feeling poorly kept rising several times a week. Covid 3/1/21 Covid symptoms return just like after Covid 19 1st vaccine. Body aches, joint pain, Chest pain, muscle aches, frozen feeling in lungs, cough, abdominal pain,eye ache, headache and fever. Temp 95.5 SPO 89% - 94% Resting heart rate 92 - 95 (After Covid shot 89%SPO, RHR 105, temp 99.7) 12:25pm temp 99 2/2/21 Feeling a little better. Still fatigue and ill feelings. At nighttime cough comes back with freezing lung feeling. Also started and body aches and joint stiffness. Went to bed took ibuprofen. 2/3/21 Still feeling ill . Woke with productive cough a little looser. Headache fatigue just feeling crummy.
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| 63 | 2021-03-02 | sweating |
Immediately after second dose of Pfizer Covid-19 vaccine given, patient developed a yellow bruise at...
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Immediately after second dose of Pfizer Covid-19 vaccine given, patient developed a yellow bruise at injection site. She reports feeling like a foreign body in injection site and reports feelings of tightness, pressure, and heat at site. Patient developed swelling of right arm over the next 3 weeks. Patient saw her PCP on 2/12/21 and an ultrasound was done to R arm. Results were negative. Five to six weeks post vaccine administration, patient is reporting weight loss over 10 pounds, possible hair loss, loose stools, and sweaty palms and feet. She also reports the right arm pressure and tightness is now radiating to her upper back.
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| 63 | 2021-03-02 | fever | LOW GRADE FEVERS 100.1, LEFT UPPER QUADRANT ABDOMINAL PAIN |
| 63 | 2021-03-02 | throat irritation |
2/28 6pm face flushed and puffy 10pm anxiety on guard, trouble sleeping 3/1 6am hea...
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2/28 6pm face flushed and puffy 10pm anxiety on guard, trouble sleeping 3/1 6am heart rate 108, no temp scratchy throat 10am diarrhea ; unease and rapid heart rate continue 5pm read about adverse events, called doctor, took Benadryl and began to feel better. 3/2 am communicated with doctor and she advised holding off on second shot, next steps tbd
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| 63 | 2021-03-03 | chills, headache, fever, fatigue | Tiredness, headache, muscle pain, chills, fever |
| 63 | 2021-03-03 | chills, fever |
Severe body aches/chills and 101 fever for about 8 hours had to be in bed couldn?t function This occ...
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Severe body aches/chills and 101 fever for about 8 hours had to be in bed couldn?t function This occurred with the 2 nd shot also
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| 63 | 2021-03-03 | dehydration, headache |
About 9 PM headache started and I had that until Saturday morning. I don' t get headaches that often...
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About 9 PM headache started and I had that until Saturday morning. I don' t get headaches that often so it was unusual. I took Tylenol - which helped. I was admitted to the hospital for February 8 for bronchitis. About the fourth of February is when I started getting symptoms of this. I was in the hospital from the 8-10th. Hospital. Bronchitis resolved around the 20th of February.
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| 63 | 2021-03-03 | fever |
Fever; joint & muscle pain; joint & muscle pain; Injection site - large red spot (about 4 inches in ...
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Fever; joint & muscle pain; joint & muscle pain; Injection site - large red spot (about 4 inches in diameter); swollen; hot to touch; other vaccine same date dose number 6; This is a spontaneous report from a contactable healthcare professional (patient). This 63-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; EL3247) via an unspecified route of administration in the left arm on 29Jan2021 at 14:15 (at the age of 63-years-old) as a single dose for COVID-19 immunization. Medical history included allergy to shellfish and allergy to eggs, both from unknown dates and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EL0142) in the left arm on 11Jan2021; codeine from an unknown date for an unknown indication and experienced allergy; celecoxib (CELEBREX) from an unknown date for an unknown indication and experienced allergy; and alendronate sodium (FOSAMAX) from an unknown date for an unknown indication and experienced allergy. The patient reported fever, joint and muscle pain 24 hours after the vaccine and stated it lasted about 18 hours. She also reported about the injection site that it was a large red spot (about 4 inches in diameter), it was swollen and hot to touch starting about 24 hours after vaccination. She reported 3 days later it was still red, swollen and hot to touch. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The clinical outcomes of fever, joint and muscle pain were recovered on 31Jan2021. The clinical outcomes of large red spot (about 4 inches in diameter), swollen, hot to touch were not recovered. The clinical outcome of other vaccine same date dose number 6 was unknown. It was also reported that since vaccination, the patient had not been tested for COVID-19.
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| 63 | 2021-03-04 | headache |
Approximately one hour after the shot, my face began feeling strange. My nose was red and warm as w...
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Approximately one hour after the shot, my face began feeling strange. My nose was red and warm as well as my cheeks. Then my lower lip began to swell. I would consider these symptoms somewhere between mild to moderate. The symptoms began around 4:30 in the afternoon and subsided as the evening progressed. The next morning (today), my face feels basically normal again. My only symptoms now are a sore arm and a slight headache. I have experienced allergic reactions before but never from a vaccine.
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| 63 | 2021-03-04 | fever |
after 6 (six) days of the 1st (first) shot, had fever of 100.2 degree by arm and whole body aches. ...
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after 6 (six) days of the 1st (first) shot, had fever of 100.2 degree by arm and whole body aches. the symptoms gradually and finally went away in 36 hours
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| 63 | 2021-03-04 | fever |
Began running a fever until 5 a.m. on 3/5/2021. The fever stayed at 100+ even with Tylenol. Tempe...
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Began running a fever until 5 a.m. on 3/5/2021. The fever stayed at 100+ even with Tylenol. Temperatures were: 101, 102, 103, 106. I literally ran the same symptoms as I had when I was ill with covid a year ago. I would have sought out help if it didn't break by the next day. I kept cold compresses on my head and back of my neck.
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| 63 | 2021-03-06 | fatigue |
3/5/21 woke with puffiness below right eye 3/6/21 extremely tired, just wanted to sleep 3/7/21 eyeli...
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3/5/21 woke with puffiness below right eye 3/6/21 extremely tired, just wanted to sleep 3/7/21 eyelids swollen near nose
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| 63 | 2021-03-07 | dehydration |
Increased heart rate; Feeling very dehydrated; This is a spontaneous report from a contactable nurse...
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Increased heart rate; Feeling very dehydrated; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization and lisinopril, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for hypertension. Medical history included patient was prediabetic. The patient's concomitant medications were not reported. On an unspecified date in 2021, patient was having a little bit of concern, she just had side effects that were a little scary. She have had like an increased heart rate and now, feeling very dehydrated. The action taken in response to the events for lisinopril was unknown. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 63 | 2021-03-07 | fatigue, nasal congestion |
Hot, flushed face and ?stuffy? nose within 20 minutes of vaccine. Abated within two hours. Extreme ...
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Hot, flushed face and ?stuffy? nose within 20 minutes of vaccine. Abated within two hours. Extreme fatigue within 7 hours of vaccine. Woke up next day with burst blood vessels in R eye.
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| 63 | 2021-03-07 | fatigue |
classic migraine-type headache 03/05-present overall muscle ache 03/05-present fatigue 03/05-prese...
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classic migraine-type headache 03/05-present overall muscle ache 03/05-present fatigue 03/05-present nausea 03/05-present L foot & ankle swelling 03/06-present
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| 63 | 2021-03-07 | fatigue |
Swelling in ankles/feet/calves/upper thighs, shortness of breath, fatigue. muscle soreness all over,...
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Swelling in ankles/feet/calves/upper thighs, shortness of breath, fatigue. muscle soreness all over, joint pain (esp. wrists & knees). Was hospitalized for 3 days 3/20 - 3/23/2021.
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| 63 | 2021-03-07 | headache, chills, fever, fatigue |
Tiredness, headache,muscle pain,chills,fever all cleared up in 24 hrs; minor dizziness on 3rd day cl...
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Tiredness, headache,muscle pain,chills,fever all cleared up in 24 hrs; minor dizziness on 3rd day cleared up after several hours.
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| 63 | 2021-03-07 | headache, fever, fatigue |
Arm aching took acetaminophen. Extremely tired, short of breath, headache, low fever, achy muscles ...
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Arm aching took acetaminophen. Extremely tired, short of breath, headache, low fever, achy muscles all lasting to 30 hours after vaccine. Itchy Rash on arm and hard sport for 4 days.
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| 63 | 2021-03-08 | chills, upper-airway cough syndrome, headache |
I started to get a headache around 6:30 - by 9:30 the whole right side of my head felt as if it had ...
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I started to get a headache around 6:30 - by 9:30 the whole right side of my head felt as if it had a knife going from the base of my skull though my eye out the top of my skull. I was up most of the night with the most severe head pain that I think I've ever experienced. My husband stayed up most of the night with meI had taken 2 Tylenol and a muscle relaxer-Ophedrine? It did nothing for the pain. -I finally fell asleep around 5am and woke at around 7am. The head pain was gone. I had another duller headache the next night but not bad. Also had nasal drip and a few chills but that didn't last long. ( I think I might've had Covid in Feb 2020-I was sick for 4 weeks with strange symptoms that ranged from headaches, extreme nasal drip, dry cough, exhaustion, 3 days of inability to taste food but no fever)
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| 63 | 2021-03-08 | chills |
Ringing in ears that I still have a week later. (I know of two friends in other parts of the countr...
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Ringing in ears that I still have a week later. (I know of two friends in other parts of the country that are also suffering with this.) Also, around 12 hours after shot I had four hours of extreme muscle pain and shivering. This was on my first dose. I know it's prevalent on the 2nd dose. I'm not worried about that but am concerned with my hearing.
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| 63 | 2021-03-08 | chills | Diarrhea for 4 hours Chills and Low Body Temperature (below 96 degrees) for 4 Hours |
| 63 | 2021-03-08 | cough |
Coughing about 15 minutes after vaccine, eacalated to asthma exacerbation; given benadryl, used alb...
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Coughing about 15 minutes after vaccine, eacalated to asthma exacerbation; given benadryl, used albuterol 2 puffs, no response. Taken to ED and given 2 duo-nebs, 40 mg prednisone, chest xray. Dischargedbhome
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| 63 | 2021-03-08 | fever, chills |
24 hrs after getting injection, stated running fever of 99. Chills, body aches and pains in the joi...
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24 hrs after getting injection, stated running fever of 99. Chills, body aches and pains in the joints
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| 63 | 2021-03-08 | fever, cough, fatigue | Fever to 101.8, body aches, fatigue. Mild cough |
| 63 | 2021-03-08 | sluggishness |
1st Day after vaccine - arm soreness, sluggish feeling 2nd Day after vaccine - flushed/warm feeling ...
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1st Day after vaccine - arm soreness, sluggish feeling 2nd Day after vaccine - flushed/warm feeling in face
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| 63 | 2021-03-09 | chills, fatigue | Bad Stomach ache, chills, pain in lower left buttocks, fatigue |
| 63 | 2021-03-09 | chills, sleepiness, fever, fatigue |
Chills; achy; low grade fever; tired; Arm sore at injection site; all the patient did was sleep.; Th...
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Chills; achy; low grade fever; tired; Arm sore at injection site; all the patient did was sleep.; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EM9809) via an unspecified route of administration on 04Feb2021 16:00 in the left arm at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, COVID (prior vaccination). There was no other vaccine in four weeks. The patient received other medications in two weeks (unspecified). The patient has no COVID tested post vaccination. The patient experienced chills, achy, low grade fever, tired, arm sore at injection site, and all the patient did was sleep. Event onset date reported as 05Feb2021 06:00. Following day, feel much better. Body temperature showed low grade fever on 05Feb2021 06:00. No treatment received for the events. The outcome of the events was recovered in Feb2021.
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| 63 | 2021-03-09 | fatigue, fever | fever of 100.4, fatigue |
| 63 | 2021-03-09 | headache, chills, fatigue |
Onset of chills, body aches, joint pain, headache, diareah During night face turned bright red and b...
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Onset of chills, body aches, joint pain, headache, diareah During night face turned bright red and body felt hot General tired and achy lasting 4 days
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| 63 | 2021-03-09 | headache |
Thickening of tongue; itching arms,legs,face, head; headache; This is a spontaneous report from a co...
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Thickening of tongue; itching arms,legs,face, head; headache; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm right on 06Feb2021 at 12:00 (at the age of 63-year-old) at single dose for COVID-19 immunization. The patient was not pregnant. Medical history included asthma, fibromyalgia, COVID-19 and allergies, all from an unknown date and unknown if ongoing. Concomitant medication included fluticasone furoate/vilanterol trifenatate (BREO ELLIPTA), tiotropium bromide (SPIRIVA), spironolactone, simvastatin and omeprazole (PROTONIX). On 06Feb2021, the patient experienced thickening of tongue, itching (arms, legs, face, head) and headache. No therapeutic measures were taken as a result of the events. The patient outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 63 | 2021-03-10 | fatigue, headache |
HA and muscle pain at injection site within 1 hour, joint pain at shoulders/hips/ feet starting at...
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HA and muscle pain at injection site within 1 hour, joint pain at shoulders/hips/ feet starting at 14 hours post dose and lasting for 36 hours. all treated with tylenol and NSAID. Moderate fatigue requiring rest for 24 hours. palpitations for 30 minutes at 14 hours post dose - no treatment, self-resolved
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| 63 | 2021-03-10 | fatigue, headache | headache, fatigue, arm pain, body aches |
| 63 | 2021-03-10 | fatigue, fever, chills |
Started feeling symptoms on Saturday when I woke up. Continued to be extremely tired for 4 days, fev...
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Started feeling symptoms on Saturday when I woke up. Continued to be extremely tired for 4 days, fever for two days (highest was 101.9), chills, whole body ached. Was extremely fatigued walking from the bedroom to the kitchen or family room. Woke up on the fifth day feeling better but doing too much brought back the fatigue.
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| 63 | 2021-03-10 | headache, chills, fever | Low grade fever, chills, body aches, headache, shot site pain - lasted 12 hours |
| 63 | 2021-03-10 | headache, throat pain, fatigue |
Had Bamlanivimab IV on December 9, 2020 at The County Hospital. On 3/9/2021 had first Covid injecti...
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Had Bamlanivimab IV on December 9, 2020 at The County Hospital. On 3/9/2021 had first Covid injection. I had slight headache, sore throat, gland in neck swollen, chills and bad hip pain that started about11:00 am on 3/10/202. Today, feeling some better but very tired.
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| 63 | 2021-03-10 | headache |
pulmonary embolism/Blood clots in the lung; heart attack; Shortness of breath; headache; jaw hurt; S...
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pulmonary embolism/Blood clots in the lung; heart attack; Shortness of breath; headache; jaw hurt; Shin hurt; heart burn; This is a spontaneous report from a contactable consumer (patient's son). A 63-year-old female patient (mom) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration in arm in Feb2021 (reported as in the first week of Feb2021) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 in Jan2021 for COVID-19 immunization. Reporter (patient's son) received his first dose of Pfizer COVID vaccine on Wednesday and wanted to know if this vaccine could cause blood clot. He stated his mom (patient) in the hospital due to pulmonary embolism from 24Feb2021, 2.5 weeks after her second shot. He stated his anxiety levels were higher than normal. He had strong response to flu vaccine this year and experienced chill, shakes, fever, received antibiotic, and loss sense of taste from the flu vaccine. Reporter read online that some people commented that they have DVTs (deep vein thrombosis) and blood clots from the Pfizer COVID vaccine. Patient experienced blood clots in the lung in Feb2021 and hospitalized on 24Feb2021. Patient got her second shot about 2 weeks before and she ended up in the hospital with pulmonary embolism. They looked at her lungs and found all the blood clots. Patient had really bad shortness of breath, headache, her jaw hurt, and her shin hurt. She was helping out at vaccine clinic and she was out of breath, she said the old people in strollers were passing her. Patient began to make complaints about how she was feeling in mid of Feb2021. Patient said in rare cases 2 weeks after the second dose reactions could happen. Patient got done working in ICU, and helped with PPE, then at 11 she left work at the hospital, she was experiencing heart burn for 3 days and so she thought had a heart attack drove to an ER (emergency room) on the way home, and then was admitted to the hospital on that same day 24Feb2021, she was supposed to be discharged today (26Feb2021). Patient had been feeling out of breath for past 2 month, it was possible it might seem like it was related to the vaccine but it could also not be related. Reporter stated that on the internet he saw how a 1000 deaths happened after the vaccine, it was all old people, but in the autopsies there was no link to the vaccine, they were going to die regardless. Lab data included: She did get a test before for Factor 5 Leiden but it was negative. They did test for COVID, it was negative, while in the hospital. In the hospital they were also testing her again for the Factor 5 Leiden, the results hadn't come back yet. They did test for blood clots, they did an MRI (magnetic resonance imaging) in Feb2021, it was positive for blood clots (blood clots in the lungs). When she was admitted her oxygen was 85%. Outcome of the events was unknown. Information on lot and batch number has been requested.
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| 63 | 2021-03-10 | sweating |
Dry mouth, anxiety, tongue swelling, flushing/sweating. BP 160/84, pulse 111. Took Benadryl 50 mg PO...
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Dry mouth, anxiety, tongue swelling, flushing/sweating. BP 160/84, pulse 111. Took Benadryl 50 mg PO.
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| 63 | 2021-03-10 | throat irritation |
pt stated that she got really warm within a couple of minutes of getting the vax. Pt got tightness...
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pt stated that she got really warm within a couple of minutes of getting the vax. Pt got tightness under eyes, checks, and inside her mouth. She had some pinching feelings in her chest which she said this may be acid reflux. Her right leg was hurting near her ankle and foot. Nurse at vax site checked her stats and everything was normal. She was given Benadryl. These symptoms subsided. After getting home she had some tickling in her throat. Pt only has soreness and redness in her left arm today.
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| 63 | 2021-03-10 | throat irritation | throat swelling, tongue swelling, throat itching, SOB, hives |
| 63 | 2021-03-11 | cough, headache |
All over body aches and soreness, headache, heaviness in lungs with shortness of breaths, cough, an...
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All over body aches and soreness, headache, heaviness in lungs with shortness of breaths, cough, and hypersensitivity on skin. Took tylenol and rested. Lasted about 4 days.
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| 63 | 2021-03-11 | fatigue, headache, chills, malaise, fever |
ADVERSE EVENTS: INJECTION SITE PAIN, TIREDNESS, HEADACHE, MUSCLE PAIN, CHILLS, JOINT PAIN, FEVER (1...
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ADVERSE EVENTS: INJECTION SITE PAIN, TIREDNESS, HEADACHE, MUSCLE PAIN, CHILLS, JOINT PAIN, FEVER (101.9 DEGREE F @ 2 AM 3/11/21 & BETWEEN 100.6 - 99.6 THROUGH THE EVENING 3/11/21), NAUSEA, FEELING UNWELL, SWOLLEN LYMPH NODE. TREATMENT: TYLENOL EVERY 4 HOURS STARTING AT 8 AM 3/11/21. SYMPTOMS SUBSIDED THROUGH THE LATE NIGHT OF 3/11/21 EXCEPT SWOLLEN LYMPH NODE & INJECTION SITE PAIN STILL PERSISTS 3/12/21.
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| 63 | 2021-03-11 | headache, fatigue | Light-headed; "foggy brain"; fatigue; headache |
| 63 | 2021-03-11 | headache, sweating, chills, fatigue |
Vomiting (vomited about eight times); massive headache; chills; sweats; and fatigue. Lasted another ...
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Vomiting (vomited about eight times); massive headache; chills; sweats; and fatigue. Lasted another 30 hours.
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| 63 | 2021-03-11 | headache |
Severe headache, taking Advil & Tylenol, having no effect on the headache, headache still present as...
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Severe headache, taking Advil & Tylenol, having no effect on the headache, headache still present as of 8am 3/12/2021.
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| 63 | 2021-03-11 | headache |
Immediate pain from injected arm, across back up the neck, causing headache and going across to ot...
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Immediate pain from injected arm, across back up the neck, causing headache and going across to other arm, down arm and making left hand tingle. Sensitivity to use of finger on left hand. That went away next day. Residual effects pain in my jaw and teeth sensitivity, continues to date. Hot flashes, shooting pains in foot, arm, hand, eye, leg randomly. raised blood pressure.
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| 63 | 2021-03-11 | headache |
extreme dizziness, nausea and vomiting for 9 hours fast heartbeat, palpitations for 9 hours overlapp...
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extreme dizziness, nausea and vomiting for 9 hours fast heartbeat, palpitations for 9 hours overlapping headache
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| 63 | 2021-03-11 | runny nose, throat pain, cough, headache |
Received Pfizer COVID vaccine 12/21/2020. 12/27/2020 developed cough, headache, rhinorrhea, and ...
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Received Pfizer COVID vaccine 12/21/2020. 12/27/2020 developed cough, headache, rhinorrhea, and sore throat.
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| 63 | 2021-03-11 | throat clearing |
11:18 am-Patient stated she felt as though throat was swelling. Clearing throat often- she said more...
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11:18 am-Patient stated she felt as though throat was swelling. Clearing throat often- she said more often than usual. Voice slightly hoarse sounding. Patient states it is more hoarse sounding than usual and husband agreed. Vital signs: B/P 150/90, pulse 75, pulse ox 98%, lung sounds bilaterally, slightly coarse sounding (pt has lung cancer), No wheezing noted, No stridor noted. 11:29 am- 25 mg Benadryl given. Monitored patient. 11:41 Vital signs B/P 154/86, Pulse 75, pulse ox 98%. No changes in lungs sounds with auscultation. 12:08pm - Advised client to proceed to ER due to current lung cancer treatment and recent prednisone. Client refused ambulance. 12:13- Patient left for hospital ER, with husband driving.
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| 63 | 2021-03-12 | fatigue |
Sore left arm, sleeplessness 10:30 pm to 5:00 am 3/12-3/13. Took 2 Somnapure natural sleep pills at ...
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Sore left arm, sleeplessness 10:30 pm to 5:00 am 3/12-3/13. Took 2 Somnapure natural sleep pills at 11 pm 3/12 and Soothsayer herbal tea at 7 am 3/13. Very tired both shoulders hurt noon 3/13. Took an hour and a half nap from 1-2:30 pm 3/13. Still tired
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| 63 | 2021-03-12 | headache |
Instant headache, fast heartbeat, instant face and headache flush, instant joint pain and very sever...
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Instant headache, fast heartbeat, instant face and headache flush, instant joint pain and very severe dizziness and lightheaded.
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| 63 | 2021-03-12 | lethargy, fever, headache |
Started vomiting, feeling lethargic . Bumpy raised red itchy rash started on my arm at injection s...
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Started vomiting, feeling lethargic . Bumpy raised red itchy rash started on my arm at injection site, but then to underneath my arm on both sides of my body and proceeded to my neck, chest, over my back, torso, abdomen and rib cage. Even the bottoms of my feet look like they have red itchy blotches and the palms of my hands????? Also developed an On and off again painful left temple headache.... thought I was going to have a stroke or some thing! That comes and goes for one week now. , slight fever for two days, and then the pain and set in: GOUT LIKE I?VE NEVER EXPERIENCED!
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| 63 | 2021-03-13 | chills, headache, fever | Headache, Fever, Chills, Muscle Aches, Nausea |
| 63 | 2021-03-13 | chills, fever, headache |
Chills, fever, headache, unable to stand without pain. This was worse than when I had COVID. My wh...
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Chills, fever, headache, unable to stand without pain. This was worse than when I had COVID. My whole body ached really bad. Worse than when I have a flare up from my fibromyalgia. For two days I could hardly move. Felt a little better the third day. Have had stomach issues since I had the shot.
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| 63 | 2021-03-13 | chills | epigastric pain, nausea, clammy, chills Hospitalized inpatient Hospital |
| 63 | 2021-03-13 | fatigue | Tiredness, muscle aches, stomachache. Rash on Neck |
| 63 | 2021-03-13 | fatigue | Body aches, fatigue |
| 63 | 2021-03-13 | headache, chills | Mild headache, moderate diarrhea, chills |
| 63 | 2021-03-13 | headache, fatigue | Bruised injection site and very sore for 2 days; fatigue; headache; body aches; very weak |
| 63 | 2021-03-13 | headache, sleepiness | After 1 1/2 could not stay awake till sunday. Body aches. Chest pain. Headache. |
| 63 | 2021-03-13 | fever, throat pain, cough |
Fever, coughing er visit bronchitis 3/4/21 Sore throat, pus on sides of tongue and tonsils unable to...
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Fever, coughing er visit bronchitis 3/4/21 Sore throat, pus on sides of tongue and tonsils unable to swallow, pain in both ears 3/13/2021 return to er, fever both times 101. I was doing good until I got the shot
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| 63 | 2021-03-13 | throat irritation | Scratchy throat about 90 minutes after vaccine. Lasted several hours. |
| 63 | 2021-03-14 | chills, headache |
Patient started to have mild queasiness about 20 minutes after vaccine was given. Within a few minut...
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Patient started to have mild queasiness about 20 minutes after vaccine was given. Within a few minutes of the queasiness, patient started to feel dizzy and nauseous. Patient endorsed feeling "not quite right". Patient was brought over to paramedics for further observation. VS taken over the course of ~1 hour prior to patient being transferred to ED. Transport occurred on date of vaccination. On post-vaccine Day #1, pt continued to endorse some dizziness. Also noted to have SOB, headache, and mild body aches with a brief episode of chills. On post-vaccine Day #2, pt still felt SOB, more upon exertion. Pt had to use rescue inhaler every 4 hours, which helped pt "breathe and relax a little bit."
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| 63 | 2021-03-14 | cough | Patient notes sob and cough after the vaccine on 3/10. Escorted to ER. Physician notified. |
| 63 | 2021-03-14 | cough |
Patient received Pfizer vaccine on 3/14/21 at 15:29, she was observed for 30 minutes was feeling fin...
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Patient received Pfizer vaccine on 3/14/21 at 15:29, she was observed for 30 minutes was feeling fine and left. She returned to the clinic an hour (or so later) reporting feeling flushed and "off". We had patient sit back down and began observing again. Patient developed a cough which became progressively worse. We monitored her O2 sat, pulse and BP. At 3:30pm Patient received epinephrine 0.5mg IM and Diphenhydramine 50mg IM. EMS was called. Patient's cough subsided. She refused transport to the hospital AMA. Patient left the clinic on her own, accompanied by her husband. ;"
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| 63 | 2021-03-14 | fatigue |
Fatigue; This is a spontaneous report from a contactable other HCP (patient). A 63-year-old female p...
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Fatigue; This is a spontaneous report from a contactable other HCP (patient). A 63-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 18Dec2020 at SINGLE DOSE at left deltoid for covid-19 immunisation. Medical history included hot flushes from an unknown date, MCI from an unknown date. The patient's father had medical history of diabetic-II, obesity, the patient's siblings had medical history of environmental allergies, pre-diabetic, obesity. Concomitant medication included venlafaxine hydrochloride (EFFEXOR) from 2005 and ongoing at 150 mg daily for hot flashes, curcuma longa (TURMERIC) from 2018 and ongoing at 1 tablet twice a day for MCI. The patient experienced fatigue on an unspecified date. The outcome was unknown. The reporter considered the Pfizer product had a causal effect to the adverse event.
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| 63 | 2021-03-14 | paranasal sinus discomfort, head discomfort, fatigue |
Both upper arms and upper back have extreme burning pain and tightness. All of my muscles ache. Bo...
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Both upper arms and upper back have extreme burning pain and tightness. All of my muscles ache. Both calves felt weak. Extreme fatigue. Increased ear ringing. Sinus and head pressure. Slight queasiness. When the shot was first given, I had immediate pain at the injection site and up my neck. As the day progressed I felt tired, achy all over. The burning, stinging pain increased, in both arms and upper back. It seems worse at night and wakes me up. It is severe enough that it makes me cry. I have used regular strength Tylenol, Regular strength Advil and Allegra, as treatment. The burning pain continues. So does the muscle aching and fatigue.
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| 63 | 2021-03-14 | fever, fatigue, headache, chills, malaise |
Headache; Swollen lymph nodes on her neck; Dizziness; Her feet felt swollen and she hurt when she wo...
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Headache; Swollen lymph nodes on her neck; Dizziness; Her feet felt swollen and she hurt when she would step down; Loss of appetite; She slept all day; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; Injection site pain; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9264B), intramuscular on 01Feb2021 at single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249) on 11Jan2021 for COVID-19 vaccination. Caller was a consumer that was calling about the Covid-19 vaccine and said that she wanted to report her symptoms after the Covid-19 vaccine. Caller reported that she experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain on, fever, feeling unwell, her feet felt swollen and she hurt when she would step down, loss of appetite and she slept all day on 01Feb2021, swollen lymph nodes on her neck and dizziness on 02Feb2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The seriousness was reported as non-serious. The outcome of the events injection site pain, chills, fever, swollen lymph nodes on her neck, dizziness, her feet felt swollen and she hurt when she would step down, loss of appetite and she slept all day were recovered and other events were recovering.
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| 63 | 2021-03-14 | runny nose, chills, nasal congestion, throat pain, productive cough, respiratory tract congestion, sinusitis |
drippy nose; She felt cold and chills but no fever; She felt cold and chills but no fever; lots of n...
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drippy nose; She felt cold and chills but no fever; She felt cold and chills but no fever; lots of nasal congestion; chest congestion; productive cough; sinus infection; allergy symptoms; testing positive for Covid infection following administration for the first vaccine dose; testing positive for Covid infection following administration for the first vaccine dose; sore throat; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), via an unspecified route of administration in Deltoid Left on 19Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included Slightly elevated blood pressure from Feb2021 and ongoing, Elevated cholesterol from Feb2021 and ongoing. Concomitant medication included pravastatin (PRAVASTATIN) from Feb2021 and ongoing for Elevated cholesterol, lisinopril (LISINOPRIL) from Feb2021 and ongoing for Slightly elevated blood pressure. The patient experienced testing positive for covid infection following administration for the first vaccine dose on 04Feb2021. COVID: Initially reported onset of symptoms as 29Jan2021, but clarified onset of symptoms night of, or morning of 28Jan2021. She always had allergy symptoms like a drippy nose; she was getting ready to go get allergy testing in a few weeks; but on 28Jan2021 she noticed a real increase of sicker drainage all through the night. She thought she might had had a sinus infection. She felt cold and chills but no fever; she never had a fever; but had chills daily. She also had really bad sore throat that went away the next day; and lots of nasal congestion; chest congestion; productive cough. She still had nasal congestion and a little bit of chest congestion but chest congestion was very light in color. She had had no trouble breathing or shortness of breath; other than from her nose being stopped up. Seriousness criteria: Caller reported no emergency room visit, doctor's office visit or hospitalization related to this event. The patient underwent lab tests and procedures which included Flu test: unknown results on 03Feb2021, SARS-CoV-2 RT-PCR test: positive on 04Feb2021. The outcome of event sore throat was recovered 1 day later on unspecified date, lots of nasal congestion was not recovered, while for other events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 63 | 2021-03-15 | chills, fatigue, headache, malaise |
Tiredness Headaches Chills Joint pain Nausea Feeling unwell Took Motrin Ate light Slept Kept moving ...
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Tiredness Headaches Chills Joint pain Nausea Feeling unwell Took Motrin Ate light Slept Kept moving All side effects ceased after 24 hours except tiredness.
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| 63 | 2021-03-15 | chills, malaise, headache, fatigue |
Second Pfizer: I had a mild headache and sore R arm the evening of the 24th. The next day, I became ...
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Second Pfizer: I had a mild headache and sore R arm the evening of the 24th. The next day, I became very ill around 1pm with incontrollable chills, severe spinal pain from Cervical to sacrum, and severe radiating pain on both sides of my back. Pain ranked as a 7-8/10. Took 800 mg of Advil and then took Tylenol 3 hours later and no change. Thought about going to ER but did not go. The next day pain was reduced to a 3/10 and was extremely tired and no energy and was lying down most of the day with extremely fatigue. Gradually better the next two days for full recovery.
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| 63 | 2021-03-15 | fever, influenza like illness, chills |
Fever; Chills; Achiness; nausea; flu-like symptoms; waking up over night; This is a spontaneous repo...
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Fever; Chills; Achiness; nausea; flu-like symptoms; waking up over night; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), on Left upper arm via an unspecified route of administration on 27Jan2021 2:30/3 PM at single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient previously took first dose (lot number: EJ1685, EXP: 31Mar2021) at 4:30 PM for covid-19 immunisation. Caller says she got this number from the pamphlet that was given to her when she gotten her first dose of the Pfizer COVID Vaccine. She got the second dose yesterday. Early this morning (around 2 or 3 AM this morning 28Jan2021) in the middle of the night she started having flu-like symptoms. She was calling to make sure to report them and she wanted to know if it was okay to take Tylenol. She cannot remember if the people who gave her the vaccine said if she could take Tylenol if she needs it. She had a fever this morning of 100.6. She also has chills and achiness. She volunteers at a healthcare facility, which is where she got the vaccine. She will call them about it. Got the second dose yesterday 27Jan2021. She kept waking up overnight and could not get warm. She just was unable to get warm. It was early this morning. She had went to be around 11:30 PM and felt perfectly fine. She tried to drink OJ and keeps trying to drink lots of water. She ate some protein, some cheese. She was concerned not to eat because she did not want to counter balance the nausea and it get worse. She had a tinge of nausea this morning. Outcome of the events nausea and flu-like symptoms was unknown, Outcome of the event waking up over night was recovering. Outcome of the other events was not recovered. Information on the Lot/Batch number has been requested
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| 63 | 2021-03-16 | headache, fatigue, malaise | Malaise, headache, fatigue for 1 day |
| 63 | 2021-03-16 | headache |
Received the vaccine on Saturday on Sunday night started getting a headache and woke Monday morning ...
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Received the vaccine on Saturday on Sunday night started getting a headache and woke Monday morning with a headache, a stiff neck and swelling on my left side of my neck, trapezoid and my dowager hump. After 2 weeks most of the swelling is gone just a slight bit. Headaches have been every day until yesterday. Went to dr the following Monday after the vaccine as was give some anti inflammatory shots in my neck as not allowed anything ( cortisone) due to vaccine. Taking Tylenol and Advil and using Valteran. Dr was not sure if from exercise or the vaccine but have been exercising throughout the pandemic. Never had headaches when my neck would bother me only hand tingling and that was not this time. The acupuncturist today said still a bit swollen and tender and feels that it is a combination of the neck and the vaccine as the vaccine attacked my most vulnerable spot. I had a massage today to to try to stretch my neck. Headache is doing better today and I can move my neck more.
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| 63 | 2021-03-16 | headache |
Dizzy, headache. Left chest pressure. Said she has an appointment with cardiologist this week. She w...
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Dizzy, headache. Left chest pressure. Said she has an appointment with cardiologist this week. She was seen in Emergency room last week with same complaint and was told it was bone or muscle, not heart. All symptoms resolved when she left.
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| 63 | 2021-03-16 | sweating, fatigue, malaise |
patient is a 63 y/o F who had her Covid 19 Pfizer vaccine 1st dose on 3/10/2021 and began feeing bad...
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patient is a 63 y/o F who had her Covid 19 Pfizer vaccine 1st dose on 3/10/2021 and began feeing bad that evening , had 1 emesis episode and felt "crummy" with fatigue/weakness/sweats/malaise for 3 subsequent days without recorded fever, rash , change in color of urine but decreased oral intake and began to feel better 3/14 Sun, she then awoke with Heart racing and presented to our ER 0300 3/15 with A fib with RVR which resolved after approx 30 min while receiving IV fluids in ER without other treatment. She was treated and released to followup here today 3/17/21 at our office. I noticed on routine ER labs that she had elevated transaminases (ALT/AST) in 300 unit range (normal up to 40-50) which she has never had on previous panels with normal bili, alk phos , and otherwise normal CMP. At the time of followup her EKG was normal and she has had no further symptoms but transaminases are redrawn and she is advised not to get her second Covid shot. Patient is elderly CHADS VASC score is 1, nonsmoker , family hx of heart disease.
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| 63 | 2021-03-16 | sweating, fatigue |
I felt fine immediately after the injection, but then about 3 minutes after the injection, I was "hi...
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I felt fine immediately after the injection, but then about 3 minutes after the injection, I was "hit" by a very intense reaction: metallic taste in mouth, nauseous, burning heat throughout my back, sweating, very hot, very anxious/scared. This quieted down after about 10 minutes, but then I got "hit" again, a few minutes after that. This time with burning heat in my chest and then burning heat traveling down my left arm, sweating, very hot, very anxious/scared. I was under observation for 45minutes before they let me drive home (just 4 miles away). Once I got home, I felt extremely exhausted and foggy headed. This lasted for about 6 hours, and then it began to lift. That night, I was woken from sleep suddenly by pain in my arm (at injection site); it was a sort of pain I've never experienced -- it was sharp and moving around. The following day (today) I'm having lingering fatigue, lingering slight nausea, and a sore arm at injection site.
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| 63 | 2021-03-16 | sweating | body aches, sweats, vomiting/diarrhea, |
| 63 | 2021-03-17 | chills, fatigue, headache, fever |
Started with joint and muscle aches at 5:30 on 3/17, by 9:30pm, very painful to take a deep breath, ...
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Started with joint and muscle aches at 5:30 on 3/17, by 9:30pm, very painful to take a deep breath, chills, fever of 100.2, injection site left arm throbbing, tired and weak, slight headache and nausea. Tired and weak, achy and slight headache when woke up on 3/18. Still somewhat painful to take a deep breath and injection arm painful. Tylenol 2 tablets at 8:30 am and 2:30pm on 3/18
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| 63 | 2021-03-17 | chills, fever, sweating, headache, fatigue |
Tues. March 16 10:20 am - Received shot. Tues. March 16 11:00 pm - Started feeling tired, achy, a...
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Tues. March 16 10:20 am - Received shot. Tues. March 16 11:00 pm - Started feeling tired, achy, and started having chills. Went to bed. Felt like I had fever, but did not take temp. Wed March 17 Throughout early morning - same symptoms except no chills anymore. Fever varied from 99.5 - 100. Wed. March 17 - Throughout day and evening - Too weak to function, fever in morning, not in afternoon, when getting up weak and had to go back to bed. Thursday, March 18 3:00 -3:30 am Running fever 99.5 - 100.1 with mostly just headache. Thursday, March 18 7:00 am Woke up with sweat and temp. was gone.
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| 63 | 2021-03-17 | fatigue | FATIGUE FOR 3 DAYS |
| 63 | 2021-03-17 | fatigue |
Immediate taste in mouth. Rash on neck and face. Slight throat swelling, slight difficulty swallowi...
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Immediate taste in mouth. Rash on neck and face. Slight throat swelling, slight difficulty swallowing. Very faint dizziness, fatigue.
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| 63 | 2021-03-17 | headache |
Severe ringing beginning in left ear. Next day right ear also affected. Two days after first vaccine...
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Severe ringing beginning in left ear. Next day right ear also affected. Two days after first vaccine. Sometimes headaches
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| 63 | 2021-03-17 | sleepiness | She reports having soreness, achiness and sleepiness since receiving the shot. |
| 63 | 2021-03-18 | chills, fatigue |
I received the 2nd vaccine around 6:00 PM on 03/17/2021. The fatigue hit me around 8:30 PM that nig...
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I received the 2nd vaccine around 6:00 PM on 03/17/2021. The fatigue hit me around 8:30 PM that night. On 3/18/2021 I woke with fatigue, body aches, and chills. I took Advil around 3:00PM and felt better within an hour. Around 9:00 PM, the fatigue, body aches, and chills returned. I took more Advil and it helped. Today, 03/19/2021 I have the same symptoms but much less severe.
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| 63 | 2021-03-18 | chills, headache |
joint pain, chills, nausea, dizziness, HA, chest is heavy, diarrhea X1 episode, spoke to doctor who ...
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joint pain, chills, nausea, dizziness, HA, chest is heavy, diarrhea X1 episode, spoke to doctor who stated the symptoms are "normal", clarified if she mentioned the dizziness & heaviness to chest, reported she did and her pcp stated it was again "normal". informed her those reported symptoms should be checked in the ED for potential cardiac events. Caller verbalized understanding.
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| 63 | 2021-03-18 | chills |
Chills; stomach pain joints; vomit; weak blood pressure; stomach pain joints; This is a spontaneous ...
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Chills; stomach pain joints; vomit; weak blood pressure; stomach pain joints; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm at 63-year-old (not pregnant at the time of vaccination) on 03Mar2021 at 16:00 (lot number: EN6198, expiration date unknown) at single dose for COVID-19 immunization. Medical history included diverticulitis. No known allergies were reported. The patient was not diagnosed with COVID prior vaccination. Concomitant medications were reported as unspecified other medications in two weeks. No other vaccine in four weeks. On 04Mar2021 at 06:00 AM the patient experienced chills stomach pain joints vomit weak blood pressure (as reported). The events resulted in hospitalization. The patient underwent lab tests and procedures which included nasal swab: negative on 04Mar2021. No COVID tested post vaccination. It was unknown whether treatment was received. The outcome of the events was not recovered.
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| 63 | 2021-03-18 | chills |
Pt received vaccine at 1231 and within 10 minutes reported feeling "shaky" with a warm tingling feel...
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Pt received vaccine at 1231 and within 10 minutes reported feeling "shaky" with a warm tingling feeling all over. She was moved via wheelchair to an observation area. Initial vitals at 1245 98% on room air, 100 HR, BP 157/94. Pt stated she was feeling better and was then escorted at 1330 to the bathroom via wheelchair. Upon her return, she reported now experiencing chills and was shaky. Vitals at 1340 were 176/86, 96%, and HR 99. Pt denied SOB, fullness in mouth, and itchiness. Further vitals: 1357 175/85, 96%, HR94. 1405 183/105, HR 107, 97%.; 1406 173/80, HR 104, 97%. It was determined by RN that 911 would should be called to further evaluate the patient. Patient was taken via EMS to the hospital with her husband in attendance.
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| 63 | 2021-03-18 | fatigue, chills, fever | Fever,chills, aches, fatigue |
| 63 | 2021-03-18 | fatigue, headache | Persistent joint pain, headache, fatigue for over 1 week |
| 63 | 2021-03-18 | fatigue |
She received the vaccine, and within 4 minutes she got a tingling feeling that swept through her who...
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She received the vaccine, and within 4 minutes she got a tingling feeling that swept through her whole body from her head to her toes. They called a doctor to stand by her, and spoke with her, and she was explaining what she had with reactions had a very warm sensation through her body. They have a medic station at the event center, and started taking her VS which her BP was high, and kept an eye on her, and kept talking to her. She still had the tingling feeling through her. She had this similar sensation from bee stings in the past. She then got very cold and started shaking all over and her went to 175/101. At that point she had probably been there for about 2 hours and she was then taken to Hospital. She was monitored at the hospital for her BP and did oxygen levels which were fine, and her heart rate was elevated, but then dropped down to 98-99. She asked for something to drink and something to eat, and they gave that to her, and was only at the hospital for about an hour. They told her that she was okay, and they did not give her any medications as the reaction had passed and her BP was down to 149/87, pulse rate 102, and her respiratory rate was good and they dismissed her. She did have fatigue since coming home from the hospital but is otherwise okay. She is scheduled to see her PCP on Monday, 3/22/21.
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| 63 | 2021-03-18 | fatigue |
blood sugar was 25, The patient then asked for information about potential hypoglycemia; Patient fel...
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blood sugar was 25, The patient then asked for information about potential hypoglycemia; Patient felt tired after the dose; This is a spontaneous report from a contactable pharmacist. A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 12Feb2021 at 13:00, at a single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 12Feb2021, the patient felt tired after the dose and laid down to take a nap. Patients husband later checked on patient and tested her blood sugar. Husband reported that the patient's blood sugar was 25. The patient then asked for information about potential hypoglycemia post vaccination and whether she is safe to get 2nd dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The information is limited and does not allow a full medical assessment. Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of blood sugar decrease, cannot be completely excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-03-18 | headache, fatigue, fever | Fever Extreme fatigue Body aches Headaches |
| 63 | 2021-03-18 | headache, fever, chills |
Sore arm, severe headache, 101.2 fever, chills, body aches i have had 3 vaccinations at a time, all...
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Sore arm, severe headache, 101.2 fever, chills, body aches i have had 3 vaccinations at a time, all in the same arm and NEVER gotten sick at all.
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| 63 | 2021-03-18 | headache, fever, chills |
Patient had Pfizer vaccine 1st dose on Tuesday AM . Later that night, starting into Wednesday morni...
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Patient had Pfizer vaccine 1st dose on Tuesday AM . Later that night, starting into Wednesday morning started to feel terrible - sore arm, headache, severe body aches, fever, chills, nausea. Continued through to Thursday. Pt started to feel intermittent SOB, difficulty with getting in air. This subsided after some time. NO rash, hives, tight airway, vomiting. Patient reports today feels a little better but entire body still has burning sensation. Going to Urgent care for evaluation.
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| 63 | 2021-03-18 | sweating |
Next morning (7am) sweating, nauseous, blurred and double vision, and dizziness Went back to bed f...
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Next morning (7am) sweating, nauseous, blurred and double vision, and dizziness Went back to bed for about 2 hours and woke up with slight dizziness. Sweats and nausea were gone
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| 63 | 2021-03-18 | fever, headache, chills |
When I first got it, I felt okay, but as I was walking out, I felt disoriented and had to sit down. ...
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When I first got it, I felt okay, but as I was walking out, I felt disoriented and had to sit down. I was very lightheaded and uneasy. I stayed about an hour because I was scared to drive. I later got chills and fever for about 24 hours. I eventually developed shortness of breath, headaches, dizziness, tightness in my throat, bruising in my legs and painful lymph nodes in my neck and arms. One day, I felt like I was having a mini-stroke. It only lasted for a brief period and then went away. That has occurred multiple times. My doctor thinks some of my issues were due to anxiety, but I don't agree because I'm fine now.
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| 63 | 2021-03-18 | sinus disorder, sinus congestion, chills, headache, fever |
Sore arm- first vaccine 12/23/20 and after 2nd vaccine- initially sore arm, fever, chills, sinus sym...
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Sore arm- first vaccine 12/23/20 and after 2nd vaccine- initially sore arm, fever, chills, sinus symptoms, headaches- continue to have sinus symptoms- "congestion, headaches, nasal drainage daily with bleeding" Not sure if related to the Pfizer vaccine- just have had continuation of sinus symptoms post 2nd vaccine. Nasal bleeding miner however, frequently throughout day when blowing nose- have been using OTC saline gel or spray-
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| 63 | 2021-03-19 | chills | Extreme Nausea Diarrhea Body Aches Chills Neck ache |
| 63 | 2021-03-19 | fatigue, fever, headache, chills |
The first vaccine listed above was given on 2/25/2021 and the second vaccine was given on 3/18/2021....
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The first vaccine listed above was given on 2/25/2021 and the second vaccine was given on 3/18/2021. I didn't know how to delete the first one after I added it. Thought both were needed. Fatigue, headache, fever, and chills 3/19/2021 9:00 am - 10:00 pm Headache & fever 3/20/2021 6:00 am - 3:00 pm
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| 63 | 2021-03-19 | fever, chills, headache |
Chills started 11pm day of shot.. Headache started shortly after. Aches pains especially in legs , f...
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Chills started 11pm day of shot.. Headache started shortly after. Aches pains especially in legs , fever, and sore injection area.
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| 63 | 2021-03-19 | throat irritation, cough |
I started coughing for about an hour around 10pm while I was on a phone call; then developed a fuzz...
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I started coughing for about an hour around 10pm while I was on a phone call; then developed a fuzziness in my throat and felt like I had mucus in my chest. I took 120 mg Allegra. I started to feel relief after about 10 minutes. I had to relieve my throat of mucus this morning. Other than muscular aches, especially at the site of the vaccine and behind my shoulder, I am ok. About 10 - 11 hours after my first vaccine on 2/26/2021, I developed a similar reaction, however much milder, and took Allegra, which relieved the symptoms.
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| 63 | 2021-03-19 | throat irritation |
coarseness, SOB, Itchy throat, swelling to the tongue, normal Vital signs and alert and oriented, hx...
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coarseness, SOB, Itchy throat, swelling to the tongue, normal Vital signs and alert and oriented, hx of anaphylactic reactions given epi, Benadryl and famotidine
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| 63 | 2021-03-20 | chills | Disregard, hives, extreme weakness, chills and shaking |
| 63 | 2021-03-20 | cough | Soar arm at the injection site on 3-20-2021 and dry cough starting on 3-21-2021 |
| 63 | 2021-03-20 | headache |
I woke up feeling very nauseous and my head started hurting. It got a little better during the day, ...
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I woke up feeling very nauseous and my head started hurting. It got a little better during the day, but returned about 4 or 5 PM and proceeded to get much worse. I tried taking Zofran and Tylenol about 10 and they helped a little. Around midnight I threw up and then started feeling much better. I'm not totally convinced it was from the vaccine.
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| 63 | 2021-03-20 | fever, fatigue | Vomiting then 101.8 fever then extreme fatigue 29 hours. |
| 63 | 2021-03-20 | throat irritation | Burning in chest and throat |
| 63 | 2021-03-21 | fatigue, chills |
Next afternoon, Wednesday, approx. 26 hours after injection - chilled and tired. Next evening, Wedne...
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Next afternoon, Wednesday, approx. 26 hours after injection - chilled and tired. Next evening, Wednesday, approx. 29 hours after injection - tried to eat some instant mashed potatoes (make with water , butter and a bit of salt) = tasted extremely salty. And two smoked sausages. Forced myself to finish it all (normal serving sizes for me) and about half-way through felt like I was going to throw up! Kept it down. Fell asleep for about 2 hours, got up, used restroom and back to sleep - 12 hours! Friday evening right upper arm itchy - Saturday morning noticed rash on upper right arm - about the size of my hand - to the backside of injection site. Sunday afternoon - upper left arm itchy with rash like right arm.
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| 63 | 2021-03-21 | fatigue |
Pt reported that the day after her vaccine, she was having severe dizziness, she went to see her doc...
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Pt reported that the day after her vaccine, she was having severe dizziness, she went to see her doctor who prescribed Meclizine. She took one dose, then the next day had fatigue and dizziness for the next three days. She is now doing fine.
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| 63 | 2021-03-21 | headache, fever |
Started with a bad headache and very sore arm the first night. The morning of the day after I was va...
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Started with a bad headache and very sore arm the first night. The morning of the day after I was vaccinated, I took my temperature and it was up to 101, which is high for me. I ached everywhere and my neck was so stiff, I could hardly stand to turn my head. My left arm, where I was vaccinated felt sore and tight in my shirt, but I couldn?t turn my head far enough to look at it to see if it was red or not. My temp went up to 102, the highest it?s been since I had osteomyelitis after my accident- no kidding! I slept most of the day both Thursday and Friday. I woke up Saturday at 2 pm and felt fine again- like nothing happened. But, I thought it was Friday. I was sick enough & sleeping enough that I acted lost a day completely! I never got nauseous- just terrible headache, stiff neck, joint & muscle pain , fatigue and 102 fever. There is a question of whether I have had Covid. I was very sick for 4 weeks- the whole month of February, 2020. My daughter had been in (Country) on business and met with collegues from all over the (Country), including (Country), in January, 2020. My brother died unexpectedly while she was gone. She flew back to (State) on a Thursday night and then got right back on a flight to (city) to stay with me for a week. She missed the wake, but was a comfort to me. I get very sick about a week after she left.
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| 63 | 2021-03-21 | headache |
20 MINUTES AFTER THE SHOT I EXPERIENCED REDDENING OF THE FACE AND NECK. A FLUSHED FEELING ALL OVER ...
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20 MINUTES AFTER THE SHOT I EXPERIENCED REDDENING OF THE FACE AND NECK. A FLUSHED FEELING ALL OVER AND TIGHTING OF MY CHEST. I TOOK ORAL BENEDRYL 10 MINUTES AFTER THE SHOT BUT UNFORTUNETLY IT DID NOT HELP. I WAS GIVE IV BENEDRYL IMMEDIATELY AFTER THAT AND WAS MONITORED FOR 4 HOURS AT THE HOSPITAL. ALSO GIVEN TYLENOL FOR A HEADHACHE DURING MY HSPTALIZATION. IT TOOK APPROX. 30 MINUTES FOR THE SYMPTOMS TO SUBSIDE. I WAS RELEASED 4 HOURS LATER.
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| 63 | 2021-03-21 | fever |
Four days after the shot my eye someone told me my eye was red. I had a hemorrhage in my left eye. I...
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Four days after the shot my eye someone told me my eye was red. I had a hemorrhage in my left eye. It was the outside of my eye but there was no pain. It lasted about five days. Seven days after the first vaccine I also had an eye hemorrhage in the same are of my eye. The doctor could not find anything wrong with my eye. Other symptoms included a few waves of Nausea and a low -grade fever.
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| 63 | 2021-03-22 | fatigue, malaise, headache |
Pain at injection site (84.1%) no ? Fatigue (62.9%) yes ? Headache (55.1%) yes ? Muscle pain (38.3%)...
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Pain at injection site (84.1%) no ? Fatigue (62.9%) yes ? Headache (55.1%) yes ? Muscle pain (38.3%) some lower back ? Chills (31.9%) no ? Joint pain (23.6%) neck ? Fever (14.2%) no ? Injection site swelling (10.5%) no ? Injection site redness (9.5%) no ? Nausea (1.1%) no ? Malaise (0.5%) yes ? Lymphadenopathy (0.3%) no Blood pressure high on 4th day with accompanying eye pressure. 155/102
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| 63 | 2021-03-22 | fatigue, throat pain, malaise |
After the 1st shot, I was ill for about a day: extreme fatigue, every joint in body ached, sore thro...
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After the 1st shot, I was ill for about a day: extreme fatigue, every joint in body ached, sore throat. After 2nd shot, not symptoms until Saturday. I noticed a swelling between my left breast and my armpit. It developed into a very pronounced lump at my armpit and toward left breast. There was tenderness when I used the arm. As of today, the swelling is down- not quite normal yet- but no tenderness.
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| 63 | 2021-03-22 | headache |
vertigo, double vision, headache, inability to stand. Went to ER, given meclizine and lorazapam. S...
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vertigo, double vision, headache, inability to stand. Went to ER, given meclizine and lorazapam. Symptoms improved over 6 hours but, other than headache, have never disappeared completely
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| 63 | 2021-03-22 | sleepiness |
Patient noticed facial drooping and increased drowsiness. She went to the emergency department on 2/...
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Patient noticed facial drooping and increased drowsiness. She went to the emergency department on 2/19 and was diagnosed with Bell's palsy. She was treated with valacyclovir 1000mg PO TID for 7 days and prednisone 20mg PO TID for 5 days. She completed the course of treatment and as of 3/16/21, symptoms had resolved.
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| 63 | 2021-03-23 | chills, malaise, fever |
fever; Chills; Felt unwell; This is a spontaneous report from a contactable other healthcare profess...
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fever; Chills; Felt unwell; This is a spontaneous report from a contactable other healthcare professional. A 63-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, via an unspecified route of administration, administered (at the age of 63 years old) in the right arm on 17Feb2021 11:00 (Lot Number: Unknown) as a SINGLE DOSE for covid-19 immunisation. Medical history included covid from Apr2020 to an unknown date. The patient had no known allergies. The patient's concomitant medications included multivitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 18Feb2021 10:30, the patient experienced chills, felt unwell and fever of 99.3. Therapeutic measures were taken as a result of fever which included the patient took acetaminophen (TYLENOL), went to bed and rested. The patient underwent lab tests and procedures which included temperature: 99.3. on 18Feb2021. The patient did not receive treatment for chills and felt unwell. Outcome of the events chills, felt unwell and fever of 99.3 was recovered in Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 63 | 2021-03-23 | fatigue, chills |
at 2 1/2 weeks after first injection had severe asthma attack that caused right posterior chest pain...
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at 2 1/2 weeks after first injection had severe asthma attack that caused right posterior chest pain, fatigue, chills- increased use of albuterol with nebulizer 3 times per day
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| 63 | 2021-03-23 | fatigue, headache |
Severe headaches, tiredness, fatigue, difficulty walking w/o assistance, lightheadedness, hallucinat...
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Severe headaches, tiredness, fatigue, difficulty walking w/o assistance, lightheadedness, hallucinations that disappeared 3 nights after the vaccination.
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| 63 | 2021-03-23 | headache, fatigue |
Saturday morning I woke up feeling fine. About an hour later I had a bad headache and my body starte...
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Saturday morning I woke up feeling fine. About an hour later I had a bad headache and my body started to be achy. That was followed by bilateral eye pain so that the only comfortable thing to do was to put on eye shades. I was exhausted by the afternoon. I had absolutely zero energy to do anything but lie down. By Sunday morning every inch of my skin was sensitive, every joint was sore and every muscle group in my body was painful. The symptoms from the previous day remained; head and eye pain. I used both tylenol and advil a few times but without relief. Monday my body/joints were still achy and I was super tired but not like the previous 2 days. I became very depressed and fearful that it would not let up. Today is Wednesday and its the first day I feel like myself again although I did have to take a nap 3 hours after I woke up today. Body still aches but nothing like it was
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| 63 | 2021-03-23 | headache, fatigue |
Injection of shot was extremely painful with heavy stinging and burning sensation. Approximately 4 ...
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Injection of shot was extremely painful with heavy stinging and burning sensation. Approximately 4 hours after receiving shot on Friday, extreme fatigue, arm ache, full body/joint ache and severe headache. Took Tylenol and slept. Symptoms lasted until Sunday morning, although low grade headache persisted until Monday morning.
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| 63 | 2021-03-23 | headache, fever, sweating |
Feverish, sweating, mid- level headache, and at 8 pm muscle pain especially in breasts, jaws and ev...
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Feverish, sweating, mid- level headache, and at 8 pm muscle pain especially in breasts, jaws and every joint that has arthritis was very painful. Couldn?t sleep until 3 a.m... Woke up at 5 a.m. and all symptoms were gone. None since.
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| 63 | 2021-03-23 | headache |
1.5-2 hours after first Pfizer Covid vaccine developed fine red itchy rash to L>R arms from elbows t...
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1.5-2 hours after first Pfizer Covid vaccine developed fine red itchy rash to L>R arms from elbows to hands and stomach. Mild headache.. Allergies to latex = similar red splotchy rash similar to this reaction. Food green chili: throat closure; NKDA and does admit to seasonal allergies. Rash persisted for a couple of days. Took Benadryl. No worsening, no resp or GI issues. Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21), HEADACHE(R51).
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| 63 | 2021-03-23 | sweating, fatigue |
3-11-21 pain in groin on right side/leg weakness around 2:00pm better next day just sore arm., Fatig...
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3-11-21 pain in groin on right side/leg weakness around 2:00pm better next day just sore arm., Fatigue on 3-12 & 3-13. On 3-14 developed intense pain right side lower back and kidney. 3-16 went to Doctor as felt I had kidney infection but urine checked find, she thought it was muscle spasms. 3-19 broke out with shingles and back to doctor on 3-22 and given Acyclovir and Gabapentin. 3-23 went to ER. In as woke with pain so severe I broke out in sweat and threw up. Gave me Hydrocodone, nurse commented was worse break out she had ever seen. Internal pain is worse than the rash which is naval to spine and 3 to 4 " wide.
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| 63 | 2021-03-23 | runny nose, chills, cough, fatigue, throat pain |
chills, extreme fatigue, severe sore throat, shortness of breath rhinorrhea, cough that lasted more ...
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chills, extreme fatigue, severe sore throat, shortness of breath rhinorrhea, cough that lasted more than one month
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| 63 | 2021-03-24 | chills, headache, fatigue |
Symptoms for approximately 12 hours: headache, chills, body aches and extremely tired feeling. At th...
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Symptoms for approximately 12 hours: headache, chills, body aches and extremely tired feeling. At the end of 12 hours the symptoms were gone.
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| 63 | 2021-03-24 | chills, malaise, fatigue |
Extreme thirst, chills, full body muscle aches, dizziness, extreme fatigue (so much so I could barel...
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Extreme thirst, chills, full body muscle aches, dizziness, extreme fatigue (so much so I could barely keep my eyes open when driving after 8 hours of sleep the night before), nausea, stomach upset. Note: I have not had a flu shot for 25 years, nor have I ever had the flu during that time, but the symptoms do seem flu like. It is now end of day 2 following the 2nd dose of vaccine and I still feel incredibly icky.
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| 63 | 2021-03-24 | fatigue, chills, headache, fever |
Next day, March 24: 6:00 am: headache, achy joints, fatigued, feeling "punk" or heavy limbs. 10:00 ...
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Next day, March 24: 6:00 am: headache, achy joints, fatigued, feeling "punk" or heavy limbs. 10:00 am: severe headache, aches and fatigue much worse, in bed and sleeping. 3:00 pm: Added chills. 7:00 pm: Added mild fever (100). Thursday, March 25. Woke up with very mild symptoms, but still fatigued and without energy. 3:00 pm back to normal.
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| 63 | 2021-03-24 | fatigue, chills |
Soreness in Arm started almost immediately. Very tired throughout day. Then around 3:00PM arm got v...
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Soreness in Arm started almost immediately. Very tired throughout day. Then around 3:00PM arm got very sore and hurt to move. At 12:15AM developed severe chills. took tylenol and seems to be working
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| 63 | 2021-03-24 | influenza like illness, chills, fever |
fever/chills/body aches/ painful arm/shoulder injection site feels like stabbed with knife can barel...
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fever/chills/body aches/ painful arm/shoulder injection site feels like stabbed with knife can barely move it or sleep on it, tired feels like a mild flu
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| 63 | 2021-03-24 | fever, fatigue, headache |
Began feeling very tired and slightly confused. Left work one hour, one home I had a slight fever o...
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Began feeling very tired and slightly confused. Left work one hour, one home I had a slight fever of 99 so I took Tylenol and tried to sleep. Woke with a headache and cold not get warm all night.
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| 63 | 2021-03-24 | fever, headache |
2 days following 1st Pfizer vaccine developed burning and stiffness, and pain in joints, followed by...
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2 days following 1st Pfizer vaccine developed burning and stiffness, and pain in joints, followed by severe pain in muscles "all over her body". She had severe headache. She had a fever of 101.9. She had no appetite and "could not eat" . She remained in bed, barely able to walk to the bathroom for 7-8 days. She was "so weak", could not get up. She did not have solid food for 1 week and was not able to take more than sips of liquid. She has continued weakness fever. Now 3 wks following the vaccine, her temp is 100.2.
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| 63 | 2021-03-25 | chills, fatigue, cough |
same day patient devloped sever shoulder pain in vaccinated arm, chills, fatigue and cough, She was ...
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same day patient devloped sever shoulder pain in vaccinated arm, chills, fatigue and cough, She was unable to work the follwoing 2 days due to severity oif her symptoms. She also reports a mild rash at injection site.
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| 63 | 2021-03-25 | chills, fatigue, headache |
Sight is hard and continues to be red and the circle is getting bigger. Bad headache, body/joint a...
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Sight is hard and continues to be red and the circle is getting bigger. Bad headache, body/joint aches, chills, fatigue.
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| 63 | 2021-03-25 | cough |
10 min after: shot rush of blood back to site of injection, 11min after: wanting to cough, next mor...
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10 min after: shot rush of blood back to site of injection, 11min after: wanting to cough, next morning: passing out on bathroom floor
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| 63 | 2021-03-25 | fatigue | Arm very tender Fatigur |
| 63 | 2021-03-25 | headache, fever, chills |
Severe aches, fever, chills, joint & muscle pain, headache started coming on about 8 hours after 2nd...
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Severe aches, fever, chills, joint & muscle pain, headache started coming on about 8 hours after 2nd vaccine & got worse through the night. Couldn?t sleep, left arm & left side of neck were sore & hurting in the beginning, then spread to my entire body. (1st vaccine 3 weeks before, no problems except my left arm was sore for a day.) Took ibuprofen & alprazolam before getting in bed & it seemed to help for a short time. My nerves felt like they were on top of my skin. Didn?t sleep much at all, maybe couple hours. Now, 3pm the next day, I?m still very sore, tender all over my body.
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| 63 | 2021-03-25 | headache, fever |
Eight days following first shot, my arm started itching near the injection location and two quarter ...
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Eight days following first shot, my arm started itching near the injection location and two quarter sized red spots showed up. This lasted a few days. 2nd shot was Mar 18 at 11 am at same facility. Had severe arm and shoulder blade pain the remainder of the day. Used an ice pack. Mar 19 had slight fever in the morning. Severe arm pain had resolved. Severe achiness in lower back and jaws and general achiness. Started taking Tylenol in afternoon. Vomited at 6pm and 10:30pm. Mar 19-21: Severe headache. Barely ate Mar 19-20. Stayed in bed or resting on couch. Experienced intermittent hiccups. No energy. Headache resolved. Mar 22. Mar 26. Still don't feel 100% normal energy level, but pretty much resolved
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| 63 | 2021-03-25 | sweating |
patient become diaphoretic and felt like she was going to pass out. pt wheelchaired to bed bp 100/64...
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patient become diaphoretic and felt like she was going to pass out. pt wheelchaired to bed bp 100/64. pt never lost consciousness. bp came up to 126/74. pt called husband to come in and drank 2 apple juices. EMS requested at 1615. patient then stated she felt woozy and became diaphoretic again. repeat bp 85/56. it later increased to 109/68, sat 97, hr 82. pt also incontinent
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| 63 | 2021-03-25 | fever, influenza like illness, chills | Chills, fever, body flu like aches |
| 63 | 2021-03-26 | body temperature increased, fatigue |
Monday pm had very sore arm. Tuesday, I had a temp of 99.9 (my normal is 97.8), all over body aches,...
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Monday pm had very sore arm. Tuesday, I had a temp of 99.9 (my normal is 97.8), all over body aches, and fatigue . This lasted 24 hours. Wednesday everything was gone except the fatigue. Thursday I was back to normal. I took Tylenol on Tuesday.
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| 63 | 2021-03-26 | fatigue, respiratory tract congestion |
fatigue, body aches, congestion, shortness of breath- appear to be typical response. Refill inhaler ...
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fatigue, body aches, congestion, shortness of breath- appear to be typical response. Refill inhaler at this visit and follow up as needed
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| 63 | 2021-03-26 | sweating, headache |
Restlessness, pain at sight of arm, unable to sleep that night, agitated, sweats, heaviness in chest...
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Restlessness, pain at sight of arm, unable to sleep that night, agitated, sweats, heaviness in chest, no care attitude, muscle pain, headache, nausea- emptiness in stomach, possibly swollen lymph nodes. This continued until 6pm the next day (3/25/2021) after receiving the covid vaccine. Should I get the 2nd vaccine, scheduled for 4/15?
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| 63 | 2021-03-26 | fever | Full body achiness and fever of 100 or higher for 36 hours |
| 63 | 2021-03-26 | fever | Fever 101.8, achy legs, face extremely red and hot, headache, nausea |
| 63 | 2021-03-27 | fatigue, headache |
severe neurological symptoms of limb parasthesias gradually decreased over six weeks , vision loss i...
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severe neurological symptoms of limb parasthesias gradually decreased over six weeks , vision loss intermittent left eye for 5 minutes at a time ( 5 events over one month), continued to this day intermittent diplopia vertical , with blurring vision and eye fatigue , general fatigue with ADL ( missed multiple days of work), bouts of tachycardia and palpitations ( slowly abating over 6 weeks ) , original neck pain and headache severe in first 2-3 weeks especially after second vaccine 1/29/21 lot number EL3246. multiple MRI's done brain ( white matter and demylination dating back to before 2015) and cervical and thoracic spine showing existing disc disease all old , neurology work up was done for MS and it was ruled out. visual disturbances persist and neuro-ophthomologist appointment schedule for mid april .
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| 63 | 2021-03-27 | head discomfort |
0925 pt reported feeling dizzy and lightheaded with blurry vision while sitting for 15 minute post ...
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0925 pt reported feeling dizzy and lightheaded with blurry vision while sitting for 15 minute post observation time. transported via wheelchair to observation area and placed on gurney in trendelenburg position. 0930 BP 156/84 P 121 pox 96%. 0945 pt reports feeling "better" BP141/73 P 103 , placed in supine position. 0950 placed HOB at 45 degree angle with pt reports feeling "well". BP 167/83 P 83. 0956 pt report feeling "heavy headed and vaccine arm tingly" . Drank 3 oz water. Pt reports being T2 diabetic on metformin. did not check BS this am, but ate breakfast as routine. Reports not regularly checking BS with breakfast. Primary care provider called and spoke with pt. at clinic. PCP advised pt to return to home and self monitor and contact their office if not feeling well today. Husband present and verbalized understanding along with pt of PCP instruction . PT reports BP is occasionally high when anxious. 1010 Pt sitting in chair and feeling well w/o furthur c/o dizziness or blurry vision or heavy headedness . States "feeling good to leave". BP 165/81 P 85 pox 96%. Pt left on foot with husband.
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| 63 | 2021-03-28 | fatigue, chills |
At approximately 12:30 pm on the day following the vaccination, I began to feel tired. With about 30...
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At approximately 12:30 pm on the day following the vaccination, I began to feel tired. With about 30 minutes, I began to get chills and felt very cold. Took two Tylenol and went to bed. Fell asleep and slept approximately 5 hours. Woke up feeling very tired but not chilled or headache. Ate soup and a grapefruit. Went back to bed and slept until approximately 06:30 the next morning. I felt great except for the soreness around the injection site. The injection site showed no evidence of swelling or redness at any time.
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| 63 | 2021-03-28 | fatigue, fever |
Adverse systemic events for the duration of March 17-March 27: Swollen lymph glands (mild) Fatigue (...
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Adverse systemic events for the duration of March 17-March 27: Swollen lymph glands (mild) Fatigue (severe) Brain "fog" (severe) Sensation of overheating / burning Fever (few mild elevations) Loss of Appetite /Indigestion (resolving as of March 26)
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| 63 | 2021-03-28 | fatigue, runny nose |
runny nose since day after getting shot; nervous about second shot; worried; facial neuropathy flare...
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runny nose since day after getting shot; nervous about second shot; worried; facial neuropathy flare; facial neuropathy flare; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6201, expiry date not reported) via an unspecified route of administration, administered in left arm on 25Feb2021 08:30 at a single dose for COVID-19 immunisation. Medical history included facial neuropathy, sleep apnea from 2003, and Guillain-Barre syndrome from 2001. Patient said she had Guillain-Barre syndrome 20 years ago and has residual neuropathy from that. There were no concomitant medications. Patient have not had any other recent vaccinations or started any new medications. Patient called about the Pfizer COVID-19 vaccine shot, as she was supposed to call about possible side effects, to report. She said that she had her first dose of the vaccine on 25Feb2021 and hasn't had her second yet. She said that the first dose was injected in the morning, around 08:30AM. She said that there was a sticker on her vaccine card that says mRNA Pfizer-BioNTech, and (withheld), she didn't know what that means. She said actually that was abbreviation for (withheld), her vaccine provider. Her side effects included fatigue on an unspecified date in 2021, which she thinks a lot of people do have. She didn't know if this was available but she was hoping to advice about getting her second shot. She has had a runny nose since day after getting the shot, so since 26Feb2021, it hasn't stopped. She was not saying this was from the shot, it could be chronic runny nose, but it didn't stop. She said that the worst thing she was calling about was she has facial neuropathy flare in 2021, described as slight facial neuropathy which felt like it has flared since the shot. She was calling because she was nervous about second shot in 2021, since it flared with the first one a bit. She didn't want this to get worse, she can live with it currently, but she has heard people have more problems with the second dose and she didn't want to risk full blown neuropathy. She has done no treatment for the neuropathy, but for the runny nose there were a couple nights she took Benadryl and today she took Claritin, so put that she has taken sporadic over the counter stuff. No further details provided about Claritin or Benadryl. She has been experiencing continuous runny nose, flare of facial neuropathy, and fatigue. She was worried in getting the 2nd dose in 2021 and wanted to have recommendations as her doctor was reluctant in giving an advice whether she may have the 2nd dose or not. The patient reported that facial neuropathy flare as serious medically significant while the other events was non-serious adverse events. Patient was advised by the Pfizer colleague of the overall safety summary that indicated throughout the safety follow-up period to date, Bell's palsy (facial paralysis) was reported by four participants in the Pfizer-BioNTech COVID-19 Vaccine group. Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of Bell's palsy were reported in the placebo group. Currently available information is insufficient to determine a causal relationship with the vaccine. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19. The outcome of the events facial neuropathy flare, fatigue, nervous and worried was unknown. The event runny nose was not recovered.
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| 63 | 2021-03-28 | headache |
had Parkinson's and my symptoms got worse; Full blown period with clotting/haven't had period since ...
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had Parkinson's and my symptoms got worse; Full blown period with clotting/haven't had period since 18 years so now it's heavy; Headache; Acne/cramping/was very irritable/it was PMS; tremor; an itchy chest including nipples/itchy rash, not swollen but a rash on chest and nipples which were itchy; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 06Mar2021 14:45 (Batch/Lot Number: EL3302) as a single dose for COVID-19 immunization. Medical history included Parkinson's, hypothyroidism, aortic insufficiency, allergies: penicillin, tea tree oil, latex, whey. Patient is not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from 1998 and ongoing, carbidopa, levodopa (CARBIDOPA LEVODOPA) taken for Parkinson's disease from Feb2013; and estradiol (VIVELLE DOT) for estrogen therapy. Patient previously took prochlorperazine edisylate (Compazine) and morphine and experienced allergies for both. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has not had a period for 18 years. On 07Mar2021 12:00, patient got an itchy chest including nipples, irritability, acne and a heavy full blown period with clotting, cramping, etc. AE resulted in doctor or other healthcare professional office/clinic visit. Events were also reported as follows: patient experienced itchy rash, not swollen but a rash on chest and nipples which were itchy. Patient had Parkinson's and her symptoms got worse. She just went to her neurologist and thought that was a little strange and patient had headache. It was reported that she was irritable, it was PMS. Then patient had full blown period and patient have not had period since 18 years so now it was heavy. Patient had neurology appointment a short time ago and she was doing great and she also had her urology appointment on 23Feb2021 and everything was fine. Patient did use Vivelle-Dot which is half of a milligram, it is an estrogen therapy, but patient have never had any problems with bleeding at all, "nothing like that ever". Itching started on 06Mar2021, and then over the next couple of days, patient started having headaches, irritability, cramping, just overall Parkinson's symptoms, and tremor (medication wasn't controlling her tremor anymore). Patient has not recovered from the events.
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| 63 | 2021-03-30 | fatigue |
Thyroid test spiked; Hot and cold flashes; Hot and cold flashes; Tired; This is a spontaneous report...
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Thyroid test spiked; Hot and cold flashes; Hot and cold flashes; Tired; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Mar2021 (Sunday) 18:30 (Lot Number: EN6205; Expiration Date: 30Jun2021) (at 63-year-old) at single dose in arm right for COVID-19 immunization. Medical history included mitral valve and atrial valve leaking from last year (2020), thyroid removed. No additional vaccines administered on same date of BNT162B2, no prior vaccine within 4 weeks, and no family medical history. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration Date: 30Jun2021) on 14Feb2021 18:30 at single dose in the right arm for COVID-19 immunization. She noticed on "Monday" (08Mar2021) she had some hot and cold flashes and she felt tired, which went away the same day. They always checked blood test for thyroid levels randomly because she had her thyroid removed in the past. It has been three months since the last test and the nurse called her "today"/ "this morning" (09Mar2021) to report the result was spiked (thyroid test spiked). She didn't know the actual result, just it was spiked. She usually took 125 mcg levothyroxine sodium (SYNTHROID) once daily by mouth. The events didn't require a visit to physician or ER, and no other relevant test. The outcomes of events tiredness, hot and cold flashes was resolved on 08Mar2021, while of event thyroid function test abnormal was unknown.
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| 63 | 2021-03-30 | headache, chills |
Headache still present began day of vaccine; Chilled afternoon of vaccine; minor arm soreness at inj...
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Headache still present began day of vaccine; Chilled afternoon of vaccine; minor arm soreness at injection site; This is a spontaneous report received from a contactable consumer (patient reported herself). A 63-year-old non-pregnant female patient received first dose of (COVID 19, Pfizer, Formulation: Solution for injection, Lot number: EM9809), via an unspecified route of administration on 05Feb2021 09:30 AM at single dose to her left arm for Covid-19 immunization. The patient's medical history included hypertension controlled with medication. Covid was not tested prior or post vaccination. No known allergies. Concomitant medications included irbesartan, spironolactone, vitamin D NOS (VITAMIN D) and MULTIVITAMIN. On 05Feb2021 02:00 PM, the patient experienced headache still present began day of vaccine now day 5. Chilled afternoon of vaccine administration. Minor arm soreness at injection site for 24 hours. She did not receive any treatment in response to the events. Outcome of the events was not recovered.
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| 63 | 2021-03-30 | headache, malaise |
really bad headache, excruciating headache; nauseous, nausea/queasy; blurred vision; holes in her vi...
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really bad headache, excruciating headache; nauseous, nausea/queasy; blurred vision; holes in her vision; not right; like an allergic reaction; She had soreness in the arm; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2, via an unspecified route of administration, administered in Arm Left on 05Mar2021 16:32 (Lot Number: EN6198; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history included allergies to Sulfa drugs, Penicillin, and believes she has allergies to Ploymers (She cannot wear polyester and she has to wear 100% cotton). The patient's concomitant medications were not reported. The patient (at the age of 62-year-old) previously received the second dose of Shingles Vaccine in Jan2021 for immunization. The patient experienced really bad headache, excruciating headache on 09Mar2021 21:00, nauseous, nausea/queasy on 09Mar2021, she had soreness in the arm on 05Mar2021, blurred vision on 09Mar2021, holes in her vision on 09Mar2021, not right on 09Mar2021, like an allergic reaction on 09Mar2021. She developed a "really bad headache" around 9pm on Tuesday 09Mar2021, that caused holes in her vision and pain "straight across my forehead". She did treat with Tylenol and was able to finally sleep around 5am. She states that the headache has persisted, and she's felt "nauseous, queasy, and not right" since the headache started. She is hesitant to get the second dose. She was experiencing headache following. She mentioned she is allergic to sulfa drugs, penicillin, and polymers, and thought maybe the headache was a result of an allergy to the vaccine? Ingredients don't appear to have any of her reported allergens. She had soreness in the arm the first 48 hours, which was to be expected and no big deal for her. However, starting on Tuesday, she had an excruciating headache. She normally does not typically get headaches. She believes in vaccinations and as a teacher the minute she could sign up to get one she did. Now she is terrified to get the second one. When this excruciating headache began she woke her husband up to tell what happened. She thought she was going to die, that is how bad it was and she wanted him to be aware and prepared if anything should happen. The excruciating headache started at 9PM. It was excruciating all night. The headache made her queasy because she hurt so bad. It continued into Wednesday. Today and today the pain is duller in her head, much duller than it was. However, she still feels queasy/nauseous. The headache also started with blurred vision. The blurred vision has gone away. It was like there were holes in the TV. She was thinking it was interesting and did not think much of it at first. She thought one of her contacts had a hole in it, but she did not even have any on. The blurred vision lasted 24 hours. The soreness in arm lasted until Sunday or Monday. She confirmed the pain in arm is gone and was gone by Monday. She initially could not wait to get her shot. Now she is terrified to get the second one. She took Tylenol in the middle of the night on Tuesday and Wednesday for the headache. Has allergies to Sulfa drugs, Penicillin, and believes she has allergies to Ploymers. She cannot wear polyester. She has to wear 100% cotton. She is questioning if the vaccine has polymers in it. From what she heard it does and is wondering if this caused her to have like an allergic reaction. The outcome of the event vaccination site pain was recovered in Mar2021, the events Nauseous and headache was not recovered, other events was unknown.
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| 63 | 2021-03-30 | headache |
dysuria; abdominal pain; pelvic pain; bladder spasms; left flank, low back and upper back pain; left...
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dysuria; abdominal pain; pelvic pain; bladder spasms; left flank, low back and upper back pain; left flank, low back and upper back pain; headache; This is a spontaneous report received from a contactable nurse. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL0142) via an unspecified route of administration left arm on 14Jan2021 08:15 at single dose for COVID-19 immunization. Medical history was not provided. Concomitant medications included colecalciferol (VITAMIN D) and vitamin b complex. Patient previously took BNT162B2 (lot number: Eu1685) on 23Dec2020 07:45 to Left arm for COVID-19 immunization. On 26Jan2021 Lab data was reported as PCR test, Nasal Swab and Veritor rapid test results were negative. On 15Jan2021 the patient experienced with dysuria, abdominal pain, pelvic pain, bladder spasms, left flank, low back and upper back pain, headache. Patient received Bactrim, Toradol and Advil as treatment for events. Seriousness was reported as non-serious. Outcome of events was unknown. No follow-up attempts are possible. No further information was provided.
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| 63 | 2021-03-31 | influenza like illness, fever |
passed out; Unfortunately hit my head.; felt light headed; slightly nauseous; intense right knee pai...
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passed out; Unfortunately hit my head.; felt light headed; slightly nauseous; intense right knee pain; temperature of 99.6; flu-like symptoms; This is a spontaneous report from a contactable Other Health Professional (patient). A 63-year-old non-pregnant female patient received bnt162b2 (Pfizer Brand COVID 19), dose 2 intramuscular, administered in left arm on 26Feb2021 12:00 (Lot Number: EN6198) as single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient was not diagnosed of Covid prior vaccination and has not been tested for Covid post vaccination. The patient has no known allergies. Concomitant medication included levothyroxine, liothyronine (NP THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (Pfizer Brand COVID 19), dose 1 intramuscular, administered in left arm on 05Feb2021 11:30 AM, (Lot Number: EM9810) for COVID-19 immunisation. There was no other vaccine in four weeks. On 27Feb2021 07:45, the patient passed out, unfortunately hit head, felt light headed and slightly nauseous. It was also reported that patient had intense right knee pain, a temperature of 99.6 and flu-like symptoms. The events were also described as follows: 18hrs after the injection, I had intense right knee pain that lasted for 24hrs. Also in that same time period, I felt a huge rush of energy come over me and passed out. Unfortunately hit my head. I had a temperature of 99.6 and flu-like symptoms that lasted 24hrs. For 4 days I felt light headed and slightly nauseous but that could have been due to hitting my head. Called 911, EMT evaluation and the patient received treatment for events. Outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events and other events. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified, as appropriate.
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| 63 | 2021-04-01 | headache |
onset of symptoms of left-sided Bell palsy (twitching, paralysis, lost of taste/sensation of tongue,...
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onset of symptoms of left-sided Bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). I knew I had Bell palsy; Awakened with brief episode (10 min) severe abdominal pain; Severe muscle aches; Head pain; Neck pain; Developed sore on left side of tongue; Neck/mastoid pain; Swollen gland lasted a few days; This is a spontaneous report from a contactable other HCP (patient). A 63-year-old (non pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6200, Expiry Date: unknown) via an unspecified route of administration in left arm on 24Feb2021 13:30 at single dose for COVID-19 immunisation. Patient had historical vaccine at 63-year-old BNT162B2, lot number: EL9262 at left arm on 03Feb2021 13:30 at SINGLE DOSE for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's medical history included penicillin and neomycin allergy. Patient's concomitant medications included ergocalciferol (VIT D), rosuvastatin calcium (CRETOR) (medications the patient received within 2 weeks of vaccination). On 25Feb2021, the patient experienced onset of symptoms of left-sided bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). I knew I had bell palsy, awakened with brief episode (10 min) severe abdominal pain, severe muscle aches, head pain, neck pain, developed sore on left side of tongue, neck/mastoid pain, swollen gland lasted a few days. Event was reported as on 25Feb, patient awakened with brief episode (10 min) severe abdominal pain. Later, severe muscle aches, head and neck pain, lasted until following Wednesday (03Mar). Patient developed sore on left side of tongue, neck/mastoid pain, swollen gland; lasted a few days, then noted onset of symptoms of left-sided Bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). By friday 12Mar she knew she had Bell palsy. Medrol dosepak, OTC pain meds was received as treatment for adverse events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The outcome of event was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Bell's palsy and other events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI and viral serology, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-04-01 | runny nose, fatigue, dehydration, influenza like illness, sleepiness |
rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso...
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rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso, had it on legs/face was so red like the rough sunburn feeling; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Felt dizzy and weak/had less energy today; Dizziness and lightheadedness /felt dizzy and weak; Worst and really sharp Charlie horse between ankle and calf- took forever to walk; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Anaphylaxis due to vaccination; Vomited; Major diarrhea; She was so cold that her toes were purple; Blood Pressure so low: 58, couldn't find a bottom number at first but then at the hospital it was 58/38; Face was extremely pale; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; Too cold to function or do anything; Nauseated- almost like morning sickness/Extremely nauseated/queasy feeling; Nauseated- almost like morning sickness; very extremely tired; creatinine /it was still high; sick; body temperature was low; She thought she was going to die because of the purple toes; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; her body catching up on sleep or she's just tired; This is a spontaneous report from a contactable consumer (patient herself). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), via an unspecified route of administration, on 11Mar2021 as single dose in left arm for COVID-19 immunisation. Medical history included ongoing High Blood Pressure (It's under control now, fairly healthy; diagnosed probably when she started menopause in early 50s), ongoing Anxiety (Diagnosed probably when she started menopause in early 50s), ongoing Sinus headache (Worst sinuses; Takes Excedrin because Tylenol does not have an effect on her), ongoing smoker (Pack a day, but smoking about only about half of it each time. started when she was a teenager. She was without a cigarette for 3 days in the hospital, but when she came home she had to start again), menopause (in early 50s), shoulder- torn rotator cuff-operated in 2018. Family history included cardiac and heart disease, Parkinson's and Frontal lobe dementia (husband). Concomitant medication included colecalciferol (VITAMIN D3) 1000 IU, once a day, by mouth (Taken these for as long as she can remember, they kept advising it, husband takes it for Parkinson's so she just throws one in for her), calcium ascorbate (VITAMIN C) 1000 IU, once a day, by mouth (Started at least 2 years ago, doesn't drink enough orange juice, doesn't do fruits, doesn't get enough Vitamin C), linum usitatissimum seed oil (FLAXSEED OIL) 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for cardiac and heart disease, takes as preventative, fish oil 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for family history of cardiac and heart disease, takes as preventative, hydrochlorothiazide, lisinopril 20/12.5 mg, once a day, by mouth (She has been taking this medication for years, under control with this medication) for High Blood Pressure, lansoprazole from 2020 30 mg, once a day, by mouth (Started years ago) for Stomach pill for acid reflux, duloxetine hydrochloride 60 mg, once at bedtime, by mouth (Started forever ago) for just being achy and anxiety, lorazepam .05 mg, 1 tablet 3 times a day, takes one tablet a day at bedtime, by mouth for Anxiety (Started this a while back- with the heart disease and everything else, gave this to help with menopause symptoms too), meloxicam 15 mg, at bedtime as needed from 2017 for back issues- really sore at times, takes if really stressed or she overdoes it. Patient previously took Tylenol for sinus headache and does not have an effect on her. After the first dose of the vaccine the patient reported that she was extremely tired on 11Mar2021. She was completely nauseated most of the day on the second day. On Saturday, she was extremely nauseated (12Mar2021) with vomiting and major diarrhea on 13Mar2021. By 4 PM that afternoon (12Mar2021), she could not function because she was so cold; she felt like she was in a really bad dream and couldn't wake up. She called on 13Mar2021, her blood pressure was so low-they got 58 for the top number, they were unable to pull up bottom number at that point. patient reported that when the ambulance arrived, they described her face as extremely pale on 13Mar2021; her major complaint was that she was so cold- she has never been that cold in her life. When she got to the ER- they had to use the old blood pressure cuff to get her blood pressure because it wasn't coming up on the machine- the kind where you pump it up and watch the needle, they said it was 58/38. patient states that they asked her about the rash that was all over her body in 2021; caller reports that she did not have a rash when she called at 4 PM. patient describes the rash as an extremely red sunburn rash- like you got really bad sunburn, most of it was on her torso, she also had it on legs on 13Mar2021. patient mentioned she remembers them taking off sock and her toes were purple on 13Mar2021. She also had a red on her eyelids- she described as itchy and swollen on 13Mar2021. patient mentions that unbelievably as sick as she was in 2021, she could understand everything that they were telling her. Treatment was given as they prescribed her Prednisone and Benadryl; she was also hooked up to an IV, and they were trying to warm up her body because body temperature was low in 2021. Discharge paper reads as anaphylaxis due to vaccination on 13Mar2021. patient states that she came home from hospital on Monday, 15Mar2021. patient reports she started a diet. 2nd day (12Mar2021)- From the time she got up, she was too cold to do anything; she couldn't walk and she was feeling like she was getting the flu. Saturday (13Mar2021)- She woke up and had the worst Charlie horse between ankle and calf- took forever to walk Charlie horse off. Really sharp Charlie horse. Even had less energy today. Really nauseated. patient reports that yesterday and today, she is just tired. She doesn't know if it's just her body catching up on sleep or she's just tired; she will find out today when she goes to doctor. Caller mentions that she is normally more active than she feels right now. patient reports her eyes have been itchy and she has a rash on her eyelids. patient doesn't know if it's from the shot; patient mentions that she decided on 01Mar2021 she would start a diet, get healthy, and see a nutritionist. patient reports that initially she didn't think her symptoms were from the vaccine and thought it was that she wasn't eating enough food on Friday. She got in touch with the dietitian. patient reiterated she did not attribute this to shot right away. patient reports that she was wondering if she had asymptomatic covid, and it would have been within a 3-month period that she reacted to the shot. She was not sick if she did have asymptomatic covid. There still trying to figure out why her body had this reaction. patient states that every now and then she was still cold, but she doesn't know if its her imagination and plus it is cold outside where she is. She is still on the cuff on that one. patient describes the nausea she first felt as almost felt like morning sickness on 12Mar2021-that's why she attributed it to her diet. patient mentions that the day she started feeling better, late Sunday afternoon, she wanted salty foods. Anything salty, chips, she just really wanted salty stuff. She was not normally a salt person, but the saltier it was, the better it was. patient reports that when she was vomiting with diarrhea and laying down, she would be throwing up in a towel because she couldn't make it to the bathroom when she was laying, it would just gush. patient describes it felt like her body was going to be locked into the position it was in, she doesn't know how to describe it. patient states that she had vomit on her clothes when she called. patient reports the nausea stopped late Monday and the queasy feeling went away. patient reports she stopped vomiting when they gave her Zofran- they had to give her a couple because she didn't stop throwing up right away. patient reports she was extremely dehydrated and her kidneys were showing some damage; her creatinine level was really off on 13Mar2021. The diarrhea was gone, but now she has a mixture of soft stools and semi formed. It is trying to improve but hasn't yet. patient states that because of her creatinine level, they did want her to drink and she might have soft stools because she was drinking so much. patient reports she knows when her husband put the shirt on her she did not have the rash, but when the ambulance arrived, they said she had the rash. Upon discharge, they told her not to receive any further covid vaccines- she cannot get her second one which was scheduled for 01Apr2021. She started experiencing the really cold feeling on 12Mar2021 after receiving the vaccine. She went to bed at 7, that's not like her, she was usually up all hours of the night. symptoms she was experiencing were beyond typical. patient reports she also felt dizzy and weak on 13Mar2021. She thought she was going to die because of the purple toes in 2021- she knew that was a sign of her body shutting down and she got the most scared. patient mentions she is experiencing a residual side effect from the covid and influenza tests-both were negative on 13Mar2021, but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph in 2021. patient reports she feels human today, but she is still sleepy in 2021. She thinks she would feel a whole lot better if her nose stopped running. The tiredness might be from nose blowing and stuff. patient remembers the nurse was thrilled that her toes weren't purple anymore. It started going away when her blood pressure and everything came back up. patient states that she was so scared that she was dying so she remembers everything that happened. patient remembers she was in the ER still when her blood pressure improved. Treatment for her face was so red like the rough sunburn feeling and putting moisturizer on the dried cheeks. patient reports that she doesn't see any patches of red on her. Part of her has a fear that the stuff is not totally out of her system and it will happen again. patient mentions she has heard comments that this was not a typical reaction from the first one and wants to know if it is typical to be that sick from the first dose. patient reports that now her eyes just feel like she's allergic to something. She doesn't know if the redness is from crying now- it was improving, but was still there. Husband has Parkinson's and Frontal lobe dementia and she is his caregiver, she cannot afford to get Covid, she wants to get back to normal. patient reports that she did not take any of her prescriptions the day of the vaccine, she did not want to get a reaction. patient reports she had her shoulder- torn rotator cuff-operated on in 2018. If nose is really stuffed up or allergies, or Fluticasone nasal spray- she can take it 2 times a day, 2 squirts in each nostril, take it as needed. patient reports that she has the worst sinuses- when it gets too bad, she'll go to the doctor and she'll prescribe Flonase, take Metamucil or whatever she thinks will help with sinuses. she still wants to get the second vaccine. patient reports her creatinine came down well enough that she could come home from the hospital, it was still high on 15Mar2021 so they told her to drink lots of water so she does not get dehydrated. Patient was hospitalized from 13Mar2021 to 15Mar2021 for Anaphylaxis, Tiredness, Nauseated, Morning sickness, Vomited, Activities of daily living impaired, Walking difficulty, Flu like symptoms, Pale, Photosensitive rash, Asthenia, Dizziness, Charley horse, Dehydration, Renal disorder, Creatinine low, Cold, Diarrhea, Purple toes syndrome, Blood pressure low, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid. For rash also patient was hospitalised. The outcome of Vomited, Pale, Photosensitive rash, Dizziness, Asthenia recovered on 13Mar2021, Nauseated, Morning sickness recovered on 15Mar2021, Activities of daily living impaired, Walking difficulty, Flu like symptoms recovered on 17Mar2021, Diarrhea, Cold, Blood pressure low, Purple toes syndrome, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid were recovering, Tiredness and Creatinine high were not recovered, while remaining events were unknown. No follow-up attempts are possible. No further information is expected.
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| 63 | 2021-04-06 | headache, chills, fatigue |
Smelling roast beef and cotton candy (phantosmia - or olfactory hallucination); Severe headache; Mus...
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Smelling roast beef and cotton candy (phantosmia - or olfactory hallucination); Severe headache; Muscle aches; Chills; Fatigue; This is a spontaneous report received from a contactable pharmacist reporting for herself. A 63-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534), via an unspecified route of administration on 23Mar2021 10:00 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medications included calcium carbonate (CALTRATE), ascorbic acid, retinol, tocopherol (OCUVITE). Historical Vaccine included first dose of BNT162B2 (Lot number EN6203) on 23Mar2021 at 10:00 AM for COVID-19 immunization. The patient experienced Smelling roast beef and cotton candy (phantosmia - or olfactory hallucination), Severe headache, Muscle aches, Chills and Fatigue on 23Mar2021 20:00. Treatment received for event headache included Tylenol 1grm at 9:30 am 3/24. The outcome of the events were resolving. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported event parosmia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-04-07 | fatigue |
Only initial side effect following both injections was moderately sore arm and fatigue. Following 2...
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Only initial side effect following both injections was moderately sore arm and fatigue. Following 2nd dose I experienced 1 episode of severe vertigo while just sitting doing nothing. Dizziness cleared completely in about 4 minutes. Then on March 13th, was at work, sitting at desk and same thing happened again. After the dizziness cleared I got up and went to see a patient. I work in a rehab unit of a hospital. Got pt approx 50 feet down the hallway when dizziness started coming back. Handed patient over to other staff. I took my blood pressure and checked my blood sugar. Both WNL . Dizziness never got better. Went to ER. They had no clue of cause. All labs were normal. Saw Physical therapist who performed Eply maneuver as well as a ENT. Both got same result. Negative for BPPV. MD gave me Antivert. Didn't work. Are waiting to be seen in May 2021 for NVT test and another with Neurologist. In the meantime the dizziness has remained constant rendering me unable to return to work.
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| 63 | 2021-04-09 | chills, fever, sweating |
Chills, fever-diminished sweats-resolved 4/5/2021 migrating erythema, tenderness under erythema, ...
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Chills, fever-diminished sweats-resolved 4/5/2021 migrating erythema, tenderness under erythema, anorexia, bladder irritation-persistent
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| 63 | 2021-04-09 | sweating, malaise, fatigue |
sick; exhausted/wiped out; stomach kind of hurts; started to feel lousy; tiny bit of dizziness; Weak...
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sick; exhausted/wiped out; stomach kind of hurts; started to feel lousy; tiny bit of dizziness; Weakness; lower abdomen hurt; tired; vomiting; diarrhea; sweaty; little bit of rectal bleeding after diarrhea; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in Left upper arm on 24Mar2021 (Batch/Lot number was not reported; Time the Vaccination Was Given was around 15:30) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing thyroid, renal disorder from an unknown date and unknown if ongoing , diabetes from an unknown date and unknown if ongoing, blood pressure measurement from an unknown date and unknown if ongoing, vaginal disorder from an unknown date and unknown if ongoing, colitis from an unknown date and unknown if ongoing. Reported following prior vaccinations was stated she had a sore arm sometimes with the flu shot and felt kind of sick but not always. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for thyroid from an unspecified start date and ongoing (reported she started taking this decades ago); metformin (METFORMIN) taken for diabetes from an unspecified start date and ongoing ((reported she started taking this decades ago); lisinopril (LISINOPRIL) to protect kidneys with diabetes and for blood pressure, started years ago and took a small dose, stated her blood pressure was usually fine; estradiol (ESTRACE) taken for when the vaginal tissues get disintegrated from an unspecified start date and ongoing (stated she started this a very long time ago). The patient experienced little bit of rectal bleeding after diarrhea on 25Mar2021 with outcome of unknown, sick on an unspecified date with outcome of unknown, tired on 25Mar2021 with outcome of not recovered, vomiting on 25Mar2021 with outcome of unknown, diarrhea on 25Mar2021 with outcome of unknown, sweaty on 25Mar2021 with outcome of unknown, exhausted/wiped out on an unspecified date with outcome of unknown, stomach kind of hurts on 25Mar2021 with outcome of unknown, started to feel lousy on 25Mar2021 with outcome of unknown, tiny bit of dizziness on 25Mar2021 with outcome of not recovered, weakness on 25Mar2021 with outcome of unknown, lower abdomen hurt on 25Mar2021 with outcome of unknown. The event little bit of rectal bleeding after diarrhea considered serious as medically significant. The AEs not require a visit to Emergency Room or Physician Office. Received the first dose of the Pfizer Covid 19 vaccine Wednesday afternoon, yesterday, patient felt okay, but was off, got really sick in the middle of the night. during the day , tired, expected that, but at night vomiting, diarrhea and weak, sweaty, kind of bad. it stopped today she was just exhausted and her stomach kind of hurts. She was better than last night, today she was just more worn out by this, she took a Imodium. She had the vaccine Thursday afternoon and yesterday she felt lousy, nothing severe and last night she was very sick. Stated she was still trying to get better today. Stated she called and left a message with the FDA/CDC vaccine adverse event reporting system a little while ago. Caller clarifies she got the vaccine on Wednesday 24Mar2021 and that she started to feel a little lousy 25Mar2021, more like the symptoms that are described, she was tired and had a tiny bit of dizziness that came and went, it was mostly tired. Stated in the middle of the day she laid down for an hour and that was around lunch time. Stated the dizziness was off and on like when she was driving and just here and there. Stated the tired was still persisting. She stated she did not have NDC, lot, expiry date or dose to provide. Stated she see EUA on the sheet but not much else. Stated it was the 1st dose. Stated she forgot to tell about last night. Stated she woke up around midnight very sick with vomiting and had diarrhea and was sweaty. Stated her stomach hurt and her lower abdomen hurt. Stated she was not sure if these are from the vaccine or a coincidence. Stated she had stopped throwing up, just did that a few times. Stated the diarrhea stopped after a little while. Stated she still has abdominal pain today and weakness was with the diarrhea and she would lay down in bed. Stated she was still a little weak, that she was more wiped out and tired. Caller stated she was bleeding a little bit after the diarrhea and it scared her because a couple years ago she had colitis and it scared her, that she called a relative who is a retired nurse and she thought it was from the diarrhea. Caller clarified she contacted her relative about this current event with the bleeding. Caller provided that she took Imodium this morning and has been sipping on water and had a little breakfast, she thought she may be a little dehydrated. Patient stated her symptoms were pretty bad last night, it was acute. Patient clarified that it was rectal bleeding and it was just a little this morning. Stated it happened last night and again this morning. Stated she was not sure if it was still occurring and hopes it stopped as it it's scary. Stated today she was just resting and trying to get better. Patient said that if it gets worse she will call her doctor and that she had called the hospital last night and they didn't have anything to say. Stated that if it was from the vaccine she was hoping that it's very temporary and went away and be gone if it was from the vaccine. Patient was asking if there was information about the chance that this was related to the vaccine, stated they were not listed as possible side effects. Stated she had people from the hospital and relatives she has talked to that say it may be. Information on the lot/batch number has been requested
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| 63 | 2021-04-09 | pneumonia, influenza like illness, fever |
pain; flu-like symptoms/felt like she had a little bit of the flu; she has one area with a "big circ...
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pain; flu-like symptoms/felt like she had a little bit of the flu; she has one area with a "big circle around it and it's hard; she had a little bit of pneumonia; got a fever; felt like she couldn't go to the bathroom, cramps; had trouble breathing; the site was red; swelling/her arm is swelling; it does hurt her, right in that area where the shot was given; arm was sore and achy/her arm started aching; Diarrhea; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6208, expiration date unknown), via an unspecified route of administration, administered in left arm on 22Mar2021 at the age of 63 years old at a single dose for COVID-19 immunisation. Medical history included ongoing pre diabetic, ongoing high blood pressure, ongoing non-alcoholic liver disease, edema, to help her breathe, pneumonia, COVID in 2021, respiratory problems, asthma, little bit of obesity, swelling in her legs, varicose veins. Concomitant medications included benzonatate at 100 mg to help her breathe, azithromycin (six pills of that, 200mg, two one day and one pill a day until gone) for pneumonia. Patient had her second dose scheduled on 12Apr2021. She explained after the shot, her "arm was sore and achy" she said she also had "pain". She added she experienced "flu-like symptoms". She specified these adverse reactions are all gone now but her arm is still "a little sore" and she has one area with a "big circle around it and it's hard". She said it could be "swelling". She asked if her reaction was reported as side effects to the vaccine. She expressed being in a rush and is expecting her daughter soon and asked us to be quick. She said she will also consult with her HCP this afternoon. Patient stated she had the first shot on Monday 22Mar2021 and today and last night the site was red, but today in that area she has gotten a big circle around it and its hard. Patient stated she's had it before with shots and just wanted to make, sometimes she has had to be put on medicine for it, wanted to be sure its healing because it does hurt her, right in that area where the shot was given. She also stated that after she has her second shot on 12Apr2021, she would like to talk to somebody and she would like to be able to have people in her home. She was reporting she had COVID three weeks ago, would she be ok after the 2nd shot to go out? She stated her daughter thinks she needs to wait until the end of April. She verified she did receive the Pfizer BioNtech Covid 19 vaccine. Swelling: Patient stated her arm is swelling. Also stated she always gets that and today there's a circle there and it is red and hard. Also stated occurred after the shot. Patient reported that the shot hurt like heck and she couldn't really tell, she has big arms, she knows it was swollen. Reported she took over the counter medicines, last night she noticed it was a circle and it was hard there. Stated area is not swelling anymore, now just one hard red circle. Red and a hard circle: She also reporting her entire arm ached after the shot, she stated she knows her entire muscle was aching. Stated it was swollen quite a bit but now its just red and a hard circle, and it's ongoing. Arm swelling outcome: Patient reporting yesterday afternoon, she was feeling better, except that one spot. She stated it does hurt when she bends it because she had that one little area that's swollen. Also stated the swelling started later that afternoon after the shot. Reported she went for a walk with her daughter and her arm started aching. It felt like she couldn't go to the bathroom, cramps. It felt like she had a little bit of the flu, and it was from the shot but it only lasted a few days. Stated that part went fast, got a fever, other than that, just the one area on her arm. Stated she doesn't even feel sick from the shot or anything. Stated she had Diarrhea: Stated she had diarrhea in the beginning after the shot then had trouble going to the bathroom. Stated she thinks its because she has IBS and that's how her body is. She doesn't know if that's from the shot or not because that's how her body always is. Pfizer BioNtech Covid 19 Vaccine: Patient stated she doesn't want COVID again. She has respiratory problems anyway, she has asthma and a little bit of obesity. She states she was in fear of herself. She doesn't do well with hospitals and being put under with that medicine. Also stated patient knew COVID causes a lot of people having trouble breathing and she doesn't want to end up on a breathing tube where its breathing for her and she never sees her family again. Caller states it kind of scared her. Patient stated her niece and nephew, whos got it worse. She stated she went to the hospital and haven't been back. She stated she was hospitalized about 2 weeks ago, and that's when she was diagnosed with COVID, before she got the first COVID shot. About the medical history, non-alcoholic liver disease: Stated diagnosed about eight years ago, she would say the same time, about 7 to 8 years ago because she had a virus and when she went in the hospital, the virus had attacked her right kidney and liver. She stated with non-alcoholic liver disease, she is overweight, and that causes her to have issues with her liver. The last few times her liver has been okay. Pre-Diabetic: They have been watching that for a while. Stated she gets edema, swelling in her legs, well, all the time. She has had this the last two years because she is pre-diabetic and a lot of overweight people have that. She also has varicose veins so that doesn't help. Stated that was given those to help break up, because she had pneumonia when she got the COVID and she had a little bit of pneumonia and had trouble breathing. The patient was recovering from arm was sore and achy/her arm started aching, swelling/her arm is swelling and for other events it was recovering.
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| 63 | 2021-04-11 | fever, chills, headache | Severe headache, nausea, weakness, fever and chills. Only headache remains 2 days later. |
| 63 | 2021-04-13 | fatigue |
Initial mild fatigue day 2 & 3 followed by abdominal pain day 3. Accute Appendicitis, followed by s...
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Initial mild fatigue day 2 & 3 followed by abdominal pain day 3. Accute Appendicitis, followed by surgery to remove appendix
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| 63 | 2021-04-13 | headache |
On 04/04/2021 after having memory issues I went to the emergency room and was diagnosed as having 3 ...
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On 04/04/2021 after having memory issues I went to the emergency room and was diagnosed as having 3 strokes. I woke up with a throbbing headache and then had difficultly remembering simple things like using the remote control for TV. My vision was also somewhat blurry. I then went to drive and my focus was off making driving difficult so I then went to the emergency room
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| 63 | 2021-04-14 | chills, fatigue, fever |
Chills and fever (~101.0F) at initial onset which lasted approximately 8 hours. Fatigue which laste...
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Chills and fever (~101.0F) at initial onset which lasted approximately 8 hours. Fatigue which lasted ~24 hours. Nausea which lasted ~8 hours. All resolved 48 hours after injection.
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| 63 | 2021-04-15 | fatigue, throat pain |
Started with arm being very sore at vaccination site, thrm developed a round red spot at vaccine sit...
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Started with arm being very sore at vaccination site, thrm developed a round red spot at vaccine site which is becoming bigger. Also, have a canker side in my throat-I send to get them as a child, in my throat. Also, broke my knee cap 2 years ago and it had become painful
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| 63 | 2021-04-17 | cough |
has possible atrial fibrillation; Arm would get hurt; her arm felt like a bruise; irregular heart ra...
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has possible atrial fibrillation; Arm would get hurt; her arm felt like a bruise; irregular heart rates; She'll have a slight cough and she feels a little short of breath then she's fine. That happened leaving the Covid 19 vaccine site. And it's been happening more at night.; When probing for specific event information she reports it's kind of like she coughs a little more and she is a little more short of breath and it's happening more often; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 63 years, via an unspecified route of administration on 27Mar2021 04:06 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history included asthma, hysterectomy, dark chocolate or red dye (she starts coughing and has an allergic reaction and shortness of breath), bursitis (in her right). The patient's concomitant medications were not reported. The patient previously took penicillin, experienced allergy and had really ad hives (several years ago) she was given a cream to put on. She had to get another medication and she doesn't remember the name. That medication made her dizzy and she couldn't even get out of bed so they had to half the dosage. When she had her hysterectomy she learned she couldn't take any types of "cillins" medications. The patient had been watching her heart rate with a device and since getting the Covid 19 vaccine she's noticed her heartrate was always higher than it normally is. Her heartrate was going crazy, the device was not recording right. She reports that for the last 2 days the device has been telling her she has possible atrial fibrillation. This is worrying her. She doesn't feel anything different. She was usually hyper. Her resting heartrate was higher. Normally her resting heartrate was in the 80s (beats per minute) Now it's going up to the 90s (beats per minute) then her heartrate drops to 40 something (beats per minute) Then the device said her heartrate was 118 and 107 and she's not even doing anything. She hasn't even worked out yet. She doesn't like to take medicine. Medications don't work out with her. She had a slight cough and she feels a little short of breath then she's fine. That happened leaving the Covid 19 vaccine site. And it's been happening more at night. It was reported that she feels fine. She has no other symptoms. She's been reporting online. Clarified she's reporting online through the V check through the CDC. She's been trying to get the Covid 19 vaccine forever. She did research on all the Covid vaccines and she felt more confident with the Pfizer Covid 19 vaccine. Her daughter was against the Covid 19 vaccine. Her daughter thinks the vaccine was just going to kill her. She reports she was healthy and she works out 6 days a week. She recently tried to get a CT scan for her heart. Her husband's cardiologist recommended her husband have a CT scan of his heart and she decided she needed a CT scan too. She's also watching her heartrate on her watch. Her husband's heartrate is completely normal and stable on the device so she knows the device isn't messed up. It was also reported that the device will tell her she has too much muscle movement and she's standing completely still. Then she'll get the device to record her heart rhythm and it goes sporadic. The device tells her 90 beats per minute at resting then over 100 beats per minute. Her heartrate on the device was going up and down a lot. When she's been watching the device record her heart, it looks like it's going crazy. Her heartrate goes way up and way down like in the 40s (beats per minute) She noticed when her heartrate is in the 40s (beats per minute) and she's never had her heartrate go down that far, it's really really weird. She thinks maybe she'll get back to normal. She keeps watching hear heartrate. She reports she noticed her heartrate right away on Saturday evening after she received the Covid 19 vaccine. Her heartrate was higher than normal for resting, it was in the 90s (beats per minute). Her resting heartrate is usually in the 60-80s (beats per minute) and it was the in 90s. Now the device says possible atrial fibrillation. It was further reported that she received the Covid 19 vaccine in her left arm because she has bursitis in her right. If she hit her arm the second day after the Covid 19 vaccine, her arm would hurt. Her arm felt better the next day. She clarifies, on Sunday, 28Mar2021, she noticed her arm felt like a bruise and that was it. Then the next day on Monday, 29Mar2021, the feeling was gone. She didn't have any redness. The outcome of the events her arm felt like a bruise and arm would get hurt was recovered on 29Mar2021, irregular heart rates, dyspnea, cough was not recovered and unknown outcome for has possible atrial fibrillation. Information on the lot/batch number has been requested.
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| 63 | 2021-04-18 | cough | shortness of breath, wheezing, coughing, low oxygen levels, high blood pressure |
| 63 | 2021-04-18 | headache, head discomfort |
intracranial pressure; angioedema near her ears and the gland secretes and the passage way swells up...
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intracranial pressure; angioedema near her ears and the gland secretes and the passage way swells up; rush of pressure to back of head and the lower part of head; Headache; dizzy/Dizziness/light headed; out of body experience like floating; my arm started to really hurt/Sore Arm; sore to touch; cloudy and pressure in her ears/Ear Pressure; vertigo issues; vestibular migraines; patient can't walk; tunnel vision; eyes felt funny. States like walking through a stream of pollen, not that she had itchy eyes, but it felt like she had been effected by something; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Left Arm on 01Apr2021 about 13:30-14:00 pm (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Hashimoto's disease, Diagnosed 13 Years ago, patient was allergic to penicillin and Avalox (anaphylactic and I am sensitive to medications). Don't know if this happened when she got Hashimoto's, Thyroid, ongoing Vestibular Issues Started 5 years ago. States one doctor thinks it is her bad neck. States when she got old things shifted and changed. One ENT said she has neuritis, where something hit her ear nerve in right ear. States hence that was what the acyclovir was for, when she feels an earache coming on, she takes acyclovir. No previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks). AEs following prior vaccinations: None; reported she hadn't had any flu vaccines in years because of the ingredients. States because of her Hashimotos because of everything with her health it was not conducive. Last one was 2014. Concomitant medications included guaifenesin (MUCINEX) taken for hypersensitivity from an unspecified start date and ongoing; fexofenadine hydrochloride (ALLEGRA) taken for hypersensitivity from an unspecified start date and ongoing; levothyroxine sodium (LEVOXYL) taken for thyroid disorder from an unspecified start date and ongoing; azelastine hydrochloride (AZELASTINE HYDROCHLORIDE) taken for hypersensitivity from an unspecified start date and ongoing; aciclovir (ACYCLOVIR ACTAVIS) taken for ear pain from Mar2021 to an unspecified stop date; naltrexone (NALTREXONE) taken for autoimmune thyroiditis from an unspecified start date and ongoing; alprazolam (XANAX) taken for an unspecified indication from an unspecified start date and ongoing; magnesium (MAGNESIUM) taken for an unspecified indication from an unspecified start date and ongoing; fish oil (FISH OIL) taken for an unspecified indication, start and stop date were not reported; curcumin (TURMERIC MERIVA) taken for an unspecified indication from an unspecified start date and ongoing; 7-keto-dehydroepiandrosterone (7 KETO DHEA) taken for an unspecified indication, start and stop date were not reported; ferritin (FERRITIN) taken for an unspecified indication from an unspecified start date and ongoing; boric acid, zinc sulfate (OPTIZINC) taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; lactobacillus reuteri (PROBIOTICA) taken for an unspecified indication from an unspecified start date and ongoing; calcium saccharate (CALCIUM D GLUCARATE) taken for an unspecified indication from an unspecified start date and ongoing; berberine hydrochloride, coptis chinensis, glycyrrhiza uralensis, mahonia aquifolium, phellodendron chinense, rheum officinale, scutellaria baicalensis, zingiber officinale (CANDIBACTIN BR) taken for an unspecified indication from an unspecified start date and ongoing; cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID) taken for an unspecified indication from an unspecified start date and ongoing; alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME) taken for an unspecified indication from an unspecified start date and ongoing; pancreatin enzymatic hydrolysate (PANCREATIN ENZYMATIC HYDROLYSATE) taken for an unspecified indication from an unspecified start date and ongoing; levoglutamide (L GLUTAMINE) taken for an unspecified indication from an unspecified start date and ongoing; betaine hcl (BETAINE HCL) taken for an unspecified indication, start and stop date were not reported, Bio Identical Hormone Cream taken for an unspecified indication, start and stop date were not reported. On 01APR2021, she could feel rush of pressure to back of head, tunnel vision, cloudy and pressure in her ears and was dizzy. Hx of Hashimoto's - autoimmune disorder, vestibular issue, concerns with getting the second one (dose). Read about adverse reactions and dizziness was on the list of severe reactions. The instant, within a minute, patient could feel this happening to her, she instantly could feel she becoming dizzy, light headed, out of body experience like floating. (didn't mention this in report) felt like walking on air. While sitting and chit chatting with other people to distract myself. Patient didn't have any anxiety. She will admit she was reluctant to get the vaccine because of my health problems. She was more concerned, she instantly got a headache with the pressure, when she was leaving, she felt her eyes feel weird, almost like an allergy issue, burning, not quite burning either. Kind of like a burning, not quite like a burning, felt like when you walk into the wind that has lots of pollen, that feeling. She didn't walk out side, she was inside when this happened, the pressure was already starting, no headache in front of head, it was in back of my skull, at top of her neck and pressure within the ears and ache and pressure on back of her head. Not dizzy, not like when you are in the hospital and they give she something and patient can't walk, or where you tried to stand and you couldn't , it was more like light headed, like walking on air like. It lasted all yesterday. As the night progressed by 10PM or 11PM her arm started to really hurt, patient took Tylenol and went to bed, took Xanax as she did and slept, woke up fine. This morning it felt like she wanted to have a headache but haven't had it since. It's almost like patient had intracranial pressure, because she had these conditions, so she read a lot. Investigation Assessment was No. States she is calling to report a potentially strange side effect. She states as soon as she got the injection, approximately within one-two minutes, she could feel a rush to the back of her head and the lower part of her head which then made her feel like she had somewhat of her vision clouded, like a tunnel vision. Clarifies her vision was clouded on the sides but she could see forward. Caller states that she was not dizzy like falling over and she does have vestibular migraines and vertigo issues, but she had that feeling of dizziness and when she got up and walked, it felt like she was walking on a cloud. Clarifies she felt a heavy pressure in the back of her head. States as soon as the injection was over, she could feel it. States she is concerned regarding the second dose because of her autoimmune and vestibular conditions. She states is caused immediate pressure in her ears. States that could've affected her and put her into a migraine, she doesn't know. States a friend said jeez you should report that and she read more on the list of side effects and saw something about an allergic reaction and dizziness, and she did have some sort of adverse reaction. States she doesn't know and it is concerning to her. States she is doing fine today, other than a little headache that comes and comes. States it was bizarre with the clouded, not cloudy, but tunnel vision. States she does not want to release any medical records; she declines for now to provide. She states CVS administered it, not her doctor. States she is going to discuss it with him. States she doesn't want to have a worse reaction with the second dose. Caller states a headache is a headache but the pressure she felt within one minute and continuing it concerns her on the second one with the larger dose. States she is also concerned with the second dose if dizziness is a severe allergic reaction, not saying she fell over and wiped out. Patient wondering if that was an allergic reaction. States as the evening went on and she took Tylenol, it improved. States the dizziness improved as the night went on but had a bizarre feeling when she went to bed. States her arm was sore in the evening and is still sore to the touch. Clarifies that her eyes felt funny. States like walking through a stream of pollen, not that she had itchy eyes, but it felt like she had been effected by something. States it was not like a tired and burning feeling, states she can't explain it but something felt like had an allergy type situation if she has a problem with seasonal allergies. Treatment included took Tylenol. States when someone has an autoimmune issue they have a lot of issues regarding the stomach and take a lot of vitamins and supplements. Caller states she wants to report she has a lot of food sensitivities and environmental sensitivities because of her Hashimotos. States anything can set off an immune response. States what happens with that is she would get on her face, angioedema near her ears and the gland secretes and the passage way swells up. States she takes Pepcid AC to treat it. States this did not happen with her first vaccine. States she was very hesitant on taking the vaccine because knows she has these issues and she didn't want to have adverse reactions. States that her reaction to the first vaccine potentially concerns her for the second dose. States going to speak with the medical information department is a good idea. States the location she received her vaccine was very busy. States they did a nice and good job on getting people in. States the girl administering it did good, but she didn't mention unless you knew you had to wait 15 minutes due to possible adverse reactions, they didn't really check on people. States she just had to do whatever and she didn't know whether or not to report it then because she was not in distress. States she thought she just has to get home and drove 30 miles. All events (AEs) did not require a visit to Emergency Room nor Physician Office. The events of Tunnel vision, rush of pressure to back of head and the lower part of head, Headache, dizzy/Dizziness/light headed, cloudy and pressure in her ears/Ear Pressure, was recovered on 01Apr2021, of my arm started to really hurt/Sore Arm; sore to touch was not recovered, of other events was unknown.
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| 63 | 2021-04-18 | fever, headache |
Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third...
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Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; This is a spontaneous report from a non-contactable consumer (Patient). A 63-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732), dose 1st via an unspecified route of administration, administered in Arm Left on 01Apr2021 08:00 as single dose for covid-19 immunisation. Patient medical history and concomitant medications were not reported. On 01Apr2021 11:15, the patient experienced Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack. The patient had other medications in two weeks of vaccination. Patient did not took any treatment for adverse event. Patient did not had covid prior vaccination and not tested for covid post vaccination. She did not have any Known allergies and had other medical history. No follow up needed. No further information is excepted.
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| 63 | 2021-04-24 | body temperature increased, fatigue, dehydration, chills, sinus pain, throat pain, sweating, headache |
Also felt that she almost faint, not dizzy not vertigo type for under a minute; stroke; meningitis; ...
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Also felt that she almost faint, not dizzy not vertigo type for under a minute; stroke; meningitis; have massive diarrhea; had a sore throat and could not swallow or eat; menstrual cramps; felt alot of extreme fatigue; felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it; sinus pain; her face and eyebrows hurt; throw up viscously that it is almost coming out of her nose and also went to sheer panic/vomiting; she is not speaking well or understood well; profusely sweating and had whole body sweat drenched on the floor; ice-cold ends; painful arm; baseline temperature is 94.6; Neck pain; Woke up Monday morning and couldn't get out of bed, wanted to die; Caller states she is losing her mind; had her gripping her pelvis because of the pain; sheer panic.; woke up with gut ripping food poisoning; still very tired; couldn't get out of bed; had a sore throat and could not swallow or eat; feel nauseous; feeling dehydrated; her head because of the ache; getting sick; nausea; experienced severe headache which led her to stay in bed all afternoon/her headache is more severe and describe it as she would like to shot her head because of the ache; has a flu-like chills; body ache symptom which comes and go; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration in arm left on 21Mar2021 as single dose for covid-19 immunisation. Medical history included taking a anti-HTN medicine (beta blocker) and had slowly been weaned off of that prior to getting his shot as her cardiologist is afraid that it might affect the efficacy of the vaccine shot and had not been put back in any BP regulating meds until then and quite concerned because of her fluctuation BP. anxiety and gets to panic immediately, also is disabled and doesn't live with any nearby family, has allergies to alot of foods. State she comes from family of strokes, heart attacks, and high blood pressure and one of her biggest fears is having a stroke. States her boyfriend has a family of strokes too, 2 blood pressure medicines, which contain polyethylene glycol (PEG). and concomitant medications not reported. The patient stated after 1 week of getting the vaccine- getting sick, felt alot of extreme fatigue, felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it. On 03Apr2021 experienced severe headache which led her to stay in bed all afternoon, she also has a flu-like chills body ache symptom which comes and go. On 04Apr2021 experienced nausea and took Tylenol for feeling so sick and felt well 2 hrs after. On 05Apr2021 woke up feeling all the symptoms like the other days, her headache is more severe and describe it as she would like to shot her head because of the ache, she also had a sore throat and could not swallow or eat for 2 1/2 days, she also feel nauseous and throws up water already, she already was feeling dehydrated. After which she called her doctor and mentioned that no organization or her doctor cant guide her well with regards the symptoms that she is feeling if this is common after receiving the vaccine. She asked her doctor and her doctor said that it could probably be a symptom of COVID19 infection. So she got tested and turned out she had a negative result. After a while she also experienced some sinus pain that was not normal for her, she also mentioned that her face and eyebrows hurt. She went to her ENT and ENT who she trusted and respected a lot as a surgeon because according to her is very well versed mentioned that these are not normal side effects that she is experiencing. She also consulted with a brain surgeon and the brain surgeon mentioned that if the side effects won't go away , advised that she need to go to an ER and that doctor feared that he could be having stroke or meningitis. In shock, patient called her cardiologist again and cardiologist advised her not to be alarmed about brain surgeon's advised. She was back to her BP management medication for 2 days already and cardio advised that she should get the vaccine still. On Wednesday and Thursday- her sinus pain went away she had experienced the worst pain ever and had her gripping her pelvis because of the pain, she also have massive diarrhea, had nausea and throw up viscously that it is almost coming out of her nose and also went to sheer panic. Also felt that she almost faint, not dizzy not vertigo type for under a minute. Called her neighbor and neighbor said that she is not speaking well or understood well. She was profusely sweating and had whole body sweat drenched on the floor. Called her physician and physician said that it could be food poisoning. Patient even said that she is not blaming the above event with Pfizer. Also mentioned she experienced sore throat in between. Patient states she is losing her mind, she is a highly anxious and panicky person, she was worried about getting the vaccine at first, but went ahead with it. States she has removed herself from her blood pressure medication, Bystolic, because there is an ingredient in there that is a beta blocker, polyethylene glycol or polysorbate or something. Worried of having an anaphylactic reaction now after the vaccine to the medication, states she has allergies to alot of foods. Patient states she had a very painful arm at first, that she had no symptoms for the first four days, states a week later she started getting sick, states last Saturday symptoms worsened significantly, that she had a headache and it wouldn't go away for 4-5 days, nausea, vomiting a couple of days, dehydration, a little diarrhea, chills, mild body aches. One day she was down for the count, then on Easter Sunday she took a Tylenol and was better. Later in the afternoon the nausea came back. Woke up Monday morning and couldn't get out of bed, wanted to die. States her baseline temperature is 94.6 and she went all the way up to 98 it was rising, body aches, sore throat. Went and got tested for Covid, flu, and strep and were all negative at urgent care. There the doctor told her because of her neck pain that she says she has had for years, she could die of a stroke or meningitis and so she called her ENT and they told her to wait a couple days and then to go to the emergency room if she was not better and the headache does not go away soon. patient states she does feel better today, only last night she woke up with gut ripping food poisoning, like she had the flu, Had worst menstrual cramps in that area, then she was throwing up, had diarrhea, felt like she was going to faint, went into this ungodly sweat. Saw on news that more people are getting sick a week or more after the shot, did not mention which shot they received. States she has a previous disability and a broken foot. Today she is feeling fine, just still very tired. experienced side effects between 1-1.5 weeks after the injection. She listed the following symptoms: headaches, chills, nausea, a sore throat, fatigue, ice-cold ends, vomiting, and diarrhea. She specified her sore throat was from hell, her temperature was up, but she had no fever, and both the vomiting and diarrhea were little. She added last Saturday was when she felt sick the most and it lasted 4-5 days. She said she tested for COVID-19 and the Flu. She specified the doctors also thought she had a stroke then meningitis. She explained she spoke with 3 doctors but feels like she's on her own to determine whether she should get the second dose. The patient underwent lab tests and procedures which included body temperature: up, body temperature: 94.6, body temperature: 98, influenza: negative, sars-cov-2 test: negative, streptococcus test: negative. Seriousness was non-serious. The outcome of the events was unknown.
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| 63 | 2021-04-24 | headache, chills, fatigue |
some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headach...
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some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headaches; left sided neck and shoulder stiffness; acute weakness; tiredness; severe chills throughout my whole body; generalized severe body aches; extreme joint pains; her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains; numbness; tingling sensations; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Apr2021 15:30 (Batch/Lot Number: ER 8737) as single dose, for covid-19 immunization. Medical history included chronic interstitial cystitis, hypertension, COVID-19 flu in Jan2021. Concomitant medications included telmisartan (MICARDIS) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (TOPROL) taken for an unspecified indication, start and stop date were not reported. within the first 15 minutes of observation, the patient did not have any anaphylactic symptoms from the covid-19 flu shot. But as patient was driving home, at around 15:45, her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains and numbness and tingling sensations. By around 19:00 that same day, she began having severe headaches, left sided neck and shoulder stiffness, acute weakness and tiredness, severe chills throughout my whole body, with generalized severe body aches, and extreme joint pains, BP of 200-210/100- 110, irregular heart palpitations and some delirium episodes x 2 days. The outcome of events was reported as recovering. The patient has been treating herself with OTC Tylenol and motrin as the result of the events. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the delirium, hypertension and other reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-04-24 | headache |
Pain in elbow; Trigger finger; Rheumatoid arthritis flare up; Grip strength decreased/could not make...
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Pain in elbow; Trigger finger; Rheumatoid arthritis flare up; Grip strength decreased/could not make fist or grasp or grip/ inability to grip or grasp with her hands; pain in arm; right ear & head pains; right ear & head pains; This is a spontaneous report from a contactable nurse, the patient, and based on information received by Pfizer from Abbvie Pharmacovigilance (Mfr. Control No.: 21K-163-3848385-00). A 63-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6207) intramuscular in the right arm on 18Mar2021 at 11:00 (at the age of 63-years-old) as a single dose for COVID-19 immunization; adalimumab (HUMIRA) solution for injection, subcutaneously, from an unspecified date at an unspecified dose and frequency for rheumatoid arthritis (RA). Medical history included polymyalgia rheumatica (PMR), RA, hypothyroidism, anemia. The patient had no known allergies. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications included prednisone, levothyroxine sodium (SYNTHROID), folic acid, calcium carbonate (CAL). The patient did not receive any other vaccinations within 4 weeks of BNT162B2. On 18Mar2021 (within 4 hours of the vaccination), the patient experienced a rheumatoid arthritis flare up. The clinical course was as follows: on 18Mar2021 at 15:00, the patient experienced pain in elbow and finger pain (like trigger finger of both hands). On Mar2021 (within 24 hours), all fingers were involved, the patient's grip strength was decreased (she could not make a fist or grasp or grip/ inability to grip or grasp with her hands) and experienced left wrist pain. On Mar2021 (within 48 hours), the patient experienced finger edema, was still unable to make fist or grasp, experienced painful shooting pains up inner arms, right ear & head pains. The patient increased the prednisone dose to 4 mg daily as treatment for the events. On 21Mar2021 at 11:00 (72 hours after vaccination), the patient continued to experience bilateral arm pains, slight hand grips but could not lift, new right knee and right outer foot pains. On 21Mar2021 (94 hours after vaccination), there was less arm pain and finger edema, continued right ear/head pains. The patient saw the primary physician, there was no ear infection and the physician agreed with the prednisone increase. The physician felt the patient should not take the second vaccine dose and alerted the rheumatologist. On 22Mar2021 (116 hours after vaccination), the patient was able to lift and grasp with both hands, had less ear and arm pain. Since the vaccination, the patient was not tested for COVID-19. The action taken with adalimumab in response to the events was unknown. The reporter's causality for the events trigger finger, inability to grip or grasp with her hands, severe flare of RA symptoms 4 hours post vaccine, pain in arms and elbows, pain in ears was not provided. The clinical outcome of rheumatoid arthritis flare up, trigger finger, "grip strength decreased/could not make fist or grasp or grip/ inability to grip or grasp with her hands", pain in arm, right ear & head pains was resolving; while of pain in elbow was unknown.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the RA flare and other events. The reported events may likely represent intercurrent medical conditions. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 63 | 2021-04-26 | fatigue, headache |
Vertigo; nausea; headache; swollen glands; fatigue; This is a spontaneous report received from a con...
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Vertigo; nausea; headache; swollen glands; fatigue; This is a spontaneous report received from a contactable consumer (patient). A 63-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP7534) via an unspecified route of administration on 21Mar2021 at 14:30 (at the age of 63-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high cholesterol and allergic to plants and pollen. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included simvastatin, thyroid (ARMOUR THYROID), progesterone, and estradiol from unknown dates for unknown indications. The patient previously received oxycodone hydrochloride, paracetamol (PERCOCET) and montelukast (SINGULAIR) from unknown dates and experienced allergy. On 22Mar2021 at 16:45 the patient experienced vertigo, nausea, headache, swollen glands, and fatigue. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of vertigo, nausea, headache, swollen glands, and fatigue were recovered. It was also reported that since the vaccine, the patient had not been tested for COVID-19. No follow up attempts are needed. No further information is expected.
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| 63 | 2021-04-27 | headache, fatigue |
her throat got swollen; burning sensation at the site; tiredness; achiness all over; her throat got ...
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her throat got swollen; burning sensation at the site; tiredness; achiness all over; her throat got red; could not sallow; her lymph nodes in the neck were swollen, they hurt really bad; Her lymph nodes in the neck were swollen, they hurt really bad; had pressure in the ears; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; This is a spontaneous report received from contactable consumer (patient). A 63-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 63-year-old) for covid-19 immunisation. Medical history included COVID-19, she was tested positive for COVID in Jan2021. The patient's concomitant medications were not reported. On an unspecified date she experienced burning sensation at the site (that went away), later experienced tiredness, achiness all over, and her throat got red and swollen, could not sallow, she felt like getting COVID again after the vaccine. Her lymph nodes in the neck were swollen, they hurt really bad, had pressure in the ears, pain in the shoulder, back of the head, in the back and in the neck. She wanted to know if she should to get the second dose or not, if she can get the shot in the gluteal or other sites. The event her throat got swollen was considered medically significant. The outcome of Vaccination site burning was recovered, of all other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 63 | 2021-04-30 | chills, fever |
Chills; Fever; Muscle soreness; Diarrhea; Nausea; I still have it and I tried to eat, if I eat anyth...
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Chills; Fever; Muscle soreness; Diarrhea; Nausea; I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life; I kept thinking everyday will get better and it's just haven't; Anatomical site of administration-The consumer stated, "On my shoulder, left shoulder."; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left shoulder on 26Feb2021 (Lot Number: EL3247) as single dose (at 63 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included curcuma longa (TURMERIC [CURCUMA LONGA]), colecalciferol (VITAMIN D 3). Previously the patient received the first dose of BNT162B2 (Lot Number: EM9810) on 05Feb2021 in the left shoulder for COVID-19 immunisation. On an unspecified date (as reported), the patient experienced chills, fever, muscle soreness, diarrhea, nausea, I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life, I kept thinking everyday will get better and it's just haven't. Therapeutic measures were taken as a result of diarrhea included antidiarrheal. The outcome of the events was unknown (as reported). The consumer stated, "I had my Pfizer second shot on 26Feb2021 and I had chills and the fever and sore muscles and about four days later I started having Diarrhea, nausea and I had it the entire month and I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life". Anatomical site of administration, the consumer stated, "on my shoulder, left shoulder". No follow-up attempts are needed. No further information is expected.
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| 63 | 2021-04-30 | chills |
she was dying from the first shot; Nausea; right arm got sore; Migraine headache; got chills shaking...
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she was dying from the first shot; Nausea; right arm got sore; Migraine headache; got chills shaking bad; got chills shaking bad; muscle aches, even in her fingers; Feet being Ice cold; no energy; dizzy; This is a spontaneous report from a contactable consumer(patient). A 63-year-old female patient received the first dose of BNT162B2 (Lot Number: ER8737, expiration date: 31Jul2021), via an unspecified route of administration in right arm on 13Apr2021(between 10:15 and 10:30) at single dose for covid-19 immunisation. The patient's medical history included COVID in 2020(had the COVID virus about a week and a half before Christmas/had COVID in the past). Concomitant medications included two unspecified medications. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient was calling about the Pfizer COVID shot. The patient stated she received her 1st shot on Tuesday(13Apr2021) and she didn't know if you have had the COVID virus you weren't suppose to take the shot. She stated that she had the COVID virus about a week and a half before Christmas. The patient stated that she went through a vaccine drive thru and after she got the shot, by time she drove around the corner to park her car, she was dizzy. The patient stated that around 8 o'clock Tuesday night, her right arm was so sore, she stated that she got the shot in her right arm because she uses that arm more. The patient stated her arm got real sore, she had a migraine headache, she got chills and was shaking so bad on 13Apr2021. She had never had chills like that before. Her muscles were aching real bad, it was aching even in her fingers, they were hurting on 13Apr2021. The patient stated that the bottoms of her feet were ice cold on 13Apr2021. She had nausea on an unknown date. She stated that she had the same symptoms as when she had COVID, except the lack of taste and smell. The patient stated that she has no energy on 13Apr2021. She says now, she is afraid to get the second shot because she hears it is worse than the first shot. She stated that still today, she has no energy what so ever. The patient stated she thought she was dying from the first shot on an unknown date. She was scared to take the second one. The patient confirmed she got her 1st dose on 13Apr2021. The patient stated the dizziness started 5 minutes after getting the shot. She said she didn't pay much attention to when it stopped but it was probably later on in the afternoon. The patient said that the dizziness was really noticeable when she was sitting in the car. The patient said her arm is still sore. She said that it is not as sore. She said that on Tuesday it hurt to move her arm but now it is just sore to the touch. The patient stated that her headache, last night started easing off and she woke up this morning and it was gone. The patient stated that the chills and shaking are much better but she still gets cold and then she gets warm and then cold again. The patient stated she took Aleve because her head, and it was easing up before she went to bed, she took Aleve for the pain and headache and she woke up and it was gone. She stated that she is a little better but still doesn't have a lot of energy. The patient stated she was on two medications but it's not for COVID. The patient stated the facility gave her paper work, and she filled out the paper work and she told them that she had COVID in the past on the paper work. No Emergency Room or Physician Office visit was required for the events. The outcome of the events "she was dying from the first shot" and "Nausea" was unknown, of the event " dizzy" was recovered on 13Apr2021, of the event " Migraine headache" was recovered on 15Apr2021, of the event " muscle aches, even in her fingers" and "Feet being Ice cold" was recovered on 14Apr2021, of the other events was recovering.
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| 63 | 2021-04-30 | fatigue, chills, fever |
Dizzy; fatigue; chills; aches; fever; This is a spontaneous report from a contactable consumer (pati...
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Dizzy; fatigue; chills; aches; fever; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 15Apr2021 at 4:00 PM (Batch/Lot number was not reported) at the age of 63-years-old, as a single dose in the left arm for COVID-19 immunisation. Medical history included low thyroid and allergies to penicillin, both from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, unknown lot number), dose 1 on 25Mar2021 at 4:00 PM at the age of 63-years-old as a single dose in the left arm for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient experienced dizzy, fatigue, aches, fever and chills on 16Apr2021 at 12:00 PM. The reported adverse events resulted in emergency room/department or urgent care. Treatment received included fluids and test run to rule out any other problems. The patient had no COVID prior vaccination. The patient was tested for COVID post vaccination which was a nasal swab with negative result on 16Apr2021. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 63 | 2021-04-30 | fever, sleepiness, headache, head discomfort, cough |
stomach abdominal cramping; Appetite decreased; like gassiness; back pain; she was so sick.; she has...
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stomach abdominal cramping; Appetite decreased; like gassiness; back pain; she was so sick.; she has a rash about the size of a quarter at the injection site; temperature of 102 degrees/fever; tightness in her chest; She threw up five times; She felt nauseous; Nightmares; She started coughing; muscle weakness; Her arm is sore; She could barley lift her arms; very very weak; delirious; restless; her head was pounding; has been sleeping an enormous amount.; headache; restless; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm right on 12Apr2021 15:00 (Lot Number: EW0153) as single dose for COVID-19 immunisation. Medical history included Neuropathy, Blood pressure abnormal, and allergic to cats, dogs, and everything outside. Concomitant medications included clonazepam taken for neuropathy peripheral, start and stop date were not reported; captopril taken for blood pressure abnormal, start and stop date were not reported; cyanocobalamin (VITAMIN B12) taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 23Mar2021 15:40 (Lot number: EH6204, She has difficulty reading the handwriting, she stated that the second character H, may not be an H.) (at age of 63-year-old) in right arm for Covid-19 immunisation and she felt like she got hit by mac truck, she was that tired and She felt like she could hardly move. There was no additional vaccines administered on same date of the Pfizer suspect or prior vaccinations (within 4 weeks). On the weeks that she received the first and second dose of her COVID vaccine, she skipped getting her allergy shot that week. She normally got her allergy shots every week. Patient weight: 176-178 pounds. It was reported that the patient was fine after she received the second dose, until about 11:00PM on 12Apr2021. She started to get muscle weakness. She was delirious on Monday night (12Apr2021). She also felt restless on 12Apr2021. Her head was pounding on 12Apr2021. She felt nauseous on 13Apr2021, very very weak began on 12Apr2021 23:00 and had tightness in her chest on 13Apr2021. She has only thrown up three times in 50 years. She threw up five times on Tuesday, 13Apr2021. She started coughing Tuesday morning, 13Apr2021. She thought maybe she was coughing because she needed to throw up. She does not know why she is coughing. Over the past few days, she has stayed in her pajamas so she did not look for a rash. She noticed she has a rash about the size of a quarter at the injection site. She did not really pay the rash much attention since she was so sick. She has a rash about the size of a quarter at the injection site, She noticed it on 14Apr2021 whenever she took a shower and took of the band aid. Clarified that it is about the size of a silver dollar. There was also a knot. She began running a fever on 13Apr2021. Yesterday (14Apr2021), she had a fever of 102 degrees. She has been taking 2,000-3,000mg of Tylenol and it has not been helping her fever. Yesterday (14Apr2021), her temperature was the same, and her head was pounding. She was able to eat a little bit, she drank a lot. She has been sleeping an enormous amount from 12Apr2021. Last night (14Apr2021) her temperature was at 100 degrees. It started to come down, before she got up. She normally does not sleep eight hours a night. She has been sleeping more than eight hours. Before she got up out of bed this morning (15Apr2021), she checked her temperature and it was 98.6 degrees. She knows that most people do not consider that a fever, but for her that is. Her temperature is usually 97 something degrees. 98.6 degrees is still sick to her. She was going to work from home today (15Apr2021), but whenever she sat at the keyboard to type, she could barley lift her arms. She could barley lift her arms began about 11:00PM on 12Apr2021. She has not tried to work. She still has a bit of a headache, and her fever broke, so she thought she could work today (15Apr2021). She felt extremely weak. Her stomach was cramping. She drank some tea, and ate a banana. She would describe it as stomach abdominal cramping. She was not expecting to feel this way. Her arm was still sore. Her arm was sore began about 11:00PM on 12Apr2021. She was going to see her doctor next week for a semi annual check up appointment.She was restless all day yesterday (14Apr2021). She has a back back, and has back pain. Whenever she has muscle weakness, her back is bad, and makes her hurt every where. Yesterday (14Apr2021), she was still restless and could not sit still. It is better today (15Apr2021), but has not gone away. On the morning of 13Apr2021, she felt nauseous. Now she feels a different type of nauseous. Before the nausea was in her chest, she thought she was going to have a heart at-tack. She called her husband at work, and asked him to come home because she was so scared. Whenever she threw up, it relived the pressure in her chest. She vomited four times and it gave her immediate relief. She vomited one more time later that evening after trying to eat some chicken broth. She just drank liquids after that. Nauseous intestinal: It feels more intense today (15Apr2021). It feels like it is moving down. Clarified that this is the same feeling as stomach abdominal cramping. She has issues with IBS, and diver-ticulitis. But this is different. She has not eating anything. With IBS, it is eating and the diarrhea. This is more like gassiness. She has had bowel movements, they are more intense with abdominal con-tractions. Very weak: Began about 11:00PM on 12Apr2021. She knew that night that she was not going to be able to go to work the next day. It is better. She thought that is was resolved this morning (15Apr2021), but then she could not get up the stairs. Her office is upstairs. Whenever she got to her office, she lifted her her arms to type and it was hard for her to hold her arms up. She has been sleeping an enormous amount: She did not do anything but drink, use the bathroom and sleep on 13Apr2021. Whenever she was sleeping, it was not a good sleep. Her temperature was 102 degrees, and her head was pounding. She was having nightmares. She was in a constant state of dreaming that she could not get out of. She still has been sleeping a lot. She has been trying to walk around. She put on a lidocaine patch, and is wearing a back brace. She was sleeping less than she was but it is still an enormous amount for her. She normally sleeps about five to six hours a night. The events did not result in emergency room visit or physician office visit. Therapeutic measures were taken. The outcome of events muscle weakness, restless, 'Her head was pounding', Weakness, cough, was recovering, of delirious was recovered on 14Apr2021, of 'tightness in her chest' was recovered on 13Apr2021, of nightmares was recovered on 14Apr2021, of other event was unknown.
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| 63 | 2021-05-03 | chills, fever, fatigue |
passed out at home; Migraine; chills; aches; tired; slight temp; This is a spontaneous report from a...
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passed out at home; Migraine; chills; aches; tired; slight temp; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in right arm on 12Apr2021 (Lot Number: EW0151) as single dose for covid-19 immunisation. Medical history included High cholesterol, hypothyroidism. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2, at the age of 63-year-old, via an unspecified route of administration, administered in left arm on 20Mar2021 18:30 (Lot Number: ER8727) as single dose for covid-19 immunisation. The patient was not pregnant. The patient experienced migraine, chills, aches, slight temp and tired on 13Apr2021 10:00; passed out at home 22:30 13Apr2021. No treatment received. The outcome of the events was recovered in Apr2021.
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| 63 | 2021-05-04 | head discomfort, fatigue, body temperature increased |
she actually feels like she has covid; she actually feels like she has covid; felt like her head was...
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she actually feels like she has covid; she actually feels like she has covid; felt like her head was in a tunnel/surround sound in her head; she was scared to death; ringing in her ears; diarrhea; nausea; ear aches that make it feel like her hearing is off; the vaccine may have poked her in the bone; temperature and it has been pretty normal for the most part and went up to 99.9 degrees Fahrenheit; felt like I wished I were dead; sick; tired; This is a spontaneous report from a contactable consumer (the patient). A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318; Expiration Date: 2021), via an unspecified route of administration, on 09Apr2021 at 14:30 (at the age of 63-years-old) as a single dose in the right arm for COVID-19 immunization. The patient's medical history was not reported. Historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EP69556121) on 18Mar2021 (at the age of 63-years-old) as a single dose in the right arm for COVID-19 immunization. There were no concomitant medications. The reporter state that exactly seven (7) days after her second dose, she "felt like I wished I were dead." She reports having diarrhea and nausea that she is still struggling with, and also reports ear aches that make it feel like her hearing is off, describing it as an echo "like I'm in a tunnel or buried in the sand." She reports that this "head thing" was so severe in the beginning and reports that it is still ongoing. She states she couldn't even stand to hear the television and reports that it felt like there was a "surround sound" in her head. She also reports that she just wanted to lay in bed one afternoon and when she woke up the next morning, she was still tired. She reports now that she is progressively feeling "some better" and thinks in 3 days that it will be gone, but she also believes that she may have COVID-19 now and feels like the 2nd Pfizer Vaccine actually bred the disease in her for some reason and she wished she was dead for three days. She also stated that she has spoken with her HCP about this who suggested she visit an urgent care; however, the caller states she cannot drive and has no means of transportation to this appointment. She continued to say that the symptoms were horrible and she is still going through it; states last night she was scared to death and she does not drive or she would have taken herself to the emergency room. She stated that she still had the ear ache, it is not so "echoey" but she still hears some of the ringing in her ears. The other thing concerning happened yesterday - she has also been monitoring her temperature and it has been pretty normal for the most part and went up to 99.9 degrees Fahrenheit and she has been trying to get ahold of someone to report this. States last night was the worst night with diarrhea and she was up and down all night long. The patient also mentioned that her second dose of the Pfizer Vaccine was in her right arm and the woman who gave her the vaccine may have poked her in the bone and caused her to jump. The patient experienced that she actually feels like she has COVID on an unspecified date with outcome of unknown, felt like "I wished I were dead" in Apr2021 with outcome of unknown, the vaccine may have poked her in the bone on 09Apr2021 with outcome of unknown, diarrhea on 16Apr2021 with outcome of not recovered, ear aches that make it feel like her hearing is off on 16Apr2021 with outcome of not recovered, tired in Apr2021 with outcome of recovering, felt like her head was in a tunnel/surround sound in her head on 16Apr2021 with outcome of recovering, nausea on 16Apr2021 with outcome of not recovered, she was scared to death on 16Apr2021 with outcome of not recovered, ringing in her ears on 16Apr2021 with outcome of unknown , temperature and it has been pretty normal for the most part and went up to 99.9 degrees fahrenheit in Apr2021 with outcome of unknown and sick in Apr2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 99.9 degrees Fahrenheit on Apr2021.
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| 63 | 2021-05-07 | fatigue |
incredibly horrible itching under her Fitbit; whelp; her lips had started swelling; her tongue was t...
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incredibly horrible itching under her Fitbit; whelp; her lips had started swelling; her tongue was tingling; she thinks that it was the beginning of anaphylactic reaction; she was just tired; type 1 hypersensitivity; a little soreness; It was like heaviness on her chest; having trouble breathing; allergic contact dermatitis; This is a spontaneous report from a contactable consumer (patient) and a physician. A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 10:00 (lot number: EP7533) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing nickel allergy for decades which was under control and panic attacks. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Apr2021, it was reported that the patient didn't have any of the normal side effects such as fevers or chills but she was just tired and went to sleep early that night. She woke up on 15Apr2021 at 05:00 with incredibly horrible itching under her Fitbit that she wears to bed. She has a history of nickel allergy and she bought this particular Fitbit on purpose because it doesn't have any nickel in it that touches her skin and she has had no problems all year with the Fitbit. The itching was unbelievably bad and when she took the Fitbit off she had a horrible whelp under a tiny piece of metal that isn't even supposed to touch her skin. She thought well if it has exacerbated her nickel allergy then maybe it is doing something else to her body. On that day (15Apr2021), she thought that she had a panic attack and upon reading some information online, she thinks that it was the beginning of anaphylactic reaction because the symptoms are the same. She was thinking that the vaccine is doing something with her nickel allergy. It had used to be bad until she got it under control and she had it under control for many years. But with the things under the Fitbit she was blaming or associating it with the COVID vaccine so she took it off and then finally fell asleep again. But when she woke up in the morning, just a few hours later (15Apr2021), the bad whelp was still there and then her lips had started swelling and her tongue was tingling so she decided to look some more on google and she thinks that this is another version to an allergic reaction. She has had panic attacks before and she knows what they are now and she has learned through a therapist on how to get past and manage them but this was different for her. It was like heaviness on her chest and it felt like something was on top of her chest and she was having trouble breathing; both on an unspecified date in 2021. Her husband knows when she has a panic attack but this one was different she can't really explain it. She asks, what is the difference between a panic attack breathing and this type of breathing and later mentioned that she also had a little soreness (2021). In addition, the physician also called to report that this patient was complaining about 2 types of symptoms. The first was more an allergic contact dermatitis (2021) which the physician is not worried about. The second was lip swelling and tongue tingling which could be a type 1 hypersensitivity (2021). The physician is more concerned about the latter and would like to know if it is okay to pre-medicate the patient with Benadryl before getting the second dose. The outcome of the event 'she was just tired' was recovered on 14Apr2021; incredibly horrible itching under her Fitbit; whelp was recovering; her lips had started swelling and her tongue was tingling was recovered on 15Apr2021. The outcome of the other events was unknown.
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| 63 | 2021-05-13 | malaise |
immune system is obviously compromised; shingles; pain; Rash; Nerve Pain; back ache; hip ache; not f...
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immune system is obviously compromised; shingles; pain; Rash; Nerve Pain; back ache; hip ache; not feeling well; blistering; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), via an unspecified route of administration, administered in Arm Left on 07Mar2021 18:00 as 1st dose, single for COVID-19 immunization. The patient has no medical history and concomitant medications. No history of previous vaccinations. No vaccinations in four weeks. On 13Mar2021, 6 days after vaccination, the patient had nerve pain, back ache, hip ache, was not feeling well, and had blistering. The patient went to the urgent care/emergency room because of the back pain and was given Capscian which burned and acyclovir. On 17Mar2021, the patient had pain and rash. The patient's visited a dermatologist due to symptoms and was diagnosed with shingles which developed on the right side of her body on 21Mar2021. The dermatologist changed the acyclovir to valacyclovir at 1 gram three times a day and Triamcinolone Acetonide: ointment Dose: 0.1%, twice a day both starting on 23Mar2021. The patient was also given Lidocaine patch and Biofreeze. Patient states steroid ointment was very amazing and that was just yesterday it was started, already her rash is disappearing, blistering is going away. Dermatologist also said she hadn't been given the right antiviral. The patient requested reassurance that the first dose received would still be effective even though the patient thinks her immune system is obviously compromised (no treatment was reported), says her immune system took away guard for other virus, triggered but not caused it. Maybe just a theory my immune system is working overtime to produce antibodies from having received vaccine and maybe wasn't protecting from dormant chicken pox virus. Patient wanted to make sure the efficacy of first shot is still intact. Patient also stated second dose is scheduled for 29Mar2021 and she was wondering if she would be able to receive the second dose or if she would have to wait a period of time. The outcome of the event immune system is obviously compromised was unknown while for the rest of the events was recovering.
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| 64 | 2021-01-01 | fatigue, headache, fever | Body aches, fever less than 101, headache, nausea, lymphadenopathy, fatigue ,loss of appetite |
| 64 | 2021-01-03 | fatigue, fever, chills |
LATE EVENING OF 12/30/20 DEVELOPED FEVER, CHILLS, VOMITING, BODY ACHES, AND FATIGUE. LASTED 3 DAYS. ...
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LATE EVENING OF 12/30/20 DEVELOPED FEVER, CHILLS, VOMITING, BODY ACHES, AND FATIGUE. LASTED 3 DAYS. IS NOW RESOLVED.
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| 64 | 2021-01-04 | headache, chills | headache,nausea and vomiting ,chills |
| 64 | 2021-01-05 | chills |
Rash on lateral breasts/felt a bit of itching.; blotchy rashes; Itchiness on Scalp; broke out in hiv...
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Rash on lateral breasts/felt a bit of itching.; blotchy rashes; Itchiness on Scalp; broke out in hives/welts came up on right ear and behind neck/welts under buttocks and behind knees, welts were large and red; Slight chills; Tenderness in injection arm; was just a little cold; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: PAA156571), via an unspecified route of administration in left deltoid on 28Dec2020 10:00 at 0.3 mL single for covid-19 immunization; sulfamethoxazole, trimethoprim (BACTRIM DS), at twice a day for 10 days for perineal cyst. The patient was on her last day of sulfamethoxazole, trimethoprim on the day she got the COVID-19 vaccine (28Dec2020). Medical history included perineal cyst, COVID-19 in Apr2020 with no problem, only had a cough. Husband had COVID-19 and had loss of taste and smell, had fever, but he was not serious. Both her and her husband got tested for antibodies and were positive. Family medical history was none. The patient had unspecified flu vaccine (Lot: UJ428AB) on 18Dec2020 injected in left deltoid in two weeks prior to COVID-19 Vaccine. Checked with three different people who stated the Flu vaccine would not interfere with COVID-19 Vaccine. Checked with two pharmacists who stated Bactrim DS would not affect her taking the COVID-19 Vaccine. She received COVID-19 Vaccine through her work in a nursing home. There were no additional vaccines administered on same date of Pfizer suspect. On 28Dec2020 about 7 to 8 hours after vaccination, patient had slight chills and tenderness in her arm: was just a little cold. Thirty-six hours after injection, midnight on 29Dec2020, her scalp itched like crazy, broke out in hives. On 30Dec2020, rash developed on both lateral sides of her breast, welts came up on right ear and behind neck. On 31Dec2020, welts under buttocks and behind knees, welts were large and red. Rash on lateral breasts: felt a bit of itching. The patient had blotchy rashes, rash up in her hair above her neck and back of ear, had intense itching; which subsided. It was a little pink on her chest, little itching on her head. Her ear was better. Symptoms were most mild because she was still able to function. Clarified as not serious. The patient was taking diphenhydramine (BENADRYL, Lot: SMF011, Exp: May2022) at 25mg every 3.5 to 4 hours, cortisone cream 10 Maximum Strength (Lot: 20K434, Exp: Sep2023) for rash and welts; and doing tepid soaks. It was tolerable and faded. Rash had subsided, but was a little red. Her greatest concern was what to do in regards to the second dose in three weeks. The reporter considered events were related with COVID-19 Vaccine. The action taken in response to the events for sulfamethoxazole, trimethoprim was unknown. The outcome of events was unknown.
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| 64 | 2021-01-05 | chills |
a slight chill the first night; slight tenderness to arms; This is a spontaneous report from a conta...
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a slight chill the first night; slight tenderness to arms; This is a spontaneous report from a contactable nurse reported for her identical twin sister. A 64-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included unspecified flu vaccine on 18Dec2020. The patient experienced a slight chill the first night and slight tenderness to arms on 28Dec2020 with outcome of unknown. Information about Lot/Batch number requested.
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| 64 | 2021-01-05 | throat pain, chills, fever, headache, sinus disorder |
I got the vaccine at 9am. At 4pm that same day I experienced terrible pain to left arm. No redness o...
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I got the vaccine at 9am. At 4pm that same day I experienced terrible pain to left arm. No redness or swelling at the site. I couldnt lie on my left arm at all that night. By 11pm I also experienced headache, sinus drainage, sore throat, body aches, taste and smell were off, upset stomach, queezy stomach but no nausea or vomiting, very weak , dry mouth, fever at 99.2 then 98.6, chills, lots of chills. The covid hotline at my work told me I had a moderate reaction to the vaccine. Treatment was rest and tylenol which didn't alleviate any symptoms whatsoever. I had all these symptoms til Jan 6th at 4am. At 4am all the symptoms left and have not returned.
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| 64 | 2021-01-06 | chills, fever, influenza like illness |
Flu-like illness (fevers, rigors, chills) and one episode of presyncope due to orthostatic hypotensi...
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Flu-like illness (fevers, rigors, chills) and one episode of presyncope due to orthostatic hypotension upon getting up the day after the vaccine
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| 64 | 2021-01-06 | cough, fatigue |
Patient contacted provider 12/26 with following symptoms: Dry cough, diarrhea, fatigue for 7 days. C...
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Patient contacted provider 12/26 with following symptoms: Dry cough, diarrhea, fatigue for 7 days. Covid test ordered and positive. presented to ED on 12/31 and admitted into hospital. Still inpatient as of 1/7/2021.
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| 64 | 2021-01-06 | fatigue, fever, headache, chills | Fever, chills, body aches, headache, Fatigue, several days, now resolved |
| 64 | 2021-01-06 | headache, chills, fever | fever, chills, headache, muscle and joint pain, duration 24 hours |
| 64 | 2021-01-06 | headache, lethargy, chills, fatigue |
At twelve hours post injection I awoke with severe chills even though I did not have a temperature. ...
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At twelve hours post injection I awoke with severe chills even though I did not have a temperature. After taking 1000 mg of Tylenol the chills past in approximately an hour. The rest of the day I had extreme fatigue, headache, lethargy, and loss of appetite. By the next morning I still had the fatigue and weakness which improved gradually over the next 12 hours.
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| 64 | 2021-01-06 | headache, fever | Headache & Fever |
| 64 | 2021-01-06 | headache |
I exp headache and diarrhea The next day after I was urinating blood. I went to my PCP I got Culture...
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I exp headache and diarrhea The next day after I was urinating blood. I went to my PCP I got Culture and given antibiotics.
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| 64 | 2021-01-06 | headache |
Mild headache, pressure over forehead/eyes. Feeling feverish. Temp 97.6 oral. Generalized aches and ...
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Mild headache, pressure over forehead/eyes. Feeling feverish. Temp 97.6 oral. Generalized aches and pains. Slight dizziness. The next day, all symptoms gone. Injection site/sore arm for 3 days.
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| 64 | 2021-01-07 | fever, influenza like illness, headache |
swelling; Flu like symptoms; low grade fever; headache; joint pain; This is a spontaneous report fro...
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swelling; Flu like symptoms; low grade fever; headache; joint pain; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 64-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) intramuscularly in the left arm on 18Dec2020 at 12:00 am, and the second single dose intramuscularly in the left arm on 04Jan2021 at 12:00 pm (as reported), for COVID-19 vaccination. Medical history included osteoarthritis from an unknown date and unspecified if ongoing. No unknown allergies. Concomitant medication included levothyroxine sodium (SYNTHROID), hydroxychloroquine, progesterone, colecalciferol (VITAMIN D), calcium, magnesium. No other vaccine received in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced flu like symptoms, low grade fever, headache, joint pain and swelling on 05Jan2021 at 01:00 am. The events were non-serious. The patient received paracetamol (TYLENOL) and ibuprofen for the events. The patient was recovering from the events. Information on Lot/batch number has been requested.
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| 64 | 2021-01-08 | fatigue, headache | headache, sore arm, fever, body aches, tiredness |
| 64 | 2021-01-08 | nasopharyngitis, fatigue |
Fatigue Narrative: Went to work for a few minutes -- really tired. Fellow employee said she should ...
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Fatigue Narrative: Went to work for a few minutes -- really tired. Fellow employee said she should go home or be reported. First shot had a sore arm & a bit of a cold for a few hours and back to work. This time has sore arm and is more tired than usual. 98.7 F No cough, HA, N/V. No medications taken for s/e.
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| 64 | 2021-01-08 | fever | Nausea, diarrhea, low grade fever. Lasted 4 days, treated with Zofran |
| 64 | 2021-01-09 | body temperature increased, chills, headache |
About 24 hours after I got my injection I began to feel cold. I am by nature always cold but within...
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About 24 hours after I got my injection I began to feel cold. I am by nature always cold but within 30 minutes I began to shiver. This intensified and I got to the point I was shaking hard and so cold. I had also had a headache all day but that is not unusual for me as I frequently have sinus headaches that can last all day. I took my temperature which was 98.3 but I took Tylenol anyway realizing I was likely having a vaccine reaction. I got into bed under my electric blanket. Ninety minutes later I had finally warmed up. In fact my feet and hands felt like they were on fire. I rechecked my temperature and it was up to 100.9. I peeled off my numerous clothing layers and I actually felt better since the chilling had stopped. I ate some dinner and watched TV and went to be around 11pm. I slept fitfully which is normal for me. As the night wore on I began chilling again. I got up sometime around 5am and took more Tylenol. If I remember my temperature was around 100.1. I slept several hours and woke up feeling ?back to normal?.
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| 64 | 2021-01-09 | body temperature increased, influenza like illness |
Developed significant aching in lower extremities, HR 100, Temp 100.4, slight nausea, general flu l...
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Developed significant aching in lower extremities, HR 100, Temp 100.4, slight nausea, general flu like feeling
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| 64 | 2021-01-09 | chills, headache, fatigue, fever | Fever (100.5 F oral temp) Body Aches Headache Chills Fatigue Pain at Right Deltoid Injection site |
| 64 | 2021-01-09 | fatigue, chills, fever, headache | Fever (oral temp 100.5) Body Aches Chills Headache Fatigue Right arm pain |
| 64 | 2021-01-09 | headache, chills, fatigue |
Violent chills, headache, abdominal pain especially on the right side and vomiting. Muscular aches...
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Violent chills, headache, abdominal pain especially on the right side and vomiting. Muscular aches all over the body. Fatigue. 1/10/21: Still experiencing headache and muscle pain, occasional chills.
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| 64 | 2021-01-09 | fever, headache, lethargy | Fever, headache, lethargy for 36 hours |
| 64 | 2021-01-10 | chills, fatigue, headache |
8th Jan@1430-Tired 9th Saturday-tired, nauseated, aches, chills 10th Jan Sunday-nauseated, tired, ch...
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8th Jan@1430-Tired 9th Saturday-tired, nauseated, aches, chills 10th Jan Sunday-nauseated, tired, chills, aches-body 11th Jan Monday-aches-body, tired, nauseated, Headache-Treatment-none, When she can she eats a little & drinks when not nauseated
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| 64 | 2021-01-10 | chills, headache |
blasting headaches; chills all night; dry heaving all night; Nausea; no fever but her skin felt hot;...
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blasting headaches; chills all night; dry heaving all night; Nausea; no fever but her skin felt hot; sore left arm; This is a spontaneous report from a contactable nurse for herself. This 64-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 18Dec2020 at single dose on left upper arm (lot: EKS730), via an unspecified route of administration on 05Jan2021 14:30 at single dose (lot: EL1284 or EKI284) for COVID-19 immunisation. Medical history and concomitant medications were none. The patient did not have anything with the first shot except a sore left arm on 18Dec2020. She stated that if she lays on left side it is sore. The patient had the sore left arm both times that she got the vaccine. She got second dose of vaccine on 05Jan2021 at 2:30pm and had a blasting headache and just had chills that went away about hour ago on 05Jan2021. She did not have a fever but her skin felt hot on 05Jan2021. She stated that she had dry heaves on 05Jan2021. The patient started that she had a blasting headache within a few hours of the vaccine and it gradually got worst by the time she went to bed. Stated that the chills and dry heaves started then and throughout the night. The chills stopped an hour before she got up. Stated that she went to check her temperature and did not have a fever despite having chills and her skin feeling hot. Stated that nausea started about 10 at night on 05Jan2021. Seriousness for blasting headache, chills and dry heaves was disabling, for nausea was medically significant, for other events was non-serious. The patient took Ibuprofen for the headache. Stated that she was going to try to drink something. The outcome of sore left arm was not recovered; of chills was recovered on 06Jan2021. The outcome of other events was recovering. The causality for blasting headache, chills, dry heaves, nausea and skin felt hot was related (Source of assessment: Primary Source Reporter, Method of assessment: Agency Information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the headache, chills, dry heaves and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 64 | 2021-01-10 | cough, nasal congestion | Diagnosed with COVID-19, Cough, Congestion, Mild Respiratory Illness |
| 64 | 2021-01-10 | headache, fatigue, chills |
8th Jan-1430-tired 9th Jan-tired, nauseated, aches/body, chills 10th Jan-nauseated, tired, chills, a...
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8th Jan-1430-tired 9th Jan-tired, nauseated, aches/body, chills 10th Jan-nauseated, tired, chills, aches-body 11th Jan -aches-body, tired, nauseated, Headache
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| 64 | 2021-01-10 | headache, fever, chills | Headache Neck pain Fever/Chills Nausea/Vomiting Diarrhae |
| 64 | 2021-01-10 | malaise, chills |
Patient had the vaccine on Friday (2:30pm) and was fine. Saturday then she had a sore arm. She went...
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Patient had the vaccine on Friday (2:30pm) and was fine. Saturday then she had a sore arm. She went to work and was fine (10 hour shift). She had Gammagard around 6pm and then the infusion was fine and went on as normal (a little burning at the beginning), then chills at the end (not unheard of). An hour later she went to sleep since not feeling 100%. She woke up with severe chills, headache, body aches all over, She has bad chills and is shaky. She went home and no fever. Her eyes are kind of burning. She has a call with her doctor today.
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| 64 | 2021-01-11 | chills, headache |
APPROXIMATELY 30 HOURS AFTER VACCINE I NOTICE SORENESS AND A VERY HOT, RED, SWOLLEN, ITCHY AREA AT...
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APPROXIMATELY 30 HOURS AFTER VACCINE I NOTICE SORENESS AND A VERY HOT, RED, SWOLLEN, ITCHY AREA AT INJECTION SITE APPROXIMATELY 3 INCHES ACROSS. THIS KEPT SPREADING UNTIL 12 HOURS AFTER THAT WHEN I TOOK BENEDRY L AND THAT TOOK AWAY A LOT OF REDNESS, HEAT, AND RECEEDED SLIGHTLY. THE BENEDRY HELPS BUT HAS NOT TAKEN IT AWAY. ALSO HAD THE EXPECTED REACTION 14 HOURS AFTER VACCINE OF FEVER, CHILLS, BODY ACHES, & HEADACHE FOR 48 HOURS WHICH IMPROVED EACH DAY.
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| 64 | 2021-01-11 | fatigue, chills, malaise, fever |
at day 18 or 19, post first covid vaccine shot, I began to have many symptoms and did not feel well....
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at day 18 or 19, post first covid vaccine shot, I began to have many symptoms and did not feel well. These were chills, slight fever, no appetite, nausea, muscle aches, fatigue
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| 64 | 2021-01-11 | fatigue | Recipient reported heartburn sensation, chills, fatigue. |
| 64 | 2021-01-11 | headache, chills, fatigue |
fatigue; Nausea; Headache; chills; This is a spontaneous report from a contactable other health care...
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fatigue; Nausea; Headache; chills; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 64-year-old not pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number: EK9231, Intramuscular on right arm on 05Jan2021 at single dose for COVID-19 immunization. Medical history included Covid-19 and allergy to penicillin. Concomitant medications were not provided. Patient did not receive other vaccine in four weeks. On 05Jan2021 patient experienced nausea, headache, chills, fatigue. She was not treated for the events. Patient had not been tested for COVID-19 post vaccination. Patient was recovering from the events, at the time of the report.
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| 64 | 2021-01-11 | headache |
I developed a headache, burning of my face and upper gums 45-60 minutes after the vaccine. As the ...
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I developed a headache, burning of my face and upper gums 45-60 minutes after the vaccine. As the day went on I developed slight swelling of my upper lip. The burning of my face lasted until the following day but then would come and go. The swelling of my upper lips lasted 4 days. Last Thursday 1/7/2021 my face was burning and lasted the day.
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| 64 | 2021-01-11 | sweating, chills |
Nausea; Chills; sweats; vomit; This is a spontaneous report from a non-contactable consumer (patient...
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Nausea; Chills; sweats; vomit; This is a spontaneous report from a non-contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (Lot number and expiry date unknown), via an unspecified route of administration on 02Jan2021 14:15 at SINGLE DOSE in the left arm for COVID-19 immunization. Medical history included depression from an unknown date. Concomitant medication included marijuana, depression meds and sleep meds. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Jan2021 04:00, the patient experienced nausea, chills, sweats and vomit. The patient did not receive any treatment for the events. The outcome of the events was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
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| 64 | 2021-01-11 | sweating |
Pfizer-BioNTech COVID-19 Vaccine EUA 64-year-old female presents as a rapid response team patient st...
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Pfizer-BioNTech COVID-19 Vaccine EUA 64-year-old female presents as a rapid response team patient status post immunization her second shot was done on Tuesday 2 days ago. She had some diarrhea last night and had some body aches in her arms following the rules today she woke up did not eat breakfast which is not abnormal for her did have some coffee came to work describes some myalgias and felt sweaty felt chilled so she went downstairs had a glass of orange juice to see if that would help had a small helping of hashbrowns did not help she was so she went to employee health in the then was sent here for further evaluation. Patient denies any heart or lung problems high blood pressure diabetes has URI symptoms. No history of PEs or DVTs denies hypertension she fell your blood sugar is low but has no documented history of hypoglycemia is not on any hypoglycemic medications. No history of PEs or DVTs no travel or surgeries. No nausea or vomiting with the diarrhea. Also complains of body aches.BP 120/69 | Pulse 76 | Temp 37 °C (98.6 °F) (Oral) | Resp 21 | Ht 1.676 m (5' 6") | Wt 198 lb (89.8 kg) | SpO2 95% | BMI 31.96 kg/m² Labs reviewed on the chart are normal symptomatically she feels better offered Toradol for myalgias she refused she I suspect is having a reaction/side effect not an allergic reaction to her vaccination she received. Patient discharged.
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| 64 | 2021-01-11 | nasopharyngitis |
10 hrs after shot uncontrollable shaking & frezzing cold. 5 hrs later really bad muscle pain in hip...
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10 hrs after shot uncontrollable shaking & frezzing cold. 5 hrs later really bad muscle pain in hips & legs. Couldnt stand up. 24hs Later symptoms gone.
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| 64 | 2021-01-11 | throat pain, headache, chills, cough, fever |
Difficulty swallowing, fever 102, headache, ears plugged, earaches, all joints ache including finger...
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Difficulty swallowing, fever 102, headache, ears plugged, earaches, all joints ache including fingers, ankles, etc., legs ache, shinbones ache, roots of teeth ache, chills, nauseous, dizzy, delirious, ovaries ache, short of breath, brain fog, not able to multitask, vomiting, sore throat, cough, left arm pain
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| 64 | 2021-01-12 | chills, fatigue, headache, fever |
Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Sev...
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Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Severe, Systemic: Abdominal Pain-Severe, Systemic: Diarrhea-Severe, Systemic: Nausea-Severe, Systemic: Swollen Hands. Couldn't make fist-Severe; symptoms lasted 4 days.
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| 64 | 2021-01-12 | cough |
After the vaccination I developed a non productive cough, had creepy crawly feeling skin and felt as...
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After the vaccination I developed a non productive cough, had creepy crawly feeling skin and felt as if my eyes were burning but no fever develop. I got tested for COVID via rapid/PCR test on12/25 which was neg but got retested on 12/28 via the rapid COVID test and was positive then.
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| 64 | 2021-01-12 | fatigue, chills, headache, fever |
Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Sev...
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Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Severe, Systemic: Abdominal Pain-Severe, Systemic: Diarrhea-Severe, Systemic: Nausea-Severe, Systemic: Swollen Hands. Couldn't make fist-Severe; symptoms lasted 4 days
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| 64 | 2021-01-12 | fatigue, chills | Body aches Muscle soreness Chills Fatigue |
| 64 | 2021-01-12 | fatigue, cough | PAIN INJECTION SITE,TIRE,MUSCULAR PAIN,JOINT PAIN,COUGH AND TARDICARDIAC. |
| 64 | 2021-01-12 | fatigue, fever, headache, body temperature increased, fatigue, headache, fever |
Systemic: Exhaustion-Mild, Systemic: Fever-Mild, Systemic: Generalized Body Aches -Mild, Systemic: H...
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Systemic: Exhaustion-Mild, Systemic: Fever-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Headache-Mild, Systemic: patient experienced pain when taking deep breaths but was positive for covid in march2020 and out of work until june 2020. last covid swab was 12/22(negative)and 12/29. temperature was 99.6 and pulse
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| 64 | 2021-01-12 | fatigue |
Vaccine recipient received vaccine on 1/10/2021 and reported severe fatigue. She woke in the middle ...
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Vaccine recipient received vaccine on 1/10/2021 and reported severe fatigue. She woke in the middle of night with severe bilateral leg pain, similar to sciatica, painful to get out of bed and walk, similar to Charlie Horse. She took Tylenol and laid around most of the day 1/11/21. Pain in right leg stopped in evening on 1/11/21, however pain continues in left leg. Nerve pain in left leg is still continuing from left gluteal muscle to inner thigh above knee cap. She declined occupational health follow-up and will self-manage at home. Pfizer-BioNTech COVID- 19 Vaccine
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| 64 | 2021-01-12 | headache, chills, fever, malaise |
Arm soreness @ 11pm 1/11/2021; continual headache starting @ 2am 1/12/2021 accompanied by chills,...
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Arm soreness @ 11pm 1/11/2021; continual headache starting @ 2am 1/12/2021 accompanied by chills, low grade temp of 99.7 , skin hurt all over & generally feeling unwell. These symptoms continued until 11 pm 1/12/2021. Took Tylenol, wet to bed & woke up 1/13/2021 without symptoms.
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| 64 | 2021-01-12 | headache |
felt flushed; BP elevated 226/97; dull occipital headache/dull headache; This is a spontaneous repor...
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felt flushed; BP elevated 226/97; dull occipital headache/dull headache; This is a spontaneous report from a contactable other HCP (patient). A 64-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date not provided) via an unspecified route of administration (vaccination location: left arm) on 06Jan2021 09:30 at SINGLE DOSE for COVID-19 immunisation. Medical history was reported as 'none'. It was also reported that patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, and prior to vaccination, the patient was not diagnosed with COVID. The patient has no allergies to medications, food, or other products (no known allergies). The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899; expiration date not provided), via an unspecified route of administration (vaccination location: left arm) on 18Dec2020 18:00 at SINGLE DOSE for COVID-19 immunisation. It was reported that patient received second dose of Pfizer Covid vaccine on 06Jan2021 at 09:30 am. One hour after the 2nd dose (10:30 am), patient experienced dull occipital headache. Patient took paracetamol (TYLENOL). At 10:45 am, patient felt flushed. The nurse took patient's vital signs and noted no fever, normal heart rate and respiratory rate. BP elevated 226/97 (reported at 10:30, no unit provided; normal BP: 130's/80's). At 12:45, patient was taken to ED. CT scan and lab work were reported as all normal. BP continues to be elevated. Amlodipine (NORVASC) 10 mg was given at 17:00. BP slowly came down. Twenty-four hours later, BP was normal at 137/72 (no unit provided). No additional medication taken. It was reported that patient continues to have dull headache. No arm soreness or other symptoms. It was also reported that since the vaccination, the patient has not been tested for COVID-19. Outcome of the events 'BP elevated 226/97' and 'felt flushed' was recovering, outcome of the event 'dull occipital headache/dull headache' was not recovered.; Sender's Comments: Based on the compatible temporal association and in absence of strong confounding factors, the Company considers the reported event blood pressure increased is possibly related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 64 | 2021-01-12 | headache |
I developed a headache and nausea that lasted 36 hours. Headache gone after the 36 hours but still h...
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I developed a headache and nausea that lasted 36 hours. Headache gone after the 36 hours but still have some nausea 48 hours later. I am fine, but wanted to at least let you know that's how the second shot affected me. I had no reaction other than a sore arm after the first injection. I did not need to seek medical attention.
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| 64 | 2021-01-12 | influenza like illness, fever |
awakened at 3am with fever 101 and shaking chills the night after my second SARS Pfizer vaccine. flu...
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awakened at 3am with fever 101 and shaking chills the night after my second SARS Pfizer vaccine. flu-like sx lasted for one day; fever resolved by this am 1/13
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| 64 | 2021-01-12 | lethargy, fever, headache, chills | Headache Fever Chills Lethargy DIzzy |
| 64 | 2021-01-12 | malaise, chills | Chills, body aches, malaise, nausea |
| 64 | 2021-01-12 | nasopharyngitis, fatigue, influenza like illness |
Patient reports flu like symptoms, felt very cold and myalgia. Next day she self treated and went to...
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Patient reports flu like symptoms, felt very cold and myalgia. Next day she self treated and went to work and had to leave. Patient reports night sweats, severe fatigue. Patient says the night sweats is the reason she is calling.
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| 64 | 2021-01-12 | fever |
I had server out break of HSV 1 for 10 days , low grade fever 99. and anti-viral Vancylerver, Ty...
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I had server out break of HSV 1 for 10 days , low grade fever 99. and anti-viral Vancylerver, Tylerol and Advil
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| 64 | 2021-01-12 | respiratory tract congestion, cough | Numbness of tongue, change in taste, congestion, body aches, diarrhea, cough |
| 64 | 2021-01-13 | body temperature increased, body temperature increased | Received Covid Vaccine on Jan 13, 2021. Woke up on January 14, 2021 with a temperature of 103 |
| 64 | 2021-01-13 | body temperature increased, headache |
Temp 101.6, chills, extreme body aches and HA, nausea, vomiting, hyperactive bowel movements, (7 sof...
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Temp 101.6, chills, extreme body aches and HA, nausea, vomiting, hyperactive bowel movements, (7 soft formed in 9 hours) resolved about 30 hours from onset.
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| 64 | 2021-01-13 | headache |
45 min after injection face became red and flushed and headache began, redness left in about 4 hour...
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45 min after injection face became red and flushed and headache began, redness left in about 4 hours, headache still remains 24 hours later but mild. joints ache for 24 hours and neck slightly stiff after about 12 hours
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| 64 | 2021-01-13 | headache | headache, body aches |
| 64 | 2021-01-13 | fever, headache, chills, sinus congestion |
Injection site pain; headache; fever 102; chills; muschle & joint pain; face pain; sinus congestion;...
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Injection site pain; headache; fever 102; chills; muschle & joint pain; face pain; sinus congestion; chest tightness by day 3- increased swelling of arm with redness; hot to touch; increased pain radiating to under arm.
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| 64 | 2021-01-14 | body temperature increased | Patient had an elevated temperature that reached a maximum of 102.5 before resolving. |
| 64 | 2021-01-14 | chills, fever, fatigue |
a few hrs. after receiving the vaccine patient had swelling to bilateral hands and feet. patient als...
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a few hrs. after receiving the vaccine patient had swelling to bilateral hands and feet. patient also developed weakness, fatigue and had chills unknown if she had fever Patient was seen by family MD after a few days of swelling
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| 64 | 2021-01-14 | chills, fever |
Fever 101, chills, Arthralgia, red,hard sore painful left deltoid. Treated with Tylenol, Doxycycline...
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Fever 101, chills, Arthralgia, red,hard sore painful left deltoid. Treated with Tylenol, Doxycycline started on 1/15
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| 64 | 2021-01-14 | chills |
chills; extremely painful injection site and was unable to lift affected arm over head easily; extre...
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chills; extremely painful injection site and was unable to lift affected arm over head easily; extremely painful injection site and was unable to lift affected arm over head easily.; This is a spontaneous report from a contactable nurse. A 64-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular (anatomical location: arm left) from 07Jan2021 18:00 to 07Jan2021 18:00 at SINGLE DOSE for an unspecified indication. Medical history included known allergies: PCN. There were no concomitant medications. On 08Jan2021 at 12:00, The patient experienced extremely painful injection site and was unable to lift affected arm over head easily and then chills. The patient did not received any treatment for the events. Outcome of the events was recovering.
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| 64 | 2021-01-14 | cough, headache, fever | Fever, headache, lightheaded and mild cough. |
| 64 | 2021-01-14 | headache, fatigue |
burning of the tongue; Difficulty in breathing; headaches; Pressure in the chest area; nausea; dizzi...
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burning of the tongue; Difficulty in breathing; headaches; Pressure in the chest area; nausea; dizziness; fast heartbeat; tiredness; Had a hard time swallowing at night from the dryness; bitter taste; her mouth went completely dry; patient received 0.45 mL, single dose (225mcg) of PFIZER-BIONTECH COVID-19 VACCINE; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 23Dec2020 15:00 at 0.45 mL, single dose (225mcg) at left arm to prevent COVID. Medical history included a bout of dry mouth about 7 years ago, no other relevant medical history (including any illness at time of vaccination). The patient's concomitant medications were not reported. There's no adverse events following prior vaccinations. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. From the time she got the vaccine her mouth went completely dry on 23Dec2020 and she kept thinking it would go away and she still had it. Event was reported as serious per medically significant. Had a hard time swallowing at night from the dryness. Patient had the bitter taste was also on 23Dec2020, but it went away. It lasted about 5-6 hours. Then after that the dry mouth started right after. It is tolerable but she still had it. Mentioned she had a bout of dry mouth about 7 years ago and it did go away, but she never got a diagnosis for it. Patient thought that something underlying may have triggered it again. Patient also experienced burning of the tongue, tiredness, headaches, pressure in the chest area similar to difficulty in breathing, nausea, dizziness, and a fast heartbeat on unspecified date. Outcome of event dry mouth was not recovered, outcome of event bitter taste was recovered on unspecified date in Dec2020, outcome of other events was unknown. No family medical history relevant to adverse events. No relevant tests. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Relatedness of Pfizer BioNTech Covid-19 vaccine with dry mouth and bitter taste per primary source reporter with method of assessment of global Introspection was related. Reporter seriousness for event bitter taste was not serious.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of dry mouth cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 64 | 2021-01-14 | headache |
Employee reported having SOB with chest pains, severe headache (rated pain as 8/10), excessive saliv...
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Employee reported having SOB with chest pains, severe headache (rated pain as 8/10), excessive salivation with nausea, lightheadedness, she has a h/o migraines headaches and was incapacitated for 24 hours, Employee she was treated and sent home by end of her scheduled shift
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| 64 | 2021-01-14 | throat pain, cough, fever, headache, lethargy |
almost like a thrush in her mouth, white tongue/ believes she had thrush; almost like a thrush in he...
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almost like a thrush in her mouth, white tongue/ believes she had thrush; almost like a thrush in her mouth, white tongue; felt a little cold; legs were sore; headache; Sore arms; severe sore throats; back ache; low grade temp/Low grade fever; coughing; body aches/ whole body was achy; it was sore to swallow; lethargy; This is a spontaneous report from a contactable consumer reporting for self. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Batch/lot number: EL1284, Expiry Apr2021, intramuscularly on 30Dec2020 02:15 (Dose 1), right arm as a single dose (age at vaccination 64 years old) for COVID-19 immunization. Medical history included allergy (usually in the fall she has allergy problems). Her age is considered high risk, works in medical profession (Surgical Tech). Concomitant medication included levocetirizine (Walgreen's generic) 5mg, tablet, by mouth, at night for allergy. The patient had the first dose of the vaccine last 30Dec(2020) and after 2 days (on 01Jan2021) she developed symptoms: Sore arms, severe sore throats, back ache/ back was sore, temperature was up / low grade temp (never high), coughing, body aches. Her back and her legs were sore. Her whole body was achy. It was "like flu-ish kinda." She also had a headache. She started getting the sore throat and headache on 01Jan2021, and she felt a little cold on 02Jan2021. On 02Jan(2021), her first temperature was 100.5 degrees Fahrenheit. She states she had everything except for the GI issues. Around 02Jan(2021) or 03Jan(2021), her symptoms were progressively getting worse. She was told to get COVID tested. There were three exposures since Christmas Eve. So, she went and got a rapid COVID test (04Jan2021) and it came back negative. They also sent out a test that day. She was also tested for Strep (04Jan2021) too because her throat was so sore. It was almost like she had like thrush along with it. She states it was almost like a thrush because she had like a white tongue (onset 03Jan2021). Her throat was so sore, but it was a different kind of sore throat compared to a sore throat she has had before. She explains where the nasopharynx was at the top, it's almost like it was sore from there. It was sore to swallow, it was "a bizarre sore throat." She clarified she noticed the "thrushy" part of her throat around 03Jan2021. The strep test ended up being negative but she believes she had thrush because she was given medication and the medication was clearing that up. However, she still had the symptoms. Because her symptoms only started a few days before, they thought she should maybe wait a couple of days and if she is not feeling any better, she should be retested (for COVID). She went back again yesterday (07Jan2021). She had another Rapid COVID test and also a flu swab and both tests came back negative. She mentions they also did another COVID test (the send out type) and she should get that back around 1pm to find out the results of that. They also did a CBC (07Jan2021) and everything was normal. Her white count was at 7. She was waiting for the 3rd COVID test result today (08Jan2021). She reported that about three days afterwards, she didn't notice the soreness in /her arm. Her throat has improved. Her fever was down to 98 degrees Fahrenheit yesterday (07Jan2021). She states she was feeling better today (08Jan2021). She commented "the lethargy, though." She emptied the dishwasher yesterday (07Jan2021) and had to sit down after emptying it. She states her symptoms have her a little worried. She recovered from the sore arms in Jan2021. The patient was recovering from the severe sore throat, back ache, low grade temp, coughing, body aches/ whole body was achy, believes she had thrush, white tongue, legs were sore, headache, and felt a little cold. The outcome of the event lethargy was not recovered. She was wondering if this was a reaction to the vaccine.
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| 64 | 2021-01-17 | chills, fatigue, headache | very sore arm, headache, muscle aches, tiredness, chills |
| 64 | 2021-01-17 | cough, chills, sinus pain, headache |
severe headache; nausea; chills; sinus pain; cough; joint pain; Bedridden; Arm still sore at 60 hour...
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severe headache; nausea; chills; sinus pain; cough; joint pain; Bedridden; Arm still sore at 60 hours; This is a spontaneous report from a contactable other Health Professional (patient). A 64-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EH9899), via an unspecified route of administration on 07Jan2021 10:30 at single dose in right arm for covid-19 immunization. Medical history included hypertension (Htn), chronic kidney disease (CKD), the patient had known allergies to ibuprofen, bee stings. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EH9899), on 17Dec2020 at the single dose for covid-19 immunization and experienced very sore arm. Concomitant medications the patient received within 2 weeks of vaccination reported as yes. The patient experienced severe headache, nausea, chills, sinus pain, cough, and joint pain for 24 hrs; headache and nausea continued another 12 hours. Bedridden first 24 hours. Arm still sore at 60 hours on 07Jan2021 22:00. The patient did not receive any treatments. The outcome of the events was recovering.
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| 64 | 2021-01-17 | fatigue, headache, nasal congestion, fever |
Symptoms started at 10:30 PM on 01/04/2021, complains of headache, body aches, temp 100.4, congestio...
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Symptoms started at 10:30 PM on 01/04/2021, complains of headache, body aches, temp 100.4, congestion, fatigue. Took Tylenol for fever.
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| 64 | 2021-01-17 | fatigue, headache |
Extremely sore arm, muscle aches, headache, slight nausea, fatigue. Onset 12 hours after administra...
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Extremely sore arm, muscle aches, headache, slight nausea, fatigue. Onset 12 hours after administration. Effects lasted for 3 days despite round the clock Tylenol dosing.
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| 64 | 2021-01-17 | headache, fatigue |
Headache, total body muscle aches, chills, slight nausea, fatigue, arm soreness lasting for 3 days. ...
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Headache, total body muscle aches, chills, slight nausea, fatigue, arm soreness lasting for 3 days. tiredness and muscle soreness, intermittent nausea lasted for 5 days
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| 64 | 2021-01-18 | chills, fatigue, sleepiness |
Pain at injection site; swelling,(size of my palm,); warm to touch, all over body; muscle aches, esp...
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Pain at injection site; swelling,(size of my palm,); warm to touch, all over body; muscle aches, especially shoulder blades; tired/sleepy; tired/sleepy; chills; This is a spontaneous report from a contactable other HCP (patient). This 64-year-old female other HCP reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL128H), via unspecified route at right arm on 08Jan2021 07:45 AM at single dose for COVID-19 immunization. Facility type vaccine was hospital. Medical history included elevated blood pressure and atrial septal defect repair 2008. Concomitant medications included olmesartan medoxomil and hydrochlorothiazide. Historical vaccine included the first dose of BNT162B2 (lot# EH9899) on 18Dec2020 at age of 64 years old for COVID-19 immunization and having arm pain. No Covid prior vaccination. No Covid tested post vaccination. No known allergies. On 08Jan2021 07:00 PM, patient experienced pain at injection site, swelling (size of her palm), warm to touch all over body and muscle aches, especially shoulder blades, very tired/sleepy with chills. No treatment was received. It was reported normal temperature for patient was 97.2 (+) or (-) 98.6. Outcome of events was recovering.
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| 64 | 2021-01-18 | cough, respiratory tract congestion, upper-airway cough syndrome, fever, throat pain, nasal congestion |
She woke up soaking wet. She had sweats kind of.; Tested positive for COVID; Tested positive for COV...
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She woke up soaking wet. She had sweats kind of.; Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable nurse (patient herself) reported that a 64-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730, expiry date not reported), via an unspecified route of administration in the upper left arm on 21Dec2020 17:00 at SINGLE DOSE for Covid-19 immunisation. Medical history included ongoing hypertension (blood pressure high). She was a former smoker, a teenage smoker. She has not smoked since the age of 19 years old. Concomitant medication included amlodipine for high blood pressure. The patient informed that she was vaccinated on 21Dec2020. On 05Jan2021, she had a positive COVID Test and she was wondering when she should have the second dose of the COVID Vaccine. She thought initially she just had a cold. She took the COVID test as a precaution. It started out with a stuffy nose. She had a congested cough, upper airway cough, nothing deep in the lungs. She had a low grade fever. It was like 99.9. It was possible it was higher, but she had taken Ibuprofen at night. She woke up soaking wet. She had sweats kind of. Her temperature however never registered a true fever if a fever was considered 100.4. She was not really having body aches any more unusual than one would have for a 64 year old. She has a very mild sore throat. Her stuffy nose had improved, it's still there slightly, but not like it was the first few days. The outcome of events was unknown.; Sender's Comments: Test positive for covid19 found 14 day following the first dose of COVID-19 vaccination, bnt162b2, no adequate effect of the suspect vaccine thus could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.
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| 64 | 2021-01-18 | fatigue, headache | Headache, body aches, headache, extreme fatigue |
| 64 | 2021-01-18 | fatigue, sleepiness |
Physical exhaustion, slept all afternoon, Got up around 6PM and went back to bed at 9 and slept fro...
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Physical exhaustion, slept all afternoon, Got up around 6PM and went back to bed at 9 and slept from 9 AM till the next morning at 8AM. Felt tired all morning and no appetite ,and felt nauseous. Began feeling better around 2 PM.
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| 64 | 2021-01-18 | fever, chills |
right groin became red and develop lymph node; right groin became red and develop lymph node; Fever/...
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right groin became red and develop lymph node; right groin became red and develop lymph node; Fever/ temperature went up around 101.4; Chills; This is a spontaneous report from a contactable nurse (patient). This 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EJ1685) via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was a nurse anaesthetist who received the COVID-19 vaccine on the 19Dec2020 and on 22Dec2020 after she got home from work that afternoon in the evening, her temperature went up around 101.4 and had the chills and the fever. Later that evening and next morning (23Dec2020) her right groin became red and develop the lymph node that patient did not never felt before. Patient called physician and they put her on Antibiotics Keflex (treatment) for four times a day for 10 days. After the reaction, patient had a COVID test and Flu A and Flu B test and all of them were negative. The outcome of events was unknown.
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| 64 | 2021-01-18 | fever, chills | Sore arm the next morning , not bad Almost exactly 24 hrs later, fever, chills and achiness. |
| 64 | 2021-01-18 | fever |
Started feeling achy; temperature of 99.2; Sore arm; This is spontaneous report from a contactable c...
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Started feeling achy; temperature of 99.2; Sore arm; This is spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on 08Jan2021, temperature of 99.2 and started feeling achy on 09Jan2021. Event details: The patient received the first dose of the vaccine yesterday (08Jan2021). Yesterday night, she started with a sore arm which she expected then this afternoon (09Jan2021) she started to experience feeling achy and when she checked her temperature it was 99.2, for the sore arm last night and this morning she took Ibuprofen for treatment. The outcome of the events was unknown. Information on the batch/lot number has been requested.
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| 64 | 2021-01-19 | chills, headache, fever |
I experienced chills; mild headache; fever ranging from 100.8 - 101.8; Mild body aches; This is Spon...
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I experienced chills; mild headache; fever ranging from 100.8 - 101.8; Mild body aches; This is Spontaneous report from a contactable consumer. A 64-year-old female consumer reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0142), into the left arm on 08Jan2021 at 01:00 PM at single dose for COVID-19 immunization. The patient had a medical history of Rheumatoid Arthritis, Sjogren's Syndrome, Osteoarthritis and known allergies to penicillin, Valium, ketamine. Concomitant drug included Synthroid and Humira - Abbvie on 31Dec2020 (lot number 1136949). On 09Jan2021 approximately 24 hours after BNT162B2 administration, the patient experienced chills, mild headache and fever ranging from 100.8 - 101.8 and mild body aches. 48 hours later she still had fever ranging 100-101. No treatment was received. The patient did not have Covid prior vaccination and was not covid tested post vaccination. At the time of reporting the patient was recovering.
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| 64 | 2021-01-19 | fatigue |
Worsening diarrhea at onset followed by significant fatigue, weakness, and vibratory sensation in ar...
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Worsening diarrhea at onset followed by significant fatigue, weakness, and vibratory sensation in arms and legs Exam on 19 Jan 2021 revealed hyperreflexia and slightly spastic gait concerning for transverse meylitis
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| 64 | 2021-01-19 | headache, fever | FEVERISH; HOT FLASHES; MUSCLE ACHES; MILD HEADACHE; SORE ARM. TOOK ADVIL 600MG 2X DAILY |
| 64 | 2021-01-19 | fever, chills, fatigue, headache |
On second day after vaccine-1/8/21-shakes, chills, left arm swollen, bruised, tender, warm, and sore...
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On second day after vaccine-1/8/21-shakes, chills, left arm swollen, bruised, tender, warm, and sore with a knot at injection site. Nausea and fever of 101.8-patient took Zofran=8mg. All over body aches and joint tenderness and soreness. Day 3-1/9/21-extreme fatigue and body aches, no fever or chills. Day 4 and 5 only had headaches, and on Day 6 no symptoms at all.
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| 64 | 2021-01-19 | fever |
Fever 101.5, migraine, eyepain, severe arthralgias, nausea and vomiting, weakness, inability tji ...
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Fever 101.5, migraine, eyepain, severe arthralgias, nausea and vomiting, weakness, inability tji think clearly. Residual symptoms at the time of this report
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| 64 | 2021-01-20 | chills, fatigue |
Patient received her first dose of the Pfizer vaccine on 1.20.2021. Patient reports chills, fatigue,...
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Patient received her first dose of the Pfizer vaccine on 1.20.2021. Patient reports chills, fatigue, and heel numbness. The heel numbness began the night of the injection. Patient said half of their left foot and heel felt numb. Patient states that the numbness has fully resolved by the next morning, 1.21.2021. Patient encouraged to call PCP with worrisome or bothersome problems. Patient encouraged to call back with any new changes or questions about the vaccine.
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| 64 | 2021-01-20 | headache, body temperature increased | Elevated T of 100.3, body muscle/joint pain; severe headache, nausea, dizziness |
| 64 | 2021-01-20 | headache |
Approx. 10-12 post immunization, pt. reports dizziness and nausea. She refused to lay down, remained...
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Approx. 10-12 post immunization, pt. reports dizziness and nausea. She refused to lay down, remained in wheelchair. She asked for cola, it helped settle stomach. As dizziness subsided she had HA. We observed her for an additional 30 min. until dizziness gone. She still had some nausea & HA. Hx: migraines. (She often feels dizzy/nausea prior to migraines)
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| 64 | 2021-01-20 | fever | low grade fever, chills, aches, sensitivity to light, shakes |
| 64 | 2021-01-21 | headache, chills | chills, skin hurts, headache, nausea, body aches, muscle aches |
| 64 | 2021-01-22 | headache, fever, fatigue, chills | Chills, fever, headache, muscle pain, fatigue, weakness |
| 64 | 2021-01-22 | headache, fever | Hives,achy,fever,nausea,headache,diarrhea |
| 64 | 2021-01-23 | body temperature increased, chills, fatigue, headache |
I am reporting the following reaction, as I was unable to enter it on V-safe due to the site not fu...
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I am reporting the following reaction, as I was unable to enter it on V-safe due to the site not functioning properly. Twelve hours post vaccination: onset of shaking chills, temperature 101 F, severe headache, nausea, myalgia, arthralgia and fatigue Twenty four hours post vaccination: severe headache and moderate nausea, myalgia, arthralgia and fatigue, temperature 98.8F Forty eight hours post vaccination: moderate headache, mild nausea and fatigue Seventy two hours post vaccination: slight headache, nausea and fatigue Ninety six hours post vaccination: symptoms resolved
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| 64 | 2021-01-23 | headache, fatigue | Moderate Fatigue and body aches, moderate headaches |
| 64 | 2021-01-23 | headache, sleepiness, chills |
chills, headache, nausea, sleepiness, body aches for 2 days. Took Tylenol every 4 hrs. for 24 hrs. ...
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chills, headache, nausea, sleepiness, body aches for 2 days. Took Tylenol every 4 hrs. for 24 hrs. Felt better by day 3.
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| 64 | 2021-01-24 | fatigue, fever |
forceful beat feeling in her chest/she was really uncomfortable in her chest, the force was the most...
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forceful beat feeling in her chest/she was really uncomfortable in her chest, the force was the most uncomfortable at this point; seemed like UTI symptoms were coming back; felt really wiped out and worn down/tired; anxiety; racing/ pounding in chest; potassium was a little low; elevated blood pressure; arm a little bit sore; 99.1 degrees Fahrenheit fever; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via intramuscular on 28Dec2020 07:15 at single dose on deltoid left for COVID-19 immunisation. Medical history included hepatitis C which cleared in 2016, hysterectomy was done in 2004 or 2005, cyst removed from breast long ago, ongoing arthritis in left knee, urinary tract infection was treated in Nov2020. The patient's concomitant medications were not reported. She received the first vaccine on 28Dec2020. She did fine that day. She came home and laid down and rested. Her temperature went up to 99.1 degrees Fahrenheit but was resolved that same day/night. Early in the morning on 29Dec2020, around 3:30 a.m., she woke up and had a racing/pounding feeling in her chest. She took her blood pressure and it was 158/86, heart rate (HR) was 83. She felt really funny. She hadn't been diagnosed with high blood pressure before, so this was high for her. She took her blood pressure again about an hour later and it was 165/95, HR 73. She took it again about an hour later and her blood pressure read 180/98, HR 77. Her heart rate stayed in the normal range, but the force felt really strong. She did go to the emergency room around 5:00 am on 29Dec2020. She told them what she was experiencing and that she had received the COVID-19 vaccine. About the time she got to the hospital, her blood pressure was starting to come down. An EKG was done and they drew bloodwork. Her potassium came back a little low-they didn't tell her how low or what her level was. She was given 2 potassium tablets which did help. She confirms she doesn't have any NDC, Lot number or expiration date for the potassium she was given. It was given to her at the hospital. She was also given a sheet to monitor her salt intake, which she already does that. She confirmed she was not admitted into the hospital, she was discharged from the Emergency Room. She felt pretty good. She didn't go to work that Wednesday, 30Dec2020, but she went to work on Thursday, 31Dec2020. On 01Jan2021, the same thing happened to her again. She had elevated blood pressure, forceful beat. She went back to the ER early in the morning, around 5:00 am, on 01Jan2021. Her pulse stayed within normal range, but she had such a forceful beat. She informed them that she was really uncomfortable in her chest, the force was the most uncomfortable at this point. They wanted to make sure she wasn't have a stroke or heart attack, so they did their normal procedures to rule this out. They did 2 EKG's, 2 sets of labs, Chest X-ray, CAT scan and everything came back normal. She had a discussion with the physician that saw her about what she was experiencing and the physician was asking her about having anxiety. Caller explains she has never really had problems with anxiety before, but she can't say she hasn't had it. Being around COVID patients and getting the shot, sometimes anxiety can be there. The physician wanted her to try a low dose of Hydrochlorothiazide 12.5mg. She was to only to take a half dose by mouth, if her top number (systolic blood pressure) was between 140-160. Caller clarifies when she means half of a dose, the dose equals 12.5mg. She was instructed to take this 12.5mg dose until she saw her PCP. So, she did this and called her PCP and wasn't able to get an appointment to speak with a provider until the following Wednesday, 06Jan2021. She did a tele visit with her provider and let her know what had happened and that the half of the pill will only bring her top number (systolic blood pressure) to 130's-140's. Caller states she was used to her top number (systolic) being maybe in the 120's, low 130's. Her doctor increased her dose to 25mg. She was prescribed to take 25mg, tablet, by mouth, once a day. She confirmed she still checks her blood pressure before she takes the medicine. Caller verifies she has 2 bottles, one being the 12.5mg dose and the second being the 25mg dose. With the 12.5mg bottle, she sees refills and the date 05Jan2022. Caller clarifies both bottles are dispensed in pharmacy vials with no NDC, Lot number or expiry date. About a month prior to all of this and receiving the COVID-19 vaccine, clarified as Nov2020, she was treated for a UTI. During that time, her blood pressure went up a little and kind of bounced around a little bit, but came back down. Then, she got the COVID-19 shot. She initially felt fine but later on by the time she got a chance to do the tele visit with her PCP, she was telling her about her previous UTI, and the provider put her on Cipro because it seemed like her UTI symptoms were coming back. Caller verifies she doesn't have any NDC, Lot number or expiration for the Cipro. She already took of all of that. She went to the ER for the third time on 08Jan2021 because she again felt the forceful beat feeling in her chest. She explained she felt really wiped out and worn down and she was tired. An EKG was done and they did labs. She confirms she doesn't have any results with her at this time. She was taken off of work for a couple of weeks. She is currently getting in contact with a Cardiologist to make sure everything is alright. The cardiologist wants her to have a stress test. The caller states so this is where she is now. She is taking blood pressure medicine and getting set up to do a stress test. Sore arm outcome: Caller confirms she recovered from the arm soreness within that same day. Her arm didn't stay sore long at all. Racing/pounding in chest: This had improved. It's not like it was. She still has it a little bit of it now, but she is going to see her cardiologist and do a stress test. The blood pressure medicine has helped some. Elevated blood pressure: Today her blood pressure top number got to 161 and she had to take medication but her blood pressure has improved. Outcome of elevated blood pressure, racing/ pounding in chest was resolving; outcome of forceful beat feeling in her chest, UTI, potassium was a little low, felt really wiped out and worn down/tired, anxiety was unknown; outcome of arm a little bit sore, 99.1 degrees Fahrenheit fever was resolved on 28Dec2020.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 64 | 2021-01-24 | fatigue, fever |
ran low grade fever 12/19/2020 ,12/20/2020 Fever, fatigue 12/22/2020 sever diarrhea , 12/26/2020 fe...
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ran low grade fever 12/19/2020 ,12/20/2020 Fever, fatigue 12/22/2020 sever diarrhea , 12/26/2020 feeling worse and worse and tested on 12/26/2020 on 12/28-29/2020 shortness of breath and admitted on 12/31/2020
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| 64 | 2021-01-24 | fatigue |
Have written to Health dept no answer-they must be busy. First shot resulted in very sore upper arm ...
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Have written to Health dept no answer-they must be busy. First shot resulted in very sore upper arm 1.5 days, no other effects. Clean injection into deltoid muscle bulk. Second shot, injection shot extremely high above main muscle bulk of the deltoid into area of supraspinatus tendon one finger below acromial shelf. First shot, two sensations: initial puncture then injection. Shot 2 one huge painful bump met with resistance in my tissue. Also Shot 2 not one response except mild fatigue still today, but no pain in upper arm unless I pressed specifically into injection site itself. WAS THIS VARIATION IN INJECTION SITE ACCEPTABLE? WAS IT OK TO DO INJECTION SO VERY HIGH UP? Secondly, had a wonderful, professional nurse, but I question the practice of retrieving a dose for me that comprised of doses left over at bottom(s) of other vial(s). We had a new vial in the office where I was, but she left and came back with a syringe already full, saying that it was important to use up every drop. At first I agreed, but now I question this practice and just want to make sure I don't need to come back for another second dose. Are there no substrates that would settle out of the solution as the vial gets depleted of everything except only a bit of fluid left in it? Is retrieving every last drop from each vial and putting them together to make a dose acceptable practice? if not, from the Pfizer standpoint, then I should get another dose? I am a pediatric physical therapists working within 1-2 feet a children's faces at all times and transmissibility is a real issue both ways in my job. I truly do not want o become a Covid victim. please let me know if both the injection site and the method b y which my dose was put together is acceptable in the eyes of Pfizer. Thank you.
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| 64 | 2021-01-24 | headache |
bloodshot left eye; injection site soreness/injection site soreness of L arm; Lack of energy; (time)...
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bloodshot left eye; injection site soreness/injection site soreness of L arm; Lack of energy; (time) confusion; lightheadedness; headache/slight headache; This is a spontaneous report from a contactable nurse, reporting for herself. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection lot number: EL1284), intramuscularly on the left arm on 05Jan2021 18:30 at a single dose for COVID-19 immunization. Medical history included received immunotherapy injections for environmental allergies from an unknown date and unknown if ongoing. Concomitant medication included diltiazem, spironolactone, trazodone, lorazepam, colecalciferol (VITAMIN D), zinc and fish oil. On 05Jan2021, the patient received Pfizer COVID-19 vaccine and experienced (time) confusion, and lightheadedness within one hour of receiving. Later that evening, the patient experienced headache. On 06Jan2021, the patient experienced injection site soreness x 2 days, continued with slight headache, lack of energy. On 08Jan2021, resolved injection site soreness of left arm, continue with slight headache. On 11Jan2021, The patient woke up with bloodshot left eye after having had headaches x 5 days which began the same evening of receiving the Pfizer COVID-19 vaccine. Blood pressure was 125/80. No headache or eye pain. BP was 128/89 on 10Jan2021, 11 PM. No headache. BP was 120/80 on 11Jan2021, 10 AM. The patient had never had a bloodshot eye before. The patient underwent lab tests and procedures which included Blood pressure:125/80 mmHg on an unspecified date, 128/89 mmHg on 10Jan2021 and 120/80 mmHg on 11Jan2021. The outcome of the event injection site soreness/injection site soreness of L arm was recovered on 08Jan2021 while the outcome of all other events was unknown.
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| 64 | 2021-01-25 | fatigue, fever, chills, cough |
Has arthritis prior to having the COVID vaccine and after getting it, it went after the over growth ...
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Has arthritis prior to having the COVID vaccine and after getting it, it went after the over growth bones in her hands; She still has a cough and no taste; She still has a cough and no taste; The doctor didn't know what to tell, they said if they were her, they would not take the second shot; Body aches; Chills; Nausea; Tired; Diarrhea; Had a fever reached 100.0; Joint hurt, all of them; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 in Nov2020 (8 weeks ago). Concomitant medications were not reported. After getting the vaccine, she got sick as a dog and couldn't work. She had a fever that reached 100.0, she had body aches. It was explained that she has arthritis prior to having the COVID vaccine and after getting it, it went after the over growth bones in her hands. The caller continues that her joint hurt, all of them, but it was throbbing the most where she has visual arthritis. To sum it up, she had chills, nausea, and body aches the first day. The caller took Tylenol regardless of what the paper said; this was on Friday, 08Jan2021. She kept taking the Tylenol. The next day, she was still tired but when she quit taking the Tylenol on the 2nd day the symptoms returned. It was clarified that she took it in the beginning of the second day twice but at the end of the day wanted to see if she was over it all so she stopped the Tylenol. The symptoms all returned so she took again at bed time, the Tylenol, this was Saturday. On Sunday, she had diarrhea but only a couple times and though it was weird, after that is was over. That day she took Tylenol once. She was calling because she was scared about the second dose, this one produced a big immune response and she says that usually happens with the second dose. The caller wants to know if she should take the second shot, she doesn't want to have this happen again or it be worse. She thought since she had already had COVID it wouldn't be as bad, her immune response. The first dose was given on 07Jan2021. It was explained the only thing unresolved was from when she had COVID, she still has a cough and no taste. There are just few thing she can taste and smell now. The patient said that all the symptoms had resolved as of Monday, the 11Jan2021. Actually, she felt pretty good on the 10Jan2021 so let's say Sunday. She explained that most people get this on the second dose and so if she going have a third response she doesn't want the second dose. She was calling to get an answer to her question, the doctor told her to call to see what could be recommended. She has really good doctors, three of them. The doctor didn't know what to tell, they said if they were her, they would not take the second shot. The patient said she really needs to go. No need to continue when there is no one to tell her if she should take the second shot or not. The patient asked to be contacted via email to relay information about people's immune response to the first dose verses the second dose, is it greater or less. Clinical outcome of the events recovered on 11Jan2021. Information on the Batch/Lot number has been requested.
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| 64 | 2021-01-25 | headache, fever, chills |
Heaviness in chest; Chills; Headache; Body aches; 20 Hours after vaccination; fever of 100.5; This i...
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Heaviness in chest; Chills; Headache; Body aches; 20 Hours after vaccination; fever of 100.5; This is a spontaneous report from a contactable Nurse reported for herself. A 64-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 16:00 at single dose on left arm for COVID-19 immunisation. Medical history included Anxiety, GERD, gluten and lactose intolerant, no known allergies, no COVID prior to vaccination. There were no concomitant medications. There were no other vaccine in four weeks and no other medications in two weeks. The patient previously received the first dose of BNT162B2 in Dec2020 13:00 in Left arm for COVID-19 immunization. About 20 Hours (as reported) after vaccination, on 14Jan2021 at 11:00 AM, the patient experienced fever of 100.5, headache, body aches, heaviness in chest, chills. No treatment was received for the events. The patient had not recovered from the event. The patient didn't test COVID post vaccination. Information on the lot/batch number has been requested.
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| 64 | 2021-01-25 | headache | Nausea and Vomiting this morning at 8:30 am on 1/26/21. Slight headache yesterday. |
| 64 | 2021-01-26 | chills, headache | VERTIGO, CHILLS, NAUSEA, HEADACHE, LEFT ARM ARM UP TO BASE OF SKULL |
| 64 | 2021-01-26 | cough | A cough and then vomiting |
| 64 | 2021-01-26 | headache |
Headache and body aches for 24 hours; Headache and body aches for 24 hours; edema left arm pit and l...
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Headache and body aches for 24 hours; Headache and body aches for 24 hours; edema left arm pit and left collarbone and neck; edema left arm pit and left collarbone and neck; tingling down the back of neck to shoulder blade for 1 week; All left side, pain at injection site with warm to touch for three days; All left side, pain at injection site with warm to touch for three days; This is a spontaneous report from a contactable nurse (patient). A 64-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EL1283), via intramuscular in left arm on 08Jan2021 13:15 at second single dose for covid-19 immunization. Medical history included diabetes type 2, allergies. Concomitant medication included metformin, simvastatin, semaglutide (RYBELSUS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose BNT162B2 (LOT# EL1685) on 20Dec2020 01:15 PM, via intramuscular in left arm for Covid-19 immunization. The patient experienced headache and body aches for 24 hours, edema under left arm pit and left collarbone and neck with tingling down the back of neck to shoulder blade for 1 week. All left side, pain at injection site with warm to touch for three days. Adverse event start date/time: 09Jan2021 06:00 AM. Events were considered as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. Outcome of the events was recovering.
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| 64 | 2021-01-26 | headache |
Patient received Covid Vaccine Dose 1 on 01/25/2021. Patient states within 15-20 mins of receiving d...
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Patient received Covid Vaccine Dose 1 on 01/25/2021. Patient states within 15-20 mins of receiving dose, felt extreme coldness from shoulder to tips of fingers for about 30 mins and then resolved. Then afterwards, started to develop redness/itching/hives on back. Patient also felt very lightheaded and blood pressure taken and elevated at 188/84. (20-25 mins after injection). Injection site did swell and got red after. Also had mild HA after arriving home but didn't last long & nauseous feeling the whole day after getting vaccine. Patient did not take any medications and all symptoms resolved on own.
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| 64 | 2021-01-26 | fever, chills, headache |
Fever to 101.2 x 12 hrs. Continued fever at 100 through 24 hrs. Total body aches. Chills. Nausea...
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Fever to 101.2 x 12 hrs. Continued fever at 100 through 24 hrs. Total body aches. Chills. Nausea. Severe headache. All mostly resolved in a total of 36 hrs.
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| 64 | 2021-01-27 | fatigue, chills, fever |
body ache; Chills; Low fever; Fatigue; This is a spontaneous report from a contactable consumer (pat...
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body ache; Chills; Low fever; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown (as reported: "EK5230 or EK5730, it could 52 or 57, I am not sure, that may be 5730"), via an unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization. There were no medical history and concomitant medications. The patient reported some side effects from the COVID vaccine. The patient reported she had 3 days (as reported-pending clarification) of really bad body ache, chills, low fever, and fatigue from 14Jan2021. The patient received "Flu syrup" as treatment for the adverse events. The outcome of events was not recovered (as reported "still experiencing"-pending clarification). Information about lot/batch number has been requested.
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| 64 | 2021-01-27 | fatigue |
Inflammatory pain; Little dizziness/Light headedness; Fatigue; Arthritis pain in hip, in hand and in...
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Inflammatory pain; Little dizziness/Light headedness; Fatigue; Arthritis pain in hip, in hand and in wrist; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer's COVID Vaccine; lot number: EL1284; expiration date: 30Apr2021), via an unspecified route of administration left upper arm on Jan2021 at a single dose for covid-19 immunization. Medical history included lupus. There were no concomitant medications. The patient reported that she got her first dose of the COVID Vaccine 2 weeks ago today (Jan2021), and this is her second dose next Saturday. She was a non-medicated, non-kind of remission level of lupus. She mentioned that she was okay the second day, she thinks. She had a little dizziness, fatigue and light headedness that kind of thing. But the top 3 or 4 days ago, so like on her 8th or 9th day, she started to get like inflammatory symptoms like arthritis pain in her hip, in her hand, in her wrist. It was also reported that the patient experienced inflammatory pain on an unspecified date. So, she was just wondering if there are any reports of people with lupus and if the other people have reported that. She mentioned that she wanted to get the second dose but was a little concerned if those arthritis symptoms are going to be worse. No treatment was received. The causality was reported as yes. The patient she hasn't gone visit any emergency room/ physician's office for the adverse events. The outcome of the events was unknown.
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| 64 | 2021-01-27 | headache, body temperature increased |
patient developed a fever right after injection, went up to 103.5 overnight, called off work the fol...
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patient developed a fever right after injection, went up to 103.5 overnight, called off work the following day sick - headache and vomiting
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| 64 | 2021-01-27 | headache, fever | Fever, diarrhea. Vomiting, body aches, headache, back of neck aches, pain at site of shot |
| 64 | 2021-01-27 | headache, respiratory tract congestion | H/A with nausea and dizziness, slight congestion. lasted 1/2 day |
| 64 | 2021-01-27 | throat pain |
I had a sore throat like it was inflamed and my lymph nodes were swollen. I went to Urgent Care in ...
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I had a sore throat like it was inflamed and my lymph nodes were swollen. I went to Urgent Care in about 2 weeks after the vaccine. The rapid strep test was NEG.
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| 64 | 2021-01-27 | fever, malaise, chills |
Low grade fever/fever; Chills; Body ache/whole body aches; Nausea/I am getting nauseated; Not feelin...
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Low grade fever/fever; Chills; Body ache/whole body aches; Nausea/I am getting nauseated; Not feeling well; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) , via an unspecified route of administration on 13Jan2021 at a single dose as patient works in a Healthcare Facility, also under the recommendation of her physician (COVID-19 immunization). Medical history included cardiomyopathy and patient has pacemaker defibrillator. Concomitant medication included sotalol. The patient had the injection (patient described the product as Pfizer EL3246) yesterday, the first dose and about 2 o'clock this morning (14Jan2021) she woke up and have been having symptoms, the side effect symptoms, she had fever, the chills, the body ache, the nausea and just not feeling well at all. The patient was still experiencing the events. The patient stated that they are actually kind of getting worse, she was getting nauseated, her entire whole body aches, not feeling well at all, she had a fever, she just took temp of herself and she has a low grade fever. No treatment was administered for the events. The outcome of the events was not recovered. Information on lot number has been requested.
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| 64 | 2021-01-28 | chills, throat pain, fever |
Fever, chills, body aches and sore throat. Treatment: Tylenol, Outcome: body aches, chills and fever...
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Fever, chills, body aches and sore throat. Treatment: Tylenol, Outcome: body aches, chills and fever improved, report of sore throat and not feeling 2 weeks later. Referred for testing.
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| 64 | 2021-01-28 | cough, fever, headache |
High heart rate, 125. high respiration, 110, severe coughing. They started IV OF SODIUM CHLORIDE...
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High heart rate, 125. high respiration, 110, severe coughing. They started IV OF SODIUM CHLORIDE, GAVE ME STERIODS, AND LORATIDINE, AND SOMETHING ELSE. WAS IN EMERGENCY FOR 4 HOURS. STILL COUGHING, HEADACHE, FEVER NOW 24 HOURS LATER
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| 64 | 2021-01-28 | headache, chills, fatigue |
The day at 7:00 PM symptoms started with headache, chills, temperature, fatigue, nausea. 48 hours l...
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The day at 7:00 PM symptoms started with headache, chills, temperature, fatigue, nausea. 48 hours later your feeling much better. Took Tylenol and also Ibuprofen and stayed hydrated. Also had arm soreness, which she had with 1st vaccine as well.
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| 64 | 2021-01-28 | fever, headache |
headache, bone and muscle aches on left side (collar bone, shoulder blade, rib cage, neck, back), fe...
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headache, bone and muscle aches on left side (collar bone, shoulder blade, rib cage, neck, back), fever (99.5-100.5 for 1+ days), nausea (5+ days)
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| 64 | 2021-01-28 | fever |
Patient was found with AMS 1 day after receiving vaccine. Patient had pain at the injection site an...
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Patient was found with AMS 1 day after receiving vaccine. Patient had pain at the injection site and fever of 103.
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| 64 | 2021-01-29 | fatigue, chills | Chills, fatigue, heart flutters |
| 64 | 2021-01-30 | chills, fever |
Approximately 19 hours after my second Pfizer vaccine, I experienced dizziness, plus fever and chill...
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Approximately 19 hours after my second Pfizer vaccine, I experienced dizziness, plus fever and chills. I experienced two bouts of extreme dizziness, within minutes of each other. I did not go to the hospital nor did I call 911. My husband helped me to my bed where I went to bed and slept off and on for over two hours. I felt well enough to eat lunch, then went back to bed, where I slept for three hours. No more episodes of dizziness occurred.
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| 64 | 2021-01-30 | chills |
a few minutes after getting vaccine patient started to have left knee redness/itching and then whol...
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a few minutes after getting vaccine patient started to have left knee redness/itching and then whole body itching. has a erythematous papular rash that is also very itchy on her back had chills that night
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| 64 | 2021-01-30 | headache | Dizziness and headache the following day after vaccination |
| 64 | 2021-01-30 | lethargy, fever, chills, headache |
Approximately 18 hours after the injection, I felt like I had been hit by a truck. My arm hurt like...
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Approximately 18 hours after the injection, I felt like I had been hit by a truck. My arm hurt like blue blazes, itched intensely, and I had a fever of 102.4. To get my temperature down to 100 degrees I had to alternate Motrin and Advil. I continued to have a fever, headache, body aches, chills, and lethargy for the next 48 hours and stayed in bed because I felt so awful. Unable to do normal activities of daily living.
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| 64 | 2021-01-31 | chills, fatigue, headache |
Severe muscle and tendon pain, chills, moderate headache, chest pressure and pain, trembling, fever ...
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Severe muscle and tendon pain, chills, moderate headache, chest pressure and pain, trembling, fever of 99, fatigue, pronounced pain in arm and shoulders
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| 64 | 2021-01-31 | headache, fatigue, chills |
Approximately 24 hours after COVID 19 vaccine administered, started with headache, body aches and ch...
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Approximately 24 hours after COVID 19 vaccine administered, started with headache, body aches and chills and fatigue. Occasional nausea but no vomiting. Lasted from 1/29/21 to 2/1/21.
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| 64 | 2021-01-31 | lethargy, fever |
Fever spike 102.1, lethargy, refusal to eat, drink and take medication; sent to ER on 1/30/21; COV...
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Fever spike 102.1, lethargy, refusal to eat, drink and take medication; sent to ER on 1/30/21; COVID tested (negative) returned home same day.
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| 64 | 2021-01-31 | malaise, fever, headache |
Fever; Muscles started to ache; Headache; Nauseous; doesn't feel good; Arm is sore; This is a sponta...
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Fever; Muscles started to ache; Headache; Nauseous; doesn't feel good; Arm is sore; This is a spontaneous report from a contactable consumer reporting for herself. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were unknown), via an unspecified route of administration, on 11Jan2021, at a single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient reported that she received her COVID Vaccine on Monday afternoon 11Jan2021. The patient experienced events doesn't feel good and her arm is sore on an unspecified date in Jan2021. On 11Jan2021, after she got the shot, an hour after she started getting nauseous. On Tuesday, 12Jan2021, she experienced headache that went away the next day. On 13Jan2021, her muscles started to ache. That lasted on Wednesday (13Jan2021), Thursday (14Jan2021). On Friday (15Jan2021) afternoon, when she got home from work, she started running a fever and at the time of report she was still running a fever. She stated, "as of right now starting yesterday afternoon, I've got my fever, I don't feel good, I ache, my arm is sore but that's okay. It started Monday afternoon after I got the shot, an hour after I started getting nauseous that was Monday afternoon. Tuesday, I got headache that went away on Wednesday. On Wednesday my muscles started to ache. And that was Wednesday, Thursday and Friday afternoon when I got home from work, I started running a fever and I am still running a fever." When confirmed if the consumer wanted to report the same or looking for some information, consumer stated, "I want to report this and I just want information, what do I do? I test twice a week, rapid test and saliva test for COVID. And I have tested negative for months. And I tested negative before I got the vaccination, I tested on Thursday (14Jan2021), I am still negative. That was the rapid test." The patient took ibuprofen as a corrective treatment for the reported adverse events. Outcome of the event headache was recovered on 13Jan2021, outcome of fever was not recovered, while outcome of the other events was unknown. Information on the lot/batch number has been requested.
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| 64 | 2021-01-31 | fever, fatigue, headache |
Fever up to 101.8 before taking Tylenol at 2:30 pm on January 30, 2021. Fever started at 6:30 am tha...
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Fever up to 101.8 before taking Tylenol at 2:30 pm on January 30, 2021. Fever started at 6:30 am that morning. Intense fatigue and moderate headache. I had joint and body aches. I experienced lightheadedness when I got up when fever was 101.8 at 2:30 pm. I had to lay down again and apply a wet towel. Once I felt able to walk (about 10 minutes later) I ate a popsicle and then proceeded to take two 325 mg of Tylenol. Within 30 to 45 minutes fever subsided. I then ate soup, crackers and an orange and drank cranapple juice. I went back to bed and slept some more. I woke up at 5 pm and had a cup of soup, a quarter of an apple and gatorade. At 9 pm I took two more Tylenol to be safe and when to sleep. Sunday I was fine. My arm, never was swollen only a little sore.
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| 64 | 2021-01-31 | fever, headache |
Patient received 2nd COVID vaccine on 1.28.2021. Patient states she experienced fever, vomiting, he...
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Patient received 2nd COVID vaccine on 1.28.2021. Patient states she experienced fever, vomiting, headache, and body aches beginning a few hours after receiving the second vaccine. Patient states all side effects except for the fever have resolved as of this morning. Patient also reports that she began having hallucinations this morning (2/1). She says she is seeing spiders all over her home. Put the patient on hold and reached out to family practice staff. Patient states that hospice nurse is coming at 1:30pm today. I told the patient about informing her PCP due to the hallucinations. The patient does not voice any other complaints. Instructed the patient to seek emergency care for severe/concerning symptoms
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| 64 | 2021-01-31 | throat irritation |
Approx. 10 minutes after receiving vaccine, pt. reported an "itchy throat", following another 10 min...
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Approx. 10 minutes after receiving vaccine, pt. reported an "itchy throat", following another 10 minutes, approx. of "funny feeling in her throat". Then MD was paged in allergy, she talked with pt. and RN on speaker phone to assess patient. Two sets of vitals were taken, and pt. was administered another Zyrtec 10 mg. was given p.o. Pt. entire time was able to drink water and swallow. Pt. accompanied with a family member who can drive her home. Pt. stayed approx. 45 min, until all symptoms resolved. Other nurses in clinic made aware. MD instructed pt. that she would be contacted by allergy for further follow up prior to her second appointment for dose 2, and that patient was ok to come in for dose two. Pt. had epi pen with her at al times in her purse.
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| 64 | 2021-02-01 | body temperature increased, fever, chills | Day after vaccine developed fever, chills, body aches temp 100.2 F lasted for 4-5 hours. |
| 64 | 2021-02-01 | chills, fatigue, headache, fever |
Pfizer-BioNTech COVID-19 Vaccine EUA: Was perfectly fine for the first 10 hrs following injection. T...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Was perfectly fine for the first 10 hrs following injection. Then 11pm Sar night sudden intense pain at inj site spreading rapidly around back of neck and down other arm and up to head. Wracking chills for about 8 hours. Shaking uncontrollably, aches and pains, very weak, exhausted, nauseous. About 8 hours later, 7am Sunday, fever developed, eye pain with severe headache. In bed 30 hours. Monday morning felt much better but still fever @100 and weirdly dizzy. Ate and drank water. Today, almost 72 hours later fever gone, still very dizzy. Drinking water to see if that will help.
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| 64 | 2021-02-01 | headache, fever, chills |
Sore arm immediately after getting second dose of COVID Vaccine; Chills; Myalgia; severe headache; N...
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Sore arm immediately after getting second dose of COVID Vaccine; Chills; Myalgia; severe headache; Nausea; She felt like she had a temperature and by the time it was checked her temperature was 101.9/febrile; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at left upper arm on 07Jan2021 14:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, not a Military Facility. The patient's medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient got the Flu Vaccine last part of Sep2020 or Beginning of Oct2020. The patient received the first dose of BNT162B2 (lot number: EK57530), via an unspecified route of administration at left Upper arm on 17Dec2020 9:10AM for covid-19 immunization. She only had a sore arm. It started the same day, a couple of hours after getting the vaccine. It went away a day to a day and a half after it started. After that she was fine. She got the second dose on 07Jan2021. After the second dose, immediately, like within five minutes her arm became very sore, this event was assessed as non-serious by HCP. Also, that Thursday (07Jan2021) night after getting the second dose of the Vaccine around 9PM-10PM she started to get chills, myalgia, severe headache, and nausea. She also mentioned she was so sick during the night she was not able to get up and around. She felt like she had a temperature and by the time it was checked her temperature was 101.9. She was febrile all through 08Jan2021. She started to become afebrile 09Jan2021 with improvement and by 10Jan2021 all her symptoms had gone away and completely resolved. Seriousness Criteria: Stated she felt these are serious. She was unable to go to work on Friday. She could not return back to work until Monday. The HCP assessed all events were related to the vaccine. The outcome of the events was recovered on 10Jan2021. She stated, even though she got so sick with getting the vaccine she was just continuously telling her self this is better than having COVID. She stated she even told people even if she knew after getting the shot she would have this reaction she would still take it. She has seen death occur from COVID and does not want that to happen.; Sender's Comments: Based on plausible temporal relationship, clinical course and known safety profile of the product, the reported events chills, myalgia, severe headache, nausea and fever were likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 64 | 2021-02-01 | headache |
tingling in her legs and arms/ tingling in the feet; severe burning in her legs and arms; arm pain; ...
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tingling in her legs and arms/ tingling in the feet; severe burning in her legs and arms; arm pain; headache; myalgias; This is a spontaneous report from a contactable physician. A 64-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included mechanical valve, atrial fibrillation. No known allergies. There was concomitant medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On day 1-3 (13Jan2021), the patient had arm pain, headache, myalgias, then day 4 felt better and on day 5-7 (17Jan2021) developed tingling and severe burning in her legs and arms, that gradually improved to only included tingling in the feet at this date 7 day after injection. No treatment received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. Information on the lot/batch number has been requested.
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| 64 | 2021-02-01 | malaise, headache |
felt really sick; chest pain; bad headache; it spiked blood pressure the very first day/Her blood pr...
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felt really sick; chest pain; bad headache; it spiked blood pressure the very first day/Her blood pressure spiked the first day; This is a spontaneous report from contactable consumers (one is patient). A 64-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscularly on left arm on 28Dec2020 at single dose for COVID-19 prophylaxis. The patient medical history included: Chronic hypertension and elevated cholesterol levels. Concomitant medication included ongoing acetylsalicylic acid (BABY ASPIRIN) for chronic hypertension and elevated cholesterol levels, then developed GI problems and she skipped days. On 28Dec2020 she received the 1st dose of the Pfizer vaccine. She was scheduled for her 2nd dose on 22Jan2021 (Friday). The patient developed a bad headache on 28Dec2020 that evening was better by the next morning then came back, it spiked my blood pressure the very first day, it usually responded to the medication but this time it didn't. The patient's blood pressure stayed like that for 2 to 3 days, she felt really sick on unknown date, on the 3rd day on 31Dec2020 the patient had some chest pain, but later that day she was feeling back to normal. Right now she felt fine, her blood pressure was back to my normal, baseline. Weight 153-154 lbs. Reporter said that what concerned her most was that her blood pressure spiked. She said that has never happened in the past that with her blood pressure before. Her blood pressure did not respond to her medication. The patient was trying to research the high blood pressure and hadn't been able to find any information and want to know if there was any information can provide. The patient wanted to take the vaccine, she just wanted to be sure she would be okay. The outcome of event headache was not recovered. The outcome of events blood pressure increased and chest pain was recovered on unknown date. The event of rest event was unknown.
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| 64 | 2021-02-02 | chills |
Flushing 10 min after injection followed by heart palpitations then increased blood pressure. I too...
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Flushing 10 min after injection followed by heart palpitations then increased blood pressure. I took 2 loratidine tablets and symptoms slowly subsided over the next 50 min. The next day had chills and nausea for 8-10 hr. The nausea lasted another 3-4 days.
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| 64 | 2021-02-02 | cough, fever, nasal congestion, headache, fatigue |
Symptoms started at 5 PM on February 1, 2021 pain at the injection site then lead to severe headache...
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Symptoms started at 5 PM on February 1, 2021 pain at the injection site then lead to severe headache pain in the neck and shoulders tiredness Fever 100.5Nasal congestion and a dry cough
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| 64 | 2021-02-02 | fatigue, fever |
faintness; fevers 101.5. Day 3 102.7; myalgia; fatigue; tracheitis; Respiration 40; This is a sponta...
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faintness; fevers 101.5. Day 3 102.7; myalgia; fatigue; tracheitis; Respiration 40; This is a spontaneous report from a contactable physician (patient). A 64-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3426, expiration date: unknown), via an unspecified route of administration on the left arm on 16Jan2021 at 13:30 at a single dose for COVID-19 immunization. Medical history included cardiac hypertrophic cardiomyopathy. The patient has no known allergies. Concomitant medications were not reported. No other vaccine in four weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm on 24Dec2020 at the age of 64 years old, lot number: Ek9231. On 16Jan2021 at 11:00 PM, the patient experienced faintness, fevers at 101.5 and 102.7 (on day 3), myalgia, fatigue, tracheitis for 3.5 days- stopped around 4AM on Wednesday, and respiration rate of 40. The patient has no COVID prior vaccination and has not tested for COVID post vaccination. The patient underwent lab tests and procedures which included body temperature: 101.5 on 16Jan2021, heart rate (HR): 80 on 16Jan2021, respiration: 40 on 16Jan2021 and body temperature: 102.7 on 20Jan2021. No treatment was administered for the events. The patient recovered from the event tracheitis on 20Jan2021 at 04:00 while recovering from the rest of the events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Faint cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 64 | 2021-02-03 | fatigue, runny nose |
more tired; Weakness; increased heart rate; Diarrhea; soreness at the injection site; Runny nose; Th...
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more tired; Weakness; increased heart rate; Diarrhea; soreness at the injection site; Runny nose; This is a spontaneous report from a contactable Nurse (patient). A 64-year-old female patient received BNT162B2 (Pfizer BioNTech COVID-19 vaccine), intramuscularly on 15Jan2021 at single dose into the left arm for COVID-19 prophylaxis. Medical history included asthma; blood pressure abnormal (she takes blood pressure medication); palpitations at times; having mild chest discomfort, had experienced this before, that she was attributing to her wearing a mask, she wore 2-3 masks; stated that she had Covid once and she did not want it again. Concomitant medications included some blood pressure medication, and salbutamol (ALBUTEROL) inhaler periodically. Caller is a LPN nurse that was calling about the Covid-19 vaccine and reported that she received it Friday 15Jan2021 and just wanted to report some mild side effects. Caller clarified that she was more tired, had weakness, had diarrhea for 2 days, increased heart rate, and a runny nose, soreness at the injection site . She stated that she was not in a lot of distress. More tired started from 17Jan2021 and soreness at the injection site started from 16Jan2021. Weakness started from 17Jan2021: She stated that went home straight from work and went to the couch and slept about 6 hours. She had been up since 0300 and it was almost 1200 now. She stated that her energy level and weakness was pretty good right now. Diarrhea started from 16Jan2021: She said that she had the urgency to go and it was definitely soft and foul like when you had the flu. She stated that she has had it once since this morning. It was semisolid. Increased heart rate started from 17Jan2021: she felt palpitations at times. She said that she did not know if they were related, but stated that they were aggravating yesterday. She stated that she took blood pressure medication. She stated that she used a inhaler albuterol. She was using her inhaler periodically and said that it could be because of the albuterol inhaler. Runny nose started from 15Jan2021: Runny nose started about 8-10 hours after her injection. Stated that it was not bad, she would just have to blow her nose really good every so often. She said that she has not had to blow her nose today since she had been up. She said that the vaccine was sitting on the table and they just told her it was the Pfizer BioNTech vaccine. She did not have her vaccination card with her at the time of the call. The patient had recovered from weakness on 18Jan2021, recovered from increased heart rate and soreness at the injection site on 17Jan2021; she was recovering from more tired, runny nose, and she had not recovered from diarrhea. Reporter seriousness for increased heart rate, runny nose and soreness at the injection site was not serious. The reporter (nurse) considered the events more tired, weakness, diarrhea, runny nose and soreness at the injection site were related to bnt162b2, and relatedness of bnt162b2 to reaction increased heart rate was unknown. Information on the lot/ batch number has been requested.
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| 64 | 2021-02-03 | headache, fever, chills |
fever; chills; headache; extreme bodyaches; This is a spontaneous report from a contactable nurse re...
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fever; chills; headache; extreme bodyaches; This is a spontaneous report from a contactable nurse reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 19Jan2021 at 12:30 PM (at the age of 64 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included anemia, hemachromatosis, and penicillin allergy. The patient previously received the first dose of BNT162B2 on 29Dec2020 at 12:15 PM (at the age of 64 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Concomitant medication included epoetin alfa (PROCRIT) and deferasirox (JADENU). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 at 08:00 PM, the patient experienced fever, chills, headache, and extreme bodyaches. The patient did not receive any treatment for these events. The outcome of the events fever, chills, headache, and extreme bodyaches was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 64 | 2021-02-03 | paranasal sinus discomfort, chills, headache, fatigue |
Shortly after the vaccination I developed a really bad headache for the first 2 days. Stopped for a...
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Shortly after the vaccination I developed a really bad headache for the first 2 days. Stopped for a day and returned for another day and went away on its own. I had inside body chills, felt weak and tired and had a little sinus pressure but no fever which lasted for about 2 or 3 days. I took aspirin to help with the discomfort and today I still have just a little nagging headache that comes and goes but all other symptoms has since subsided. The injection site swole and developed a knot which stayed about a week and is still a little red.
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| 64 | 2021-02-04 | chills, headache, fatigue |
Headache; body aches; joint pain; chills; fatigue; This is a spontaneous report from a contactable n...
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Headache; body aches; joint pain; chills; fatigue; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el0142), via an unspecified route of administration on left arm on 20Jan2021 at single dose for Covid-19 immunization. The patient medical history was not reported. Concomitant medication included solifenacin succinate (VESICARE), dl-alpha tocopheryl acetate (VITAMIN E), omeprazole and Multivitamin. The patient previously received her firs dose of BNT162B2 at 11:00 AM on 02Jan2021 intramuscularly on left arm for Covid-19 immunization. The patient experienced headache, body aches, joint pain, chills and fatigue on 21Jan2021 05:00 AM. The events were reported as non-serious. The patient did not receive any treatment from events. The outcome of events was not recovered.
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| 64 | 2021-02-04 | chills, fever |
WAS TOLD THAT MY ARM WOULD BE MORE SORE AFTER THIS SECOND SHOT BECAUSE i CHOSE TO GET IT IN THE SAME...
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WAS TOLD THAT MY ARM WOULD BE MORE SORE AFTER THIS SECOND SHOT BECAUSE i CHOSE TO GET IT IN THE SAME ARM AS THE 1ST DOSE. WHILE I DIDNT FEEL THAT SORE IN MY SHOULDER on 2/3 THE FOLLOWING DAY AFTER A HIGH FEVER AND GENERAL/ALL OVER MUSCLE ACHE, CHILLS my left armpit began to hurt like I'd pinched or been punched in it, today my armpit is swollen with a knot under the skin and very sore to the touch and slightest movement (injection site is red and swollen with a knot in that area as well. *my son also received his second shot on same day & he is reporting to me the exact same issue.* icing the area is not helping.
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| 64 | 2021-02-04 | fatigue, headache |
Sore Injection site left arm (same arm as first one) thru the armpit, swelling in left arm, tirednes...
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Sore Injection site left arm (same arm as first one) thru the armpit, swelling in left arm, tiredness & fatigue, foggy brained, extreme body aches and pain, unable to walk from weakness, nausea, excruciating headaches, irregualar heartbeat, nausea. Reddness and swelling in arm for over 1wk. Nausea about 10 days.
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| 64 | 2021-02-04 | fatigue |
Pain in the arm of the injection; muscle pain; fatigue; This is a spontaneous report from a contacta...
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Pain in the arm of the injection; muscle pain; fatigue; This is a spontaneous report from a contactable nurse reporting for herself. A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3249), via an unspecified route of administration on the right arm on 22Jan2021 08:45 am at single dose for COVID-19 immunisation. Medical history included hyperthyroidism, BP elevation, hyperlipidaemia and allergies to chocolate, coconuts, pineapple, and red dye from an unknown date. Patient previously took codeine, statins, Diflucan, and experienced allergies. Concomitant medication included methimazole, dexlansoprazole (DEXILANT), amlodipine, ezetimibe (ZETIA), evolocumab (REPATHA) from unspecified date and indication. On 22Jan2021 at 08:45 pm, it was reported that the patient experienced pain in the arm of the injection, muscle pain, and fatigue. No treatment was received. The events were considered as non-serious and did not resulted in death, life threatening condition, prolonged hospitalization, disability, and congenital anomaly or birth defect. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since vaccination. No other vaccines were received within the last 4 weeks prior to receiving the COVID-19 vaccination. The patient was reported to be not pregnant at the time of vaccination. The outcome of the events were not recovered.
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| 64 | 2021-02-04 | headache, throat irritation |
20 mins. after injection itching of face and gradual body. approx. 1 hour throat itching, approx. 4 ...
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20 mins. after injection itching of face and gradual body. approx. 1 hour throat itching, approx. 4 hours mild headache, some rash only on neck and chest but within less than 8 hours full body rash, some milder aches but NEXT morning horrible pain all over like I had been thrown into my worst ever fibromyalgia flair. Complete muscle, joint, entire deep body. WORST i ever had. then a few welps and even though 90% was under the skin rash husband and I could feel the 10 % was red, small pimple like IF not the neck welps and then on the 4 day had a few hives on face only. Worst itching I have ever had and I have had chicken pox and antibiotic rashes. I think the problem has been came off of antibiotic and gradually got ok but can not get this out of system so easy of course. Today is 1 week. rash is better but not gone and itching is some better but still not good. I did not take benadryl or anything since I DO NOT want to interfere with me getting as much benefit from the injection since I now can not have number 2.
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| 64 | 2021-02-04 | headache | Nausea, vomiting , headache, body ache |
| 64 | 2021-02-04 | fever, chills | razor sharp pain at injection site delirious with fever chills whitening of skin lasting 5 hours |
| 64 | 2021-02-04 | fever, headache |
Head ache, nausea first day, second day diarrhea, fever, head ache and body aches. Third day injecti...
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Head ache, nausea first day, second day diarrhea, fever, head ache and body aches. Third day injection site red the size of a quarter, hot and sore to the touch and hard. Arm aches into shoulder.
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| 64 | 2021-02-05 | fatigue, headache |
I developed a headache, muscle aches and fatigue the day after the vaccine. The symptoms dissipated ...
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I developed a headache, muscle aches and fatigue the day after the vaccine. The symptoms dissipated after Motrin, but kept returning. I tested positive for Covid on 1/2/21.
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| 64 | 2021-02-05 | headache |
Dizzy Heart Palpitations Shortness of Breath Tingling of Lips & Tongue Swollen Face Head Pain Throa...
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Dizzy Heart Palpitations Shortness of Breath Tingling of Lips & Tongue Swollen Face Head Pain Throat Tightness
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| 64 | 2021-02-06 | fatigue, chills, headache | Chills, headache, extreme fatigue |
| 64 | 2021-02-06 | fatigue, cough |
I made a mistake my vaccine was jan 16th not 15th. That evening i was Very tired got a sore arm an...
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I made a mistake my vaccine was jan 16th not 15th. That evening i was Very tired got a sore arm and fever blister break out on my upper lip 10 hrs after vaccine. Next day Sharp pain in my right big toe joint on day 2, then day 3 burning and stinging pain above my left knee last 6 or 7 hours and also a very sharp pain between my toes like a splinter on the same side as knee pain. I Have felt tired and bad brain fog since vaccine, just have felt really off. Now i am scared to get the second dose. My father had a rare neurological disease after being exposed to chemicals in the army. I then got a cough and had some off color mucous for several days. I am thinking of waiting to get second does, please advise.
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| 64 | 2021-02-06 | fatigue, headache, malaise, fever, chills |
Injection site: Bright Redness 2 inches in diameter, hardness, moderate pain, itching ; malaise; nau...
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Injection site: Bright Redness 2 inches in diameter, hardness, moderate pain, itching ; malaise; nausea; vomiting x 1; headache; chills; low-grade fever; myalgia; fatigue
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| 64 | 2021-02-06 | headache |
Five days post first injection I woke up at 2am with a severe headache which lasted approximately 3 ...
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Five days post first injection I woke up at 2am with a severe headache which lasted approximately 3 hours. This happened for 4 nights the same way, then stopped for several days then reoccurred for several days then stopped. The night of the second injection (2/3/2021) I woke up with severe head pain which lasted approximately 5 hours. This happened again the next two nights. The third night was not a severe as the first two.
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| 64 | 2021-02-07 | chills, body temperature increased |
Arm started hurting about 6 hours later. That night she was restless. Temp was 100.7, Took Advil, te...
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Arm started hurting about 6 hours later. That night she was restless. Temp was 100.7, Took Advil, temp came down. The next day, she experienced chills, joint pain, body ache. The next day, still had symptoms but not as bad. She is getting back to normal but is still having some mild symptoms.
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| 64 | 2021-02-07 | chills, headache, lethargy, fever | Headache, chills, fever (102.4), joint pain, fatigue, slight lethargy, lasting 24 hours. |
| 64 | 2021-02-07 | fatigue, chills, headache |
shaking chills lasting 10 hours; severe frontal headache; nausea; intermittent dizziness; muscle pai...
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shaking chills lasting 10 hours; severe frontal headache; nausea; intermittent dizziness; muscle pain; joint pain; fatigue; This is a spontaneous report from a contactable nurse (patient herself). A 64-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), intramuscular (left arm), on 20Jan2021 09:00, at single dose, for covid-19 immunization. Medical history included allergies: penicillin, sulfa, environmental. Concomitant medications included levothyroxine; cetirizine hydrochloride (ZYRTEC ALLERGY); calcium; and colecalciferol (VIT D3). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), on 30Dec2020 16:00, intramuscular (left arm), for covid-19 immunization at 64-years-old. The patient experienced, "10-11 hr" post injection, on 20Jan2021 20:00 started shaking chills lasting 10 hours. The patient also experienced on 20Jan2021 20:00 severe frontal headache with nausea and intermittent dizziness, muscle pain, joint pain, and fatigue - which all resolved after about 24 hr after onset. No treatment was received for these adverse events. The patient recovered from all the events on 21Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination and have not been COVID tested post vaccination.
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| 64 | 2021-02-08 | fatigue |
Immediately following injection the patient developed paresthesia's of the lips. Six days later he d...
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Immediately following injection the patient developed paresthesia's of the lips. Six days later he developed symmetrical paresthesia's of the lower extremities that have progressed up the legs to the knees bilaterally. Additional symptoms include brain fog, fatigue and migraines with increasing frequency. Symptoms have continued to progress now one month later. No treatment. Pending neurology evaluation.
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| 64 | 2021-02-08 | headache, cough, sweating, throat clearing |
37 hours after Pfizer injection, experienced severe abdominal pain that caused me to have vasovagal...
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37 hours after Pfizer injection, experienced severe abdominal pain that caused me to have vasovagal syncope. Started sweating, and I lost my vision, then must have fallen on the floor. When I came to, felt very headachy and nauseous. went to urgent care - they ordered an abdominal scan for 2/8/21 but scan did not reveal the cause of the pain. 8 hours later on 2/5/21, started feeling asthma like symptoms. Throat felt tight, voice became hoarse, kept having to cough because airway was starting to feel thickened. went to ER, they took vitals and told me that i wasn't having an allergic reaction because my symptoms were outside the time frame for an allergic reaction. After 3 hours there, they sent me home. Next morning felt like I was having heart palpitations. that feeling eventually went away if I walked around. But the following two mornings, I had the same feeling.
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| 64 | 2021-02-08 | headache |
Immediate paresthesia's of the lips that last around 48 hours. Headache with onset at 24 hours follo...
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Immediate paresthesia's of the lips that last around 48 hours. Headache with onset at 24 hours following injection and lasting 3 days.
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| 64 | 2021-02-08 | pneumonia |
Client reported metallic taste in her mouth approx. 1 minute after receiving the vaccine. She said h...
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Client reported metallic taste in her mouth approx. 1 minute after receiving the vaccine. She said her trouble breathing was before the vaccine, not after. " I have trouble breathing because of my COPD and my back hurting". Client says she was diagnosed this week with pneumonia. She tried to take Trilogy but she couldn't tolerate it.
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| 64 | 2021-02-10 | headache, fatigue |
Left side of neck stiff with ache, left side of mouth (teeth) ached up to behind the ear. Headache,...
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Left side of neck stiff with ache, left side of mouth (teeth) ached up to behind the ear. Headache, body ache, fatigue, low energy, Ibuprofen 400 mg every 6 hours
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| 64 | 2021-02-14 | chills, sinus pain, nasal congestion, headache, fever, fatigue |
fast heartbeat, dizziness and weakness, excessive fatigue/tiredness, chills, joint and muscle pain, ...
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fast heartbeat, dizziness and weakness, excessive fatigue/tiredness, chills, joint and muscle pain, back of the neck/headaches and pain, disoriented, injection site swelling, tenderness, and hot to the touch, fever, sinus infection like symptoms ( stuffiness, difficulty breathing, ear pain, sinus/facial pain )
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| 64 | 2021-02-14 | headache, fatigue |
first 48 hours fatigue, nausea, headache Day #9 post vaccine rash on Left upper arm and upper chest ...
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first 48 hours fatigue, nausea, headache Day #9 post vaccine rash on Left upper arm and upper chest Day #18 rash on Right arm
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| 64 | 2021-02-14 | runny nose, cough | Runny nose, cough, and achy. No fever the day after vaccine. |
| 64 | 2021-02-15 | fatigue |
At 6:30 p.m. I began with palpitations of heart, lasted about 90 minutes. The palpitations were in...
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At 6:30 p.m. I began with palpitations of heart, lasted about 90 minutes. The palpitations were intermittent. The night and next day I had musculoskeletal pains, and tiredness. The primary thing I would like to report is that starting on Saturday, Feb. 13th around 8 pm, I began with a cold sore, or fever blister of upper lip. Over the course of the next 24-36 hours, I developed at least 4 more fever blisters. I am not prone to fever blisters, and have never in my life had more than one, infrequently. They are on upper and lower lip, and one is even immediately below my lip, on my skin that is not mouth mucosa. They are painful .
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| 64 | 2021-02-15 | headache, fever, chills | On 2/7 at 01:00, woke up with headache, chills, fever, nausea and increased arm pain. |
| 64 | 2021-02-15 | headache | swelling of mouth, light headache, |
| 64 | 2021-02-16 | cough |
Right after the vaccine was administered, started with a cough that did not improve for the next few...
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Right after the vaccine was administered, started with a cough that did not improve for the next few minutes. Needed respiratory therapy
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| 64 | 2021-02-16 | malaise |
I woke up 37 hours after first dose of vaccine with dizziness, which became dizziness. I began vomi...
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I woke up 37 hours after first dose of vaccine with dizziness, which became dizziness. I began vomiting within a couple hours. Around noontime I vomited twice more. I got worse, could not walk around. I felt extremely sick but felt better when I lay down in bed. I was not able to go to work, had to cancel the substitute teaching assignment I had taken. I did sleep some. No doctor called me back except my daughter texted with me. She is an intern, said she wished she could be with me. My neighbor brought some Pedialyte. This morning, the next day, I am still weak and nauseous, but it is less. At the end of the day yesterday, I did eat a little rice with carrots. And I just ate a little plain oatmeal with raisins and salt. I am praying the 2nd dose will not be worse, as my daughter warned, because I can't remember when I was so sick and incapacitated. Maybe a long time ago.
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| 64 | 2021-02-16 | pneumonia |
Patient developed pneumonia Admitted to hospital on 12/25. Determined to have pseudomonas bacteremia...
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Patient developed pneumonia Admitted to hospital on 12/25. Determined to have pseudomonas bacteremia and passed away on 12/27.
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| 64 | 2021-02-17 | throat irritation |
Swollen and blistered lips; Swollen and blistered lips; Itching inside my mouth and throat, and on m...
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Swollen and blistered lips; Swollen and blistered lips; Itching inside my mouth and throat, and on my hands and legs; Itching inside my mouth and throat, and on my hands and legs; Itching inside my mouth and throat, and on my hands and legs; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiration date was not reported) given at 64 years of age, via an unspecified route of administration in the left arm on 25Jan2021 14:30 at a single dose for COVID-19 immunisation. Medical history included known allergies. Concomitant medication included thyroid (ARMOUR THYROID), aluminium hydroxide gel, dried, magnesium carbonate (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]), and metronidazole. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was she tested for COVID-19 since the vaccination. It was reported that less than one hour after receiving the vaccine on 25Jan2021 at 04:00 PM, the patient developed itching inside her mouth and throat, and on her hands and legs. The itching stopped with BENADRYL. Four days later on 29Jan2021 14:30, she developed swollen and blistered lips. The outcome of the events was recovering and were reported non-serious. Treatment received for the events included steroid injection five days after the vaccine. The events resulted to doctor or other healthcare professional office/clinic visit then emergency room/department or urgent care.
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| 64 | 2021-02-18 | chills, fatigue, fever |
I had fatigue for a few hours, that night I had chills and a fever, it felt like my lymph nodes were...
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I had fatigue for a few hours, that night I had chills and a fever, it felt like my lymph nodes were swollen, by 10 am the next day all my symptoms were gone. I did not seek medical advice but my employer made me go take a covid test and a flu swab they were both negative
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| 64 | 2021-02-19 | cough, headache, throat irritation |
Within a few minutes of sitting in waiting zone, I had what I thought was severe heartburn. Simulta...
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Within a few minutes of sitting in waiting zone, I had what I thought was severe heartburn. Simultaneously I felt my heart racing and feeling flush. I raised my hand to alert attendant. Took pulse and it was very high. They called EMT. Upon connecting me to heart monitor is was erratic, Very high blood pressure. When they touched chest it hurt more. They said I was bright red. They transported me via residue to Hospital. Residual mild rash under skin for several days. Had severe headache for 14 hours.
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| 64 | 2021-02-19 | fatigue, headache |
extreme muscle pain (first 24 Hours) severe headache (first 24 Hours) Dull headache (Second and Thir...
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extreme muscle pain (first 24 Hours) severe headache (first 24 Hours) Dull headache (Second and Third day) Fatigue (every day) Nausea (first 24 Hours) Dizziness (every day) Took Tylenol on first day, later in the evening, and It really helped
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| 64 | 2021-02-21 | headache |
Patient complained of stiffness/right side; headache, dizziness after receiving first dose of Pfizer...
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Patient complained of stiffness/right side; headache, dizziness after receiving first dose of Pfizer; Comprehensive nursing assessment done including vital signs, pain, neurological status. Patient stated she had no difficulty swallowing. She was given water. Vital signs remained stable.
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| 64 | 2021-02-22 | fatigue, fever, chills | Fatigue, muscle aches, chills, fever, nausea, diahrea, vomiting |
| 64 | 2021-02-22 | headache |
I had my 2nd dose of covid vaccine on 1/15, around 5 pm. Next day when I got up about 7:20 I felt d...
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I had my 2nd dose of covid vaccine on 1/15, around 5 pm. Next day when I got up about 7:20 I felt dizzy nausea and wanted to vomit. Then I passed out, I fell down and hit my face on the floor. My family called 911 paramedica. They ,measured d my blood pressure and it was too low. The area around my right eyebrow was swollen and my neck hurt as precaution I went to the hospital. I suspect the incident and its symptom are side effects of the vaccine given the timing. Later on I had headache off and on and brain fog.
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| 64 | 2021-02-22 | fever, influenza like illness, fatigue |
vaccine 1/6, flu like symptons (achy, fever, tires) 1/7-1/8, low grade temp 1/9-1/10, felt fine 1/11...
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vaccine 1/6, flu like symptons (achy, fever, tires) 1/7-1/8, low grade temp 1/9-1/10, felt fine 1/11, achy, fever, tired 1/12-1/14, got covid test to double check, negative
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| 64 | 2021-02-23 | fatigue, headache | For 8 days: heavy fatigue, headache, For 3 days: rash For 5 days: nausea |
| 64 | 2021-02-23 | fatigue |
arm was very black and blue where the shot was administered and way around it/severe black and blue ...
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arm was very black and blue where the shot was administered and way around it/severe black and blue mark and bump like a golf ball on the arm where she got vaccinated; arm was very black and blue where the shot was administered and way around it/severe black and blue mark and bump like a golf ball on the arm where she got vaccinated; yeast infection from it; incredible arm pain/arm was really hurting bad; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), via an unspecified route of administration on 23Jan2021 at 12:00 at a single dose on the arm for COVID-19 immunization. The patient's medical history included high blood pressure. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that she was fine but on 23Jan2021 at 16:00, she experienced an incredible arm pain and fatigue. Her arm was really hurting bad. On 25Jan2021, the patient stated that her arm was very black and blue where the shot was administered and way around it. There was a severe black and blue mark and bump like a golf ball on the arm where she got vaccinated and had yeast infection from it. She never had this before since she never had a vaccine when she was a little kid. She wanted to know if they have heard about this before. She wanted to know if this was normal and if she needs go to the doctor. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient can't get appointment for second shot. The patient was not pregnant at the time of vaccination. The outcome of the events incredible arm pain and fatigue was recovering while the other events was not recovered.
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| 64 | 2021-02-23 | headache, fatigue | Headache 48 hours Fatigue 48 hours |
| 64 | 2021-02-23 | headache, malaise |
Psoriasis came back all over my body. Psoriasis on hands for the first time! Extreme burning on sk...
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Psoriasis came back all over my body. Psoriasis on hands for the first time! Extreme burning on skin lesions. Headache, weak, overall feeling sick. I had Covid over thanksgiving 2020. I still had antibodies when I got my Covid vaccine.
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| 64 | 2021-02-24 | influenza like illness, headache |
Pfizer Was the manufacturer 24 hours after receiving the vaccine, I started having headaches follow...
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Pfizer Was the manufacturer 24 hours after receiving the vaccine, I started having headaches followed by illness that remined me somewhat of getting the flu. Also, very tired and lack of appetite.
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| 64 | 2021-02-24 | throat irritation | Itchy throat, rash around the mouth. Patient cleared by EMS |
| 64 | 2021-02-25 | fatigue, throat pain |
Patient started having tingling in her lips 5 days after the injection, then she began having a sore...
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Patient started having tingling in her lips 5 days after the injection, then she began having a sore throat, she started having a hoarse voice and she felt very tired. 911 was called. In route they were transporting patient she was hypertensive had normal heart rate they gave her Benadryl 50 mg orally and then epinephrine 0.3 mg IM which did not help patient at all.
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| 64 | 2021-02-25 | fatigue | Normal arm soreness, very achy, tiredness |
| 64 | 2021-02-25 | fever | RASH, DYSPNEA, CHEST PAIN, FEVER JOINT PAIN, CHILLS, FEVER. TREATMENT: KENALOG, BENADRYL, PEPCID. |
| 64 | 2021-02-26 | head discomfort, throat clearing |
Face flushed, head felt full. Other than that nothing until we started home. Upper lip began to it...
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Face flushed, head felt full. Other than that nothing until we started home. Upper lip began to itch a little. A little itching around eyes. About an hour after, felt tightness in my throat and neck, glands felt swollen. Became slightly hoarse, had to clear my throat often. Felt a little like asthma attack. Have had similar reaction when eating seafood
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| 64 | 2021-02-27 | fatigue, headache, fever |
Site pain transferred to neck and down arm 2/25 6:00 pm lethargy; 7:00pm 2/25 8:30 low grade fever; ...
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Site pain transferred to neck and down arm 2/25 6:00 pm lethargy; 7:00pm 2/25 8:30 low grade fever; exhaustion 2/26 extreme fatigue; 2/27 extreme fatigue; nausea; diarrhea; headache
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| 64 | 2021-02-27 | fatigue, malaise, headache | TIRENESS, HEADACHES, NAUSEA, FELLING UNWELL, SOME ON AND OFF DIZZENESS. |
| 64 | 2021-02-28 | chills, fatigue, headache |
Chills; headache; muscle and joint pain; muscle and joint pain; tiredness; nausea; Like a mild flu; ...
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Chills; headache; muscle and joint pain; muscle and joint pain; tiredness; nausea; Like a mild flu; This is a spontaneous report from a contactable other healthcare professional (patient). A 64-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL 8982, expiry date: not reported), via an unspecified route of administration, on 26Jan2021 12:15 PM at a single dose on the right arm for COVID-19 immunization. The patient did not receive any other vaccine in four weeks prior to receiving bnt162b2. The patient was not pregnant. She was not diagnosed with covid prior to vaccination. Medical history included high bp (blood pressure) and type 2 diabetes. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EL 1284, expiry date: not reported), on 05Jan2021 10:30 AM on the right arm for COVID-19 immunization (at the age of 64-year-old). On 26Jan2021 04:30 PM, the patient experienced chills, headache, muscle and joint pain, tiredness, nausea; like a mild flu. No treatment was received for the events. Outcome of the events was recovering. The patient was not tested for covid post vaccination. No follow up attempts are possible. No further information is expected.
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| 64 | 2021-02-28 | headache, fatigue |
Headache; left arm is hurting from the shoulder; tired; Nauseous; injection site pain; This is a spo...
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Headache; left arm is hurting from the shoulder; tired; Nauseous; injection site pain; This is a spontaneous report from a contactable consumer (patient) and a contactable physician. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration at arm left on 09Feb2021 at 14:10 (at the age of 64 years) at single dose for COVID-19 immunization. Medical history included ongoing Crohn's disease, ongoing allergies, ongoing blood cholesterol abnormal. Concomitant medication included mesalamine (strength: 400 mg) oral at 400 mg twice daily for Crohn's disease, atorvastatin oral at 400 mg once a day for blood cholesterol abnormal, azathioprine oral at 50 mg twice daily for Crohn's disease, cetirizine oral at 10 mg for allergies, vitamin D at 1000 iU daily for supplementation, ketotifen fumarate (strength: 0.025 %) ophthalmic twice daily for allergies and ipratropium bromide (strength: 0.06%) nasal daily for allergies, all from an unknown date and ongoing. The patient experienced sore at the injection site on 09Feb2021, headache on the left side and her left arm was hurting from the shoulder down and she feels really tired and nauseous, all on 12Feb2021. The patient outcome of injection site pain was recovered on 09Feb2021; the outcome of the other events was not recovered. The information on the batch number has been requested.
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| 64 | 2021-02-28 | headache |
Moderate to severe pain in arm, shoulder, back started about one hour after shot. Lasted until next ...
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Moderate to severe pain in arm, shoulder, back started about one hour after shot. Lasted until next morning. No medication taken. Moderate headache lasting through next morning, general grumpiness for 2 days, brain fog beginning following morning - forgetfulness, depression. Still continued through today (Monday, March 1, 2021). Symptoms are not severe, but are acute enough that they are impacting quality of life.
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| 64 | 2021-02-28 | sweating |
Sweating, nausea, dizziness, aching joints. Effects seem to come in waves, sometimes feeling ok, an...
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Sweating, nausea, dizziness, aching joints. Effects seem to come in waves, sometimes feeling ok, and then completely down for a couple of hours, ending by day 3. Have been constipated for five days now, with no bowel movement since vaccine. I have had extreme insomnia since vaccine.
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| 64 | 2021-03-01 | headache, chills, fatigue |
About four hours after the innoculation, I began to get nauseous. Three hours after that, I had vom...
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About four hours after the innoculation, I began to get nauseous. Three hours after that, I had vomiting and diarreah that lasted most of the night. I had chills, aches and headache which tylenol helped relieve. I began to feel better 24 hours later but still experienced extreme fatigue. It is now Tuesday (vaccine on Sunday) and I am still fatigued and have trouble concentrating.
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| 64 | 2021-03-01 | lethargy |
Extreme edema at injection site, area about 4? x 6? Hot to the touch, itchy, red, still swollen afte...
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Extreme edema at injection site, area about 4? x 6? Hot to the touch, itchy, red, still swollen after 5 days. Overall itchy, but no rash. Thursday-Saturday diarrhea and lethargy Some intermittent vertigo. Rest, fluids, Tylenol and benedryl
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| 64 | 2021-03-01 | respiratory tract congestion | hives, congestion, swelling |
| 64 | 2021-03-02 | cough, nasal congestion |
12Jan was the first dose of the covid vaccine, 18Jan she had a positive covid test; Congestion; Coug...
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12Jan was the first dose of the covid vaccine, 18Jan she had a positive covid test; Congestion; Cough; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. A 64-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her right arm, via an unspecified route of administration on 12Jan2021 08:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient started to feel symptoms on 16Jan2021 09:00, which is cough and congestion. On 18Jan2021, she tested positive for COVID. She is scheduled for getting her second dose on 09Feb2021. She is calling to question if she should get the second dose since she was diagnosed with COVID. The outcome of the events was unknown.
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| 64 | 2021-03-02 | fatigue, headache |
mild headache; tiredness; bruised arm not at injection site; This is a spontaneous report from a con...
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mild headache; tiredness; bruised arm not at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 64 -year-old female (not pregnant at time of vaccination) patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Ek9231), via an unspecified route of administration (on the left arm) on 07Jan2021 14:30 (at the age of 64-years-old), single dose for COVID-19 immunization. Relevant medical history included Allergies, mvp, hbp, thalassemia all from an unknown date. The patient's concomitant medication was not reported. The patient experienced mild headache, tiredness and bruised arm not at injection site, all from an unknown date. The patient underwent lab tests and procedures which included sars-cov-2 test on 10Jan2020, 15May2020 and 01Oct2020, all negative. Patient has no other vaccine in four weeks. No covid prior to vaccination. No treatment received for the adverse events. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021143321 same reporter/patient/drug, different events separated with time
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| 64 | 2021-03-02 | fatigue |
very ill; very bad stomach issues; felt like someone was stabbing; couldn't eat/hadn't eaten for a c...
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very ill; very bad stomach issues; felt like someone was stabbing; couldn't eat/hadn't eaten for a couple of days; every time food reached her stomach, it was a horrible pain; fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3284, NDC number and expiration date were unknown), intramuscularly in the left arm on 25Jan2021 at 12:30 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the nursing home. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL0140, expiry date was unknown), on 04Jan2021 intramuscularly in the left arm for COVID-19 immunization. Relevant medical history included problems in blood pressure and sleep and restless leg syndrome; pain in legs; all from an unknown date and unknown if ongoing. Concomitant medications included amlodipine for blood pressure, gabapentin for restless leg syndrome; pain in legs, venlafaxine for antidepressant therapy, bupropion (also reported as the generic for Wellbutrin) for antidepressant therapy, and chlordiazepoxide to help sleep; all medications were ongoing. There were no additional vaccines administered on the same date of the Pfizer suspect. The patient had no prior vaccinations within 4 weeks. The patient worked at a nursing facility, but she was not a healthcare professional. After receiving the first vaccine, she felt great. The vaccine built her immunity up, which was good. With the second vaccine, she got very ill over it on an unspecified date. The patient was asking if there had been other people reporting side effects of the vaccine. The patient further reported that after she was given the second vaccine, they had a waiting time where she had to sit and wait about 15 minutes and it was fine. After work on an unspecified date, she had gone to pick up some groceries and it hit her like a ton of bricks. It was really, really bad. When she was given the vaccine, she asked the pharmacist from the time she was given the vaccine, if there would be any special time she would have symptoms or experience what would be going on. The pharmacist told her everyone was different, but that she would definitely know. The patient stated she had very bad stomach issues; it felt like someone was stabbing her on an unspecified date. She had no vomiting or diarrhea, but when she ate, it was horrible. She couldn't eat; every time food reached her stomach, it was a horrible pain. She also experienced some fatigue on an unspecified date. She got tired a lot. She had to call her employer and tell them that she wouldn't be coming in. This went on for a week. She still had some side effects, but its working its way out of her and she could tell. The patient stated she didn't believe her employer believed her. She had called and left messages and it went no where. She was afraid and she didn't want to lose her job. The patient stated that she really hadn't eaten for a couple of days at the time of the report. She asked one of the nurses where she worked if she should be drinking water and continue to try and eat and the nurse told her to drink as much water as she could and rest her body. The patient didn't believe her employer believed that this was actually happening to her. The patient was very upset that she could lose her job and she didn't know what to do or who else to call. The patient explained that mentally, she was feeling better, but her body hadn't caught up with her mind. The patient stated she needed any information to show that she spoke with Pfizer that she could give her employer. The adverse events (AEs) did not require any visit to an emergency room or the physician office. The patient had no investigation assessment and relevant tests. The outcome of all the events was unknown.
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| 64 | 2021-03-02 | fatigue |
Moderate anaphylactic reaction - according to doctor I consulted afterward. Throat swelled - diff...
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Moderate anaphylactic reaction - according to doctor I consulted afterward. Throat swelled - difficulty breathing and swallowing, weak, dizzy, rapid heart beat - started about 16-17 minutes after the vaccination. Lasted a little over 3 hours. Profound fatigue the next day.
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| 64 | 2021-03-02 | headache, fever |
sore arm; mild headache; slight fever; swollen painful axillary lymph nodes; swollen painful axillar...
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sore arm; mild headache; slight fever; swollen painful axillary lymph nodes; swollen painful axillary lymph nodes; This is a spontaneous report from a contactable healthcare professional. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) at the age of 64 years, via an unspecified route of administration on the left arm on 28Jan2021 14:30 at a single dose for COVID-19 immunization. Medical history included allergies, MVP (Mitral valve prolapse), HBP (High blood pressure) and thalassemia. The patient's concomitant medications were not reported. The patient is not pregnant. The patient previously received the first dose of BNT162B2 on 07Jan2021 (age at vaccination: 64 years), lot number: Ek9231 and experienced mild headache tiredness bruised arm not at injection site. On 29Jan2021, the patient experienced mild headache, slight fever and swollen painful axillary lymph nodes. The patient did not received treatment for the events. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date, COVID test: negative on 15May2020 and nasal swab: negative on 01Oct2020. The outcome of the events was not recovered.
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| 64 | 2021-03-02 | headache |
Patient taken to ED by EMS after COVID vaccine. Patient with SOB, dizziness, and HA after first COVI...
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Patient taken to ED by EMS after COVID vaccine. Patient with SOB, dizziness, and HA after first COVID vaccine.
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| 64 | 2021-03-03 | throat pain, malaise, headache |
skin is burning up, her arms, her face, her stomach, her back, and her chest are burning up/burning ...
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skin is burning up, her arms, her face, her stomach, her back, and her chest are burning up/burning skin has probably gotten worse; Nausea; no appetite; Headache; bad sore throat; felt sick since she got it; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: EL9262), via an unspecified route of administration on left arm (at the age of 64 years) on 24Jan2021 at single dose for covid-19 immunization. Medical history included type 2 diabetes (borderline about 15 years ago/started taking a medication a year ago for her high sugar numbers/had some blood tests, her A1C was normal, her diabetes was the same way it always has been); hypertension from 2012 (diagnosed about 9 years ago); sleep apnea from 2020 (uses a C-PAP machine/diagnosed approximately a year ago); Epstein Barr from 1995 (diagnosed when she was 39); high cholesterol (sometimes she didn't take her medication for that); cataract and cataract surgery in Jan2021 (had this last month/they used anesthesia/didn't know which type/had some eye drops for this). Concomitant medication included an unspecified high blood pressure medication (she thinks she tried a few times). The patient called about Pfizer COVID-19 vaccine and she had questions and side effects. She did get one shot, and was not due for her second for a couple weeks. The patient felt sick since she got it, some side effects have been less, some stayed the same or got worse. Her skin was burning up, her arms, her face, her stomach, her back, and her chest were burning up. She has done no treatment, because she didn't know what to do to treat it and it was difficult to be able to get in to see a doctor. The burning skin has probably gotten worse. She also had nausea and no appetite, though she has gotten a little better, it has been at least a full week or so. She had a headache and a bad sore throat also. She got home from getting the shot, probably maybe 5 or 6 hours after getting the shot. The patient's weight was 145-150lbs. The outcome of the event skin burning sensation was not recovered while for the remaining events was unknown.
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| 64 | 2021-03-03 | throat pain |
Tightness in left bicep (front—not where shot administered) and forearm and tingling in hand (left ...
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Tightness in left bicep (front—not where shot administered) and forearm and tingling in hand (left side where shot administered. Tightness has dissipated somewhat, but tingling in hand continues to be present Sore throat right after administration Extremely sore arm for 2 days after administration
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| 64 | 2021-03-04 | cough |
Residents was previously positive for Covid-19 on 6/17/20. She received both doses of the Pfizer va...
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Residents was previously positive for Covid-19 on 6/17/20. She received both doses of the Pfizer vaccine. She tested positive again for Covid-19 on 2/10/21.
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| 64 | 2021-03-04 | fatigue, chills |
I had severe COVID and was hospitalized on Dec 7, I was in hospital (non ICU setting) for 5 days an...
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I had severe COVID and was hospitalized on Dec 7, I was in hospital (non ICU setting) for 5 days and had O2, remdisiver and dethemethzone IV. I recovered fully, and have felt very good since mid January. My reaction after my 1st dose of vaccine on Feb 25 started 20 hours after shot. Worsened through the day and I got sicker at 24-36 hours, and then stayed in bed another day. Symptoms were identical to my bout with COVID: chills (no fever), nausea, aches in joints and muscles, fatigue. They were quite significant==I could not be out of bed. As it went along I also developed the feeling in my chest like COVID--tough to take deep breath, chest hurt---but my O2 readings were fine. Recovered after 48 hours, People who have had COVID should be aware that they will have a significant response to the vaccine on the 1st does. I am questioning having a second dose I have not reported this to my doctor
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| 64 | 2021-03-04 | fatigue |
Nausea, vomiting, pain under breastbone , tired unable to eat, has stayed in bed basically from the...
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Nausea, vomiting, pain under breastbone , tired unable to eat, has stayed in bed basically from the evening of 02/25/2021 through 03/05/2021.
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| 64 | 2021-03-04 | head discomfort |
At Approximately 1240, patient (Age 64) received her 2nd dose of Pfizer vaccine (Lot# 6200 Exp. 06/2...
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At Approximately 1240, patient (Age 64) received her 2nd dose of Pfizer vaccine (Lot# 6200 Exp. 06/2021). At approximately 1245, EMT was alerted by patient that she felt "difficulty breathing" and also feeling congested in the head. Pt reported she had no reaction to First dose. Patient remained A&Ox4. Vital Signs at 1252: HR 84, RR 22, BP 130/80. Vital signs at 1258: HR 76, RR 18, BP 124/76. At 1301, patient reported she feels better, patient was advised to stay longer. At 1306, Patient requested to leave because she felt better, patient then left with her son in a vehicle. Upon departure, Pt A&Ox4, pink in color, ambulating with steady gait, son drove vehicle. Pt verbalized understanding to call her doctor or 911 if she felt anything worsening.
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| 64 | 2021-03-06 | fatigue |
This 64 year old female experienced an adverse event. At baseline, she presented in a wheelchair. Wi...
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This 64 year old female experienced an adverse event. At baseline, she presented in a wheelchair. Within 5 minutes after vaccination, she complained of a racing heart, a new onset tremor of hands and head, and slurred/stuttering speech. She denied chest pain, shortness of breath or itching. No facial droop or one-sided weakness was observed. The patient had a history of hypertension and history of an adverse reaction to albuterol in November 2020. The patient described being nervous to get the vaccine due to her previous reaction to alberterol which had the similar effects as today's. The patient's new tremor worsened, and speech became more slurred and stuttered while we observed her. The patient denied any pain and described a similar event that caused her to be hospitalized for a week with no definitive diagnosis. Her primary care doctor had cleared her to get the vaccine. Her Vitals were as follows: BP 160/90. HR 65, RR 20. Heart sounds were regular with occasional PVC's. Lung sounds were clear No visible rash on neck, trunk or injection site. Capillary refill was normal. Mild edema in both lower extremities. No swelling of the lips. No visible droop in facial muscles. Patient was tearful and struggled to speak. She repeatedly said she was tired. She reported nausea. EMT was called and found similar vitals and O2 saturation at 100% on room air by pulse ox. O2 via nasal canula was begun. Rhythm strip showed NSR. Patient refused transport to the hospital for further evaluation. She was informed of a possible Transient Ischemic Attack (TIA) could be occurring which could need a blood thinner and further work up. Patient was tearful saying her previous hospitalization was traumatic and did not want to return. EMS offered her transport to another hospital facility via private vehicle, and she refused. We offered to contact her primary care doctor and she also refused. She was concerned about the cost of a hospital stay if she signed out AMA. EMS left the facility and offered to return if the patient changed her mind. The patient's symptoms had not resolved by 4:30pm. The patient's son, by phone, confirmed she would be monitored until 5pm. She was driven home by one of our staffers. The next day, the patient told our staffer that she felt well. She said it took about 7 hours for her speech to return. She said her head, stomach and body felt better in the morning. She said she going to see an allergist as her doctor recommended. Our presumed diagnosis was a TIA related to uncontrolled HTN with anxiety.
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| 64 | 2021-03-06 | head discomfort |
Patient received her first Pfizer vaccine today at 12:24pm .She was sent to observation feeling wel...
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Patient received her first Pfizer vaccine today at 12:24pm .She was sent to observation feeling well. About 10 to15 minutes later she began to complain to her son that her head felt "bloated", her eyes felt heavy and her head felt hot. The nurse removed the patient to the nurses station and took her vital signs, then notified the clinical lead PN. The patient Initial vital signs taken at 13:15 were BP 157/85 P 78 , O2 sat 99%,. R 18. Denies Shortness of breath, difficulty breathing or swallowing. No skin color changes noted. No rash or pruritis. Denies chest pain, pressure or palpitations. Consumed a bottle of water without difficulty. About 20 minutes after the vaccine was received she began to feel faint, but did not feel as though she was "going to pass out" . VS remained stable; BP 157/85/P78.O2sat 99% She continued to c/o head fullness, but now was reporting feeling chills, and flushing . Son administered an extra strength Tylenol at 13:10. Nurse acted as interpreter as well as her son. Paramedics were called initially at 12:56 and again at 13:21 Patient was able to get up and walk to the bathroom with attendants , voided under observation and return to her chair without complaints of instability or dizziness. Paramedics arrived at 13:45. Vs were noted to be 160/90 , pulse 75, O2sat 99% Patient continued to complain of head and eye fullness and vertigo( Paramedic looked like her was swaying). Patient appeared stable ,in no acute distress when she was escorted out of the building ambulance by paramedics at 13:55 to be taken to a Hospital for evaluation.
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| 64 | 2021-03-06 | sleepiness, fatigue |
Approximately 17 hours after vaccine, suddenly got very tired, brain fog, and had some type of sleep...
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Approximately 17 hours after vaccine, suddenly got very tired, brain fog, and had some type of sleep attacks, yet couldnt sleep, head just nodded up and down. felt very hot suddenly from the sides of the throat down straight and under both breast, felt as if I was being squeezed to death. chest felt very heavy. yet not gasping , or breathing fast. Im a respiratory therapist disabled now. I took bp was 120/80, o2 sat was 97, heart rate was 16, pulse 83. I could not lie down as felt as if being smothered. had to lie down but elevated very high. felt as if throat and chest were hot, but i did not get up to see if red, as i was having severe brain fog and oh so sleepy, yet felt so wired on friday evening March 5,2021 when I had the shot. I was awake, this tiredness and heaviness didnt happen until 1pm the next day. Saturday evening, I took o.1 ativan , thinking it was maybe anxiety as the brain for cleared after 3 hours, the chest heaviness got better, but still persisted over to sunday, march 7, but throat feeling closed in dissipated after 3 hours on saturday. 3/6. Sunday still unable to lie down as chest still felt heavy, bp 140/80 which was elevated. pulse elevated, respirations were 20. however all side effects seemed to be subsiding
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| 64 | 2021-03-07 | fatigue, headache |
I was okay until after arriving home at which time I developed and headache and exhaustion. I went s...
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I was okay until after arriving home at which time I developed and headache and exhaustion. I went straight to bed for 2 days with headache, stomach pain, couldn't eat or drink. I started to feel a little better but still was unable to eat and was fatigued. When I did try to eat I got terrible diarrhea almost immediately. Over the next few days, realizing this was probably not normal, I contacted the advice nurse at my provider and eventually talk to a doctor on Friday (March 5). That doctor thought it sounded like I contracted COVID. I had a test that day that came back the next day negative. I have an appointment to talk to my regular doctor on Wednesday (March 10), particularly to get advise about whether to get the 2nd dose on March 20. My blood pressure has been unusually low (as low as 85/58) but is now about 120/60. I did not have a fever. My breathing has been more labored than usual, but my oxygen level is at 97% and my pulse is around 65.
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| 64 | 2021-03-07 | fatigue |
Extreme anxiety. I felt like I was coming out of my skin. Extremely anxious. I had to walk outside s...
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Extreme anxiety. I felt like I was coming out of my skin. Extremely anxious. I had to walk outside several times. Felt very fatigued. Not nervous but as if I couldn?t stay in one place.
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| 64 | 2021-03-07 | headache, fatigue | Injection site very sore; Fatigued; headache; nausea |
| 64 | 2021-03-07 | malaise, fatigue, headache, chills |
My arm hurt so badly that I couldn't lift it or sleep tiredness headache chills joint pain feeling u...
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My arm hurt so badly that I couldn't lift it or sleep tiredness headache chills joint pain feeling unwell difficulty breathing a fast heartbeat weakness
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| 64 | 2021-03-07 | fever, headache, fatigue, chills |
Huge headache, high fever 103,and chills for two days then lowgrade for 36 hours, dizziness,severe m...
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Huge headache, high fever 103,and chills for two days then lowgrade for 36 hours, dizziness,severe muscle pains, extraordinary fatigue, diarrhea and nausea, swelling feet, weakness
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| 64 | 2021-03-07 | fever, headache |
Fever, headache, nauseous, diarrhea, body aches. took 800mg ibuprofen for fever, headache and body ...
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Fever, headache, nauseous, diarrhea, body aches. took 800mg ibuprofen for fever, headache and body aches. symptoms lasted about 30 hours.
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| 64 | 2021-03-07 | fever | Fever, weakness, nsusea, dizziness |
| 64 | 2021-03-08 | chills, fever | Severe muscle spasms (requiring a muscle relaxer); low grade fever (99.3) and chills. |
| 64 | 2021-03-08 | cough, respiratory tract congestion, fever |
The day after vaccine during the night I started coughing and feeling congested. Low grade fever and...
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The day after vaccine during the night I started coughing and feeling congested. Low grade fever and bas cough. Goopy eyes similar to pink eye and congestion and coughing. I did not go to work. I went to a clinic and they tested for Covid-19 the test was negative. Used compresses on the eyes and medication for cold like symptoms. The symptoms lasted an entire week. The cough hung around for three weeks after vaccine.
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| 64 | 2021-03-08 | headache, fever, chills | Low grade temp (98.8), chills and headache. The symptoms were gone the morning of 3/8 when I woke up |
| 64 | 2021-03-08 | headache | Pain in neck, base of scull, shoulder and back on right side one week later for 2 to three days. |
| 64 | 2021-03-08 | sweating, head discomfort, headache |
One and a half hours after the vaccine, I suddenly became very dizzy and had a hard time focusing. ...
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One and a half hours after the vaccine, I suddenly became very dizzy and had a hard time focusing. I was extremely happy that I was NOT driving. I could not think straight and had sweat pouring down my face. My head was very heavy and as the day progressed, my neck also became sore. I took Advil and later Tylenol and they helped the head ache but not the dizziness. I lost appetite. I consulted the reading material about the vaccine and all of my symptoms were normal side effects, so I did not seek medical assistance. My daughter is a doctor and wanted me to report for statistical reasons.
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| 64 | 2021-03-08 | fever, fatigue | Fever of 100 degrees, pain at injection site, fatigue, muscle aches, difficulty breathing |
| 64 | 2021-03-08 | fever | low grade fever, blotchy rash on neck and chest area |
| 64 | 2021-03-09 | fatigue, headache |
reports that she starting having a flutter in right side of chest ( a little catch) and then went aw...
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reports that she starting having a flutter in right side of chest ( a little catch) and then went away on the drive home from receiving vaccine. then 5 hours later her teeth and nose began to hurt. Fatigue, headache, nausea, continued pain in nose and teeth over the weekend. seen NP on Monday and was prescribed allergy meds and was told that this is symptoms of the vaccine. she reports today that the right side of her face is swollen and that she feels like there is a boil in her nose.
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| 64 | 2021-03-09 | headache | headache, diarrhea |
| 64 | 2021-03-09 | headache |
Very sore arm for 2 days. Headache started in the evening and had the next morning. Used cold wet ...
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Very sore arm for 2 days. Headache started in the evening and had the next morning. Used cold wet cloth at injection site and used the arm as suggested to relieve pain. Headache was a dull throb. Chose not to use Tylenol as I wanted to do nothing that might affect the efficacy of the vaccine. Just rested.
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| 64 | 2021-03-09 | headache |
pt. had a potential COVID exposure at work prior to getting the COVID vaccine, she is experiencing s...
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pt. had a potential COVID exposure at work prior to getting the COVID vaccine, she is experiencing symptoms of vomiting, headache, muscle aches. I recommend you get tested for COVID just to rule out whether you have COVID or not, if test comes back positive you would have to wait till the symptoms subside prior to getting your second dose.
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| 64 | 2021-03-09 | sweating, runny nose |
at 1420 pt reports having a runny nose, sweating, feeling hot and having sever lightheadedness. BP=...
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at 1420 pt reports having a runny nose, sweating, feeling hot and having sever lightheadedness. BP=127/85, P=83, T= 99, O2 sat 98%. Appears anxious. Stating "Oh my god. I can't believe I am having a reaction" multiple times. Fanning herself with her vaccine card frequently. Placed in front of a large fan by this RN. Pt states that the wind feels good. has stopped fanning herself. At 1430 reports mild lightheadedness, no sweating and reports she is ready to go . When this RN turned around pt was gone.
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| 64 | 2021-03-09 | fever |
Dizziness/light-headed, feeling like I was about to faint started morning after vaccine along with s...
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Dizziness/light-headed, feeling like I was about to faint started morning after vaccine along with severe neck pain. Possible intermittent fever. Dizziness continued for 2 days. Neck pain improved somewhat but is still bothering me, woke me up at night. Now a week later and my neck still hurts. I called my primary care office on March 3 and they said call 211. That made no sense so I asked again and they finally said I could see a nurse practitioner the next day. However I didn?t go because I couldn?t drive. I am a little worried about the second dose.
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| 64 | 2021-03-10 | chills, throat pain |
Patient is a 64 y.o. female admitted for acute DKA, glucose is 771 Severe ketoacidosis, bicarb is o...
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Patient is a 64 y.o. female admitted for acute DKA, glucose is 771 Severe ketoacidosis, bicarb is only 7 AKI, pseudohyponatremia K 5.3 LFT's ok Got the covid 19 vaccine 2 days ago She has sore throat and chills She did vomit up coffee ground material
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| 64 | 2021-03-10 | head discomfort |
first dose - sore arm about 12 hours after injection lasting for approx 2 days. second dose - pressu...
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first dose - sore arm about 12 hours after injection lasting for approx 2 days. second dose - pressure in top of head about 17 hours after injection dissipated after about 4 hours after taking tylenol. second dose - nausea starting about 17 hours after injection and lasting approximately 20 hours. second dose - sore arm about 12 hours after injection very similar to sore are when you get flu shot
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| 64 | 2021-03-10 | fever, fatigue |
Sore injection site, fatigue, low grade fever, sore armpit ( radiating to left breast ). Fatigue. A...
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Sore injection site, fatigue, low grade fever, sore armpit ( radiating to left breast ). Fatigue. And Temperature lasted approximately 24 hours. Pain in at injection site and armpit pain lasted 3 days.
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| 64 | 2021-03-10 | fever, headache | SEVERE HIVES, GANGLION CYST, FEVER, HEADACHE |
| 64 | 2021-03-11 | chills, fatigue, fever | Fever & chills, muscle aches all over body, fatigue (slept a lot). |
| 64 | 2021-03-11 | fatigue, malaise, headache |
Pfizer injection Jan 26, 2021 First symptoms 4-5 days after: "unsettled" feelings, disturbed sleep, ...
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Pfizer injection Jan 26, 2021 First symptoms 4-5 days after: "unsettled" feelings, disturbed sleep, general "dumpiness" ~9 days after: Tender joints in toes, leg pain and weakness, dry, irritated, blurry eyes, brain issues: dizzy, word retrieval issues, derealizing Feb 11: fatigue, muscle weakness and pain in legs Feg 12: headache, heavy feeling in chest, continuing leg pain and weakness. March 12 Pain in legs persists, but improved, brain issues improving, but not resolved, eyes still somewhat dry and blurry/strained
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| 64 | 2021-03-11 | headache |
64 yo female with hx bipolar disorder on multiple psych meds, Htn, here for same day visit. Pt repor...
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64 yo female with hx bipolar disorder on multiple psych meds, Htn, here for same day visit. Pt reports got her second covid vaccine on 3/92021 in the left arm, Pfizer. Yesterday (3/10/21) woke up with severe right knee pain, felt like she could not bear weight/ws going to fall. She went to son's apartment who is in same building and then went to lie down in bedroom. Because she drinks a lot of water, she had to get up to go to bathroom to urinate. She was about to sit down on toilet, when she felt both her legs go numb as well as her arms and her vision was blurred. She tried to grab the tub but fell forward on the floor. She states she urinated on the floor. She was on the floor for about 30 mins until her son got her up and back to bed. Later in the day she needed to urinate again and when she got up, she felt unsteady and fell on the bureau bruising the left arm. Since she feels a bit unsteady with gait and used a walker to come hre today. She denies feeling dizzy before her falls. She denies striking her head. She denies convulsions or hx of seizure disorder. She reports no new meds, only recent change an increase in her alprazolam dose. She does report a headache day after her vaccine.'She denies vomiting or diarrhea or antecedent illness. No longer has headache. She denies positional changes Of note she is on propranolol (prescribed by psych) as well as lisinopril-hydrochlorothiazide for HTN 64 yo female with bipolar disorder on multiple psych meds, htn on propranolol 20 mg bid and lisinopril-hydrochlorothiazide, s/p recent Pfizer covid vaccine, s/p presyncope episode after experiencing severe right knee pain and attempted micturition. Pt felt like her sight was affected and experienced numbness/weakness in legs and arms causing a fall. Did not hit head. The history is most suggestive of a vagovagal episode.
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| 64 | 2021-03-11 | headache |
Woke at 32hrs with severe pain in Rt hip joint and Rt knee joint. later in day rt leg was numb, unab...
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Woke at 32hrs with severe pain in Rt hip joint and Rt knee joint. later in day rt leg was numb, unable to bear weight, go up stairs without assist or sleep. Next day #3, severe pain in Rt hip, Rt knee and femur. Not responding to Motrin 800mg Q6-8hrs, Tylenol 1gm Q6-8 hours. Day #4 pain now radiating down rt leg through both joints and into Rt calf. Now Monday- called PCP, advised symptoms and would be starting perocets for 2 days of severe pain post vaccine. Also took ASA 325mg for blood clot risk know with virus even through pain was hip to ankle now (not ascending but descending) Percocet Q6hours without improvement but could sit and sleep with pain (dulled brain response to pain). Day #5- leg completely numb, pain now following sciatic nerve, stopped meds as no improvement and developed headaches, stomach aches and constipation from meds. Day#6 Pain severe in am, from hip to ankle- leg and heal of Rt foot numb. Today #7 pain on awaking, Rt hip all along sciatic nerve to foot which remains numb in heel.
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| 64 | 2021-03-11 | headache | 6 hours of Diarrhea, vomiting, flushing, headache, shaking. No fever |
| 64 | 2021-03-11 | sweating |
Patient received her first dose of the Pfizer COVID-19 vaccine and during the post-vaccination wait ...
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Patient received her first dose of the Pfizer COVID-19 vaccine and during the post-vaccination wait period she stated that she felt tingling, numbness and itching on the front part of her tongue. She has a history of allergies and is allergic to eggs, cats, pollen and Benadryl. During examination by the nurse, she stated that she felt ?sweaty? and her neck was itching. She however stated that she did not want the EMT called, but would wait and let us know if the symptoms were getting worse. She waited for half an hour and stated that she was feeling better and was ready to leave. She was asked to call ?911? if the symptoms returned and she voiced understanding.
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| 64 | 2021-03-11 | fever, chills, cough, headache, sweating |
Shortness of breath, chest pain. coughing, diffuse headache and some body aches, fever, chills, swea...
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Shortness of breath, chest pain. coughing, diffuse headache and some body aches, fever, chills, sweats. increased work of breathing, tachycardic, tachypnic,
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| 64 | 2021-03-12 | chills, headache, cough | Chills, headache muscle aches all over, coughing, nausea. |
| 64 | 2021-03-12 | fatigue, fever, headache |
Nausea, diarrhea, pounding headache, fever (101.6), extreme fatigue, sore joints, aches, loss of app...
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Nausea, diarrhea, pounding headache, fever (101.6), extreme fatigue, sore joints, aches, loss of appetite (3 days)....
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| 64 | 2021-03-12 | head discomfort |
When driving home following 15 minute wait period I felt my throat tighten, ears flush and heart rat...
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When driving home following 15 minute wait period I felt my throat tighten, ears flush and heart rate increasing. I immediately began to monitor my heart rate with my Watch. My resting heart rate is in the 60?s. At the time I looked at the watch my heart rate was already in the low 100?s but was rapidly escalating until in a matter of a few minutes had reached 140 bpm and my head began to have a full sensation and I was becoming very shaky. I pulled over into the parking lot of a restaurant and asked them to call 911. As they were talking with the dispatch my pulse started to decline so I cancelled the request. I stayed at the restaurant until friends to could come pick me up. By the time they arrived my pulse was in the low 100?s. I took 2 Benadryl. I monitored my BP through the night and it did not return to the 60?s until 1:00 am. I took (2) 25 mg Benadryl at approximately 4:00 pm, took another 2 at around 9:00 pm when my heart rate started to escalate and then a final 2 before going to bed at 1:00 am. My pulse dropped back into the 60?s while I was sleeping and stayed that way through the night. I woke up with no further symptoms nor side effects from the shot. The throat tightness and flushing of the ears resolved after the first dose of Benadryl. I had no adverse reactions or significant side effects from he first dose of Pfizer.
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| 64 | 2021-03-12 | headache, chills |
2-3 days prior to getting the vaccine, I was experiencing my typical Irritable Bowel symptoms (cramp...
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2-3 days prior to getting the vaccine, I was experiencing my typical Irritable Bowel symptoms (cramping while defecating ). Normally, if the cramping gets severe, I take one Hyosycamine Sulfate .0125 mg and the cramping stops within 10-15 minutes. The morning after the vaccine , starting at 6 am, I had severe cramping...took one Hyosycamine Sulfate pill and the severe cramping did not ease for 2.5 hours. I called my primary physician and she felt that this intensity/duration could have been connected to the vaccine. I was not producing any feces during this event, just severe episodic cramping. I also had the expected headache and chills. I felt stomach discomfort for the rest of the day. My doctor advised me taking the pill 3 times each day and two during an intense episode. I took one more pill at 2:45pm. I had another episode of severe cramping from 10:30-11:00pm , took two pills and then the cramping stopped and resolved in some diarrhea (two movements).
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| 64 | 2021-03-12 | headache | Bad headache, pain and muscle stiffness at injection site |
| 64 | 2021-03-12 | headache | Extreme headache, Burning Face and lips, Tingling hands |
| 64 | 2021-03-12 | fever, headache, chills |
12 hours after -- fever around 100 degrees F, chills, headache, body aches, nausea - cleared in a d...
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12 hours after -- fever around 100 degrees F, chills, headache, body aches, nausea - cleared in a day. Sore at site of shot. 6 days after - still sore at site, but now red, rash, intense itching, swollen, and swollen lymph nodes under arm at the site of shot. This continues 5 days later despite treating with Benadryl and Aleve and topically with hydrocortisone cream.
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| 64 | 2021-03-13 | fever, headache |
I had my second dose of the Pfizer vaccine on Tuesday at 4:30 pm. Wednesday morning, I woke up wi...
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I had my second dose of the Pfizer vaccine on Tuesday at 4:30 pm. Wednesday morning, I woke up with a moderate headache and some minor body aches. Those symptoms lasted throughout the day Around 5 pm, I developed at low grade fever ( up 2 degrees from my normal) which lasted 5-6 hours. My arm was mildly sore for 2 days. When I woke up on Thursday morning, I felt fine.
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| 64 | 2021-03-14 | fatigue, headache, chills | Soreness at injection site, chills, headache, nausea, tiredness |
| 64 | 2021-03-14 | fatigue, sweating, dehydration, fever, chills |
dehydration; slight fever (99); chills; passed out in floor; sweating; Broke a tooth; Dizzy; Diarrhe...
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dehydration; slight fever (99); chills; passed out in floor; sweating; Broke a tooth; Dizzy; Diarrhea; Super tired and went to bed by 8pm after COVID-19 vaccine; Arm was sore; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Feb2021 at 15:00, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. Patient did not have known allergies. Patient did not receive any other vaccine the same day and in four weeks. Patient did not have COVID-19 prior to vaccination. The patient experienced passed out in floor (medically significant) on 24Feb2021 at 10:30 PM, diarrhea (disability) on 24Feb2021, broke a tooth (medically significant) on 24Feb2021 at 10:30 PM, dehydration (disability) on 25Feb2021 12:00 AM, slight fever (99) (disability) on 25Feb2021 at 12:00 AM, chills (disability) on 24Feb2021 at 10:30 PM, super tired and went to bed by 08:00 PM after COVID-19 vaccine (non-serious) on 24Feb2021, arm was sore (non-serious) on 24Feb2021, sweating (non-serious) on 24Feb2021 at 10:30 PM, dizzy (non-serious) on 24Feb2021. No therapeutic measures were taken as a result of the events. Patient stated that all side effects resolved completely by 25Feb2021 evening, except for broke a tooth. Patient did not tested positive for COVID-19 post vaccination. The information on the Lot/Batch number has been requested.
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| 64 | 2021-03-14 | headache, chills |
The NEXT day: chills, headache, heavy nausea, dry cotton mouth, but couldn't drink. Dizzy. Couldn't...
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The NEXT day: chills, headache, heavy nausea, dry cotton mouth, but couldn't drink. Dizzy. Couldn't barely lift legs to walk. No bladder control. Hard to get to bathroom. Fell twice. Second time hitting head. Then, Difficulty breathing. And heart racing. (Please note: I did actually have Covid last summer from July through August).
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| 64 | 2021-03-14 | headache |
had flush feeling (much like injection during CT scan); Within hour my ears felt hot and turned brig...
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had flush feeling (much like injection during CT scan); Within hour my ears felt hot and turned bright red Subsided within hour.; Ate supper, Went to bed, upon waking in nite experienced imbalance; vertigo; Neck pain; headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female non-pregnant patient received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264, Solution for injection), via an unspecified route of administration in the left arm on 29Jan2021 (at the age of 64-years-old) as a single dose for COVID-19 vaccination. Medical history included CAD (coronary artery disease), Irregular heart rhythm, BPPV, degenerative disc disease, anxiety, ptsd (post-traumatic stress disorder), pre diabetic, Allergies to food, chemical and sensitivities and med and sensitivites. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. Concomitant medications were not reported. Upon receiving injection, on 30Jan2021, patient had flush feeling (much like injection during CT scan). Within hour her ears felt hot and turned bright red Subsided within hour. After supper, went to bed, upon waking in night experienced imbalance. Laying back down experieced vertigo (what she thought was a BPPV episode, a prior cond) but she couldnt figure out which side to treat, she performed maneuver. But did not resolve. She was remaining off balance and spinny even being upright with movement of head or eyes. Neck pain and headache residual nausea. About 12 hours after injection. Upside, her arm doesnt hurt. The patient did not receive any treatment for the events. No seriousness criteria was reported. The patient underwent lab tests and procedures which included computerised tomogram and results are unknown. The outcome of events was unknown.
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| 64 | 2021-03-14 | fever, fatigue, headache, chills |
Fever, chills, headache, extreme joint pain. Lasted six hours until I took Tylenol. I took Tylenol ...
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Fever, chills, headache, extreme joint pain. Lasted six hours until I took Tylenol. I took Tylenol every six hours for 24 hours, was very tired with body and joint aches.
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| 64 | 2021-03-14 | fever |
Thursday fever, diarrhea, nausea, body aches, Friday fever, headache, diarrhea, Saturday fever and d...
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Thursday fever, diarrhea, nausea, body aches, Friday fever, headache, diarrhea, Saturday fever and diarrhea, Sunday diarrhea
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| 64 | 2021-03-15 | body temperature increased, chills, fatigue |
Extreme chills (teeth chattering); low temp (100); fatigue, wheezing and couldn't move my body from ...
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Extreme chills (teeth chattering); low temp (100); fatigue, wheezing and couldn't move my body from my neck to the bottom of my back and "rice" sound in my ears when moved head.
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| 64 | 2021-03-15 | headache, pneumonia |
Admitted to hospital- Acute severe progressive hypoxic respiratory failure- intubated, trach placed,...
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Admitted to hospital- Acute severe progressive hypoxic respiratory failure- intubated, trach placed, COVID-19 pneumonia, Afib Patient treated at primary care office 01/13/2021 for respiratory illness (tested negative for COVID at this time), had vaccine 01/20/2021, developed headache and tested positive COVID-19 the following day 01/21/2021. Symptoms worsened with nausea and shortness of breath. Patient admitted 01/29/2021, condition progressed- intubated 02/07/2021, trach placed 02/25/2021.Discharged to specialty hospital 03/12/2021 for continued respiratory support and rehabilitation
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| 64 | 2021-03-15 | headache |
persistent headache; This is a spontaneous report from a contactable 64-year-old female consumer rep...
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persistent headache; This is a spontaneous report from a contactable 64-year-old female consumer reported that. A 64-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3Z47), via an unspecified route of administration in the left arm, on 11Feb2021 09:00 AM, SINGLE DOSE for covid-19 immunisation. Medical history was none. The patient's concomitant medications were unknown. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not received treatment. The patient was not pregnant at the time of vaccination. On Feb2021 at 6:00 PM, the patient experienced persistent headache. Outcome of the event was recovering.
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| 64 | 2021-03-15 | fever, fatigue |
Within hours mild mental fog and fatigue. Intense fatigue leading to bed rest last four days accompa...
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Within hours mild mental fog and fatigue. Intense fatigue leading to bed rest last four days accompanied by mild mental fog, myalgia, intermittent low grade fever and marked depressed mood. Severe left breast pain and left axilla pain on the third day severe enough to wake from sleep. Lasted about 48 hours.
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| 64 | 2021-03-15 | fever, headache | Beginning February 28, 2021 stroke, seizure, fever, headache and weakness. |
| 64 | 2021-03-15 | sneezing, fatigue |
ringing in ears (high pitched screech) within 1 hr of vaccine,( getting louder 1 day later), sneezi...
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ringing in ears (high pitched screech) within 1 hr of vaccine,( getting louder 1 day later), sneezing, fatigue started next day,
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| 64 | 2021-03-16 | chills | Redness, swelling, bruising at injection site, pain in armpit lymph glands, chills & body ache |
| 64 | 2021-03-16 | fatigue, malaise |
With in 5 minutes of the shot my chest and left arm pain and heart started to race,,face turned rash...
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With in 5 minutes of the shot my chest and left arm pain and heart started to race,,face turned rashy red and hot, had the shakes, nauseous dizzy and short of breath, blood pressure was high, with in hour my heart rate started to slow down, I took a Benadryl, felt ill. Tuesday started having diarrhea then around 11:30 pm had same reactions as Monday after shot was given. Took another Benadryl. Wednesday still bouts of diarrhea, tired,weak.nauseous.
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| 64 | 2021-03-16 | headache, fatigue, upper-airway cough syndrome |
EXTREME post-nasal drip event resulting in extended choking. Throat did not close, but it happened l...
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EXTREME post-nasal drip event resulting in extended choking. Throat did not close, but it happened less than 10 minutes post vaccine. On site staff was prepared with epi-pen, which I also had with me, but wasn?t needed. Only needed water and many tissues, and on site staff said it was not a reaction. But as it was so sudden, extreme, and immediately following the vaccine, Dr. at Clinic said he felt it was indeed a reaction. It cleared up in about an hour. Other side effects were mild (fatigue, head ache, achÃness, stomach ache) and were gone in two days.
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| 64 | 2021-03-17 | chills |
After leaving the parking lot of the church, I started to feel dizzy, having hotflashes, weak, and I...
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After leaving the parking lot of the church, I started to feel dizzy, having hotflashes, weak, and I was experiencing fast heartbeat. I pulled over the car, and then I was shacking. I opened the window to get some fresh air, and drunk water. I could not moved or do anything. I waited in my car for over 20 minutes hoping that I would feel better. I was still feeling weak and shacking. Finally a member of my family came to pick me up. and took me back to the church which was less than one mile. I explained the situation, they told me that they did not have a doctor on premise and to contact my primary care physician or to go to an emergency care facility. I started to shack less. So the member of my family took me back home and I just relaxed while I had chills for two hours.
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| 64 | 2021-03-17 | fatigue, chills, headache, fever |
Tiredness - couple of days; Headache - day; Chills - day; Fever - few hours; Nausea - few hours; Cou...
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Tiredness - couple of days; Headache - day; Chills - day; Fever - few hours; Nausea - few hours; Couldn't pee or have a bowel movement - few hours
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| 64 | 2021-03-17 | fatigue |
extreme fatigue since 3/9/21 Caller reports she received a call from someone from med center the day...
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extreme fatigue since 3/9/21 Caller reports she received a call from someone from med center the day she received her vaccine on 3/9/21 stating she had been given a "stronger dose" of vaccine and they called to see if she was feeling ok. She reports that day she felt tired, but no other sx. Today she still reports extreme fatigue 6 days post vaccination. Recommend caller contact PCP as fatigue maybe r/t something other than vaccine given hx of DM and HTN. Pt agreeable.
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| 64 | 2021-03-17 | head discomfort |
20 Minutes after I get the shots I have numbness on the right side of the face. The following day I...
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20 Minutes after I get the shots I have numbness on the right side of the face. The following day I have dropping on the right side of the face. 7 days later the symptoms came back worst and I was Advice by Doctor to go to ER to rule out stroke. I spend 2 days in the Hospital, every thing came back negative for stroke. I did follow up with my regular doctor and neurologist. I continue to have numbness in on the right side of my face and my tonged and pressure in my head. I register in V-safe but no one called me. I also try CDC but no results. I HAVE A 3,000 Hospital bill .
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| 64 | 2021-03-17 | headache | Patient had a headache post vaccination |
| 64 | 2021-03-17 | influenza like illness, chills |
Woke up with FLU LIKE symptoms the morning after the injection ( Chills, body ache, debilitated al...
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Woke up with FLU LIKE symptoms the morning after the injection ( Chills, body ache, debilitated all day long)
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| 64 | 2021-03-17 | fever |
Within 10 hours of receiving the first vaccine I had a robust reaction with a high fever that resolv...
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Within 10 hours of receiving the first vaccine I had a robust reaction with a high fever that resolved within 24 hours. On 3/12 /21 I got symptoms of Shingles. It was at the same site as a previous bout in 2019. It did not develop beyond pain and high fever and lasted 3-5 days. I got but one shingles blister at the site. I still have a very slight pain at the shingles site rated at 1/10 on pain scale. I suspect that the shingles reaction was triggered by the Covid shot. I am aware that if one searches the internet hard enough one will find the answer one seeks. Sure enough I found a newspaper article written by a dermatologist in LA that wondered if there is a link between Covid vaccine and shingles. He had treated 2 patients in a timeframe that suggested this link. There is no research available on this. I am a little concerned about getting the second Covid vaccine as it typically provokes a stronger immune system response than the first one. I believe that I had Covid-19 in July with typical symptoms but I tested negative. They say that the first Covid vaccine can cause a greater reaction if one has already had the Covid virus. I am hoping that this is the case and my second vaccine will provoke a milder reaction.
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| 64 | 2021-03-18 | chills, fever, fatigue |
For two days following the vaccine (March 6 & 7) I experienced severe body aches, fever, chills, fat...
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For two days following the vaccine (March 6 & 7) I experienced severe body aches, fever, chills, fatigue. Horrible shortness of breath began on the third day, March 8, and continued to worsen. For the next week my breathing became more and more labored with difficulty in functioning and needing to be in a reclining position in order to breathe. By the 10th day, o n March 15th I was hospitalized and subsequently had tests run on heart and lungs. My blood oxygen would drop to the low 80's if I took just a few steps. Today, on March 19th I am home and slowly improving but still needing to be mostly resting.
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| 64 | 2021-03-18 | chills, fever, headache, fatigue, cough |
extreme congestion; Loss of appetite; nausea; fever; chills; headache; fatigue; dry cough; injection...
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extreme congestion; Loss of appetite; nausea; fever; chills; headache; fatigue; dry cough; injection site pain; pain; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201, Expiry date: unknown), via an unspecified route of administration on 09Feb2021 at 03:00 PM (at the age of 64-year-old) on Left arm at single dose for covid-19 immunisation. The patient's medical history was not reported. Patient had unspecified other medications in two weeks. The patient previously took first dose of BNT162B2 (Lot number: EL9262) on 22Jan2021 at 02:30 PM on Left arm at single dose for covid-19 immunisation and had vancomycin and experienced drug allergy. The patient experienced Loss of appetite, nausea, fever, chills, headache, fatigue, dry cough, extreme congestion, pain at injection site and aches on 10Feb2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient was recovering from the events. No follow-up attempts are possible. No further information is expected.
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| 64 | 2021-03-18 | cough |
Experienced fullness in the chest that I initially attributed to bronchial or epigastric irritation,...
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Experienced fullness in the chest that I initially attributed to bronchial or epigastric irritation, then I realized I was having irregular heart beats and a feeling of 'heart irritation'. I have a stethoscope so I listed to my heart and was able to identify 4-10 irregularities / minute intermittently for the next 10 days. At times this was symptomatic with a feeling of irritation or congestion in my chest that would reduce with a cough. I am a runner and symptoms did not increase with exercise and when I started watching closely they decreased with walking , slow running or my weigh lifting. Symptoms are receding, on occasion, I feel an irritation in my chest but heart irregularities are subsiding.
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| 64 | 2021-03-18 | cough |
This was my second COVID vaccine. At 23.5 hours since the shot every joint in my body lit up and my...
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This was my second COVID vaccine. At 23.5 hours since the shot every joint in my body lit up and my whole body felt like dead weight. I started coughing as well. I left work, went straight home and was in bed by 5:00PM. I slept all night, got up @ 4:30 AM and went to work. I felt 100% better. Just my shoulders kind of ached and my back was achy but that has mostly subsided by 11:00 AM today.
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| 64 | 2021-03-18 | fatigue, chills, fever, headache |
Current: Severe pain and swelling in left armpit; feels as if it is cut open. Swelling is visible, a...
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Current: Severe pain and swelling in left armpit; feels as if it is cut open. Swelling is visible, and armpit is hard and hot to the touch. Yesterday (resolved): fever of 102, profound chills, skin was painful all over, mild headache and low backache, exhaustion.
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| 64 | 2021-03-18 | fatigue, chills, fever |
2:30 am uncontrollable shaking, chills, lasted 3 hours. All next day fever 102, body aches, fatigu...
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2:30 am uncontrollable shaking, chills, lasted 3 hours. All next day fever 102, body aches, fatigue, nausea, last 20 hours.
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| 64 | 2021-03-18 | fatigue | Joint pain and fatigue. |
| 64 | 2021-03-18 | headache, chills | Minor symptoms. Headache and chills |
| 64 | 2021-03-18 | headache, fatigue |
Reports to ED 2 days after first Pfizer vaccine with SOB, chest pain, headache, fatigue. Normal EKG ...
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Reports to ED 2 days after first Pfizer vaccine with SOB, chest pain, headache, fatigue. Normal EKG and troponin, normal D-dimer. Likely normal vaccine reaction. Discharged home in stable condition. 3 days later presents to PCP, still symptomatic and now with tingling all over body and slight numbness to right side of face and arm. No deficits, likely extended vaccine reaction.
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| 64 | 2021-03-18 | headache |
Flushed face, burning and tingling, tight. Started within 8 minutes of injection. 30 minutes later i...
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Flushed face, burning and tingling, tight. Started within 8 minutes of injection. 30 minutes later it spread to back of the neck and went up through the scalp at the back of the head to the crown of the head. Headache the whole time. Face returned to normal in 90 minutes. Scalp in 2 1/2 hours. Muscles aches starting in left arm, moved to left leg and then to right leg. Headache is persistent but mild 4 hours later.
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| 64 | 2021-03-18 | sweating |
Patient complained of feeling hot and diaphoretic and then complained of chest pain and some shortne...
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Patient complained of feeling hot and diaphoretic and then complained of chest pain and some shortness of air
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| 64 | 2021-03-18 | malaise, fever, headache, fatigue, chills |
Feeling unwell; All over upper body itchiness/she itches all over; Fatigue/feeling very tired/little...
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Feeling unwell; All over upper body itchiness/she itches all over; Fatigue/feeling very tired/little fatigue; Severe arm/injection site pain; Severe arm/injection site pain/very sore arm; Chills; Low grade fever; Headache; Lightheaded; Weakness/really weak; Itchy rash on chest/has a rash on her chest/little rash on my back; Nausea; Loss of appetite; She is flushed; tested positive for Covid and 6 days; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (Solution for injection, Batch/Lot: EL9265) in right arm via an unspecified route of administration on 08Feb2021 07:45 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included osteoporosis, Inappropriate sinus tachycardia, known allergies. Concomitant medication included estradiol benzoate (ESTRADIOL [ESTRADIOL BENZOATE]), calcium (CALCIUM), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), naproxen (NAPROXEN), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) all at once a day. The patient was not diagnosed with covid-19 before vaccination and covid was not tested post vaccination. The patient had the first vaccine on 08Feb (complete date not clarified), two days after that it had most of the side effects, with the one very sore arm, headache, fever chills, nausea, feeling very tired, about 6 days after that she tested positive for Covid and 6 days after the first vaccine. She tested positive for Covid so for the last couple of weeks. She had Covid, the fever broke about 5 to 6 days ago, she had a low grade fever after that, also the symptoms were gone now, there was little fatigue and little rash on back. She was scheduled to take second shot now and was trying to find in research about taking the second shot inspite of having covid. She cant find anything, most of the people never heard this and primary care physician said to go ahead and take the shot, but some people and some researchers said you should not, because she might have symptoms later and she should wait. The treatment was not received for the adverse events. Outcome of tested positive for Covid and 6 days was unknown and for other events it was recovering.
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| 64 | 2021-03-18 | throat pain |
Sore throat starting 2:00 pm the next day. Better at night with Tylenol then recurred 2nd day at no...
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Sore throat starting 2:00 pm the next day. Better at night with Tylenol then recurred 2nd day at noon.
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| 64 | 2021-03-18 | fever, fatigue, chills, headache |
Most severe headache ever Fever and chills Extreme fatigue Nausea and Vomitting 10xs Joint and muscl...
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Most severe headache ever Fever and chills Extreme fatigue Nausea and Vomitting 10xs Joint and muscle ache
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| 64 | 2021-03-18 | fever |
24 hours after second shot had fever of 100.8 and chills. I would consider mild symptoms which last...
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24 hours after second shot had fever of 100.8 and chills. I would consider mild symptoms which lasted about 6 hours.
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| 64 | 2021-03-18 | fever |
Pain on injection site with fever at night on the first day. Right arm pain has not subsided until n...
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Pain on injection site with fever at night on the first day. Right arm pain has not subsided until now (3/19/2021). I have ROM but there is a lingering muscular pain??? Pain with certain movement such as raising Right arm or swinging the right arm.
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| 64 | 2021-03-19 | chills |
Chills, body aches, redness in arms, shaking, some neurological issues appearing to be related to sh...
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Chills, body aches, redness in arms, shaking, some neurological issues appearing to be related to shock (shaking, rapid eye movements)
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| 64 | 2021-03-19 | cough |
Pt started coughing and having chest tightness about 10-15 min after receiving her vaccine. She des...
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Pt started coughing and having chest tightness about 10-15 min after receiving her vaccine. She described the incident as "like when my asthma acts up". Dr listened to her lungs and administered an albuterol nebulizer treatment. Her O2 sats were between 96-98 and her pulse was 70-80 during the entire incident. She did get relief from the treatment and was breathing better and not coughing after the treatment. She was evaluated by Dr and was allowed to go after 30min with instructions to call 911 if symptoms returned or worsened.
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| 64 | 2021-03-19 | fatigue |
Muscle soreness through the shoulders right to left. Occasional tightness through my eyes, fatigue. ...
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Muscle soreness through the shoulders right to left. Occasional tightness through my eyes, fatigue. Muscle soreness and fatigue lasted 2 days. The vision/ headache tightness was very subtle almost not worth mention.
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| 64 | 2021-03-19 | fatigue |
Almost immediately I felt a tightening on the back of my neck. It was familiar to me; I feel exactl...
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Almost immediately I felt a tightening on the back of my neck. It was familiar to me; I feel exactly that same symptom when I eat something with MSG. Within minutes I felt light headed and exhausted. I went to the pharmacist and he gave me Benadryl; I don't know the exact amount, but it was in the small cup that comes with different kinds of meds. It made no difference, so I had to call my husband to pick me up. I was very, very tired so I slept for the next 3 hours. I went back to bed 2 hours later and slept through the night. I was up the next day and by 11 am was very tired; I slept for 4 hours, then again through the night. By the next day, I felt normal.
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| 64 | 2021-03-19 | headache, fatigue | Dizzy, headache, weak, sore arm, sore muscles very tired |
| 64 | 2021-03-19 | headache, malaise |
I woke up on the second day after first dose (not the very next day) and my face was swollen and eye...
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I woke up on the second day after first dose (not the very next day) and my face was swollen and eyes swollen, Right eye swelling more prevalent. I itched all over at various times and took Benadryl for 3-4 days. I also had slight headache, nausea, malaise.
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| 64 | 2021-03-19 | headache |
About an hour after receiving the vaccine I started getting pins and needles in my face/jaw. About ...
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About an hour after receiving the vaccine I started getting pins and needles in my face/jaw. About 2 hours later my blood pressure was high - 150/90 (checked on a home monitoring machine) and then I started with heart palpitations which lasted throughout the night - did not sleep more than an hour or two. Next day around noon had diarrhea a few times - tired and weak. Slight headache for about 4 days. Nausea for about 3 or 4 days.
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| 64 | 2021-03-19 | headache | Severe headache and nausea |
| 64 | 2021-03-19 | fever, chills, fatigue |
2/18/2021 Developed fatigue, low grade fever and chills. 2/19/2021 Around 5:00PM noted new sudden on...
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2/18/2021 Developed fatigue, low grade fever and chills. 2/19/2021 Around 5:00PM noted new sudden onset of blurriness of vision on the left eye. 2/20/2021 Opthalmologist evaluation noted cataract like changes on posterior lens capsule of left eye; no treatment recommended.
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| 64 | 2021-03-19 | fever, headache, chills, fatigue |
Ten hours after the shot I experienced chills for over 2 hours, followed up with fever, headache, na...
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Ten hours after the shot I experienced chills for over 2 hours, followed up with fever, headache, nausea, extremely tired, no appetite. Felt pretty much back to normal the second day after the shot.
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| 64 | 2021-03-20 | chills, fatigue |
Pain at injection site Chills Achiness Fatigue Stomach discomfort About 4 hours after injection, g...
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Pain at injection site Chills Achiness Fatigue Stomach discomfort About 4 hours after injection, getting better the next evening, now feeling some fatigue. Slight pain at injection site. Took Tylenol.
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| 64 | 2021-03-20 | chills |
Chills; severe diarrhea; vomiting; nausea; dizziness; This is a spontaneous report from a contactabl...
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Chills; severe diarrhea; vomiting; nausea; dizziness; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (solution for injection, Lot number: EK9231), administered in left arm via an unspecified route of administration on 03Feb2021 at single dose for covid-19 immunisation. Medical history included High blood pressure, strabismus, known allergies Sulfa antibiotics, quinolone antibiotics. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. Historical vaccine included BNT162B2 First dose: lot EJ1686, expiry Mar2021, 0.3ml single dose by injection once to left arm for covid-19 immunisation. Concomitant medications included Atorvastatin 20mg, amlodipine-benazepril 2.5-10 taken for an unspecified indication. The patient experienced chills, severe diarrhea, vomiting, nausea, dizziness on 03Feb2021 23:00. The outcome of the events was recovering. Treatment received for the adverse events as nausea medication. Follow-up activities are completed. No further information is expected.
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| 64 | 2021-03-20 | fatigue, chills, headache, fever |
3/18/2021 9:00am Vaccine administered Around 2:00 pm Chills and stomach pain Around 3:00 pm 101.2 Fe...
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3/18/2021 9:00am Vaccine administered Around 2:00 pm Chills and stomach pain Around 3:00 pm 101.2 Fever, chills, worsening stomach pain, vomiting, light headed Around 5:00 pm went to ER on advisement of Doctors office While in ER experienced more vomiting, fever chill, stomach pain ER administered IV fluids, Tylenol, blood draw 10:00 pm Released from ER and went home 3/19/2021 No appetite, extreme fatigue, some dizziness, slight headache, chills in evening 3/20/2021 Very little appetite fatigued, some dizziness, backache Around 5 pm stomach pain which subsided an hour later, 6:00pm chills
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| 64 | 2021-03-20 | headache, chills |
Pain in arm could not lift above head. Severe chills. Was checking and teeth chatting. Headache for ...
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Pain in arm could not lift above head. Severe chills. Was checking and teeth chatting. Headache for two days straight.
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| 64 | 2021-03-20 | headache, fatigue, fever |
Fever 101.3 Migraine head pain Joint muscle aches Fatigue- 48 hrs Left arm still hurts at injection...
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Fever 101.3 Migraine head pain Joint muscle aches Fatigue- 48 hrs Left arm still hurts at injection site and there is a small lump
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| 64 | 2021-03-20 | nasal congestion, headache |
Headache and stuffy head night of vaccine. took Tylenol Next morning--Left armpit sore/tender--coul...
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Headache and stuffy head night of vaccine. took Tylenol Next morning--Left armpit sore/tender--could see swelling in armpit and feel lump. by evening could feel pain down into left breast. following morning--could see little "lumps"/swollen areas on left side of left breast. Armpit still swollen and sore
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| 64 | 2021-03-20 | throat irritation |
post injection: 8 minutes-heart pounding so strong I could hear it, continued for 5 or 6 minutes 8 m...
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post injection: 8 minutes-heart pounding so strong I could hear it, continued for 5 or 6 minutes 8 minutes-slight drop in blood pressure (I've gone as low as 32/18 during a bad reaction so I know this time was a much smaller drop) 13 minutes-stomach pains started, these would continue throughout the night waking me, and lasted approximately 17 hours 30 minutes- sudden feeling of lightness in my body, and that a light had gone on 60 minutes-odd sensations in throat but did not feel swelling, simultaneously at 60 minutes-dizzy the next day, 10 bowel movements until 2 pm
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| 64 | 2021-03-21 | chills, fever, headache | Fever. Chills. Nauseous, joint pain, headache Until approx 10 pm sunday night Ok on 3/22/21 |
| 64 | 2021-03-21 | chills |
Sore left arm, chills, monitored my blood pressure. I noticed elevations started to occur after the ...
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Sore left arm, chills, monitored my blood pressure. I noticed elevations started to occur after the second dose. I was on Lisinopril before my first dose vaccine my doctor changed my BP medication to Losartan. I was basically allergic to the Lisnopril medication. My doctor increased the dose of the Losartan.
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| 64 | 2021-03-21 | headache |
Bad headache; nausea; vomiting; This is a spontaneous report from a contactable consumer. A 64-year-...
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Bad headache; nausea; vomiting; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 17Feb2021 13:15 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes mellitus, asthma, and GERD. Concomitant medications included alprazolam; omeprazole; sitagliptin (JANUVIA [SITAGLIPTIN]); all taken for unspecified indications, start and stop dates were not reported. The patient previously took flagyl [metronidazole]: Known allergies: Flagyll. On 18Feb2021, the patient experienced bad headache, nausea, and vomiting. The patient did not receive treatment for the events. The outcome of the events was not recovered.
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| 64 | 2021-03-22 | fatigue |
I have fibromyalgia and follow the injection the nerves started firing like crazy. After they calmed...
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I have fibromyalgia and follow the injection the nerves started firing like crazy. After they calmed down I felt severely drained like post seizure? I was in bed with body aches everywhere I have been injured for 3 days.
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| 64 | 2021-03-22 | headache, chills |
dizzy; Then I passed out; Headache; Nausea; Arm soreness 2 hours after injection.; Chills for well o...
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dizzy; Then I passed out; Headache; Nausea; Arm soreness 2 hours after injection.; Chills for well over 12 hours; stomach pain; big bump on my head where I hit the tile floor; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the first dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 05Mar2021, 16:30 as a single dose for covid-19 immunisation. The patient's medical history included allergies to Sulfa based meds from an unknown date and unknown if ongoing. The patient had Covid prior to vaccination. Concomitant medications included cranberry; colecalciferol (D3), fish oil, and multi-vitamin taken for an unspecified indication, start and stop date were not reported. On 05Mar2021 at 18:30, the patient experienced headache, nausea, arm soreness 2 hours after injection. Chills for well over 12 hours. Most concerning, patient got up in the middle of the night. Used facilities. Washed hands, and was having stomach pain. Then she passed out. she came to, and have a big bump on her head where she hit the tile floor. Sunday Morning (07Mar2021) she was dizzy. Maybe from the bump on her head. The patient did not received treatment for the events. The outcome of the events was recovering at the time of the report. The has not tested positive for Covid-19 post vaccination.
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| 64 | 2021-03-22 | headache, fatigue, chills, fever | Covid symptoms - fever [highest 100.1], chills, headache, fatigue |
| 64 | 2021-03-22 | malaise | Blood pressure raised to 160/120, a feeling of unwell |
| 64 | 2021-03-22 | fever, chills, headache | 101.3 fever/teeth chattering chills/severe headaches/body pains |
| 64 | 2021-03-23 | fatigue |
Light headed, dizzy,neck pain, tiredness, blood pressure high, nausea Thought I was having a heart...
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Light headed, dizzy,neck pain, tiredness, blood pressure high, nausea Thought I was having a heart attack.
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| 64 | 2021-03-23 | headache, fatigue, chills | Chills nausea bad headache extreme fatigue aches pains |
| 64 | 2021-03-23 | headache |
First dose 3/2/21 chills and sore arm. Second dose 3/23/21 sore arm, achy muscles and joints, heada...
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First dose 3/2/21 chills and sore arm. Second dose 3/23/21 sore arm, achy muscles and joints, headache, hives Allergist Dr. recommended Allegra
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| 64 | 2021-03-23 | sweating, sleepiness, headache |
After 10 minutes of receiving shot I felt a cold surge in my left arm and felt lightheaded. I felt ...
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After 10 minutes of receiving shot I felt a cold surge in my left arm and felt lightheaded. I felt sweaty, weak and faint. The EMTs quickly came to my side and administered my blood pressure and oximeter. When I continued to feel lightheaded they took me to a back room and hooked me up to an EKG with electrodes throughout my body. They retook my blood pressure and told me that my blood pressure had risen to 180/90 earlier! After sitting for a while they took it again and read 160/80. They told me to get it checked again, asked if I need go to ER, Walk-in or doctor. They walked me out to my husband, who was waiting in car. I went home and slept for 11/2 hours. Took my blood pressure the next day 3 times and averaged in the low 120s.
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| 64 | 2021-03-23 | malaise, headache, fatigue |
After one hour develop severe headchage, extrimly tired, body and muscle pain,chills,feeling unwell,...
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After one hour develop severe headchage, extrimly tired, body and muscle pain,chills,feeling unwell,fast heartbeat,join pain
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| 64 | 2021-03-23 | malaise | covered in hives throughout the body besides face, hands, and feet. Feeling under the weather, |
| 64 | 2021-03-23 | malaise | Nausea, Overall body unwell, now a week later, a sore lump in armpit on vaccination arm. |
| 64 | 2021-03-23 | throat pain |
Aside from the soreness of the left arm where I was injected, the left side of my neck and esophagus...
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Aside from the soreness of the left arm where I was injected, the left side of my neck and esophagus is sore and I have numbness on the left side of my face. The numbness is on the left jaw, the cheek, the eye brow and forehead. It's itchy and tingly. It feels somewhat like when a part of the body is coming out of being asleep and it tingles. This is the second day of the numbness. I did not expect this reaction to this COVID-19 vaccination and I have never had such a reaction to vaccinations in the past. I read on the internet of people getting Bell's palsy from the COVID-19 shot and wondered if this is similar. With this reaction from the first COVID-19 shot, I'm concerned what my reaction might be if/when I have the 2nd vaccination.
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| 64 | 2021-03-23 | fever, chills, sweating |
Recieved second Pfizer injection (was Covid symptom free for 5 days) at 10 am. AT 3 am awoke with c...
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Recieved second Pfizer injection (was Covid symptom free for 5 days) at 10 am. AT 3 am awoke with chills and 102.5 fever, nausea and followed by sweats. This has continued thru 3/23/21, so far. On 3/23/21 fever maintained between 100 & 100.8. Still felt badly. Awoke this am 3/24/21, sweaty but no fever thus far. Feeling better.
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| 64 | 2021-03-23 | fever, headache, fatigue | headache, tiredness, low fever, muscle aches, injection site pain. |
| 64 | 2021-03-23 | sleepiness, headache, fatigue |
fatigue( 5 days- slept and did nothing but lay on the couch) , whole body muscle aches ( 2 days), l...
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fatigue( 5 days- slept and did nothing but lay on the couch) , whole body muscle aches ( 2 days), left arm itchy and red bumps(2 days put cold compresses on it) , very sleepy( slept on couch-3/4 days) , serve headaches (3 days- took Advil every 8 hours and drank 64 ounces of water daily)
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| 64 | 2021-03-23 | throat irritation |
Tingling in lower extremities (mostly below knee) bilaterally within first 5 minutes or so. Followe...
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Tingling in lower extremities (mostly below knee) bilaterally within first 5 minutes or so. Followed by tingling tip of tongue and portion of lower lip tingling. Itchy/tingly sensation back of throat on right with very slight hoarseness and slight chest tightness. Also noted some ectopy on my Kardia monitor--looked like PACs, but lots of interference in the reading. Symptoms not severe enough to use albuterol inhaler. By two hours, they had completely abated. Primary care doctor notified on 3/24/21 for counseling as to future immunization plan.
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| 64 | 2021-03-24 | chills, fatigue, malaise, headache |
tiredness; Headache; muscle pain; chills; joint pain; nausea; feeling unwell; This is a spontaneous ...
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tiredness; Headache; muscle pain; chills; joint pain; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 13Feb2021 at 14:00 (at the age of 64-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. Concomitant medications were not reported. The patient did not receive any other medications in two weeks. The patient did not receive other vaccines within 4 weeks prior to vaccination. On 13Feb2021 at 22:00, the patient experienced tiredness, headache, muscle pain, chills, joint pain, nausea, and feeling unwell. Therapeutic measures were not given for the events. The clinical outcome of the events tiredness, headache, muscle pain, chills, joint pain, nausea, and feeling unwell was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 64 | 2021-03-24 | chills, headache |
Chills then headache and extreme nausea. These all occurred beginning about 10 hours following my fi...
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Chills then headache and extreme nausea. These all occurred beginning about 10 hours following my first dose of Covid-19 vaccination.
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| 64 | 2021-03-24 | fatigue, fever, chills, malaise |
101.5 degree fever, chills, dizziness, tiredness, joint pain (L) leg, feeling unwell, swollen lymph ...
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101.5 degree fever, chills, dizziness, tiredness, joint pain (L) leg, feeling unwell, swollen lymph nodes (L) armpit Lasted 24 hrs Slept most of the time treated with Advil
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| 64 | 2021-03-24 | fatigue |
24 hours after receiving shot I experienced severe vomiting that occurred every 20 mins for the firs...
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24 hours after receiving shot I experienced severe vomiting that occurred every 20 mins for the first 12 hours..every hour for the 2nd 12 hours and every couple of hours for the third set of 12 hours for a total of 36 hours. Unable to hold down even a drink of water. I suffer from migraines and had one during a 3 day span from Sunday until Tuesday evening 9 pm. Now a full 4 days from the vaccine I still have nausea and extreme fatigue.
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| 64 | 2021-03-24 | fatigue |
Almost immediately after receiving the shot, I began having a metallic taste in my mouth. It lasted ...
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Almost immediately after receiving the shot, I began having a metallic taste in my mouth. It lasted about 4 hours. In addition, I experienced mild flushing (lasting about an hour) and extreme tiredness., which is still ongoing the day after.
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| 64 | 2021-03-24 | headache, fatigue |
Dizziness, disorientation, very bad headache on the top of my head, confusion, problems with concen...
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Dizziness, disorientation, very bad headache on the top of my head, confusion, problems with concentrating and comprehending, lightheaded, fatigue, sensitivity to light. I had a concussion 5-years ago from a car accident and recovered after one year. The symptoms of my concussion have returned within 30 minutes of receiving the Covid vaccine.
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| 64 | 2021-03-24 | headache, fatigue | Headache Tired Generalized joint pain |
| 64 | 2021-03-24 | fever, fatigue, chills | covid 19 Pfizer biontech chills/ fever/ aches/ exhaustion mar 24 exhaustion mar 25 |
| 64 | 2021-03-24 | sinus headache, sinus pain, chills |
On March 17, 2021 I got a really bad sinus headache and my sinuses began hurting. This headache is s...
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On March 17, 2021 I got a really bad sinus headache and my sinuses began hurting. This headache is still and issue. A few days later I got hot flashes at night and had disturbed sleep. The headache has at times caused ear ringing, but not all the time. March 23 I had chills at night. March 24th, I had chills all day. March 25 I still have the headache and my right arm hurts which is where I have lymphedema.
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| 64 | 2021-03-24 | throat irritation, cough | Itch in throat, cough, swelling in throat and body itching |
| 64 | 2021-03-25 | cough |
Patient began to feel dizzy 5 minutes after vaccination. !0 minutes later started coughing related t...
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Patient began to feel dizzy 5 minutes after vaccination. !0 minutes later started coughing related to acid reflux. VSS. Patient improved.
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| 64 | 2021-03-25 | fatigue |
Arm pain at injection site, Severe Nausea with vomiting and diaherrea, mild shortness of breath, ext...
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Arm pain at injection site, Severe Nausea with vomiting and diaherrea, mild shortness of breath, extreme fatigue
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| 64 | 2021-03-25 | headache | Tachycardia body was on fire high bp shaking Nausea feeling of impending doom headache |
| 64 | 2021-03-25 | headache |
Patient states that about 12 hours following her 1st dose of this vaccine she began to experience si...
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Patient states that about 12 hours following her 1st dose of this vaccine she began to experience side effects including nausea, diarrhea, vomiting, and a headache. Patient states that these effects lasted throughout most of the following day and then began to dissipate .
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| 64 | 2021-03-25 | headache |
Patient had a really bad headache first and thought she was going to pass out several times for a fe...
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Patient had a really bad headache first and thought she was going to pass out several times for a few days after the dose. It also made patient wheeze for 3-4 days, and then starting the second week until now her blood pressure is continuing to be out of control even after her doctor doubled her dose of bp meds.
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| 64 | 2021-03-25 | malaise |
Felt fine for about 6 minutes after receiving vaccine. Then started feeling sick and got worse quic...
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Felt fine for about 6 minutes after receiving vaccine. Then started feeling sick and got worse quickly. Told nurse felt bad and also pulse was fast. When nurse took my pulse it was 100. Regularly my pulse is around 60. She then took my blood pressure and it was 179/? My B/P is normally 106/65. The nurse said my color was bad. Gradually over an hours time started feeling better and went home. Next day I felt malaise and tylenol helped. Today I am a bit weak but better. That was my 1st shot
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| 64 | 2021-03-26 | chills, fatigue, fever, headache |
Pfizer-BioNTech COVID-19 Vaccine EUA. Chills and low grade fever about 11 hrs after being vacci...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Chills and low grade fever about 11 hrs after being vaccinated and the worse body aches I have ever had and tiredness and a splitting headache. Took some tylenol when I finally got out of bed at about 11:30 a.m. on the 24th, then at around 4:00 p.m. the same day, I started getting chills again, headache and ran 102.6 fever for about 2 hours, then fever gradually went down and was gone by 10:00 p.m. on 24th. The actual body aches finally started to diminish at the same time.
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| 64 | 2021-03-26 | cough, fever |
Very sore arm , more than any other vaccine I have ever received. It has been improving less than 24...
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Very sore arm , more than any other vaccine I have ever received. It has been improving less than 24 hour later. I woke with a fever (my feet were especially warm) Body aches, especially my joints. Mild cough I have taken ibuprofen and acetaminophen, which help. This was my second Pfizer dose. Other than a mildly sore arm, I had no issues with the first dose
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| 64 | 2021-03-26 | sweating, sluggishness, fatigue |
6 days after 1st shot - woke up to severe veritgo (spinning) ,, dizzy,sweating , nauseous, lasted 2 ...
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6 days after 1st shot - woke up to severe veritgo (spinning) ,, dizzy,sweating , nauseous, lasted 2 1/2 full days . tingling of hairline and under the eyes, eyes were blurry for two days, starting getting heart palpatations, and blood pressure high and resting heart rate low and other times blood pressure was real low and resting heart rate as high as 125 even at rest not due to exercise... this continued with the heart irregularaties for abour two weeks. . i experienced unusal forgetfulness and couldnt recall things I knew .. i had mild fatigue... 3 weeks later Im about 90 percent but a little sluggish. finally was able to do yoga(bending over ) weights,,walking,etc.
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| 64 | 2021-03-26 | sweating | Onset of weakness, dizziness, blurred vision, sweating, harder to breathe |
| 64 | 2021-03-27 | chills, fever | Violent trembling from chills (3 hours), high fever (16 hours), diarrhea, vertigo, migraine |
| 64 | 2021-03-27 | headache, fatigue |
Felt no systems on the first shot, on the second shot on 3/24 I felt dizzy and nausea when first out...
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Felt no systems on the first shot, on the second shot on 3/24 I felt dizzy and nausea when first out of bed the following day, went back to bed for 2 hours, got up had coffee and toast, back to bed for another 2 hours, felt better but head ache and muscle aches over entire body, and fatigue. Had better strength at times through out day. Went to bed and woke up Friday and felt fine.
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| 64 | 2021-03-27 | headache, fever, chills | Vomiting, cramps, Fever 101.2, Chills, headache still experiencing |
| 64 | 2021-03-27 | headache | 24 hours after vaccine. Started vomiting for 5 hours, headache |
| 64 | 2021-03-27 | malaise |
Within 15 minutes of receiving the shot, I became extremely dizzy and lightheaded. I also had tingli...
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Within 15 minutes of receiving the shot, I became extremely dizzy and lightheaded. I also had tingling and pain in the other arm from the wrist up to my neck. The medics took me into a room to lie down for 30 minutes and it seemed to pass. I have felt off and foggy for the past 3 weeks. And now for the past 3 days, I have been feeling the same feeling of lightheadedness and dizziness that I had after the shot throughout every day. I am sure this is related to the vaccine. I never had anything like this in my life. I did not take the second shot and still feel awful. I have spoken to people who had the same immediate allergic reaction.
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| 64 | 2021-03-28 | headache, chills |
I seem to be getting a new addition every day. Day 1 sore arm and chills Day2 neuralgia - on right h...
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I seem to be getting a new addition every day. Day 1 sore arm and chills Day2 neuralgia - on right headache, jaw pain, numbness in eye and ear and face. Heavy,wheezines in right lung. A total of 6 Tylenol eased pain. Day 3. Tremors. Body feels as if it's vibrating inside. Ongoing
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| 64 | 2021-03-30 | cough, chills |
Chills; Vomiting; Diarrhea; shakes; Shortness of breath; Coughing; respiratory distress; This is a s...
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Chills; Vomiting; Diarrhea; shakes; Shortness of breath; Coughing; respiratory distress; This is a spontaneous report from a contactable retired nurse. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EN6198; expiration date: unknown), at vaccination age 64-year-old via an unspecified route of administration in the right arm on 13Mar2021 09:30 as a single dose for covid-19 immunisation. The patient medical history was none. There were no concomitant medications. The patient reported that she had side effects after getting her first dose of the Pfizer COVID-19 vaccine Saturday morning (13Mar2021) at 09:30am. She mentioned that she developed side effects Monday (15Mar2021) night that she also had all day Tuesday (16Mar2021), it was pretty significant. She mentioned that she is concerned about getting the second dose, and she is thinking that she is not going to get that after having her first dose. She stated that her side effects lasted all night Monday night, she had shortness of breath and coughing. She added that on Tuesday morning she started having chills, shakes, throwing up or vomiting, and having massive diarrhea all day long. She also mentioned that she thought it was serious, and she was going to have to go to the hospital soon. She wasn't going to have a choice if it hadn't gotten better. She reported that all her side effects are better, and that for treatment, she took some Delsym cough medicine and diarrhea medicine, Imodium, she thinks it was called. She says she took one dose of the cough medicine yesterday morning, and she has taken 3 doses of Imodium today. She wondered if she should take the second shot or if she would get the same symptoms again. She says she is hesitant to take second one because she doesn't want respiratory distress again (Mar2021), it was horrible, and she has never had massive diarrhea before to where she couldn't get to the bathroom, it was the worst thing she has went through. The outcome of the events was recovering.; Sender's Comments: The contributory role of the suspect productbnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EN6198; expiration date: unknown), to reported events is possible.
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| 64 | 2021-03-30 | malaise |
she found out later it was an allergic reaction to the vaccine; blotches/rash all over right side of...
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she found out later it was an allergic reaction to the vaccine; blotches/rash all over right side of face; She had pain, but she didn't feel that it will kill her, it was sort of burns where the red spots/blotches are.; swelling of the face; throat was a little swollen but not bad; little bit of weakness; didn't feel all that great; She isn't sure if she had muscle pain or joint pain, she may have had a little bit of that.; She isn't sure if she had muscle pain or joint pain, she may have had a little bit of that.; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 10Mar2021 (Lot Number: EN6208) (at the age of 64-year-old) as single dose for COVID-19 immunisation. The patient medical history included hearing problem from an unknown date and ongoing. Concomitant medications were not reported. On Mar2021, the patient reported that she started getting blotches all over her face, clarified on the right side of her face, she found out later it was an allergic reaction to the vaccine. 2 days later, she had a few blotches on the left side of her face. She clarifies the blotches have not gone away completely. She had pain, but she didn't feel that it will kill her, it was sort of burns where the red spots/blotches were. The symptoms that she had were swelling of the face, her throat was a little swollen but not bad. She had a rash on her face. She had a little bit of weakness. She didn't feel all that great. She wasn't sure if she had muscle pain or joint pain, she may have had a little bit of that. Therapeutic measures were taken as a result of the events and included treatment with NEOSPORIN (formulation: cream, Lot: 164012, Expiry date: May2022) and BENADRYL (formulation: cream, Lot: 3290LZ, Expiry date: Oct2022) and she mentioned she also took BENADRYL tablets. The patient outcome of the events was unknown.
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| 64 | 2021-03-30 | fever |
fever; she couldn't walk good; muscle aches; This is a spontaneous report from a contactable consume...
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fever; she couldn't walk good; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201, expiry date: Jun2021), in left arm, shoulder area, on 09Mar2021 at 13:30 (at the age of 64-years-old) at single dose for COVID-19 immunization. Medical history included multiple sclerosis (MS), cervical myelopathy, and arthritis that was bone on bone in her right hip. No COVID prior vaccination and no COVID tested post vaccination. The patient had no known allergies. Family medical history relevant to AEs was reported as no. No history of all previous immunization with the Pfizer vaccine considered as suspect. Concomitant medications included ongoing duloxetine hydrochloride (CYMBALTA), ongoing baclofen, ongoing calcium, ongoing multivitamins (vitamins NOS), ongoing tamsulosin hydrochloride (FLOMAX), ongoing ergocalciferol (VITAMIN D), vitamin D3, diclofenac sodium (VOLTAREN). No additional vaccines administered on same date of the Pfizer suspect, no prior vaccinations (within 4 weeks). The patient reported fever post vaccination. She was told by a nurse to not take MOTRIN but TYLENOL 24 hours after receiving the vaccine. The patient got the vaccine on 09Mar2021 and was told she could not take her MOTRIN. She had multiple sclerosis, cervical myelopathy, and arthritis that was bone on bone in her right hip. She told not to take pain relievers for 24 hours after the shot as it would cause something to happen with the vaccine. Patient explained that when someone had all these different things, it was hard to be told that they could not take medications. After the vaccine, she could not walk good and had a fever. The fever and the other events started on 10Mar2021, about 3am. She could not walk well at 3am in the morning when she got up. When a person had multiple sclerosis, whenever anything happened it took out their legs. It was also noted that she had muscle aches after the shot on 10Mar2021 at 3 am, all of that too. This was getting better. The patient was told she could take TYLENOL and relayed she did take a couple TYLENOL for the fever. The events did not require a visit to emergency room or to physician office. Relevant tests were reported as no. No treatment was administered for muscle ache and walking difficulty. The patient was recovering from the events.
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| 64 | 2021-03-31 | fatigue |
At work suddenly became dizzy drunk feeling with I went on FLMA. nausea. Unsteady on my feet. felt a...
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At work suddenly became dizzy drunk feeling with I went on FLMA. nausea. Unsteady on my feet. felt as if my heart was vibrating. I am sure later I had a TIA. Was unable to communicate. I knew what I wanted to say but I could not get the words out. March 1/2021 I went on FLMA. It never dawned on me the vaccine could have affected my already stressed heart. I am still experiencing these symptoms. I just thought of this this week. I still have extreme fatigue, increased palpitations, and increased SOB. I do not feel able to work right now.
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| 64 | 2021-04-01 | headache | Nausea and headache |
| 64 | 2021-04-01 | fever, fatigue |
continued throwing up; diarrhea; Nausea; Slight fever; Difficult breathing/ shortness of breath; sli...
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continued throwing up; diarrhea; Nausea; Slight fever; Difficult breathing/ shortness of breath; slight pain at injection site; tired; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 64-years-old, administered in Arm Left on 26Feb2021 09:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included allergies: sulfites. The patient was not pregnant. There were no concomitant medications. The patient experienced slight pain at injection site and tired on 27Feb2021 12:00, nausea, slight fever, and difficult breathing on 28Feb2021, continued throwing up, diarrhea, shortness of breath on 01Mar2021. The patient experienced slight pain at injection site, tired on Saturday, then on Sunday nausea, slight fever, difficult breathing, and on Monday continued throwing up, diarrhea, and shortness of breath. The patient was hospitalized for 1 day for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 08Mar2021.Therapeutic measures were taken as a result of the events which included steroid and meds for stomach. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The outcome of the events was recovered on an unspecified date. Facility type vaccine was Hospital. No other vaccine in four weeks. No other medications in two weeks. Patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. Information on the lot/batch number has been requested.
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| 64 | 2021-04-02 | head discomfort, malaise, headache |
headache; dizziness; chest was tight; was not breathing very well for 3- 4 days; wheezing; bad press...
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headache; dizziness; chest was tight; was not breathing very well for 3- 4 days; wheezing; bad pressure in the back of her head; felt like her heart was skipping beats; heart rate and blood pressure seem to be very erratic; erratic heartrate; arm swelled up and was sore; arm swelled up and was sore; lump in throat; unwell feeling all over like she was going to pass out.; unwell feeling all over like she was going to pass out.; She kept getting an icky feeling; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [26Mar2021], this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report from contactable consumers (one is patient). A 64-year-old female patient received the first dose of BNT162B2 (BNT162B2, Lot Number: EN6204), intramuscular, administered in right arm on 08Mar2021 14:10 (at the age of 64-year-old) at single dose for Covid-19 immunization. Medical history included high cholesterol, osteoporosis, high blood pressure, arthritis, stenosis of neck and spine, allergies to dust and cleaners (when she cleans, the bottom of her neck swells up huge); all were ongoing. She has very high cholesterol, she believes it was close to 400 the last time it was checked and that's why she was given Repatha which brought it way down, but she doesn't know if she can take the Repatha again. She also has quite a few allergies - allergic to cats, sulfa, grass and Pre-diabetes. She has a fair amount of allergies. Her doctor thinks she has some asthma because she has had a little trouble breathing at different times, but she doesn't have an inhaler or anything. She mentions asthma and allergies run in her family. The patient also stated that a majority of her life, has had low blood pressure until about 9 years ago when her father passed. States that her blood pressure had been out of control for 6 months and was then put on a low dose of Carvedilol, and eventually evened out. Concomitant medications included ongoing carvedilol taken for blood pressure; ongoing loratadine (CLARITIN) taken for allergies from 1996 (has been taking for 25 years); ongoing lansoprazole taken for acid reflux; ongoing rosuvastatin calcium taken for cholesterol since Sep2020; ongoing calcium; carvedilol (COREG) taken for blood pressure. The patient had a previous reaction to a cholesterol medication evolocumab (REPATHA) from 23Oct2020 to 23Oct2020 - her neck swelled up pretty big and she had hives on her chest, which ended up going away. Therefore, she doesn't know if she can take that again or not. The patient also previously took rosuvastatin calcium (CRESTOR) 5-6 months ago and it made her legs ache really bad; esomeprazole sodium (NEXIUM) and had the problem; lansoprazole (PREVACID) for acid reflux. She took Nexium which was a different product with different ingredients and her blood pressure was still high the whole day. States that her doctor had prescribed another brand, which had the same main ingredient as the Nexium, and told her to double up on it one night, so she did that and about an hour later she just about hit the floor because her blood pressure shot up to about 200 over 100 and something, so she talked to the pharmacist who said that this was not a normal reaction to the ingredients in Nexium, but it happened to her every time she took it. She had been taking Prevacid for a long time but then started to get an allergic reaction. Clarified that feeling like she was having an allergic reaction after taking the Prevacid at night, was something that she has just started noticing within the last month. Wondering if the 2nd dose of the Prevacid is too much. States that she still takes this in the morning but not in the evening. States that she has started taking 15mg at night from an over the counter version of the same medicine (Lansoprazole). She explained that she hasn't had any vaccines as an adult, she never has had a flu shot. About 5 years ago, she had a bat in the house for 3 days and the bat ended up hitting her in the head and forehead as they were trying to get the bat out of the house, so she ended up getting a rabies vaccine. She was wondering and hoping there were no interactions with that. With the rabies vaccine, she did have a headache. She had to get 4 or 5 shots and she did not feel well most of the time. It took a long time to pass for her to feel normal again. The caller received the first dose of the vaccine last Monday on 08Mar2021, after the shot and while waiting those 30 minutes, she felt a lump in her throat which lasted all day and the next day, but it went away. She confirms by 10Mar2021, she recovered completely. Her arm swelled up and was sore for a day and half on 08Mar2021, but that went away. She isn't worried about that. She also has a really bad headache and was very dizzy on unspecified dates. She is concerned about the dizziness. She has been driving, but about the second day after getting the vaccine, she was leaning over talking to her mom and she felt like she going to pass out. She didn't, but she felt like she was. She has been using hot packs. It's like she has a headache around her temples and the back of her head seems to be hurting. In fact, she put a hot pack there while waiting to speak to this call handler. She doesn't know if its tension or what. She didn't have hives or none of that from COVID vaccine which she was excited about, but she is so dizzy she can hardly stand. She can't get rid of the headache and dizziness. She wants to know whether or not to go ahead with the next vaccination. This is the 5th day of having this dizziness. She was thinking the dizziness was going to last for a couple of days, but its going on 5 days. Even just sitting, She states it's kind of scaring her. She was thinking it would just go away, but it isn't. Her heart rate and blood pressure seemed to be very erratic on 12Mar2021. She woke up this morning (12Mar2021) and her blood pressure was very high, but she checked it within a few minutes and was dropping low. Her heart goes fast and then slows down, but she has had problems with this in the past. The dizziness has been bothering her a lot, she has been afraid to drive. The patient had a blood pressure of 150/102 on unspecified date. On 17Mar2021, She mentioned she will see her HCP at 2:00 PM. She has already filed a report regarding the side effects she had. She filed a report and asked if she should get the second dose shot. However, she was informed if her HCP called, they may be able to provide her with more information. She was informed her HCP could call the medical line. On 26Mar2021, she stated that the first report was filed the first week and that during the second week, more not good things have been happening. She wrote down the report number from the first report but does not have it now. Since the vaccine, she has been having different symptoms; she is not sure if it is related to the vaccine but wanted to report it. She was a little concerned because she has allergies, stating she had just tried an injectable cholesterol drug and she did break out hives and her neck had swelled. States that she has not had any vaccines as an adult, so she was a little bit cautious anyway. She clarified that she did not have hives and did not have any breathing problems when she left. Stated that later that evening and the next day had a really bad headache and bad pressure in the back of her head, which she knew was typical. States that 3 or four times she felt a rush over her body and felt like she was going to pass out. That night and the next day (unspecified date), she was having breathing problems (was not breathing very well for 3- 4 days) and her chest was tight and she was starting to wheeze, and continued for about 3 or 4 days. She kept getting an icky feeling Monday and Friday when she got up and had unwell feeling all over like she was going to pass out on unspecified date in Mar2021. States she had real bad pressure in her head and high blood pressure and felt like her heart was skipping beats on unspecified date. States her blood pressure was around 152/100 on 09Mar2021. One-day blood pressure was real low, 88 over something but that kind of went away. States all that information was already reported. The next week, she thought she was feeling better and that Monday and Tuesday felt back to normal. Stated that on Thursday night (Mar2021), she was just sitting and around 8 o'clock her blood pressure spiked within a few minutes to around 184/105 and she wasn't doing anything; she couldn't get it to go down. States that she went to the ER to check everything out last Thursday. Every night since then, somewhere around 8 o'clock, her blood pressure spikes really high. Stated she then called her doctor. Stated she was on a really low dose of blood pressure medication, stating that she had occasional problems with her blood pressure in the past but it never went that high. Her blood pressure was usually in the 140's or 150's over 90 something. States that now it is much higher and happening every night. Caller stated that Wednesday night (24Mar2021) her blood pressure started to spike every 5 to 6 hours, stating it first started at 830 at night and again at 230 in the morning. She has been feeling unwell since that shot. Her doctor thinks it may be causing inflammation. States that they doubled her medication last night and her blood pressure is still going up and up, but usually goes down after a couple of hours. It is totally uncontrolled and her doctors are trying to figure it out. States that meds have been added, including Xanax and will be going to see a heart doctor. States that this has all been since the vaccine. Caller would like to know if people are reporting these symptoms. States that it is pretty terrible, and that she feels normal and then it rushes over her. States that it is exhausting and that she almost went to the ER last night. States that she does not want to go back if she does not have to. When she filed the first report she did not have issues with blood pressure yet. Again, she had the vaccine on Monday 08Mar2021 and that the next Thursday she felt like her heart rate was really high. During that first week, she felt out of rhythm, like missing beats. Her blood pressure dropped low the first week and that just one time was around 152/100 but it didn't sustain. It then dropped pretty low one day. The next Thursday, it was uncontrollable. It was around 180 over 104 or 105 and that it kept going up, but then back down to 160/90 something. Took Xanax and went to bed, when she woke up this morning it was low, but went right back up within 5 minutes. In the first couple of days, they increased her blood pressure medicine and it seemed to be bringing her blood pressure down and she was able to go to bed. The caller stated that Monday, it will be three weeks. States that a day and a half after the vaccine, her arm was not hurting but was still puffy, but not bad. States that when she runs her hands over it, it is still sore to the touch and a little swollen but nothing extreme. She was concerned that her blood pressure keeps going up and then down. States that the blood pressure started spiking on the 18Mar2021, in the evening very quickly and was very high. Stated that this was happening every night since then until the 24th, when it started spiking every 5-6 hours; and her blood pressure medicine wasn't controlling it like it was earlier in the week, even though the dose was doubled. For one day it worked good and brought it down low but then, it wasn't controlling it anymore. She stated no relevant tests, related to this event but states that in her last 2 labs her cholesterol was high. States that it was over 300 and her bad cholesterol double or more triple. States this has been going on for many years. States that she changed her calcium to calcium with vitamin D and her vitamin has come back up. When she was in the ER they did a Metabolic panel and everything looked okay. The adverse events require and emergency room visit. The patient recovered from the event lump in throat on 10Mar2021; the events arm swelled up and was sore recovered in Mar2021; the events erratic heart rate, chest was tight, was not breathing very well for 3- 4 days, wheezing resolved on unspecified date. The outcome of dizziness, blood pressure seem to be very erratic was not recovered and the outcome of the remaining events was unknown.
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| 64 | 2021-04-04 | fever, sleepiness, chills | Meningo-encephalitis Pt started having fever, chills, altered mental status, drowsiness, confusion. |
| 64 | 2021-04-06 | fatigue |
she is disabled and lives in chronic pain.; Hair is falling out; was too tired; This is a spontaneou...
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she is disabled and lives in chronic pain.; Hair is falling out; was too tired; This is a spontaneous report received from contactable consumer, the patient. A 64-year-old adult female received the first dose of BNT162B2 (solution for injection; Lot EN6204 expiry 30Jun2021) as a single dose in the left deltoid (left shoulder) on 22Mar2021 (at 64-years-old), for COVID-19 immunization. Relevant medical history included a failed back surgery. The patient had no family history. Concomitant medications included many [unspecified] medications that the patient has taken for years. The patient denied receiving any prior vaccinations within four weeks of the vaccination, and the patient denied any adverse events (AE) following prior vaccinations. The patient reported that very early in the morning on 24mar20201, she did not know what time as she was too tired to look at the clock, she noticed her hair was failing out. The patient also mentioned that she is disabled and lives in chronic pain from an unspecified date (pending clarification). There was no emergency room visit required and the patient denied any physician office visit though commented she made an appointment with dermatologist for Friday. The outcome of the events too tired, hair is falling out, and disabled and lives in chronic pain was unknown.
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| 64 | 2021-04-06 | headache |
Within 45 secs to 2 mins of receiving the Pfizer vaccine #1, patient (myself) experienced tingling...
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Within 45 secs to 2 mins of receiving the Pfizer vaccine #1, patient (myself) experienced tingling in Lt, eye then swelling in Lt. eye lids, lt. cheek, lt. corner mouth which progressed. This was witnessed by the team giving vaccine and later on by EMT on the scene. Post feeling dizzy along with swelling the EMT person had me leave my car & placed me on litter in ambulance waiting in parking lot. Within 5 -6 mins. of the shot, I then felt severe HA, and swelling in my throat. EMT immediately started IV - gave IV Benadryl, then gave 1 shot of Epinephrine. Called EMT which took me via ambulance to hospital. There EM MD assess then gave me Solumedrol IV push & admitted me to ED OBS formally. Felt better but then few hours later all symptoms returned along with severe pain in hand with red palms & cyanotic finger tips. ED MD treated me again with higher dose of Benadryl & add Prilosec for potentiation of Benadryl and observed me. Felt better after several more hours. Was discharged on 50 mg Prednisone X 5 days & prescription for Epinephrine pen. Followed up w/PCP couple days later.
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| 64 | 2021-04-07 | fatigue, malaise, headache, fever |
Severe Nausea; Fatigue; Muscle and body aches; Muscle and body aches; headache; low grade fever; mal...
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Severe Nausea; Fatigue; Muscle and body aches; Muscle and body aches; headache; low grade fever; malaise; severe Tremor; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Mar2021 at 15:15 on the left arm as single dose for COVID-19 immunization. Medical history included bipolar disorder type 2, known allergies to sulfa. Concomitant medications included taking unspecified other medications in two weeks. The patient did not receive other vaccine in four weeks. The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies. The patient did not have covid prior vaccination and there was unknown if the patient had covid tested post vaccination. On 13Mar2021 at 12:00 PM, the patient experienced severe nausea, fatigue, muscle and body aches, headache, low grade fever, malaise 3 days after vaccine since then patient had developed a severe tremor; that all events resulted in disability or permanent damage. Patient received a positive result from a serum antibody test for covid 19 on 29Mar2021 (reported as two days ago, as of 31Mar2021). Patient cancelled her second vaccination appointment. Lab data included serum antibody test was positive on 29Mar2021. There was no treatment received for the adverse events. The outcome of events was not recovered. Information about Batch/Lot number has been requested.
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| 64 | 2021-04-07 | headache, fever, fatigue, chills |
pain in the heart; semi-hallucinatory dreams; 3 day duration: extreme headache; fatigue; nausea and ...
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pain in the heart; semi-hallucinatory dreams; 3 day duration: extreme headache; fatigue; nausea and vomiting; nausea and vomiting; diarrhea; chills; cold sweats; fever spiking to 103.9 F; This is a spontaneous report from a contactable consumer (Patient) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727), via an unspecified route of administration, at the age of 64 years, administered on the left arm on 21Mar2021 09:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included atypical homozygous pseudocholinesterese deficiency from an unknown date and unknown if ongoing. Concomitant medications included liothyronine (LIOTHYRONINE) and levothyroxine (LEVOTHYROXINE); both taken for an unspecified indication, start and stop date were not reported. The patient received first dose of COVID vaccine BNT162B2 (lot number: EN6203) on 02Mar2021 09:00 AM on the left arm for COVID-19 immunization. On 21Mar2021 18:00, the patient experienced 3 day duration of extreme headache, fatigue, nausea, vomiting, diarrhea, chills, cold sweats, fever spiking to 103.9 F, pain in the heart and semi-hallucinatory dreams. The patient underwent lab tests and procedures which included body temperature: 103.9 fahrenheit on 21Mar2021. Treatment was not received for the events. The outcome of the events was recovering. Additional information has been requested.
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| 64 | 2021-04-08 | fatigue, fever, malaise |
Pt received the shot on Thurs 4/1/21. This is a 64-year-old patient who presents with 1-1/2 days of ...
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Pt received the shot on Thurs 4/1/21. This is a 64-year-old patient who presents with 1-1/2 days of body aches, fevers, tachycardia, fatigue and does not have any exposure to COVID-19 but she just got on Thursday her first shot of her vaccination she also has vomiting and malaise. TTP rash started on 4/7/21.
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| 64 | 2021-04-09 | sweating |
feeling almost to pass out; lightheaded/dizzy; extreme confusion; cognitive issues (more than 'brain...
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feeling almost to pass out; lightheaded/dizzy; extreme confusion; cognitive issues (more than 'brain fog'); cognitive issues (more than 'brain fog'); nausea; weak to the point of needing to sit down often; break out in sweat a couple of times daily; arm hurt; I am not confident to drive and am having difficulty performing my dailing routine; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient (Patient was not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unknown route on 18Mar2021 at 13:30 PM (at the age of 64-years-old) at single dose on the left arm for COVID-19 immunization. Relevant medical history included neutropenia. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient was perfectly well prior to vaccine administration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She did not receive any other medications within 2 weeks of vaccination. On 19Mar2021 at 14:30 PM, she has been lightheaded and dizzy to the point of feeling almost to pass out. She had extreme confusion/cognitive issues (more than brain fog) and nausea. She was weak to the point of needing to sit down often and break out in sweat a couple of times daily. Her arm hurt for a couple of days but that has resolved. She was not confident to drive and having difficulty performing her dailing routine. The patient was concerned about ever recovering and receiving the second dose. No treatments were given for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The outcome of the event arm hurt was recovered in Mar2021 while the outcome of the remaining events was not recovered. Information on the lot/batch number has been requested.
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| 64 | 2021-04-16 | headache |
Rash on face, sensitivity to light, headaches. Sore mouth -- these disappeared after a week and tre...
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Rash on face, sensitivity to light, headaches. Sore mouth -- these disappeared after a week and treatment with Advil and cortisteroid cream. Chilblains on fingers continue to be a problem. Doctor has done blood test for Lupus and report is negative.
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| 64 | 2021-04-17 | fatigue |
heart started fibrillating for 36 hours/she would be in atrial fibrillation for 3-8 hours, or maybe ...
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heart started fibrillating for 36 hours/she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours; body feels like hit with mac truck; tired; This is a spontaneous report received from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm at age 64 years, on 29Mar2021 14:25 (Batch/Lot Number: ER8732) as single dose, for COVID-19 immunisation. Medical history included atrial fibrillation as a pre-existing condition that normally she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most and overweight from unspecified date but working on it. Only she has heart history in her family. The patient's concomitant medications was none. Patient historically took first dose of BNT162B2 (Lot: EN6199) with anatomical Location of left arm on 08Mar2021 around 1300 for COVID-19 immunization and flu vaccine received back in 2020 for immunisation. Patient reported that she had the second dose of the Pfizer COVID Vaccine on Monday, 29Mar2021 and three hours later, her heart started fibrillating for 36 hours. She has a pre-existing condition of atrial fibrillation and normally she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours. Patient contacted the doctor right away via phone. Her doctor, an electrophysiologist, stated not to eat or drink anything after midnight and of patient was still in atrial fibrillation in the morning they would have to perform a cardioversion, with the paddles. Doctor believed this could happen and said its a delicate balance when you put anything else into the system that it could affect persons. On 31Mar2021 at 05:15 that morning, the patient went out of atrial fibrillation and back into normal sinus rhythm. Patient only called the doctor and would have had to go in today if the fibrillation did not stop. Patient also stated that well, it was not a good thing to fibrillate for that long, with due time it can cause congestive heart failure and stated its dangerous. Patient was resting at the time of report and was relieved she is not fibrillating anymore. Patient reported that her body feels like it was hit with a mac truck on Mar2021. Heart fibrillating for 36 hours makes you really tired. The outcome of the event 'heart started fibrillating for 36 hours/she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours' was recovered on 31Mar2021 at 05:15 in the morning, while for the rest of the events it was unknown. Follow-up attempts are completed. No further information is expected.
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| 64 | 2021-04-17 | headache |
Lymph nodes hurting a lot; Hypersensitive to light; A lot of dizziness; Nausea; Headaches; affecting...
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Lymph nodes hurting a lot; Hypersensitive to light; A lot of dizziness; Nausea; Headaches; affecting all organs; Chest pain; Felt like the Covid-19 vaccine was hydrating eyes/Film on eyes; Losing vision; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208), first dose via an unspecified route of administration on 16Mar2021 10:30 (at the age of 64 years old), single dose for covid-19 immunisation. Medical history included ongoing thyroid (disorder) (Unspecified thyroid condition). It is the vaccines with aluminum and bovine extract that she knows that she can't handle. Caller reported that she got a flu vaccine at work and that she definitely got the flu within a few minutes of receiving the flu vaccine. Caller reported that another time after receiving the flu vaccine, she definitely got the flu but she was unsure of the time frame. Caller reported that she did have the flu vaccine several times but that two times, the flu vaccine definitely gave her the flu. She has 3 brothers and that one of her brothers that she is a caregiver for has Type 1 Diabetes. Her brother just felt like he had to have 2 vaccines several years ago and that he received the pneumonia and flu vaccines. Her brother was hospitalized within days of receiving the flu and pneumonia vaccines. Her brother was placed in the ICU for heart patients and the medical staff at the hospital was not sure if her brother was going to live. She couldn't remember how long her brother was hospitalized for, caller stated she thinks maybe around 10 days.She knows what she knows, her 2 other brothers were also hospitalized as children. She didn't know if her brothers had vaccines before they were hospitalized but that she would bet money that vaccines they had received are what resulted in hospitalization.When hospitalized, her second brother was not expected to live. At the time of the event, her brother was only 1 or 2 years old. Her brother's infection was so bad that the hospital sent blood to the CDC and that the CDC couldn't figure out what was wrong with her brother.The hospital kept giving IV antibiotics to her brother and he lived. Her third brother hospitalized around 5 years old with pneumonia during the summer. She didn't know if her brother had received any vaccinations at that time. She just thinks the vaccines did that to them but she doesn't know that. Someone gave her first brother the information on the pneumonia and flu vaccines he received prior to his hospitalization. She didn't have information regarding the details of the vaccines that her brother received.The facility where her first brother was vaccinated with flu and pneumonia vaccines would not give her the information on the vaccines that her brother received. Caller reported that it was a really hard time to fight the facility for that information and she was shocked the facility wouldn't give her the requested information. Caller reported that they wouldn't give her any medication records or anything. Caller reported that it was a bad time for her to fight it, and that she will eventually go back and tell them they have to give her the information.Her brother that she is a caregiver for and that was hospitalized after receiving the flu and pneumonia vaccines also had the Covid-19 vaccine on 16Mar2021. Caller reported that she had been more concerned about her brother having a reaction as he has serious health issues, including Type 1 Diabetes and a heart condition. Caller reported that her brother stated that he's fine and to the caller, her brother seems fine. Concomitant medication included levothyroxine. Patient has experienced that the Pfizer Covid-19 vaccine made her hypersensitive to light on 20Mar2021. She is losing vision on Mar2021 because of the hypersensitivity to light. On 20Mar2021, patient had a lot of dizziness and nausea. It is effecting all of her organs. She has had headaches, chest pain. The Covid-19 vaccine is affecting all of her organs. Yesterday, 30Mar2021, her lymph nodes were hurting a lot, at least she thinks it was her lymph nodes. All of her organs that have been affected by the Covid-19 vaccine and that it seems like it moves day to day. She is mostly sensitive to UV light but is also sensitive to artificial light. She thinks that the hypersensitivity to light has improved a little bit but it's still a problem. The hypersensitivity to light was the absolute worst on 20Mar2021. She doesn't know how much she is still dizzy when asked if it was still ongoing. She added she has been taking Benadryl and ginger for the dizziness and nausea and it helps a lot.She has been taking ginger for the nausea, and if she still has a little, it's not as much.Today is an overcast day and that it's an easy day for her. Caller reported that bright, sunny days are the worst.She was unsure of when the vision loss occurred but stated that she knew by 20Mar2021 that she had lost vision. She didn't know if she was continuing to lose vision but she can tell she lost vision. She did have a headache in the evening on 16Mar2021 after receiving the Covid-19 vaccine. She thinks the headache occurred in the evening on 16Mar2021.She may have had some headaches between 16Mar2021 and 20Mar2021, but that the headache she had on 20Mar2021 was a horrible headache.She is still getting headaches. She would say the headaches are a little better but she is still having them.She is having headaches that she doesn't think she would normally have. She wasn't having headaches before receiving the Covid-19 vaccine.She thinks she did have headaches between 16Mar2021 and 20Mar2021, but 20Mar2021 is when the headaches really hit her.The chest pain is intermittent and that the chest pain coincides with when the light is affecting her. When it's UV light, more so in the afternoon on sunny days, but technically the artificial light in the evening some days bothers her too.She doesn't think her lymph nodes were bothering her before 29Mar2021. Her lymph nodes are ok this morning, 31Mar2021.Different organs have hurt at different times. The effect on organs started within minutes of getting the Covid-19 vaccine.She could feel her eyes and that her eyes felt different within minutes of getting the Covid-19 vaccine. It felt like the Covid-19 vaccine was hydrating her eyes on 16Mar2021 but at the time it felt good. Afterward she was freaking out because she was concerned about her eyes.In the evening of 16Mar2021, it seemed like there was a film on her eyes and she had a headache.On 17Mar2021, 18Mar2021, and 19Mar 2021 she had headaches that she wouldn't have normally had.On 20Mar2021 different organs started hurting.Her biggest concern was the chest pain. After looking back on it, the chest pain may have started between 17Mar2021 and 19Mar2021 also.The effect on her organs from the Covid-19 vaccine occurs on different organs at different times on different days. The effect today isn't bad because it overcast outside and that her organs are really affected when she is exposed to a lot of light.She had 2 blood tests yesterday at her primary care doctor. The doctor ordered labs for VEGF and Leptin. She doesn't get vaccines.No Prior Vaccinations (within 4 weeks). The outcome of the event Photophobia, Nausea, Headache, Lymph node disorder was recovering; other events was unknown. Follow-up attempts are completed. No further information is expected.
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| 64 | 2021-04-18 | headache |
Passed out on Monday hit head and got a concussion.Went to ER had . Headaches caused by optical and ...
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Passed out on Monday hit head and got a concussion.Went to ER had . Headaches caused by optical and vestibular systems does to hitting head. Bump on right side of head that continues to hurt.Balance is off due to vestibular. Some short term memory issues.OT and PT.
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| 64 | 2021-04-19 | fatigue, fever |
Pt reported she noticed fatigue and achiness about 12 hours after vaccine. The next day, she noticed...
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Pt reported she noticed fatigue and achiness about 12 hours after vaccine. The next day, she noticed a bump on her hairline by her lymph node with pain radiating to under her jaw. A few days late she reported a fever, red eye, and increased blood pressure. She went to the emergency room and ended up being admitted and checked for a heart attack or blockage. The cardiologist who cared for her said she did not have a heart attack. He could not conclude that the symptoms were a result from the vaccine, but advised her against getting the second dose out of an abundance of caution.
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| 64 | 2021-04-20 | fatigue, malaise |
Appendicitis; Abdominal pain/abdominal soreness; stomach started bothering her; not feeling well; ti...
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Appendicitis; Abdominal pain/abdominal soreness; stomach started bothering her; not feeling well; tired; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 25Mar2021 10:00 at a single dose for COVID-19 immunisation. Medical history included ongoing asthma (Never smoked a cigarette in my life), Hypothyroidism (started taking levothyroxine about 23 years ago), Diverticulitis (hospitalized for it once in 2015), allergy and environmental allergies. Concomitant medications included levothyroxine for hypothyroidism, loratadine for asthma is triggered by allergies, montelukast for allergy from 2017, fluticasone propionate, salmeterol xinafoate (SALMETEROL AND FLUTICASONE) taken for asthma from 2017, albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for asthma attack and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for environmental allergies from 2017 all were ongoing. The patient previously received first dose of BNT162B2 on 03Mar2021 for COVID-19 immunization (IM left arm); flu vaccine (Received every year for the past 14 years) and pneumonia vaccine (gotten the pneumonia vaccine the year prior) both for Immunisation. On 26Mar2021, caller stated that she was not feeling well, her stomach started bothering her and she thought she was going to have diarrhea, but she did not. She was really tired, stating she had to take her mom to an appointment, which was about an hour away and patient slept in the car on the way, and noted that she never sleeps in the car. Felt really really tired. On 28Mar2021 her stomach pain started. She thought it was diverticulitis and that she has history of having diverticulitis years ago and being hospitalized for it once in 2015. She got very sick very quickly. She went to the emergency room on 28Mar2021 at about 1130 and they did a CT scan and found out it was her appendix and she was operated on that afternoon at which time they removed her appendix. Appendicitis require a visit to the emergency room. The patient was hospitalized for appendicitis from 28Mar2021 to 29Mar2021. The doctor told her that she was very fortunate, there was a slight perforation and there was no leakage and she was able to go home on early Monday evening. Shortly after the surgery she felt better. She still does not feel 100% still tired. Glad she got the surgery when she did and it did not rupture. Stated she did not need pain medication. There were no additional vaccines administered on same date of Pfizer suspect. Outcome of the events appendicitis and stomach started bothering her was recovered on 29Mar2021, not feeling well recovered on 28Mar2021, event tired as not recovered while unknown for the other event. Information on the lot/batch number has been requested.
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| 64 | 2021-04-21 | chills |
Five days after receiving the Pfizer vaccine, I had a sudden onset of neck & shoulder pain on my lef...
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Five days after receiving the Pfizer vaccine, I had a sudden onset of neck & shoulder pain on my left side, radiating up into my left ear & across my chest. My chest was tight. It hurt in my neck and shoulder and chest to take a deep breath. Shortly after, I felt jittery inside & started getting chills. The backs of my legs were quaking against the chair and I got really cold. My blood pressure went up to 149/78. I also had one bout of diarrhea.
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| 64 | 2021-04-23 | malaise |
itchiness/itching on both legs; body malaise; This is a spontaneous report from a contactable consum...
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itchiness/itching on both legs; body malaise; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3242), second dose via an unspecified route of administration in right arm on 03Feb2021 as SINGLE DOSE for covid-19 immunization. The historical vaccine included First Dose of BNT162B2 which was on 02Jan2021 (Lot: EL3302) in right arm. The patients medical history included diabetes mellitus and blood pressure. Concomitant medications included LISINOPRIL taken for blood pressure and METFORMIN taken for diabetes mellitus, both on unspecified date. On 04Feb2021 the patient experienced body malaise and itchiness/itching on both legs. Outcome of the events was not recovered.
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| 64 | 2021-04-24 | fatigue, headache, body temperature increased |
Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms las...
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Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Headache; distorted facial sensory; slight torso rash; tremor; spasticity; cognitive fog; fatigue; joint/tendon stiffness/inflammation; joint/tendon stiffness/inflammation; slightly increased temp; sensory distortion; cutaneous vasculitis on feet (aka "COVID toes"); slow digestion; This is a spontaneous report from a contactable consumer. A non-pregnant 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on right arm on 10Mar2021 13:00 (Batch/Lot Number: EN6200) at single dose (at the age of 64 years old) for COVID-19 immunisation. Medical history included known allergies: oats, also saturated fats (trigger multiple sclerosis symptoms), intolerant of many drugs but not allergic, Multiple sclerosis/fibromyalgia, systemic rheumatoid disease, Raynaud's, underweight and very low bone density . Concomitant medications included naltrexone taken for an unspecified indication, start and stop date were not reported. On 11Mar2021, the patient experienced headache and distorted facial sensory, slight torso rash, flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing. Includes tremor, spasticity, cognitive fog, fatigue, joint/tendon stiffness/inflammation, sensory distortion, cutaneous vasculitis on feet (aka "COVID toes"), slow digestion, slightly increased temp. No new symptoms yet. Postponed 2nd dose due to flare. The patient received no treatment. The outcome of the events was recovering.
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| 64 | 2021-04-24 | fatigue |
she feels weak; Blood Sugar Drops at Lunch; feeling bad; hear wheezing in the stethoscope; Shortness...
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she feels weak; Blood Sugar Drops at Lunch; feeling bad; hear wheezing in the stethoscope; Shortness of breath; kind of fatigued; This is a spontaneous report received from a contactable consumer reporting for his wife (patient). This 64 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EP7534), single dose, dose 1 via an unknown route of administration in the left arm on 17Mar2021 at 08:30 (at the age of 64 years-old) for COVID-19 vaccination. Medical history included aortic aneurysm from 2012 to 2012, thyroid problems and headache. There was no family history. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. There were no events following prior vaccinations. Concomitant medications were not reported. In Mar2021, a week after vaccine administration, the patient was kind of fatigued. She went to the doctor in Mar2021 because she was feeling bad and they said they could hear wheezing in the stethoscope when they listened to her lungs. She was sent her for x-ray and they are waiting on the results. He said that this can also be symptoms of something going on with her thyroid and he has been trying to get her to go to the doctor. He stated she goes up and down the stairs at work and hasn't had problems but has noticed she feels weak and he has noticed she is getting more fatigued everyday. On 24Mar2021, the patient had no energy and her blood sugar has been dropping sometimes at lunch and has never had problems with it before. it is not all the time but when she comes home for lunch after she eats, it drops low. It happens sometimes at lunch, never at breakfast nor supper. In Mar2021, the patient experienced shortness of breath for the last couple of weeks, especially with the stairs. The patient went to the physician's office on 07Apr2021. Laboratory tests included blood work due to the patient's thyroid problems, blood sugar decreased and chest x-ray all on 07Apr2021. The clinical outcome of weak, shortness of breath, feeling bad, wheezing, fatigued and blood sugar dropped was unknown. No follow-up attempts are needed. No further information is expected.
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| 64 | 2021-04-24 | headache, fever |
stomach ache; Day two past out; bodyaches; vomited; Headache; nauseous; fever; This is a spontaneous...
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stomach ache; Day two past out; bodyaches; vomited; Headache; nauseous; fever; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Ew0151), via an unspecified route of administration, administered in left arm on 05Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Mar2021 for COVID-19 immunization. The patient had no other vaccine in four weeks. It was reported that on day two (06Apr2021), the patient past out and vomited. The patient also experienced headache, nauseous, fever, bodyaches on 06Apr2021; and stomach ache on 10Apr2021. No treatment was received for the events. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The outcome of the events was not recovered.
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| 64 | 2021-04-24 | sweating, headache |
passed out two times; Left arm shoulder and neck completely numb; Left lower section of my head seve...
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passed out two times; Left arm shoulder and neck completely numb; Left lower section of my head severe pain; dizziness; vertigo; nauseous; heavy sweats; my head feels very foggy; Having spots of memory issues; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 30Mar2021 11:30 (Batch/Lot Number: EM9810) as single dose for covid-19 immunization. Medical history included asthma, neuropathy, high cholesterol, and several allergies from an unknown date. The patient has no history of COVID prior vaccination. She was not COVID tested post vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (Lot number=EN6200) on 09Mar2021 12:15, on left arm for COVID-19 immunization. The patient experienced having left arm, shoulder and neck completely numb for four days since 30Mar2021, 19:00. Left lower section of her head with severe pain; she had dizziness, vertigo and was nauseous. She started having heavy sweats and passed out two times. She reported it has been a week since she had the shot and she was still dizzy and her head feels very foggy. She was also having spots of memory issues. The events were experienced on 30Mar2021, 19:00. No treatment was received for the events. The outcome of the events was not recovered from dizziness, and recovered with sequela from "Left arm shoulder and neck completely numb" on 03Ape2021, and recovered with sequelae on an unspecified date for other events..
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| 64 | 2021-04-24 | malaise, fatigue, headache |
slight swelling; no energy; shooting pain into her ear; She asked if this could be a lymph node situ...
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slight swelling; no energy; shooting pain into her ear; She asked if this could be a lymph node situation, She stated this pain has been going on since Thursday night; I started headache with my TMJ and the left side of face; I don't remember a lot of it, we're like that, I can't concentrate, around in my ear; it hurts to open my mouth really wide sometimes; bothers to swallow; just actually feeling unwell; Spot below your jaw bone in your neck; pain in my ear; I still feel very tired; messed with her TMJ on the left side; extremely tired; This is a spontaneous report of a contactable consumer (reported for herself). A 64-year-old female consumer (patient) received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration in the left arm, administered on 30-Mar-2021 at 14:45 (Batch/Lot number: ER8727) as SINGLE DOSE for covid-19 immunisation. The patient medical history includes blood pressure and cholesterol. Concomitant medications included ascorbic acid/rosa canina fruit (VITAMIN C & ROSEHIP) (started 20-25 years ago) at 1000 mg, twice a day for immune system, ongoing, calcium phosphate/colecalciferol (CALCIUM plus D) at twice a day for bone health. Vitamin E (Capsule, soft) for cancer preventive 400 iU, once a day(night) , potassium acetate (Solution for injection), 99 mg, twice a day, magnesium sulfate (Solution for injection) 400 mg, once a day (morning) for unspecified indication, multivitamin/sambucus nigra/sodium, zinc (Chewable tablet) one every other day; fish oil at 500 iU, once a day (morning) taken for cholesterol; colecalciferol (VITAMIN D3 1000) at 1000 iU, twice a day taken for an unspecified indication from 06Apr2021 and ongoing; ascorbic acid/betacarotene, calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide (PRENATAL VITAMINS) at every other day taken for Hair; pravastatin at 80 mg, once a day(night) taken for cholesterol; zinc chloride (Solution for injection) at 50 mg, twice a day taken for bone health and immunity health; acetylsalicylic acid (ASPIRIN (E.C.) at 81 mg,twice a day, loratadine at 1 tablet taken for an unspecified indication from Oct2015 and ongoing for all drug from an unspecified start date and ongoing. ibuprofen (ADVIL 12 HOUR); amlodipine besilate (Film-coated tablet) taken for blood pressure; atorvastatin calcium at 80 mg taken for cholesterol; omeprazole; fluoxetine hydrochloride (FLUOXETIN) 40 mg. It was reported that she had the first dose of the vaccine and has been having fatigue/tiredness/no energy. She stated she would compare it to if you have had surgery and go home and the anesthesia keeps kicking you. It makes her want to sleep a lot. Additionally, around her ear/jaw/TMJ area when she pushes on her neck it sends shooting pain into her ear. She asked if this could be a lymph node situation. She stated this pain has been going on since Thursday night. She asked if these symptoms are from the vaccine and if they just have to run their course/how long do they last. She took an Advil for swelling but it did not do anything. She was scheduled to get her second dose a week from today. It was also reported that Vitamin C she started taking it years ago, 20-25 years ago for immune system, Calcium plus D she started taking it years ago. She is supposed to take at least 1000. Vitamin E she started taking it many years ago. Regarding Potassium her doctor wants her to continue to take that. In her lab work last year her potassium was low. States she started taking it at least 20 years ago, longer than that, not sure. Magnesium the doctor before told her she should be taking at least 400 mg so she does when she can get it, sometimes she takes 250 mg. Caller states she started taking it 20 years ago. Multivitamin it was Normal CT Plus Equate, same as Centrum. States it had Lutein and she started taking some several years ago. Products Multivitamin was taking for general purposes, health protection. Additional Information for Fish oil states she accidentally grabbed 1000 IU so right now is taking 1000 IU. States she started about 10 years ago. States her cholesterol reporting is really good. Products vitamin d3 she was concerned she wasn't getting enough and she just started taking it a week ago. Pravastatin: Caller states it was good for other things too but the main reason was cholesterol. States she was guessing maybe in 2009, usually takes 40 mg and he raised it to 80 mg. Zinc she started taking it maybe 15 years ago. coasted aspirin she started taking it probably 3 years ago. Loratadine it was over the counter, Equate Loratadine. States it seems to work pretty well. She had a cough that wouldn't go away in the fall, the doctor told her to take one every day. Caller states from the day she got her vaccine she has been extremely tired, no energy, and is normally pretty quick on and more her feet. Sometimes she takes 3 naps a day, and still sleeps for eight hours. She is just really, really tired. She feels like when she's had surgery and came out of the hospital and anesthesia is kicking her and makes her want to sit. States it's messed with her TMJ on the left side but it continued to get worse, feels kind of like the mumps. She had the mumps as a kid and doesn't remember much about it, but discovered it wasn't it because she was able to drink milk. States she drank milk and was able to eat and drink. States it is concentrated around her left ear and sometimes aggravating to swallow, push something below her jaw bone and shoots pain into her ear. When probed for outcome she stated she was extremely tired the other day but got enough energy to vacuum and wash the dishes, but took about 3 naps a day for two days after that. pain- Stated initially she has taken Advil for the pain in the jaw. However, it does not phase it. She is not really supposed to take it, but didn't do anything when she took it a couple of times, so she thought maybe she just should not take it. States the pain is the same as it was yesterday and the day before. Confirmed outcome as persisting. Prenatal vitamin Caller states it was normal over the counter. States it is Vitamin A 4000 IU, Vitamin D 400 IU, Vitamin E 30 IU, Thiamin 1.8 mg, Riboflavin 1.7 mg, Niacin 20 mg, Vitamin B6 2.6 mg, Folic Acid 800 mcg, Vitamin B12 8 mcg, Calcium 200 mg, Iron 28 mg and Zinc 25 mg. Caller states she was taking Tylenol and Advil for pain. She took Tylenol this morning but can't say it's done anything yet. She clarified the Tylenol is 500 mg Equate Tylenol, it did not seem to be working, she took it two hours ago. Patient didn't remember a lot of it, we're like that, she can't concentrate, around in her ear, where you know TMJ is, and it hurts to her my mouth really wide sometimes, it bothers to swallow and she can push on a she did not know what it was the spot below your jaw bone in your neck and it shoots up the pain in my ear and she just wonder, and she know, Consumer further stated, 'Yes, just actually feeling unwell.' Consumer was informed about the department: consumer stated, 'Yes she thought she was talking to some one. she was told to hold on the line.' At site of vaccination: consumer stated, 'Left shoulder muscle at the top.' Probed for any Medical conditions or Concomitant medications. Outcome of the event messed with her TMJ on the left side was not recovered. Outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.
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| 64 | 2021-04-24 | malaise, fatigue |
I felt very tired and weak; I felt very tired and weak; my heart was skipping really bad I could hea...
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I felt very tired and weak; I felt very tired and weak; my heart was skipping really bad I could hear it, could felt it in my chest. Then trembling; heart palpitations and it was skipping and trembling off and on; arm is sore; weird feeling; trembling; trembling, shaking and she thought she was going to have a seizure, she had no control over her muscles; muscles twitching, like if I had no control over the muscles; she had to use the bathroom a couple hours after the shot. She stated she has been drinking a lot; didn't feel good last night; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 06Apr2021 13:00 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation, at 64 years old. Medical history included cholesterol (abnormal, takes cholesterol medication 3 times a week as she gets side effects from it), cutaneous lupus (She always has to do bloodwork and goes in every 3 months), heart problem that is not major (she takes 1 medication, patient stated once in a while she sees her cardiologist every 6 months and she did get a halter monitor for 24 hours for a week and they take an average and said it wasn't as bad and knows that is a problem), 2 cervical spine surgeries, arthritis, allergic to contrast dye for CAT scans, allergy to medications (sensitive to medications), shrunk a lot because of issues, and had surgery which shrunk her because of her spine from an unknown date. Concomitant medication included atorvastatin calcium (LIPITOR) taken for blood cholesterol abnormal from 2016 and ongoing; and nadolol (CORGARD) taken for an unspecified indication from 2001 and ongoing. Patient's son got COVID on an unspecified date. Patient previously took generic atorvastatin which made her sick on an unspecified date and LIPITOR and experienced muscle weakness on an unspecified date. No additional vaccines administered on the same date of the Pfizer vaccine. No prior vaccinations. Patient never got a flu shot as she was scared. On 06Apr2021, her arm was sore which is normal. Normal side effects from the arm did not concern her, patient had no fever nothing else. She stated she came home and felt like she had to use the bathroom a couple hours after the shot. She stated she has been drinking a lot and she made sure of that. At 19:00 (also reported as 7-8pm), patient experienced her heart was skipping really bad. Patient could hear it and could felt it in her chest. Patient clarified her heart was not fast, it was more skipping, and she could feel it beating in her throat. She commented has a problem but that has not happened in a long time. Patient then experienced trembling described as lots of body trembling concerned like a seizure. She thought she was going to have a seizure. It was not chills; she had no fever or anything. The trembling came on and off. Her muscles were twitching, like if patient had no control over the muscles. Patient did not feel dizzy, it was a weird feeling. She did not feel good. On 07Apr2021 at 02:00, patient felt very tired and weak, her heart was better. About 02:00 she fell asleep. She woke up at 6:30 and she felt tired but that does not bother her. Her concern was the body trembling. She called her doctor but was not available. She was advised that it does not sound like a symptom of the vaccine. She was worried she needs to go to the cardiologist and see what is happening. She stated if it keeps happening, she will go, and she does not know if this is a side effect other people are reporting. Patient was wondering if this is a reaction as she cannot find it, one says a severe reaction is a fast heartbeat, really fast and skipping and she does not know. She expected anything, tired, headache, muscle aches but these did not happen, but she was expecting them to. Patient is wondering why her heart is doing that is it from the shot or what is going on with her which is weird, and stated the shaking, trembling of her whole body is weird. She mentioned she is sensitive to medication and gets reactions to a lot of medications. She stated this is why she was scared to get the vaccine and what the reaction was with the 1st. Patient stated her heart is a lot better than it was last night, that she feels very tired and feels unwell. She stated she took her temperature (Apr2021) and she had no fever, no nothing a little unwell, a weird feeling. Patient stated she is not trembling anymore and has no heart skipping, that went away about 2am when she fell asleep for a few hours (also reported as went away after about an hour, she had it off and on 3-4 times in an hour). Patient clarified she has not had testing done for the reported symptoms. The patient stated she is concerned and does not know what to do about second dose, which is scheduled for 04May2021. She does not if it was a reaction and stated she is very sensitive to medicine. Events did not require emergency room and physician office visit. Outcome of the event heart was skipping, tremor and palpitations was recovered on 07Apr2021 02:00 while unknown for the other events. Follow-up attempts are completed. No further information is expected. Lot number has been obtained.
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| 64 | 2021-04-27 | dehydration, fever, malaise |
? Tuesday, April 6th ? Patient receives the 2nd Pfizer vaccine shot ? Thursday, April 8th ? Patient ...
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? Tuesday, April 6th ? Patient receives the 2nd Pfizer vaccine shot ? Thursday, April 8th ? Patient is sick with vomiting and diarrhea ? Friday, April 9th ? Patient is delirious and still sick with vomiting and diarrhea. She is also has pain in her stomach. An ambulance is called to take her to the hospital. The hospital determines her white blood count is elevated, indicating an infection. Blood sugar is very high ? approximately 400. Covid test is negative. She is restless upon arrival. She tries to climb out of bed continuously. She is restrained. o Saturday, April 10th ? Patient is running a fever and is in pain. She is also confused and doesn?t recognize her oldest sister. Meds are administered to handle both items. (Toradol?). Blood sugar around 200. She continuously counts and calls for Mother and Father. Patient continues to be restless o Sunday, April 11th - at request of family, a CT scan is done of her stomach and abdomen. Nothing is found. Potassium was at 3.2 (normal is 3.5) so she received an IV drip to help with potassium levels. Sugar ? 206. Later drops to 176. Patient calms down some. She is still confused and doesn?t recognize her oldest sister. ? Monday April 12th ? the hospital attempts to do an MRI, but patient panics. This is a closed MRI and her 1st husband died in one. The MRI isn?t done. ? Tuesday, April 13th ? she is asked by the doctor to state her name and wiggle her toes. She complies. Doctor orders speech therapy. She is sedated for an MRI and a CT scan. Both are successfully completed. She sleeps for the rest of the day. Blood sugar ? 274 @ 5:09pm. ? Wednesday, April 14th ? Patient was asleep all day. Most of the day she isn?t responsive when nurses come in and do things like take blood. She normally responds even if she is asleep. Around 5pm she starts to respond and make noises; she briefly opens her eyes then falls asleep. She continues to run a temperature. ? Thursday, April 15th ? Patient is asleep most of the day. She is responsive when nurses do things like take blood. A spinal tap is performed. There was mention of dementia. Hospital is sharing little information, varying from she is retreating into herself vs. something worth isolating is going on. Temp was 102.3 at 7:37, but later dropped to 99.3 without meds. Dr. (neurologist) provides an update to the family. Tests so far are negative. EEG showed sleeping brain (she was asleep during test). MRI showed nothing. Spinal tap negative so far. No infection or anything has shown up. Orders another EEG and MRI ? Friday, April 16th ? Patient tried to open her eyes. ? Saturday, April 17th ? a met code was called on her and she was moved to ICU. A circulation issue was found in right leg. Occlusion was really bad. Initially the doctor was concerned about blood clots. None were found, just swelling. Pressure was relieved. Blood pressure issues. She was put on 2 blood pressure meds, at least. She was dehydrated and acidic. Diabetic ketoacidosis was mentioned. A cytokine storm was expected. ? Sunday, April 18th ? blood pressure not stable. She was put on dialysis. Peripheral circulation was worse. ? Monday, April 19th ? she coded around 5am. Doctors were trying to save her. She passed away about 30 minutes later .
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| 64 | 2021-04-30 | chills |
body is responding to food, water and medicine like it is foreign; she is frustrated; elevated heart...
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body is responding to food, water and medicine like it is foreign; she is frustrated; elevated heart rate/rapid heart rate; Angioedema; having a hard time finding food to eat; water makes tongue swell and tingle; lip swelling; respiration changes from clothing; extreme hypersensitivity; heart racing; tongue tingling; rapid breathing/rapid respirations; nervousness; chills; burning sensation in her body; skin itches; bumps on back and abdomen; lock jaw at night; skin feels like it is thinning out; breathing stops and starts at night; electrical charges that were prickly in her body; warm flush; high blood pressure/blood pressure went up; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 17Mar2021 at 08:00 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. On an unspecified date, the patient experienced body is responding to food, water and medicine like it is foreign and she is frustrated. On 17Mar2021, the patient experienced high blood pressure/blood pressure went up (which required an emergency room visit), electrical charges that were prickly in her body, and warm flush. On 18Mar2021, the patient experienced angioedema, extreme hypersensitivity, heart racing, tongue tingling (which required an emergency room visit), rapid breathing/rapid respirations (which required an emergency room visit), nervousness, chills, burning sensation in her body, skin itches, bumps on back and abdomen, lock jaw at night, skin feels like it is thinning out, breathing stops and starts at night, having a hard time finding food to eat, water makes tongue swell and tingle, lip swelling (which required an emergency room visit), and respiration changes from clothing, elevated heart rate/rapid heart rate (which required an emergency room visit). The patient underwent lab tests and procedures which included blood pressure measurement: high on an unknown date, blood pressure measurement: had gone down on 17Mar2021, blood pressure measurement: 164/100 on 17Mar2021, blood pressure measurement: 176/100 on 17Mar2021, blood pressure measurement: went up on 17Mar2021, heart rate: rapid on 18Mar2021, heart rate: elevated on 18Mar2021, respiratory rate: rapid on 18Mar2021. Therapeutic measures were taken as a result of high blood pressure/blood pressure went up (hypertension). The outcome of electrical charges that were prickly in her body, body is responding to food, water and medicine like it is foreign, warm flush and frustrated was unknown. The outcome of the other events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021427769 Pfizer
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| 64 | 2021-04-30 | cough, fatigue |
Patient presented to ED on 3/28/21 with the following information: patient reports home daughter wa...
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Patient presented to ED on 3/28/21 with the following information: patient reports home daughter was diagnosed with COVID-19 infection a few days ago. For about a week now the patient herself has had severe fatigue, loss of taste, loss of appetite, nausea, vomiting and diarrhea. She denies fevers. She has however had a persistent cough and over the last few days has been short of breath. Tested positive for COVID-19 on 3/27/2021 at outside facility. Last night patient had multiple episodes of diarrhea making her fatigue significantly worse today. Has been drinking a lot of free water. Additionally noted increased cough and shortness of breath. Patient was admitted to the hospital with COVID-19 pneumonia on 3/28/21 and expired on 4/13/21.
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| 64 | 2021-04-30 | headache |
had a headache since then.; This is a spontaneous report from a contactable consumer. Follow-up (PRD...
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had a headache since then.; This is a spontaneous report from a contactable consumer. Follow-up (PRD 08Apr2021) received from a contactable consumer was processed together with initial information. A 64-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6205; Expiration Date: 31Mar2021), via an unspecified route of administration, administered in Right arm on 30Mar2021 09:00 as SINGLE DOSE for covid-19 immunization. Dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 09:30 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. Medical history included Kidney transplant from 2012 and ongoing, hyperglycaemia on an unspecified date, she started out with hypoglycemia then after her kidney transplant had hyperglycemia so maybe it was before her kidney transplant, ongoing hypertension diagnosed when she was 19 years old, on an unspecified date back pain, back injury, ongoing diabetes mellitus, ongoing high blood pressure. On an unspecified date the patient concomitant medication(s) included loratadine taken for back pain LOT: P121557; EXP: Aug2022; acetylsalicylic acid taken for back injury. The patient previously received bnt162b2, dose 1 for COVID-19 immunization and experienced mild headache on 02Mar2021 with recovering. First shot, she had a mild headache for three or four days, that was the only side effect. second shot, she still has a headache, but more intense and for longer. She takes Aspirin and it doesn't seem to go away. Second Dose: Headache, but more intense and for longer: the intense headache started that evening of her second shot, 30Mar2021. She's been taking Aspirin and taking, she has back injuries, so she has some pain medicine and has been taking that. Caller states it will go away and then the pain medications will wear off and it's back. She has had a kidney transplant. Because of a back injury, she takes pain medicine. She hates taking pain meds but sometimes takes it three times a week due to her back pain. The headache will go away. when she takes the pain medicine, as soon as it wears off, the headaches back again. Its nagging, not intense, she just knows it's there. She can function and everything. The patient experienced had a headache since then (headache) on 30Mar2021. The outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.
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| 64 | 2021-04-30 | throat pain |
she has been having some sore throat or tightness of the throat issues that she felt should be looke...
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she has been having some sore throat or tightness of the throat issues that she felt should be looked at.; she has been having some sore throat or tightness of the throat issues that she felt should be looked at.; she feels like her voice is getting either strange or raspy or something and had worsened; events are getting worse/Feels like she is going downhill/debilitating; Discomfort; She is in pain constantly and is scared and had worsened; Burning skin; She is in pain constantly and is scared and had worsened; electrical sensation/electrical sensations on most of the left side of the body and had worsened; severe neurological burning pain and getting worse; She can't walk straight, has a rocking feeling when she walks which is really weird; it is not a balance problem it's more like something is not firing telling her left side to work, which is very strange and was worsened; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Right Arm on 08Mar2021 14:00 (Batch/Lot Number: EN6198) as SINGLE DOSE (at the age of 64 years) for covid-19 immunisation. Patient had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 17Feb2021 for covid-19 Immunization Batch/lot number EN9804, as single dose into right arm. Medical history included hypersensitivity from an unknown date and unknown if ongoing , allergy to animal from an unknown date, skin burning sensation and paraesthesia from an unknown date following unspecified brand shingles vaccine following first dose, Lot/NDC/Expiry: unknown. Concomitant medications included loratadine (LORATADINE) taken for an unspecified indication and flecainide acetate (FLECAINIDE ACETATE) taken for an unspecified indication. The patient experienced severe neurological burning pain and getting worse (medically significant) on 08Mar2021 23:00 with outcome of not recovered , she can't walk straight, has a rocking feeling when she walks which is really weird; it is not a balance problem it's more like something is not firing telling her left side to work, which is very strange and was worsened (medically significant) on 08Mar2021 23:00 with outcome of not recovered , she has been having some tightness of the throat issues that she felt should be looked at (medically significant) on an unspecified date with outcome of unknown , she is in pain constantly and is scared and had worsened (medically significant) on 08Mar2021 23:00 with outcome of not recovered , electrical sensation/electrical sensations on most of the left side of the body and had worsened on 08Mar2021 23:00 with outcome of not recovered , she has been having some sore throat that she felt should be looked at on an unspecified date with outcome of unknown , burning skin on 08Mar2021 23:00 with outcome of not recovered , she feels like her voice is getting either strange or raspy or something and had worsened on an unspecified date with outcome of not recovered , she is in pain constantly and is scared and had worsened on 08Mar2021 23:00 with outcome of not recovered , and discomfort (discomfort) (non-serious) on an unspecified date with outcome of not recovered. The events are getting worse/feels like she is going downhill/debilitating and she is not recovered. She has been trying to get help for these events for about a month, but events are getting worse and no one seems to know what to do. Therapeutic measures were taken as a result of she is in pain constantly. She has seen several doctors and no one can seem to help her. She is trying to get into a neurologist as referred by caller's primary care physician, but the neurologist can't see her for 5 weeks. She was seen in the hospital emergency room last night, 13Apr2021 but not admitted to the hospital. No one there seems to know what to do. ER did some blood work which turned out fine in the hospital and put her on Gabapentin. They told her to take Gabapentin 300mg 3 times daily for 2 weeks. She mentioned that next Tuesday, 20Apr2021 they are sending her in for a thyroid ultrasound but that was at her own request. Blood work done in the hospital on 13Apr2021 came back fine. The patient is not in a study or programme. No additional vaccine was administered on same date of the Pfizer Suspect. She has not taken any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No follow-up attempts are needed. No further information is expected.
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| 64 | 2021-05-02 | headache, fatigue | diarrhea, severe muscle aches, headache, extreme fatigue |
| 64 | 2021-05-03 | sleepiness, sneezing, cough, runny nose |
Angioedema; Shock; stridor; dry cough; Hoarse voice; Sneezing; Rhinorrhea; Dizzy; nausea; Hypotensio...
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Angioedema; Shock; stridor; dry cough; Hoarse voice; Sneezing; Rhinorrhea; Dizzy; nausea; Hypotension; Weakness feeling; Generalized erythema; Generalized pruritus with skin rash; Generalized pruritus with skin rash; Diarrhoea; Vomiting; Throat closed in; the sides of the throat, down my neck , straight over my chest felt as if someone was squeezing me, chest felt heavy; Potential anaphylactic reaction; Difficulty breathing; severe brain fog; Severe chest pain hard to breath felt as if being smothered; difficult to sleep nights before as felt wired after the shot; bp slightly elevated 140/80; Became very groggy; eyes heavy, had about 3 sleep attacks; 3 sleep attacks; This is a spontaneous report from a contactable Health Care Professional (patient). A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN4206) at single dose, intramuscularly, in the left arm, on 05Mar2021 at 10:00 AM, for COVID-19 immunization. The patient also received hylan g-f 20 (SYNVISC), via an unspecified route of administration, in knee, on 04Mar2021, at single dose, for an unspecified indication. Relevant medical history included narcolepsy from an unspecified date, in 1973, cataplexy from an unspecified date, complex regional pain syndrome (CRPS) from an unspecified date, in 2003, osteoporosis from an unspecified date, gastrooesophageal reflux disease (GERD) from an unspecified date, hypertension from an unspecified date and arthritis from an unspecified date, in 2003. Concomitant medications included methylphenidate hydrochloride (RITALIN), imipramine, baclofen, atenolol, rosuvastatin calcium (CRESTOR), ezetimibe (ZETIA), imipramine hydrochloride (TOFRANIL), montelukast sodium (SINGULAIR), acetylsalicylic acid (BABY ASPIRIN) and clonidine, all taken for an unspecified indication, start and stop date were not reported. The patient reported allergy for drugs like lisinopril, spirolactone, ghb (gamma-Hydroxybutyric acid), epinephrine and all seizure type medications. The patient became very groggy, felt eyes heavy, had about 3 sleep attacks, on 06Mar2021, at 13:00. Also reported difficulty to sleep nights before as felt wired after the shot (insomnia) and bp was slightly elevated 140/80 on 07Mar2021. On 27Mar2021 at 13:00, throat closed in, felt the sides of the throat, down her neck, straight over her chest felt as if someone was squeezing her, chest felt heavy (severe chest pain hard to breath, felt as if being smothered, throat closing in severe chest heaviness). Severe brain fog. Potential anaphylactic reaction and difficulty breathing were reported. On an unspecified date, the patient experienced angioedema, shock, stridor, dry cough, hoarse voice, sneezing, rhinorrhea, dizzy, nausea, hypotension, weakness, generalized erythema, generalized pruritus with skin rash, diarrhoea and vomiting. Decrease level of consciousness and loss of consciousness were not reported. The patient underwent lab tests and procedures which included oxygen saturation: normal on 06Mar2021 and blood pressure measurement: 140/80, slightly elevated, heart rate: 99, respiratory rate: 20 on 07Mar2021. The patient was not hospitalized and was not admitted to an Intensive care unit. The patient did not have COVID prior to vaccination and the patient did not test COVID post vaccination. The patient recovered from throat constriction, chest heaviness, potential anaphylactic reaction and difficulty breathing. Clinical outcome of angioedema, shock, chest pain, stridor, dry cough, hoarse voice, sneezing, rhinorrhea, dizzy, nausea, hypotension, weakness, generalized erythema, generalized pruritus, skin rash, diarrhoea and vomiting was unknown. Outcome of the other events was reported as recovering. Follow up attempts are completed. No further information is expected. Follow up (26Mar2021): New information received from a contactable Health Care Professional includes: adverse events added, clinical course and case seriousness updated from non-serious to serious. Follow-up (20Apr2021): New information received from a contactable Health Care Professional includes: medical history, concomitant medications details and additional adverse events added (Potential anaphylactic reaction and difficulty breathing added as additional adverse events). Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on known safety profile and/or temporal association, the contribution of the suspect drug to the onset of serious events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 64 | 2021-05-04 | body temperature increased, chills, fatigue |
Monday, the day after the 2nd vaccine injection, I had a Temperature of 103.1, Chills, Muscle & join...
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Monday, the day after the 2nd vaccine injection, I had a Temperature of 103.1, Chills, Muscle & joint pain, dizziness, Fatigue Tuesday day, felt better. I was able to go out to the grocery store. Around 1 p.m. on Tuesday, I began feeling inflammation on the gums of my teeth, and roof of my mouth felt like it was burned; it got so bad that I could not eat or drink due to tongue hitting the roof of my mouth & causing MUCH pain. I did the best I could on Wednesday but then could no longer take it. I contacted my doctor who prescribed viscous lidocaine in order for me to eat & drink. I was only able to eat very soft food. My doctor had not come across anyone with this side effect. But the lidocaine helped a lot and I had to use it for several days. Symptoms started to subside on Saturday and are improving daily but it is still very sensitive even as of this time, 10 days after this 2nd vaccine shot.
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| 64 | 2021-05-04 | fatigue, chills, malaise, headache |
Swollen facial/lip,, very painful arm, feeling disoriented, severe trouble breathing, very tired, fe...
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Swollen facial/lip,, very painful arm, feeling disoriented, severe trouble breathing, very tired, fever/chills,headache My left arm became very painful immediately after injection(the injection didn't hurt,it was after needle removed & she was getting bandage), then I started to feel lightheaded & disoriented and trouble breathing and Blood pressure elevated but it was very low immediately after injection. Didn't start feeling well until more than 2 wks after shot.
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| 64 | 2021-05-04 | fatigue, lethargy, headache, chills |
Kidney infection; UTI; tightness around her rib cage; size of her arm at the injection site is down ...
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Kidney infection; UTI; tightness around her rib cage; size of her arm at the injection site is down to 2.5 inches by and inch.; allergic reaction; when they injected the vaccine that it burned; lethargic; half a bandage was covered in blood; it felt like three baseballs are sitting on her arm.; The muscles were so tight in her ribcage that she couldn't take a deep breath.; She states that the front of her shoulder, the sides, and the back of her arm was all hard and tense.; teeth chattered after getting the vaccine; Dizziness; difficulty breathing/hard time breathing; headache; fatigue; can still feel where the injection went; feels like an electrical shock; arm pain that radiated under her arm to her rib cage right after the vaccine/arm hurting; nerves were jerking starting at her temple going down throughout her body to her arms and fingers; itching; muscle aches; joint aches; arm pain that radiated under her arm to her rib cage right after the vaccine/arm hurting; arm pain that radiated under her arm to her rib cage; nerves were jerking starting at her temple going down throughout her body to her arms and fingers; hit a nerve upon vaccination; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6206), dose 1 , single dose via an unspecified route of administration in the right arm on 27Mar2021 at 11:00 (at the age of 64 years-old) for COVID-19 vaccination. Medical history included hypertension from an unknown date and unknown if ongoing History: Caller states that she does have health problems but they are not relevant to this event. She takes high blood pressure medication and is diabetic, diabetes mellitus from an unknown date and unknown if ongoing History: She has health problems but they are not relevant to this event. She takes high blood pressure medication and is diabetic. Hostorical vaccine included tired when she gets flu shot and got the thing where she couldn't lift her arm up and it hurt down the ribcage; still hurts in the lower quarter along the back side of the rib cage; still tender and goes to the bottom where the rib cage ends when she got the pneumonia shot . She is not sure if it effects the lungs more. The patient had no family history relevant to the adverse events. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medications were not reported. The patient experienced kidney infection, urinary tract infection (UTI), itching all over and that lasted two days and didn't get hives, muscle aches and in the beginning she couldn't get out of bed, fatigue, arm pain that radiated under her arm to her rib cage right after the vaccine/arm hurting, hurts down her arm, nerves were jerking, feels like an electrical shock in her, would feel like her eyebrow or her nose would twitch in the center; it was so bizarre, starting at her temple going down throughout her body to her arms and fingers, it was jerking like lightening fire, the jerking started at the temple on right side and went down the face, it made her knees and ankles jerk, her arm was jerking, she still has some jerking in her left hand so it jerks over to the thumb, she can't control that, the nerves were doing their own thing, her leg and knee would move with out her wanting it to, that the moving is still happening in her shoulder, arms, knees, leg, and foot and joint aches, they hit a nerve upon vaccination and can still feel where the injection went on 27Mar2021, headache and difficulty breathing/hard time breathing and changed her position to sitting up more than laying down on 28Mar2021, dizziness on 29Mar2021, really tired for a good week and a half, size of her arm at the injection site is down to 2.5 inches by and inch, arm felt like it was big in the front, on the side and the back, it felt like three baseballs are sitting on her arm, allergic reaction, it burned when they injected the vaccine, more lethargic than normal on an unknown date. It was also reported that she had difficulty breathing, described as tightness around her rib cage on day 3 and was having a harder time breathing when laying down on day 2.5-3. She states that it still hurts down her arm. It took 4 days for her to be able to lift her arm to her head. She didn't want to lift up because it was still tender around the chest area, especially on right side. it was still tender around the chest area, especially on the right side. The muscles were so tight in her ribcage that she couldn't take a deep breath. On an unknown date, half a bandage was covered in blood and the front of her shoulder, the sides, the back of her arm was all hard and tense and teeth chattered after getting the vaccine. There was no laboratory tests performed. Treatment was received for difficulty breathing/hard time breathing and fatigue. She used her inhaler for her breathing and took ibuprofen (ADVIL, lot: RA467, expiration date: Jul 2022) liquid gel minis at night for her pain. She was prescribed cephalexin. She had an albuterol inhaler on the 28th, 29th, 30th, and 31st, so she took that treatment for 3 days. She was only trying to use one dose of the albuterol inhaler because it can raise the blood pressure, but she also wanted to breathe easier. The muscles were so tight in her ribcage that she couldn't take a deep breath. She still has that in the right lower quarter from her back side ribcage under the arm to the side of the leg. The events did not require emergency room or a physician's office visit. The clinical outcome of Itching was recovered on 29Mar2021 and dizziness was recovered on 30Mar2021, headache recovered around 31Mar2021, unknown for her leg and knee would move with out her wanting it to, felt like three baseballs are sitting on her arm, hit a nerve upon vaccination, half a bandage was covered in blood, kidney infection, urinary tract infection (UTI), fatigue, tightness around her rib cage, size of her arm at the injection site is down to 2.5 inches by and inch, allergic reaction, injected the vaccine that it burned and lethargic and recovering for muscle aches, joint aches, difficulty breathing/hard time breathing, pain in arm, nerves were jerking and feels like an electrical shock, arm pain that radiated under her arm to her rib cage and the front of her shoulder, the sides and the back of her arm was all hard and tense.
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| 64 | 2021-05-07 | dehydration, headache |
feeling so bad; couldn't hold anything down/Vomiting that wouldn't stop/vomiting; Diarrhea; Nauseous...
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feeling so bad; couldn't hold anything down/Vomiting that wouldn't stop/vomiting; Diarrhea; Nauseous; It was just bile coming up; Headache; Was passing clots/were clots/in the vaginal area; Was passing clots/were clots/in the vaginal area/vaginal bleeding; Being dehydrated; couldn't hold her own weight up; stomach pain; So sick; White blood cell count and kidney and liver function were all elevated; White blood cell count and kidney and liver function were all elevated; White blood cell count and kidney and liver function were all elevated; A sharp pain in her side; Stools were dark tarry stringy stuff; Stools were dark tarry stringy stuff; Passing blood in her urine; allergic internal reaction; Weighing 130 pounds but lost about 4 pounds during this illness, so 4 pounds lighter; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, at age 64 years, administered in left arm on 05Apr2021 10:30 (Batch/Lot Number: ER8734) as single dose, for COVID-19 immunization, in order to go back to normal, without a mask so she was told she had to have one. Medical history included hysterectomy, anxiety, disorder in thyroid and cholesterol. Patient had family history of dementia, had to stay home and take care of her mom who is a heart patient and has dementia. Patient had no history of previous immunizations. Patient's concomitant medication includes unspecified medications one is for thyroid, one is for cholesterol and the other 2 are for anxiety. Patient had no prior vaccinations within 4 weeks. No additional vaccines administered on the same date. Patient's symptoms started with a headache the morning after the shot (05Apr2021), was on and off for a couple of days, lasted 3 days or so for a couple days and she took paracetamol (TYLENOL). On 09Apr2021, Friday morning, patient woke up so nauseous she couldn't hold anything down. It was just bile coming up, and she had severe diarrhea and so sick vomiting that wouldn't stop, stomach pain, couldn't hold her own weight up. She got medication at a walk in clinic and that didn't stop it. She started out at acute/urgent care, where she was taken by her daughter on Sunday, 11Apr2021, because she was feeling so bad and was tested for COVID and they said if it does not get better to go to the Emergency Room and she continued having problems. It was not COVID. They said she was dehydrated and send her home to push fluids and drink Pedialyte. Monday or Tuesday (Apr2021) she was in the ER all night (she does not remember the day because all of her days are mixed up). They did CAT scans on her abdomen and ran blood work. They didn't see anything in her abdomen. Her white blood cell count and kidney and liver function were all elevated and they said it was from being dehydrated from diarrhea and vomiting. They gave her fluids and sent her home. Within another 48 hours she still had vomiting and diarrhea, it was a clear bile and a sharp pain in her side. Her stools were dark tarry stringy stuff so she went back to the ER and waited in the lobby for 9 hours. In that 9 hours as she was waiting, she felt like she had to go to the bathroom. She was then wheeled into the bathroom and started passing blood. It wasn't coming from the urethra. It must have come form the vagina, she doesn't have a uterus. There were clots. She started passing blood in her urine but most was in the vaginal area but she has already had a hysterectomy. She was passing clots and her doctor who works in the healthcare field looked at it and said they were clots. Very shortly after, she passed the clot and the pain went away. The pain was passing clots/were clots/in the vaginal area at one point went away but she still have nausea and diarrhea and they gave her more fluids and sent her home. They didn't really want to address the vaginal bleeding. Patient have not been back and was not sure if she is still dehydrated. Patient was still pushing fluids and still not back to normal. Patient's daughter told her that since it was 5 days later it was not a reaction. Patient was thinking maybe it was an allergic internal severe reaction. Patient was weighing 130 pounds but lost about 4 pounds during this illness, so 4 pounds lighter. She stated her daughter-in-law was doing research and found a blog and there are woman the caller's age complaining of these symptoms (unexplained bleeding) after the vaccine. She asked if this was from the vaccine. She stated she was so sick that if there is even a chance then she doesn't want the second dose. She asked if this is a coincidence or has it been reported. She stated she is trying to make a decision on if she should get the second dose because she heard other people have symptoms and take the second shot. The outcome of the events passing clots/were clots/in the vaginal area, headache, a sharp pain in her side, passing blood in her urine, passing clots/were clots/in the vaginal area/vaginal bleeding was recovered on Apr2021, while for the other events, it was unknown.
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| 64 | 2021-05-12 | fatigue |
arm soreness; tiredness; hives that is getting worse on legs, stomach, breast, on head, arms back an...
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arm soreness; tiredness; hives that is getting worse on legs, stomach, breast, on head, arms back and thigs; constriction of the windpipe; This is a spontaneous report from a contactable consumer who reported for herself. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, at the age of 64 years, on 09Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included back pain, fibromyalgia, restless legs syndrome, depression from 1987 to an unknown date, headache, hyperthyroidism. Concomitant medications included gabapentin (GABAPENTIN) taken for restless legs syndrome, start and stop date were not reported; hydrocodone (HYDROCODONE) taken for an unspecified indication, start and stop date were not reported; fluoxetine (FLUOXETINE) taken for depression, start and stop date were not reported; methimazole (METHIMAZOLE) taken for an unspecified indication, start and stop date were not reported; topiramate (TOPIRAMATE) taken for headache, start and stop date were not reported and apixaban (ELIQUIS) taken for an unspecified indication from Feb2021 to an unspecified stop date. The patient received first dose of COVID vaccine BNT162B2 on 19Mar2021 for COVID-19 immunization and experienced hives on legs, top of the arm and swollen lips/lip swelled really big. The patient stated, "I have had both shots of the COVID Pfizer and that the first time I had it, I had some symptoms about a little over a week out. What I had was hives. It is not that real big. This time, I have been about a week out. I was starting to have have hives and I keep having them. They are not just complete blocks just all over but spreaded and I am having kind of constriction of my wind pipe also (14Apr2021). Is that a symptom to that with the COVID virus, the shot. Yes, last I had was April 9th and I am still having spots coming out of me and I am taking Benadryl like crazy and today I have still got them on me, you know the spots and I have like something is cutting my wind pipe off, you know, constriction, you know it's not all the time but its quite a few times a day on that and I am wondering if that. When I started having the problem. The first vaccine I had on night on March 19th and about a week and a half, I had about, I would say 8 to 9 days after that. I started having the hives and then I had a real bad frozen layup out of that (further not clarified) but the second time I had the vaccine also the night and I had the hives about a week out and then I have had constriction of the wind pipe that just completely chocked me out." The patient stated that after the second dose she had arm soreness, tiredness, hives that is getting worse on legs, stomach, breast, on head, arms back and thigs and constriction in the wind pipe. She took Benadryl and Phenergan for it. Therapeutic measures were taken as a result of constriction of the windpipe and urticaria. The outcome of the event constriction of the windpipe was not recovered while other events were unknown.
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| 65 | 2021-01-02 | chills, headache, fatigue, body temperature increased |
Temp. 102, chills, body aches, headache, extreme fatigue; slept most of the day on the 1st; still w/...
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Temp. 102, chills, body aches, headache, extreme fatigue; slept most of the day on the 1st; still w/body aches, less fatigue, decreased headache, temp 100 on 01/02; back to normal by 2:00 on 01/02
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| 65 | 2021-01-03 | chills, body temperature increased |
Jan 3, 2021 mild pain at injection site, diarrhea all day, chills in morning , no fever, temp 97.6 J...
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Jan 3, 2021 mild pain at injection site, diarrhea all day, chills in morning , no fever, temp 97.6 Jan 4, 2021 significant arm pain at injection site (awakened by it at 3 am) with chills, temp 99.6. Took One tablet ALEVE followed by temp 98.6
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| 65 | 2021-01-03 | throat pain, headache | Headache, Sore throat gradually increasing over the past 3 days |
| 65 | 2021-01-03 | fever, fatigue, chills | low fever, chills, aches, foggy head and fatigue |
| 65 | 2021-01-04 | body temperature increased, chills, headache, fatigue |
I had a temperature of 103.8; nauseated and dizzy; eyes hurting; headache; chills; tired; nauseated ...
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I had a temperature of 103.8; nauseated and dizzy; eyes hurting; headache; chills; tired; nauseated and dizzy; pain at the site; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 23Dec2020 at 10:30 as single dose for covid-19 immunization. Medical history included covid-19 from May2020. The patient's concomitant medications were not reported. The patient reported that " I had a temperature of 103.8 " on an unspecified date with outcome of unknown; pain at the site on 23Dec2020 with outcome of unknown; tired on 24Dec2020 with outcome of unknown; nauseated and dizzy on 24Dec2020 with outcome of unknown; chills on 24Dec2020 with outcome of unknown; eyes hurting on an unspecified date with outcome of unknown; headache on 24Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 101.8 Fahrenheit; temperature: 102.4 Fahrenheit; temperature: 101.3 Fahrenheit; temperature: 100.6 Fahrenheit; temperature: 99.2 Fahrenheit; temperature: 103.8 Fahrenheit on 24Dec2020; sars-cov-2 test: positive in May2020, sars-cov-2 test: negative in 23Dec2020. Therapeutic measures were taken as a result of " I had a temperature of 103.8 ". Details were as follows: the nurse received the vaccine on a Wednesday 23Dec2020 at 10:30am. That night at her night shift, she had pain at the site. After midnight, the patient felt tiredness and felt like she had to lay down. At 6:00 she felt nauseated and dizzy. She had a temperature of 103.8. Thursday night, she went home at 7:10 and called her private doctor. The temperature was 101.8 and then it went down. The nurse had been administered the first of 2 dose series of Pfizer BioNTech COVID-19 Vaccine on 23Dec2020. She had received mandatory COVID-19 testing on 23Dec2020, prior to being administered the vaccine; she received the negative results of that COVID-19 testing on 25Dec2020. After being administered the vaccine she was monitored for 15 minutes and then went home. She was fine, had no allergy or anything. She reported that after she was administered the vaccine, she had pain, was really tired, nauseous, chills, high temperature, and her eyes hurting. She mentioned history of COVID-19 in May2020. She works as nightshift nurse at a rehab facility. She woke up that night of 23Dec2020 around 9:00pm-10:30pm and had onset of pain in right arm at injection site which she did not take too seriously because when you get a shot you get pain. Around midnight that night 24Dec2020, she went to work and had onset of being really tired like she just wanted to sit or lay down; she felt like she had to sit down and could not stand well. She continued working that shift on 24Dec2020 but kept getting so tired and had onset of chills and was supporting herself with her med cart. She drank a little sip of ginger tea she brought to work think maybe that would help her feel better. She felt that if she drank more ginger tea she would throw up because she felt nauseous. She was really busy at work 24Dec2020 so she did not check her temperature until after 6:00am which was 103.8 degrees Fahrenheit; and thought no wonder she feels like throwing up. She finished her shift at like 7:00am. For 2 days her temperature was turning high temperature so every 6 hours she was taking Motrin 2-200mg and that would make her temperature go down. Then temperature would go back up to like 102.4 degrees Fahrenheit, she would take ibuprofen (MOTRIN) again, temperature would come down to like 101.3 degrees Fahrenheit. She continued feeling nauseated, having chills, headache and feeling nauseous which she felt all of which could be related to the temperature. She reported to her employee health at work. She thinks it's better. Saturday morning of 26Dec2020, she woke up with temperature of 100.6 degrees Fahrenheit at 7:00am which was the first time her temperature had gown down like that so she did not take the ibuprofen. She checked it again later at like 1:00 pm and temperature was 101.8 degrees Fahrenheit so she took 2 Motrin again. After that her temperature did not go up like that anymore, it was like 99.2 degrees Fahrenheit. As soon as she came from work on 24Dec2020 she called her doctor's office and was seen by Nurse Practitioner who let her out of work for like 2 days. She reported her eyes also have been hurting, mostly her right eye is still hurting, the top is hurting like when you have a small pimple so she keeps checking but does not see anything with her eye. She couldn't even put a cold compress on for the temperature because of her headache and her eyes hurting. She could not even put cold compress to bring her temperature down. Seriousness criteria of all events was unknown. The patient has had no rash, no breathing problems, no coughing, no sore throat or other serious events. She was scared because she wondered if she had COVID-19 again with these events. She mentioned if people do not know these are side effects they would be scared, but she knows from the information she got with the Pfizer BioNTech COVID-19 Vaccine that these are normal for everyone. The only thing she wondered about is if the tiredness she is having is serious or not. She reported prior to getting the COVID-19 vaccine she tested positive for COVID-19 in May2020 and was very sick at that time because she works in a health field with COVID-19 patients. Pfizer BioNTech COVID-19 Vaccine. The patient indicated that she was fine before she got the vaccine; she had no cold, no coughing, no sore throat. The ibuprofen tablet was administered as 200 mg, 2 of the tablets at a time. : The outcome of all the events was unknown. The relatedness of the event, pain to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, really tired to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, nauseous to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, chills to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, high temperature to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, eyes hurting to the suspect drug was reported as related from the reporter using the assessment. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 65 | 2021-01-04 | chills, headache, malaise, fever |
fever; chills; headache; nausea; General malaise 22Dec./ On 24Dec malaise; This is a spontaneous rep...
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fever; chills; headache; nausea; General malaise 22Dec./ On 24Dec malaise; This is a spontaneous report from a contactable Nurse (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left arm on 21Dec2020 17:30 at single dose for COVID-19 immunization. Medical history included Crohns disease, Penicillin allergy. The patient previously took nystatin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the patient received other unspecified medications within 2 weeks of vaccination. The patient experienced general malaise 22Dec2020. On 23Dec2020, experienced fever, chills, headache, and nausea. On 24Dec2020, experienced malaise. No treatment received for the adverse events. Events outcome was recovered on Dec2020. Information about lot/batch number has been requested.
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| 65 | 2021-01-04 | fatigue, headache, sweating |
Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 ...
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Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 cm circumference around injection site; Myalgia; headache; anorexia; fatigue; weight loss; sweats; This is a spontaneous report from a contactable physician (patient). A 65 years old years female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EM9899) via an unspecified route of administration at Left arm on 22Dec2020 01:15PM at single dose for COVID-19 immunization. The patient's medical history included hypertension, body mass index (BMI) 30, hypothyroidism and Covid-19. Known allergies: penicillin, sulpha drugs, seasonal allergies. No other vaccine in four weeks. The concomitant was reported as hydrochlorothiazide, losartan potassium (HYZAAR), levothyroxine sodium (SYNTHROID), Metformin. The patient experienced pain, edema and erythema in 4 cm circumference around injection site myalgia, headache, anorexia, fatigue, weight loss, sweats, all started from 24Dec2020. No treatment received for events. The outcome of the events was recovering.
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| 65 | 2021-01-04 | headache |
Had onset of intense headache and had difficulty breathing. A nebulizer treatment was given and exa...
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Had onset of intense headache and had difficulty breathing. A nebulizer treatment was given and examined by a provider. Her husband was summoned to bring her home to rest.
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| 65 | 2021-01-04 | headache |
She thought maybe she had food poisoning bc of the weird symptoms; headache; achy muscles; loose sto...
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She thought maybe she had food poisoning bc of the weird symptoms; headache; achy muscles; loose stools; sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), on 20Dec2020 at single dose for covid-19 immunisation. Medical history included None. There were no concomitant medications. The patient experienced loose stools on 25Dec2020, headache on 26Dec2020, achy muscles on 26Dec2020, sore arm on 20Dec2020, she thought maybe she had food poisoning bc of the weird symptoms on an unspecified date. She initially had a sore arm and the usual effects which she expected. Then, about six days into it she started having a headache and achy muscles. It all started with loose stool. She did get a COVID test because of signs of COVID. But it was negative. She thought maybe she had food poisoning bc of the weird symptoms. The headaches were bad, but they were not as bad currently. She had a loose stool that lasted a couple of days. The headaches were really mild currently. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Dec2020. Outcome of loose stools, sore arm was recovered in Dec2020, headache was recovering, achy muscles was not recovered, other was unknown.
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| 65 | 2021-01-05 | chills |
stated that she is having chills; stated that her arm is harsh; stated that her arm is sore; This is...
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stated that she is having chills; stated that her arm is harsh; stated that her arm is sore; This is a spontaneous report from a contactable nurse reported for herself. A 65-year-old female patient received bnt162b2, via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history included covid-19 from Apr2020 to an unknown date. She further stated that she had COVID back in April and survived. Stated that she had the pneumonia part of it and went back to work in June. The patient's concomitant medications were not reported. On an unknown date, patient was having chills since she had the shot. Stated that her arm was harsh and feels real sore. Patient wanted to know if the chills were common. The outcome of the events was unknown. Information on Lot/Batch number has been requested.
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| 65 | 2021-01-05 | headache |
Had onset of intense headache and had difficulty breathing. A nebulizer treatment was given and exam...
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Had onset of intense headache and had difficulty breathing. A nebulizer treatment was given and examined by a provider. Her husband was summoned to bring her home to rest.
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| 65 | 2021-01-05 | headache |
Dizziness, Headache, NauseaVomiting, terrible vertigo 2 days after vaccine, also very nauseated Narr...
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Dizziness, Headache, NauseaVomiting, terrible vertigo 2 days after vaccine, also very nauseated Narrative: Did not have to seek any medical attention, symptoms began to resolve after 3 days, but was off of work for a day. Mostly recovered, just slight vertigo.
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| 65 | 2021-01-05 | throat pain, headache |
After receiving vaccine, c/o being lightheaded, dizzy, headache, left arm pain with fingers tingling...
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After receiving vaccine, c/o being lightheaded, dizzy, headache, left arm pain with fingers tingling, sore throat and chest tightness.
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| 65 | 2021-01-05 | fever, headache, chills | Fever, chills, headache, nausea. |
| 65 | 2021-01-06 | body temperature increased |
NauseaVomiting Narrative: Received vaccine on 12/28/2020 . Was doing well until one hour before the...
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NauseaVomiting Narrative: Received vaccine on 12/28/2020 . Was doing well until one hour before the call. C/O of abdominal cramp, distention, nausea. No vomiting, temperature was 99.7F. No similar episodes before. No rash.
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| 65 | 2021-01-07 | chills, fatigue | It was 3 days after I became fatigue and chill. I also had body aches. |
| 65 | 2021-01-07 | chills, headache | awake most of the night, body aches, muscle pain, joint pain, chills, nausea, HA, ok today |
| 65 | 2021-01-07 | chills, sinusitis, fatigue |
Three days after I became very tired and had chills. Also I felt very achy and did not have a fever....
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Three days after I became very tired and had chills. Also I felt very achy and did not have a fever. The next morning I felt a little better. I had sinus infectious .
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| 65 | 2021-01-07 | fatigue | Body aches, bone pain and extreme fatigue, loss of appetite |
| 65 | 2021-01-07 | headache, malaise |
Abdominal cramps; "someone's pulling my hair"; headache; muscle pain; feeling sick; feeling warm; Th...
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Abdominal cramps; "someone's pulling my hair"; headache; muscle pain; feeling sick; feeling warm; This is a spontaneous report from a contactable Nurse reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via an unspecified route of administration in the left arm on 02Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included amlodipine (unknown manufacturer) and multivitamins. On 02Jan2021 at 03:00 AM the patient experienced abdominal cramps, "someone's pulling my hair", headache, muscle pain, feeling sick, feeling warm with outcome of recovering. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. No follow up attempts are possible. No further information is expected.
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| 65 | 2021-01-07 | malaise, headache, chills |
shakes; chills; headaches; body aches; general malaise; This is a spontaneous report from a contacta...
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shakes; chills; headaches; body aches; general malaise; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not provided) via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included Crohn's disease. The patient's concomitant medications were not reported. The patient previously took pneumococcal vaccine in 2020 (reported as last year) and she got a flu shot every year with no issues. She had no issues with vaccines in the past. Patient stated that she was calling about the Pfizer BioNtech Vaccine EUA. Patient stated that she had 1st dose 21Dec2020 and then she had reaction on 22Dec2020 23Dec2020 and part of 24Dec2020, she was scared to death, she was having shakes, chills, headaches, body aches. Due to this she would like to know if it is okay to get the second dose. Her second dose is schedule for 11Jan2021. On 22Dec2020 she had the general malaise, like she was punk'ed. She was home that night and got the shakes. All side effects ended on 24Dec2020 by dinner time. Patient stated that they didn't give her anything after getting the vaccine, they just gave information like this phone number, and websites. They gave stuff to read. She got the vaccine at (Hospital name). She has had no positive tests for Covid prior to the vaccine. She had 1 negative test at the end of Aug2020, and that was because she went to hospital for a total knee and they did Covid test then. She has had no antibody tests. Patient stated that she did vaccine reaction reporting on the website provided, she did the online reporting. The outcome of the events was recovered on 24Dec2020. Information on lot/batch number has been requested.
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| 65 | 2021-01-08 | headache | Pain Right Arm Headache Pain r side of face and r eye |
| 65 | 2021-01-08 | sweating, fever | fever/sweats for greater than a day |
| 65 | 2021-01-08 | fever, chills | Recipient reported fever and chills. |
| 65 | 2021-01-09 | headache, fever |
Tachycardia with first dose on Dec 17, then, with 2nd dose experienced off and on tachycardia and al...
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Tachycardia with first dose on Dec 17, then, with 2nd dose experienced off and on tachycardia and also irregular rhythm , no other cardiac related sequels . Second dose, 1/7/21, experienced fever on 1/8/21 of 101.6 off and on that day. Used mainly Advil and Tylenol for fever and headache.
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| 65 | 2021-01-09 | fever, fatigue, cough |
Vaccinated at 8 am,at about 7 pm I had site and muscle pain 12/31/20,then 48 hours I had loss of s...
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Vaccinated at 8 am,at about 7 pm I had site and muscle pain 12/31/20,then 48 hours I had loss of smell and taste,body aches,I was itchy all over,could not sleep that nite,I called did the Conversation at work and told me not to go to work,the next day 1/3 /21,employee health called me to get tested and tested positive on 1/4/21,I was place on quarantine for 10 days,I tried calling your office with 800 number and left my number nobody called me,I also experienced eye irritation,cough ,short of breath,low grade fever,nausea fatigue
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| 65 | 2021-01-10 | chills, fatigue, malaise | Recipient reported chills, malaise and fatigue. |
| 65 | 2021-01-10 | chills, headache | Headache, Muscle aches and chills |
| 65 | 2021-01-10 | headache | Headache, dizziness, nausea, body aches |
| 65 | 2021-01-10 | headache |
approximately 10 minutes after taking the covid vaccine client started c/o headache, tightness in he...
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approximately 10 minutes after taking the covid vaccine client started c/o headache, tightness in her throat, and slight difficulty breathing. She self administered her albuterol inhaler, and was started on O2 AT 4 L.at 10:16 she said that the symptoms were all gone. at 10:24 she said her throat tightness had returned, she was offered benadryl and epinephrine which she refused bc she said she had to drive home. she took benadryl po when she got home.when she got home, the left side of her face became numb, she had a headache and burning eyes. The next day she still had a little numbness on the left side of her mouth. no problems since.
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| 65 | 2021-01-10 | headache |
Numbness of the left side of the face and headache on the left side and part of the tongue; Numbness...
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Numbness of the left side of the face and headache on the left side and part of the tongue; Numbness of the left side of the face and headache on the left side and part of the tongue; The left side of my body, like burning (ankle, elbow); The left side of my body, like burning (ankle, elbow); This is a spontaneous report from a contactable healthcare professional (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular at left arm on 30Dec2020 11:30 at SINGLE DOSE for COVID-19 immunization. Medical history included known allergies to Uva roja. The patient is not pregnant. No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered was in the Doctor's office/urgent care. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) included atorvastatin (LIPITOR) and fexofenadine hydrochloride (ALLEGRA). The patient previously took titanium and experienced allergies. On 30Dec2020 , the patient experienced numbness of the left side of the face and headache on the left side and part of the tongue. The left side of patient's body, like burning (ankle, elbow). No treatment received for the events. The events were assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the events was recovered on unspecified date. Information on lot/batch number has been requested.
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| 65 | 2021-01-10 | lethargy, headache, fever |
Headache, fever (101.7), nausea, lethargy for several hours on day after vaccine was administered. F...
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Headache, fever (101.7), nausea, lethargy for several hours on day after vaccine was administered. Fever broke during the night. Energy level was still low second day after, slight headache that morning.
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| 65 | 2021-01-10 | fever, runny nose, cough, chills |
I developed rigors with high fever 39.4 C. I was coughing, non-productive cough, pain at the base o...
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I developed rigors with high fever 39.4 C. I was coughing, non-productive cough, pain at the base of my lungs from coughing, running nose, muscle pain, GI problems- vomited once and stool foul smelling, loose. I developed hematuria- visit to Patient first, placed on an antibiotic. Continued with high fever and shivers- went to Emergency Department, admitted. Started on cefuroxime- fever and symptoms subsided. Discharged home. One week at home- getting stronger by day. Back to work January 11, 2021
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| 65 | 2021-01-11 | chills, headache |
headache; chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 65-year...
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headache; chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 21Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, chills, and nausea on an unspecified date. The patient asked if she is going to get the same reaction on the second dose. The outcome of events was unknown. Information on the Lot/Batch number has been requested.
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| 65 | 2021-01-11 | chills, fever | Chills with fever, Acute diarrhea |
| 65 | 2021-01-11 | chills |
non stop diarrhea; nausea; chills; joint pain; sore at the injection site; This is a spontaneous rep...
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non stop diarrhea; nausea; chills; joint pain; sore at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 02Jan2021 07:30 at single dose for covid-19 immunization. The patient's medical history was none, and there were no concomitant medications. The first dose patient received on 02Jan2021 morning, and she just had symptoms she expected, she was sore at the injection site and she had some joint pain on 03Jan2021, but those disappeared on 04Jan2021. On 05Jan2021, she woke up and had non stop diarrhea with a little bit of nausea. Patient had not had a fever, but did feel chilled. Patient didn't think she ate anything bad. She was suspecting this may be a side effect of the vaccine. Patient didn't have a prescribing doctor. She got it at the hospital she worked at. She received it the 02Jan2021 7:30 am. Patient started the diarrhea on 05Jan2021 morning at 8:30. The nausea was on and off, but started this morning as well. Patient didn't take any ongoing medication. Outcome of events sore at the injection site and joint pain was recovered on 04Jan2021, outcome of event diarrhea was not recovered, and outcome of events nausea, and chills was recovering.
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| 65 | 2021-01-11 | headache, chills |
Joint pain/Her knee really hurts; Muscle pain; Headache; Chills; Her back hurts, especially at night...
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Joint pain/Her knee really hurts; Muscle pain; Headache; Chills; Her back hurts, especially at night/Her lower back hurts; Her neck is really bad; Her hands hurt; mild arthritis; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via an unspecified route of administration in left upper arm on 30Dec2020 15:20 at single dose for covid-19 immunization in hospital and vaccine was not administered at Military Facility. Medical history included car accident where she broke her neck, usually she is hot all the time, she is a health person and she went the whole year without a cold. There were no concomitant medications. Prior vaccinations included regular flu shot, but she thought it was longer than 4 weeks. There was no vaccines was administered on same date of Pfizer bnt162b2. The patient clarified the side effects she was experiencing as: joint pain, muscle pain, occasional headache, and chills that were coming in and out. The patient explained she got the vaccine on 30Dec2020. The patient started to have the joint pain 3-4 days after getting the vaccine in Jan2021. She stated it was still uncomfortable. Her back hurts, especially at night. It was like all the time, but more so at night. Her neck was really bad. Pretty much every place she had mild arthritis she hurt. She felt it mainly in her neck. She mentioned historically she was in a car accident where she broke her neck. The pain in her neck was almost to the point where she was when she was initially healing from the accident. Her hands hurt. Her lower back hurts. Her knee really hurts. It all hurt more than normal. The muscle pain started 3-4 days after she got the vaccine in Jan2021. The muscle pain was sporadic. She would feel it a little bit and then it went away and then she would feel it again. The headache started within the last 2-3 days in Jan2021. She thought it had gone away for the most part. She just got an occasional headache when her neck hurt a lot. It kind of went with the neck hurting. The chills started around 02Jan2021 or 03Jan2021. Usually she is hot all the time. However, lately she had been feeling chills. She was not sure if it was due to weather or if she was really having chills. This is unusual for her. She stated the chills was kind of the same or maybe a little better. She had a COVID test done on 26Dec2020 which was negative. She had to have the test done for pre-surgical reasons. The adverse events did not require a visit to emergency room or physician office. The outcome of joint pain/knee really hurt, muscle pain and chills were not resolved, outcome of rest events were unknown.
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| 65 | 2021-01-11 | headache, fatigue |
I had body aches, headaches, and just felt tired. I took Tylenol extra strength every 6 hours for a ...
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I had body aches, headaches, and just felt tired. I took Tylenol extra strength every 6 hours for a 24 hour period. After that I felt fine.
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| 65 | 2021-01-11 | headache |
received the vaccine on December 17th and tested positive for Covid on December 27th/COVID PCR (poly...
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received the vaccine on December 17th and tested positive for Covid on December 27th/COVID PCR (polymerase chain reaction) test: positive on 28Dec2020; received the vaccine on December 17th and tested positive for Covid on December 27th/COVID PCR (polymerase chain reaction) test: positive on 28Dec2020; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable nurse (patient) reported that a 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 17Dec2020 11:00 in left deltoid at single dose for covid-19 immunization. Medical history included thyroid cancer from an unknown date and unknown if ongoing, bilateral thyroidectomy in 2014. Family Medical History: Father died of lung cancer. Mother died of cardiac arrest in 1972. Concomitant medication included levothyroxine sodium (SYNTHROID) for bilateral thyroidectomy. The patient received the vaccine on 17Dec2020 and tested positive for covid on 27Dec2020. The adverse events resulted in emergency room visit. The patient underwent lab tests and procedures which included tested positive for COVID on 27Dec2020, COVID PCR (polymerase chain reaction) test: positive on 28Dec2020. Vaccination facility type was hospital. No additional vaccines administered on same date of Pfizer suspect. Received COVID Vaccine on 17Dec2020. Tested positive for COVID in emergency room on 27Dec2020. Tested positive on a COVID PCR test on 28Dec2020. Prior vaccinations within 4 weeks was none. Caller received the first dose of the COVID Vaccine. Tested positive for COVID on 27Dec2020. Is about to get the second dose of COVID Vaccine and would like to know if she should proceed or wait. Since quarantine, she has had no fever. Is slightly short of breath and has a headache. Works in COVID units in a hospital. Wants to make sure she can receive the second dose. Stated she had no adverse reaction to the COVID Vaccine unless an adverse reaction can occur two weeks after. Is attributing the shortness of breath and headache to testing positive for COVID. Shortness of breath and headache only occurred after testing positive for COVID. Reason she went to the hospital is because she lost her sense of smell. She got tested and was positive for COVID. Lost sense of smell, went to Emergency Room, and notified doctor of positive test the following day, 28Dec2020. Clarified she just went to the emergency department to get tested for COVID and then went home. Was called with positive results in an hour. Caller wanted to know when she should proceed with getting her second dose of Covid vaccine. She is supposed to receive her second dose tomorrow. She thought she was going to take second dose when I completely recovered. Caller asked if she waited until the 13th to receive second dose of Covid vaccine, would it be effective. She would feel more comfortable doing that. The outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID-19 based on the known safety profile. However the short duration of 9 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
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| 65 | 2021-01-12 | chills, fever | chills, low grade fever, diarrhea |
| 65 | 2021-01-12 | fatigue, headache | Slight sore arm at injection site, headaches, body aches, fatigue |
| 65 | 2021-01-12 | fatigue |
24 hr after vaccine developed body aches in shoulders, hip and back. Moderate to severe fatigue and...
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24 hr after vaccine developed body aches in shoulders, hip and back. Moderate to severe fatigue and sore left arm at site of injection. Symptoms remained for 36 -48 hrs. Took Tylenol for body aches , increased fluid intake and rested for 2 days. Completely resolved by day 3
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| 65 | 2021-01-12 | headache, fever, fatigue, chills |
Most extreme chills Fever 100 F Headache Neck ache Body aches Fatigue All lasted until about 6pm and...
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Most extreme chills Fever 100 F Headache Neck ache Body aches Fatigue All lasted until about 6pm and then patient was fine. Got Covid at work in March 2020
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| 65 | 2021-01-13 | chills, body temperature increased |
Awoke on 1/8/21, about 18 hours after injection with body aches and aching joints persisting for the...
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Awoke on 1/8/21, about 18 hours after injection with body aches and aching joints persisting for the rest of the day, taking ibuprofen every four hours. 1/9/21 I woke with moderate itching of scalp, body aches continue. Throughout the day I had large itching whelps at different places on my body. At 11:00am my temperature was 100.5, at which time I also had moderated chills for about an hour. I took ibuprofen and tylenol and benadryl at 4 hour intervals. after the chills stopped (about an hour) symptoms began to calm down. Sunday I woke with no symptoms at all.
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| 65 | 2021-01-13 | headache, chills, fatigue | Fatigue,headache, chills lasting about 36 hours |
| 65 | 2021-01-13 | lethargy, malaise, sweating |
1/13/2021 at 3:11 pm EMT was alerted to client in observation area. Client was lethargic and compla...
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1/13/2021 at 3:11 pm EMT was alerted to client in observation area. Client was lethargic and complained of dizziness and feeling sick. Client brought to medic area. EKG and B/P and blood sugar taken. Client diaphoretic.
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| 65 | 2021-01-13 | fever, headache | Fever , body aches, shortness of breathe, headache |
| 65 | 2021-01-14 | chills, fatigue, sweating |
generalized body aches; chills; heart rate in 140s; diaphoretic; dizzy; fatigue; This is a spontaneo...
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generalized body aches; chills; heart rate in 140s; diaphoretic; dizzy; fatigue; This is a spontaneous report from a contactable healthcare professional. A 65-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), via an unspecified route of administration from 07Jan2021 13:30 to 07Jan2021 13:30 at a single dose for an unspecified indication. Medical history included covid (COVID prior vaccination: Yes). Concomitant medication included valacyclovir and vitamin d3. The patient previously took ampicillin, Keflex and metronidazole; the patient had allergies with all. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Dec2020. It was reported that 9-hours post second vaccine, the patient had generalized body aches, chills, 2 hours later Heart Rate in 140s, diaphoretic, chills and dizzy. HR normalized 6 hours later. Diaphoresis lasted 10 hours. No treatment was received for the events. The patient also reported to have extreme fatigue. The outcome of the event heart rate abnormal and diaphoretic was recovered on 08Jan2021 while recovering for the other events.
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| 65 | 2021-01-14 | chills, headache | CHILLS, HEADACHE, MUSCLE PAIN |
| 65 | 2021-01-15 | headache, chills, sweating | chills, bodyache, headache, sweating |
| 65 | 2021-01-15 | fever |
Had fever of 102.3 deg F oral. Took 1000 mg of acetaminophen and fever broke. No further fevers occ...
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Had fever of 102.3 deg F oral. Took 1000 mg of acetaminophen and fever broke. No further fevers occurred. Also had muscle aches during fever.
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| 65 | 2021-01-16 | chills, malaise, fever | This AM developed malaise, fever, and chills |
| 65 | 2021-01-16 | fever, fatigue, chills |
Severe chills began at 10:30 pm; then fever spiked; slept fitfully and finally got up around 2 am to...
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Severe chills began at 10:30 pm; then fever spiked; slept fitfully and finally got up around 2 am to get a thermometer -while in bathroom the room started spinning and I fainted or passed out. I came to on the bathroom floor and managed to crawl back to the bed. There was confusion and the inability to understand what was going on. I remained in bed until the next morning when all symptoms abated except for some fatigue.
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| 65 | 2021-01-17 | body temperature increased |
12 hours after receiving the second vaccine I developed a temp of 103 that lasted approximately 36 h...
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12 hours after receiving the second vaccine I developed a temp of 103 that lasted approximately 36 hours. I also developed a rash on my forearms 24 hours after the vaccine which lasted approximately 24 hours
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| 65 | 2021-01-17 | headache, fever |
Patient reports re-occurrence of Left arm pain, redness, swelling and warmth 10 days post vaccinatio...
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Patient reports re-occurrence of Left arm pain, redness, swelling and warmth 10 days post vaccination. States she had these same symptoms up to 3 days after vaccine but they resolved. She is also reporting onset of headache, joint pain yesterday (9 days post vaccine) and low grade temp today (10 days post vaccine).
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| 65 | 2021-01-17 | headache, respiratory tract congestion |
chest congestion; throat hurts; arm hurt; body aches; Weakness; Headache; This is a spontaneous repo...
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chest congestion; throat hurts; arm hurt; body aches; Weakness; Headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELI283, expiration date not reported), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. Medical history included 'Blood pressure'. Concomitant medication included doxorubicin hydrochloride (LIPISOL) for blood pressure. The patient reported that on 08Jan2021 (Friday), she had the COVID vaccine. On 09Jan2021 (Saturday), her arm hurt, she had body aches, and weakness. She also had a headache Saturday night. On 10Jan2021, she started getting chest congestion and her throat was hurting. When she was spitting out it felt like her throat was scratchy. Patient further reported that her arm does not hurt now. It still bothers her a little if she touches it, but doesn't if she doesn't touch it. Patient also reported that she does not have too much body aches now. She had a good dinner and took two of the 600mg Ibuprofen. It helped her. It still hurts a little. Patient reported that her weakness feels a little better. No fever and she has been checking her temperature. Patient clarified that her throat wasn't bothering her last night, but today it was bothering her. It was the bottom of her throat. She was supposed to go back on the 29th to get the other part. The patient was recovering from arm hurt, body aches, and weakness; has not recovered from chest congestion; and unknown outcome for the remaining events.
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| 65 | 2021-01-17 | headache |
TOOK TYLENOL SINUS HEADACHE AT 2PM ON FRIDAY. WOKE UP FRIDAY AT MIDNIGHT WITH CHILLS, HEADACHE AND S...
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TOOK TYLENOL SINUS HEADACHE AT 2PM ON FRIDAY. WOKE UP FRIDAY AT MIDNIGHT WITH CHILLS, HEADACHE AND SHAKING. TOOK TYLENOL SINUS. REPEATED TYLENOL SINUS EVERY 4 HRS FOR HEADACHE. ON SAT AND SUNDAY WAS WEAK--MONDAY FELT BETTER.
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| 65 | 2021-01-17 | fever, lethargy |
Six days after having our first COVID-19 vaccine my husband and I started experiencing fever, aches,...
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Six days after having our first COVID-19 vaccine my husband and I started experiencing fever, aches, and lethargy. We notified our primary care facility. We were sent to get a test for COVID-19. We both tested positive. We need to know how this affects our second vaccine which is scheduled for January 27th. Please advise us.
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| 65 | 2021-01-18 | chills, fever, headache |
was burning up; Sore arm; Throbbing headache; I was hot, I was cold; Fever; Chills; This is a sponta...
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was burning up; Sore arm; Throbbing headache; I was hot, I was cold; Fever; Chills; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received the second dose of BNT162B2 (BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration, on 07Jan2021, at single dose, for COVID-19 immunization, in the hospital. Medical history included blood pressure high and high cholesterol. The patient reported "I just got my second Pfizer Vaccine (clarified as BioNTech Covid 19 vaccine) yesterday (07Jan2021) and I just wanted to call to report the side effects that I have because they told me you should specially after the second one. And I have had fever, headache, and chills. So, I just wanted to report this". When asked about the event start date, the patient stated, "I went to sleep, I got the shot yesterday morning on early (07Jan2021). And then I was fine except for the sore arm. And then I woke up in the night. I fell asleep fine; I woke up through the midnight and it was burning up. So, I took my temperature. So, I'd say about 3 am (08Jan2021)". When asked if the patient was still experiencing the events, the patient stated, "Little bit because I had also throbbing headache and I was hot, I was cold. I did take Tylenol (treatment) and I did think that it started to help a little bit. Because I did got, my fever has gone down." The outcome of the events was recovering.
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| 65 | 2021-01-18 | chills |
Appendicitis; Vomiting; Nausea; Chills; This is a spontaneous report from a contactable consumer. A...
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Appendicitis; Vomiting; Nausea; Chills; This is a spontaneous report from a contactable consumer. A consumer reported that her 65-year-old mother received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number Unknown), into the arm at single dose on 31Dec2020 for COVID-19 immunization. The patient did not have any medical history and did not receive any concomitant products. On 31Dec2020 the same evening of vaccination, the patient experienced vomiting, nausea and chills that were considered flu like. On 03Jan2021 or 04Jan2021 her appendix ruptured. She entered emergency room on 07Jan2021 and was diagnosed with appendicitis. She was admitted to hospital on 07Jan2021. She has been given hospital care for past four days. She will have surgery in 6 weeks to repair and right now they are cleaning ruptured area. Her care team is wondering if she should get second dosage. The patient is currently hospitalized. The patient recovered from the event vomiting on 31Dec2020, recovered from the events Nausea and Chills on 07Jan2021 and was Recovering from the appendicitis. Information on the lot/batch number has been requested.
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| 65 | 2021-01-18 | fatigue, runny nose, headache | Runny nose, diarrhea, headache, fatigue, abd pain. |
| 65 | 2021-01-18 | malaise, chills, fever |
Received second vaccine on 1/5/21 and on 1/6/21 started having chills, malaise and 102.3F fever. Sy...
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Received second vaccine on 1/5/21 and on 1/6/21 started having chills, malaise and 102.3F fever. Symptoms persisted appx. 24 hours and she took two days off work. She has now returned to normal and back to work.
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| 65 | 2021-01-18 | fever, chills, headache, fatigue | Fever, chills, nausea, h/a, fatigue, vomiting lasting > 48* |
| 65 | 2021-01-19 | fatigue, chills, headache, fever |
passed out; dizzy; hit the ground; nausea; pain at injection site; fever; chills; tired; severe head...
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passed out; dizzy; hit the ground; nausea; pain at injection site; fever; chills; tired; severe headache; vomiting x 2; cold; experienced orthostatic hypotension; This is a spontaneous report from a contactable other HCP. A 65-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EK9231) vaccine , intramuscular in the left arm on 07Jan2021 11:00 at single dose for Covid-19 immunisation . Medical history included rubber sensitivity (Latex). The patient's concomitant medications were not reported. On 09Jan2021 12:00 the patient experienced orthostatic hypotension , passed out with outcome of recovered , dizzy with outcome of recovered , hit the ground with outcome of recovered. These events were considered serious because medically significant. On 09Jan2021 12:00 the patient also experienced the following non serious events: nausea with outcome of recovered , pain at injection site with outcome of recovered , fever with outcome of recovered , chills with outcome of recovered , tired with outcome of recovered , severe headache on with outcome of recovered , vomiting twice with outcome of recovered , cold with outcome of recovered. The reporter stated the patient attempted to get out of bed and she passed and hit the floor. Caller states she think she may have experienced orthostatic hypotension. Caller stated if she had stayed in bed she probably would not have fallen. Her husband found her laying in vomit The patient underwent lab tests and procedures which included body temperature: 99.6 fahrenheit on unknown date.; Sender's Comments: Based on a chronological temporal association a causal relationship between events orthostatic hypotension , passed out dizzy and falling down and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 65 | 2021-01-19 | headache, chills, fatigue, fever | Fever of 101.5 Headache Pain at injection site Body aches Chills, extreme fatigue |
| 65 | 2021-01-19 | fever, fatigue, headache | fever, myalgia, rash, headache, nausea, fatigue |
| 65 | 2021-01-20 | headache, fever, chills | Severe chills, fever, lower stomach pain, headache, injection site pain |
| 65 | 2021-01-20 | sweating |
In less than 60 seconds, I became Diaphoretic, had substernal chest pain radiating to back, nausea a...
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In less than 60 seconds, I became Diaphoretic, had substernal chest pain radiating to back, nausea and eventual vomiting. This lasted for a long period of time, I asked to go to ER because I was so alarmed. I felt great all day prior to injection. I had been at work as a nurse with Mobile County Public School System, until I came to get vaccination .
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| 65 | 2021-01-20 | runny nose | Swelling at injection site, swelling of hands, next day runny nose |
| 65 | 2021-01-20 | throat irritation | generalized rash, tickle in throat sensation |
| 65 | 2021-01-21 | chills, fever |
First: headache for 6 days. Body aches and low grade temp intermittently. Itching on day 8? Second:...
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First: headache for 6 days. Body aches and low grade temp intermittently. Itching on day 8? Second: chills and low grade temps x 10 days. Joint pain x 10 days. Itching on day 13. Intermittent headaches and brain fog x 10 days.
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| 65 | 2021-01-21 | chills | Chills for 1.5 hours beginning approx 2 hours following injection |
| 65 | 2021-01-21 | fatigue, headache | ACHES/ HEADACHE/ FATIGUE/ NAUSEA. LASTED UNTIL 1/14 AFTERNOON. TOOK ADVIL AND REST |
| 65 | 2021-01-21 | fatigue, influenza like illness, headache, chills |
Flu like symptoms Major chills could not get warm Fatigue had to leave work No fever Headache Resolv...
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Flu like symptoms Major chills could not get warm Fatigue had to leave work No fever Headache Resolved by 11:00am 01/22/2020 No adverse events with first dose
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| 65 | 2021-01-21 | fatigue |
Patient began to experience nausea, dizziness, generalized weakness, and an elevated BP (209/101) ap...
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Patient began to experience nausea, dizziness, generalized weakness, and an elevated BP (209/101) approximately 5 minutes after receiving the 2nd dose of the COVID vaccine. The patient was taken to the emergency department for further workup. In the ED, the patient was given acetaminophen and ondansetron with resolution of all symptoms except generalized weakness and fatigue. Workup in the ED was negative, and the patient was discharged home.
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| 65 | 2021-01-21 | headache, chills, fever | One week later, fever of 102.8, chills, headache, body aches lasting 2 days |
| 65 | 2021-01-21 | headache, fatigue |
Nausea on 1/19. Awoke on 1/20 with extreme muscle aches and fatigue, more nausea in evening, fatigu...
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Nausea on 1/19. Awoke on 1/20 with extreme muscle aches and fatigue, more nausea in evening, fatigue,. Got up on 1/21 still slightly achy but headache all day. Slept a great deal and took advil.
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| 65 | 2021-01-21 | sweating, fever, fatigue, headache |
Approx 5.5 days after receiving her first COVID-19 vaccine, reporter developed a low-grade fever of ...
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Approx 5.5 days after receiving her first COVID-19 vaccine, reporter developed a low-grade fever of 99.1-99.4F, headache, light nausea, and fatigue. Noted profuse sweating upon waking on 1/21/21.
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| 65 | 2021-01-21 | sweating |
Has a flush feeling over entire body, then broke out in a sweat. Felt prickly (pins and needles] in...
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Has a flush feeling over entire body, then broke out in a sweat. Felt prickly (pins and needles] in my arms on and off all day.
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| 65 | 2021-01-21 | fever, chills, fatigue, headache |
First: headache x 6 days . Pruititis day 10 which incurred eruption on finger. Generalized muscle...
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First: headache x 6 days . Pruititis day 10 which incurred eruption on finger. Generalized muscle and joint pain x 7 days with low grade temp and chills. Fatigue Second dose: low grade temp and chills and body aches x 10 days. Fatigue. Brain fog
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| 65 | 2021-01-21 | fever | fever 4 days later and diarrhea |
| 65 | 2021-01-21 | sleepiness, fatigue |
Monitored for 15 minutes at facility. Left and came home. Within 1hour I was lightheaded and dizzy. ...
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Monitored for 15 minutes at facility. Left and came home. Within 1hour I was lightheaded and dizzy. Mental fog and exhaustion. Symptoms lasted through. 1/21/2021. Today mental fog lifted, lightheaded but not dizzy. Not as sleepy. Seems to be lessening as day goes on (1/22/2021)
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| 65 | 2021-01-21 | throat irritation |
Angioedema, which consisted of tingling/pressure in lips, chin, roof of mouth, tongue, and pharynx; ...
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Angioedema, which consisted of tingling/pressure in lips, chin, roof of mouth, tongue, and pharynx; feeling of swelling and burning in throat; slight difficulty swallowing; hoarseness; pruritus
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| 65 | 2021-01-22 | headache | Severe nausea, syncope, headache |
| 65 | 2021-01-22 | fever, chills | After I got home from work on Friday 1/22 I developed a fever of 100.8 with chills. |
| 65 | 2021-01-22 | throat irritation |
Swollen lower face with rash, swollen lips, swollen throat, swollen tongue, throat hot on inside and...
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Swollen lower face with rash, swollen lips, swollen throat, swollen tongue, throat hot on inside and outside, throat tightening, lungs heavy , not, and tightening. Body heavy. Mind disconnected. Happened with in 5 minutes of injection.
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| 65 | 2021-01-22 | throat irritation |
Patient received 2nd dose of Pfizer COVID vaccine (Lot# EL9261). Within the 15 min wait time the pat...
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Patient received 2nd dose of Pfizer COVID vaccine (Lot# EL9261). Within the 15 min wait time the patient reported swelling of tongue. ( 1040 am) Immediately reported and responded. Patient alert and verbalized she felt "ok". Patient then reported increase in symptoms and was treated with 100 mg of Benadryl IM left deltoid. B/P 110/60, HR 77 and Pulse Ox 98%. Patient then reported a "tickle in the back of my throat" Patient immediately treated with Epinephrine 0.5 mg IM right thigh @ 1059. B/P 137/65, HR 73, Pulse OX 99% EMS arrived and patient transported.
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| 65 | 2021-01-23 | fever |
Reported fever of 101 degrees F yesterday with joint pains and today diarrhea with continued joint p...
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Reported fever of 101 degrees F yesterday with joint pains and today diarrhea with continued joint pains. Has had BM five times already. Temp decreased to 100 degrees F. along with diarrhea and joint point
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| 65 | 2021-01-24 | chills, fatigue | Diarrhea Chills Muscle aches Extreme fatigue |
| 65 | 2021-01-24 | headache, chills | Raid heart beat headache chills and extremely high blood pressure |
| 65 | 2021-01-24 | headache |
BY the evening I developed a headache and had serve pain for about 5 days in the middle of my back....
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BY the evening I developed a headache and had serve pain for about 5 days in the middle of my back. After that my nose got stocked up and I ended up getting Covid.
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| 65 | 2021-01-24 | headache |
At 53 hours after injection experienced piercing headache throughout different parts of head, face ...
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At 53 hours after injection experienced piercing headache throughout different parts of head, face and neck accompanied by nausea though no vomiting or fever. Tylenol did not touch it. Slept on and off. Lasted 24 hours and then disappeared.
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| 65 | 2021-01-24 | fever, chills, fatigue, headache |
I had two shots one 12/30 and the other 1/20 had side effects from each. First shot fever, chills, e...
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I had two shots one 12/30 and the other 1/20 had side effects from each. First shot fever, chills, exhaustion for 4 days. shot given on Wednesday and not able to shower or get up till Sunday Second shot symptoms more severe. Headache, sick to my stomach vomited, and exhaustion same thing shot given on Wednesday and not able to get up till Sunday. First 24 hours of the second shot I was so weak I good not get up even to get a drink.
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| 65 | 2021-01-24 | throat irritation |
At 1000, RRT was called in the post-vaccine recovery area for a 65 y/o female who complained of itch...
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At 1000, RRT was called in the post-vaccine recovery area for a 65 y/o female who complained of itchy throat and swollen upper lip. 2 RNs responded with stethoscope, pulse ox, and emergency kit. Head-to-toe assessment completed. Assessment WNL. Vitals: 02: 96%, HR: 65, manual BP: 180/100. Client took Losartan 100 mg in the AM, only. Fire Chief on site, activated 911 response. Paramedics arrived and completed their work-up. Vitals stable, client AA0x4, assessment continues to WNL. Client speaking in full sentences with no labored breathing. 2 RNs determined to have client wait in recovery area for 15 more minutes. EMS did not transport client to hospital. After 15-minute period, client was stable and left AMA.
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| 65 | 2021-01-25 | chills, fever, headache, chills, headache, fever | HA, chills, fever, body aches, swelling at injection site. Symptoms resolved after 48 hrs |
| 65 | 2021-01-25 | chills, fever, headache | Low fever, Chills, Body aches, Sore arm, Mild head ach |
| 65 | 2021-01-25 | fatigue, fever | DAY AFTER VACCINATION, HAD LOW GRADE FEVER, FATIGUE, AND WEAKNESS |
| 65 | 2021-01-25 | headache, chills, respiratory tract congestion | About 15 hours later headaches, chills, congestion, weakness, body aches |
| 65 | 2021-01-25 | headache |
Headache not too bad but hot nauseated 24 hours after injection; Headache not too bad but hot nausea...
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Headache not too bad but hot nauseated 24 hours after injection; Headache not too bad but hot nauseated 24 hours after injection; Headache not too bad but hot nauseated 24 hours after injection; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284) intramuscular in the right arm on 11Jan2021 07:30 AM at a single dose for Covid vaccine. Medical history included high BP. The patient had no known allergies. Concomitant medications included lisinopril, colecalciferol (VITAMIN D), vitamin B complex (B COMPLEX), calcium, and cetirizine hydrochloride (ZYRTEC) (other medications in two weeks). The patient had no other vaccine in four weeks. The patient experienced headache not too bad but hot nauseated 24 hours after injection on 12Jan2021 08:00 AM. Treatment was not received for the events. The patient had no Covid prior to vaccination. She did not have Covid tested post vaccination. The outcome of the events was not recovered.
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| 65 | 2021-01-25 | sinus congestion, headache, fever, fatigue |
First night awoke 3am with muscle pain and fever. By morning also had sinus congestion/headache/eye ...
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First night awoke 3am with muscle pain and fever. By morning also had sinus congestion/headache/eye ache; fatigue. Temp continue to rise throughout day, reaching 100.8 by 5:30pm. All symptoms began to dissipate by 9pm, awakening normal by morning..
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| 65 | 2021-01-26 | chills, headache |
I had chills, body aches and a headache. I also had pain at the injection site. I went to bed and ...
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I had chills, body aches and a headache. I also had pain at the injection site. I went to bed and when I woke up the next day, I only had a slight headache which was gone by noon.
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| 65 | 2021-01-26 | headache |
1/20/21: Headache; slight nausea with flip-flop stomach feeling; no appetite; sore arm injection are...
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1/20/21: Headache; slight nausea with flip-flop stomach feeling; no appetite; sore arm injection area 1/21/21: Lingering headache but only slight; sore arm injection area 1/22/21: Lingering sore arm but dramatically decreased
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| 65 | 2021-01-26 | malaise |
When I signed up for the vaccine, the website said that i was at high risk for the vaccine and would...
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When I signed up for the vaccine, the website said that i was at high risk for the vaccine and would need to wait 15-30 minutes after the injection. I checked with doctor re: this warning and she felt the vaccine was still beneficial but to do my research and make a decision. I received the vaccine at the Center. I sat down as instructed. 5 minutes later, something felt off and I removed my protective visor. A paramedic came over about a minute later and asked if i was ok. I said that i didn't feel well. He said that he was going to get a chair with wheels for me and at that time i must have passed out. The next thing that i remember was waking up laying on the floor. My husband said that there were 4 paramedics in attendance. The primary paramedic was telling me that my BP was 72/60. An ekg was being run, an iv inserted and run full force. they checked my blood sugar which was fine. The primary paramedic kept talking to me to check my level of consciousness. I was there for quite a while. Not sure who the paramedics checked with, but they decided that i needed to go via ambulance to the hospital. The paramedics were very concerned that the ambulance go to the back door to pick me up so others getting the vaccine would not be frightened. I was transported to Medical Center for further evaluation. I was there for a few hours and my labwork was normal. EKG and chest xray were completed as well as cardiac monitoring. I called doctor's office the next morning to notify her of the event. It was very scary!!!
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| 65 | 2021-01-26 | fever, headache, chills |
slight headache; low grade fever and chills for approx 10 hours post injection; low grade fever and ...
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slight headache; low grade fever and chills for approx 10 hours post injection; low grade fever and chills for approx 10 hours post injection; This is a spontaneous report from a contactable other healthcare professional (HCP). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), intramuscular on 08Jan2021 18:00 (reported as 06:00 PM) at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. There were no other medical history. No known allergies. The patient's concomitant medications were not reported. No other vaccine in four weeks. Facility type vaccine was hospital. No COVID prior vaccination. The patient experienced slight headache, low grade fever and chills for approximately 10 hours post injection on 09Jan2021 02:00 PM. No treatment for the events. Outcome of the events was recovered in Jan2021. Patient was not tested for COVID post vaccination. No follow-up attempts are possible. No further information is expected.
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| 65 | 2021-01-27 | chills, fever | Chills; Fever; itchy skin; nervousness |
| 65 | 2021-01-27 | fatigue, headache | Severe headache, body aches, fatigue - tx with rest, ibuprofen - feeling better today |
| 65 | 2021-01-27 | headache, fatigue | Nausea, Continuous headache, Exhaustion for THREE days |
| 65 | 2021-01-27 | headache | Dizziness, nausea, headache, loss of taste |
| 65 | 2021-01-27 | headache |
I ached and had a headache, very bad body aches. It lasted till that Sunday. I called hospital numbe...
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I ached and had a headache, very bad body aches. It lasted till that Sunday. I called hospital number and they set me up with an NP and to get Covid tested. Test came back negative. I had Covid back in June, and Covid is much worse than the vaccine.
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| 65 | 2021-01-27 | nasopharyngitis |
my lower extremities went cold for an instant when they gave the vaccine but it quickly passed. Wait...
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my lower extremities went cold for an instant when they gave the vaccine but it quickly passed. Wait half an hour of post vaccination observation and it went well. On the return car the feeling of cold returned to me in my arms and legs. When I got home I felt good and I prepared something for lunch, when I started eating, around 3.30 pm (about an hour and a half after getting the vaccine) I started to feel bad, my heart was beating very strong and fast, I was gasping for air, dizzy. I used the oximeter and I saw that my heart rate was at 110 and kept going up and the oxygen was going down. I called 911 when the blood pressure monitor and oximeter reached the limit and started flashing, oxygen at 92 and pulses at 141. I thought I was dying. The 911 operator told me to lie down and wait for the paramedics and she stayed with me on the line. I also put ice on my chest. When they arrived my signs began to normalize. I can't quite remember what happened next that day.
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| 65 | 2021-01-27 | fever, headache |
Headache; Chapped lips; Body is aching from her groin and going down, especially in both thigh areas...
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Headache; Chapped lips; Body is aching from her groin and going down, especially in both thigh areas; Fever; Tightness in jaw; Sore arm and muscles; Sore arm and muscles; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 12Jan2021 08:40 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tightness in jaw within one hour after vaccination and noticed on her way home, sore arm and muscles on 12Jan2021, fever last night (13Jan2021). Her body was aching from her groin and going down, especially in both thigh areas on 13Jan2021. It woke her up. She didn't take anything for it. She laid there until she went back to sleep. It was gone now. The patient also experienced a headache on an unspecified date and chapped lips on 14Jan2021. The outcome of the events chapped lips and headache was unknown, tightness in jaw was not recovered, body is aching from her groin and going down, especially in both thigh areas were recovered while other events were recovering.
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| 65 | 2021-01-27 | fever, headache | Sore arm. body aches, low grade fever, headache, |
| 65 | 2021-01-27 | fever | low grade fever, body aches, swollen lymph node under armpit |
| 65 | 2021-01-27 | fever |
I have had all the side effects listed as well a being febrile for 15 hours with alleviation of feve...
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I have had all the side effects listed as well a being febrile for 15 hours with alleviation of fever or symptoms yet. Additional symptoms are enlarged lymph nodes and infrequent but sharp shooting pains in the ear and lymph regions. At the time of this report, symptoms are ongoing.
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| 65 | 2021-01-28 | fatigue |
Starting the next night my feet wer freezing when trying to lie down at night, could not get them wa...
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Starting the next night my feet wer freezing when trying to lie down at night, could not get them warm unless wrapped in a blanket which is not normal for me, still ongoing but less intensity today 1-29 Ongoing fatigue and having to nap daily and if working go home and going to be early and sleeping about 10-11 hours a night, again not normal Improving daily but still ongoing
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| 65 | 2021-01-28 | headache |
136/78, SPO2 98% on RA, 56 HR, Patient complains of HA behind right ear. Upon questioning she states...
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136/78, SPO2 98% on RA, 56 HR, Patient complains of HA behind right ear. Upon questioning she states that she nhas been crying all day due to a family death/burial today. Encouraged to hydrate, Therapuetic listening by RN initiated. Patient states that she is feeling better after 15 minutes. Vitals remain stable, Instructed to call 911 w/ any emergent symptoms, pt verbalized understanding and signed document.
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| 65 | 2021-01-29 | fatigue |
About 26 hours after receiving the Pfizer Covid Vaccine, I experienced about half an hour of extreme...
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About 26 hours after receiving the Pfizer Covid Vaccine, I experienced about half an hour of extreme dizziness, starting about 6:00 pm. It lasted so long that I decided to just go to bed. I have never experienced such intense dizziness before. Also, I felt tired the next day, and just stayed home and rested. So far, I have not had any more dizzy spells.
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| 65 | 2021-01-29 | headache |
developed numbness/tingling of tongue, headache and also pain across chest, as well as high BP and H...
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developed numbness/tingling of tongue, headache and also pain across chest, as well as high BP and HR. Given water, benadryl 50 mg IM with improvement of everything except chest pain. Sent to CSMC ER for further evaluation.
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| 65 | 2021-01-29 | throat irritation | numb lips with tightness and itching in throat, flushing |
| 65 | 2021-01-30 | headache, fever | Fever 191.2, muscle aches , headache. |
| 65 | 2021-01-31 | fatigue, malaise |
Paresthesias of left hand, general malaise, fatigue, ? HTN urgency ? however missed HTN med doses at...
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Paresthesias of left hand, general malaise, fatigue, ? HTN urgency ? however missed HTN med doses at the time of evaluation
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| 65 | 2021-01-31 | headache, cough |
Body aches, random shooting pains through body. Upper back pain, abdominal pain, severe coughing th...
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Body aches, random shooting pains through body. Upper back pain, abdominal pain, severe coughing that evening, headache, sore arm. Took Tylenol.
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| 65 | 2021-02-01 | fatigue, headache, malaise |
hallucinations; having stroke like symptoms; having intense headaches; felt exhausted; has pain in h...
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hallucinations; having stroke like symptoms; having intense headaches; felt exhausted; has pain in her arm; her vision affected/wavy lines throughout her eyes; numbness in her face, hands, and lips; This is a spontaneous report from contactable Nurse reporting for herself. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Patient age at time of vaccination was 65 years. The patient did not have reactions with other immunizations except a severe reaction with the measles, mumps, and rubella (MMR) vaccine when she was younger. She had seizures after receiving the MMR vaccine. The patient's concomitant medications were not reported. The patient mentioned she had a severe reaction. She described her adverse reaction by having intense headaches, having stroke-like symptoms in which she described as she cannot speak, having headaches, having numbness in her hands, face, and lips. She also felt exhausted. She also had some pain in her arm that she is not concerned about. She mentioned that she also has her vision affected, she couldn't drive, there were wavy lines all though her eyes. She started to have hallucinations such as seeing people that weren't there, seeing snow storms, and seeing things whipping throughout the wind. All the events started on 04Jan2021. She reported she was very sick in the hospital and is now getting well. However it was unknown if she was admitted to hospital (clarification pending). She wanted to know recommendations about the second shot of the COVID-19 vaccine because with her experience, she is not comfortable having the second shot of the COVID-19 vaccine. Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 65 | 2021-02-01 | headache, fatigue |
headache; nausea; fatigue; sore arm; This is a spontaneous report from a contactable consumer report...
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headache; nausea; fatigue; sore arm; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient (not pregnant), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283), via an unspecified route of administration, on left arm on 16Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included Diverticulosis, hypothyroid, osteoarthritis, vitiligo, psoriasis, anxiety/depression, known allergies: Iodine, sulfa, bivalve shellfish, garlic, onions. Concomitant medications included first dose of pneumococcal vaccine polysacch 23v (PNEUMOVAX) on 23Dec2020 on left arm, celecoxib (CELEBREX), sertraline, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL). The patient experienced fatigue, sore arm the day after vaccine was administered on 17Jan2021. Two days after administration on 18Jan2021, patient experienced fatigue, headache, nausea. No treatment received for all events. The outcome of the events were resolving.
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| 65 | 2021-02-01 | lethargy, fever, dehydration, chills |
Starting on 1/17/21 had fever of 101.6, 1/18/21 fever of 101.2, 1/19/21 fever of 102.6. From 1/19-1...
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Starting on 1/17/21 had fever of 101.6, 1/18/21 fever of 101.2, 1/19/21 fever of 102.6. From 1/19-1/23 she had defervesed to normal temp. Afternoon of 1/23/21 temp 101.4, 1/24/21 fever of 103 and 101. On 1/25/21 the nurses called the doctor and said that she was lethargic. Dr. found her to be hypotensive, lethargic, tacchycardic, They sent her to the ER. She also had during that day they found her with neck pain with movement, chills and fever. From 1/25-today she is still admitted to the hospital. They found her to have staph aureus sepsis - source unknown, encephalopathy related to sepsis, they did rule out meningitis, hyponatremia, UTI with E-coli and some staph, urinary retention, rhabdomyalisis with acute kidney injury and dehydration. They are treating her with antibiotics, getting better but still hospitalized.
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| 65 | 2021-02-02 | chills, sweating, headache, fatigue, body temperature increased |
16 hours: awakened at 1:30am with joint pain; 19 hours 99.4 temp; 26 hours: 100.5 temp and chills co...
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16 hours: awakened at 1:30am with joint pain; 19 hours 99.4 temp; 26 hours: 100.5 temp and chills continuing through day and night; 34 hours: 102 temp, fatigue; 40.5 hours: awakened with severe headache, fever continues; 46 hours (7am) sweating for about 10 minutes and then all symptoms were completely gone. I took Tylenol or Advil every 4-5 hours. The fever never went down even after taking the Tylenol.
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| 65 | 2021-02-02 | cough, chills |
Heart palpitations 45 minutes after shot , only lasted a few minutes, shortness or breath at random ...
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Heart palpitations 45 minutes after shot , only lasted a few minutes, shortness or breath at random times . First time 1&1/2 hours after injection without any asthma triggers, then 4-5 times lasted a few minutes each time during first 24 hrs, coughed more frequently, only used my rescue inhaler 3x during the first 48 hrs, fine rash on my face the next morning, lasted 48 hrs. I had body aches, chills , didn?t feel well for first 48 hours after the shot, ok now, just still tender at injection site, that is improving. Concerned I may have had a mild allergic reaction, worried about getting 2nd dose, but my doctor told me to take Benadryl prior to second dose & have someone drive me to the appointment, and get the second dose.
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| 65 | 2021-02-02 | cough | Drainage in throat and down into chest slight cough from time to time. |
| 65 | 2021-02-02 | fatigue |
nausea, diarrhea, dizziness, aches & pains all over body, feeling weird, tired, can't get up, all l...
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nausea, diarrhea, dizziness, aches & pains all over body, feeling weird, tired, can't get up, all lasting 3 days
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| 65 | 2021-02-02 | headache | Injection site pain & headache |
| 65 | 2021-02-02 | fever | Projectile vomiting and diarrhea from 11:00 PM ? 4:00 AM, fever through late afternoon on Tuesday. |
| 65 | 2021-02-02 | throat irritation |
About 15 minutes after receiving Pfizer vaccine dose 1 IM LD, pt experienced itchiness and tightness...
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About 15 minutes after receiving Pfizer vaccine dose 1 IM LD, pt experienced itchiness and tightness of the throat and breathing difficulty. Pt immediately brought to nearby cots to lay down. BP 130/78, Pulse 92, O2 99. 5 minutes later BP increased to 142/86, Pulse 70, O2 99. Pt began to relax a bit but symptoms were unchanged and Epinephrine 0.3mg x1 given & EMS called. BP 10 minutes later 144/80, pulse 70 O2 99. EMS arrived 10 minutes later, BP 146/90, and brought to nearby hospital.
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| 65 | 2021-02-03 | chills, headache, fever, fatigue |
Around 1:00 am on the 2/3/21 I got a fever and was shivering. When I got up I was very weak and ti...
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Around 1:00 am on the 2/3/21 I got a fever and was shivering. When I got up I was very weak and tired. I started with a headache in the evening of 2/2/21
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| 65 | 2021-02-03 | cough, malaise |
Got tested and came positive after receiving first vaccine; Got tested and came positive after recei...
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Got tested and came positive after receiving first vaccine; Got tested and came positive after receiving first vaccine; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported similar events in two patients. This is the first of two reports. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not reported), intramuscular on 10Jan2021 at single dose for COVID-19 immunization. Medical history included asthma. Concomitant medication included vitamins nos. It was reported that both the patient and her husband received the Pfizer Vaccine on 10Jan2021; and they had reaction to it. They both both had bad arm swelling and pain. Her was worst she couldn't even lift or move her arm. At first, they just thought it was a reaction as they read reactions could be and then she started to get small cough but by Friday, her husband went and got tested and on Wednesday he was tested positive and this is after the vaccine and then he got the results and it said he was positive. So, Saturday, they both went and got tested, they did the rapid and they did what they call the PCR, and they both came positive for both of them and this was after they receive the first vaccine. So, she thought they need to know that they got sick and it was after the vaccine. The patient needed to ask a question as they were supposed to go for their second vaccine on 31Jan2021 and do they do it even though they got sick. They knew they were claiming that they can't get sick because of the vaccine but it's very ironic that they did get this. They had been following CBC guidelines, both her husband and the patient because they are older and they wear mask all the time and they did everything they needed to and they could not understand how they got this. The patient underwent lab tests and procedures which included Rapid and PCR: positive in Jan2021. Therapeutic measures were taken as a result of "bad arm swelling and pain; worst she couldn't even lift or move her arm" which included treatment with Tylenol. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092094 same reporter and drug, similar events in a different patient
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| 65 | 2021-02-03 | fatigue |
Blurred vision; fatigue; dizziness; tachycardia; arm soreness; This is a spontaneous report from a c...
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Blurred vision; fatigue; dizziness; tachycardia; arm soreness; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EJ 1685), via an unspecified route of administration in the left arm on 20Dec2020 08:00 at a single dose for covid-19 immunization. Medical history included prediabetes, spinal stenosis of right back, allergies in penicillin, sulfa and yellow jacket venom. Concomitant medication included gabapentin, metformin, paracetamol (TYLENOL), diclofenac (DICLOFENAC), zinc and vitamins. On 20Dec2020 20:00, 12 hours after vaccine administration, the patient experienced blurred vision, fatigue, dizziness, tachycardia and arm soreness. The patient did not receive treatment for the events. The patient had not tested positive for COVID post vaccination. The outcome of the events was recovered on unspecified date.
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| 65 | 2021-02-03 | headache, chills | Chills, body aches, severe headache |
| 65 | 2021-02-03 | headache |
headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female p...
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headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 10:15 AM at single dose in left arm for COVID-19 immunisation. The most recent COVID-19 vaccine was administered at workplace clinic. Patient age at vaccination is 65 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 06:15 PM, at single dose in right arm. Medical history included high blood pressure and high cholesterol. The patient has no allergies to medications, food, or other products/known allergies. The patient received unspecified concomitant medications. On 20Jan2021 on 01:00 PM the patient experienced a headache after second dose, it started about 24 hours after the 2nd dose. Still have it on day 2, but is not severe. Using generic Tylenol to treat it. The event was reported as non serious. The event was resolving. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 SR008138-Salivary, SARS-COV-2 COVID-19 test on 14Jan2021 with negative result.
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| 65 | 2021-02-03 | headache |
Bad headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old fema...
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Bad headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 first dose on 18Jan2021 15:30 on left arm at single dose for COVID-19 immunization at Parking lot of a big stadium. Medical history included stressed and headache, both from 18Jan2021 before vaccine and medication to help sleep. Concomitant medication included ongoing clonazepam (KLONOPIN) tablet at 2mg pill at night to help sleep. Vaccine not Administered at Military Facility. No History of all previous immunizations with the Pfizer Vaccine considered as suspect. No Additional Vaccines Administered on Same Date. No Prior Vaccinations within 4 weeks. She is calling because she got the vaccine today and she has a bad headache. She mentioned she knows headache is a possible side effect. However, she is calling to see what she can take or what she cannot take for the headache. She stated before getting the vaccine she was stressed and had a headache that had started today, 18Jan2021, before she got the vaccine. She mentioned she was waiting 3.5 to 4 hours before getting the shot and that is when the headache started. However, after getting the vaccine it has gotten worse and it is to the point where she wants to place an icepack on her face. Stated it could be situational. She knows she was in the car for at least 5 hours. She also mentioned the paperwork we provide with a list of symptoms should also have listed what medications she can or cannot take. She finds it troubling that we do not have the listed on the paperwork. We have headache could be a possible symptom, but no information on what can be taken for symptoms. She also mentioned she needed her reading glasses to attempt to read the patient card provided that list the lot number and details regarding date for next dose. She then stated after looking at the card it is impossible to read. She cannot read the person's handwriting. The lot number is so messy. She believes it is: L2 7 or 8, 922 or 422, something like that, she cannot really tell the handwriting is so messy. The event not require a visit to Emergency Room or Physician's Office. The outcome of the event was not recovered. Information on the lot/batch number has been requested.
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| 65 | 2021-02-03 | malaise, fatigue, headache, chills |
After receiving second dose of Phizer COVID19 Vaccine I became ill with shaking chills, muscle aches...
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After receiving second dose of Phizer COVID19 Vaccine I became ill with shaking chills, muscle aches, headaches and fatigue. Event started at home the day after receiving vaccine.
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| 65 | 2021-02-04 | chills, fever |
a few hours after injection my arm was unusually sore past; my elbow chills that lasted for about 6 ...
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a few hours after injection my arm was unusually sore past; my elbow chills that lasted for about 6 hrs; temp of 100.6; body aches; nausea; This is a spontaneous report from a contactable consumer. A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3302), via an unspecified route of administration in the left arm on 21Jan2021, at 08:00 a single dose for covid-19 immunization. Medical history included breast cancer stage one from Oct2019. There were no allergies to medications, food, or other products. Concomitant medication included rosuvastatin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), benazepril (MANUFACTURER UNKNOWN). The patient experienced the following event on 21Jan2021, at 03:00: a few hours after injection my arm was unusually sore past, my elbow chills that lasted for about 6 hrs, temp of 100.6, body aches and nausea. The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit on 21Jan2021. Details were as follows: a few hours after injection, the patient noted that her arm was unusually sore past elbow chills that lasted for about six hours. Temp of 100.6 body aches nausea. It was reported that treatment was not received for the events; however she used a heating pad to relieve the pain. The events were non-serious. No diagnosis of COVID-19 prior to vaccination was noted. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events, a few hours after injection my arm was unusually sore past, my elbow chills that lasted for about 6 hrs, temp of 100.6, body aches and nausea was recovered in Jan2021.
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| 65 | 2021-02-04 | chills |
Within 12 hrs of receiving the vaccine the pt began to experience generalized weakness, chills, shor...
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Within 12 hrs of receiving the vaccine the pt began to experience generalized weakness, chills, shortness of breath with symptoms worsening as time went on. Pt remained afebrile. Pt presented to the ED and was diagnosed with a Pulmonary Embolism.
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| 65 | 2021-02-04 | fatigue, headache |
At 11:30 pm, I experienced body aches ( neck, back, legs, and head) and insomnia. 3:00 am I took Ad...
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At 11:30 pm, I experienced body aches ( neck, back, legs, and head) and insomnia. 3:00 am I took Advil. Woke up a bit better. Just headache remained. Totally exhausted though. Took 2 naps. Went to sleep at 9:30 pm-6:00, second night. Today, day 3, so far so good
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| 65 | 2021-02-04 | fatigue |
fatigue; arm soreness; flare up of right hip pain; flare up of right hip pain; This is a spontaneous...
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fatigue; arm soreness; flare up of right hip pain; flare up of right hip pain; This is a spontaneous report from a contactable Nurse (patient). A 65-years-old female patient received second dose of bnt162b2 (BNT162B2, LOT: EL 3248), via an unspecified route of administration from on 10Jan2021 10:30 at SINGLE DOSE on Left arm for covid-19 immunisation. Medical history included Prediabetes, spinal stenosis of right back, right hip pain, known allergies: Penicillin, sulfa, yellow jacket venom. No pregnant. The patient had no covid-prior-vaccination. The patient Historical Vaccine included COVID 19 for covid-19 immunisation at 65 years old, product=COVID 19, brand=PfizerBioN Tech, lot number=EJ 1685, administration date=20Dec2020, administration time=08:00 AM, vaccine location=Left arm; and After 12 hours (08:00 PM) experienced Blurred vision, fatigue , dizziness, tachycardia, arm soreness, after first vaccine 20Dec2020. Concomitant medication included gabapentin (GABAPENTIN), metformin (METFORMIN), paracetamol (TYLENOL), diclofenac (DICLOFENAC), zinc (ZINC). The patient experienced fatigue and arm soreness, and flair up of right hip pain after had received a epidural right hip block 5 days before 2nd injection since Jan2021. No treatment received. The event recovered in Jan2021. No covid-tested-post-vaccination.
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| 65 | 2021-02-04 | headache, influenza like illness | Body aches, joint pain, muscle ache, headache, flu like symptoms. |
| 65 | 2021-02-04 | headache |
body ached so badly that felt like a truck ran over; severe headache; This is a spontaneous report f...
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body ached so badly that felt like a truck ran over; severe headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 20Jan2021 at 09:45 in the left arm at a single dose for COVID-19 immunization. The patient's medical history was reported as none. Concomitant medications included trazodone, escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN), and raloxifene hydrochloride (EVISTA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 20Jan2021 at 09:45, the patient's body ached so badly that felt like a truck ran over and had severe headache. The patient had a physician office visit but did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 65 | 2021-02-04 | nasal congestion |
immunocompromised patient; immunocompromised patient; tested positive for COVID/nasal congestion; te...
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immunocompromised patient; immunocompromised patient; tested positive for COVID/nasal congestion; tested positive for COVID/nasal congestion; This is a spontaneous report from a contactable physician. A 65-year-old female patient (nurse) received bnt162b2 (Pfizer BioNTech COVID 19 vaccine), via an unspecified route of administration, the first dose on an unspecified date and the second dose on 14Jan2021, at single dose for covid-19 immunisation. The patient's medical history included immunocompromised. Concomitant medications were not reported. The immunocompromised patient received her second dose of Pfizer vaccine on 14Jan2021. On 20Jan2021, she developed nasal congestion and her son became sick the same day. Both tested positive for COVID. The physician asked would you consider giving the monoclonal ab to her? Physician knew the expectation was mild disease not severe but would you consider giving her the monoclonal? Outcome of the events was unknown. Information about lot and batch number had been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "tested positive for COVID".
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| 65 | 2021-02-04 | throat pain, chills |
Light headed and mild heart arrhythmia (fast beat). After 10 days, chills, joint pain and sore thro...
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Light headed and mild heart arrhythmia (fast beat). After 10 days, chills, joint pain and sore throat
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| 65 | 2021-02-04 | fever, headache |
fever, headache, bp 155/79 (usdually in 110's 120's/ baseline), and nausea. Caller wanted to know i...
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fever, headache, bp 155/79 (usdually in 110's 120's/ baseline), and nausea. Caller wanted to know if any interaction with APAP. Advised no interaction between Pfizer covid Vaccine and APAP, increase fluid intake as well, PIC will call back to f/u at later time.
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| 65 | 2021-02-04 | fever |
Injection site very sore; arm swollen; Feverish; This is a spontaneous report from a contactable con...
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Injection site very sore; arm swollen; Feverish; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL8982), via an unspecified route of administration in the left arm, on 21Jan2021 at 10:15 (at the age of 65-years-old) at a single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFIB), shellfish allergy, allergy to pain medications, cancer, diabetes, high blood pressure, and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications, taken within two weeks of vaccination, included amlodipine (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), and esomeprazole magnesium (ESOMEPRA). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced arm swollen and feverish on 21Jan2021 at 19:30 and injection site very sore on 23Jan2021. The events were reported as non-serious. It was reported that the injection site was very sore on the third day. Therapeutic measures were taken as a result of the events, which included paracetamol (TYLENOL) and icing arm. The clinical outcome of injection site very sore, arm swollen, and feverish was not recovered.
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| 65 | 2021-02-05 | fatigue, headache |
Evening following injection and next day: Mild headache was treated with acetaminophen. Slightly ...
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Evening following injection and next day: Mild headache was treated with acetaminophen. Slightly chilled. Next day: fatiqued.
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| 65 | 2021-02-05 | malaise, chills |
Vaccine 10 am- fine all day and evening. Awoke at 3:40 am and rolled off of arm where injection giv...
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Vaccine 10 am- fine all day and evening. Awoke at 3:40 am and rolled off of arm where injection given and a wave of pain and nausea and malaise overwhelmed me. I passed completely out still lying in bed (so out that I wet myself in bed) and gradually came to, still feeling horrible. Got up, changed clothes, and major chills when I returned to bed. Around 6am I felt nauseous, got up to vomit, but instead passed completely out on the bathroom floor for about 15 minutes. Remainder of day I felt very stiff, low energy and slightly woozy. By afternoon, energy was returning (I vacuumed the house). Minimal pain in arm this time compared to previous.
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| 65 | 2021-02-05 | fever, lethargy, chills, fatigue |
Soreness at injection site, Extreme chills and fatigue, beginning about 8am Feb 5, chills continued ...
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Soreness at injection site, Extreme chills and fatigue, beginning about 8am Feb 5, chills continued until evening but were not as bad in afternoon. Low grade fever, migraine and nausea began around 2:00. Woke up with migraine at 6:30 am on February 6 which has subsided since taking sumatritam. Some fatigue and lethargy this morning but ok otherwise
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| 65 | 2021-02-05 | fever | Sore arm at injection Fever of 102 |
| 65 | 2021-02-06 | headache | Diarrhea 02/04/21;Headaches 02/04/22;Headaches 02/05/21;Headaches 02/06/21 |
| 65 | 2021-02-06 | nasal congestion |
Wheezing, slight difficulty breathing, I took 2 puffs of my ventilin and Used my Flonase as my nose ...
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Wheezing, slight difficulty breathing, I took 2 puffs of my ventilin and Used my Flonase as my nose felt congested and also had a Hall?s cough drop and my breathing and overall. Symptoms improved
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| 65 | 2021-02-07 | chills, lethargy, headache, fatigue |
Chills, headache, body aches, joint pain , neck and low back pain, eye and mouth pain, skin sore to ...
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Chills, headache, body aches, joint pain , neck and low back pain, eye and mouth pain, skin sore to touch all over, excessive tiredness, lethargy, loss appetite.
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| 65 | 2021-02-07 | headache, chills |
With the second does I experienced headaches . blurred vision I would not say that these are adverse...
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With the second does I experienced headaches . blurred vision I would not say that these are adverse events but I experienced nausea and chills. as well.
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| 65 | 2021-02-07 | headache, throat irritation |
Headache; scratchy throat; This is a spontaneous report from a contactable consumer. A 65-year-old f...
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Headache; scratchy throat; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), via an unspecified route of administration on 15Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included blood pressure high, thyroid disorder and mental health disorder. Concomitant medication included took one medication for high blood pressure and a thyroid medication, both of those have been diagnosed quite a while and she had been on those medications a while. Patient was also on a mental health medication as well. Patient had a headache Tuesday (19Jan2021) or Wednesday (20Jan2021) this week. Patient also had a really scratchy throat. She didn't know if that was related to bnt162b2 or not. Treatment included ibuprofen (ADVIL 200mg, lot: R88356, expiration date: May2023). Patient took two 200mg, no more than every 4 hours or something, then clarified that patient took a couple at nighttime. Headache hadn't gotten worse. It was not as bad today (22Jan2021). It seemed to be subsiding. Outcome of headache was resolving. Outcome of scratchy throat was unknown.
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| 65 | 2021-02-07 | headache |
for the first few hours I had a Chronic pounding headache that transferred to a headache that causes...
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for the first few hours I had a Chronic pounding headache that transferred to a headache that causes my Head and ears to ringing within a few days .. I was given steroids that could have possibly helped with the headaches but I received the second shot.
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| 65 | 2021-02-07 | headache |
feeling like I had the flu without the high fever; had a very bad headache; soreness in the arm wher...
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feeling like I had the flu without the high fever; had a very bad headache; soreness in the arm where I received the shot; This is a spontaneous report from a contactable consumer reported for self. This 65-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL8982) at single dose in right arm on 20Jan2021 at 10:30 AM for COVID-19 immunization. Medical history included hypothyroidism. Allergies to medications, food, or other products were unknown. Concomitant medications included duloxetine; levothyroxine; montelukast; trazodone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient felt fine the day she received the vaccine, with only soreness in the arm where she received the shot. The next day at 11:00 AM, she started feeling like she had the flu without the high fever. The worse symptom was that she had a very bad headache. These symptoms were continuing 48 hours after the vaccine was administered. She was generally very healthy, had a very active life, and didn't get headaches. She was rarely sick. She just didn't seem to be feeling any better. Seriousness was no: not results in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. There was no treatment received for the adverse events. The adverse events was not resolved.
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| 65 | 2021-02-07 | fever, chills | chills, fever, aches, enlarged lymph nodes, tiredness (0200-2000) 1/8/2021 |
| 65 | 2021-02-07 | sluggishness |
Woke up with vertigo. Felt dizzy, nauseated and cold. Around noontime this feeling had passed, alt...
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Woke up with vertigo. Felt dizzy, nauseated and cold. Around noontime this feeling had passed, although still feeling a bit sluggish.
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| 65 | 2021-02-08 | chills, headache, malaise |
I became ill 24 hours after receiving my 2nd dose. I started with chills, cold sweats, headache,horr...
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I became ill 24 hours after receiving my 2nd dose. I started with chills, cold sweats, headache,horrible body pain. No temp. I missed 6 days of work I was so sick.
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| 65 | 2021-02-08 | headache, malaise, fatigue, chills |
She felt same the way but worst; Lack of appetite; Passed out; Chills; Aches; Headache; Had no energ...
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She felt same the way but worst; Lack of appetite; Passed out; Chills; Aches; Headache; Had no energy; Tired; Feeling sick; She was shaky, cold; She was shaky, cold; She had the flu; This is a spontaneous report from a contactable consumer reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1284), via an unspecified route of administration left arm single dose on 18Jan2021 17:30 for covid-19 immunisation. Medical history was none. There were no concomitant medications. No other vaccine was received in four weeks. The patient experienced passed out on 20Jan2021 14:00, tired on 18Jan2021 21:00, feeling sick on 18Jan2021 21:00, chills on 19Jan2021 09:00, aches on 19Jan2021 09:00, headache 19Jan2021 09:00, had no energy on 19Jan2021 09:00, lack of appetite on 22Jan2021 09:00, she was shaky in Jan2021, cold in Jan2021, she had the flu on Jan2021, she felt same the way but worst on an unspecified date. The outcome of the events was recovered on 22Jan2021
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| 65 | 2021-02-08 | headache |
The patient had a headache within 5 minutes of receiving the vaccine. The patient was monitored and...
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The patient had a headache within 5 minutes of receiving the vaccine. The patient was monitored and her blood pressure taken three times, 5 minutes apart; the readings were 95/65 SBP/DBP, then 106/64, and finally 93/67. The patient was counseled by a pharmacist that since her headache was not severe she was able to leave if she wanted to. She did leave and upon follow up 6 hours later, the patient reported taking over the counter Tylenol to treat the headache that still persisted. The patient was asked to please report back to the pharmacy if the headache persists to tomorrow.
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| 65 | 2021-02-08 | headache |
my body collapsed and I had a Pulmonary embolism/I have clot in my lung; I have behind my knee like ...
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my body collapsed and I had a Pulmonary embolism/I have clot in my lung; I have behind my knee like a deep wide black spot and it is hard; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medication included amlodipine, metformin and propranolol. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization and experienced severe headache and diarrhea. On 13Jan2021, the patient reported that: "my body collapsed, I had a pulmonary embolism. I had to go to the hospital in ambulance. When I was there, they find out that I have clot in my lung. I was in an intensive care for 2 days or 3 days and about 5 days in the hospital (from 13Jan2021 to 17Jan2021). I have behind my knee like a deep wide black spot and it is hard, my body did not have anything like that". Therapeutic measures were taken as a result of event pulmonary embolism/ clot in lung and included treatment with "some medications", one of which ELIQUIS. The patient outcome of pulmonary embolism and "clot in lung" was recovered on an unspecified date and of deep wide black spot was unknown. The information on the batch number has been requested.
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| 65 | 2021-02-09 | chills, headache |
vomited; chills; headache; had some itching, ongoing soreness and lump at site; had some itching, on...
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vomited; chills; headache; had some itching, ongoing soreness and lump at site; had some itching, ongoing soreness and lump at site; had some itching, ongoing soreness and lump at site; nauseous; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL9262), via an unspecified route of administration in the left arm on 22Jan2021 19:00 at a single dose for COVID-19 immunization. She takes thyroid daily (as reported) as it was removed when she was 20. The patient was not pregnant at the time of vaccination. The patient had no COVID prior to vaccination. The patient had not been tested for COVID post vaccination. The patient has not received any vaccine in 4 weeks. Concomitant medication included teriparatide (FORTEO) daily injection, diphenhydramine hydrochloride (BENADRYL). The patient previously took codeine and experienced allergies: codeine. The patient reported that no one knew if she should inject with teriparatide. On 22Jan2021, she received teriparatide at 4pm and bnt162b2 at 7pm. She took a diphenhydramine and had some itching, ongoing soreness and lump at site. She took teriparatide at 3:30pm at about 7pm she was nauseous and vomited. She had chills but felt better afterwards. She went to bed and have headache, not sure if she should discontinue teriparatide or discontinue before next shot. According to the reporter, the events started on 23Jan2021 19:00; vomited started on 23Jan2021 21:00. The outcome of the event was recovering.
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| 65 | 2021-02-09 | fatigue |
feeling pretty bad/ feel awful; she doesn't want to eat; her back hurts; she's irritable; depressed;...
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feeling pretty bad/ feel awful; she doesn't want to eat; her back hurts; she's irritable; depressed; pain in the injection site; joint pain; muscle pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3247), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. The patient thinks she could have COVID last Mar2020. She was not sure because her doctor's office was close for around a month and she couldn't get tested. There were no concomitant medications. On that day, 19Jan2021, after she received the vaccine she started feeling pain in the injection site, joint pain, muscle pain and fatigue. On 25Jan2021, she was feeling pretty bad, she doesn't want to eat, her back hurts, she's irritable and depressed. The patient would like to know if these side effects could be associated with the vaccine in someone who had the virus. She felt awful and she felt like she has gone right back to where she was 8 months ago, 10 months ago and started over with fatigue and everything. It was awful. She thinks she could have had COVID in Mar2020 and the symptoms she was having now, she had then and when she has had basically the whole time and that would just come back worse. There was no treatment received for the events. The outcome for the events was unknown.
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| 65 | 2021-02-09 | headache, chills, fever, fatigue | Headache, chills, fatigue, low grade fever |
| 65 | 2021-02-09 | headache, fatigue, chills |
On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, h...
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On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; This is a spontaneous report from a contactable nurse (patient). A 65-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 11Jan2021 14:00 at SINGLE DOSE on Right arm for covid-19 immunisation. Medical history was none. No-covid-prior-vaccination. No Known- allergies. Concomitant medication included atenolol (TENORMIN), clonazepam (KLONOPIN), sertraline hydrochloride (ZOLOFT), atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]). No-other-vaccine-in-four weeks. Since 19Jan2021, On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine. AE-resulted-in: [Doctor or other healthcare professional office/clinic visit]. No treatment received. Covid-test-post-vaccination: included Nasal Swab, Pixel by Labcorp, covid test date on21Jan2021 was Negative. The event recovered in Jan2021. Information about lot/batch number has been requested.
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| 65 | 2021-02-09 | headache, fatigue, malaise |
Stomach pain; Nausea; headache; Joint pain; did not feel good; more tired than usual; redness/arm wa...
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Stomach pain; Nausea; headache; Joint pain; did not feel good; more tired than usual; redness/arm was red; arm was hurting; arm red with a red bump; diarrhea; she has arthritis and her pain has gotten worse; This is a spontaneous report from a Pfizer-sponsored program. A nurse aide (consumer or other non hcp) reported for herself that the 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: E13302), intramuscular injection in the left arm on 20Jan2021 at single dose for COVID-19 prophylaxis. Medical history included ongoing arthritis from an unknown date. Concomitant medication included duloxetine hydrochloride (CYMBALTA) and ibuprofen for arthritis. The patient got the vaccination on 20Jan2021 and experienced redness, pain and nausea on an unspecified date in Jan2021. She said that that night (on 20Jan2021) and the next morning her arm was hurting and it was red with a red bump. On Thursday (21Jan2021) and Friday (22Jan2021), she felt joint pain, no fever, and did not feel good. The patient experienced more tired and did not feel good on 21Jan2021. The patient experienced headache on 23Jan2021. Saturday (23Jan2021) she was more tired than usual and on Sunday (24Jan2021) she was home and felt completely tired and had stomach pain, joint pain, nausea, headache, but did not have a fever. She was feeling the same today (on 25Jan2021) and worse. The patient said that her arm was not red anymore, but it still had a small bump. Stomach pain comes and goes. She stated that she had some diarrhea, but not much in Jan2021. Her nausea comes and goes as well. She said that it was like you want to throw up, but she had not thrown up. She said that you just know that something was not right. She said that her headache was like a heaviness on top of her head and forehead. She said that it was bothering her but it was not terrible. Next dose is due on 10Feb2021. The patient said that she worked in a facility with elderly people. She said that she has arthritis and her pain has gotten worse in Jan2021. She said that even with the medication. She did not take her medication until Thursday evening to see if she had any effects from the vaccine. She took Ibuprofen 800mg and CYMBALTA for her arthritis. She said that her tiredness had nothing to do with her medications. She said that it was very rare that she even had a headache. The reason that she called was to see if she should she do anything, is it safe for her to go back to work. Event Joint pain, more tired and did not feel good were reported as worsened. The outcome of event arm was red was recovered on an unspecified date in Jan2021. The outcome of events arm was hurting, arm with a red bump, diarrhea was recovering. The outcome of events Joint pain, did not feel good, more tired than usual, Stomach pain, Nausea, headache was not recovered. The outcome of the other events was unknown.
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| 65 | 2021-02-09 | headache, sleepiness |
On 01/30/2021 at 08:00 had an extreme headache. Then having extreme difficulty keeping my eyes open...
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On 01/30/2021 at 08:00 had an extreme headache. Then having extreme difficulty keeping my eyes open, like I was trying to drift off to sleep. Immediately there after, I started vomiting. These symptoms lasted 4 days extremely fast and hard. Tylenol was take for the headache and helped very little. I slept a lot and I couldn?t eat or drink anything witching vomiting it back up. Even my regular meds with a little water came back up. The evening of the 4th day, I was able to keep clear broth down and crackers helped with the nausea some. The following week, I still didn?t feel quite right and kept fighting off sleep. Today is the 10th of February and toe nausea has returned. Getting out of bed, I dry heaved for an hour. I feel if I eat anything it?s going to come back up. My theory is that the side effects didn?t go away the week I felt somewhat better and had resurfaced, starting out slowly like before. I called my primary at the VA and we discussed what I was already doing i.e. a bland diet until I feel better.
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| 65 | 2021-02-09 | headache |
Light headache; her face was swollen; her throat was swollen little bit; This is a spontaneous repor...
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Light headache; her face was swollen; her throat was swollen little bit; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9262 and expiration date May2021), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included diabetes. The patient has concomitant medications (unspecified), taking a lot of medications. The patient had light headache on 23Jan2021, and she noticed her neck, her throat was swollen little bit, and her face was swollen in Jan2021. She doesn't know what she should do. She doesn't have any pain or anything, she feels great. The patient took Tylenol one time and that's it, the headache went away. It was not a bad headache, it was a light headache. Outcome of the event headache was recovered in Jan2021 while unknown for other events.
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| 65 | 2021-02-09 | headache |
Diarrhea; With the first one I had was severe headache; This is a spontaneous report from a contacta...
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Diarrhea; With the first one I had was severe headache; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 18Dec2020 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included amlodipine (AMLODIPINE), lansoprazole (LANSOPRAZOLE), metformin (METFORMIN) and propranolol (PROPRANOLOL). The consumer stated, "I had this number to call. After I took the vaccine, the Pfizer vaccine on 18Dec2020, with the first one I had was severe headache on 19Dec2020 and I had some diarrhea on an unspecified date too. So, the headache started like from Saturday night sometimes until Monday and then after that it goes away, it went slowly but it goes away, severely, it was for two days." The outcome of the event headache was recovered on 21Dec2020 while the other event was unknown. Information about batch/lot number has been requested.
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| 65 | 2021-02-09 | malaise, cough, fever |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous re...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 65-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunisation. Medical was none. There were no concomitant medications. The patient got covid positive/the covid-19 virus molecular test was positive on an unspecified date with outcome of unknown. On 20Jan2021 the patient started with the first symptoms of got very sick, had terrible body pain, sharp pain and aches, terrible cough, fever and felt completely like physically collapsed. The patient got positive covid-19 virus molecular test on 23Jan2021 with outcome of recovering. On 22Jan2021 the antigen test was negative. On 23Jan2021 the patient had also a negative flu rapid test.
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| 65 | 2021-02-09 | paranasal sinus discomfort |
Face and chest became bright red; felt very hot; sinus pressure increased; blood pressure was up 155...
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Face and chest became bright red; felt very hot; sinus pressure increased; blood pressure was up 155/94; pulse rate up; This is a spontaneous report received from a contactable consumer (the patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL 9261), via an unspecified route of administration in the left arm on 21Jan2021 15:45 (at the age of 65-years-old) as a single dose for COVID-19 immunization. The patient's medical history included high cholesterol, indoor and outdoor allergies, and allergies to latex and contrast. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient previously took and had allergies to: amoxicillin/ clavulanic acid (AUGMENTIN), sulfamethoxazole/ trimethoprim (BACTRIM), levofloxacin (LEVAQUIN), and gabapentin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Within 5 minutes of receiving the dose on 21Jan2021, at 15:45 (as reported), the patient's face and chest became bright red, felt very hot, sinus pressure increased. The EMT's took her blood pressure- was up 155/94, and her pulse rate was up (21Jan2021, 15:45 (as reported)). Her temperature and blood sugar were within normal limits (21Jan2021). The patient did not receive any treatment for the events. The clinical outcome of face and chest became bright red, felt very hot, sinus pressure increased, blood pressure was up 155/94, and pulse rate up was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 65 | 2021-02-09 | fever, headache, chills, fatigue |
Headache; chills; fever; Vomiting; exhaustion; This is a spontaneous report from a contactable other...
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Headache; chills; fever; Vomiting; exhaustion; This is a spontaneous report from a contactable other healthcare professional. A 65-years-old female patient received bnt162b2 (BNT162B2; lot number=EL8982) second dose, via an unspecified route of administration on 20Jan2021 10:30 AM at SINGLE DOSE left arm for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. No allergies to medications, food, or other products. Concomitant medication included venlafaxine hydrochloride (EFFEXOR) 75 mg for hot flasjes. Historical vaccine included first dose of Pfizer COVID 19 vaccine (lot number=EL1284) on 30Dec2020 10:00 AM at left arm for covid-19 immunisation. The patient experienced headache, chills, fever, vomiting and exhaustion, all on 20Jan2021 20:00 with outcome of recovered with sequelae (recovered with lasting effects). Reported as headache, chills, fever, vomiting, and exhaustion the exhaustion lasted more than 3 days and it was severe. Patient had reactions after each short. No treatment received for the adverse event. All events reported as non-serious. Patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19.
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| 65 | 2021-02-09 | fever, headache | Extreme headache, nausa,low grade fever, vomiting |
| 65 | 2021-02-09 | throat irritation |
I had a metallic taste in base of my throat and after that I have like burning in my throat; I had a...
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I had a metallic taste in base of my throat and after that I have like burning in my throat; I had a metallic taste in base of my throat and after that I have like burning in my throat; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 65-year-old female patient received bnt162b2 (BNT162B2, Covid Vaccine, lot: EL3247, Expiration Date: 30May2021), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were none. Consumer stated, "I had the shot (Covid vaccine, Pfizer) a couple of days ago and I experienced the weird side effects. I just wanted to know if that was normal things or if I need to report this? I had a metallic taste in base of my throat and after that I have like burning in my throat. I had another question before you change. I was reading the pamphlets that was given to me at the clinic and it says that it is been in clinic trial an approximately 20,000 individuals have received the vaccine is that all? I had the vaccine on 21Jan2021 and it started immediately afterwards. No, it went away on following day." No treatment received. The outcome of the event was recovered in Jan2021.
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| 65 | 2021-02-10 | body temperature increased, chills, headache, sweating, fever |
Vac administered at 10:30am yesterday. In Observation >10:45am.. no side effects at that time. While...
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Vac administered at 10:30am yesterday. In Observation >10:45am.. no side effects at that time. While in a store buying flowers... approximately 11:45am... experienced sudden and overwhelming onset of profuse heat and perspiration. Eyeglasses immediately fogged up, perspiration ran down my back and ran under my face mask. I felt lightheaded and faint. My husband confirmed that my back was "on fire". Last night, I was awakened by extreme chills and shivering... every muscle and joint tense and painful. This continued for some time and then I became feverish with bed cloths and bedding soaked. Had a temp of 102 @7:30 am with HA and muscle & joint pain.
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| 65 | 2021-02-10 | chills, headache, fever | Sore arm nausea headaches chills fever |
| 65 | 2021-02-10 | headache, fever |
Left arm was sore to move for one day after the shot. I began developing a dull headache and low gr...
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Left arm was sore to move for one day after the shot. I began developing a dull headache and low grade fever around 1:00 pm the day after the shot. My fever started at 100.3 degrees F and rose to 101.9 degrees F by 10:00 pm. I did not take any pain reliever until midnight. The fever was gone by 3:00 am on 2/6/21, and the headache dissipated by noon the same day. My left arm has continued to be sore to the touch and pressure (like a bruise) at the shot site, but there has never been any redness or swelling. This pain is going away slowly each day.
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| 65 | 2021-02-10 | headache | Severe pain in left arm muscle-icing, Tylenol, Advil Headache Nausea, vomitX1 |
| 65 | 2021-02-10 | lethargy, malaise, headache, influenza like illness |
Flu like symptoms began 12 hours or so after injection: headache, lethargy, naseau, felt "unwell". ...
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Flu like symptoms began 12 hours or so after injection: headache, lethargy, naseau, felt "unwell". Symptoms continued for 3-4 days. Noted that I previously had COVID infection in April 2020 for which I was hospitalized for a week on oxygen.
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| 65 | 2021-02-11 | chills |
Tues: sore arm, sore glands in neck, hurt to turn. Thurs. 2 am.started with Stomach cramps and di...
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Tues: sore arm, sore glands in neck, hurt to turn. Thurs. 2 am.started with Stomach cramps and diahrea also chills . Fri. Am stomach still not feeling great. Some cramping and gas and a little nausea. Feel cold
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| 65 | 2021-02-11 | influenza like illness, fever | flu like symptoms, including fever and dizziness |
| 65 | 2021-02-14 | chills, headache, fever |
Approximately 10 hours after vaccination (Pfizer-BioNTech Covid-19), developed severe arm pain, feve...
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Approximately 10 hours after vaccination (Pfizer-BioNTech Covid-19), developed severe arm pain, fever of 101.5F followed by shaking chills,, then fever again. Experienced myalgia and severe migraine-like headache with light sensitivity. The arm pain from shoulder to mid-palm was so severe that I couldn?t lift my arm. This resolved by approximately noon on 02/10/2021. The other symptoms largely resolved by midday 02/11/2021 wit residual low-grade headache, dizziness, and unsteadiness on my feet. I woke up on 02/11/2021 around 7AM with left axillary lymphadenopathy approximately the size of a tennis ball cut in half with associated moderate discomfort. The discomfort resolved by 02/14/2021, but the lymphadenopathy remains at about half the mass noticed originally.
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| 65 | 2021-02-14 | chills, malaise, headache, fatigue | tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell |
| 65 | 2021-02-14 | headache, chills |
Sore arm, slightly red at injection site. The shot hurt more than the first one. Had small waves of ...
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Sore arm, slightly red at injection site. The shot hurt more than the first one. Had small waves of stomach upset, headache, chills, lethargy but none lasted longer than an hour. All symptoms are gone now, 3 days later.
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| 65 | 2021-02-14 | headache |
Diarrhea started Wednesday 2/10 and continues, headache Saturday 2/13, muscle aches entire body Sund...
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Diarrhea started Wednesday 2/10 and continues, headache Saturday 2/13, muscle aches entire body Sunday 2/14.
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| 65 | 2021-02-14 | sweating, fatigue, sinus pain, headache |
Injection site soreness; headache (front of forehead across top of head all the way back to ears); s...
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Injection site soreness; headache (front of forehead across top of head all the way back to ears); sinus ache under eyes; muscle ache across shoulders; hint of nausea; early morning awoke to profuse sweating; tired.
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| 65 | 2021-02-15 | headache, fatigue |
Very Sore rt arm first sx at 2030 pm. Then during night,12 hrs later a headache/posterior neck, uppe...
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Very Sore rt arm first sx at 2030 pm. Then during night,12 hrs later a headache/posterior neck, upper body shoulders to wrists aching. Weakness of upper extremities. 2\16\2021 generalized weakness fatigue,Felt cold, discomfort to skin during shower from water pressure. Difficult getting dressed/ stiffness. Tylenol 500mg q6 hrs and rest all day TX. Feeling better by 4 pm
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| 65 | 2021-02-15 | headache, fever | Low grade fever Nauseated Headache |
| 65 | 2021-02-15 | headache |
Had chest pain, difficulty breathing approximately 30 minutes after shot. Also sharp pain left fore...
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Had chest pain, difficulty breathing approximately 30 minutes after shot. Also sharp pain left forehead. Lasting approximately 15-20 minutes.
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| 65 | 2021-02-15 | headache |
She was eating after the vaccine which started as a stiffness, down both of her shoulders and into h...
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She was eating after the vaccine which started as a stiffness, down both of her shoulders and into her waist, severe nauea and headache. She felt like her feet were in cinderblocks. She took some Tylenol, and woke up at 4:00 AM and had two severe headaches and nausea since Sunday. That night she felt as though she could not stand it any longer. Went to UC and they tested her for the virus which was negative, and still having symptoms. She thought the symptoms would get less, but it has been quite a few days. She takes a short walk and the intense pain in her arms, and legs are terrible. Her PCP told her that there was nothing they could do, and what she had been doing what she needed to do. They also told her to go back to UC if she did not improve.
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| 65 | 2021-02-15 | fever |
Received vaccine on 2/9. Only sore arm until 2/12. Woke up that morning with extremely sore arm, re...
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Received vaccine on 2/9. Only sore arm until 2/12. Woke up that morning with extremely sore arm, red, blotchy patch of skin around injection site about the size of the palm of my hand. It was hot to the touch. At the injection site itself, there was an area about the size of a quarter that was slightly swollen. The entire area was extremely itchy! Today is 2/16 and the red area is just disappearing. It still itches. My arm is still sore. I have also been running a low grade fever since the injection.
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| 65 | 2021-02-16 | headache |
About 10 hours after vaccination a headache started. Then my joints started hurting almost like a ne...
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About 10 hours after vaccination a headache started. Then my joints started hurting almost like a nerve was firing off but only at the joints, ie knee, shoulder, toes, ankle, fingers, toes, etc. It would happen randomly. Never all joints at once. Very weird. Continued throughout the night making it difficult to sleep. In the morning, at 7 am, got up out of bed. Took 2 Advil. At 10:20 I still have the joint happening but not as frequent and not as strong. I still have the headache. It hasn't changed.
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| 65 | 2021-02-17 | malaise |
trouble sleeping; lump in her throat; high blood pressures; feeling very shaky and very weak; feelin...
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trouble sleeping; lump in her throat; high blood pressures; feeling very shaky and very weak; feeling very shaky and very weak; feeling unwell; alternating slow heartbeat and fast heartbeat; a weird feeling in her head like pressure but not a headache/pressure feeling in my head; they are going to check me for all the ingredients in the Pfizer vaccine that could give me an allergic reaction.; This is a spontaneous report from a contactable consumer. A 65 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 31Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included allergic to shrimp, lupus anticoagulant syndrome, chronic kidney disease and antiphospholipid syndrome. Concomitant medications included amlodipine, HCTZ, losartan, acetylsalicylic acid (ASPIRIN (E.C.) and atorvastatin calcium (LIPITOR ORIFARM). The patient informed that immediately after receiving the injection she felt a lump in her throat and could not swallow, still present now. Patient also informed that after vaccination she was having a very high blood pressures, feeling very shaky and very weak, a weird feeling in her head like pressure but not a headache, trouble sleeping because of the pressure feeling in my head, feeling unwell and alternating slow heartbeat and fast heartbeat. Patient also reported she had scheduled an allergist appointment and they are going to check me for all the ingredients in the Pfizer vaccine that could give me an allergic reaction. At the time of the reporting event outcome was unknown.
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| 65 | 2021-02-18 | chills, headache, sweating, fever, fatigue |
I got up around 9:00 am and felt weak. I ate breakfast and began to feel achy and nauseous so I went...
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I got up around 9:00 am and felt weak. I ate breakfast and began to feel achy and nauseous so I went back to bed. For the rest of the day I experienced: Feaver 102.4 Feaver 100.6 Severe vomiting 3x chills sweats body aches pain behind my eyeballs headache extreme weakness I continued to rest and take Tylenol all day to break the fever. The next morning, 2/17/2021 I woke up with a fever of 100.4 and took Tylenol. All other symptoms were gone by 2/17 except for low grade fever and fatigue. Fatigue continues still as of this reporting 2/19/21
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| 65 | 2021-02-18 | chills |
Dizziness started early afternoon and got worse thru evening, when nausea began. At about 11:00 PM,...
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Dizziness started early afternoon and got worse thru evening, when nausea began. At about 11:00 PM, I vomited 4 times. After that, shaking chills set in. I did not take anything for it. When I woke up the next morning, I felt fine.
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| 65 | 2021-02-18 | chills |
Extreme dizziness Diarrhea Dry heaves Tingling in arms and legs Extremely weak Chills and hot Hus...
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Extreme dizziness Diarrhea Dry heaves Tingling in arms and legs Extremely weak Chills and hot Husband cared for me. Spoke to nurse at my doctor?s office. Water. Eventually bland food. Condition improving. She told me to go to ER if extreme dizziness recurs.
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| 65 | 2021-02-18 | fatigue |
Tasted vaccine within minutes of dose. Within 15 minutes had itching of face and forearms which las...
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Tasted vaccine within minutes of dose. Within 15 minutes had itching of face and forearms which lasted about 8 hours. For 2 nights, but especially the first night, had vivid dreams and woke up every 2 hours. Had some minor fatigue day after shot. All resolved by themselves. Was totally back to normal after 2nd nights sleep.
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| 65 | 2021-02-18 | headache, fever, fatigue, chills |
1 PM I received the vaccine and withing 5 minutes had a slight pain on the left side of my head whic...
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1 PM I received the vaccine and withing 5 minutes had a slight pain on the left side of my head which then continued to a pain in my neck. also left side, then back pain, then slightly short of breath. I remained in the waiting area for over a half hour and felt no worse, but did report it to the young woman at the exit who said that was odd and seemed the kind of response with the second dose. I presumed it might be due to my already having antibodies. As I continued my day those symptoms quickly dispersed and I felt fine, albeit with a light soreness at the site on my left arm. At approximately 6pm I felt very fatigued and rested until 10pm, when I began to have chills, a headache and nausea. My left arm was also so sore I could not lay comfortably. I took Tylenol and aspirin both at 11:30 pm and attempted to sleep, which was fitful and disturbing. I had strange neurological events, such as odd visions in my half sleep and bizarre semi dreams but could not waken. At 4:00 AM I finally was able to pull out of this state and the last thing in my mind was a conversation with someone trying to explain what was happening to me, in my mind not vocal, that was in Italian. That is my second language. All day I had unwanted words, ideas etc. floating about in my brain. I could no longer sleep and was very weak, had terrible head and body aches and my legs also ached terribly. I was also slightly nauseous.These were all symptoms, minus the disturbing neurological one, that I had with Covid. I was too weak to leave the bed until much later in the day. I am still having effects but much less and I am at the 72 hour mark. I remained at rest all day and ran a low fever, then again a fever
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| 65 | 2021-02-18 | headache | Very bad pain and weakness in left arm and headache |
| 65 | 2021-02-18 | headache |
Woke up morning after with headache. By noon was nauseous and began throwing up. Threw up for 10 hou...
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Woke up morning after with headache. By noon was nauseous and began throwing up. Threw up for 10 hours.
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| 65 | 2021-02-18 | throat pain |
Started feeling bad, throat started hurting, lost voice. Still am unable to talk very well and has ...
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Started feeling bad, throat started hurting, lost voice. Still am unable to talk very well and has been going on for 4 weeks.
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| 65 | 2021-02-18 | fever, headache |
3 hours post vaccine =headache, resolved post Tylenol and aspirin. In the middle of night had achy,...
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3 hours post vaccine =headache, resolved post Tylenol and aspirin. In the middle of night had achy, feverish feeling- no fever. About 26 hours after vaccine=underarm tenderness- unable to palpate anything but very localized, lasted 3-4 days in same location, gradually less tender.
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| 65 | 2021-02-21 | fatigue, head discomfort, headache, sweating, chills |
Feeling mostly normal but tired fell asleep at 11PM day of second vaccine. Woke up 1 hour later and...
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Feeling mostly normal but tired fell asleep at 11PM day of second vaccine. Woke up 1 hour later and got up to go to the bathroom but felt fine. Went out to the hall bathroom so as not to wake husband in Master bath. Urinited and got up slowly as I always do and walked out to the hallway to go back to bed. I lost consciousness and came to when my husband who heard a thud came and found me out having fallen down the stairs.. head on the landing and feet above the landing. I have no recollection of it once leaving the bathroom and i would have headed away from the stairs which was just to the left of the bathroom doorway. I didn't feel any pain. Later found a bump on my forehead of the right side of my face and a bruised lip. He said my back was wet with sweat and I took a couple minutes to come to. After returning to the bed.. i immediately had to empty bowels. Diarrhea.. then the rest of the night in Chills. No fever. Slept most of the next day and night. Headache and joint aches and swelled lymph nodes in neck.. Fatigue through 20th. Mostly better by the 21st. Still today on 22 I am being careful when going from prone to standing. I feel more head pressure getting up and maybe I notice a little nausea when rising. I may just be worried about fainting again. It has never happened to me before. I do have very good blood pressure on the lower side so I was always careful to get up slowly but never fainted. Neck is sore.. Not sure if lymph nodes or something to do with fall.
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| 65 | 2021-02-21 | headache, fatigue, chills |
I had injection site discomfort, about 4-6 hours after vaccination. I had generalized aching over a...
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I had injection site discomfort, about 4-6 hours after vaccination. I had generalized aching over all my body (joint/muscle pain) that started about 10 PM the night. I woke up Saturday morning with a bad headache, felt like I was pass out, I had chills. Saturday afternoon I noticed under right armpit the lymph nodes were swollen. The pain radiates throughout my chest and shoulder but most severe under the armpit. As of today 22nd I feel tired and I am still experiencing the swollen lymph nodes under my right arm pit. All the other symptoms have went away. The lymph node feels warm to touch, there is also a small area of redness around the injection site. I am still having post COVID-19 symptoms as well which include nasal issues, weakness and brain fog. I have had all these symptoms since November.
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| 65 | 2021-02-21 | influenza like illness |
Feeling achy all over body (flu-like) about 8 hours after shot and continued for about 3 days, even ...
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Feeling achy all over body (flu-like) about 8 hours after shot and continued for about 3 days, even soles of feet. Difficulty sleeping that night. Could not sleep on left side for about 3 days. Knees ached, difficulty walking.
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| 65 | 2021-02-21 | runny nose, cough, malaise, headache |
my results came back stating I was positive; feel ill with a severe back pain on my left side. The s...
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my results came back stating I was positive; feel ill with a severe back pain on my left side. The same side where I was given the shot; cough; runny nose; headaches; a lot of pain in my bones; a lot of pain in my bones, and eye lids; Feel ill; This is a spontaneous report from a consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on the left arm on 25Jan2021 at 11:00 at the age of 65 years old at a single dose for COVID-19 immunisation at the school/student Health Clinic. Medical history was none. The patient has no allergies to medications, food and other products. The patient is not pregnant and was not pregnant at the time of vaccination. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 at 07:00, patient began to feel ill with a severe back pain on her left side. The same side where she was given the shot. In addition, patient also experienced a cough, runny nose, headaches, a lot of pain in my bones, and eye lids. At first, she believed it was due to the vaccine but as she got worse, she decided to take a COVID test (nasal swab) on 31Jan2021 and the results came back stating she was positive. Since then the patient has been in quarantine. No treatment was received in response to the events. The patient was recovering from the events. The patient has a second vaccination appointment scheduled on 13Feb2021 and would like to know if she will still go as scheduled or will she need to go in a later date. Information on the lot/batch number has been requested.
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| 65 | 2021-02-21 | runny nose, headache, fatigue, cough |
all over body pain, headache, body ache, joint aches, very sore arm that was hard to move no redness...
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all over body pain, headache, body ache, joint aches, very sore arm that was hard to move no redness but hot to touch, periodic cough, runny nose, throat felt like it was closing up, extreme fatigue and body weakness, unable to sleep first night
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| 65 | 2021-02-22 | fatigue, malaise, headache, chills |
I was vaccinated nine days ago. I have consistently been having chills, a dull headache and fatigue...
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I was vaccinated nine days ago. I have consistently been having chills, a dull headache and fatigue. I was really sick by the end of the day after the vaccine. The fatigue, initially, put me in bed for a few days. It is not as severe now. It is mild to moderate. I feel week sometimes. It comes and goes.
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| 65 | 2021-02-22 | headache, sleepiness |
Headachy. Feel very soundly asleep for 3 hrs on day of shot. Same thing next day. Woozy head most of...
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Headachy. Feel very soundly asleep for 3 hrs on day of shot. Same thing next day. Woozy head most of the day. Considered not drivinv.
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| 65 | 2021-02-22 | malaise, chills |
78 hours after injection I got dizzy and had fairly severe vertigo , nausea and threw up 4 times. I ...
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78 hours after injection I got dizzy and had fairly severe vertigo , nausea and threw up 4 times. I felt hot and chilled... I am not sure it was related to the injection. It resolved on sat Feb 20th 2021. I still have mild nausea but am on Ozempic which gives me nausea some of the time. I did not feel well but finally fell asleep and slept until AM.
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| 65 | 2021-02-22 | fever, chills, headache |
In the pt's words " received our second covid-19 vaccination on Sunday. I got my vaccination about 1...
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In the pt's words " received our second covid-19 vaccination on Sunday. I got my vaccination about 10:00. By 8:00 PM I was not feeling well. Had all of the side effects, chills, fever, muscle aches, joint pain and a wicked headache. Monday was the same minus the headache. Today, still have joint pain and feel very weak. The nurse that gave us our vaccinations said that if we experienced any of the side effects, we should let our primary physician know. Hopefully all of this is normal and I will be back to my normal self soon. I am concerned because most of the information I have read says 24 hours and effects should be gone. Not so with me. Hope all is well with you and your family. " Spoke w/ pt on phone and she stated her s/s are subsiding, other than the arthralgia, RN
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| 65 | 2021-02-23 | chills, fever |
pt developed rash on b hands that appeared to be chillblains, along with usual side effects of myalg...
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pt developed rash on b hands that appeared to be chillblains, along with usual side effects of myalgias, fever, chills, arthralgias. rash lasted a little over a week and resolved on its own.
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| 65 | 2021-02-23 | chills, fever | 1 day of fever, chills and bad diarrhea |
| 65 | 2021-02-23 | cough, chills, fatigue |
Shaking from being cold. Chills, left ear pain, nausea, very tired and rundown fir 3 days afterwar...
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Shaking from being cold. Chills, left ear pain, nausea, very tired and rundown fir 3 days afterwards. Couldn?t eat for / days afterwards. Bad dry cough still persists now 2 weeks later. Took Tylenol nothing helps the dry cough
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| 65 | 2021-02-23 | headache, paranasal sinus discomfort |
About 5 minutes after vaccine was given c/o neck feelingstiff and headache. He of migraines, asthma,...
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About 5 minutes after vaccine was given c/o neck feelingstiff and headache. He of migraines, asthma,, and sinuses. States burning feeling is easing yard headache spending to top of head. Client instruct to go home and have husband drive. Plans to take her migrain meds. Says her migraines can start this way too. Left AR 12:13
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| 65 | 2021-02-23 | influenza like illness |
I was sick like when you get the flu for two straight weeks. I had absolutely no energy or will to ...
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I was sick like when you get the flu for two straight weeks. I had absolutely no energy or will to do anything. Couldn't get out of bed and it felt like my skin was crawling all the time. I have never been so sick in my life. I am NOT getting second shot because NO doctor will help me understand what happened to me. But, you need to know!
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| 65 | 2021-02-23 | fever, fatigue, headache, chills |
5:00 pm 2/23 headache/ fatigue 1:30 am 2/24 chills, headache, racing heart, shortness of breath, low...
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5:00 pm 2/23 headache/ fatigue 1:30 am 2/24 chills, headache, racing heart, shortness of breath, low grade fever , aches
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| 65 | 2021-02-23 | fever |
pfizer jan 29 pfizer feb 19 Pfizer #1 EL 9263 Pfizer #2 EL 9267 low grade fever of 99.0, palpitatio...
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pfizer jan 29 pfizer feb 19 Pfizer #1 EL 9263 Pfizer #2 EL 9267 low grade fever of 99.0, palpitations, and diarrhea yesterday. Recommended that she see her primary provider if symptoms worsen.
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| 65 | 2021-02-23 | sinus headache |
Severe frontal sinus headache that started around 5 pm. No relief with Extra Str. Tylenol. Pain so s...
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Severe frontal sinus headache that started around 5 pm. No relief with Extra Str. Tylenol. Pain so severe, I could not sleep all night. Had telehealth visit on 1/12/2021 and APN recommended I take 1000 mg. Tylenol and 600 mg Ibuprofen at the same time and to rest and to repeat these medications in 6 hours. Headache resolved after 2nd dose of medications. Since that episode, I continue to have intermittent frontal sinus headaches, not as severe as the first one.
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| 65 | 2021-02-24 | chills, headache |
Hot red face and neck; Hot red face and neck; possible slight swelling of face and eyes (minor); pos...
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Hot red face and neck; Hot red face and neck; possible slight swelling of face and eyes (minor); possible slight swelling of face and eyes (minor); chills; headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264 and expiry date: unknown), via an unspecified route of administration on the left arm, on 29Jan2021 15:15 at a single dose for COVID-19 immunization. Medical history included hypertension and kidney disease, and was allergic to bee stings, penicillin, aluminum chloride. Patient was not pregnant at the of vaccination. There were unspecified medications received within 2 weeks of vaccination, and no other vaccine in 4 weeks prior to. The patient experienced hot red face and neck, possible slight swelling of face and eyes (minor), chills and headache on 29Jan2021 15:30. Outcome of the events was recovered. No treatment was received for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
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| 65 | 2021-02-24 | chills, fever, malaise, headache, fatigue | Tiredness, headache, muscle pain, chills, fever, nausea, feeling unwell |
| 65 | 2021-02-24 | chills |
She did not have any reactions initially, but noticed the morning after the vaccine that her regular...
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She did not have any reactions initially, but noticed the morning after the vaccine that her regular cup of coffee did not taste good. She then had a rash that started on the left side of her neck, went towards the back now. This started a few days after the vaccine, all on the left side. She also got a cold sore on her lip which she had all the time as a child, but not as an adult, which has pretty much resolved. She has been cold, chills and some dizzy spells. She did get a bump on her head concussion in December. One day last week she just stayed on the sofa with a blanket due to feeling poorly. 3 days ago on her back by her shoulder blade an area has been really sore. She did take some Tylenol for the back pain which did not help so she stopped this. She did not call her doctor. The rash is still there but not as intense. It has not itched, but she has felt it.
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| 65 | 2021-02-24 | fatigue, headache |
Headache, tightness in chest, legs hurting from my knees down, hard to focus vision, and super tired...
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Headache, tightness in chest, legs hurting from my knees down, hard to focus vision, and super tired. started about an hour later. Did not sleep well. Stayed in bed the next 2 days. Tightness in chest went away the second day. Third day I felt like myself. These were things that I also experienced with Covid.
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| 65 | 2021-02-24 | headache |
The rash is up under arm, in armpit and is in the same arm of injection but there is no rash at the ...
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The rash is up under arm, in armpit and is in the same arm of injection but there is no rash at the injection site.; because there was some itching under the arm. I went to see a dermatologist who says it has nothing to do with vaccine. I also had a slight headache; I also had a slight headache a day or two after the shot; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249, expiration date: unknown), via an unspecified route of administration on 14Jan2021 on left arm at a single dose for COVID-19 immunisation. Medical history included chronic kidney disease. The patient had chronic kidney disease and its real important for someone with her disease to get the vaccine, because if she got the actual virus it would hit the kidneys hard. The patient had no positive covid or antibody test prior to the vaccine. Concomitant medications were none. The patient stated that only thing she thinks would be related was that, she noticed this rather after using the hot tub, her husband just cleaned the hot tub and put chemicals in it, maybe she had a reaction to chemicals used to clean the hot tub. On 24Jan2021, the patient was reported after 10 days the patient had rash was up under the arm, near the arm pit, in the same arm of injection but there was no rash at the actual injection site, however her skin was beautiful, there was no spot except under the armpit. She got the injection a week ago Friday, she noticed the rash days later, on Sunday with itching under the arm. The Dermatologist says it has nothing to do with vaccine. The patient also had a slight headache a day or 2 (on 15Jan2021) after the shot, not a migraine, it was a slight dull headache, but went away. The patient went to the dermatologist yesterday, and he said it had nothing to do with the vaccine. She went to the dermatologist on 26Jan2021. Caller again stated that there was no rash at the injection site, but there was a rash underneath the arm in the arm pit. She still has it, she just started to use medicine last night. It's getting better. The Dermatologist prescribed a topical cream and its some kind of cortisone. The patient did not have any severe reaction like head swelling or swelling. The patient was scheduled for her second dose on 05Feb2021. The patient recovered from headache on 16Jan2021, recovering from rash, and for itching it was unknown.
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| 65 | 2021-02-24 | headache |
No discomfort until 2:00 a.m. on 2/11. Woke up in intense pain in right arm, shoulder, front right ...
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No discomfort until 2:00 a.m. on 2/11. Woke up in intense pain in right arm, shoulder, front right bodice, up the back of my neck and head on only the right side. I took Tylenol, placed hot packs on the area and drank fluids. I took Advil at 4:00 a.m. Fell asleep and woke up at 8 a.m. I had no temperature but headache was intense. I ate a small breakfast and stayed quiet with hot packs on all areas - 5 p.m. I was feeling much better - went to bed at 7:00 p.m. next morning I was ok.
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| 65 | 2021-02-24 | sweating |
Within 15-minutes of vaccination, the patient reported feeling flush, near-syncopal, dizzy, and ligh...
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Within 15-minutes of vaccination, the patient reported feeling flush, near-syncopal, dizzy, and lightheaded with diaphoresis. EMS evaluated patient on-site. Patient was hypotensive (89/60). 12-lead EKG showed sinus tachycardia, rate 102 bpm, no ST elevation. EMS transported the patient to Emergency Department for further evaluation. In ED, patient was hypertensive (155/65) with all other vitals WNL. Repeat EKG indicated NSR, low voltage QRS, with no ischemic appearing ST changes. ED physician administered 1L saline bolus and 650mg Acetaminophen. Patient reported feeling better and was discharged with a differential diagnosis of vasovagal episode, electrolyte imbalance, and volume depletion.
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| 65 | 2021-02-25 | chills, cough, fatigue | same symptoms as when I had Covid in March 2020. Pain, fatigue, chills, cough, ... |
| 65 | 2021-02-25 | headache, fatigue |
one day later, headache and a few instances of vertigo. 3 days later sudden fatigue/weakness/dizzine...
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one day later, headache and a few instances of vertigo. 3 days later sudden fatigue/weakness/dizziness in the evening that went into the next day.
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| 65 | 2021-02-25 | headache |
Diagnosed with May-thurner syndrome; Deep vein thrombosis; Both of her feet were only slightly swoll...
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Diagnosed with May-thurner syndrome; Deep vein thrombosis; Both of her feet were only slightly swollen; Dull minor headache; Off-label use; Inappropriate schedule of vaccine administered; Localized discomfort where injection of second dose of Pfizer COVID-19 Vaccine was given; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (weight: 77.56 kg, height: 157 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the upper left arm, on 23Jan2021, for COVID-19 immunisation. Relevant medical history included thyroid condition from an unspecified date (over 25-30 years before this report) and ongoing, controlled with levothyroxine sodium (SYNTHROID); and breast cancer from an unspecified date, in 2019 (treatment and surgery on an unspecified date, in 2019. Presumed resolved with radiation treatment, but no treatment within a year prior to getting Pfizer COVID-19 vaccine). The patient previously, on 05Jan2021 (18 days before the second dose), received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) for COVID-19 immunisation. After the first dose, the patient experienced localized discomfort at the injection site and swelling of feet. Concomitant medication included levothyroxine sodium (SYNTHROID) from an unspecified date and ongoing, 0.88 mg, daily, for thyroid condition. On 23Jan2021, the patient experienced injection site discomfort described as "localized discomfort where injection of second dose of Pfizer COVID-19 Vaccine was given". On 24Jan2021, she had dull minor headache. On an unspecified date, the patient was hospitalized after the second dose and was diagnosed with May-thurner syndrome. She clarified that May-Thurner syndrome was where the iliac artery collapses and crushed the iliac vein in the upper abdomen; from that point down it started creating a blood clot. She developed a deep vein thrombosis (DVT) from her left ankle up to her right rib cage area; it was a monster. On 10Feb2021, the patient experienced deep vein thrombosis and thrombectomy was performed on the same day (outpatient thrombectomy surgery, performed 10Feb2021. It was a great surgery, very corrective. She never did have any pain or discomfort which confused everyone. She felt fine this whole time, no issues). On an unspecified date, both of her feet were only slightly swollen. Relevant laboratory test, performed on an unspecified date, in 2021, included computerised tomogram (CT scan with contrast of her abdomen and chest) that showed deep vein thrombosis: left ankle-right ribcage area. The adverse events May-Thurner syndrome and deep vein thrombosis were assessed as serious, hospitalization required from 02Feb2021 to 10Feb2021. The patient recovered from deep vein thrombosis on 10Feb2021, recovered from headache on 26Jan2021, recovered from swelling of feet and vaccination site discomfort on an unspecified date, while clinical outcome of the other events was unknown. Her vascular surgeon said he did not believe these events were vaccine related but cannot rule it out; her Primary Care Physician absolutely believed the events were vaccine related. The information on the lot number has been requested.
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| 65 | 2021-02-25 | headache | Headache; BP 136/84 (pulse 74), O2 sat 98%. Given crackers and water. |
| 65 | 2021-02-25 | malaise |
anaphylactic reaction; having issues breathing/didn't have normal respiratory support; swallowing, w...
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anaphylactic reaction; having issues breathing/didn't have normal respiratory support; swallowing, weakness, unable to take anything by mouth/had lost ability to swallow; swallowing, weakness, unable to take anything by mouth; affected my lungs, gut, muscles, everything.; still having lung issues; This is a spontaneous report from a contactable consumer(patient). A 65-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number RM9809), via an unspecified route of administration on 03Feb2021 at the 65 years old at single dose for COVID-19 immunization. The medical history included Muscular dystrophy. The concomitant medications included unspecified multiple medications. The patient received the first dose on 03Feb2021. Immediately after the vaccine on 03Feb2021 she had an anaphylactic reaction, received an Epipen, went to the ER was given steroids and sent home. Next day, still having symptoms, received second Epipen administration, went to Urgent Care, was admitted to hospital 04Feb2021. The patient stated she had a history of muscular dystrophy. She stated she was having issues breathing, swallowing, weakness, unable to take anything by mouth, didn't have normal respiratory support in Feb2021. It had affected her lungs, gut, muscles, everything. She may leave here on hospice. She wanted to know if there were others who had reported side effects such as hers. She had anaphylactic reaction to the mineral. She was still in the hospital. She had lost ability to swallow and she was still having lung issues in Feb2021. She was a disabled rehab healthcare worker. She did not have an address right now in the hospital but if sent her something later once she get out she will be able to do that but she did not have it now. She takes multiple medications. Right now she cannot take medications she need orally. She had gone to hospital getting meds via primarily IV. She had acute anaphylactic reaction immediately after the vaccine and went by ambulance to hospital and was given steroids, care basically and sent home and she still had issues the next day and it kept going from home to urgent care to admission at the hospital. She had done lot of lab tests in Feb2021. She was very concerned that this was not going to be a temporary issue. She had form of muscular dystrophy and now what was happening was the week before she got the vaccine totally independent in her home, feeling ok, medications okay and now she was at IV medications not being able to swallow. She talked to someone yesterday and they told she should be calling and reporting what happened and that was why she had been on the phone all day. She just want make sure she did not feel like the healthcare was reaching out to their own vaccination department and she want to make absolutely sure that not only does Pfizer know that have a horrid reaction but she want the healthcare firm that she had a horrid reaction and she want the CDC to know that she had a horrid reaction because right now she would tell all her friends with the severe form of muscle dystrophy she had not going to be vaccinated even though the researchers were telling her to get vaccinated. It was going to take a while to stop the efficacy again and having to be on the phone everyday when she was barely breathing. The patient underwent lab tests and procedures, which included Lab test unknown result in Feb2021. The outcome of the events was unknown.
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| 65 | 2021-02-25 | sinus pain, fatigue, headache, throat pain |
On February 23 (1 week after 2nd vaccine), I experienced sudden onset of swollen lymph node in left ...
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On February 23 (1 week after 2nd vaccine), I experienced sudden onset of swollen lymph node in left side of neck and sore throat, headache, difficulty swallowing, fatigue, some sinus symptoms and stuffy ears. Today is February 26 and I am still experiencing the same symptoms, somewhat less intense than initially. I called my primary care doctor's office and was told by the receptionist that this was a reaction to the vaccine and should subside in a few days and if not to call back.
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| 65 | 2021-02-25 | throat irritation |
Pt has a history of multiple drug allergies including anaphylaxis. Prior to COVID 19 vaccination we ...
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Pt has a history of multiple drug allergies including anaphylaxis. Prior to COVID 19 vaccination we discussed her reaction to previous Pneumovax 12 years prior. Several minutes following administration of the Pneumovax, she developed scratchy throat and hoarseness. Benadryl was administered with improvement in symptoms. She did not require epinephrine or ER visit. We discussed that she had a higher risk of reaction to the COVID 19 vaccine and advised her to wait 30 minutes post injection. During her wait time she began to develop scratchy throat and hoarseness that progressed over 10 minutes. She was taken to the treatment area where vital signs were obtained and 50 mg of oral Benadryl was given. Initial VS were SpO2 of 98, P 82, BP 140/100. She was alert and oriented. No edema lips or tongue. Heart RRR Lungs CTAB with no wheezes. She remained under observation for 30 minutes, vital signs remained stable and BP ranges from 138-140/80-90. She had noticable improvement in her throat and voice and she was discharged in good condition to home under the care of her husband. They were advised that Benadryl could be repeated in 4-6 hours if needed. Should she develop any facial swelling, shortness of breath, wheezing or lightheadedness they should proceed to the emergency department. Reviewed the newly updated CDC guidance on reactions. Although her reaction was immediate it was not considered severe. CDC advised against getting the second vaccine. She is advised to discuss further with her allergist, Dr if she would like to discuss the possibility of getting the second dose with premedication or other precaution. She and her husband understood well and all questions answered.
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| 65 | 2021-02-26 | headache | Headache off and on for three days so far; treatment--bed rest. |
| 65 | 2021-02-27 | chills, fatigue, body temperature increased |
103.1 Fever, Extreme Migraine Headache, Chills, Extreme Body Aches, fatigue, Nausea and on second da...
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103.1 Fever, Extreme Migraine Headache, Chills, Extreme Body Aches, fatigue, Nausea and on second day: 101 fever, chills, terrible fatigue and a red rash over entire body.
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| 65 | 2021-02-27 | headache | Headache, very sore muscles in body as if struck byatruck,fever 100.7 |
| 65 | 2021-02-27 | influenza like illness, fatigue, headache | flu-like symptoms - no fever, muscle and joint aches, headache, flare up of psoriasis, fatigue |
| 65 | 2021-02-27 | malaise, chills, fatigue, headache, fever |
injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swell...
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injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, malaise
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| 65 | 2021-02-28 | fatigue, headache, cough |
Body aches/random shooting pains throughout body; Fatigue; Upper back pain; abdominal pain; severe c...
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Body aches/random shooting pains throughout body; Fatigue; Upper back pain; abdominal pain; severe coughing that evening; headache; very sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EK9231), via an unspecified route of administration on the right arm on 14Jan2021 08:30 at a single dose for COVID-19 immunization at a hospital. Medical history included very chemically sensitive and drug sensitive, interstitial lung disease, and interstitial cystitis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included vitamin D, zinc, and an unspecified thyroid medication. On 14Jan2021 13:00, the patient experienced body aches, fatigue, random shooting pains throughout body, upper back pain, abdominal pain, severe coughing that evening, headache, and very sore arm. Treatment included self prescribed paracetamol (TYLENOL). Since the vaccination, the patient has not been tested for COVID-19. The patient has not yet recovered from the events.
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| 65 | 2021-02-28 | fatigue, headache, fever, chills |
Within a couple hours I had nausea my are hurt and I just didn't feel good. I woke up in the night w...
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Within a couple hours I had nausea my are hurt and I just didn't feel good. I woke up in the night with fever, chills, bad headache and body aches head to toe. Took Tylenol. Woke in the morning with fever (101.8), chills, bad headache, body aches head to toe, joint aches and nausea. Took Tylenol. Too sick to get up all of Saturday. Saturday afternoon vomited. Saturday evening fever broke and began feeling a little better. Sunday still had a bad headache, body aches and joint aches. Today, Monday, feeling better but still have a mild headache, body aches and joint aches. I also feel really week and tired.
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| 65 | 2021-02-28 | headache, chills, fever |
shaking; chills; loss of appetite; fever; joint pain; headache; This is a spontaneous report from a ...
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shaking; chills; loss of appetite; fever; joint pain; headache; This is a spontaneous report from a non-contactable consumer. A 65-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not available/provided to reporter at the time of report completion), via an unknown route of administration on 25Jan2021 at 10:00 AM at a single dose at the age of 65 years old for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID). Historical vaccine included at the age of 64 years, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Dec2020 for COVID-19 immunization. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 25Jan2021 at 22:00, after receiving 2nd dose of COVID-19 vaccine in morning, patient experienced chills, shaking, fever, joint pain, loss of appetite, and headache later that evening. She stayed home from work for 2 days and felt better 48 hours later. The reporter assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown since the vaccination, if patient was tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 65 | 2021-02-28 | headache, fatigue | Bilateral numbness, headache, tongue feels weird, really tired, hx liver transplant |
| 65 | 2021-02-28 | headache |
Technician thought the dose looked funny in the syringe but, didn't notify the pharmacist until she ...
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Technician thought the dose looked funny in the syringe but, didn't notify the pharmacist until she gave the vaccine and the next one pulled funny too. Then she notified me about the vaccine looking funny and upon inspection, there was no vaccine in the syringe. We pulled the rest of the shots in the vial and found that there was an extra shot. We concluded that this patient must not have actually received any vaccine in her dose and called her back to give her another dose. Patient was fine at the time of the incident and I followed up with her n 48 hours and she is still fine and no side effects to her arm. She did say that she had a headache but, that could have been due to the weather and not necessarily the vaccine and otherwise she feels fine with no other side effects or health issues.
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| 65 | 2021-02-28 | influenza like illness |
I went for my second shot of Pfyzer vaccine and everything was fine (including the waiting period be...
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I went for my second shot of Pfyzer vaccine and everything was fine (including the waiting period before leaving the event). During the night felt mild flu symptoms, but not bad. The next day, Sunday February 28, around 8:00 pm I noticed (while putting my car seatbelt ) I felt a lump on my left side of my neck below my ear. Before going to bed last nine I had some mild flu symptoms but no pain. As of today, I still have the lump or nodule.
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| 65 | 2021-02-28 | malaise |
She didn't feel well last night; Weakness in left thigh and leg/leg was so weak she could not get up...
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She didn't feel well last night; Weakness in left thigh and leg/leg was so weak she could not get up; Fell down 3 times; This is a spontaneous report from a contactable consumer (patient) and healthcare professional. A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1283), via an unspecified route of administration on 25Jan2021 11:30 at single dose (arm left) for COVID-19 immunization. Medical history included costochondritis, vertigo, autoimmune disease, uses a walker, inflammation of the cartilage between the rib and sternum and pulled muscle. Concomitant medications included methylprednisolone (MEDROL) (also reported as steroid pak) from Jan2021 to Jan2021 for pulled muscle and ketorolac tromethamine (TORADOL) from Jan2021, both for inflammation of the cartilage between the rib and sternum. The patient previously took iodine and experienced allergies. It was reported that the patient just got the first Pfizer BioNTech Covid-19 vaccine yesterday, 25Jan2021, 11:30 am. Last night, at 19:00, she had weakness on the left side of the body, especially in the thigh, and she fell down 3 times last night. Her leg was so weak she could not get up. She just got off the phone with the doctors office and was told to report this. The patient did not received therapy for the events weakness in left thigh and leg/leg was so weak she could not get up and Fell down 3 times. On 26Jan2021, the patient experienced didn't feel well last night. She was also on a Medrol pack about a week ago and just finished her last dose last night when she took the vaccine. The nurse practitioner at the doctor's office was wondering if it could have been an interaction between the Medrol pack and the vaccine. She got an email saying she could get the vaccine, but didn't think to call the doctor office to ask about the Medrol pack (steroid pack) or if it could cause any interactions. So the office told her to call. Later mentions along with the Medrol pack, she got an injection in the office of Toradol and this was before getting the vaccine. She stated that she did have her on a steroid pack for a pulled muscle so that may have exacerbated the issue. The weakness and things have improved so she was still a little nervous and uses a walker and just making sure to take it easy today. The patient had no other vaccines in 4 weeks and other medications in two weeks included steroid Pak. Patient had no problems with vaccines in the past. The patient had no Covid prior vaccination and was not Covid tested post vaccination. The patient had no events following prior vaccinations. Patient stated that they had been lucky and they have been tested before and has not had it yet, so that was why they wanted to get the vaccine done. She just rested and her husband helped her to bed since she didn't feel well last night. She did not have any trouble breathing. Patient underwent a Chest x-ray in Jan2021 and nothing showed up on it, but just some old calcifications from many years ago. That was done sometime last week and she also had like 3 MRI's on an unspecified date. Patient was wondering if she should she get the second dose. Her next appointment was on 16Feb2021. She was pretty banged up and does not want to have to go through that again. Outcome of events was recovering.
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| 65 | 2021-02-28 | throat irritation |
20 minutes after the injection of COVID -19 vaccine, patient reports a itchy throat, administered pa...
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20 minutes after the injection of COVID -19 vaccine, patient reports a itchy throat, administered patient own dose 0.3mf EpiPen into right thigh and Benadryl 50mg IM right deltoid, patient taken by EMS to hospital
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| 65 | 2021-03-01 | chills, fatigue, malaise, fever |
Low grade fever, violent chills, night sweats, swollen neck glands, fatigue, malaise, weight loss la...
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Low grade fever, violent chills, night sweats, swollen neck glands, fatigue, malaise, weight loss lasting 6 weeks
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| 65 | 2021-03-01 | chills, headache, fever, fatigue | Fever, chills, joint and muscle pain, headache, nausea, exhaustion,dizziness |
| 65 | 2021-03-01 | fatigue, fever | Simply tired and exhausted. 2 / 28/ 21 felt feverish / clammy. 3/ 2 / 21 still tired and exhausted |
| 65 | 2021-03-01 | fatigue |
Guillain-Barre Syndrome. 3-day hospitalization, IVIg infusion. Symptoms of tingling feet (started in...
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Guillain-Barre Syndrome. 3-day hospitalization, IVIg infusion. Symptoms of tingling feet (started in toes and progressed to whole foot), lower leg weakness and fatigue began 16 days post vaccination. Hospitalization 4 days post symptom onset.
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| 65 | 2021-03-01 | headache |
Approximately 19 hours after having the vaccination, I awoke with a sore arm, stiff neck, and pinpoi...
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Approximately 19 hours after having the vaccination, I awoke with a sore arm, stiff neck, and pinpoint headache. These symptoms continued throughout the day. At approximately 1:30 pm, I took 2x500mg acetaminophen and the stiff neck and headache pretty much went away.
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| 65 | 2021-03-01 | malaise, sweating |
patient started feeling dizzy and sweaty about 5 minutes after vaccine given and was sitting in cha...
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patient started feeling dizzy and sweaty about 5 minutes after vaccine given and was sitting in chair and falling to the side. I tried talking to her and getting her attention and she would look at me and then close her eyes like she was going to pass out. She started talking to me and after a couple minutes then began to complain about a sick stomach and started vomiting and diarrhea on and off for about an hour. Patient would seem to feel better but then vomit again. After about an hour she had us call her daughter to come get her to take her home. Daughter came to get her and she was still complaining her stomach hurt. I called patients daughter a few hours later and she said her mom was still feeling sick and I told her to call her doctor or take her to the ER if she didn't start feeling better soon.
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| 65 | 2021-03-01 | nasopharyngitis, fever, headache, chills |
Received 2nd shot around 1:30pm,. Approximately 12 hours after 2nd shot woke up shivering and havin...
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Received 2nd shot around 1:30pm,. Approximately 12 hours after 2nd shot woke up shivering and having muscle cramps in legs and feet. I had to actually get out of bed to try and relieve the cramping. I was cold and muscles were cramping but with extra blankets was able to fall back to sleep. Woke up in the morning feeling very sore with muscle pain/aches. Neck was so sore I could barely keep my head up. My whole body hurt, had a bad headache and fever of 100.4 when I finally took it. For the next 24 hours all I wanted to do was sleep. When I woke up the following morning still had a slight headache that went away as day progressed. Just thought you might want to hear about this. Not sure what you do with this information but hope it is helpful.
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| 65 | 2021-03-01 | throat pain, fatigue |
Light-headedness a few hours after injection. Following morning: Very sore arm; very tired; sligh...
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Light-headedness a few hours after injection. Following morning: Very sore arm; very tired; slight sore throat; generally out-of sorts. Started to improve in the evening. Symptoms resolved by the next morning except for sore arm. 72 hours after injection, just a slightly sore arm and no other symptoms. Side effects were more than from a flu shot but were tolerable.
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| 65 | 2021-03-01 | fever, fatigue |
Fever 100 - 101.5 24+ hours Chills 3.5 hours at noon 2-28, dizziness, nausea 2-3 hours one episode s...
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Fever 100 - 101.5 24+ hours Chills 3.5 hours at noon 2-28, dizziness, nausea 2-3 hours one episode syncope with fall, no injury extreme lassitude 24 hours
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| 65 | 2021-03-01 | fever |
At site of injection: redness of skin about 2 inches in diameter lasting 4 days, swelling, soreness ...
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At site of injection: redness of skin about 2 inches in diameter lasting 4 days, swelling, soreness decreasing in severity over the days until 6 days after injection. Fever 99.5 degrees and fatigue for 24 hours after injection.
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| 65 | 2021-03-01 | respiratory tract congestion, pneumonia, cough |
2/3 rehab visit: PA - 02/03/2021 12:25 PM CST Formatting of this note might be different from the or...
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2/3 rehab visit: PA - 02/03/2021 12:25 PM CST Formatting of this note might be different from the original. NURSING HOME ACUTE VISIT 6/24/1955 MD SUBJECTIVE: Chief Complaint Patient presents with ? Cough Pt has COVID 19 and she is coughing and congestion. This is an acute visit with pt. Status and changes discussed with staff. Advanced directives on file. Allergies reviewed at NH, though may not be fully updated in electronic record. Problem List reviewed. ROS: Gen: Denies fever CV: Denies chest pain Resp: Denies dyspnea GI: Denies abdominal pain. GU: Denies dysuria. Psych: Denies depression. OBJECTIVE: VITALS: Vitals: 02/03/21 1226 BP: (!) 94/54 Pulse: 79 Resp: 18 Temp: 37 °C (98.6 °F) SpO2: 96% PHYSICAL EXAM: General: Alert, awake, no acute distress Skin: Intact HEENT: Grossly normal Neck: Supple Lungs: Within normal limits/clear CV: RRR Abdomen: Soft, BS active Extr: WNL Neuro: Unchanged and nonfocal ASSESSMENT/PLAN: Reviewed and signed orders. Recheck in 60 days. Patient was seen today for cough. Diagnoses and all orders for this visit: COVID-19 Cough CXR 2 view. Plan to start melatonin, vit D3, zinc. Rehab nurse note: Table of Contents for Miscellaneous Notes Telephone Encounter - RN - 02/09/2021 9:30 AM CST Telephone Encounter - 02/09/2021 9:16 AM CST Telephone Encounter - RN - 02/09/2021 9:30 AM CST Discussed with Dr. and he recommended that patient go to ER for urgent evaluation/treatment with dyspnea and low O2 levels even with supplemental oxygen. Electronically signed by RN at 02/09/2021 9:32 AM CST Back to top of Miscellaneous Notes Telephone Encounter - 02/09/2021 9:16 AM CST Rehab called, they stated PT was having trouble breathing and her O2 was 80 with oxygen. They wanted to know if they should bring her in but PT is Covid positive. Staff recommended that she go to the ER. Electronically signed at 02/09/2021 9:17 AM CST 2/9 ER-> admission note: (6day admission) History The patient is a 65 y.o. female with a past medical history notable for History of anemia, anxiety, cirrhosis, COPD, CHF, diabetes, reflux, hypertension. The patient presents for evaluation of Worsening issues of cellulitis in addition to the patient's history of recent Covid 19 infection. Patient also tested positive for influenza. Patient was started on steroids at skilled care facility. Patient was already on breathing medications. Patient has had issues with CHF and lower extremity swelling. Patient was taking a diuretic for this. Due to patient's cerebral kidney function patient is not a candidate for certain medications or either influenza, Covid 19 and we are limited on antibiotics. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. 3/1/21 er to admission note: currently inpatient History The patient is a 65 y.o. female presents for evaluation of altered mental status. Notable PMHx: CHF, morbid obesity, diabetes, Patient is 3 weeks out from hospitalization for COVID-19 pneumonia. She has been more confused over the couple of days before admission. Because of altered mental status, patient was transferred to the emergency room. Patient also had some shortness of breath. In the ER, she had a chest x-ray which showed moderate interstitial infiltrate secondary to pulmonary edema or pneumonia. Lab work did show a UTI. BNP was normal at 45. Creatinine was near her baseline at 1.8. She did have elevated alkaline phosphatase at 452. White count was elevated at 14.7. Patient was difficult to arouse in the ER. On my exam, patient is difficult to arouse. After shaking her shoulder and yelling at her, she did open her eyes and say to me "I'm ok" before closing her eyes again. She is satting well on nasal canula oxygen.
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| 65 | 2021-03-02 | chills |
Pt performed TV with PCP on 2/24/21. Per PCP " She relates that yesterday morning (2/23/21) she got ...
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Pt performed TV with PCP on 2/24/21. Per PCP " She relates that yesterday morning (2/23/21) she got her 2nd COVID-19 vaccination by Pfizer. She had no ill affects until approximately 10:30 p.m. yesterday (2/23/21) at which time she developed chills her symptoms worsened and by midnight she could not move her arms or her legs and her arms and legs felt numb. She did not have any difficulty breathing. She did not have any numbness in her chest and she did not have any shortness of breath. She did not have any rash and she did not have any swelling or have any headache. She relates that she is better now (2/24/21) although she does still feel like she has weakness of her arms and legs she is now able to walk. The only remaining parenthesia is a little bit of tingling in her right arm. She is still experiencing significant fatigue".
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| 65 | 2021-03-02 | fatigue, chills, headache |
Severe headache, joint pain, nausea, muscle pain, tiredness, chills with second shot. four days la...
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Severe headache, joint pain, nausea, muscle pain, tiredness, chills with second shot. four days later: itching, redness and welts on over both elbows, knees and ankles.
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| 65 | 2021-03-02 | fatigue, chills, sweating, sneezing |
Pronounced pain at injection site started around 6pm, the day of the shot, 3/2/2021. After 8pm, sta...
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Pronounced pain at injection site started around 6pm, the day of the shot, 3/2/2021. After 8pm, started going downhill with chills and some sneezing. Managed to get to sleep, but woke up at 1:15 am and could not get back to sleep. Feeling chilled all night. At 5:30 am, got out of bed to take Tylenol and experienced dizziness (briefly blacked-out), sweats, nausea (vomited) and slight diarrhea. After that episode, started to feel a little better, though still a bit woozy and exhausted from lack of sleep.
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| 65 | 2021-03-02 | fatigue, headache, sleepiness |
She is having a hot flash; she gets warm; left arm started hurting really bad, it was throbbing; Hea...
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She is having a hot flash; she gets warm; left arm started hurting really bad, it was throbbing; Headache; Tiredness; Sleepy like/She had the sleepiness last night; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not available), on the left arm, intramuscularly, on 30Jan2021 at 14:30 at single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. No vaccine administered on the same day as BNT162B2 and no other vaccines administered within 4 weeks prior to administration. On 30Jan2021, it was reported that after the patient got the shot she felt the tiredness, sleepy-like. She had the sleepiness last night, she slept really good. The patient added that she had the first dose and she was fine. Then at night on 31Jan2021 around 1am or 130am her left arm started hurting really bad, it was throbbing. She could not put her hand over her arm, it was so painful. She called her work and was told to put ice on it and take ibuprofen. Patient also experienced headache on 31Jan2021 and took Tylenol which took away the headache, however, the patient reports headache at the time of reporting. Patient reports that on an unspecified date, she is having a hot flash, states she gets warm and then it goes away. The patient did not visit an emergency room but will see her doctor to report what is going on with her. Patient reports she is not going to take the second dose. She took off work Sunday since it was so bad and could not work like that. She is asking what happens if she does not take the second dose and how long does it take for the first dose to wear off. The outcome of the events tiredness and sleepy-like was unknown, for the event headache was not recovered, for the event left arm started hurting really bad, it was throbbing was recovering, while for the events having a hot flash, states she gets warm was recovered. The patient was vaccinated at an assisted living facility for 65+ and not in a military facility. Information regarding batch/lot number has been requested.
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| 65 | 2021-03-02 | headache, chills, fatigue, malaise |
Nausea; Dizziness; she feels like the whole house is turning around; slight headache; Chills; overal...
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Nausea; Dizziness; she feels like the whole house is turning around; slight headache; Chills; overall tiredness; overall not feeling good; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiration date: May2021), via an unspecified route of administration on the left arm on 29Jan2021 09:49 at single dose for COVID-19 prophylaxis. Medical history included ongoing hypertension (Stated that it is under control with her medication), prevent heart attack, high cholesterol, hepatitis B in 1996, Rubella/measles in 1996. Concomitant medication included ongoing acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) to prevent heart attack, hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ), simvastatin for high cholesterol. The patient previously took Flu shot for flu vaccination. She stated that she has had adverse events to previous vaccines. She stated that she had a rash and feeling bad. Profuse bleeding with her menses and stated that it lasted a week. Whenever she takes the Flu shot it disrupts her system for a while. Patient also previously took Hepatitis B in 1996 and a booster in 1997, Rubella/measles in 1996 and a booster in 1997, Tdap in 1996, OPV in 1996, Polio in 1996, TD 0.5mg in 2006. The patient experienced chills and overall tiredness on 29Jan2021; slight headache on 30Jan2021; nausea, dizziness and she feels like the whole house is turning around on 31Jan2021. Patient reported that she received the vaccine on Friday 29Jan2021 and said that she has had most of the events that were reported. Patient reported that she had chills, overall tiredness, nausea, slight headache, and overall not feeling good, like unwell feeling. She said that she had dizziness too. She said that she was wondering if she should call the doctor also. She was hoping her symptoms would go away. She said that she feels awful. She said that she feels like the whole house was turning around. She said that she cannot even drive. She said that she had a little bit of soup for lunch and she was nauseous. She said that she took Benadryl after she got home from getting the injection because she was not feeling good. She stated that she went to bed and slept and felt good when she woke up and said that feeling good was short lived. Chills: She said that she had to sleep with 2 layers of clothes. Noticed the chills at 9-10 pm that evening. She stated that she is still feeling chilly, but reported that the temperature is chilly outside. Tiredness: Started that evening after she received the vaccine. She said that she can still work, but she can hardly concentrate. She has to use a lot of focus to get the tasks done. Nausea: She noticed the nausea on Sunday. Slight Headache: She noticed the headache on Saturday 30Jan2021 and said that last night she had to take a Advil for her headache. Overall not feeling good: She thought it would have improved, but it is still there as of today. She said that she just wants to rest and she feels tired. Dizziness: Dizziness started yesterday 31Jan2021 and stated that it was awful yesterday. Patient said that it has slightly improved. The patient was recovering from chills and dizziness; not recovered from slight headache and nausea; unknown outcome for she feels like the whole house is turning around.
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| 65 | 2021-03-02 | headache |
chest pain; dizziness; joint pain; muscle pain; bad headache; Extreme facial swelling began in areas...
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chest pain; dizziness; joint pain; muscle pain; bad headache; Extreme facial swelling began in areas of dermal filler, which was administered 10/2019 and progressed throughout face; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6200, expiry date unknown) via an unspecified route of administration on 13Feb2021 13:15 in left arm at single dose for COVID-19 immunization. Medical history included migraine, joint pain and dermal filler in Oct2019; allergies to penicillin, mango, tree nuts, bees, shrimp. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication received within 2 weeks of vaccination included estrogens conjugated (PREMARIN), celecoxib (CELEBREX), levothyroxine, colecalciferol (D3), cyanocobalamin (B12), ascorbic acid (C) and Mul. The patient previously received first dose of BNT162B2 (lot number EL9262), on 23Jan2021 09:30 AM at Left arm. At 4:30 am 14Feb2021, the patient woke with chest pain, dizziness, joint and muscle pain; and bad headache. Extreme facial swelling began in areas of dermal filler, which was administered Oct2019 and progressed throughout face. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Benadryl and Tylenol (today 1 Celebrex). The outcome of the events was recovering. The events were reported as non-serious, did not result in death, life threatening, caused or prolonged hospitalization, disabling or incapacitating, congenital anomaly or birth defect
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| 65 | 2021-03-02 | lethargy, fever, chills |
Low-grade fever, chills, lethargy, muscle soreness; Low-grade fever, chills, lethargy, muscle sorene...
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Low-grade fever, chills, lethargy, muscle soreness; Low-grade fever, chills, lethargy, muscle soreness; Low-grade fever, chills, lethargy, muscle soreness; Low-grade fever, chills, lethargy, muscle soreness; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of bnt162b2 (BNT162B2 also reported as product COVID 19 brandPfizer, lot EL9265), via an unspecified route of administration in left arm on 30Jan2021 13:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included MAC (mycobacterium avium complex) and allergic to strawberries. She had her first dose of bnt162b2 (lot EL3246) on 09Jan2021 in the left arm. The patient's concomitant medications were not reported. The patient previously took rifampin and and experienced, both had drug allergy. On 31Jan2021 12:00, the patient experienced low-grade fever, chills, lethargy, muscle soreness with no treatment. The outcome of events was unknown.
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| 65 | 2021-03-02 | fever, cough, fatigue, headache |
Low grade fever; headache; cough; fatigue; diarrhea; This is a spontaneous report from a contactable...
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Low grade fever; headache; cough; fatigue; diarrhea; This is a spontaneous report from a contactable consumer (patient). This 65-year-old female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3247) via an unspecified route of administration on 28Jan2021 at 14:30 (at the age of 65-years-old) as a single dose in the right arm for COVID-19 immunization. The patient had no medical history (as reported). The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was diagnosed with COVID-19 on an unspecified date. Concomitant medications included levothyroxine from an unspecified date for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient did not have any allergies to medications, food, or other products. On 01Feb2021, the patient experienced low-grade fever, headache, cough, fatigue, and diarrhea. The events were reported as non-serious. The patient did not receive any treatment for the events. The patient was not hospitalized for the events. The outcomes of low-grade fever, headache, cough, fatigue, and diarrhea were recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 65 | 2021-03-03 | sweating |
First Reaction: Three minutes after receiving injection felt lightheaded and dizzy. Symptoms resolve...
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First Reaction: Three minutes after receiving injection felt lightheaded and dizzy. Symptoms resolved with food, water, and time Second Reaction: About 36 hours later while doing dishes, felt prickly on both sides of my neck. Both sides of my neck turned pink as though I had a sunburn. Broke out in profuse sweating. Called my doctor who was on call that night. He told me to get Benadryl right away and to keep taking it until symptoms subsided. If they did not subside or got worse I was to go to urgent care, or ER. Treatment: Benadryl every 4-6 hours for 2 days. As each dose wore off I waited to see if the symptoms came back and then took more Benadryl. Issue lasted until Saturday night - 2 days.
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| 65 | 2021-03-03 | malaise, fatigue | Nauseous, pain at injection site, fatigued, feeling unwell. |
| 65 | 2021-03-03 | fever, fatigue | Fever migraine extreme fatigue Migraine headache since this vaccine |
| 65 | 2021-03-03 | throat irritation | Tachycardia, throat "feels funny" - Evaluated by EMS-Cleared |
| 65 | 2021-03-04 | chills, fatigue |
about 24 hours later, I started feeling chill, tire and rash on my stomach, feel itchy on my back bu...
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about 24 hours later, I started feeling chill, tire and rash on my stomach, feel itchy on my back but very small area. Rash got spread out little by little as day go by, and the chill and tirdness are the same. Rash spread my whole from but not the breast area and the part of the back , my inner upper arm and inner thigh but not a big area. I went to see doctor on the 5 of March and doctor give me Hydroxyzine to take.
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| 65 | 2021-03-04 | chills, malaise |
Dizziness Chills General malaise Temperature (when feeling better temp was 99.3, dont know how high ...
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Dizziness Chills General malaise Temperature (when feeling better temp was 99.3, dont know how high it was, didnt feel like I had a temperature)
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| 65 | 2021-03-04 | headache | Numbless head face arm and headache. Call to Dr |
| 65 | 2021-03-04 | headache |
Following day around 8pm started having neck pain then numbness in left arm and face with slight hea...
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Following day around 8pm started having neck pain then numbness in left arm and face with slight headache. Lasted two days. Let up a little on third and 4th day. Day 5 almost gone still lingering numbness in left side of face.
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| 65 | 2021-03-04 | malaise, fatigue | Feeling generally well, malaise, tired Injection site sore |
| 65 | 2021-03-04 | fever, fatigue, headache, chills |
nausea; diarrhea; Could not lift her head because her eyes were hurting. When she opened them it gav...
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nausea; diarrhea; Could not lift her head because her eyes were hurting. When she opened them it gave her a headache; Feeling cold; chills; muscle pain; joint pain; fever; headache/Headaches was reported as worsened; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (also the age at vaccination) receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9263), via an unspecified route of administration at the left arm on 26Jan2021 11:00 AM SINGLE DOSE for covid-19 immunization (reported also as To protect herself). Medical history included that she had a heart cath under anesthesia about two weeks prior to getting the vaccine. She clarifies it was on 30Dec2020. There were no concomitant medications. There was no additional vaccines administered on same date. There was no prior vaccinations (within 4 weeks). No family medical history relevant to AE(s) reported. The patient was vaccinated at a Clinic. The patient previously had a flu shot in Oct2020 and the shingles vaccine in Aug2020 (for immunization). It was reported that the patient had headache, fever, chills, muscle pain, joint pain, nausea and diarrhea after the first dose of the pfizer covid 19 vaccine. The patient wanted to know how long these side effects will last. It was also asked if she should get the second dose of the covid 19 vaccine because she had side effects to the first dose and if the side effects to the second dose or worse than the first dose. It was further reported that the patient got her first shot last Tuesday (26Jan2021). Starting Friday (29Jan2021) she got symptoms. Should she be concerned? She has had tiredness, headaches, (on 27Jan2021) and this morning (01Feb2021) she could not lift her head because her eyes were hurting. When she opening them it gave her a headache. She also had muscle and joint pain (on 29Jan2021) and chills (on 30Jan2021) and fever (on 28Jan2021). She got so cold she covered up with blankets and fell asleep (on 01Feb2021). Then when she woke up it was gone. How long should these side effects last? Should she be concerned? Should she contact her doctor? The reporter also says that most of her symptoms started Friday 29Jan2021. Then she clarifies that actually her symptoms started small before then, on Wednesday 27Jan2021. As the week went on more symptoms came and became other things. It was added that she felt like Friday 19Jan2021 is when she felt the infusion all of a sudden hit her body. That is when she felt the virus hit her with symptoms. Right now her head still hurts. She is not taking as many Tylenol or staying on it regularly like she was. Maybe she should do that again. Could not lift her head because her eyes were hurting. When she opened them it gave her a headache: She says she still has dull pain behind her eyes. She no longer has chills but is feeling cold (on 01Feb2021). Like she chest was frozen on the same side that she got the shot in. They told her to take Tylenol to get relief. But she got concerned as the days went on. She is supposed to get the second dose on 16Feb2021. It was added that it was unknown specific times that these occurred. Friday she would say that she felt it all hit her bad around 11 AM after lunch. The outcome of the event headache, Muscle and joint pain was not recovered; for the event Could not lift her head because her eyes were hurting. When she opened them it gave her a headache and Feeling cold were recovering; for the event nausea, fatigue and diarrhea was unknown; and recovered for the events Chills on 31Jan2021, Fever on 29Jan2021. The AE(s) did not require a visit to Physician office nor ER. Case was considered as non-serious.
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| 65 | 2021-03-04 | fever, headache |
very bad nausea; Throwing up mucus 5 times last sat.; 99.1 temp; dizzy/ think the dizziness was for...
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very bad nausea; Throwing up mucus 5 times last sat.; 99.1 temp; dizzy/ think the dizziness was for the need of a blood transfusion, which I got Tues after vaccine; head ache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration (at the age of 65-years-old) on 28Jan2021 10:30 at a single dose in right arm for COVID-19 immunization. Medical history included anemia with blood transfusions, fat, diabetic, constipation, sinus, and manic depression, allergies, immune compromise. Concomitant medication included cyclosporine, lithium, metformin, omeprazole (OMPRAZOLE), paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]). The patient reported, "I am immune compromise. I have had some of these health complaints ongoing. The vaccine made the problems worst. Can you tell me what the 2nd dose will do to me? I think the dizziness was for the need of a blood transfusion, which I got Tues after vaccine." The patient experienced very bad nausea, throwing up mucus 5 times last Sat., 99.1 temp, dizzy/ think the dizziness was for the need of a blood transfusion, which I got Tues after vaccine, head ache; all on 30Jan2021 with outcome of not recovered. The patient underwent lab tests and procedures which included body temperature: 99.1 on 30Jan2021, SARS-CoV-2 test: negative on 01Feb2021. Unknown if treatment received for the adverse events. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events resulted Emergency room/department or urgent care. The case was assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 65 | 2021-03-04 | respiratory tract congestion |
Six days after receiving my second vaccine at a mass drive-thru site (on 2/25), I experienced plugge...
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Six days after receiving my second vaccine at a mass drive-thru site (on 2/25), I experienced plugged ears -- a feeling of congestion, pressure and mild pain. Then three days after that, on 2/28, I became dizzy and nauseous, causing vomiting and a feeling that I may faint. My husband took me to Urgent Care where I was diagnoses with BPPV and prescribed meclizine and ondansetron. I have been doing the Epley maneuver and my condition has improved somewhat, but I still feel fatigued and the pressure in my ears has not subsided. I cannot hear correctly out of my left ear. I am concerned that I now have Meniere's disease, which can be caused by "abnormal immune response" -- the vaccine? I have an appointment with an ENT specialist on 3/25 and hopefully can get some answers at that time.
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| 65 | 2021-03-04 | sleepiness, headache |
0913 Pt started having r arm,shoulder,neck pain and HA. VS as follows146/85, HR-71, 02 sat 97%ra,r-1...
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0913 Pt started having r arm,shoulder,neck pain and HA. VS as follows146/85, HR-71, 02 sat 97%ra,r-18.She states no issues with 1st dose on 2/12.0923 Pt report pain and HA has resolved now she feels sleepy. VS as follows 148/86, HR-68, 02 sat 98%, r-20. Pt grandaughter accompanied her here.0937 Pt allowed to go home with grandaughter she reports she feels much better. VS as follows 150/89, HR-77, 02 sat 96%, r-18. Pt instructed to f/u with MD as needed.
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| 65 | 2021-03-05 | chills, fatigue, fever |
Approximately 20 hours after injection, I began to have chills and fatigue; by 6pm, chills/coldness ...
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Approximately 20 hours after injection, I began to have chills and fatigue; by 6pm, chills/coldness seem to be strong in my feet slowly moving up my entire body; after about one hour; the chills subsided and a fever ensued ranging from 99.7 - 102.9; low grade fever remained thru the night with aching in the left leg; had some fatigue the next morning but by 1pm, was feeling much better with very little fever and a little soreness in the right arm; again around midnight, feet were extremely cold and aching (had to put on some socks in order to get to sleep). I would say the side effects lasted about 36 hours.
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| 65 | 2021-03-05 | cough, headache |
1) 25 minutes from injection: fluttering heartbeat, hot flush spreading from arm throughout body, we...
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1) 25 minutes from injection: fluttering heartbeat, hot flush spreading from arm throughout body, weakness in arm and then all over, shaking, dry mouth and tongue. The worst of it lasted about 5 minutes but weakness and shaking continued for about an hour. 2) Over the course of several hours developed sore arm and headache which worsened over the next 12 hours but was not terribly bad. 3) Days 3-6 had stiffness which began at injection site and went up left shoulder into the left side of neck. Resolved by day 7. 4) ON DAY EIGHT I developed a rash and itching at the injection site. Also had a dry cough and sinus drainage but cannot be certain this was from the vaccination but the rash and itching definitely was. The rash resolved by day 12. It was not terribly bad and no drugs were needed to calm the itch.
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| 65 | 2021-03-05 | fever, chills, fatigue, headache |
Exactly twelve hours after getting the second dose of the Pfizer vaccine, I experienced severe chill...
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Exactly twelve hours after getting the second dose of the Pfizer vaccine, I experienced severe chills for three gruesome hours that rattles my teeth, plus fever, fatigue, & joint pain (especially in my elbows, fingers, shoulder, knees, and back) and headache. My fever ranged from 100 degrees F to 102 degrees F for 36 hours. After consultation with my doctor at the 16 hour mark past vaccination, I took Tylenol every 6 hours to reduce my fever, which helped tremendously. These side effects lasted 36 hours almost to the minute then were gone.
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| 65 | 2021-03-05 | fever, headache |
Excruciating headache, 101.8 fever after 800 mg Advil. Fever did not break for 24 hours, then went u...
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Excruciating headache, 101.8 fever after 800 mg Advil. Fever did not break for 24 hours, then went up again two days later -3/1/21 at 3:30pm. Again 101.3. Headache lasted 24+ hours. Used ice packs on top, back and eyes for minimal relief. Advil did not lower temperature or aid in headache relief.
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| 65 | 2021-03-06 | headache |
Within a minute or two my heart started beating fast and hard and a headache began in my forehead. I...
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Within a minute or two my heart started beating fast and hard and a headache began in my forehead. I took off my mask, rolled down the window. This helped and it subsided within the 15 minute wait when we left the vaccination site. My head continued to feel a little woozy and the hard fast heartbeat returned with the headache three more times throughout the day with last one around 5:30pm. Next day just felt washed out.
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| 65 | 2021-03-06 | fever, headache, lethargy, chills |
Severe lethargy, mild chills, low fever, bad headache, so very tired for 5 days. Not sure if symptom...
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Severe lethargy, mild chills, low fever, bad headache, so very tired for 5 days. Not sure if symptoms are over yet. Still tired, but other symptoms are better
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| 65 | 2021-03-07 | chills, headache, fever |
Woke at 3am with chills, body aches, headache and fever. Fever was 2 degrees higher than normal tem...
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Woke at 3am with chills, body aches, headache and fever. Fever was 2 degrees higher than normal temp and continued until about 8pm when I took ibuprofen. Symptoms were gone when I woke up on 3/6. On 3/8 I experienced swollen glands and a cold sore. the right side of my face was achy. Ibuprofen helped.
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| 65 | 2021-03-07 | chills, fever |
Chills, Muscle contractions, Fever = 102.7 Patient on antibiotic for a sinus infection at time of in...
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Chills, Muscle contractions, Fever = 102.7 Patient on antibiotic for a sinus infection at time of injection
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| 65 | 2021-03-07 | fatigue, fever |
Fever - temp of 99.4 started about 24 hours after vaccination and lasted about 36 hours. Took ibupr...
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Fever - temp of 99.4 started about 24 hours after vaccination and lasted about 36 hours. Took ibuprofen. Fatigue - same as above. Rested.
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| 65 | 2021-03-07 | headache, chills, fatigue | Headache, chills, nausea, fatigue, soreness at injection site |
| 65 | 2021-03-07 | headache, chills | Headache within 1 hour chills diarrhea Lasted til 10 P M. Felt fine next day |
| 65 | 2021-03-07 | headache |
High Blood Preaseure 183/79, headache, disorientation, temporary forgetfulness, vomit. All these hap...
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High Blood Preaseure 183/79, headache, disorientation, temporary forgetfulness, vomit. All these happened around 9:00 p.m. As soon as those signs appeared we rushed her to the ER. The results showed Brain bleed. She was transfered to Hospital where she was valorated again and other series of test were performed. On Tuesday, 02/16/2021 she was discharged from the hospital with Discharge Diagnoses: //Bilateral subarachnoid hemorrhage //Intractable headache //Essential hypertension, uncontrolled//Generalized anxiety disorder. Thursday 03/04/2021 we follow up with the neurologist. Saturday 03/06/2021 she went to the ER with blood preasure of 189/83.
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| 65 | 2021-03-07 | headache |
3:20PM C/O TINGLING TO RT 5TH DIGIT. A/O, PINK, W/D, RESP REG WITH EASE. DENIES ANY SOB OR DYSPNEA. ...
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3:20PM C/O TINGLING TO RT 5TH DIGIT. A/O, PINK, W/D, RESP REG WITH EASE. DENIES ANY SOB OR DYSPNEA. STATES SHE 'HAS BEEN NERVOUS ABOUT GETTING THE SHOT.' 4:12PM STATES 'SHE IS FEELING BETTER'. 3-3-2108:10AM TC PT STATES 'STILL HAS TINGLING TO RT 5TH DIGIT, HEADACHE & RT ARM IS NOW SORE. STATES SHE 'FEELS LIKE SHE IS PREOCCUPIED AS SHE WAS SO NERVOUS ABOUT GETTING THE SHOT'. ADVISED TO F/U WITH HER PCP IF S/S CONTINUE. SHE STATES 'SHE MAY TAKE A TYLENOL TONIGHT AT BEDTIME.'
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| 65 | 2021-03-07 | sweating, throat pain, headache, fatigue, influenza like illness |
slept from Friday pm through Saturday about 2pm,exhausted, slept until 10am Sunday. nightmares, mi...
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slept from Friday pm through Saturday about 2pm,exhausted, slept until 10am Sunday. nightmares, minor sweating. on Sunday began nausea, headache, neck and shoulder aches, fluish, minor sore throat. knew I would sleep heavily again and did.
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| 65 | 2021-03-08 | chills, fatigue, headache |
With the 1st one I had severe chills whre my teeth were chattering the second day, body aches and so...
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With the 1st one I had severe chills whre my teeth were chattering the second day, body aches and some fatigue. Lasted about 3 days. With this 2nd one, I woke up the first night with a terrible headache and chills. By morning the chills were gone but I am so tired and my whole body hurts. I had Covid in November and the symptoms are similar to what I experienced with Covid except I had a 103-104 fever and no chills. I had to go in the hospital to get an IV with steriods to help my lungs so I could breathe.
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| 65 | 2021-03-08 | chills, headache |
Headache by 1am 3/4/21, by noon body aches, chills, skin tenderness to touch, by 4pm fever 100.5 and...
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Headache by 1am 3/4/21, by noon body aches, chills, skin tenderness to touch, by 4pm fever 100.5 and felt very bad. Was taking Tylenol every 4-6 hours but headache continued to get worse throughout the evening and into the night 3/4-3/5/21. Left arm began hurting too on 3/4/21 but no swelling or redness, just sore. Finally began feeling a little better by late evening on 3/5/21 and headache was beginning to ease but did not fully go away until 3/6/21. Was able to manage the side effects at home without going to my Dr.
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| 65 | 2021-03-08 | chills, sweating |
Approximately 15 hrs after injection and feeling no side effects all day. I woke up with sweats - us...
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Approximately 15 hrs after injection and feeling no side effects all day. I woke up with sweats - used an ice pack to cool. 100.7 temp (normal temp is 97.7) then chills which required a heated blanket to get some comfort. I was dizzy and could not stand without support for any length of time during the next 5 hrs. My sensecof taste was affected for almost a week- a weird "milk of magnesia " taste no matter what I ate. 12 hours later I was well enough to be on my feet, 24 hours after that I had very little recollection of the prior days activities or conversations. (Like a lost a day in my mind- that was scary- what's in this vaccine??) The next several days, did not have my normal energy level. I am a healthy person, high energy person. I have never taken a flu vaccine, my body has a pretty great immune system, but I did this vaccine " mostly, for the good of the whole"- I will think long and hard before I would take this vaccine again or recommend doing so to anyone else. I have been told- those with the greatest immunity system will have the worst side effects- I am not sure that makes
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| 65 | 2021-03-08 | chills, fever | Migraine headache, chills, fever, body ache, stomach ache |
| 65 | 2021-03-08 | fatigue, chills, headache, fever | 101.1 fever Chills Fatigue Headache |
| 65 | 2021-03-08 | fatigue, chills, sweating |
Strange feeling in head. Felt like wave rushing then sudden intense feeling to have bowel movement. ...
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Strange feeling in head. Felt like wave rushing then sudden intense feeling to have bowel movement. Started to black out and went down but not unconscious. Then bowel movement and nausea at same time and started dripping sweat profusely. Soaked my clothes. So weak could not get up or felt as though will pass out. Then got the chills and loud ringing in my ears. Whole episode lasted about 20-30 minutes then went to bed at 7:30 p.m. felt so exhausted and fatigued. Woke up about 4a.m. arm hurt but felt okay. Little off balance, fatigued, weak all day. Next day arm sore but improving. Now fine. Saw doctor today, he advised me to report and wait to see advice from Pfizer as to get2d dose or not.
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| 65 | 2021-03-08 | fatigue, influenza like illness |
1-3 days of achy flu like symptoms, and fatigue. Felt better each day & Completely subsided within ...
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1-3 days of achy flu like symptoms, and fatigue. Felt better each day & Completely subsided within 3 days.
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| 65 | 2021-03-08 | head discomfort |
approximately 1 1/2 hours after vaccination, I developed transient nausea, followed by a strange sen...
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approximately 1 1/2 hours after vaccination, I developed transient nausea, followed by a strange sensation in my head, fullness in the ears, ringing associated with nausea, the following day it was worse, upon waking and walking my legs felt rubbery which spontaneously resolved after briefly walking, the nausea, supratentorial symptoms, fullness in the ears persisted, no vomiting, today is the 4th day post injection without improvement. Injection site pain lasted 2 days-not bothersome. Consider my symptoms moderate and interfering with daily activities.
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| 65 | 2021-03-08 | headache, chills, fever |
Fever of 3 degrees, muscle aches and pains, chills, some loss of hearing, brain processing slowness,...
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Fever of 3 degrees, muscle aches and pains, chills, some loss of hearing, brain processing slowness, headache, loss of appetite, dizziness.rash and itchiness of arm.
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| 65 | 2021-03-08 | headache | Headache, dizziness and red knot under right knee |
| 65 | 2021-03-08 | sweating |
Initial sweaty and short of breath with pulse of 126 and oxygen saturation of 99%; rapidly improved ...
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Initial sweaty and short of breath with pulse of 126 and oxygen saturation of 99%; rapidly improved with stable vital signs
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| 65 | 2021-03-09 | fatigue | shortness of breath, chest pressure, fatigue |
| 65 | 2021-03-09 | lethargy, chills |
Starting with my first dose on 2/5/21 my psoriasis and psoriatic arthritis (worsened. After my seco...
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Starting with my first dose on 2/5/21 my psoriasis and psoriatic arthritis (worsened. After my second dose I had chills, lethargy and severe joint and body pain (difficult to sleep) which improved after 36 hours--except worsening of left knee pain--by 3/5/21 I was unable to stand, walk or move my left knee due to pain. I self treated with Naprosyn (400 mg bid) and went to urgent care on 3/6/21. The XRAY was negative with slight effusion. I have had no injuries or trauma to my leg. I am a physician and have had psoriasis and PsA for about 25 years--have on and off medical care (topical steriods, creams and NSAIDS). Due to my +BRCA2 gene I have not taken stronger immuno-suppressive therapies.
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| 65 | 2021-03-09 | fever, malaise, headache, chills |
That night I didn't feel well, I went to bed early. Chills in mddle of night. I didn't go to work (w...
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That night I didn't feel well, I went to bed early. Chills in mddle of night. I didn't go to work (wasn't planning on it) and I didn't get up and I realized I couldn't get out of bed. I somehow got up and put leggings on and I couldn't stand up and I unlocked the door because a repair man was going to be coming to fix the dishwasher. I fell asleep after he left - he had to bring me my checkbook - never took my prednisone for the day - I had chills and fever all day. I had fever - 104. I had nausea, body aches, vomiting, diarrhea and my husband gave me 20 mg of steroids when he got home and two of my Florinef and two ice chips to swallow. He carried me upstairs - I was not cognizant of what was going on. I wasn't cognizant the whole day of Wednesday. He gave me soup later and more doses of steroids. I didn't have a fever - or else it was down to 100. I still had diarrhea, nausea, headaches, body aches and I only ate the BRAT diet. I couldn't go to the office Thursday or Friday. On Friday, I still had a horrible headache. I was still doubling up on my steroids that day as I still felt so horrible. That Friday night, I finally felt wonderful. But I had taken a lot steroid after all that.
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| 65 | 2021-03-10 | chills, fatigue |
I was slightly dizzy about 5 minutes after but then was fine. 10 days later I was fatigued, dizzy, n...
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I was slightly dizzy about 5 minutes after but then was fine. 10 days later I was fatigued, dizzy, nauseous and had the chills. Body ache and fatigue only lasted a few days but the dizzy and nausea remained on and off for next few weeks. Today it has been 38 days later and the dizzy has subsided over past week but I continue to experience nausea on and off and this is very worrisome. Due to this I have not had the second shot because I feel unwell. I saw my primary doctor and did not find anything wrong. I also have not heard of anyone who has had this same experience so I am scared to have the other shot even though I know I need it. I just need some answers. Thanks for responding.
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| 65 | 2021-03-10 | chills, fever, fatigue | chills, fever, vomiting, muscle spasms, extreme fatigue, for three days; fatigue lasting 7 days |
| 65 | 2021-03-10 | fatigue, chills, fever | Sore arm, fatigue, chills & low fever, body aches. Lasted about 48 hours. |
| 65 | 2021-03-10 | fatigue |
Rhabdomyolysis; her CPK was over 2400; Muscle cramps/Muscle spasms; Petechia; Dry skin; Itching; Fat...
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Rhabdomyolysis; her CPK was over 2400; Muscle cramps/Muscle spasms; Petechia; Dry skin; Itching; Fatigue extreme/felt tired; Myalgia; Pain; This is a spontaneous report from a contactable Nurse. A 65-year-old female patient received first dose of BNT162B2 (BNT162B2; Lot number EL0140 for both doses, expiry date not reported) via an unspecified route of administration to right deltoid on 23Dec2020 at 15:00 single dose, and second dose via an unspecified route of administration to right deltoid on 13Jan2021 15:15 at single dose for covid-19 immunization, hepatitis a vaccine (HEPATITIS A) intramuscular on 29Dec2020 at single dose for immunization and varicella zoster vaccine rge (cho) (SHINGRIX) intramuscular from 29Dec2020 at single dose for immunization. Medical history included osteoporosis from 2011, osteoarthritis from an unknown date, Knee replacement (Reported due to the osteoarthritis, she had her one knee replaced in 2004 and her other knee replaced in 2011), Spinal compression fracture in 2011 (Reported she fell at work and had a spinal compression fracture in 2011. She said the spinal compression fracture was repaired by a vertebroplasty in 2011) and Hypothyroidism (she has had hypothyroidism for a long time, since either 1998 or 2000). The patient's concomitant medications were not reported. The patient experienced rhabdomyolysis on 06Feb2021, fatigue extreme/felt tired on 30Dec2020, myalgia on 30Dec2020, pain on 30Dec2020, petechia on 06Feb2021, muscle cramps/muscle spasms on 17Feb2021, dry skin on Feb2021, itching on Feb2021 and her cpk was over 2400 on an unspecified date. The patient was hospitalized for rhabdomyolysis from 06Feb2021 to 09Feb2021 and reported to have caused disability. All the other events were reported as medically significant. She said she wanted to report to Pfizer that she was admitted to the hospital on 06Feb2020. She said she was in rhabdomyolysis, and the rhabdomyolysis was really bad. She said she had so much fatigue, myalgia, and pain that she couldn't walk. She said she was given a lot of fluids while she was in the hospital. She said her CPK was over 2400 when she was admitted to the hospital on 06Feb2021. She said she had so much fatigue, myalgia, and pain that she couldn't walk. She said she has a petechia rash, cramps, muscle spasms, dry skin and itching now. Reported she literally saved herself from dialysis by going to the hospital. She said she kept putting off her symptoms, and took Tylenol and Naproxen for the whole month of Jan2021. She said her symptoms started brewing up from day 1, clarifying that her symptoms were not really bad until 30Dec2020 and 31Dec2020. She clarified on 30Dec2020 she took Naproxen, Ibuprofen, and Tylenol for her symptoms, and nothing helped her. She said she knew her symptoms were not normal for her, and she went for the whole month of Jan2021 with her symptoms. She said finally there came a time when she said "oh no, this is not normal at all", and she told herself she needed to check in at the hospital. She said she took Naproxen and Tylenol, and felt a little better, and drove herself to the hospital. Reported she kept walking and taking medicines, and while at work she diverted her mind from her symptoms, but when she came home she felt tired, and would tell herself she couldn't do it anymore. She said she doesn't know if what she experienced was from the COVID-19 Vaccine, but that definitely she had a reaction to either the Hepatitis A booster, the Shingrix Vaccine, or the Pfizer COVID-19 Vaccine. Reported she received 11 bags of Normal Saline (1000ml per bag) while she was in the hospital. She said fluid resuscitation was the only way to bring her CPK levels down and to treat the rhabdomyolysis. Reported her symptoms have improved. She said her last CPK was 134 on Wednesday, 17Feb2021. Reported she had cramps and severe muscle spams in her right leg on 17Feb2021, and then had cramps and muscle spasms in her left leg the following day. She said the cramps and muscle spams have not gone away completely. Reported she has a small petechia rash on her lower legs. She said at the moment the petechia rash shows up on her leg, she knows she is going to have a muscle spasm in that area. She said last night she had 2 petechia rashes show up on the lateral side of her right ankle. She said the petechia rash started to burn, and her right leg calf muscle became heavy. She said she could tell her right leg calf muscle was going to start to spasm, so she took some coconut oil and applied the coconut oil to her right leg calf muscle and massaged her right calf muscle. She said she had 2 areas of petechia last night (23Feb2021). She said the first time the petechia was noticed was when she went to the Emergency Room on 06Feb2021. She said the petechia has been persisting since that time. She said prior to being admitted to the hospital she never had dry skin or itching, but now she has dry skin and itching. She said she was using coconut oil to keep her skin moist. She stated she had 2 telehealth calls (11Feb2021 & 18Feb2021) because of a petechia rash and muscle cramps and was asking her doctor is she may need to go back to the hospital. The patient underwent lab tests and procedures which included blood work, CBC and Thyroid level on 06Jan2021 with unknown results (she had regular blood work done for her yearly checkup on 06Jan2021 (BMP, CBC, and Thyroid level). Also included CPK on 06Feb2021 greater than 2400, CPK on 09Feb2021 566 and CPK on 17Feb2021 134 (units were unspecified), She said her last CPK was 134 on Wednesday, 17Feb2021. Therapeutic measures were taken as a result of rhabdomyolysis, fatigue extreme/felt tired, myalgia, pain, muscle cramps/muscle spasms, her CPK was over 2400. Outcome of the event rhabdomyolysis, fatigue extreme/felt tired, myalgia, pain and her cpk was over 2400 was recovering. Outcome of petechia, muscle cramps/muscle spasms, dry skin and itching was not recovered.; Sender's Comments: Based on the information currently available, a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. The Hepatitis A booster and the Shingrix Vaccine may have also played a contributory role. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 65 | 2021-03-10 | headache, fever, fatigue, malaise |
12 hrs. after 1st vaccine, woke up with body aches and headache, feeling like I had the flu. This a...
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12 hrs. after 1st vaccine, woke up with body aches and headache, feeling like I had the flu. This all passed after 3 hrs. 13 hrs. after 2nd vaccine, woke up at 4:00 a.m., with sever body aches all over, slight fever, headache, severe tiredness, and general feeling sick, like I had the flu. Took Tylenol, went back to bed, and slept 24 hrs,, then woke up feeling somewhat like I had a hangover, but as the day progressed, felt back to normal. Small price to pay to get vaccinated!!!!
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| 65 | 2021-03-10 | headache | Sore arm Headache Palpitations All lasted 24 hours and then completely resolved |
| 65 | 2021-03-10 | sweating, headache, chills | Chills, sweats, massive headache, body aches, nausea |
| 65 | 2021-03-10 | sleepiness, throat irritation |
apprx 2 minutes after shot, upper and lower lips, tongue started to tingle and get numb. some swelli...
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apprx 2 minutes after shot, upper and lower lips, tongue started to tingle and get numb. some swelling of lips tongue, roof of mouth and throat started to itch, flush feeling. Observed for apprx 10 minutes, symptoms did not go away, offered care in emergency room. Admitted 11:28 am about 18 minutes after shot. Observed until 12:05pm, took two Benadryl, 3 corticosteroids, and pepsid. Became drowsy, slept about 1 hour. Symptoms went away was released a round 3:00pm. Advised not to get second dose
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| 65 | 2021-03-10 | upper-airway cough syndrome, cough | lump appeared on back of neck, cough, post nasal drip |
| 65 | 2021-03-11 | chills, body temperature increased, headache |
Pounding ,throbbing headache so bad I did not want to lift head from pillow. Chills 99.7 temperatu...
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Pounding ,throbbing headache so bad I did not want to lift head from pillow. Chills 99.7 temperature where as my normal temp is nearer97.8. Sickness started almost 24 hour after shot and last about16 hour with aching head and neck.. till next morning
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| 65 | 2021-03-11 | chills, fever, headache, fatigue | Tiredness for several hours followed by chills, fever, arm pain, headache for 30 hours. |
| 65 | 2021-03-11 | fatigue |
Dizziness, unstable when walking, great fatigue. Bedrest and Tylenol. In bed for 7 days. Still not s...
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Dizziness, unstable when walking, great fatigue. Bedrest and Tylenol. In bed for 7 days. Still not steady on feet. Still fatigued.
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| 65 | 2021-03-11 | headache, fatigue | mild headache, sore arm, fatigue |
| 65 | 2021-03-11 | headache |
Extreme migraine. Head pain, neck pain, nausea, vomiting,, dizziness, overall weakness, light sensit...
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Extreme migraine. Head pain, neck pain, nausea, vomiting,, dizziness, overall weakness, light sensitivity. I have migraine disease but since I began Aimovig injections nearly a year ago I have very few migraines, Those I have had have been extremely mild, just headache usually relieved by otc meds. Additionally I have not had nausea and vomiting with any migraine episode for many years. When I woke at yesterday morning, I was in extreme pain across the right side and back of my head and down to my neck and shoulders. 9 out 10. I took my prescription, Eletriptan .5 mg at 5:45 and went back to bed. It gave little relief of symptoms. I was unable to sleep and at about 7 a.m. I was hit with waves of nausea and extreme violent vomiting. This last for several minutes. At approximately 9 a.m. I took a 2nd dose of Eletriptan and slept a little. Again at about 11: a.m. I was hit with another round of extreme nausea and vomiting which lasted about 5-6 minutes. I slept a bit and around 3 p.m. was finally able to drink a little water. Still very weak but pain had subsided significantly, down to about a 4 / 10. By 6 pm. I was almost pain free ? symptom free though very weak still. Ate a little at about 7 p.m. I know this was a migraine which I am diagnosed with but it was extreme even for me, and especially in recent years. It was very unusual in timing and severity and I felt it needed reporting.
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| 65 | 2021-03-11 | sweating |
Patient experienced vasovagal response 10 minutes after dose given. Diaphoretic, vital signs remaine...
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Patient experienced vasovagal response 10 minutes after dose given. Diaphoretic, vital signs remained stable. Patient stated "feel like I could pass out". Observed for 30 minutes with full resolution of symptoms.
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| 65 | 2021-03-12 | chills, headache | I experienced sore arm, chills, muscle aches, and headache. I remained in bed for the whole day. |
| 65 | 2021-03-12 | cough, runny nose, sinus disorder, sneezing |
Within 30 minutes upper body muscles became very achy. Within next hour sinus tickle and nose runnin...
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Within 30 minutes upper body muscles became very achy. Within next hour sinus tickle and nose running. Within two hours a tickling discomfort in lungs, coughing. (Left lung in particular.) Remembered then in early 2000's had pneumonia several times with scarring on left. Monday evening while trying to sleep much sneezing, nose blowing, fluids moving into chest and by morning a severe left calf cramp for which I had to stand up to relieve. Leg very sore until the 12th. Been very cold all week.
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| 65 | 2021-03-12 | fatigue |
1 hour after receiving vaccine became dizzy. It passed within an hour. Following day had severe lowe...
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1 hour after receiving vaccine became dizzy. It passed within an hour. Following day had severe lower burning back pain.. it resolved following day. The next day Feb 11, was severely nauseated all day. Feb 12 nausea resolved. Feb 18 nausea returned. Stomach upset for over 2 weeks then began to resolve. Called Dr . He rec delay 2nd vaccine 1-2 weeks.. Saw Dr on March 8 to discuss 2nd vaccine. Had 2nd vaccine March 11. Same symptoms again but much milder. Also had fatigue for weeks after 1st vaccine and again after 2nd vaccine. .
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| 65 | 2021-03-12 | headache |
right frontal/temporal throbbing headache on 2/3/2021 (day of vaccine) followed by right eye optic n...
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right frontal/temporal throbbing headache on 2/3/2021 (day of vaccine) followed by right eye optic neuritis on 2/8/2021. No history of demyelinating disease.
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| 65 | 2021-03-12 | headache |
March 12, 2021 @ 12:01 am. Developed Severe headache, nausea, body aches. Headache worsened when lay...
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March 12, 2021 @ 12:01 am. Developed Severe headache, nausea, body aches. Headache worsened when laying down. Self treated with over the counter Dimenhydrinate 3 times. For nausea. Tylenol 1. Headache did not go away after 4 hours. Took a Butalb/asa/caff/codeine 30mg at 4am. (PRN order for migraines) Headache eased up a lot. Felt flushed through the night. March 12, 2021- About mid afternoon on started a painful swelling under left armpit. (Injection was in left arm). Treated with Ice packs. March 13, 2021- swelling under left armpit worsening. Cannot put my arm down. Treating with ice packs. Nausea, headache are better. Body aches are reduced.
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| 65 | 2021-03-12 | headache | Headache, light headed, dizzy, eyes blurry at times. |
| 65 | 2021-03-12 | headache |
Within 10 minutes I felt faint, my neck tightened, headache started.. Still have a headache 5 weeks...
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Within 10 minutes I felt faint, my neck tightened, headache started.. Still have a headache 5 weeks later
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| 65 | 2021-03-13 | chills, fatigue, influenza like illness |
Some arm soreness and dizziness 12 hours after vaccine. Awoke with chills 18 hours after vaccine. Fl...
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Some arm soreness and dizziness 12 hours after vaccine. Awoke with chills 18 hours after vaccine. Flu-like symptoms from that time for another 12 hours or so: body aches, tiredness, nausea.
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| 65 | 2021-03-13 | chills, sweating |
The minute I stood up after vaccine, I was very dizzy and my heart started pounding. Then I got naus...
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The minute I stood up after vaccine, I was very dizzy and my heart started pounding. Then I got nausea. Was sent to Urgent Care office where I got EKG, which showed no problems with my heart. Went home, weak. Woke at 2:00 am with night sweats. When I got up I noticed swelling on face, throat, hands & feet. Faint pink rash ran up both fore arms and I had welts rising on my wrists. Nurse line I called said to to to ER asap, Took me a few hours to find a ride, my throat was closing up more by that point. I could tell over a few hours that my throat was swelling up. Went to nearest ER where I was very mentally confused. They gave me a shot of steroids and Benedryl. Later that night I got chills and was VERY weak. Had night sweats again. After a few days of rest, am still weak.
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| 65 | 2021-03-13 | headache, fatigue |
Slight headache right after. I took Tylenol. After 12 hrs, rash on chest, stomach and legs. I too...
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Slight headache right after. I took Tylenol. After 12 hrs, rash on chest, stomach and legs. I took Benadryl. 2nd Day, Next morning: headaches. Tylenol. Foggy and not clear headed. L arm hot and hurts, Hip, knee and ankle on L side painful. Very tired. Rash is gone. Mid day: anxiety and feeling down. Called Dr. and got nurse and then called therapist. headache still continues. I took a nap, I never take naps unless very sick. Eve: Rash came back. Benedryl Headache. Tylenol 3rd day: Diarrhea. headache, still foggy and tired.
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| 65 | 2021-03-13 | headache |
The morning after the shot extreme pain above my temples that moved also to the upper part of the le...
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The morning after the shot extreme pain above my temples that moved also to the upper part of the left side of my head. Only could ease the pain be keeping eyes closed for a day and a half. When got out of bed after very dizzy for a day.
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| 65 | 2021-03-13 | headache |
3/13/2021 migraine headache the following day, never had a migraine before, woke up at 5:00 A.M. the...
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3/13/2021 migraine headache the following day, never had a migraine before, woke up at 5:00 A.M. the following morning with eyes feeling very heavy, headache and lightheaded, sunlight bothered me. Took Advil and stayed in a darkened room. Felt fine 3/14/21 when I woke up.
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| 65 | 2021-03-13 | headache |
Headache after vaccine; denied vision changes, trouble breathing, no lightheadedness. Reports headac...
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Headache after vaccine; denied vision changes, trouble breathing, no lightheadedness. Reports headache 3 hours after first vaccine; reported to MD "if severe, seek medical care". Will be following up with MD tomorrow (as is Sunday); Neurologist (seizures, hx stroke) on Wednesday. HA same as when started 8/10; VSS; BP 132/80. Last time, took tylenol for headache; rested in "dark room" (gets migraines). Has BP cuff at home, pulse ox. Will f/u if symptoms worsen.
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| 65 | 2021-03-13 | malaise, chills, cough, fatigue, headache, sweating |
Very severe headache, pain at injection site, chills, sweating, cough, malaise, R hip pain (osteopen...
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Very severe headache, pain at injection site, chills, sweating, cough, malaise, R hip pain (osteopenia), fatigue
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| 65 | 2021-03-13 | throat pain, cough |
Very tender and swollen lymph nodes on left side -- continued low energy - sore throat and cough whe...
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Very tender and swollen lymph nodes on left side -- continued low energy - sore throat and cough when lying down. (I know the lymph nodes are from the injection -- not sure about the rest of it.) Not overly concerned -- just reporting so you have accurate data.
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| 65 | 2021-03-14 | throat pain, fatigue, headache |
fatigue, sore throat, HA, feeling hot and cold, light headedness/dizziness recommended she get covid...
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fatigue, sore throat, HA, feeling hot and cold, light headedness/dizziness recommended she get covid tested due to sore throat being reported. stated she would check her local pharmacy
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| 65 | 2021-03-14 | fever, headache, chills | Headache Chills Sever body pain Fever |
| 65 | 2021-03-14 | fever, malaise |
Full anaphylaxis, Vertigo, Blood Pressure spike to 200 and it lingered there. Sent immediately to ...
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Full anaphylaxis, Vertigo, Blood Pressure spike to 200 and it lingered there. Sent immediately to Hospital. Was administered IV Benadryl and Prednisone. Slept for three hours. BP dropped to 165 and was released with Benadryl and Prednisone to take for the next four days. Next several days of nausea, diarrhea, fever, weakness, shakes. No energy. Not feeling well until March 14th.
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| 65 | 2021-03-14 | throat clearing, throat irritation |
9:40 am - Husband states patient has lip swelling and itching. 9:45 am - Patient states mouth and th...
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9:40 am - Husband states patient has lip swelling and itching. 9:45 am - Patient states mouth and throat itching, lips swelling. Given sip of water - difficulty swallowing but denies difficulty breathing. Patient states she is allergic to multiple meds. 9:55 am - Itching in multiple places and repeatedly clearing throat with difficulty swallowing. Lip swelling noted - patient now moved to a bed and 911 is called. 10:00 am - Fire medics arrive and patient assessed. Patient taken to hospital via ambulance.
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| 65 | 2021-03-15 | chills, sweating |
Approx. 6 hours after first dose - she developed a funny feeling in her head. This feeling became pr...
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Approx. 6 hours after first dose - she developed a funny feeling in her head. This feeling became profuse sweating, stomach irritability, blacked out and fell to the ground. She had chills and ringing in her ears. symptoms resolved by next morning.
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| 65 | 2021-03-15 | chills |
Time of injection felt a stinging sensation, lasted a few minutes. Within hour, iced arm as was qui...
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Time of injection felt a stinging sensation, lasted a few minutes. Within hour, iced arm as was quite sore. Woken during night with chills, sweats and feeling of numbness from shoulder down to elbow and unable to raise arm. Took 2 acetominophen and iced arm, able to fall back to sleep. Very sore and difficulty in raising arm for 2 days.
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| 65 | 2021-03-15 | fatigue, chills, fever | Fever over 100°F, body aches, chills, fatigue starting about 16 hours after injection |
| 65 | 2021-03-15 | headache, malaise, lethargy |
Prior to vaccine took 2 acetominophen. Upon injection had sensation of an angry bee sting that subs...
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Prior to vaccine took 2 acetominophen. Upon injection had sensation of an angry bee sting that subsided in a few minutes. Left shoulder, neck & arm very sore, iced injection site within 1 hour of receiving. Early evening, didn't feel well-- upset stomach, loss of appetite, head ache, lethargic. Ended up sleeping abnormal amount over next 3 days with aches in joints, specifically in hands & knees.
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| 65 | 2021-03-15 | headache, fever |
The morning of 1/27, the day after the shot, I awoke with floaters in both eyes and a flasher in the...
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The morning of 1/27, the day after the shot, I awoke with floaters in both eyes and a flasher in the right eye. On the following morning 1/28 I awoke with a headache and fever(100 - 101) that lasted through 1/29 and 1/30.
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| 65 | 2021-03-15 | headache |
Patient felt like going to pass out and she did then, she was probably out less than in a minute; Se...
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Patient felt like going to pass out and she did then, she was probably out less than in a minute; Severe headache; Nauseous; Throwing up/Vomiting; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient (weight: 81.65 kg, height 170 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6201) at single dose, on 22Feb2021, for COVID-19 immunisation. Relevant medical history included thyroid disorder form an unspecified date. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder. On 22Feb2021, the patient experienced sore arm. On 25Feb2021, the patient developed severe headache, nauseous, and vomiting (throwing up) and the patient felt like going to pass out and she did then, she was probably out less than in a minute. The patient described as following: so, on 25Feb2021, the headache increased throughout the day and her nauseousness continued throughout the day and in the afternoon with the pain of the headache she thought she passed out, she vomited that gave her little bit of relief but then she took "two (not clarified) Advil and went to bed". Clinical outcome of the adverse events was unknown at time of this report. Patient asked if should be expected the same kind of reaction when she got her second shot.
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| 65 | 2021-03-15 | headache |
Headache, Aleve , the Aleve helped some, resolved after 48 hours Body aches, Bolus (Dialadid) from p...
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Headache, Aleve , the Aleve helped some, resolved after 48 hours Body aches, Bolus (Dialadid) from pain pump 1 time, Aleve, duration 72 hrs, Dizziness, 72 hours, had to be very careful when I walked around or stood up Triggered a Fibromyalgia flair up. My pain level has gone up to 6 in some areas, started 48 hours after vaccination and is continuing though long-term pain is coming down. Increased the shakiness I have in my hands, 72 hours, it has gotten somewhat better
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| 65 | 2021-03-15 | throat pain, nasal congestion, headache, fatigue, cough |
COVID-19; COVID-19; Fatigue; general achiness; respiratory symptoms; loss of taster intermittent los...
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COVID-19; COVID-19; Fatigue; general achiness; respiratory symptoms; loss of taster intermittent loss of smell; loss of taster intermittent loss of smell; coughing; congestion; sore throat; headache; Exposure to SARS-CoV-2; Nausea; injection site pain; lightheadedness; Stomach pain; extreme exhaustion; This is a spontaneous report received by Pfizer from Agency, (Mfr. Control No: 2020US004529) through a contactable physician. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 29Dec2020 (at the age of 65-year-old) as a single dose for Covid-19 immunisation and also started to receive abaloparatide (TYMLOS, Formulation: injection, Lot number: RT01102, Expiration date: Dec2022) via subcutaneous from 20Dec2020 to an unknown date, at 80 ug, once a day for osteoporosis. The patient medical history, included autoimmune disease-Behcet's disease causing ulcers, osteoporosis and constipation, and all were ongoing. The patient concomitant medication was not reported. On 29Dec2020, the patient experienced injection site pain, fatigue, nausea, Stomach pain and Light headness and the patient believed these symptoms were due to the vaccine. On 04Jan2021, the patient was Exposure to SARS-CoV-2. It was also reported that on 16Jan2021, the patient experienced coughing, fatigue, lost taste/smell, congestion, sore throat, headache, respiratory symptoms, general achiness and also had COVID-19 on an unknown date. It was reported that general achiness and respiratory symptoms possibly related to Covid-19 which resulted in emergency room visit on 16Jan2021. The cough was treated with benzonatate pearls. The following relevant laboratory tests were performed: Rapid COVID-19 (12Jan2021), negative, COVID 19 PCR test (15Jan2021), negative, and chest x-ray (16Jan2021), clear, negative. The action taken in response to the events for abaloparatide was unknown. The outcome of the events COVID-19, light headedness, stomach pain, exposure to sars-cov-2 was unknown, for the events nausea, general achiness, respiratory symptoms, loss of taster intermittent loss of smell, coughing, congestion, sore throat, fatigue, headache was not recovered and for the events injection site pain, extreme exhaustion was recovered on 31Dec2020. Information on batch/lot number was requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 29Dec2020, and contracted COVID on an unspecified date. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection. Further information like COVID infection date needed for a full meaningful medical assessment.
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| 65 | 2021-03-15 | fever, headache |
2/23 Headache, Fever (100-102) lasted until 3/1 2/25 Left arm node, noticed swelling 2/27 Awoke with...
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2/23 Headache, Fever (100-102) lasted until 3/1 2/25 Left arm node, noticed swelling 2/27 Awoke with right parotid gland very swollen... stayed enlarged until morning of 3/1
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| 65 | 2021-03-15 | fever |
Fever (100F) started evening of 3/12/21 and has continued to this date.. Using Tylenol extra streng...
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Fever (100F) started evening of 3/12/21 and has continued to this date.. Using Tylenol extra strength.
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| 65 | 2021-03-16 | chills |
Severe vomiting within 45 minutes of receiving vaccine. I had 4 distinct vomiting episodes, vomitin...
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Severe vomiting within 45 minutes of receiving vaccine. I had 4 distinct vomiting episodes, vomiting 3 or 4 times during each episode. I took a single dose of Zofran at about 2 pm and had last vomiting episode around 4 pm. Vomiting episodes lasted a total of about 6 hours. I had chills for about an hour right after 1st vomiting episode. I had significant left arm pain that prevented use of arm for 2 days. I also had extreme weakness the 1st day, I couldn?t get out of bed except to vomit. I got the vaccine on Wednesday and didn?t feel fully recovered until Sunday.
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| 65 | 2021-03-16 | fatigue, chills, malaise, headache |
1st day after-fatique/headache/weakness/chills 2nd day- better 3rd day- dizziness started late nigh...
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1st day after-fatique/headache/weakness/chills 2nd day- better 3rd day- dizziness started late night, subsided next morning. 4th day- same as 3rd 5th day- extreme dizziness at night, continued next day with sick feeling, stomach pain, leg weakness. Heart palpitations and racing(during night) Symptoms continued following 6th-10th days. Went to hospital emergency room 11th day due to doctor concerns of possible aFib. Admitted in Observation Unit overnight with IV fluids & heart monitor. Heart attack ruled out. Tachycardia event with follow up at cardiologist.
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| 65 | 2021-03-16 | headache, fatigue, chills, fever |
Severe headache, fever (100.4º), chills, fatigue I have not taken anything for it, but plan to on t...
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Severe headache, fever (100.4º), chills, fatigue I have not taken anything for it, but plan to on the next day.
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| 65 | 2021-03-16 | headache, fatigue, chills, fever |
Lightheaded first. Arm soreness, Late evening tired, headache, chills, fever up to 100.6, slight bl...
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Lightheaded first. Arm soreness, Late evening tired, headache, chills, fever up to 100.6, slight blood pressure increase, pulse to 99 (normally 65), chest pain. Woke up 2/17 feeling better. Fever down to 98.8, pulse down to 74
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| 65 | 2021-03-16 | headache |
Pt was in COVID-19 Observation area pt complained of Headache , shakyness, and Nausea. B/P @ 128/53 ...
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Pt was in COVID-19 Observation area pt complained of Headache , shakyness, and Nausea. B/P @ 128/53 P-82. Doctor available in Observation area to evaluate pt and pt taken to Clinic via W/C by R.N..
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| 65 | 2021-03-16 | headache | Headache, then subsequent nausea, vomiting, and abdominal pain several hours after vaccine |
| 65 | 2021-03-16 | throat irritation |
Patient began to feel dizzy with a scratchy throat, felt better when she laid down. No significant m...
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Patient began to feel dizzy with a scratchy throat, felt better when she laid down. No significant medical hx
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| 65 | 2021-03-17 | chills |
Began as H/A and some overall achiness, nausea, moved quickly to severe chilling for several hrs, di...
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Began as H/A and some overall achiness, nausea, moved quickly to severe chilling for several hrs, did hv small episode of vomiting. Took Tylenol ES 2 caps+ 1 generic maximum strength acid reducer ice chips, comforter blankets and heating pad. By Midnite, chilling, n/v subsided. Just remained for the nite w/multiple blankets. Woke up in am w/o issue
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| 65 | 2021-03-17 | cough, throat irritation |
30 mins post vaccination, client complained of new onset tickling in throat, voice hoarseness then c...
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30 mins post vaccination, client complained of new onset tickling in throat, voice hoarseness then cough. Client awake and alert. Vital signs stable, BP slightly elevated 164/71 @ 1226, O2 sats 98%. Blood glucose 154. Per staff protocol, Benadryl discussed but doctor declined to order administration. Daughter is driving her home.
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| 65 | 2021-03-17 | headache, chills, fever |
Within 2 days of vaccination, I began to experience moderate constitutional symptoms: headache, low ...
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Within 2 days of vaccination, I began to experience moderate constitutional symptoms: headache, low grade fever of 99, and mild chills. Sunday AM I noted the onset of intense vaginal itching and burning. By the evening, I was clearly having an HSV2 outbreak. While it was similar in ?scope? to past outbreaks (none for more than 2 yrs.), it was more intense. Lasted slightly longer at 6 days rather than 4. No MD contact made as 1) I cannot take antivirals as they precipitate arrhythmia; and 2) taking antivirals at this time would clearly seem antithetical given the circumstances. This was shot #1.
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| 65 | 2021-03-17 | headache, malaise |
general malaise and sore arm on March 16th. Wednesday felt better but not perfect. March 18th got ...
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general malaise and sore arm on March 16th. Wednesday felt better but not perfect. March 18th got up with headache, nausea and dizziness.
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| 65 | 2021-03-17 | headache | Headache and tinnitus |
| 65 | 2021-03-17 | headache |
The morning after the shot I began to feel achy in joints, headache, upset stomach and slight nause...
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The morning after the shot I began to feel achy in joints, headache, upset stomach and slight nausea, my arm hurt at the site, Temp 98.9 temporal. I took Ibuprofen, worked and 6 hours later felt the same so repeated Ibuprofen and then it was over with. No further untoward problems. The injection site still hurt 2 days and was bruised 3 days.
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| 65 | 2021-03-17 | headache | Headache. Evaluated by EMS-Cleared |
| 65 | 2021-03-17 | headache |
Caller c/o headaches & dizziness since receiving the vaccine on 3/08/2021. Spoke with PCP who prescr...
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Caller c/o headaches & dizziness since receiving the vaccine on 3/08/2021. Spoke with PCP who prescribed her meclizine, however she is still symptomatic.Spoke with caller who states that she is feeling much better, symptoms resolved as of yesterday.
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| 65 | 2021-03-17 | headache | Bad headache day 2 thru day 7 but off and on by end of week |
| 65 | 2021-03-17 | fever, chills, fatigue, headache |
Fever 100.7; chills; headache; nausea; injection site pain redness & swelling; injection site pain r...
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Fever 100.7; chills; headache; nausea; injection site pain redness & swelling; injection site pain redness & swelling; injection site pain redness & swelling; exhaustion; This is a spontaneous report from a contactable 65 reporting for herself. A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6201/expiration date: not provided), via an unspecified route of administration, on 12Feb2021 at 11:00 (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included Hashimoto's hypothyroidism. The patient has allergies to halibut and sea kelp. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL8982/expiration date: not provided), via an unspecified route of administration, on 22Jan2021 at 03:30 PM (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine sodium (SYNTHROID), rosuvistatin, acetylsalicylic acid (ASPIRIN), probiotic, and vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021 at 23:00, the patient experienced fever 100.7, chills, headache, nausea, injection site pain redness and swelling, and exhaustion. The events did not require hospitalization. The outcome of the events fever 100.7, chills, headache, nausea, injection site pain redness and swelling, and exhaustion was recovering. Since the vaccination, the patient had not been tested for COVID-19.
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| 65 | 2021-03-17 | fever | fever 3 days after vaccine, daily fevers since |
| 65 | 2021-03-18 | chills, cough, fatigue, fever |
Mild soreness below injection site the day of injection. Fever started day after injection lasting 5...
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Mild soreness below injection site the day of injection. Fever started day after injection lasting 5 days, above 100 everyday, 101 to 102.2 on the 4th and 5th days, then back to normal (97.8). Chills and shaking on 3rd and 4th days. Mild nausea and dizziness. Stayed in bed 2nd to 4th day with fatigue. Coughing mostly when temperature was high. Still some coughing now after 10 days. Severe allergic reaction with rash starting at groin area the day after injection, moving up sides to underarms the 3rd day, then hands and feet the 4th day. Dermatologist recommended not getting 2nd shot.
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| 65 | 2021-03-18 | chills, headache, fever, fatigue | Headache, fever, chills, nausea, body aches and pains, tiredness. |
| 65 | 2021-03-18 | fatigue, headache, fever |
uncomfortably hot ankles and feet; Low grade fever; soreness at injection site; tiredness; headache;...
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uncomfortably hot ankles and feet; Low grade fever; soreness at injection site; tiredness; headache; muscle and joint pain; muscle and joint pain; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EL9266), via an unspecified route of administration in the right arm on 19Feb2021 at 12:00 PM (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation and penicillin allergy, both from an unknown date and unknown if ongoing. Concomitant medications included atenolol (ATENOLOL), pravastatin (PRAVASTATIN), eicosapentaenoic acid ethyl ester (VASCEPA) and multivitamin, all were taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162b2 (lot number: EL9264), via an unspecified route of administration in the left arm on 29Jan2021 at 01:15 PM (at the age of 65-years-old) for COVID-19 immunisation, prochlorperazine maleate (COMPAZINE) and experienced Compazine allergy and codeine and experienced codeine allergy. The patient did not receive any other vaccines within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced low grade fever, soreness at injection site, tiredness, headache, muscle and joint pain, including uncomfortably hot ankles and feet on 19Feb2021 at 11:00 PM. The patient did not receive treatment for the events. The outcome of events, low grade fever, soreness at injection site, tiredness, headache, muscle and joint pain, including uncomfortably hot ankles and feet was recovering.
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| 65 | 2021-03-18 | fatigue, headache |
Fatigue; severe headache but lasting only moments, hives chest area came to top of skin like poison ...
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Fatigue; severe headache but lasting only moments, hives chest area came to top of skin like poison ivy and broke open. Was starting to go away until second dose. Came back and took double dose Benadryl
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| 65 | 2021-03-18 | headache, runny nose | patient developed HA, rhinorrhea, loss of taste/smell |
| 65 | 2021-03-18 | headache |
Seizures; throat swelled up; Troponin level increased; Mild heart attack; arm was hurting; breathing...
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Seizures; throat swelled up; Troponin level increased; Mild heart attack; arm was hurting; breathing issues; Dry heaves; Mucus to come out; Nauseous; Dizzy; Headache; Ears became hypersensitive; Senses heightened; Throwed up; This is a spontaneous report from a contactable other health professional (patient). A 65-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 27Feb2021 (lot# EN6205), as 0.3 ml single, for COVID-19 immunisation. Medical history included seizure from 2017 (she hasn't had a seizure in 8 months), allergy (to a lot of things). Concomitant medications were not reported. The patient did not have other vaccinations in 4 weeks prior. Within 15 minutes from having the vaccination at the center the patient experienced the first seizure that lasted about an hour. The seizure was really bad, she had breathing issues, dry heaving like she was trying to throw up, mucus to come out. The paramedics checked her out, they stayed around until she came out of the seizure. The patient went home and then at 07:50 PM she started heavy shallow breathing, was nauseous, dizzy, had a headache, which also happened at the center. Ears became hypersensitive, it was so noisy like loud, but her husband and the paramedics said it wasn't loud but she could hear it, all of her senses were heightened. She had a second seizure and didn't known how long it lasted. Patient had another seizure at 08:25 PM, at 08:40 PM she had another one, at 09:00 PM patient was coming back around and had another seizure and her throat closed up and that's when she went to the hospital, when her throat started to close up. While the patient was in the emergency room (ER) she had another seizure, she had 6 total seizures, she has never had this many before so she knows it was an adverse event to this vaccination. The seizures also increased the patient's heart enzymes- troponin levels. The patient has an EEG, was given 4 baby chewable Aspirin, as she had a mild heart attack. She thought the seizure increased her troponin. The patient mentioned that during the first event at the center, she was so into the seizures, she remembers grabbing her left shoulder, her arm was hurting. She was so into the seizure and trying to throwing up that it didn't dawn on her. The hospital didn't tell her she had a mild heart attack, it just dawned on her because her troponin levels were up mildly and she thought the seizures were triggering something in her heart, not just her seizures. The patient got another headache and was dizzy and had shallowing breathing. Seizures recovered on 28Feb2021. The patient underwent lab tests and procedures which included chest x-ray: normal, it didn't show pneumonia or fluid on the lungs on 27Feb2021, electrocardiogram (EKG): normal on unspecified date, electroencephalogram (EEG): normal on 27Feb2021, troponin: increased on 27Feb2021. Follow-up attempts are completed. No further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 65 | 2021-03-18 | headache |
Blurry vision, difficulty with memory, nausea, brain fog, weakness right hand, weakness both legs...
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Blurry vision, difficulty with memory, nausea, brain fog, weakness right hand, weakness both legs, pis and needles sensation toes, slight headache, sore arm
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| 65 | 2021-03-18 | malaise |
Patient was waiting after vaccination in a car with another family member, The family member alerted...
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Patient was waiting after vaccination in a car with another family member, The family member alerted staff that patient did not feel well. Nurse immediately assessed the patient and found the following signs of adverse event: garbled stuttered speech, right arm limp, staring in one direction. Nurse alerted another staff member to call 911. Second nurse arrived to car with Epi Pen and administered the Epi Pen. Immediately, the patient's symptoms resolved and she said that she felt better. Patient was transported via EMS to hospital as a precaution. At the time the patient left the vaccination facility, she no longer had any symptoms.
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| 65 | 2021-03-18 | malaise |
Patient had general malaise unknown cause. Onsite EMS was called vitals BP 185/64 HR 87 Patient r...
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Patient had general malaise unknown cause. Onsite EMS was called vitals BP 185/64 HR 87 Patient refused evaluation or care, released against medical advise.
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| 65 | 2021-03-18 | fever, chills, headache | Fever, headache, chills, joint pain, gas, diareah, loss of appetite, anger |
| 65 | 2021-03-18 | fever, fatigue, headache | Injection site soreness Extremely tired Headache Low grade fever Muscle and joint pain |
| 65 | 2021-03-18 | sinus congestion, headache | TERRIBLE HEADACHE, NAUSEA, BODY ACHES, SINUS CONGESTION |
| 65 | 2021-03-19 | fatigue |
Pfizer-BioNtech COVID-19 Vaccine EUA: 3/16 Left arm was sore at injection site, ached when I moved m...
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Pfizer-BioNtech COVID-19 Vaccine EUA: 3/16 Left arm was sore at injection site, ached when I moved my arm, No Treatment. But, not as sore as it was after 1st injection. 3/17 Day after injection, very tired all day. Went to bed at 7:30pm. Arm soreness waning. No Treatment. 3/18 Noticed slight dizziness, sometimes. Not as tired. Arm pain almost gone, just a bruised feeling at injection site. No Treatment. 3/20 Dizziness more noticeable, today. My head feels like it's full of cotton. No Treatment.
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| 65 | 2021-03-19 | headache, chills |
Vaccine injection (right arm) 1015 am 3/17/21. Felt sore arm (right) , dull headache and slight chi...
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Vaccine injection (right arm) 1015 am 3/17/21. Felt sore arm (right) , dull headache and slight chills and enlarged lymph on right side neck below ear ~7pm. Following day 10/18 had dull headache and sore arm but minor significance. Friday 10/19, slight sore arm, no headache. Around 7pm felt sore right nipple. Upon examination it appears to be a small 2mm cyst-like bump -- white, round, mildly painful, a bit itchy. Inside of right breast felt itchy and became rash like red when rubbed/scratched to relieve irritation. Saturday 10/20 Noon, right nipple still sore and a bit itchy, bump still there, rash from rubbing night before has subsided some but still there. No recurrence of headache, pain in arm at injection site or sore lymph node on right neck. Have not consulted with a medical professional but will do so if condition persists on Monday.
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| 65 | 2021-03-19 | headache, nasopharyngitis |
I woke up about 11 hours later, in the middle of the night. I felt radiating heat going through my ...
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I woke up about 11 hours later, in the middle of the night. I felt radiating heat going through my body. I could not get warm. I started shaking violently from being cold. This probably lasted about 20 minutes. I think I had a fever, but I didn't want to move once I got warm. I cat napped for the rest of the night. I had a headache the next day. I took some Tylenol the next day alternating with ibuprofen. I was unable to get out of bed for two days. I stopped taking the medicines this morning. I feel week today, but other than that, I feel fine.
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| 65 | 2021-03-19 | fever, headache, chills |
Started with chills in the evening of the day of my vaccination, had body aches, headache and fever ...
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Started with chills in the evening of the day of my vaccination, had body aches, headache and fever of 102 by the next day at 2 pm.
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| 65 | 2021-03-19 | fever, influenza like illness, headache |
Flulike symptoms (fever, muscle aches, headache) beginning 16 hours after vaccine and lasting 14 mis...
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Flulike symptoms (fever, muscle aches, headache) beginning 16 hours after vaccine and lasting 14 miserable hours
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| 65 | 2021-03-20 | chills, fatigue, headache, malaise, fever |
March11,12,13 injection site pain /March14 -21 tiredness,severe headache,muscle pain chills, joint p...
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March11,12,13 injection site pain /March14 -21 tiredness,severe headache,muscle pain chills, joint pain, fever,nausea, feeling unwell
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| 65 | 2021-03-20 | chills, fatigue |
8 hours after receiving the vaccine I could feel the effects of body aches coming on. I went home f...
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8 hours after receiving the vaccine I could feel the effects of body aches coming on. I went home from work, put warm clothing on and fell asleep. Several hours later I woke up with severe chills. Ibuprophen was my friend and I had body aches and exhaustion for the next full day. A total of 48 hours of symptoms that kept me home.
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| 65 | 2021-03-20 | fatigue, head discomfort, headache, influenza like illness |
After Dose 1, that night, sore arm, pressure headache in top of head, fatigue. Everything improved w...
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After Dose 1, that night, sore arm, pressure headache in top of head, fatigue. Everything improved with exception of lingering headache for about 2 weeks. Evening after Dose 2, sore arm, worse headache, next day burning eyes, felt like flu. After 48 hours all improved but headache lingered in top of head pressure and nausea. On 3/3/21 8:15 am full blown sharp pain left side of head and then vise grip type headache like top of head was going to explode, severe shaking uncontrollable jerking, stuttering, worst headache ever, high BP over 200/170. Went to ER. CTA head wi 3D reconstruction, labs, etc. gave Toradol, Ativan Zofran Compazine and Fluids, Released after several hours, unspecified headache. Slept for 11 hours, next day severe brain fog and fatigue. On 3/6/21 awoke with same dull headache, but seemingly more jitteriness, by 10:40, another full blown extremely painful headache pins/needles from head to toe. Ambulance arrived BP 208/160ish. Transport to hospital. Ran many tests CT, etc. Gave Morphine, sent home after 5 hours. Saw Neurologist 3/17
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| 65 | 2021-03-20 | fatigue, sweating, fever, chills |
Started getting chills about 8 hours later. 3/17/2021 10pm Fever reached 103 3/18/2021 12:00 am Exc...
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Started getting chills about 8 hours later. 3/17/2021 10pm Fever reached 103 3/18/2021 12:00 am Excessive sweating with high fever 12:30 am Fever dropped to 97.6 3/18/2021 8am Fever increased to 101 3/18/2021 1pm Fever broke 3/18/2021 9 pm Fever came back 101 3/19/2021 6 am, excessive sweating Fever dropped to 99 3/19/2021 Fever came back averaging 99-101 3/20/2021 Fever broke evening of 3/2021 Temperature in normal range 3/21/2021, Very tired seem to be improving.
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| 65 | 2021-03-20 | fatigue |
Day 3 post vaccine (3/10/21)began with tingling of lower lip and full sensation, red rash neck, uppe...
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Day 3 post vaccine (3/10/21)began with tingling of lower lip and full sensation, red rash neck, upper chest,back and thighs. Seen by PCP and communicated with my rheumatologist . By next day upper lip felt tingly and full Dri increased my daily medrol to 8 mg .as throat felt tight . Noted next day mucoid eruptions on upper lips ,palate. Enlarged bilateral axillary lymph nodes. Rash dissipated by 3/14/21. Still have tight right throat feeling. Still on 6 mg medrol. Still have left shoulder and clavicular discomfort, intermittent tingling both hands and right leg, muscular weakness and fatigue.
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| 65 | 2021-03-20 | headache, fatigue |
Site pain. - Tiredness. - Left sided posterior neck pain with headache that was also left sided. T...
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Site pain. - Tiredness. - Left sided posterior neck pain with headache that was also left sided. Through the night then experienced the following: Muscle and joint pain, in shoulders and collar bone, elbows, hands and fingers. Hips, legs, and extreme hot feeling in knees with an extreme throbbing pain that lasted briefly. Then same hot throbbing pain in soles of feet, briefly. This followed by sharp stabbing pain in right heel, that also was a brief passing sensation. The following day, used Tylenol for headache. Felt extremely cold, especially hands. Continued with knee and ankle soreness. By mid day on 3/21. Felt more normal.
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| 65 | 2021-03-20 | fever, headache, chills |
About 12 hours after my 2nd dose of Pfizer vaccine I had extreme chills, fever of 102 degrees, vomit...
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About 12 hours after my 2nd dose of Pfizer vaccine I had extreme chills, fever of 102 degrees, vomiting, and severe headache. Most lasted about 36 hours and all gradually went away. Severe headache was the last symptom to go away but receded about 6 hours after other symptoms . About a week after 2nd dose my injection site became very sore for 3 days. Had not been very sore prior.
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| 65 | 2021-03-21 | chills, headache |
delirium; Bone freezing chills; left arm, shoulder and neck intense pain; left arm, shoulder and nec...
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delirium; Bone freezing chills; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain/soreness in neck; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; soreness in neck and armpits; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm, on 03Mar2021 09:15, at a single dose, for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took codeine and experienced allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) administered on the left arm on 10Feb2021 09:15 for covid-19 immunization at the age of 65-years-old. The patient did not receive other vaccines in four weeks and did not have other medications in two weeks. The patient did not have covid prior vaccination. The patient experienced the following adverse events on 03Mar2021 at 18:00 - bone freezing chills; delirium; left arm, shoulder and neck intense pain; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; continued soreness in neck and armpits and; headache for 3 days. The patient recovered from headache on 06Mar2021 18:00. The patient recovered from all the other remaining adverse events on Mar2021. The patient took ibuprofen as treatment for all the reported adverse events. The patient was not covid-tested post-vaccination. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
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| 65 | 2021-03-21 | fatigue, malaise, cough |
Presented to ED on 3/14/21 with shortness of breath. She started feeling sick march 6th, with fatigu...
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Presented to ED on 3/14/21 with shortness of breath. She started feeling sick march 6th, with fatigue and no appetite. She developed a cough, loss of taste/smell, and then nausea/vomiting. She tested positive for Covid-19 on the 11th. She hasn't been able to hold down meds for the last week. She is having intermittent chest pains which she attributes to not being able to take her cardiac meds. Was started on supplemental oxygen and admitted to hospital. Is still admitted at time of writing.
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| 65 | 2021-03-21 | headache |
experienced body aches, skin sensation to touch, nasal drainage, injection site tenderness, eyes wat...
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experienced body aches, skin sensation to touch, nasal drainage, injection site tenderness, eyes watering, headache, vomiting x6 over period of 10 hrs. Spent all day March 18 in bed due to vomiting , and above symptons. Continued with low grade nausea and HA on March 19. Felt fine on March 20. Treated self with Tylenol and restarted routine meds March 19 PM. Unable to take any meds on March 18 due to vomiting. Did not require seeing healthcare.
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| 65 | 2021-03-21 | fever | fever (spiking at 101.7), vomiting, body ache, heart racing and blood pressure raised |
| 65 | 2021-03-22 | chills |
Started 10 min post vaccine, began to feel chills, nauseous with body aches. Next day, symptoms wors...
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Started 10 min post vaccine, began to feel chills, nauseous with body aches. Next day, symptoms worse with vomiting. PCP prescribed zofran to use as needed. Denies fever. Symptoms resolved as of 3/21/2021, except for nausea. Follow up with PCP as needed.
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| 65 | 2021-03-22 | fatigue, headache |
Immediately after receiving the vaccine she experienced a very strong, pungent and sharp taste and s...
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Immediately after receiving the vaccine she experienced a very strong, pungent and sharp taste and smell, which passed within 5 minutes. In those 5 minutes the next thing was tingling in her face, cheeks, lips and her sinuses which were not clogged up at the time cleared, which stayed that way until Saturday morning. She did have tingling and numbness in her fingers, but nothing in her feet, and did not extend beyond her face and cheeks. Then 20 minutes later at 1:55 PM her tongue became sort of thick and a little numb, but did not swell. The area between her tongue and mouth tightened and her jaw tightened but nothing swelled. No itching in the throat. She had some sort of aching like menstrual cramps but has had a hysterectomy. She did also have a headache, took a Tylenol at 2:15 and went to sleep. When she woke up had fatigue, sore arm, and everything else had passed other than the lips feeling prickly and numb. The tongue was no longer tight or in the jaw. Just still had the open sinuses and the headache. The most significant thing was the thickness and lack of feeling of her tongue. By Saturday she was fine other than the normal side effects, soreness of arm, no red rash, but had been moving it around.
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| 65 | 2021-03-22 | fatigue |
Pt notes that her BG levels started to rise about 5 days after the vaccination and remained elevated...
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Pt notes that her BG levels started to rise about 5 days after the vaccination and remained elevated for a little over a month later. Her BG readings have been improved since then. She also noted to worsening depression, fatigue, arthralgias associated beyond the initial period of the vaccination.
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| 65 | 2021-03-22 | headache, cough |
Patient vaccinated 12/22/2020. On 12/23/2021 patient had body aches, cough, headache, pharyngitis, ...
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Patient vaccinated 12/22/2020. On 12/23/2021 patient had body aches, cough, headache, pharyngitis, and shortness of breath without hypoxia. Outpatient infusion of bamlanivimab administered.
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| 65 | 2021-03-22 | headache | Roaring headache, vomiting and diarrhea. Duration 2 hours. |
| 65 | 2021-03-22 | malaise, chills, headache, fatigue |
Started with severe headache, moved to base of skull and neck. Next day (Thurs. 3/18) extreme pain i...
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Started with severe headache, moved to base of skull and neck. Next day (Thurs. 3/18) extreme pain in neck, chest and shoulder area, headache, chills, fatigue, shortness of breath, heart palpitations, brain fog, malaise. I thought it would pass. Friday I felt no better - by evening I felt swelling in my neck and chest area. Noticeable swelling in clavicle area on both sides. Saturday & Sunday I rode it out until I could see my Dr. on Monday March 22. Dr. gave me a shot of steroids and a script for MethylPREDNISolone - 21 tablets. Today is Tuesday, March 23, 2021 and I feel much, much better. Dr. said to NOT get the 2nd shot and to report this reaction.
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| 65 | 2021-03-22 | nasal congestion |
Patient received dose 1 of COVID vaccine on 1/4/2021. On 1/18/2021 developed body aches, nasal cong...
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Patient received dose 1 of COVID vaccine on 1/4/2021. On 1/18/2021 developed body aches, nasal congestion, and nasuea/vomiting. Tested positive for COVID.
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| 65 | 2021-03-22 | fever, headache | Fever of over 100. Headache, body aches. Lasted about 36 hours. |
| 65 | 2021-03-23 | chills |
Friday @ 1am started throwing up and could not stop for 7 hrs. Very Nauseous through Sat and part o...
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Friday @ 1am started throwing up and could not stop for 7 hrs. Very Nauseous through Sat and part of Sunday . Had hot and cold chills through Sunday. Legs and arms were feeling fatigue. Started eating again by Monday afternoon. Tues just arms and legs feeling like wet noodles. Today Wednesday feeling 50% better then day before.
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| 65 | 2021-03-23 | fatigue |
Shortly after the patient received the vaccine, she felt short of breath. The symptoms lasted > 7...
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Shortly after the patient received the vaccine, she felt short of breath. The symptoms lasted > 7 days. The patient also had significant fatigue.
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| 65 | 2021-03-23 | headache, sleepiness |
Couldn't eat, very sore over whole body, needed to sleep most of days, very weak, nauseous, headache...
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Couldn't eat, very sore over whole body, needed to sleep most of days, very weak, nauseous, headaches, felt at times I might have been having a heart attack, very hard to breathe deep & felt like chest constricting. Lasted for a full 5 days.
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| 65 | 2021-03-23 | sweating |
Felt outside of my body, hazy, not myself, now I am nausous, sweaty, for the last two days (3/21 - ...
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Felt outside of my body, hazy, not myself, now I am nausous, sweaty, for the last two days (3/21 - 3/22) Just feel yucky. Have not gone to work.
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| 65 | 2021-03-23 | fever, fatigue | 24 hours of fever between 100 and 101, muscle ache, joint pain, fatigue |
| 65 | 2021-03-24 | chills, headache | Vomiting, nausea, headache, muscle aches and muscle weakness, chills for several days after vaccine |
| 65 | 2021-03-24 | cough, upper-airway cough syndrome, sinus disorder, fatigue |
Sinus drainage with cough; Sinus drainage with cough; fatigue; Terrible Laryngitis; post nasal drip;...
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Sinus drainage with cough; Sinus drainage with cough; fatigue; Terrible Laryngitis; post nasal drip; minimal raspy voice/Mild hoarseness; This is a spontaneous report from a contactable Nurse reporting for herself. A 65-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Deltoid Left on 25Feb2021 13:00 (Batch/Lot Number: EN6203) as single dose for covid-19 immunisation . Medical history included diabetes mellitus from 2017 (Diabetes diagnosed 4 years ago) , obesity (Obesity has been 10 years or more) , hypersensitivity (Allergies for lifetime) , arthritis (Arthritis diagnosed 20 some years ago) , hypertension from 2011 (High blood pressure diagnosed 10 years ago) , depression (Depression diagnosed 30 years ago) , breast cancer female from 2019 , breast conserving surgery. Concomitant medication included anastrozole (ANASTROZOLE) taken for breast cancer. The patient experienced terrible laryngitis on 28Feb2021 with outcome of not recovered , fatigue on 01Mar2021 with outcome of recovering , sinus drainage with cough on 04Mar2021 09:00 with outcome of not recovered , post nasal drip on 2021 with outcome of unknown , minimal raspy voice/mild hoarseness. All the reported events were considered Important Medical Events. Course of the events: the patient received the vaccine on 25Feb2021, and 3-4 days after, she started getting terrible Laryngitis. It is a little better. She also was fatigued. She did not run a fever. She did develop a little sinus drainage and cough within the last 4 days. She can smell and taste. She called her doctor and he said it is a side effect or reaction to the COVID vaccine. She wanted to know if that was likely or if there had been reports of any others having this reaction. He told her not to get second vaccine. The patient was difficult to understand due to minimal raspy voice. Follow up information has been requested; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported events cannot be totally excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 65 | 2021-03-24 | fatigue, headache, cough, malaise, nasal congestion, fever |
Started about 3am Saturday Morning March 6 with extreme pain between shoulder blades. Took 2 Advil a...
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Started about 3am Saturday Morning March 6 with extreme pain between shoulder blades. Took 2 Advil and was able to go back to sleep. Woke in the morning feeling fine. Then started becoming ill early afternoon. Fever every day for 2 weeks. Nausea, vomiting, lose of appetite, extreme fatigue, headache, light sensitivity, rash, nagging slight cough and some nasal stuffiness mostly when talking (this might be because of the pollen) We were told it was an unidentified virus that would have to "run its course". Even though we are vaccinated, we continue to quarantine because we provide child care for my grandson. There was virtually no circumstance where I would have been exposed to a virus. Also, my husband had to care for me because I could do almost nothing for myself and he did not contract the virus.
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| 65 | 2021-03-24 | headache, fatigue, fever, chills | Fever, Chills, Headache and joint and muscle pain. Fatigue. 48 hours. Resolved. |
| 65 | 2021-03-24 | headache |
I tested positive for Covid in early December, 2020. 5 days after I received the vaccine, I woke up...
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I tested positive for Covid in early December, 2020. 5 days after I received the vaccine, I woke up to extreme dizziness with the room just spinning. My blood pressure increased to around 212/101 for much of the day. Normal is around 120/70. The dizziness finally subsided later in the day and the blood pressure went down to about 168/85 by evening. Then I minor developed a headache. I also developed sores in my mouth and on my tongue. I still have those today (the day after).
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| 65 | 2021-03-24 | sinus headache |
Patient received 1st dose COVID vaccine on 2/23/21. Presented at clinic for 2nd dose on 3/16/21. Rep...
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Patient received 1st dose COVID vaccine on 2/23/21. Presented at clinic for 2nd dose on 3/16/21. Reported "swollen glands that were achy in neck area and a sinus headache" after the first dose. Denied any rash, dyspnea, or other s/s allergic reaction or anaphylaxis. Clinic staff discussed with medical advisor before giving 2nd dose. Medical advisor recommended continuing with 2nd dose, as swelling was likely immune response and patient did not have any breathing difficulties. Patient agreeable and received 2nd dose.
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| 65 | 2021-03-25 | fatigue |
Very deep fatigue. It feels like the life force is drained out of me. I'm not able to function and s...
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Very deep fatigue. It feels like the life force is drained out of me. I'm not able to function and spend most of my time in bed. Sometimes I can sit up on the couch and watch TV. I have trouble concentrating and even talking to someone on the phone is exhausting. My brain is not functioning like it usually does.
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| 65 | 2021-03-25 | headache |
Mar 24, 2021 very slight soreness, spose noted burgundy, swollen area R deltoid site. assoc with sli...
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Mar 24, 2021 very slight soreness, spose noted burgundy, swollen area R deltoid site. assoc with slight h/a, very slightly swollen glands in posterior neck. March 25, 2021 warm to touch, increased size and soreness at site 69.85mm x 76.2mm, swelling with no discoloration 95.25mm with and slight soreness axillary nodes. March 26, 2021 No change size, hot to touch, uncomfortable, less red, itchy entire pink area.
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| 65 | 2021-03-25 | headache | Patient experienced dizziness and headache |
| 65 | 2021-03-25 | fever, fatigue, headache |
103.9 fever, excruciating headache, lymph nodes under both arms swollen and hurt, fatigue, hurt all ...
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103.9 fever, excruciating headache, lymph nodes under both arms swollen and hurt, fatigue, hurt all over my body, nausea, injection site sore
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| 65 | 2021-03-26 | chills | Chills and body aches, achinesss at injection site. |
| 65 | 2021-03-26 | headache |
Had slight headache and pain in back of neck on 26, assumed back of head was sinus, tool Sudafed, ha...
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Had slight headache and pain in back of neck on 26, assumed back of head was sinus, tool Sudafed, had taken acetaminophen about every 12 hours since evening of 25th,. Woke in the night of 26 which was early am of 27 with collarbone on right side hurting with a knot on it about the size of a nickel. Around 8 am on 27 th it seemed to spreading down and up into my neck, slight pain, more like an ache. Called Er in hospital told I could come to the emergency room if I thought I needed to, couldn?t give any advice on the phone but gave me this site.
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| 65 | 2021-03-27 | headache, fever |
3/26 - afternoon onwards, mild arm soreness 11p fever 3/27 - 7a 100 degree fever & headache, remain...
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3/26 - afternoon onwards, mild arm soreness 11p fever 3/27 - 7a 100 degree fever & headache, remained at 99-100 through day 2p onwards blurry vision 7p Tylenol 11p normal temp of 97.6, no headache 3/28 - 7a no fever or headache, feeling normal except blurry vision 11a Tylenol, in hopes it would help blurry vision
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| 65 | 2021-03-28 | cough |
received 1st dose 1/15/21, complaints of cough, nausea, diarrhea started 1/20/2021. Presented to th...
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received 1st dose 1/15/21, complaints of cough, nausea, diarrhea started 1/20/2021. Presented to the ED on 1/24/2021 with the same symptoms; COVID-19 test came back +. Per ED physician, "On repeat evaluation she is resting comfortably in the room. O2 saturation remains in the low 90s on room air. Vital signs otherwise stable. Her Abbott Covid test was positive. CBC does show leukopenia otherwise unremarkable. BMP shows mildly elevated creatinine, no other significant abnormalities. Chest x-ray unremarkable. Patient was ambulated with pulse oximeter and O2 saturation dropped into the mid 80s. Recommended she be admitted and she agrees. Case discussed with hospitalist who agrees to meet the patient. We will give her Decadron here". Admitted to the RCU where she received ceftriaxone and azithromycin for bacterial pneumonia. Transferred to healthcare facility on 2/1/2021.
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| 65 | 2021-03-28 | cough |
30 min post vaccine, patient developed slight dry cough and feeling of tightness in back of throat. ...
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30 min post vaccine, patient developed slight dry cough and feeling of tightness in back of throat. Noted hoarseness of her voice. Brought to medical area where she then noted flushing, warmth of skin on face, neck, upper arms and chest. Slight nausea. On exam, no abnormalities except flushed skin. Vitals remained normal and stable. Monitored vital signs, had epi pen ready and elected to send her to ED via EMS for further monitoring, esp given her long hx of anaphylaxis. No other tx provided at site.
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| 65 | 2021-03-28 | fatigue, headache, cough, fever, dehydration |
Dehydration, hospitalized/dehydrated; My fever broke on Monday; Cruel, incapacitating headache/have ...
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Dehydration, hospitalized/dehydrated; My fever broke on Monday; Cruel, incapacitating headache/have such a painful headache that I can't eat; Eye pain; Aversion to food/ can't eat; Constant watery diarrhea despite not much food/diarrhea I have so bad; Constant nausea; Utter and complete lassitude/ exhausted; Being in bed, low energy; Stomach upset; Cough; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female consumer patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 04Mar2021 16:00 as a single dose for COVID-19 immunisation. Medical history included, in the 1990's, was diagnosed with systemic sclerosis (limited, used to be called CREST scleroderma), pretty severe Raynaud's syndrome, telangiectases, fatigue and sometimes joint aches. Patient was healthy despite this. Patient was not pregnant. The patient was not diagnosed with COVID prior vaccination. Concomitant medications in two weeks included amlodipine besylate, escitalopram oxalate (LEXAPRO), and clonazepam (KLONOPIN). The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 11Feb2021 04:00 PM and felt unwell but went to work and was fine in 2 days. On 04Mar2021, it was very different, the patient began having symptoms within 4 hours after receiving vaccine at 9 o clock that night. The patient stated "symptoms worsened and it is one week today and I am still sick. My fever broke on Monday. I still have cruel, incapacitating headache, eye pain, aversion to food (extremely weird for me), constant watery diarrhea despite not much food, constant nausea, utter and complete lassitude, dehydration (hospitalized, 2 liters of fluids), pain meds and anti-nausea meds. I have missed a week of work and this is a serious issue for many. I am OK but using precious sick time." Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient stated "I missed whole week to work and I'm still sick. I have had so many different symptoms and some have gone away like my fever is gone but I have such a painful headache that I can't eat, nausea and constant diarrhea, you get the idea. I'm not against the vaccine but I think it would be good if people like me, people that have had my experience know, I hope it's within the normal range, I still don't know I would love to talk to somebody and find out if what I am experiencing is in the normal range, but it's not, people saying they experience so far the kind of the level of being in bed, low energy, unable to eat, fever, headache, stomach upset, I didn't have a cold, I had respiratory, I had a cough that has cleared up. I was hospitalized yesterday with fluids to become hydrated. It's important for us, you know, I mean, I leave the work that not good, people need to be prepared, it should be sick time I think it's important there is a follow up, absolutely. I was very happy I got the vaccine but I am so sick and it's been a week today so, that's why I decided to call and I was in the hospital yesterday, getting fluids dehydrated and I was admitted (reason for hospitalization was not clarified). I wasn't admitted, I was in the hospital for the day on IV fluids, anti-nausea medication, pain medication also, 3 things they gave me in an IV. They sent me home but the diarrhea I have so bad, I'm exhausted, but I have to spent all my time in the toilet, I thought today might be, I might wake up it would be healing today but I'm still pretty sick." Outcome of fever and cough was recovered, and of remaining events was not recovered. The patient underwent COVID-19 virus test via nasal swab on 03Mar2021 with negative result. Information about lot/batch number has been requested.
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| 65 | 2021-03-28 | fatigue, fever, chills |
feeling sick to my stomach ended up fainting onto bathroom floor; feeling sick to my stomach; arm fe...
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feeling sick to my stomach ended up fainting onto bathroom floor; feeling sick to my stomach; arm felt mildly painful as injection went in; severe chills; fever; fatigue; restless sleep; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 65-years-old via an unspecified route of administration on 08Mar2021 08:15 (lot number: EN6203) as single dose for covid-19 immunisation. Medical history included covid-19 (covid prior vaccination: yes) from 10Jan2021 to an unknown date. There were no known allergies. Concomitant medication included acetaminophen taken for an unspecified indication, start and stop date were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 65-years-old, administered on the left arm on 15Feb2021 08:15 (lot number: EL9264) for covid-19 immunisation and experienced very painful injection site, chills, fever and fatigue. The patient reported that when she had her second vaccine on 08Mar2021, her arm felt mildly painful as injection went in, as though never healed from previous shot. This time, within 3 hours of vaccine, she began to feel fatigue, then began to experience chills and fever. She drank plenty of fluids, and took acetaminophen about 6 hrs after injection. In the evening her temp was up to 101.2 (her normal 97.2) and she took Acetaminophen at bedtime. Had very restless sleep, and at 5 AM on 09Mar2021, she got up feeling sick to her stomach ended up fainting onto bathroom floor. Luckily uninjured, and felt better upon "coming to". She was very fatigued rest of day, then normal next day. The patient underwent lab tests and procedures which included body temperature: 101.2 on 08Mar2021. No treatment was received for the events. The patient recovered from the events on an unspecified date.; Sender's Comments: Linked Report(s) : Same reporter,patient,product/ 2nd dose;US-PFIZER INC-2021269674 Same reporter,patient,product/ 2nd dose
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| 65 | 2021-03-28 | sweating, chills, fatigue |
then everything went black &collapse but not unconscious; felt slightly dizzy; sudden strange feelin...
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then everything went black &collapse but not unconscious; felt slightly dizzy; sudden strange feeling in head like wave washing over; Then intense feeling of sudden diarrhea; nausea; profuse sweating soaks clothes; weak all over; shaking with chills; shaking with chills; can't get up or will black out again; ringing in ears; Exhausted/fatigued; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6198, expiry date not reported), via an unspecified route of administration, administered in right arm on 04Mar2021 13:15 at a single dose for COVID-19 immunization. Medical history included migraine with aura, vertigo vestibular nueronitis, osteoporosis, TIA (transient ischaemic attack), B12 deficiency, IBS (irritable bowel syndrome), all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN 81, 81 mg tablet) at 81 mg, once a day; cyanocobalamin (B12-VITAMIN), and colecalciferol (D3), all taken for an unspecified indication, start and stop date were not reported. The patient previously took antihistamines, cephalexin (CEFALEXIN), amoxicillin but experienced allergies. The patient had no other vaccine in four weeks. Few minutes after shot, 04Mar2021 at 07:15 PM, patient felt slightly dizzy for few seconds then felt fine until 6 hrs after injection while sitting watching tv, wherein sudden strange feeling in head like wave washing over, then intense feeling of sudden diarrhea. Patient went to toilet, nothing happened, then everything went black and collapse but not unconscious. Patient went back on toilet, normal BM, no diarrhea, with nausea, profuse sweating soaks clothes, weak all over, shaking with chills, couldn't get up or will black out again, ringing in ears. These lasted total 20-30 minutes. Patient was also exhausted, fatigued, went to bed, and woke up 4 a.m. Her arm hurt but felt ok (Mar2021). Patient was weak, fatigued all day. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatments for the events reported. The patient was not tested for COVID post vaccination. The outcome of the events was reported as recovered in Mar2021.
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| 65 | 2021-03-28 | fever, chills |
On the day after my 2nd dose, I had the typical low grade fever, chills, and aches. But on the 2nd d...
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On the day after my 2nd dose, I had the typical low grade fever, chills, and aches. But on the 2nd day, I woke up with a red rash all around my torso and down both arms. It did not itch and was gone by the 3rd day.
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| 65 | 2021-03-29 | headache, fatigue |
Headache; tightness in chest; legs hurting from knees down; super tired; This is a spontaneous repor...
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Headache; tightness in chest; legs hurting from knees down; super tired; This is a spontaneous report from a contactable 65-year-old female consumer reported for herself. A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 21Feb2021 16:00 (Batch/Lot Number: EL9266) as single dose (at the age of 65 years old) for covid-19 immunisation. Medical history included osteoarthritis due to car wrecks in younger years, migraine headaches, muscle spasms in back, covid-19 from Jul2020 to an unknown date (still on oxygen from being hospitalized in July with Covid and still get really tired, was home for a week and a half before being transported to hospital for 2 weeks, and received a plasma transfusion). The patient previously took codeine and experienced drug hypersensitivity, hydrocodone and experienced drug hypersensitivity, lisinopril and experienced drug hypersensitivity. On 21Feb2021 17:00, the patient experienced headache, tightness in chest, legs hurting from knees down, super tired (felt almost like he did when she had Covid infection and she was still on oxygen from being hospitalized in July with Covid). The outcome of the reported events was recovered. There was no treatment reported. Since the vaccination, the patient had not been tested for COVID-19.
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| 65 | 2021-03-30 | fatigue, headache, throat irritation |
Gasping for air; Tongue swelling; Swollen lips; Throat closing/restriction in her throat; tickle in ...
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Gasping for air; Tongue swelling; Swollen lips; Throat closing/restriction in her throat; tickle in the throat; Headache; Dizzy; couldn't think clearly/her thinking wasn't clear; Confused; sensation in her chest; weak; fatigued; she had a full tongue which effecting her talking; tingling in her lips; anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot Number: EN6198; Expiration Date: Jun2021), as single dose in left shoulder on 04Mar2021 at noon for COVID-19 immunisation. Medical history included Hashimoto's disease from May2012 and ongoing (autoimmune condition), ongoing undifferentiated connective tissue disease (UCTD) (autoimmune condition, unsure when diagnosed, started with polymyalgia rheumatica, then it went to rheumatoid arthritis (RA), then it went between Lupus and undifferentiated connective tissue disease), hospitalization: she had to go hospital twice in last 4 months, one was for Amlodipine which has polyethylene glycol and another time for Lisinopril as another blood pressure medication, she had 2 mild anaphylactic reactions in the last 4 months from amlodipine and Lisinopril, patient thought they all have PEG in the ingredients; underwent colonoscopy unknown results. There were no concomitant medications. On 04Mar2021 the patient experienced anaphylactic reaction, gasping for air, headache, dizzy, could not think clearly/her thinking was not clear, tongue swelling, swollen lips, throat closing/restriction in her throat, confused , sensation in her chest, weak, fatigued, she had a full tongue which effecting her talking, tickle in the throat, tingling in her lips. Course of events was as follows: The patient drove two hours to get the vaccine. The patient was vaccinated on 04Mar2021 at noon. The reaction started immediately, the caller had a severe headache within seconds, a little bit of sensation in her chest. The patient's thoughts were getting mixed up, she was not thinking clearly. This was one of first things that happened. The patient stumbled a little bit and the nurses were there around her and said she better sit down now. Then the sensation in her throat was starting to feel like it was closing up, her lips were swollen; so she would say she was a little bit confused. The patient started getting dizzy and her thinking was not clear, her tongue swelled, she had a full tongue which effecting her talking, she was gasping for air, she needed a moment to regulate her breathing. In regards to swollen lips she added at first she had a tickle in the throat, tingling in her lips, restriction in her throat, then she started slurring her words before the ambulance got there. On site they responded and watched her because she did not know if the symptoms were going to get worse. The paramedics gave the caller oxygen and an IV, since she had a mild experience she wanted to see what she did not take any medications before taking the vaccine so she could see what it would do, she did not take an ibuprofen or Tylenol. Patient commented, she knew it was not recommended, but some people do it. The patient mentioned started speaking very badly and very fast, she started gulping for air, and was informed the histamines are hitting her. She felt like she was going to faint, she thought if she was able to count back from ten she was going to be knocked out. Once she counted back she started to feel better. Like she would not faint. She did not faint often. She mentioned counting backwards from ten when getting a colonoscopy or something like don't get passed five and then knocked out, so she knows the sensation that can occur. After 1.5 hours they decided to call the emergency number and that was when the ambulance came. The ambulance service was the one who did everything for the patient. Because the patient got in the ambulance, they required her to go to the hospital, she was in a bed in the hall, by the time her doctor had looked at her, her throat had opened up and was feeling reasonably well after an hour an half. Confirmed she was not admitted just in the Emergency Room. On 04Mar202 the patient was at the hospital and was gasping for breath. The patient was on an IV and they gave her 125 mg of Solu-Medrol, 50 mg of Benadryl, and 5 mg of nausea medicine, phedrol the caller thought it was called. They did a good job and that helped the patient down from the most severe symptoms and she wanted to report her symptoms. The patient has been looking around and she thought this reaction it was from the polyethylene glycol. She mentioned historically she had a minor reaction. She had to go hospital twice in last four months. One was for Amlodipine which has polyethylene glycol and another time for Lisinopril which is another blood pressure medication. She confirmed she visited the emergency room for all 3 of these cases. The patient was still very confused on 09Mar2021 and over the weekend, she had to rest, she was weak and fatigued. On 09Mar2021 it was first real day she went back to work. She worked and asked her brother to watch out for her. On 10Mar2021 she was starting to feel a little bit better as regarded anaphylactic reaction, she has recovered with residual effects from the anaphylactic reaction. Confusion was improved but stull a concern. The outcome of anaphylactic reaction was recovered with sequelae, of headache, swollen lips, confused was recovering, of gasping for air, dizzy, could not think clearly/her thinking was not clear, tongue swelling, throat closing/restriction in her throat, sensation in her chest, weak, fatigued, she had a full tongue which effecting her talking, tickle in the throat, tingling in her lips was unknown. Patient asked if there was a conclusion about the PEG and her anaphylactic reaction. Her second dose was scheduled on 25Mar2021. Patient stated that her PCP and the CDC recommend to not get the second dose. Caller wanted to know if the anaphylaxis could be worse in the second dose. The patient wanted to know if she should she get the next dose. She was very concerned about COVID as well but did not know if it's worth her risking her life. Patient wanted to know if she can get the Johnson and Johnson vaccine after a certain amount of time after receiving the Pfizer COVID 19 vaccine, caller cannot get the second dose of the Pfizer COVID vaccine due to a reaction. As of 12Mar2021 patent stated she does not wish to be contacted any further. A Product Complaint was filed.
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| 65 | 2021-03-30 | fatigue, nasal congestion |
she was extremely exhausted; stuffed nose; On 28Feb2021, she took a swab test and got positive for C...
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she was extremely exhausted; stuffed nose; On 28Feb2021, she took a swab test and got positive for COVID-19/ got tested for the COVID-19 Virus and tested positive/ tested positive again for the COVID-19 Virus; lost her smell/ Loss of smell; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202, expiration date: 30Jun2021), via an unspecified route of administration in left arm on 26Feb2021 at 14:00 at single dose for COVID-19 immunization. The relevant medical history included thyroid disease (had Thyroid Disease for 20 years) from an unspecified date and ongoing. Concomitant medications were reported as none. The patient said she lost her smell on 27Feb2021. She said her loss of smell was the only thing that had happened after she received her COVID-19 Vaccine. On 28Feb2021, she took a swab test and got positive for COVID-19. She said she got tested on 01Mar2021 for the COVID-19 Virus and tested positive. She clarified she had a nasal swab test for the COVID-19 Virus done on 01Mar2021 and was notified she was COVID-19 Virus positive at 5:00PM on 04Mar2021. She said she never had a fever. She said she was extremely exhausted and had a stuffed nose. She said she had no coughing, and her breathing was good. She said she didn't lose her taste. She said her smell came back a week later. She said she had no fatigue or diarrhea. She said she kept worrying about her oxygen levels during that time. She said she quarantined for 15 days. She said she tested positive again for the COVID-19 Virus on Saturday on 13Mar2021. She clarified she had a COVID-19 Virus Nasal Swab test done on 13Mar2021 and found out at the time of the report (16Mar2021) she was positive again for the COVID-19 Virus. Reported she believed she got the COVID-19 Virus from her first COVID-19 Vaccine. She needed to know when the COVID-19 Virus was coming out of her. She said she contacted her doctor, and her doctor told her she cannot take her second COVID-19 Vaccine shot this Friday (19Mar2021) since she tested positive for the COVID-19 Virus. The patient declined any treatment. No treatment received for the events. The patient underwent lab test included COVID-19 virus test showed positive (took a swab test and got positive for COVID-19) on 28Feb2021; positive on 01Mar2021; positive on 13Mar2021 (COVID-19 Virus Nasal Swab test done on 13Mar2021 and found out at the time of the report (16Mar2021) she was positive again). The outcome of the event lost her smell/ loss of smell was recovered on Mar2021, while other events were unknown.
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| 65 | 2021-03-30 | fatigue |
Extremely sore joints, particularly shoulder; Profound fatigue; This is a spontaneous report from a ...
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Extremely sore joints, particularly shoulder; Profound fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received first dose bnt162b2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 14:00 (Batch/Lot Number: EN5318) as single dose for covid-19 immunisation. Medical history included allergies extensive. Concomitant medication included thyroid, metformin and celecoxib (CELEBREX). The patient experienced on 11Feb2021 07:00 Extremely sore joints, particularly shoulder. Profound fatigue. The outcome of the events unknown.
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| 65 | 2021-03-30 | fatigue |
fatigue; she threw up; her appetite is worse/lack of appetite; dizziness; nausea; This is a spontane...
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fatigue; she threw up; her appetite is worse/lack of appetite; dizziness; nausea; This is a spontaneous report from a contactable other hcp. A 65-years-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in Arm Right on 22Jan2021 (Batch/Lot Number: EL8982; Expiration Date: 31May2021) as SINGLE DOSE for covid-19 immunisation. Medical history included renal cancer from Sep2005 to an unknown date, nephrectomy from 05Oct2005 to an unknown date, spinal fusion surgery from 23Nov2020 to an unknown date, compression fracture from Dec2020 to an unknown date, spinal fusion surgery from 22Apr2020 to an unknown date, compression fracture from 2020 to an unknown date, neoplasm from an unknown date and unknown if ongoing, vertebral body replacement from an unknown date and unknown if ongoing, lung neoplasm malignant from an unknown date and unknown if ongoing, metastases to spine from an unknown date and unknown if ongoing. Concomitant medication(s) included fentanyl (FENTANYL) taken for pain from an unspecified start date and ongoing; oxycodone taken for pain, start and stop date were not reported; paracetamol (TYLENOL) taken for pain from 23Apr2020 and ongoing; calcium taken for supplementation therapy from an unspecified start date and ongoing; panax ginseng (GINSENGIN) taken for fatigue from an unspecified start date and ongoing; ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+) taken for supplementation therapy from an unspecified start date and ongoing; vitamin d3 (VITAMIN D3) taken for bone disorder from 02Jan2021 and ongoing; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for supplementation therapy from an unspecified start date and ongoing; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for supplementation therapy from an unspecified start date and ongoing; tart cherry (TART CHERRY) taken for inflammation from an unspecified start date and ongoing. The patient experienced dizziness (non-serious) on 24Jan2021, nausea (non-serious) on 24Jan2021 with outcome of not recovered , she threw up (vomiting) (non-serious) on 28Jan2021, her appetite is worse/lack of appetite (appetite disorder) (non-serious) on 24Jan2021, fatigue (non-serious) on an unspecified date. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of fatigue (fatigue). The outcome of the events dizziness, nausea, vomiting and appetite disorder were reported as not recovered, The outcome of the event fatigue was unknown.
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| 65 | 2021-03-30 | headache, chills, fatigue |
feeling strange; ill; headache; chills; intestinal issues; tiredness; nausea; This is a spontaneous ...
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feeling strange; ill; headache; chills; intestinal issues; tiredness; nausea; This is a spontaneous report from a contactable Consumer (patient herself). A 65-year-old female non pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via left arm on 09Feb2021 11:00, as a single dose for COVID-19 immunization in hospital. Patient's medical history included Multiple myeloma (in remission for the past seven years) and hemochromatosis. Concomitant medication include verapamil and reyvow. On 09Feb2021 12:00, the patient started feeling strange within one hour from receiving the vaccination. As the day progressed, the patient became ill and experienced horrible headache, chills, intestinal issues, tiredness nausea. Patient did not receive any treatment for the adverse event. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination was not diagnosed with COVID-19. Since the vaccination patient had not tested for COVID-19. Patient had not allergies to medications, food, other products. The outcome of the events was recovered on 11Feb2021. Information on the lot/batch number has been requested.
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| 65 | 2021-03-30 | headache |
Headache; It hurts and ache all over; If I bump it(injection site) or roll over on it, it hurts; Thi...
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Headache; It hurts and ache all over; If I bump it(injection site) or roll over on it, it hurts; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 28Jan2021 at 09:00 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that, she got shot yesterday morning on 28Jan2021 about 9 o'clock 23 hours ago. And yesterday she felt fine right before she went to bed, started getting a headache. The injection site, if she bump it or roll over on it, it hurts otherwise it was okay, but she was just achy all over and she was wondering what she could take for it. The patient experienced headache, it hurts and ache all over and if i bump it (injection site) or roll over on it, it hurts on 28Jan2021. Outcome of the event was unknown. Information about lot/batch number has been requested.
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| 65 | 2021-03-30 | malaise |
felt unwell; This is a spontaneous report from a contactable healthcare professional. A 65-year-old ...
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felt unwell; This is a spontaneous report from a contactable healthcare professional. A 65-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration in arm left on 11Feb2021 16:00 as single dose for COVID-19 immunisation. Medical history included in the 1990's, patient was diagnosed with systemic sclerosis (limited) this used to be called CREST scleroderma. She had pretty severe Raynaud's Syndrome and telangiectasia, fatigue and sometimes, joint aches. She was healthy despite this. Patient was not pregnant. Concomitant medications included amlodipine besylate, escitalopram oxalate (LEXAPRO), and clonazepam (KLONOPIN). The patient felt unwell after the first vaccine on an unspecified date but went to work and was fine in 2 days. The patient underwent lab tests and procedures which included Covid test (nasal swab): Negative on 03Mar2021. Outcome of the event was resolved. Information on the lot/batch number has been requested.
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| 65 | 2021-03-30 | fever, cough, headache, pneumonia |
bilateral pneumonia; severe headaches; bronchial cough; low grade fever; body aches; This is a spont...
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bilateral pneumonia; severe headaches; bronchial cough; low grade fever; body aches; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6202; expiry date: not known), via an unspecified route of administration, administered in arm right on 24Feb2021 11:00 as a single dose for COVID-19 immunisation. Medical history included COVID-19 on 21Dec2020 with reported symptoms of bilateral pneumonia, severe headaches, bronchial cough, low grade fever, and body aches. The patient is not pregnant. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT); and codeine phosphate, guaifenesin (CODEINE GUAIFENESIN). The patient previously took gabapentine and experienced allergies. No other vaccine received in four weeks. Clinical course was reported as follows: she tested positive for COVID-19 on 21Dec2020 and recovered. She had bilateral pneumonia, severe headaches with bronchial cough, low grade fever and body aches which lasted five weeks. She was fully recovered but had intermittent mild symptoms lingering. On 25Feb2021 08:00, within 24 hours of getting the first vaccine, she developed all these symptoms again, but they were severe again and had to start prescriptions meds again daily to manage them and she still experiencing them now. She was due to have her second vaccine on Wednesday, 17Mar2021 and she was considering postponing it after her primary care (PC) doctor suggested she did so till her symptoms subsided. These adverse events resulted in doctor/other healthcare professional office/clinic visit. The patient had COVID prior vaccination and had not tested post vaccination. The patient had not recovered from all the events. No follow-up attempts are possible. No further information is expected.
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| 65 | 2021-03-30 | fever |
fever of 100.2; body aches; diarea; This is a spontaneous report from a contactable other health car...
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fever of 100.2; body aches; diarea; This is a spontaneous report from a contactable other health care professional (patient). A 65-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration, administered in left arm on 31Jan2021 20:45 at the age of 65 years old as single dose for COVID-19 immunisation. Medical history included physciatrist. There were no allergies to medications, food, or other products. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included gemfibrozil (LOPID), dexlansoprazole (DEXILANT), estradiol, paroxetine hydrochloride (PAXIL), desvenlafaxine succinate (PRISTIQ) and trifluoperazine hydrochloride (STELAZINE). The patient received other medications within 2 weeks of vaccination. On 01Feb2021, 03:30, the patient experienced fever of 100.2, body aches, diarea. The patient assessed the events as non-serious. The adverse event resulted in emergency room. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient has not recovered from the events.
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| 65 | 2021-03-31 | fatigue, malaise |
Nausea; Vomiting; Feeling unwell; Severe fatigue/Fatigue extreme; she goes to bed at 6:30PM every ni...
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Nausea; Vomiting; Feeling unwell; Severe fatigue/Fatigue extreme; she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day; like she had arthritis; Her hair has been falling out/Hair loss; Joint pain; Fingers were frozen; Couldn't eat; barely hydrated; Pain she had in her fingers/ Her toes hurt when she walks; It was hard for her to cook, wash clothes, and do anything; This is a spontaneous report from a contactable Nurse (Patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, intramuscular, administered in Deltoid Left on 16Feb2021, 13:15 (Batch/Lot Number: elg267) as SINGLE DOSE for covid-19 immunisation, at 65 years old. Medical history included ongoing Irritable bowel syndrome, she was diagnosed with IBS (irritable bowel syndrome) 15 years ago (unspecified date); Blood pressure high from 2000 and ongoing, High cholesterol from an unknown date (she has had high cholesterol for about 4-5 years or longer), depression from an unknown date (she was diagnosed with depression in her 30s after a car accident. She said she has had post-traumatic stress and depression for years); type 2 diabetes mellitus from an unknown date (she has had Type 2 Diabetes for a while. She said she couldn't take the diabetes medicine. She said she didn't say much to her doctor about the diabetes medicine. She said she tried all different medicines for her diabetes. She said her current doctor had been treating her Type 2 Diabetes for almost 4 years now); post-traumatic stress from an unknown date. Patient received the first dose of BNT162B2 on 29Jan2021 13:15, 65 years old, (lot number el9262) for covid-19 immunisation and experienced back pain, fatigue, alopecia, malaise, arthralgia, nausea, vomiting, feeling abnormal, musculoskeletal stiffness, arthritis, illness, hypersomnia and fluid intake reduced. There were no concomitant medications. The patient had her second COVID-19 vaccine on 23Feb2021. On 23Feb2021, patient experienced feeling unwell. She has never been so sick; and severe fatigue/fatigue extreme. She got her second COVID-19 Vaccine shot her tiredness was worse. Reported with the regular flu vaccine she had felt bad for maybe 3-4 days, but nothing like how she felt after getting the COVID-19 Vaccine. Reported after she received her second COVID-19 Vaccine on 23Feb2021, she didn't feel good. She said she had such severe fatigue that she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. Reported it had been 10-12 days since she had her second COVID-19 Vaccine, and she was still so tired. She is tired all of the time. Her tiredness was worse. She was tired and went to bed. She said the next morning she was tired, and then the next day she was really tired. She said the following day got so bad; she was in bed for 2 weeks. She said she only got out of bed to go to the bathroom and get something to drink and a few crackers to nibble on. She said she had such severe fatigue that she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. She said she had gone to her doctor yesterday and was exhausted when she got home. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed. She said she woke up at 5:30AM today. She said she was exhausted from just going to a doctor's appointment. On 25Feb2021, patient experienced nausea and vomiting. She said she had severe nausea and vomiting, clarifying that the nausea and vomiting lasted 2 weeks. Treatment was Phenergan Syrup 6.25mg/5ml every 6 hours, as needed. She said the Phenergan was originally prescribed for IBS. She said the Phenergan Syrup was dispensed in a pharmacy bottle, and didn't have a NDC, Lot, and Expiration Date. She said the Phenergan prescription label only had a printed barcode. Zofran 4mg tablet, as needed, three times a day. On an unspecified date in Feb2021, the patient experienced her hair has been falling out / Hair loss. She reported that her symptoms while a little better she is still tired all of the time, her hair is still falling out reporting, "If I roll it up in a clump its the size of a golf ball". She said after she got her second COVID-19 Vaccine on 23Feb2021, her hair loss was really bad. Hair Loss Treatment: She said the first thing she started taking was 1 Vitafusion Extra Strength Biotin 5000mcg Hair, Skin, and Nails Support. She stated she also took 2 Vitafusion Vitamin C 282mg Gummies a day. She said the product label said to take 3 Vitafusion Vitamin C 282mg Gummies per day, but she only takes 2 Gummies; Reported she was taking a multivitamin with Biotin and antioxidants every day. She said her doctor knew she was taking more than one vitamin and supplement and told her to watch out because she may be taking more than what was recommended. She said she stopped taking the multivitamin and now takes a regular vitamin. She said she also takes D3. She said her Fingers were frozen in a half closed position when she woke up in the morning. She said she had to work to open her fingers up. She said her fingers were sore, and she had to massage her fingers to get her fingers to unstick; Couldn't eat and was barely hydrated. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed; Pain she had in her fingers/ Her toes hurt when she walks, she never hand been like this before. She said every joint in her body ached like she had arthritis. She said her toes, ankles, knees, fingers, and arms ached. She said she still has the joint pain happening. She said her fingers were sore. Treatment: Reported when she was at her doctor appointment yesterday, she asked her doctor for a Prednisone prescription for her joint pain. She said her doctor gave her a 6 day prescription of Prednisone 50mg tablets. She said she was dispensed 6 Prednisone 50mg tablets and is to take 1 Prednisone 50mg tablet a day for 6 days; It was hard for her to cook, ash clothes, and do anything. She said she was just laying bed with an ice pack, or a heat pack, and taking pain pills. She said she told her doctor she had called the Health Department, and the CDC. She said the Health Department didn't want to tell her anything, and the CDC will only talk with someone who has had an anaphylactic reaction to the COVID-19 Vaccine. She said she asked her doctor how long she was going to have the side effects. She said her doctor said that all of her patients who had any reaction to the COVID-19 Vaccine, had mostly had called into her office to ask about the COVID-19 Vaccine side effects, and most of the patients COVID-19 Vaccine side effects resolved in a week. She said her doctor said not one of her other patients had ever told her about the kind of side effects she was having. She said her doctor told her she must be in the 2% group and to call Pfizer to report her side effects. She asked how long the events would last and what can she take. The patient underwent lab tests and procedures which included cardiac stress test: all was good right now (unspecified date). Therapeutic measures were taken as a result of her hair has been falling out/hair loss, like she had arthritis, nausea, vomiting, joint pain (arthralgia). Events did not require visit to emergency room. Outcome of the event hair loss was not recovered; outcome of feeling unwell, severe fatigue/exhausted, joint pain was recovering; nausea and vomiting was recovered on an unspecified date; and outcome of all other events was unknown. The patient considered the events as related. The reporter considered the events as serious - medically significant.; Sender's Comments: Based on a temporal association and known drug safety profile, the causal association between the events and the suspect drug BNT162B2 cannot be totally excluded. Possible contribution from patient's underlying medical condition is also considered. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.
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| 65 | 2021-04-01 | fatigue, malaise |
Nausea; Vomiting; Feeling unwell; severe pain in all my joints, toes, ankles, knees and my arms shou...
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Nausea; Vomiting; Feeling unwell; severe pain in all my joints, toes, ankles, knees and my arms shoulders fingers; didn't feel good; her fingers were frozen in a half closed position when she woke up in the morning; her body ached like she had arthritis; she couldn't eat and was barely hydrated; Hair loss; she couldn't eat and was barely hydrated; Tiredness/Fatigue extreme; Backache; "I'm so tired I go to sleep at 18:30 in the evening and don't wake up until 09:00 the next morning; sick; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: el9262, Expiration Date: Unknown) via intramuscular route of administration in left deltoid on 29Jan2021 (at the age of 65-year-old) at 13:15 as a single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown, Expiration date: Unknown) via an unspecified route of administration on 23Feb2021 as a single dose, both the doses for COVID-19 immunization. The patient medical history included Irritable bowel syndrome diagnosed 15 years ago (ongoing), ongoing Blood pressure high from an unknown date in 2000, high cholesterol for about 4-5 years or longer, depression (diagnosed in her 30s after a car accident), Type 2 diabetes mellitus (she couldn't take the diabetes medicine. She said she tried all different medicines for her diabetes. She said her current doctor had been treating her Type 2 Diabetes for almost 4 years now), post-traumatic stress, she was bedridden for 2 weeks on an unknown date in feb2021 (only able to get up to go to the bathroom), it was hard for her to cook, wash clothes, and do anything on an unknown date in Feb2021. The patient underwent stress tests, and all was good right now. The patient did not receive any additional vaccines administered on same date of the Pfizer Suspect was none. The concomitant medication was not reported. The patient previously took historical vaccine, flu vaccine on an unknown date for immunisation and felt bad for 3-4 days. It was reported that after first dose patient has been so sick. The patient experienced back pain on 29Jan2021. She reports that starting the next day that was on 30Jan2021, she has experienced severe fatigue extreme and tiredness. She reports that her symptoms while a little better she is still tired all of the time. She reports "I'm so tired I go to sleep at 18:30 in the evening and don't wake up until 09:00 the next morning on an unknown date in Jan2021. Caller also reports, my joints are in severe pain in all my joints, toes, ankles, knees and my arms shoulders fingers on an unknown date in Feb2021. My fingers are closed, and I can't straighten them out when I wake up". The patient put ice on her back and took pain pills and stuff. It was reported that patient had undergone back tests and result was not reported. The patient reported that she took she took Norco, or Hydrocodone/Acetaminophen 10mg/325mg. said her Norco 10mg/325mg prescription was for 1 Norco 10mg/325mg tablet every 6 hours, as needed, for pain. She said she normally would take 1 Norco 10mg/325mg tablet during the day, and another Norco 10mg/325mg tablet at bedtime. She said after her first COVID-19 Vaccine dose, she had been taking a Norco 10mg/325mg tablet every 6 hours. She said she also took a muscle relaxer, Tizanidine 4mg tablet. She said she took 1 Tizanidine 4mg tablet with the Norco 10mg/325mg tablet, three times a day. She said her backache felt like a belt across her lower back. She said when she has a backache, she gets off her feet, and puts her legs up on a pillow to take pressure off of her back. She said she rested, as well, but tried to do stuff around her house. She said she did have some tests on her back, and she had a fractured facet in her lower spine around the L1 vertebrae. She said she had to have some more tests done on her back. She said the backache she experienced after getting her COVID-19 Vaccine was not normal backache pain. It was Reported about 5-6 days after getting her first COVID-19 Vaccine, that was on an unknown date in Feb2021, her hair started falling out and the severity was explained by patient as "If I roll it up in a clump it's the size of a golf ball". She clarified she would brush her hair and would end up having hair everywhere (in her brush, on the counter, and floor). She said the day after she first noticed her hair falling out, she had even more hair fall out than normal. She said she was worried about her hair falling out and took Biotin and vitamins. She said after she got her second COVID-19 Vaccine on 23Feb2021, her hair loss was really bad. The patient took 1 vitamin Extra Strength Biotin 5000mcg Hair, Skin, and Nails Support (UPC Number: 2791700026, Lot Number: WA01802798, Expiration Date: Dec2021). She stated she also took 2 Vitamin C 282mg Gummies (UPC Number: 2791702071, Lot Number: WAO1887038, Expiration Date: Jan2022) a day. She said the product label said to take 3 Vitamin C 282mg Gummies. She stated she also takes 2 Calcium (UPC Number: 2791701951, Lot Number: YY01548358, Expiration Date: Jun2022) 500mg per day. Reported she was taking a multivitamin with Biotin and antioxidants every day. She said her doctor knew she was taking more than one vitamin and supplement and told her to watch out because she may be taking more than what was recommended. She said she stopped taking the multivitamin and now takes a regular vitamin. She said she also takes D3. Reported she was still tired. She clarified after she got her first COVID-19 Vaccine, she had felt tired for a few days with her back bothering her. She said she would get up and take her pain medicine, go to the bathroom, and get something to drink and go back to bed. She said she had felt a little better but wanted to take a nap every day. She said after she got her second COVID-19 Vaccine shot her tiredness was worse. Reported after she received her second COVID-19 Vaccine on 23Feb2021, she didn't feel good. She clarified when she got home from her second COVID-19 Vaccine she was tired and went to bed. She said the next morning she was tired, and then the next day she was really tired. She said the following day got so bad, she was in bed for 2 weeks. She said she only got out of bed to go to the bathroom and get something to drink and a few crackers to nibble on. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. She said she had gone to her doctor yesterday and was exhausted when she got home. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed. She said she was exhausted from just going to a doctor's appointment. Reported every joint in her body ached like she had arthritis. She said her toes, ankles, knees, fingers, and arms ached. She said she still has the joint pain happening. She said her fingers were frozen in a half-closed position when she woke up in the morning. She said she had to work to open her fingers up. She said her fingers were sore, and she had to massage her fingers to get her fingers to "unstick." Reported when she was at her doctor appointment yesterday, she asked her doctor for a Prednisone prescription for her joint pain. She said her doctor gave her a 6day prescription of Prednisone 50mg tablets. She said she was dispensed 6 Prednisone 50mg tablets and was to take 1 Prednisone 50mg tablet a day for 6 days. Reported she had severe nausea and vomiting on 25Feb2021 and clarified that the nausea and vomiting lasted 2 weeks. She said she took Phenergan and Zofran around the clock. She said she couldn't eat and was barely hydrated. Zofran 4mg tablet (NDC Number: 65862-187-30, Lot Number: OND420010-A, Expiration Date: Jun2024), as needed, three times a day. She said the Zofran was dispensed in a white manufacturer's bottle. Reported she needed to have some regular blood work done. The seriousness of the events Backache, Tiredness/Fatigue extreme, Hair loss, Feeling unwell, Joint pain, Nausea and Vomiting were reported as serious (medically significant) by the reporter. The final outcome of the events Backache, Tiredness/Fatigue extreme, Hair loss was not recovered; Feeling unwell, severe pain in all my joints, toes, ankles, knees and my arms shoulders fingers, Nausea, Vomiting was recovering; didn't feel good, her fingers were frozen in a half-closed position when she woke up in the morning, her body ached like she had arthritis, she couldn't eat and was barely hydrated, sick and "I'm so tired I go to sleep at 18:30 in the evening and don't wake up until 09:00 the next morning was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product to the development of reported events cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 65 | 2021-04-03 | headache |
sore arm; severe headache; This is a spontaneous report from a contactable physician (self-Reported)...
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sore arm; severe headache; This is a spontaneous report from a contactable physician (self-Reported). A 65-years-old non pregnant female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot number: EL9262) via an unspecified route of administration in Arm Left on 25Jan2021 09:30 as single dose for covid-19 immunisation. Medical history included atrial tachycardia and asthmatic bronchitis. Concomitant medications were not reported. On an unspecified date in 2021, the patient experienced sore arm and severe headache. The outcome of the event was unknown.
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| 65 | 2021-04-04 | headache |
After Dose 2 got my monthly nucala injection on 2/15 I started getting muscle spasm/ cramping in lef...
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After Dose 2 got my monthly nucala injection on 2/15 I started getting muscle spasm/ cramping in left foot was painful and very high anxiety. I started exp cramping in my lower arms I have been to ER, PCP, Ophthalmologist and Neurologist. I'm having terrible headaches as well. The Opthamologist applied eye drops that cause me to go to ER on 4/2 had blood work, checked pressures in eyes, prescribed medications nausea/dizziness, pain in my head and IV for low sodium.
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| 65 | 2021-04-06 | fatigue, headache, fever, chills |
Nausea; fever; chills; headache; tired; diarrhea which led to loss of fluids; low blood pressure; Th...
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Nausea; fever; chills; headache; tired; diarrhea which led to loss of fluids; low blood pressure; This is a spontaneous report received from a contactable consumer. A 65-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 18Mar2021 09:30 am (Batch/Lot Number: En6204) as single dose for covid-19 immunisation. Medical history included high blood pressure. The patient's concomitant medications within 2 weeks of vaccination were not unspecified. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received cefaclor (CECLOR) and experience allergies, and also received first dose of BNT162B2 (Lot number= En6200) on 25Feb2021 09:30 AM at single dose at left arm for COVID-19 immunization. The patient experienced nausea, fever, chills, headache, tired and diarrhea which led to loss of fluids and low blood pressure in Mar2021 08:00 PM with outcome of recovering. The adverse events resulted in hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage, emergency room/department or urgent care. Patient received treatments for the events included fluids, medicine, partial colon removal. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had been tested for COVID-19: negative in Mar2021. Additional information has been requested.
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| 65 | 2021-04-07 | cough |
anaphylactic; reactions are allergic; Terrible airway swelling, it felt like breathing through a str...
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anaphylactic; reactions are allergic; Terrible airway swelling, it felt like breathing through a straw, narrowing airway; Sensation of throat closure/narrowing of airway; significant shortness of breath/difficult to breath like through a straw; Pain in both lymph nodes, under both the armpit; Pain in both breasts; Dry cough; Itching, airway/trachea itchy; Hoarseness; Dizziness; This is a spontaneous report from a contactable nurse (patient). A 65-years-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248), via an unspecified route of administration, administered in the left deltoid on 15Feb2021 at 15:30 as a single dose for protection against Covid. Medical history included ongoing obesity as she gains and loses it, ongoing hypertension, ongoing asthma (at 59 she was bumped up to moderate degree asthma), ongoing significant food allergies, was born with and had ongoing eczema so she was allergic to milk (was given soy milk since she could not tolerate milk, when she drank milk, it produced phlegm/caused increase in mucus, ongoing significant environmental allergies wherein she would have allergies in the fall, from August through September and would have sneezing, congestion and itchy watery eyes. The patient also had a history of getting bronchitis but has not had it for a long time. The patient got stung by a bee when she was 40ish and her upper thigh got red, itchy and it lasted for 10 days and she and no other symptoms and was now careful around bees. The patient reacts to the smoky matches that blow out and make smoke, from the sulfa in the matches, fireplaces, wood burning and firepits. Concomitant medications included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma, start and stop date were not reported and fluticasone (manufacturer unknown) taken for asthma and allergies, start and stop date were not reported. The patient was on significant medications for her asthma, allergies and blood pressure. The patient previously got a flu shot at the end of Oct2020. The patient also previously took Aleve in her early 40's and was taking them for a neck injury for 2-3 months and at the end of the treatment she broke out in a rash. The patient also previously took aspirin 3 years ago and broke out in a rash. The patient also has an albuterol inhaler but has not taken it for years. The patient was careful, handwashing normally, wipes the shopping carts as they are germy. The patient stated that after receiving the vaccine, one main event was terrible airway swelling, itching and it was difficult to breathe. The terrible airway swelling felt like breathing through a straw and narrowing airway. She stated that it started 18.5 hours after the vaccine, on 16Feb2021 at 10 am and lasted for 4 hours between 10 to 2 pm. The patient also had itching wherein her airway and trachea were itchy which also started on 16Feb2021 at 10 am to 2 pm. The patient experienced narrowing of airway and sensation of throat closure also between 10 am to 2 pm. The patient also experienced that it was difficult to breathe but she did not feel like she needed to go to the hospital. If it got any worse she would gave went to the emergency department. She stated that she was sitting up, walking around and she would have had a significant shortness of breath and she was trying to wait it out. It was difficult to breath like through a straw which also started from 10 am to 2pm. She did not feel like she wanted to walk or do daily activities. She was on the phone with her mother and her mother could hear her difficulty in talking and her heavy breathing. The patient also experienced pain in both lymph nodes, under both armpits and pain in both breasts which started also on 16Feb2021 at 10 am and lasted for 24 hours the 10 am the next day. The patient had dizziness which started about noon and when she woke up the next day it as gone which she considered as medically significant since she is never dizzy and it was not due to her blood pressure and she has been on pills for a long time. The patient had dry cough and hoarseness also on 16Feb2021 from 10 am to 2 pm. The patient was afraid to take the second vaccine and she spoke to her pulmonologist who knows her history and was told that she would benefit. She thought that if she felt bad, she would go to the emergency room if it got worse but it did not. The patient stated that she thinks these reactions are allergic, the itching and narrowing of throat can be anaphylactic. The patient did not require any medical intervention and was not seen in the emergency department and was not hospitalized. The events lasted for 4 hours and stayed at that level. The patient did not get any treatment and it went away. The outcome of the events terrible airway swelling, it felt like breathing through a straw, narrowing airway, Dry cough, Itching, airway/trachea itchy, Hoarseness, Sensation of throat closure/narrowing of airway, reactions are allergic and anaphylactic was recovered on 16Feb2021 at 14:00. The outcome of dizziness was recovered on 17Feb2021 and the outcome of pain in both lymph nodes, under both the armpit and pain in both breasts on 17Feb2021 at 10:00. The patient reported that the events were considered as medically significant. The relatedness of the drug to the reactions from primary source reporter (method of assessment: Global Introspection) for the events was related.; Sender's Comments: A contributory role of vaccine BNT162B2 to reported events cannot be fully excluded since it is part of the product safety profile. Potential contributors include patient's advanced age, as well as underlying obesity, hypertension, asthma, eczema, multiple allergies and other co-morbidities. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 65 | 2021-04-07 | throat pain, malaise, respiratory tract congestion |
she got pretty sick/she did not feel good on Friday, but on Saturday it got really bad; The swelling...
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she got pretty sick/she did not feel good on Friday, but on Saturday it got really bad; The swelling in throat created an infection; throat feels dry; a lot of congestion in chest and in the lobes; a lot of congestion in chest and in the lobes; Lymph nodes in throat swelled up; throat was raw and painful and super red, and she could hardly talk; throat was raw and painful and super red, and she could hardly talk; throat was raw and painful and super red, and she could hardly talk; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (Lot Number: EN6198, NDC number: 59267100001, Expiry date: 30Jun2021), via an unspecified route of administration on 04Mar2021 (at the age of 65-year-old) at single dose for COVID-19 immunization. Medical history included ongoing asthma diagnosed about 40 years ago in 1981. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for asthma had for a number of years, keeps them on hand; and salbutamol sulfate (VENTOLIN CR) taken for asthma, had for a number of years. The patient got the first shot and she have asthma but forgot to tell them that she has asthma and no one asked her first. The patient got pretty sick on unspecified date and she is trying to figure out if this could be from the vaccine. On 06Mar2021, her lymph nodes in her throat swelled up and her throat was raw, painful, super red and she could hardly talk, it also created a lot of congestion in chest- the lobes. The swelling in throat created an infection on unspecified date. She wound up going to the doctor and they prescribed her an antibiotic which cleared the infection in her throat. Her symptoms started two days after she received the shot. She is supposed to get the second shot on Thursday 25Mar2021 and that's why she is calling to find out information on what other people reported as far as asthma patients. She is debating on getting the second shot. Initially caller states that for the most part, it cleared up and went away about three days ago, but then explains it is gradually getting better. Every once in a while, her throat feels dry and raw, but she drinks water and it feels better. At first, she did not want to really talk. She has asthma, the congestion never really goes away and it didn't really improve this time after prednisone like it usually does. She did not feel good on Friday, but on Saturday it got bad. Her side effects have improved from what they were then. The patient recovered from the event swelling in throat created an infection on unspecified date. The outcome of got pretty sick and throat feels dry was unknown and the outcome of the remaining events was recovering. No follow-up attempts are possible. No further information is expected.
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| 65 | 2021-04-07 | fever, chills, malaise, fatigue, headache |
Not feeling well; legs were restless from hips down; fatigue; sore achy body; aching joints and musc...
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Not feeling well; legs were restless from hips down; fatigue; sore achy body; aching joints and muscles throughout body; aching joints and muscles throughout body; Chills; felt "heavy & on-fire" though cool to the touch (neuropathy); diarrhea; Headache; lower GI distress; muscle cramping all over body; Low-grade fever/temperature 100.9; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 (Batch/Lot Number: EN5318) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included osteoarthritis and upper gastrointestinal (GI) distress. Concomitant medications included omeprazole (PRILOSEC) taken for upper gastrointestinal (GI) distress, start and stop date were not reported; celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported; colecalciferol (D3) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12) taken for an unspecified indication, start and stop date were not reported; calcium carbonate (CAL) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (lot number: EL3249) on 27Jan2021 04:30 PM at left arm. Other vaccine in four weeks reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Allergies to medications, food, or other products reported as no. These symptoms persisted for 24hours: on 18Mar2021 the patient was awoke midnight with chills, severe lower GI distress, diarrhea, head ache, muscle cramping all over body, legs felt heavy and on-fire though cool to the touch; temperature 100.9. Second 24 hours: the patient had low-grade fever, diarrhea, head ache, aching joints and muscles throughout body, continued lower GI distress. After 48 hours: the patient had temperature normal, sore achy body, head ache, fatigue. Consumed only water during first 72 hours then resumed liquids (broth, ginger ale) intake. Effectively treated diarrhea with loperamide hydrochloride (IMMODIUM); dicycloverine hydrochloride (BENTYL) for lower GI distress; resumed omeprazole (PRILOSEC) for upper GI distress. The patient returned to work on 23Mar2021 half-day, 24Mar2021 full-day still not feeling well. On 24Mar2021 during the night, legs were restless from hips down, felt "heavy and on-fire" though cool to the touch (Neuropathy) was similar to first night on 18Mar2021. On 26Mar2021, all symptoms have disappeared and the patient felt good, again she was in very good general health, active, appropriate weight, never ill. Events reported as non-serious. Events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event fever was recovered on 20Mar2021, of other events was recovered on 26Mar2021.
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| 65 | 2021-04-09 | fatigue |
Possibly an autoimmune disease; Possibly Fatigue; Experiencing exacerbation of pre-existing symptoms...
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Possibly an autoimmune disease; Possibly Fatigue; Experiencing exacerbation of pre-existing symptoms; This is a spontaneous report from a contactable consumer via the medical information team. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient exacerbation of pre-existing symptoms since she had the vaccine first dose. The reporter did not know the details of her pre-existing symptoms but stated that fatigue was included and possibly an autoimmune disease. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
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| 65 | 2021-04-09 | headache, malaise, throat pain |
ischemic colitis; sore throat; constant headaches; ears hurt; dizzy; generally not feeling well; Thi...
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ischemic colitis; sore throat; constant headaches; ears hurt; dizzy; generally not feeling well; This is a spontaneous report from a contactable healthcare professional (patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 65-year-old, via an unspecified route of administration, administered in left arm on 04Feb2021 (Lot Number: EL3246) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included the patient having known allergies (unspecified). Concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: EL0140) at the age of 65-year-old, via an unspecified route of administration at the left arm on 14Jan2021 at 04:00 PM for Covid-19 immunization. On 01Mar2021, the patient experienced ischemic colitis, constant headaches, ears hurt, dizzy, generally not feeling well, and sore throat. The patient was hospitalized on an unspecified date due to the events for 5 days. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. Information on the batch/lot number has been requested.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of ischemic colitis, which may likely represent intercurrent medical condition. Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the other reported events due to temporal relationship There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 65 | 2021-04-10 | headache, chills, fatigue |
Vaccine given on 3/21/2021 - Chills, headaches , weakness and fatigue started on 3/22/2021- no fever...
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Vaccine given on 3/21/2021 - Chills, headaches , weakness and fatigue started on 3/22/2021- no fever. Weakness,chills and fatigue and headaches progressed until 4/01/2021 when patient experienced complete weakness in left arm and leg and unable to stand or walk. Prior to 2nd dose, patient was recovering from a stroke and was beginning to walk with assistance and a cane. After April 1, 2021, patient is unable to stand or walk. Chills, headaches weakness and fatigue continue as of April 11, 2021
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| 65 | 2021-04-14 | pneumonia | Death R06.02 - Shortness of breath J18.9 - Pneumonia |
| 65 | 2021-04-18 | fever | High fever, severe night sweats, blood clots in lungs |
| 65 | 2021-04-20 | cough, headache, throat pain, fever, fatigue, respiratory tract congestion |
Pt presented to ED w/SOB, fever, cough, sore throat, headache, chest congestion, generalized weaknes...
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Pt presented to ED w/SOB, fever, cough, sore throat, headache, chest congestion, generalized weakness, & fatigue that had started 4/4/21 and diagnosed w/COVID-19 (4/10/21). She had just received 2nd vaccine (3/27/21), but had been exposed to COVID-19 the following day from a relative. She was discharged w/dexamethasone and pulse oximeter. Symptoms had continued to worsen and returned to ED where she was admitted for acute hypoxemic respiratory failure and tachycardia secondary to COVID pneumonia requiring steroids, remdesivir, oxygen, but unfortunately succumbed to her illness (4/18/21) given condition critical and prognosis poor.
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| 65 | 2021-04-23 | fatigue |
Left eyelid swollen and purple; Sharp pain on her left eyelid; Very weak and fatigued; Very weak and...
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Left eyelid swollen and purple; Sharp pain on her left eyelid; Very weak and fatigued; Very weak and fatigued; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered in Deltoid Right on 28-JAN-2021 16:00 at single dose for COVID-19 immunisation. Patient medical history included COVID-19 Virus and diabetes runs in family, but she just had a physical. Patient did not have diabetes. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29 Jan2021, the patient had experienced very weak and fatigued very weak and fatigued. On 30 Jan 2021, the patient had experienced sharp pain on her left eyelid. On 31 Jan 2021, the patient had experienced left eyelid swollen and purple. Next COVID-19 Vaccine in 18Feb2021. The patient did not received other medications within 2 weeks of vaccination. Patient was not on any prescription or over the counter medications. She took Eye Relief Eye drops and Benadryl for her eyelid swelling. Benadryl and Eye Relief eye drops did not do anything for swollen eyelid. Provided, lab-1451-1.0, on back of fact sheet for recipients and caregivers. On an unspecified date in 2021 the events sharp pain on her left eyelid and very weak and fatigued was resolved. At the time of reporting, the outcome of the event left eyelid swollen and purple was not recovered..
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| 65 | 2021-04-23 | headache |
Prolonged headaches; nausea; abdominal pain; This is a spontaneous report from a contactable nurse (...
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Prolonged headaches; nausea; abdominal pain; This is a spontaneous report from a contactable nurse (patient herself). A 65-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN 5318), dose 1 via an unspecified route of administration, administered in left upper arm on 25Jan2021 at 12:45 as single dose for covid-19 immunization. Medical history included cardiac disorder, hypertension, type 2 diabetes mellitus, hypothyroidism, drug hypersensitivity and allergies to Ace inhibitors. Concomitant medication was not reported. No other vaccine in four weeks. No other medications in two weeks. On 25Jan2021, at 04:00 pm patient experienced prolonged headaches, nausea and abdominal pain. On 01Feb2021, the patient underwent lab tests and procedures which included sars-cov-2 test as negative. No covid prior vaccination. The treatment medications for the events included Zofran. The patient was recovered from the all events.
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| 65 | 2021-04-24 | sweating, lethargy, malaise |
blood sugar was 140 this am; I don't feel right; don't feel right and I am breaking out in a sweat; ...
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blood sugar was 140 this am; I don't feel right; don't feel right and I am breaking out in a sweat; clammy and lethargic; clammy and lethargic; respiratory rate was 8; This is a spontaneous report from a contactable nurse (husband). A 65-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EW0153), intramuscular, administered in Arm Right on 08Apr2021 12:30 (received at 65-years-old) as SINGLE DOSE for COVID-19 immunization. The vaccine was administered at Administration facility. The patient did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. Medical history included diabetes, hypertension, depression, and known allergy to sulfa. The patient was not pregnant. Concomitant medication included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported; and BP (blood pressure) meds, ECT therapy. The reporter stated that he and his wife came around at 12:30 (08Apr2021) and got her first dose of COVID vaccine. They waited in observation for 15 minutes. They went to go eat after the shot and he stopped to get gas and his wife stated "I don't feel right and I am breaking out in a sweat." So, he just came back over here to the vaccine site. When nurse approached the car, the patient in the passenger seat appeared diaphoretic, clammy and lethargic. She was responsive oriented to four spheres and denied pain. She said "I just don't feel right." Pulse rate was 63, respiratory rate was 8, BP was 120/60 O2 saturation 97%. The patient stated "I am a diabetic and blood sugar was 140 this am." She is on insulin and BP meds her spouse stated, Advanced EMT on site checking vitals. Epi 0.3 was given in right thigh per EMT and patient was transported to ER via ambulance. All adverse events started on 08Apr2021 01:15 PM. The adverse events resulted in Emergency room/department or urgent care. The patient received corrective treatment for the reported adverse events. Outcome of the events was recovering. The patient had no COVID prior to administration of bnt162b2 and was not tested for COVID post vaccination.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
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| 65 | 2021-04-26 | cough, throat pain, chills |
emphysema; wheeze from the pollen; allergies were not exacerbating but started the last few days; wh...
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emphysema; wheeze from the pollen; allergies were not exacerbating but started the last few days; wheezing cough; she had a sore throat; agitation; chills; anxiety; tight, shallow, and labored breathing/troubles breathing/Difficulty breathing/ has to yawn a lot to get the air in; tight, shallow, and labored breathing/troubles breathing/Difficulty breathing/ has to yawn a lot to get the air in; tightness in her chest; felt like she was getting the flu; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EP7534), via an unspecified route of administration, administered in Left Arm on 23Mar2021 19:00 as single dose for COVID-19 immunisation. Medical history included ongoing laryngopharyngeal reflux diagnosed about 5 years ago, ongoing anxiety, usually happens during stressful circumstances; diagnosed about 20 years ago and she had had the sensation of labored breathing, dry mouth, and accelerated heart rate then yes for work like with public speaking; sensitive: Sulfa drugs, aesthetic filler in her face and allergic reaction Hyaluronic acid filler collagen and she doesn't smoke and drink. Family history included daughter was diagnosed with psychotic episode and diagnosed with mental illness and it was stressful getting that under control and she was sensitive to medication and surgical procedures she doesn't tolerate narcotics. Concomitant medication included clonazepam (KLONOPIN). She reported that she was prescribed .125 of clonazepam and it was a dissolvable sublingual and she doesn't use it frequently as she has read about reliance and potentially addictive and she will take a walk or watch a boring video to try to get her mind off it. The patient previously took oxycodone hydrochloride; oxycodone terephthalate; paracetamol (PERCOCET) and she was sensitive to Percocet; and darvocet and experienced sensitive to Darvocet post surgery; and codeine, and vicodin and was sensitive to both drugs, advil and causes her stomach to be upset, shingles vaccine, HPV vaccine, chicken pox vaccine and got 1 pox from that about 15 years ago when it first came out. The only post-surgical medicine pain reliever she can take was Tramadol and more often than not she doesn't have to do anything beyond Tylenol extra strength. On 24Mar2021, 04:00, the patient experienced extreme chills, and anxiety accompanied with tight, shallow, and labored breathing. She had troubled breathing due to this. She mentioned that she went to the emergency room (ER) that morning. On 27Mar2021, the patient had emphysema and agitation. On 26Mar2021, early in the morning, she had the breathing issue that she mentioned first concurrent with agitation and anxiety like at same time with the extreme chills. The sensation of agitation was all combined together, it like hit out of the blue while she was getting ready to go to sleep. She stated that at 4am it hit her with a sudden bout of extreme chills and at the same time a sense of anxiety, it felt like she hit a wall and couldn't get a full breath. She stays up late but wasn't doing anything anxiety provoking, she thought she was reading recipes. She sat to calm herself as she was not sure if it was a reaction or anxiety at the initial reaction fueling it further so she tried to sort of lower everything in her system and was concerned it could accelerate and not subside. At the hospital, they took her in an exam room and did her vitals and she was there about 2-3 hours and it was early in the morning and at that point sometime they took a chest x-ray, EKG, and blood work and at that point prior to that while she was waiting she was feeling a little better, the worst had subsided and she suggested she go and they asked her to stay since she was already checked in and to be seen. The doctor looked at the results and read the film and questioned about emphysema and she felt that was unrealistic reading as she doesn't smoke, doesn't drink and it's not in her genetic make up. The doctor told her lungs were showing a lot of air and she said maybe it was because she was gasping and they told her to take a big gulp of a breath and hold it to get the X-ray. The doctor suggested she see a pulmonologist and she didn't feel that was warranted. She contacted her general practitioner and they recommended she get the 2nd shot and had her see an allergist who also suggested she get the 2nd shot. The patient stated that she was not really overweight and doesn't drink and doesn't smoke and the allergist didn't mention but she saw in the paperwork that a side effect could be difficulty breathing. She had no swelling, body rash, dizziness or weakness. Since that episode, she periodically throughout the day, and she can't tell if it's anxiety or allergies or something but she felt labored breathing and tightness in her chest and can't get a full intake of breath. She reported that when she sleeps on her back the sensation disappears completely and when she sleeps on her side it reappears a little; 1-2 nights after, it woke her from sleep and she doesn't think she was dreaming about anxiety. She stated that she has never had anaphylactic if this should escalate what to do and she decided to go to the ER and they had her wait an additional 2 hours for a follow-up reading that was all clear, all fine, except emphysema thing which was again, she was just researching and forgot the medical term, she this it was hype aeration, too much air sucked in. Her general practitioner recommended she see an allergist for a 2nd opinion and was surprised she was up on anything and didn't mention side effect and the handout said it could be a possible side effect. She has to yawn a lotto get the air in. She does have laryngopharyngeal reflux prior and she clears her throat which is probably annoying and controls that through diet instead of taking Pepcid AC. She has had to clear her throat a lot but never had labored breathing or shortness of breath, that to get a full breath sometimes she has to yawn to get past that tightness of shallow breathing or labored breathing. On certain days she doesn't feel it and thinks it was done and she will have a spate and it happens and she thought there was something stressing and does a reality check and again it's that time of year and when she was taking her walk and walked past a certain block she started to wheeze from the pollen on an unspecified date and she called her allergist to see about getting something. She had a mask and that helped a little. Her allergies were not exacerbating on 23Mar2021 or 26Mar2021 but started the last few days and she has a wheezing cough that had an extended sort of wheeze at the end of the cough. Before her cough for LPR it was annoying throat clearing. After the vaccine, she took that walk through that one specific spot on her route she got to coughing and thinking she needs to call and get something prescribed something if anything if she gets the second shot it will address any of the side issues if they were related to allergies so don't have to contend. It was every night where she sort of feels it and she sleeps through the night so if it was tension related it subsides and can't distinguish what is emotional and physical but she was sleeping through the night and it was an indication that it was improving. She reported that when she visited her son and after she returned he told her he was unaware he had strep and didn't know it, he was asymptomatic and she had a sore throat and went to urgent care and had an exam and didn't have strep and doesn't know what it was but she was feeling better by the weekend. She was supposed to go back and everything was shutting and she didn't go. Maybe she was exposed and just had a mild thing while she was there. She was tested for Covid on 26Mar2021 and her result was negative, but they did not do an antibody test. She wanted to know if difficulty breathing was a common reaction with the vaccine, and if the side effects would be lesser after the 2nd dose since she already had a severe reaction after the 1st dose and if she should still receive the 2nd dose of the vaccine. She was concerned the 2nd shot will be more pronounced than the 1st and she doesn't want to go through that and it be more severe. She has heard if you had that reaction you may have been exposed to Covid before and she may have been around people with Covid that had positives and she may have antibodies from an asymptomatic experience and it may do more harm than good and she should do the 2nd shot. She mentioned this to her allergist and was told if she has a similar symptoms to call and get a bronchodilator. She was onboard with that but wants to discuss it because she finds it hard to believe she was the only one that had difficulty breathing and was wondering what was the duration of this labored breathing. She was scheduled for the second dose 18Apr2021. Outcome of events sore throat was recovered on an unspecified date; and outcome of rest of events was unknown.
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| 65 | 2021-04-26 | fatigue, cough, chills, fever, runny nose, throat pain |
I can't smell or taste today; Sniffles lots of mucus in throat; couldn't catch my breath; fever; Sor...
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I can't smell or taste today; Sniffles lots of mucus in throat; couldn't catch my breath; fever; Sore arm at the injection site; sore throat, felt like pins in throat; burning eyes; cough; achy; tired; chills; This is a spontaneous report from a contactable consumer (patient). This 65-year-old non pregnant female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on left arm on 11Feb2021 10:30 (Batch/Lot Number: EL 9269) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient not received other vaccine in four weeks. patient had Sore arm at the injection site the following 2 days in 20Feb2021. 18Feb2021 achy, tired, chills. 19Feb2021 burning eyes, achy, chills, cough. 20Feb2021 aches in lower back mild cough sniffles, chills, sore throat, felt like pins in throat, tired. At 20Feb2021 16:30 fever of 100.9. 21Feb2021 sore throat felt like pins poking them and also in ears. Sniffles lots of mucus in throat. Felt like I couldn't catch my breath to clear it. It's was a drowning feeling. 22Feb2021 sore throat sore ears, lots of mucus, chills. Temp of 100.1. Still stuffed up the pain in the throat and ears were better but no energy. 23Feb2021 still a lot of mucus, stuffy nose, Slight chills. 2.24 still stuffed up but better. Now I can't smell or taste today. Please get back with me as I want to know if this is just vaccine symptoms. Because if this is the case people need to know. The patient not received any treatment. patient not having covid prior vaccination; patient not tested covid post vaccination; The outcome of the events was recovering.
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| 65 | 2021-04-26 | fatigue, headache, fever |
tingle in lips; dry mouth; swallowing differences; slight fever; headaches; tried; muscle aches; Thi...
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tingle in lips; dry mouth; swallowing differences; slight fever; headaches; tried; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 65 Years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6203), via an unspecified route of administration in left arm on 28Feb2021 at 10:00 AM at single dose for COVID-19 immunisation. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: (ID) 9809), via an unspecified route of administration in left arm on 07Feb2021 at 10:00 AM at single dose for COVID-19 immunisation and experienced head rush immediately after injection, extremely sore arm from first dose. Medical history included COVID 19 and allergic to flagyl, ciprofloxacin. The patient did not received other vaccine in four weeks. The patient did not tested for covid tested post vaccination. Concomitant medications included amlodipine besilate at 2.5 mg, metformin hydrochloride (METFORMIN ER) at 500 mg. On 28Feb2021 at 10:15 PM, the patient experienced tingle in lips, dry mouth, swallowing differences, slight fever, headaches, tried, muscle aches. No treatment was received. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 65 | 2021-04-26 | headache, fatigue |
Mild pain at injection site; Slight headache; Mild fatigue; This is a spontaneous report from a cont...
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Mild pain at injection site; Slight headache; Mild fatigue; This is a spontaneous report from a contactable consumer(patient). A 65-year-old female non-pregnant patient received BNT162B2((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly in the left arm on 17Feb2021 11:00 (Lot Number: EL9266) at single dose for Covid-19 immunization. Medical history included asthma, mitral valve prolapses, gastroenteritis and leiomyoma. (Two weeks after receiving BNT162B2) the patient's concomitant medications included Calcium, Vitamin D3, Cranberry capsules and Turmeric. The past medications included Penicillin, Vancomycin, Levaquin, Ceftin and experienced known allergies to Penicillin, Vancomycin, Levaquin, Ceftin. Prior vaccination with BNT162B2 the patient had not experienced any covid symptoms. The patient reported that she was not on any other vaccine till four weeks after receiving BNT162B2. No Covid test were conducted post BNT162B2 vaccination. On 17Feb2021 19:00, the patient experienced mild pain at injection site, slight headache, mild fatigue. At the time of report, the outcome of the events mild pain at injection site, slight headache and mild fatigue was recovered on an unspecified date of 2021. The patient had not taken any treatment medications for the experienced events.
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| 65 | 2021-04-26 | headache | Severe swelling in both arms and knees. Pain in back of neck into both arms and hands. Headache |
| 65 | 2021-04-27 | malaise |
Patient with dementia NOS received COVID-19 vaccination first dose (as reported) on 3/30/2021. Famil...
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Patient with dementia NOS received COVID-19 vaccination first dose (as reported) on 3/30/2021. Family reported she was feeling unwell with vague complaints thereafter. Found dead on 4/27/2021. Autopsy performed on 4/28/2021 revealed ischemic bowel with an acute superior mesenteric artery thrombosis. She had little other cardiovascular disease to account for the thrombosis.
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| 65 | 2021-04-30 | fatigue, headache, cough |
coughing up blood; Coughing; Nausea; Headache; extreme fatigue; acute pain on the left side, she tho...
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coughing up blood; Coughing; Nausea; Headache; extreme fatigue; acute pain on the left side, she thought she cracked her rib/ rib pain; acute pain on the left side, she thought she cracked her rib/ rib pain; didn't sleep at all; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8757) at the age of 65-year-old, via an unspecified route of administration on left arm on 31Mar2021 at 13:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. There were no additional vaccines administered on the same date and no vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took aspirin and experienced allergy which was described as deadly. She never took medications since she found that out at 16-year-old. The patient received her first shot on 31Mar2021 at a pharmacy and mentioned that she was not sick at the time of vaccination, but she had a violent reaction to it. When she received it, she didn't feel anything. People said you will get a sore arm, but she got none of that. Then in the middle of the night on Friday (02Apr2021) probably around 3:00, she woke up with acute pain on the left side, it was rib pain, she thought she cracked her rib. On the same day, she also experienced difficulty breathing, and didn't sleep at all. On Saturday morning (03Apr2021), when she woke up, she had nausea, a headache, and extreme fatigue, but wondered if the extreme fatigue was because she did not sleep. The nausea and headache went away 8 hours later, on the same day. On Sunday (04Apr2021), she was coughing and coughed up blood. When she coughed, there was blood in the mucous. She mentioned that she still has acute pain, she could not get comfortable. Her sister passed away in January and she had a 5 pm train she was supposed to catch, she was responsible for the funeral. She was thinking that if she went to a hospital, they would keep her for 24 hours, she could maybe make it to the funeral but that was questionable. By Monday (05Apr2021), the acute pain was gone, she still had a cough, there was still blood in the mucous, she has occasionally blood in the mucous. The cough has not gone away but she was getting better every day. The difficulty breathing continued until about 08Apr2021 (as reported), but she still has some shortness of breath, but nowhere near as bad. She consulted her notes and said she was at 30% on 03Apr2021 and she felt today that she was at 80% and every day she was a little better and better. She has to sleep upright, she was afraid to sleep flat, she slept in her chair, last night for 2 nights she slept upright in her bed. She probably could lay down, but she was more comfortable upright. Because she was sleeping upright, she was not fatigued, she was not sleeping well but she didn't think that has anything to do with what was going on. The events did not result in emergency room or physician office visit. She is supposed to get her second dose on 21Apr2021but she did not want to get the second shot. She asked if she could wait and get the one shot from Johnson & Johnson. She didn't know where to go anymore. The outcome of the event "acute pain on the left side, she thought she cracked her rib/ rib pain" was recovered on 05Apr2021, recovered on 03Apr2021 for "nausea" and "headache", recovered on Apr2021 for "extreme fatigue", not recovered for "didn't sleep at all", and recovering for all other events.
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| 65 | 2021-05-03 | malaise, headache |
cold sweats (skin very hot, I assume I had a fever, though was too sick to check it) sleeplessness a...
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cold sweats (skin very hot, I assume I had a fever, though was too sick to check it) sleeplessness aches all over body, pain not quellable with Tylenol headache sensitive glands all lasting about 12 hours this was my 2nd dose, first dose had no effects except for site soreness
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| 65 | 2021-05-04 | chills |
leg was bruised; heart spasms; Diarrhea; inflammation along the major vein in her leg; heart palpita...
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leg was bruised; heart spasms; Diarrhea; inflammation along the major vein in her leg; heart palpitation; light headed/dizzy; severe muscle pain; tenderness and soreness in her inner thigh of the left leg/throbbing pain; Chills; This is a spontaneous report from a contactable consumer (patient, self-reported). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6208), via an unspecified route of administration in unspecified arm on 09Mar2021 (12:00) at single dose for Covid-19 immunization. The patient's medical history included ongoing hypothyroidism. Concomitant medication included levothyroxine been taking for 10-11 years for hypothyroidism. On 17Mar2021, Wednesday, the patient received the vaccine and had chills. On 18Mar2021, the patient had tenderness and soreness in her inner thigh of the left leg. On 19Mar2021, the patient had severe muscle pain on her calf of leg to inner thigh and it was throbbing so bad behind her knee on her left leg that she called her physician, and a sonogram was performed on 23Mar2021 which had found there was not a blood clot but there was severe inflammation along the major vein in her leg. On 20Mar2021, the patient had heart palpitation, her doctor told her to drink water and propel, she had heart spasms for 6 hours and felt lightheaded and dizzy. she thought she would go to the hospital, but she lives in a rural community and felt it did not make sense to go to the hospital. Palpitations and tenderness recovering. Her doctor and she was put on a heart monitor for her heart palpitations. She had heart palpitations with her hypothyroid but, this was totally different when she has had heart palpitations in the past. On an unknown date in Apr2021, the patient had diarrhea for 6 days. Patient had not been back to the doctor, but the nurse thought it was ok for her to take the second vaccine, but the patient was not comfortable with it. No prior vaccinations within the week. The patient never taken the flu shot. She had never received the flu vaccine or pneumonia nothing, so this was new for her getting the COVID vaccine. Caller clarified the chills started the week after she received the vaccine on Wednesday 17Mar2021. Severe muscle pain: Caller stated this happened on the 19, 20, 21, and 22 as well as the throbbing pain and then the next day on Monday 22Mar2021 she went to call her doctor and had a sonogram that next day on Tuesday (23Mar2021). Caller stated she still had the muscle pain in her left leg on the inner thigh but it was more so when she was active and once in a while she felt like her leg was bruised for a day or two but then it went away and she did not have a blood clot. Left leg throbbing: Caller stated this continually got worse and then on Sunday she felt so bad she laid in bed with her knee up and it throbbed like crazy. Caller stated this stopped about 2 days after she got the sonogram and it was not that severe it was just really tender and sore. Heart palpitation: Caller clarified that the heart murmurs she referred to earlier was actually heart palpitations. Caller stated this started at 8 in the morning and then at 10 in the morning she started getting light-headed and thought about going to the emergency room and figured no she will get through this. Caller stated she called her physician for the heart palpitations on Monday and she saw her doctor the following Tuesday and that is when her doctor had given her the heart monitor. Caller stated for 6 hours she felt horrible on Saturday since she knows the difference from her normal heart palpitations from her thyroid. Diarrhea: Caller stated this last for 6 days and was last week or so. Treatment: Caller stated no she is not a medicine taker she does not even take Tylenol or Advil unless it is a necessity. Outcome of the event chills recovered on 18Mar2021, tenderness and soreness in her inner thigh of the left leg/throbbing pain was resolving, severe muscle pain and inflammation along the major vein in her leg was not resolved, heart palpitation was resolving, light headed/dizzy was resolved on 20Mar2021, diarrhea was resolved on Apr2021, leg was bruised was resolved, heart spasms was unknown. No follow-up attempts are needed. No further information is expected. follow up(20Apr2021): New information was reported from a contactable consumer (patient) included: new events (coronary spasm, pain in extremity, phlebitis lower limb and bruising of leg) and event details. Case is upgraded to serious upon this follow up. No follow-up attempts are needed. No further information is expected.
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| 65 | 2021-05-04 | cough, fatigue |
kidneys were inflamed; grade IIIa kidney failure; got a flight or fight response; lower lip was full...
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kidneys were inflamed; grade IIIa kidney failure; got a flight or fight response; lower lip was full tingling; tongue tip so irritated and a strange feeling that it was a tiny bit edematous; tongue tip so irritated and a strange feeling that it was a tiny bit edematous; mucoid eruption on her lower lip/ mucoid eruptions in her mouth, on her palate and down her throat; rash to her face, neck, chest, back, shoulders and thighs; has bright red palms and sole of her feet are bright red; it looked like Kawasaki disease; voice change; had joint pain in her left arm and could not use her left arm and her whole entire arm and hand; had left clavicle pain under the clavicle; spontaneous cough where her heart races; spontaneous cough where her heart races; felt she couldn't catch her breath; issues in her throat and neck area had something pressing around her throat; she was so tired; chest flutters; tingling in her hands and her entire body from her scalp to her soles was so irritated and prickly; may be body inflammatory response to being vaccinated; This is a spontaneous report from a contactable Nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 07Mar2021 09:40 (Lot Number: EN6199) (at the age of 65 years old) as single dose (dose 1) for COVID-19 immunisation; and methylprednisolone (MEDROL), via an unspecified route of administration from an unspecified date to an unspecified date at short term increase of the Medrol dose (as reported), from unspecified date to an unspecified date at 2 mg (for four years, as reported), then from unspecified date to 10Mar2021 at 6 mg, then from 11Mar2021 to 13Mar2021 at 8 mg, then from 14Mar2021 to unspecified date at 6 mg, for Lupus. Medical history included diagnosed with asthma initially exercised induced and now it is seasonal and was diagnosed years ago (states she has not had to use her Albuterol inhaler that much now because it is seasonal but she is doing more outside and is allergic to outside things so she tends to use the inhaler more if needed), right leg paresthesia (she did have a right leg paresthesia and had that before the vaccine), autoimmune disorder, thyroid disorder and patient stated that she has lost height. Concomitant medications included salbutamol (ALBUTEROL HFA) taken for asthma; levothyroxine sodium (SYNTHROID) taken for thyroid disorder; paracetamol (TYLENOL); and diphenhydramine hydrochloride (BENADRYL). The patient had a history of Lupus and is on maintenance Medrol 2mg for four years and before that she had a short-term increase of the Medrol dose with flares of her Lupus. She had the Pfizer COVID Vaccine 1st dose and then three days later on 10Mar2021 at 16:00, she thought what is going on and had her tongue tip so irritated and a strange feeling that it was a tiny bit edematous, her lower lip was full tingling. She had mucoid eruption on her lower lip and saw then that the next day thought it was swollen but it wasn't swollen. She had eruption on her tongue, had a rash to her face, neck, chest, back, shoulders and thighs. The rash was dispersed and there is a red raised rash with Lupus called Livedo reticularis and that is usually on the thighs but this rash on her was below her thighs and came up and dispersed between all the same rash elsewhere on her body. The healthcare professionals were closed so she took increased Medrol steroids and her Albuterol inhaler and Benadryl; the Benadryl was thrown out and discarded so she has no lot number to provide for it, stated that the Benadryl was the pediatric dye free bubblegum free. The Albuterol Sulfate HFA inhaler is 90mcg per puff and she does two puffs every 6 hours as needed; she had not taken the inhaler but she has trouble with asthma and took the Albuterol inhaler now as preventative and needs to use the inhaler as of yesterday (lot Y23B with expiry date Dec2021). Patient stated that she has the tools of her Albuterol inhaler, the steroid Medrol and the Benadryl and the knowledge so she prevented the symptoms she was reporting from being life threatening but stated the reported events were a little disabling and medically significant.She had joint pain in her left arm and could not use her left arm and her whole entire arm and hand. She had left clavicle pain under the clavicle and knows this did occur in the random trials but for her it went away after two days and is now back regarding the pain. She has bright red palms and sole of her feet are bright red. The next morning on 11Mar2021, her upper lip was tingling and she did go see her healthcare professional in town and sent photos to her Rheumatologist. As time went on she had tingling in her hands and her entire body from her scalp to her soles was so irritated and prickly and her soles and palms were bright red; it looked like Kawasaki disease and she used to take care of children with Kawasaki disease. On Saturday which was the 3rd day she was on the Medrol 8mg and had the fight or flight cardiac symptom and she cut herself down on the Medrol on the next Sunday to 6mg which seemed to make her better. The redness was gone until she had the Pfizer COVID Vaccine 2nd dose yesterday and the healthcare professional initially said after her 1st dose of the vaccine to wait and see her rheumatologist do decided to do the increased Medrol dose of steroids and she stated she has got to get the 2nd dose of the Pfizer COVID Vaccine; the healthcare professional checked her lungs that were clear and her pulse ox was fine and she was not wheezing and she then went on increased steroids from Medrol 6mg to 8mg right away. She did have a right leg paresthesia and had that before the vaccine so she knows what it is like because she has issues with her spine but had not had the paresthesia in a long time. She increased to Medrol 8mg for the three days after the 1st dose of the Pfizer COVID Vaccine and got a flight or fight response. She had to increase the Medrol dose from 6mg and popped it up to 8mg and she had mucoid eruptions in her mouth, on her palate and down her throat and had a voice change. She has a laryngoscopy on Thursday (25Mar2021) with her ENT. She has pediatric doses of everything because she reacts to almost everything. The 2nd dose of the Pfizer COVID Vaccine was administered to her on 29Mar2021 09:45 with lot ER8732. Patient stated that anyone else would have gone to the emergency room but she took care of herself at home and knows the risk factors related to the vaccine. She absolutely felt the reported events were related to the Pfizer COVID Vaccine in terms of causality and she never had these issues before. The rheumatologist had experience with patients with autoimmune diseases and stated people with autoimmune disease have a heightened immune reaction to the vaccine no matter which vaccine they get and are overly active and then a vaccine is thrown in there and we are charting new territory. The next Thursday or Friday over a week now after the Pfizer COVID Vaccine she had a multisystem type of thing and on 18th and 19th of March she started having episodes and was not doing anything but quietly doing something and had chest flutters and spontaneous cough where her heart races and felt she couldn't catch her breath and is now on a 30 day event monitor. She was not sure this is due to the Medrol steroids or the Pfizer COVID Vaccine. She got her thyroid TSH level done because sometimes when the Synthroid dose needs to be lowered because it is too high for your body and you can have atrial flutter which she has had before in the past from her Synthroid dose being too high; states her Synthroid is 50mcg and takes it once per day by mouth and it is in a prescription bottle with no lot, expiry date or NDC. Patient saw her primary care physician again last Tuesday on 23Mar2021 and all the issues in her throat and neck area had something pressing around her throat and thought it was lymph nodes and woke up with a voice change and physician said he would take a look and he said it was not thrush and she would have to be scoped because he couldn't see in her throat. She had a referral for a CBC and Chemistry lab to be done on 25Mar2021 and TSH was in the usual range for her, the results from Thursday (25Mar2021) night had her BUN and creatinine and GSR (Glomerular filtration rate) abnormal. The rheumatologist called her that night and talked to the physician and said he considered this may be body inflammatory response to being vaccinated and could be that her kidneys were inflamed and she does not know as this is all new territory. For the kidney issues, the information was sent off to the rheumatologist who did orders and called the physician back the next day and she told him she thought she needed a nephrology consult and had urine chemistry, a urinalysis and looked for protein and did a blood draw for a chemistry screen with the following results on 25Mar2021: BUN 22.3, grade IIIa kidney failure, creatinine 1.28, eGSR-NAA 42ml/min, normal is over 60 and she usually runs 70 something. She went to the hospital over the years to have her chemistry lab done because she has Lupus and over the last two years she has never been below 60 for the eGSR-NAA. On 26Mar2021, she repeated the blood work and sent everything to her physician and the CMP had her BUN still elevated at 19.5, the creatinine was down to 0.97 and the eGSR-NAA was up to 58mL/min which is still abnormal; the urinalysis was all fine with no white cells and no leukocytes and no protein; the urine chemistry had the creatine of 8.5, the protein in the urine LVL was less than 0.4mg. Her CBC had her lymphs and monos down and she would expect having this response to the vaccine. Both physician called her on the weekend and they were concerned this came out of nowhere and now are monitoring her again in a month; her physician and rheumatologist both were entertaining this could be related to the Pfizer COVID Vaccine. She does not take vaccines because of what they do to the body and did take the flu vaccine in Oct2020. She was covid negative (unspecified date) and stated had to be screened on Friday 26Mar2021 before her laryngoscopy and did the PCR test and only does the PCR. States she was doing research and had conflicting information from her physician and rheumatologist who she first saw her physician, after her 1st dose of the vaccine and the rheumatologist talked about increasing her steroids and she told him she was so tired and how with increased steroids, do steroids impact the effectiveness of the covid vaccine being blunt immune suppressants. Physician said long term chronic steroids have no effect on the effectiveness of the vaccine. She has no had headaches, shaky chills like everybody else has because she is on immune suppressants and has an article that says some evidence for steroids diminishing efficacy in Pfizer COVID Vaccine. No prior vaccinations within 4 weeks. No additional Vaccines administered on same date of the Pfizer suspect. Events required a visit to physician office (No visit to the ER but did see her physician). The last action taken in response to the events for methylprednisolone was unknown. The outcome of the event had left clavicle pain under the clavicle was recovered on 12Mar2021; event has bright red palms and sole of her feet are bright red was recovered in Mar2021; outcome for the other events was unknown.; Sender's Comments: The reported events are assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association, but possible contributory effects from patient's medical history and concomitant medications cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 65 | 2021-05-04 | sweating, headache |
I have sensory neuropathy a that causes muscle and joint pain on a daily basis. Hours after getting ...
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I have sensory neuropathy a that causes muscle and joint pain on a daily basis. Hours after getting the Pfizer vaccine (on 09Apr2021) my pain became unbearable even after taking my pain meds.; Headache the following three days and still having the increased pain and sweats.; I have sensory neuropathy a that causes muscle and joint pain on a daily basis. Hours after getting the Pfizer vaccine (on 09Apr2021) my pain became unbearable even after taking my pain meds.; I have been having sweat break outs day and night.; Headache the following three days and still having; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 09Apr2021 at 12:00 (Lot Number: EW0158) (at the age of 65-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included peripheral sensory neuropathy (I have sensory neuropathy that causes muscle and joint pain on a daily basis), diverticulitis, colitis, Raynaud's phenomenon, Sjogren's syndrome, gastrooesophageal reflux disease (GERD), all from an unknown date and unknown if ongoing. The patient had known allergies: Sulfur, aspirin, cevimeline. The patient did not experience COVID-19 before vaccination. The patient did not receive any vaccination in four weeks prior COVID-19 vaccine. Concomitant medications included pregabalin (LYRICA); hydrocodone; pantoprazole and mirabegron (MYRBETRIQ), all concomitants taken for an unspecified indication, start and stop date were not reported. The patient reported that: "I have sensory neuropathy that causes muscle and joint pain on a daily basis. Hours after getting the Pfizer vaccine (on 09Apr2021) my pain became unbearable even after taking my pain meds. I have been having sweat break outs day and night. Headache the following three days and still having the increased pain and sweats. The events were serious, disabling. The patient outcome of the events was not recovered.
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| 65 | 2021-05-04 | paranasal sinus discomfort |
it sounded like a form of Bell's Palsy; left cheek tingle; my left forehead, cheek, side of lip and ...
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it sounded like a form of Bell's Palsy; left cheek tingle; my left forehead, cheek, side of lip and chin felt like I had razor burn.; My head itched; left eye felt dry; salivate more than usual from the left side of my mouth; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; feel pain in my left ear; My lymph nodes on the left side of my face became swollen; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 12:45 (Batch/Lot Number: EN6202), at the age of 65-years-old, as single dose for COVID-19 immunization. Medical history included allergy to Sulfa. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included calcium; magnesium; colecalciferol, menadione (VITAMIN K+D); glutathione; all taken for an unspecified indication, start and stop date were not reported. Within 45 mins (also reported as 20-25 minutes) of receiving the shot, she began to feel her left cheek tingle. In the intervening days, her left forehead, cheek, side of lip and chin felt like she had razor burn. Her head itched. Her left eye felt dry, but that went away. She began to salivate more than usual from the left side of her mouth. The left side of her face began to feel heavy, sometimes also my sinuses, but more often my lower jaw. Sometimes, she would feel pain in her left ear. Her lymph nodes on the left side of my face became swollen. Her doctor on Zoom said it sounded like a form of Bell's Palsy (medically significant), though she does not have the drooping eye or mouth. She had an MRI of her left lymph node that did not reveal any issues. Her symptoms, while they have abated, are still present five weeks after the shot. The events started on 26Feb2021 13:30. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event left eye felt dry was recovered while other events was not recovered.
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| 65 | 2021-05-07 | headache |
I am not, just having bad, my mouth is moving out of control, it was like wiggling and stopping; I h...
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I am not, just having bad, my mouth is moving out of control, it was like wiggling and stopping; I had like a headache on my left side.; inside of my mouth just started moving; It scared me; had side of my face was sore; I had my head hurt and I am like, my neck, oh my god, what's going on; I had my head hurt and I am like, my neck, oh my god, what's going on; it's wiggling like it and while I am breathing there is a time I go like (consumer imitates like breath-ing is stopped) and then breathing normally; This is a spontaneous report from contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8732 and expiration date was not reported), dose 2 via an unspecified route of administration, in left arm on 02Apr2021 as SINGLE DOSE for COVID-19 immunization. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiration date was not reported), via an unspecified route of administration, on an unknown date as SINGLE DOSE for COVID-19 immunization. The patient's medical history included high blood pressure and Sinus. The patient's concomitant medications included metoprolol (blood pressure), amlodipine (blood pressure), diazepam and gabapentin (problem with my leg). The patient reported on an unknown date, that she was having a reaction and got her second shot over three weeks ago. The patient experience last night was not just having bad, my mouth was moving out of control, it was like wiggling and stopping wiggling and stopping, it did all the night and up my mouth on my left side is moving, it's wiggling like it and while I am breathing there is a time I go like (consumer imitates like breathing is stopped) and then breathing normally, face just moved on it's own, it did a few time but last night which it, did it to the moment it kept doing it, kept doing it and then had like a headache on my left side. Patient was trying to sleep, for today this morning, inside of my mouth just started moving, You know, fast, fast and air coming out and this woke me up and now things started again and air coming out, oh my god, It scared me and noticed that when I am sitting up or laying it coming up and then it go back to normal. Patient had side of her face was sore and they did it so fast and quick, could hear doing stop and had my head hurt and I am like, my neck, oh my god, what's going on. Patient at the hospital had Ultrasound and X ray done. Patient took Tylenol. The outcome of the events was reported as unknown. Follow up#1 (PRD 25Apr2021, SRD 26Apr2021): This is a follow up spontaneous report from a 65-year-old female contactable consumer. This consumer (patient) reported information included concomitant medication, medical history, events, outcome, lab data. Follow up attempts are needed. Further information has been requested.
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| 65 | 2021-05-07 | headache |
This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient re...
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This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at arm left on 11Feb2021 07:30 (Batch/Lot Number: Unknown as unable to locate or read the details; expiration: not reported) as single dose for COVID-19 immunization (at the age of 65 years and the patient was not pregnant). Medical history included known allergies: penicillin. The patient concomitant medications were not reported. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Feb2021 at 07:00, exactly one week after shot, the patient experienced body aches, then severe 3-day headache during which sudden onset diplopia began and had persisted to this day, almost 10 weeks later. No other cause of the diplopia has been determined after numerous scans, MRIs, blood texts, etc. The patient went to doctor or other healthcare professional office/clinic visit. The outcome for all the events was not recovered. Follow up needed. Information on the lot/batch number has been requested.
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| 65 | 2021-05-10 | pneumonia | N17.9 - AKI (acute kidney injury) J18.9 - Pneumonia |
| 66 | 2021-01-02 | headache, fever, fatigue, chills | Headache, low fever 99.9-100, chills, fatigue started 1/3/2021 |
| 66 | 2021-01-04 | chills, fatigue |
Starting the day after vaccine I have had extreme fatigue, nausea, decreased appetite. dizziness, mu...
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Starting the day after vaccine I have had extreme fatigue, nausea, decreased appetite. dizziness, muscle aches, chills. It has continued now for 14 days, without improvement. It is actually worsening.
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| 66 | 2021-01-04 | chills |
stomach cramps; diarrhea; chills; This is a spontaneous report from a contactable other healthcare p...
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stomach cramps; diarrhea; chills; This is a spontaneous report from a contactable other healthcare professional. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at left arm on 24Dec2020 08:00 at single dose for Covid-19 immunization. The COVID-19 vaccine was administered in a hospital facility. Medical history included hypertension, and allergic to penicillin. The patient was not diagnosed with Covid-19 prior vaccination. Concomitant medication included amlodipine and irbesartan; both from unspecified date for unspecified indication. On 26Dec2020 22:30, the patient experienced stomach cramps, diarrhea and chills. The patient was not tested for COVID-19 post vaccination. The patient did not receive treatment due to the events. The outcome of the events stomach cramps, diarrhea and chills was recovering. The reporter considered the events non-serious; the events did not results in death, not life threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating, not a congenital anomaly/birth defect. Follow-up activities are possible, information on the batch number has been requested.
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| 66 | 2021-01-04 | headache, fatigue |
Headache, Extreme Fatigue; Headache, Extreme Fatigue; This is a spontaneous report from a contactabl...
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Headache, Extreme Fatigue; Headache, Extreme Fatigue; This is a spontaneous report from a contactable Other-HCP. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number Unknown), intramuscular at Left arm on 23Dec2020 10:00 at single dose for covid-19 immunisation. Medical history included Diabetes mellitus, Known allergies: penicillin. Concomitant medication included metformin. The patient experienced headache, extreme fatigue on 23Dec2020 23:00. Both events were non serious. No treatment was received. The patient was not Pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The outcome of the events was resolved in Dec2020. Information about lot/batch number has been requested.
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| 66 | 2021-01-04 | headache |
Patient was experiencing headache, lightheadedness, generalized itching, shortness of breath, wheezi...
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Patient was experiencing headache, lightheadedness, generalized itching, shortness of breath, wheezing, and nausea after 8-10 minutes of COVID-19 vaccine administration. Vital signs were stable RR 22 and SpO2 96% on RA. She was speaking in full sentence, no acute distress, with expiratory wheezing. No central cyanosis or new rash. After 15 minutes, she reports improvement on her symptoms. She was given Benadryl po and Albuterol 2 puffs in the clinic with improvement on her symptoms. Lungs have more air movement and less wheezing after the albuterol treatment. She was send home and educated in ED precautions.
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| 66 | 2021-01-04 | sweating |
66 you female who presented to to infusion clinic for lung cancer treatment. Pt received apap 650mg ...
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66 you female who presented to to infusion clinic for lung cancer treatment. Pt received apap 650mg po, diphenhydramine 50mg PO at 1000. She also was administered NaCL 0.9% as a carrier for durvalumab as an infusion between 1000-1200. Pt was administered COVID19 vaccine at 1110. At 1120 patient called out stating "I just don't feel right". Pt was diaphoretic/weak/hypotensive. No swelling or respiratory distress noted during the episode. Attending physician and PharmD alerted and were at bedside. Per note, pt has needle phobia. Please refer to relevant history below for information regarding BP. Patient was monitored closely at the infusion clinic. She was able to receive her chemo agent as planned after she felt better from eating. Patient does not wish to get the second dose of covid vaccine.
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| 66 | 2021-01-05 | headache, dehydration, fatigue, chills |
severe chills, dry stinging mouth, headache, dehydration, dry heaves,nausea, for approximately 6 hrs...
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severe chills, dry stinging mouth, headache, dehydration, dry heaves,nausea, for approximately 6 hrs. The symptoms resolved then she experienced Headache, fatigue body aches until 01/06/2021 @0600.
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| 66 | 2021-01-05 | headache | Severe headache and nausea |
| 66 | 2021-01-05 | throat pain, chills, fatigue, headache |
Significantly sore left shoulder (injection arm) with pain now radiating up into neck & downward aro...
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Significantly sore left shoulder (injection arm) with pain now radiating up into neck & downward around shoulder blade, severe headaches, nausea (no vomiting), sore throat, FATIGUE, chills/cold sweat, general body aches.
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| 66 | 2021-01-06 | chills, fever, cough |
The patient states on 12/18/2020 at approximately 1430 a rash on both arms appeared. The rash has l...
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The patient states on 12/18/2020 at approximately 1430 a rash on both arms appeared. The rash has lasted several weeks. The rash continues to be present on 01/06/2020. No itchiness. Patient also states on 12/18/2020 at approximately 1700, she started with chills which got progressively worse throughout the evening, fever (99.8 F), patient states this temperature is 'high' for her, body aches, shortness of breath and a cough. All these symptoms got worse enough where she thought she had to call 911. However, the symptoms eventually subsided that night and she did not need to call 911. The body aches, chills and "fever" lasted for about 2 days.
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| 66 | 2021-01-06 | headache, chills | Headache, nausea, really bad chills that woke her out of her sleep |
| 66 | 2021-01-06 | headache, fever |
Awoke in the middle of the night with spiking fever 101.5, headache, muscle aches, diarhea, In bed f...
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Awoke in the middle of the night with spiking fever 101.5, headache, muscle aches, diarhea, In bed from Monday night to Wednesday morning started feeling better.
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| 66 | 2021-01-09 | headache, influenza like illness | Headache and flu like symptoms lasting 20 hours |
| 66 | 2021-01-10 | body temperature increased, headache |
Patient had vaccine in Left arm. That same night patient had temp of 100.1 and the right neck at ba...
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Patient had vaccine in Left arm. That same night patient had temp of 100.1 and the right neck at base of head to shoulder began to hurt patient was unable to swallow without pain in the next few days. Patient went to ER and was hospitalized for 2 days treated with IV steroids and 2 antibiotics (clindamycin and acyclovir). Patients symptoms resolved and patient was discharged without additional issues. The admitting physician was unable to identify the cause of these symptoms, but the vaccine could not be ruled out.
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| 66 | 2021-01-10 | headache | Headache occurred at 18 hr after dose Ibuprofen 400mg po every 8 hours Duration is 48 hr |
| 66 | 2021-01-10 | influenza like illness, malaise, chills |
1/9/21-17:15- started having chills, muscle pain. Pain L arm(injection site) 18:00- low grade temp 9...
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1/9/21-17:15- started having chills, muscle pain. Pain L arm(injection site) 18:00- low grade temp 99.3, muscle pain arms and legs worse Uncomfortable during the entire night (tossing and turning) 1/10/21- 07:30-General malaise(flu like symptoms)- muscle pain-feeling weak T-99 started feeling better during the late afternoon, still with muscle pain , T-98.7
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| 66 | 2021-01-10 | fever |
Low grade fever which lasted 24 hours. Raised, reddened area at site of injection also as well as si...
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Low grade fever which lasted 24 hours. Raised, reddened area at site of injection also as well as significant left axillary lymph node enlargement which both persist.
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| 66 | 2021-01-11 | chills, headache, fever |
onset of severe headache, chills, nausea, fever to 101.5 and chest tightness (pulse ox dropped to 92...
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onset of severe headache, chills, nausea, fever to 101.5 and chest tightness (pulse ox dropped to 92% requiring treatment with albuterol several times during the day. Inset of symptoms occurred approximately 16 hours after vaccination. Fever and other symptoms began subsiding approximately 24-28 hours after vaccination.
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| 66 | 2021-01-11 | headache, chills, fever |
9 hours after receiving the vaccine I experienced joint pain, muscle pain, headache, fever and chill...
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9 hours after receiving the vaccine I experienced joint pain, muscle pain, headache, fever and chills. Symptoms resolved after 36 hours.
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| 66 | 2021-01-11 | headache |
c/o headache shortly after receiving Covid vaccine b/p 158/87 HR 81 Pulse ox 98% monitored ee, state...
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c/o headache shortly after receiving Covid vaccine b/p 158/87 HR 81 Pulse ox 98% monitored ee, states feeling better nor headache upon leaving clinic. b/p121/74, HR 78 02 sat 98%
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| 66 | 2021-01-11 | sweating, fatigue |
"45up to void min later sweat, 12hrs later when I woke up to void, I felt warm ,severe fatigue , ,...
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"45up to void min later sweat, 12hrs later when I woke up to void, I felt warm ,severe fatigue , ,muscle aches , pain some Syncope, nausea, sweating on and off, oral herpes outbreak just like I did when I had Covid -19 in April"
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| 66 | 2021-01-11 | fever, chills, headache | Injection site pain, chills, fever, headache, muscle pain, nausea 12 hours after second vaccine |
| 66 | 2021-01-11 | fever, chills |
I felt close to passing out as my first symptom after receiving the booster. Since I had not heard...
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I felt close to passing out as my first symptom after receiving the booster. Since I had not heard this as a reaction, I thought I should report it. I felt faint numerous times up to 90 hours afterward. Then complete resolution. I also had 101 fever for 24 hours, chills, body aches, but these symptoms have been listed as common.
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| 66 | 2021-01-12 | chills, fever |
fever T104.2, HR115, shivering, nausea, throat feels dry, vomiting Taking Tylenol Prescribed Zofran ...
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fever T104.2, HR115, shivering, nausea, throat feels dry, vomiting Taking Tylenol Prescribed Zofran by PMD Prescribed Ibuprofen by ED MD
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| 66 | 2021-01-12 | fatigue, headache | Headache,Fatigue, Body aches, |
| 66 | 2021-01-12 | fatigue, headache | Sudden onset of severe headache, dizziness, joint pain, exhaustion at 9:00pm |
| 66 | 2021-01-12 | headache | Headache, generalized body aches/pain, pain in legs for 18 hours |
| 66 | 2021-01-13 | chills, headache | chills, shaking, headache, neck ache, joint pain, nausea, vomiting |
| 66 | 2021-01-13 | fatigue |
extreme tiredness/reported as worsened; This is a spontaneous report from a contactable consumer (pa...
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extreme tiredness/reported as worsened; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EK9231), intramuscular on the left arm on 06Jan2021 14:50 at SINGLE DOSE for COVID-19 immunization (also reported as preventative) at the hospital. Medical history was not reported. There were no concomitant medications. It was reported that the patient had tetanus shot around 21Dec2020 or 22Dec2020. The patient also had prior vaccinations which included first pneumonia shot was fine. During the second pneumonia shot, the patient had extreme swelling on left arm and could not lift her arm. She was off work several days due to the pain. It was part of a two shot series for those over 65 years old. She had the COVID-19 vaccine yesterday (06Jan2021). The patient had extreme tiredness that started a that night of 06Jan2021 and was really ongoing at the time of the report. She does not want to fall asleep while driving home as she was at work. She has an appointment for the second dose on an unknown date. It was mentioned that the extreme tiredness was reported as worsened (not recovered).
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| 66 | 2021-01-13 | headache, body temperature increased, chills |
6:30 am 1/13/21: swelling in right axilla, headache, body aches, soreness at injection site 4:pm 1/1...
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6:30 am 1/13/21: swelling in right axilla, headache, body aches, soreness at injection site 4:pm 1/13/21: temp 99.8, chills, selling and redness in right axilla extending to right breast, body aches, severe headache 6:30 am 1/14/21: afebrile, moderate body aches and headache, increased swelling and redness in right axilla extending to right breast Called PCP office. Told to continue Tylenol and use ice packs
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| 66 | 2021-01-13 | headache, fatigue, body temperature increased |
Note: Took Tylenol 1000 mg before injection and every 4-6 hrs since injection 1/11/21 9:00 pm, sor...
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Note: Took Tylenol 1000 mg before injection and every 4-6 hrs since injection 1/11/21 9:00 pm, soreness at injection site 1/12/21 6:30 am, soreness at injection site, slight swelling in right axilla 1/13/21:6:30 am, soreness at injection site, moderate swelling in right axilla, headache, body aches 1/13/21 4:00 pm, temp 99.8, soreness at injection site, increased swelling and redness in right axilla extending to right breast, severe headache. body aches, fatigue 1/14/21 6:30 am, afebrile, increased swelling and redness right axilla extending to right breast, headache, body aches. 1/14/21 10:00 am, Called PCP office. Told to take Tylenol and use ice at axilla, and report to CDC
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| 66 | 2021-01-13 | sweating |
Dizziness Narrative: employee said her heart was low, so she laid on the floor C/o sweaty, diziness,...
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Dizziness Narrative: employee said her heart was low, so she laid on the floor C/o sweaty, diziness, lying on floor felt better. PMH of vascular response, taking beta blocker had juice felt better. Vss. 115/76 bp pulse 65. Recheck b/p 103/69 65 pulse, 101/68 pulse 69 oxygen sats room aire were 100. initial pulse was 43 b/p 115/76. Resolved after rest elevated legs, and fluids. Employee left about after and hour walking well, with no further c/o symptoms all seemed to resolved She was instructed to go the emergency room any further symptoms. She verbalized back the plan.
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| 66 | 2021-01-13 | influenza like illness |
Aching in arms & legs; After 2nd vaccine felt like I had the flu; This is a spontaneous report from ...
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Aching in arms & legs; After 2nd vaccine felt like I had the flu; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose on 15Dec2020 15:00 (lot EH9899, expiry date not reported) in the left arm, then second dose on 05Jan2021 (lot EL0142, expiry date not reported); both via an unspecified route of administration at a single dose as COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had other medications (unspecified) in the two weeks prior to vaccination. The patient was not pregnant at the time of vaccination. On 06Jan2021 02:00, the patient experienced aching in arms and legs, and reported that after 2nd vaccine felt like patient had the flu. The patient did not receive any treatments for the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The patient recovered from the events aching in arms and legs and felt like patient had the flu in Jan2021.
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| 66 | 2021-01-13 | fever, chills |
Day following: severe body aches, chills and fever and slight nausea. The second day following inje...
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Day following: severe body aches, chills and fever and slight nausea. The second day following injection felt a bit better but that evening night sweats and third day following quite nauseated.
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| 66 | 2021-01-14 | body temperature increased | Patient had an elevated temperature that reached a max of 101.2 before resolving. |
| 66 | 2021-01-14 | chills, fatigue, fever |
Body chills; fever that went up to 100.4 degrees F.; fatigue; excess mucus; bone pain 10/10; muscle ...
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Body chills; fever that went up to 100.4 degrees F.; fatigue; excess mucus; bone pain 10/10; muscle pain 8/10; other vaccine same date vaccine date 05Jan2021; This is a spontaneous report from a contactable other health professional (patient). A 66-year-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. Medical history included DM type 2, hypertension (HTN), fibromyalgia, chronic asthma, Covid prior vaccination, No Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered at Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other vaccine same date included other vaccine same date product was Pfizer, other vaccine same date vaccine date 05Jan2021. On 06Jan2021, the patient experienced Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus. No treatment received for the adverse events Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus. The events were non-serious per the reporter. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus was recovering. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bone and muscle pain cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 66 | 2021-01-14 | fatigue |
Fatigue, nausea, vomiting, fever, chills, headache, muscle aches. (All began immediately following 2...
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Fatigue, nausea, vomiting, fever, chills, headache, muscle aches. (All began immediately following 2nd dose and have continued to present day. However, as of 1/15/21 symptoms have begun to subside.)
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| 66 | 2021-01-14 | fatigue | Fatigue, body aches 1/12-13/21 and extreme nausea on 1/14/21. |
| 66 | 2021-01-14 | fatigue | Sore arm, loss of appetite, fatigue, extreme dizziness, drop in blood pressure |
| 66 | 2021-01-14 | headache, headache | Sore arm, headache |
| 66 | 2021-01-14 | sweating |
Periods of tachycardia and diaphoresis started 7 hours after vaccine Had 3 "spells" of it ending am...
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Periods of tachycardia and diaphoresis started 7 hours after vaccine Had 3 "spells" of it ending am of 1/14/21
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| 66 | 2021-01-14 | influenza like illness, lethargy, fatigue |
Flu-like symptoms; lethargy; athralgias; fatigue; This is a spontaneous report received from a conta...
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Flu-like symptoms; lethargy; athralgias; fatigue; This is a spontaneous report received from a contactable consumer. A 66-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in left arm, on 07Jan2021 08:00, at single dose, for COVID-19 immunization, in the hospital. Medical history included Meniere's disease and penicillin allergy. The patient was not pregnant at the time of vaccination. The patient had no other medications in two weeks. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in left arm, on 17Dec2020, for COVID-19 immunization. The patient experienced flu-like symptoms, lethargy, athralgias and fatigue on 08Jan2021 at 21:45. The patient did not receive treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 66 | 2021-01-15 | malaise, headache |
about 1 hour after shot i started getting bad stomach pain in the upper stomach and all over stomac...
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about 1 hour after shot i started getting bad stomach pain in the upper stomach and all over stomach and intestine cramps and 3 days later i still have them. also still have lots of nausea. body aches all over. swelling ankles more on right side, headache, fell sick all over. no treatment just staying in bed.
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| 66 | 2021-01-18 | headache |
Within minutes of receiving my first dose injection, my mouth and tongue began to itch and my tongue...
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Within minutes of receiving my first dose injection, my mouth and tongue began to itch and my tongue began to swell. I also had a headache and felt nauseous. Over time, I also had some difficulty breathing
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| 66 | 2021-01-18 | malaise, chills |
Chills; Malaise; Hives; Other vaccine same date details: [{other vaccine same date product= Pfizer/B...
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Chills; Malaise; Hives; Other vaccine same date details: [{other vaccine same date product= Pfizer/Bio, other vaccine same date vaccine date= 08Jan2021}]; Other vaccine same date details: [{other vaccine same date product= Pfizer/Bio, other vaccine same date vaccine date= 08Jan2021}]; This is a spontaneous report from a contactable other hcp. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, intramuscular on 08Jan2021 11:30 at a SINGLE DOSE and via an unspecified route of administration on 08Jan2021 at a SINGLE DOSE for covid-19 immunisation. Other vaccine same date details: [{other vaccine same date product= Pfizer/Bio, other vaccine same date vaccine date= 08Jan2021}]. Medical history included drug hypersensitivity to Penicillin from an unknown date and unknown if ongoing. Concomitant medication included lisinopril (LISINOPRIL) and atorvastatin (ATORVASTATIN). The patient previously took clindamycin and experienced drug hypersensitivity. The patient experienced Hives, Chills, Malaise on 08Jan2021 18:00. The outcome of the event was unknown. Information on the lot/batch number has been requested.
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| 66 | 2021-01-18 | fever, chills, headache, fatigue |
Fever 101-102. Chills (wearing winter coat and several winter blankets to get warm), headache, feeli...
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Fever 101-102. Chills (wearing winter coat and several winter blankets to get warm), headache, feeling of eyes popping out of head, muscle aches all over, and exhaustion. Feel like I have covid all over again.
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| 66 | 2021-01-18 | fever | Fever |
| 66 | 2021-01-19 | chills, fever, headache | Headache, fever, chills, body aches. |
| 66 | 2021-01-19 | fatigue |
Patient felt "tired' getting up from chair. Patient was seated and evaluated. Past medical history o...
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Patient felt "tired' getting up from chair. Patient was seated and evaluated. Past medical history of DM on metformin - did not take metformin today, and did not eat anything. Anxious about getting vaccine. Patient felt better after sitting, and able to get up without problems. Felt well enough to return hoe.
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| 66 | 2021-01-19 | fatigue |
Patient felt "tired" getting up from chair. Patient was seated and evaluated. Patient has past medic...
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Patient felt "tired" getting up from chair. Patient was seated and evaluated. Patient has past medical history of DM and did not take metformin today, and did not eat anything today. Was anxious about getting vaccine. Felt better after sitting and able to get up without problems. Felt well enough to return home.
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| 66 | 2021-01-19 | fever, chills | Fever 99.4, chills, aches |
| 66 | 2021-01-20 | chills, headache, fever |
Injection site pain; chills; fever; headache; muscle pain; nausea; This is a spontaneous report from...
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Injection site pain; chills; fever; headache; muscle pain; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 66-year-old female patient received the second dose of BNT162B2 (Pfizer, lot number: EL3246), intramuscularly in left arm on 08Jan2021 09:30 at single dose for COVID-19 immunization. Medical history included known allergies: sulfa drugs. Concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (lot number: EK5730), intramuscularly in left arm on 21Dec2020 17:00 for COVID-19 immunization. Patient experienced injection site pain, chills, fever, headache, muscle pain, and nausea 12 hours after second vaccine on 08Jan2021 22:00. No treatment was received. Patient was recovered from these events. No follow-up attempts are possible; no information is expected.
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| 66 | 2021-01-20 | cough, fatigue |
Patient presented with worsening fatigue and shortness of air that began Friday(1/15/21) after recei...
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Patient presented with worsening fatigue and shortness of air that began Friday(1/15/21) after receiving COVID 19 vaccination. She has also had nausea, vomiting, and diffuse abdominal pain since that time. Patient has had a cough for last five days. Patient admitted to ICU for care on 1/17/2021.
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| 66 | 2021-01-20 | cough | Cough began 12/27/20 followed by severe migraine on 12/31/20. |
| 66 | 2021-01-20 | malaise |
I am an RN at this hospital, I received second injection 1/13/2021. On 1/15/2020 felt sick enough to...
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I am an RN at this hospital, I received second injection 1/13/2021. On 1/15/2020 felt sick enough to just lay down all day, then left arm below injection site became moderately swollen, itchy and inflamed. This has lasted until today 1/20/2021 swelling, inflammation and itching has subsided 50 %. It was most of my upper arm an extensive area.
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| 66 | 2021-01-21 | fatigue | Severe weakness Extreme fatigue Loss of appetite |
| 66 | 2021-01-21 | headache, fever, chills | HAD FEVER, HEADACHE, BODY ACHES, AND CHILLS |
| 66 | 2021-01-22 | chills, fever, headache |
Nausea, headache, vertigo started 15 minutes after receiving vaccine. 24 hours later developed arm p...
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Nausea, headache, vertigo started 15 minutes after receiving vaccine. 24 hours later developed arm pain, generalized muscle aches. 36 hours after developed chills, fever 102.5, headache, fatigue 48 hours fatigue, muscle aches present but less fatigue lasted 5 days
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| 66 | 2021-01-22 | fatigue, nasopharyngitis | Tiredness, cold and muscle aches |
| 66 | 2021-01-24 | headache |
Vaccinated 1/20 at her PCP. Pt was seen by NP via telemedicine urgent care complaining of severe per...
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Vaccinated 1/20 at her PCP. Pt was seen by NP via telemedicine urgent care complaining of severe persistent headache and all-over body pain since 1/23, reportedly in too much pain to even move out of bed all day on day 4 after COVID vaccination (1/24). Still in pain today, primarily in arms and shoulders, but is able to ambulate and conduct ADLs. Headache persists with some dizziness. Encouraged to rest, hydrate, and take Tylenol PRN. Strict ED precautions for any CP, SOB, syncope, or evidence of allergic reaction.
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| 66 | 2021-01-24 | headache |
At 1132, Pfizer was administered. RRT called at 1138 in the post-vaccine Recovery area for a 66 y/o ...
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At 1132, Pfizer was administered. RRT called at 1138 in the post-vaccine Recovery area for a 66 y/o female that complains of upper chest tightness and temporal tightness, pain 3/10, non-radiating. 4 RNs responded to the scene. Head-to-toe assessment completed. She reports allergies to sulfa. She took multiple morning medications today, all regularly taken. Hx of stents, HTN, HLD, DM, WPW, irregular HR. Initial vitals: HR: 125, BP: 126/80, RR: 19, O2 98% on RA. Denies nausea and SOB. At 1148, she reported that her pain was subsiding. Given medical hx, RRT activated 911 response, called by Site Manager. At this point, client calm, AA0x4, skin WNL, resp WNL. 1201 EMS arrived and report was given to them. Client taken into ambulance for EKG. ALS response provided. Nitro and ASA given. EKG revealed A-fib, HR 120, O2 96%. Client to be taken to Hospital via ambulance, truck number 490. EMS assumed care at 1214. Husband that was with client was told of plan.
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| 66 | 2021-01-24 | headache |
?Pfizer-BioNTech COVID-19 Vaccine EUA blurry vision next day and headache, but had slightly abnormal...
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?Pfizer-BioNTech COVID-19 Vaccine EUA blurry vision next day and headache, but had slightly abnormal eye exam by eye doctor so could be primary ophthalmologic issue. also seen by neurology and normal CT scan of head
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| 66 | 2021-01-25 | chills |
Shot site on arm began hurting a lot around 1am the next day Jan 26. I began to feel nauseous the ne...
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Shot site on arm began hurting a lot around 1am the next day Jan 26. I began to feel nauseous the next day at 11 am. Also had some chills. Took Advil soon after and helped alleviate the chills right away. Received Pfizer-BioNTech COVID-19 Vaccine EUA
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| 66 | 2021-01-25 | fatigue, sleepiness |
I am quite really tired/I have never been this tired during the day time like I am right now; I fell...
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I am quite really tired/I have never been this tired during the day time like I am right now; I fell asleep sitting in the chair/I feel like I took something that helped me to sleep; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Batch/lot number: EJ1686), via an unspecified route of administration at deltoid left on 12Jan2021 at single dose for covid-19 immunization. Medical history included hypertension, diabetes, High cholesterol, asthma, Allergies, irritable bowel syndrome, depression. Concomitant medication included lisinopril, metoprolol, hydrochlorothiazide (HCTZ), glipizide, sitagliptin phosphate (JANUVIA), budesonide, formoterol fumarate (SYMBICORT Inhaler), montelukast sodium (SINGULAIR), montelukast, levocetirizine for allergies, levocetirizine dihydrochloride (XYZAL) for allergies, atorvastatin, dicycloverine (DICYCLOMINE), sertraline as anti-depressant, ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient was quite really tired, she was trying to get walked on, so, she can work because she worked from home and she was sitting here, and she fell asleep sitting in the chair in front of computer. She tried to reach employee health at work, but they were helping in the shot clinic. She had never been this tired during the daytime like she was right now, she felt like she took something that helped her to sleep on 12Jan2021. The nurse did not visit any emergency room/ physician office. The patient had drunk coffee and was drinking diet coke for caffeine. No other treatment received for the events. The outcome of the events was unknown.
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| 66 | 2021-01-25 | headache, chills, fever | Fever, body ache, HA, nausea, chills, tremors, O2 sat = 96% |
| 66 | 2021-01-25 | headache, sleepiness |
arm soreness; very achy; Drowsiness; bad headache; This is a spontaneous report from a contactable c...
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arm soreness; very achy; Drowsiness; bad headache; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 11Jan2021 at single dose (1.8 cc but unsure ((heard that but could be wrong) recommended dose)) as works with COVID positive patients. Medical history was none. No concomitant medications. Caller just wanted to know if she could take Tylenol for mild symptoms after having the COVID 19 vaccine. She received the vaccine yesterday. She was wondering if it would make the symptoms a little less. She didn't have a prescribing doctor. The side effects started last night. On 11Jan2021, she was expecting arm soreness, but this was worse. She developed it about 6 hours after the shot. This was the sorest her arm has ever been from any injection, and she had had a lot of them. Her arm was almost too sore to move. This morning, it was much better. It was really bad last night. She was also very achy, and experienced drowsiness, also has a very bad headache on 11Jan2021. The CDC website stated before the vaccine patients should not take Tylenol because it can tamper with the immune system response. It said it was alright to take after, but she just wanted to call to make sure. Investigation Assessment was no. The outcome of the event very achy was not recovered, of the events was recovering.
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| 66 | 2021-01-25 | fever, chills, headache | chills fever body aches nausea diarrhea headache |
| 66 | 2021-01-25 | throat irritation, cough |
Patient with known allergies in observation area following injection noted flushed cheeks, chest tig...
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Patient with known allergies in observation area following injection noted flushed cheeks, chest tightness, and reported to clinical manager.(10:16) Given 25mg PO Benadryl and continued observation. AT 10:30, no resolution of symptoms-telehealth visit initiated. Vital signs stable, Oxygen sat at 97%, patient with c/o cough and scratchy throat. Order given and medication administered. Solumedrol 125mg IM. Additional 1 hour observation-symptoms resolved, and patient was discharged to home.
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| 66 | 2021-01-26 | headache, chills, fatigue |
Tiredness; A sore arm/Arm was a little sore; Dizziness; Passed out; Chills; Tremor in fingers; A hea...
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Tiredness; A sore arm/Arm was a little sore; Dizziness; Passed out; Chills; Tremor in fingers; A headache; This is a spontaneous report from a contactable Nurse (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EH9899, expiry date: unknown), via an unspecified route of administration on 06Jan2021 10:30 at single dose (Right upper arm) for COVID-19 immunization. Medical history included Blood pressure (takes blood pressure medication). The patient's concomitant medications included blood pressure medication. The patient experienced a sore arm, chills, tremor in fingers and a headache when she came home from being vaccinated. The morning after, she experienced dizziness, tiredness and passed out. She then checked her blood pressure and it was fine and then she went to bed and slept all day. She got up around 7 pm and was fine. It was further reports that the patient received first COVID Vaccine on 06Jan2021. She came home and was fine. Arm was a little sore. During night had chills and noticed fingers had tremors. Had a bad headache. Woke up in morning and went to do usual things. Was dizzy and passed out. Woke up on floor. Husband helped her back into bed and she slept the whole day. After that she was absolutely fine. They were curious, but a little bit concerned about taking the second dose. Advised patient to follow up with primary care physician. She went to primary care physician yesterday. Primary care physician advised her to take the second dose of COVID Vaccine stating he didn't see why she couldn't take it. HCP Details: Address and email address are unknown Received first dose of COVID Vaccine on 06Jan2021 around 10:30. Chills: began at 23:00 Fingers had tremors: began 23:00 Bad headache: did not provide time of onset Dizzy and passed out: 08:00 Woke up absolutely fine on 07Jan2021 around 19:00 Indication: 66 years old and it was available to her Causality: Yes, because she was fine before then History and Investigations: Takes blood pressure medication, but blood pressure has been normal. Product name not provided by caller. Vaccination facility type was at a skilled nursing facility. The outcome of the events was unknown. Chills, Tremor in fingers, headache, Dizziness, and Passed out were reported as Medically significant events. Reaction assessed for Chills, Fingers had tremors, Had a bad headache, Dizzy, and Passed out. Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including chills, tremor in fingers, headache, dizziness, and passed out, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 66 | 2021-01-26 | headache |
joint pains; headaches; This is a spontaneous report from a contactable other health professional. A...
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joint pains; headaches; This is a spontaneous report from a contactable other health professional. A 66-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3246), intramuscularly on 11Jan2021 at 10:00 at a single dose for COVID-19 immunization. Medical history included pre-diabetic from an unknown date and unknown if ongoing, high cholesterol from an unknown date and unknown if ongoing; known allergies: no. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; first dose-lot number: EJ1685, intramuscularly, in the left arm at 19:30) for COVID-19 immunization on 22Dec2020. Concomitant medications included calcium (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN), simvastatin (ZOCOR); all taken for an unspecified indication from an unspecified date to an unspecified date. On 12Jan2021 at 03:00, the patient experienced: joint pains and headaches; no treatment was reached. The clinical outcome of the events was recovered in Jan2021. There were no other vaccines within four weeks of the suspected vaccine. The patient did not have COVID prior to the vaccination. The patient was not tested for COVID post vaccination.
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| 66 | 2021-01-26 | fever, fatigue | diarrhea, can't eat, 99 fever, dizzy, abdominal pain, muscle pain,fatigue |
| 66 | 2021-01-27 | chills |
Joint pain for approx. 12 hours, chills for 12 hours - extreme chills for 4 hours, accelerated pulse...
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Joint pain for approx. 12 hours, chills for 12 hours - extreme chills for 4 hours, accelerated pulse for several hours - up to 118 bpm - normal is 60-70
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| 66 | 2021-01-28 | fatigue |
Dizziness, muscle pain, tiredness, joint pain I woke up to use the bathroom. after relieving myself...
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Dizziness, muscle pain, tiredness, joint pain I woke up to use the bathroom. after relieving myself I stood up and got very dizzy, then I fell down. I fell again after I got myself up.
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| 66 | 2021-01-28 | headache, cough |
24th Jan 2021-Sunday-hurts to breathe, coughs a lot, HA, body slows when speaking she is hoarse-remi...
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24th Jan 2021-Sunday-hurts to breathe, coughs a lot, HA, body slows when speaking she is hoarse-reminded if She gets worse-GO the ER-or have someone drive her there-for instance-SOB 25th Jan 2021-Monday-legs, to mid calves-swollen 26th Jan Tuesday-still coughing a lot 27th Jan like the 24th of Jan 2021-hurts to breathe, HA, body slows, hoarse when speaking, Cough a lot. 28th Jan 2021-Thursday-her Back hurt. Her waist & shoulder blades painful 29th Jan 2021-today-she said COVID-19 reaction-that's why she called
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| 66 | 2021-01-28 | headache, fever, chills | CHILLS FEVERISH BODY ACHES JOINT PAIN HEADACHE |
| 66 | 2021-01-28 | headache, fever | Fever, aches, headache, swollen glands, and joint pain. |
| 66 | 2021-01-28 | lethargy | Joint and muscle pain/ lethargy |
| 66 | 2021-01-29 | chills |
24 hrs after 2nd COVID19 vaccine felt very cold and could not get warm, lead to mild chills. While...
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24 hrs after 2nd COVID19 vaccine felt very cold and could not get warm, lead to mild chills. While trying to get blankets, turning up heat, preparing dinner, had abnormal muscle and joint pain upon any movement. No muscle or joint pain while sitting still.. 6 hours after symptoms took acetaminophen 500mg and diphenhydramine 25mg . 9 hrs after onset of symptoms felt fine with no symptoms and slept through the night fine. 48 hrs after vaccine feel completely normal.
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| 66 | 2021-01-29 | fatigue | Extreme fatigue, unable to stand or walk, dizziness, physical weakness, upset stomach, |
| 66 | 2021-01-29 | malaise, throat irritation, fatigue, headache |
Pfizer-BioNTech COVID-19 Vaccine EUA Side Effects: Injection site pain, tiredness, headaches, join...
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Pfizer-BioNTech COVID-19 Vaccine EUA Side Effects: Injection site pain, tiredness, headaches, joint pain, feeling unwell, swollen lymph nodes, rough-feeling throat lasting just over 24 hours
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| 66 | 2021-01-30 | fatigue | On day 3 I have light headed and feeling tired. |
| 66 | 2021-01-30 | headache, fever |
This was my second dose of the Pfizer vaccine. First day I felt soreness on my left arm where shot...
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This was my second dose of the Pfizer vaccine. First day I felt soreness on my left arm where shot was administered and I had stomach cramps through the day. Had to eat very light. Woke up with an intense headache during the night, which continued all through Saturday 1/30/2021 and into the night. I started with a fever of 100.5 and it climbed to approximately 102 in late afternoon on Saturday. Saturday afternoon got nauseous and remained that way through the night. Most symptoms have stopped on Sunday morning, although my stomach is very unstable and I feel weak. I took Tylenol through the day and at midnight on Saturday at recommended doses or less. Temperature 99.1 on Sunday afternoon and haven?t taken a Tylenol since Saturday night.
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| 66 | 2021-01-31 | fatigue | Feeling achy, tired and not myself |
| 66 | 2021-01-31 | headache, pneumonia |
I got a headache and I have had one ever since receiving the vaccine (and I'm not prone to headaches...
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I got a headache and I have had one ever since receiving the vaccine (and I'm not prone to headaches) - they come and go. I never have had these before. I had wheezing and it was getting worse- on the 30th and I went to Urgent Care 31st. Was a diagnosed with Pneumonia. Doxycline - was prescribed. I'm still wheezing but I feel fine. But I'm not wheezing as heavy as it was. I received second dose of January 14 - no other symptoms.
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| 66 | 2021-01-31 | headache |
severe upper stomach pains and stomach pains all over and cramps; all over body pain; headache; naus...
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severe upper stomach pains and stomach pains all over and cramps; all over body pain; headache; nausea; ankles swelling more the right one; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration in the right arm on 13Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included Coronary artery disease (CAD), 2nd degree AV heart block, acid reflux, gastritis, high blood presure, fibromyalgia, gammaglobulinemia, allergies to sulfa, eggs, milk, fish, shrimp, and nuts. The patient is not pregnant. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included valsartan (DIOVAN), esomeprazole sodium (NEXIUM), acetylsalicylic acid (BABY ASPIRIN), alprazolam, atorvastatin (LIPITOR). The patient previously took codeine, morphine, clopidogrel (PLAVIX), isosorbide mononitrate (IMDUR) and experienced allergies. On 13Jan2021 15:00, approximately 1 hour after the shot, the patient experienced severe upper stomach pains and stomach pains all over and cramps. A few hours later, she got all over body pain, headache, nausea, and her ankles were swelling more the right one. These events are all still going on 3 days later. Treatment was not provided in response to the events. The patient has not undergone COVID testing post vaccination. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 66 | 2021-01-31 | fever |
Fever of 102, treated with 2 tablets regular strength Tylenol. Checked temp. 4 hrs. later and rec...
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Fever of 102, treated with 2 tablets regular strength Tylenol. Checked temp. 4 hrs. later and recorded 98.8. Fever never returned and I have remained fever free.
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| 66 | 2021-01-31 | throat irritation | Tingling in lips, heaviness in chest, scratchy tongue and throat. |
| 66 | 2021-01-31 | throat irritation |
itching to eyes, mouth, and throat an hour after vaccination; itching to eyes, mouth, and throat an ...
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itching to eyes, mouth, and throat an hour after vaccination; itching to eyes, mouth, and throat an hour after vaccination; itching to eyes, mouth, and throat an hour after vaccination; arm soreness; dry throat; arm discomfort; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 17Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included Cholesterol and Blood pressure, patient stated she took low dose medication for her blood cholesterol and blood pressure, but has had no new medications. She had a history of some allergies: a slight shrimp and scallops allergy, possible peanuts, penicillin, and a Neomycin product. She said they were not a big deal, and she had environmental allergies as well. She had an allergic reaction to the eye drop Neomycin, possibly, just the eye drop, she had a little breakout around her lips but she didn't know if it was the drug or not. The allergy to shrimp and scallops showed up in a blood test, her reaction to peanuts around her mouth but she had a negative scratch test and blood test for allergy to peanuts. The patient's concomitant medications were not reported. The patient stated she did get the flu vaccine, that was ok, she was fine, this was probably around Nov2020 or so, though she didn't know off hand when she got it, it was the regular flu vaccine and not an increased dose. The patient experienced arm discomfort on 17Jan2021, itching to eyes, mouth, and throat an hour after vaccination on 17Jan2021 12:00. The patient took the first shot yesterday (17Jan2021) and she had some discomfort to her arm, but it didn't bother her. She got the shot about 11:00 yesterday (17Jan2021) and about an hour after the shot she had some itching to her eyes, mouth, and throat that was not severe then was on and off through the day. She would like to know if this is common, she would like the information for the second dose, if she should expect more or less or same, she was concerned about the second dose. She did not have a severe reaction, she just wanted to make sure there weren't any adverse reaction for that make sure she known. She had not seen a doctor for her itching eyes, mouth, and throat. She didn't do any treatment for it, it was better today (18Jan2021), she just noticed it an hour after the injection that she felt a bit of eyes being itchy and all over, her mouth and throat were not severe, but she definitely felt it through the day. She felt it a little at night sometimes anyway like a dry throat. It was gone this morning and her arm was better, it seemed like the itching went with the arm things since following her arm soreness her itchiness started, then when her arm felt better the itchy was going away. The outcome of events was recovering. Information on the Lot/Batch number has been requested.
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| 66 | 2021-02-01 | chills, fever, fatigue |
flu; fever; chills; body ache; fatigue; This is a spontaneous report from a contactable healthcare p...
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flu; fever; chills; body ache; fatigue; This is a spontaneous report from a contactable healthcare professional. A 66-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248) on her left arm, via an unspecified route of administration on 15Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included Allergies, Asthma, Sleep Apnea, Obesity, IBS, Depression and Arthritis. Concomitant medication included paroxetine hydrochloride (PAXIL), buspirone, unspecified allergy shots. The patient experienced Flu, Fever, Chills, Body Aches, Fatigue; all on 16Jan2021 09:45. No treatment was received for the events. The outcome of the events was recovered on an unspecified date in Jan2021.
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| 66 | 2021-02-01 | fatigue, chills, headache, fever | Headache, Nausea, Vomiting, Chills, Fatigue, Joint pain, Fever. |
| 66 | 2021-02-01 | fatigue |
soreness; tiredness/Tired; looked bruised/Looked like a bruise and then in the afternoon I was going...
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soreness; tiredness/Tired; looked bruised/Looked like a bruise and then in the afternoon I was going to take my late night showers I looked at it and it had blister on it; blister; didn't sleep well/Didn't sleep well; sore arm; Around the skin it is discolored; This is a spontaneous report from a contactable consumer A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 15Jan2021 08:15 at a single dose for COVID-19 immunization. Medical history included covid-19 around 15Jun or 16Jun2020 and did the quarantine. The patient's concomitant medications were not reported. Patient had soreness and tiredness the next day after vaccination on 16Jan2021 and took TYLENOL every 4 hours. She was concerned because on 16Jan2021, when she was going to take shower, it looked bruised, and blister on it. Patient didn't know what to do. Patient applied ice packs. The patient had patches, blister on top of that and it was not at the injection site. It's where she applied the ice. That was on 15Jan2021. She also didn't sleep well on 15Jan2021. She took ibuprofen but was not running a fever with no itching. Around the skin it was discolored on Jan2021. Patient was scheduled to get the 2nd dose in 3 weeks. Patient took her Pfizer Vaccine (Covid Vaccine) on Friday morning the 15th approximately 8:15 in the morning. Other than a sore arm on Friday she was okay. They told her to put ice pack on it for soreness. So she did that afternoon. On 16Jan2021, she looked at it in the morning It looked like bruise on the arm, not where she gave patient the injection but down a little below her arm and it looked like a bruise and then in the afternoon she was going to take my late night showers I looked at it and it had blister on it. She took Ibuprofen. She didn't have fever. She felt herself today. On 16Jan2021, in the morning she did feel tired and she did take afternoon nap for about 2-3 hours because before that she didn't sleep well. She already knew that she need at least 8 hours. Patient height was reported as about 5'3.Outcome of the event soreness was not recovered while for the remaining events was unknown. The reporter considered the events as non-serious. Information on lot number/batch number was requested. Follow-up (17Jan2021): New information received from a contactable consumer included: new event (sore arm), patient weight, and event details.
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| 66 | 2021-02-01 | headache, fever, sweating |
Received 2nd dose of Pfizer on 1/26/21 (Tuesday). Felt fine on 1/27(Wednesday, scheduled day off). ...
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Received 2nd dose of Pfizer on 1/26/21 (Tuesday). Felt fine on 1/27(Wednesday, scheduled day off). Woke up 1/28 (Thursday) around 3:00 am drenched. Had fever/chills and headache all day. Again on 1/29 (Friday) woke up drenched - had slight fever, but no headache. Called PCP on Thursday - told to rest, hydrate and eat BRAT diet. Called Thursday & Friday was told the same. By Saturday, felt almost myself again.
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| 66 | 2021-02-01 | malaise, fatigue |
extreme tiredness, Malaise with body and joint aches, asthma minor flare up, wheezing that woke me u...
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extreme tiredness, Malaise with body and joint aches, asthma minor flare up, wheezing that woke me up during the night. Sore L upper arm
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| 66 | 2021-02-01 | fever, chills, headache | Fever chills headache for 12 hours occurring 24 hours after 2nd COVID injection |
| 66 | 2021-02-01 | fever |
Achy all over, fever maxed at 101. Started at about 4:30 pm on 2/1 and continued until approx 7 am 2...
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Achy all over, fever maxed at 101. Started at about 4:30 pm on 2/1 and continued until approx 7 am 2/2. Currently no symptoms.
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| 66 | 2021-02-01 | respiratory tract congestion, sneezing |
pain under her arm; pinched nerve in my neck and blood pressure went up to 182/98; I have pinched ne...
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pain under her arm; pinched nerve in my neck and blood pressure went up to 182/98; I have pinched nerve in my neck and blood pressure went up to 182/98; arm where she got the shot hurt like it was very tender; left breat hurt/then right breast hurt; having a little bit of trouble with asthma; congested and sneezing; congested and sneezing; bumpy rash on her chest and arms; puffiness/swelling in the neck; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration on 14Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing asthma and high blood pressure unknown if ongoing; both from unknown dates. Concomitant medications included prednisone (MANUFACTURER UNKNOWN) for asthma, unspecified vitamins and an inhaler for asthma. On 14Jan2021, the patient received the vaccination. She had a reaction to the vaccine almost immediately within 15 minutes of receiving vaccine. First, she had a pinched nerve in her neck and blood pressure went up to 182/98. Then about an hour later, the arm where she got the shot hurt like it was very tender. Then, her left breast hurt, followed by her right breast hurt. A few days later on 17Jan2021, she had breast pain and also pain under her arm. In Jan2021, she was also have some trouble with her asthma, was congested and sneezing. She had bumpy rash on her chest and arms. It was like tiny little bumps but it was not painful. She also had puffiness/swelling in the neck. The clinical outcomes of the pinched nerve in her neck, blood pressure went up to 182/98, arm where she got the shot was tender, breast pain, pain under arm, trouble with her asthma, congested and sneezing, bumpy rash, and puffiness/swelling in the neck were unknown.
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| 66 | 2021-02-02 | chills, headache, fever | Fever - 102, chills, body aches, headache |
| 66 | 2021-02-02 | headache, fatigue, chills, malaise |
I started feeling very ill the evening of my second Pfizer shot. My symptoms included headache, musc...
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I started feeling very ill the evening of my second Pfizer shot. My symptoms included headache, muscle pain, chills, nausea, vomiting and fatigue. I felt very unwell for 4 days. By Feb 1st, I started to feel better.
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| 66 | 2021-02-02 | headache, fatigue, influenza like illness, fever |
flu like symptoms - headache, achiness, low grade fever (99), extreme tiredness - lasted for about 2...
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flu like symptoms - headache, achiness, low grade fever (99), extreme tiredness - lasted for about 24 hours
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| 66 | 2021-02-02 | headache, throat pain, chills, fatigue |
Message from patietn: Due to other vaccine reactions I had to wait for 30 minutes after my shot. A...
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Message from patietn: Due to other vaccine reactions I had to wait for 30 minutes after my shot. All was okay, until I got in the car to drive home. My tongue began to tingle and headaches began. I immediately took an antihistamine as a tingly tongue for me is a sign of an allergic reaction. I then had a band like pain across my upper back, and then the chills, tiredness, nausea, sore throat, sore arm which are all normal reactions from the printed information - well except for the tingly tongue and a red rash across my nose, cheeks and chin. Tingling and rash subsided about an hour after taking the antihistamine, but all of the other symptoms remained. My shot was at 1:50 PM and just before 11 PM I had instant onset of pain in my chest wall with breathing. It went across the top of both breasts in the center where my ribs meet my sternum. This has lessoned with laying down, but when I am up and about it increases although not as bad as last night. I am also experiencing bursts of itchy spots all over. As I have an EpiPen I did not go to hospital but am wondering about what to do for the 2nd shot. I think it will be best if I take an antihistamine prior to the shot and I will continue taking them for this one until my symptoms go away.
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| 66 | 2021-02-03 | chills, fever, headache |
About 15 hours after receiving the vaccine, I started with muscle aches. Then I got uncontrollable c...
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About 15 hours after receiving the vaccine, I started with muscle aches. Then I got uncontrollable chills followed by a high fever. Woke up about three in the morning with a headache over my right eye that was unbearable. Took some Tylenol and woke up this morning and just have a slight headache
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| 66 | 2021-02-03 | fatigue, nasal congestion | Extreme fatigue, muscle pain all over even hair follicles hurt, Entirely snuffed up nose |
| 66 | 2021-02-03 | fatigue |
Approximately 6 hours after injection, I began feeling very tired. I was up walking around office w...
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Approximately 6 hours after injection, I began feeling very tired. I was up walking around office working on some computer updates and then cam back to my office. About 15 minutes later while sitting at my desk my hand and feet began tingling, then about 10 minutes later my feet became numb, from toes to ankle, both ankles began to swell and had +Edema, and blood pressure was 123/50 , pulse low and undetected on my electronic BP cuff, taken by wrist it was 42, event lasted about 30 minutes, I forces fluids, took a Benedryl, and walked in my office when numbness subsided.
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| 66 | 2021-02-03 | headache |
Awaken at night with very sore arm and a headache. Took a 500mg Tylenol and was able to go back to ...
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Awaken at night with very sore arm and a headache. Took a 500mg Tylenol and was able to go back to sleep. Headache resolved the next morning. Sore arm resolved in about 2 days
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| 66 | 2021-02-03 | influenza like illness, chills |
Body aches; Her arm was sore/ mostly in her arm; Body aches had greatly improved. It is mostly in he...
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Body aches; Her arm was sore/ mostly in her arm; Body aches had greatly improved. It is mostly in her arm and her knees are a little achy; Chills; first dose was on 05Jan2021/ second one yesterday 19Jan2021; Kind of like the flu, like she was hit by a truck; had trouble getting off of the sofa; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: May2021), via an unspecified route of administration on 19Jan2021 11:37 at a single dose on right arm for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER9231, expiry date: Apr2021), via an unspecified route of administration on 05Jan2021 at single dose in left arm for COVID-19 immunization. The patient experienced body aches, mostly in her arm and her knees are a little achy on 19Jan2021 22:00, chills on 19Jan2021, and kind of like the flu, like she was hit by a truck, had trouble getting off of the sofa, all on Jan2021. The patient just got her second Pfizer COVID Vaccine. She experienced nothing with the first dose. She had the second one yesterday 19Jan2021. Last night she had body aches and chills. The chills are completely gone and the body aches are 85%-90% better. She called out of work today, unknowing how long these would last, and her boss told her to get this reported. She does feel better. She was warned of the second dose being more ferocious. She felt great all day. Around 10 PM the body aches started. Kind of like the flu, like she was hit by a truck. She had trouble getting off of the sofa. They told her not to take Advil as it would make the vaccine not work as good. She is used to taking Advil. She confirmed she did not take the Advil. She took Tylenol instead, this morning. She had to go out and get some. The nurse told her when she got the second dose that she would have side effects and she would feel it. Her arm was sore so she circled it around. She went this morning to the pharmacy to get the Tylenol. She is unsure if because she was moving around, or because of the Tylenol that she feels so much better. Maybe like she could even go into work at Noon. She did not take Advil or Tylenol last night, which maybe that is why she was sore. The chills only lasted about half an hour last night and 15 minutes today. Body aches had greatly improved. It is mostly in her arm and her knees are a little achy. They are normally not. She is 85% better. It is going away as we speak. The outcome of the event Body aches, Pain in arm, knee pain was recovering, chills was recovered on 20Jan2021, while for the other events was unknown.
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| 66 | 2021-02-03 | throat pain |
tingling in mouth and nose with metallic taste metallic taste also went down throat with heat sensat...
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tingling in mouth and nose with metallic taste metallic taste also went down throat with heat sensation and sore throat
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| 66 | 2021-02-04 | chills, cough |
Chills/rigors; wheezing; shortness of breath; cough; myalgias; local vaccination site swelling as we...
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Chills/rigors; wheezing; shortness of breath; cough; myalgias; local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); This is a spontaneous report from a contactable physician (patient). A 66-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3283), via an unspecified route of administration on 20Jan2021 at a single dose on Right deltoid for COVID-19 immunization. Medical history included Chronic lymphocytic leukemia with 65% of cells lymph's, low WBC count (13500) otherwise; DM2, A1C usually close to 6.1; HTN. Unspecified concomitant medication taken. The patient previously took nickel and experienced allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9331), intramuscular on 31Dec2020 12:15 PM at a single dose on left arm for COVID-19 immunization. The patient experienced chills, rigors, wheezing, shortness of breath, local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop), cough, myalgias on 20Jan2021 23:30. Therapeutic measures were taken as a result of the events which included Benadryl, Aleve, Nebulizer treatment, change in local temperature to help stop rigors. The outcome of the events was recovering. No other vaccine in four weeks. The patient was not pregnant. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
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| 66 | 2021-02-04 | fatigue, runny nose, paranasal sinus discomfort, sneezing, throat irritation |
Developed runny nose, sneezing, muscle aches/joint pain, nausea, scratchy throat, sinus pressure, ra...
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Developed runny nose, sneezing, muscle aches/joint pain, nausea, scratchy throat, sinus pressure, rash on chest/neck, fatigue. Saw medical provider on 2/02/2021 who suspected above due to receiving 1st dose of covid-19 vaccine.
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| 66 | 2021-02-04 | fatigue |
Extreme tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 66-yea...
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Extreme tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 66-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 13:30 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. There was no other vaccine in four weeks. The patient did not get COVID prior vaccination and COVID was not tested post vaccination. The patient experienced extreme tiredness on 21Jan2021. No treatment was received. The outcome of the event was resolving. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
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| 66 | 2021-02-04 | headache | Headache next day. Started 0900. No prior history chronic headaches |
| 66 | 2021-02-04 | sweating |
Pfizer-BioNTech COVID-19 Vaccine EUA Drive Thru Vaccination clinic - Within 10 mins of getting the ...
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Pfizer-BioNTech COVID-19 Vaccine EUA Drive Thru Vaccination clinic - Within 10 mins of getting the vaccine, patient reports numbness to her central lips and tip of tongue. Diaphoresis and chest discomfort. Vitals were 157/78, 99, 16, 98% RA. Symptoms slowly started to resolve. 911 called and pt sent to ED. Pt takes Allegra (fexofenadine) daily. Symptoms resolved at 1:15pm. Troponins were normal - low concern for ACS. Diphenhydramine 25mg po on 1121 and prednisone 40mg at 1214. Discharge prescription for prednisone 40mg daily x 3 days.
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| 66 | 2021-02-04 | runny nose, fatigue, malaise, chills |
Runny nose; feeling unwell; muscle & joint aches; muscle & joint aches; chills; tired; stomach cramp...
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Runny nose; feeling unwell; muscle & joint aches; muscle & joint aches; chills; tired; stomach cramps; acid reflux; vomiting; This is a spontaneous report from a contactable consumer, reporting for herself. A 66-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK9231, via an unspecified route of administration on 20Jan2021 at 09:15 (at the age of 66 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included obese from an unspecified date, and cancer in 1998 & 2015. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included letrozole, vitamin (unspecified), Omega, 'TransResve', calcium, 'eld'. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 12:00PM, the patient experienced runny nose, feeling unwell, muscle & joint aches, chills, tired, stomach cramps, acid reflux, and vomiting. The patient did not receive treatment for the events. The clinical outcome of runny nose, feeling unwell, muscle & joint aches, chills, tired, stomach cramps, acid reflux, and vomiting was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 66 | 2021-02-04 | sleepiness |
facial numbness/possible migraine (resolved); Hypertension (resolved) Body aches, drowsiness (resolv...
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facial numbness/possible migraine (resolved); Hypertension (resolved) Body aches, drowsiness (resolved), neck pain (ongoing, possible fibromyalgia flare); ocular irritation redness (ongoing, possibly unrelated)
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| 66 | 2021-02-05 | chills | Mild to Severe migraine still have it. Chills and stiff neck. |
| 66 | 2021-02-05 | headache |
Client complaining of headache and feeling of throat closing immediately after receiving vaccine. RN...
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Client complaining of headache and feeling of throat closing immediately after receiving vaccine. RN and MD responded. BP 100/60 HR 95. 50MG IM Benadryl given in R arm. Shortly after administering Benadryl, client reported feeling much better. Continued to monitor. Client left site without further incident.
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| 66 | 2021-02-05 | malaise |
I was feeling pretty good until suddenly I felt lousy. My arm quickly started to get sore and my hea...
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I was feeling pretty good until suddenly I felt lousy. My arm quickly started to get sore and my heart rate doubled. It took around an hour for my heart rate to slow down again. By bedtime all I had was a sore arm. That was gone within 24 hours.
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| 66 | 2021-02-06 | fatigue, fever, headache, chills | Tiredness (no energy) Headache Chills Fever 107 Injection site redness Nausea |
| 66 | 2021-02-06 | headache, chills, cough, fatigue |
On day 2 (2/6/21)developed cough, then chills & fatigue. By 3 pm went to bed. Woke up about 7pm, mil...
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On day 2 (2/6/21)developed cough, then chills & fatigue. By 3 pm went to bed. Woke up about 7pm, mild chills lasted until about 10pm. On Sunday 2/7/21 - still fatigue, mild nausea, sporadic headaches, but no chills, no fever.
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| 66 | 2021-02-07 | fatigue, fever, headache | vomit once shakes |
| 66 | 2021-02-07 | fatigue, throat irritation, sneezing |
Itchy throat, itchy inner ear and slightly enlarged lips (at 3:00am on 1/31) Itchy throat, itchy inn...
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Itchy throat, itchy inner ear and slightly enlarged lips (at 3:00am on 1/31) Itchy throat, itchy inner ear and excessive sneezing (at approximately 5:00pm on 1/31) (I took an extra Zyrtec to subside these symptoms) These are the usual reactions to allergies (not the shellfish allergy though) I was also fatigued for several days but I know that was a listed as a side affect but I thought I would mention it.
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| 66 | 2021-02-07 | fatigue |
contracted Covid after my 2nd dose, 3 days to be exact; contracted Covid after my 2nd dose, 3 days t...
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contracted Covid after my 2nd dose, 3 days to be exact; contracted Covid after my 2nd dose, 3 days to be exact; This is a spontaneous report from a contactable other health professional (patient). A 66-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Lot # EL3246) at single dose at right arm on 14Jan2021 for covid-19 immunisation, administered at hospital. Medical history included rheumatoid arthritis, allergies to morphine and related, PCN, sulfa, quinidine, Xeljanz. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included: upadacitinib (RINVOQ), folic acid (FOLIC ACID), ropinirole hydrochloride (REQUIP). The patient previously received the 1st dose of bnt162b2 (BNT162B2, Lot # EJ1685) at single dose at right arm on 26Dec2020 03:00 PM for covid-19 immunisation, administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced contracted Covid after her 2nd dose, muscle aches and fatigue 3 days to be exact on 17Jan2021 17:00, Covid test result positive on 22Jan2021. Since the vaccination, the patient has been tested for COVID-19 (nasal swab): positive on 22Jan2021. No treatment was received for the adverse event. The outcome of Covid test result positive was unknown, of the other events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported lack of efficacy cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 66 | 2021-02-07 | fatigue |
1/29-Reported increased fatigue, weak and itchy, hands were red and blotchy. MD updated and PRN Bena...
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1/29-Reported increased fatigue, weak and itchy, hands were red and blotchy. MD updated and PRN Benadryl given with good effect. C/O nausea and decreased appetite 1/30 received PRN Zofran with good effect. No further complaints 2/1
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| 66 | 2021-02-07 | headache, fever, fatigue, chills | headache, chill, tiredness, throwing up, low grade fever |
| 66 | 2021-02-07 | malaise, headache, fatigue | Post 22 hours: headache tiredness nausea feeling unwell |
| 66 | 2021-02-07 | throat pain |
About 24 hours after the 2nd dose, I had extreme nerve sensitivity on the left side of the face. Thi...
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About 24 hours after the 2nd dose, I had extreme nerve sensitivity on the left side of the face. This pain and sensitivity to touch went from my forehead above the eyebrow down to my chin. It included my left eye. It also seemed to affect my throat. The left gland popped and the left side of my throat was very sore. This issue responded somewhat to Advil but never fully went away and only dissipated for about an hour in between Advil doses. It lasted about 30 hours. I hadn't read or heard anything about a reaction like this so wanted to provide the information.
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| 66 | 2021-02-07 | fever, chills, headache |
First Vaccine - produced fever, chills, headache, dizziness, nausea - lasted 2 days - Vaccine was a...
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First Vaccine - produced fever, chills, headache, dizziness, nausea - lasted 2 days - Vaccine was administered Sunday at 3:20 PM and I was sick Monday and all day Tuesday - by Wednesday I was fine Second vaccine was January 31st at 3 PM - the next morning I woke up - got in the shower - got nauseous dizzy and fell breaking my left leg and left ankle. I still had nausea for 6 days and headache for 6 days - seems better today
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| 66 | 2021-02-08 | chills, fatigue, fever | Fever, chills, extreme body pain, extreme fatigue |
| 66 | 2021-02-08 | chills |
I receive my second vaccination for Covid on January 4, 2021. Less than 36 hours later I experience...
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I receive my second vaccination for Covid on January 4, 2021. Less than 36 hours later I experience a rapid heart rate (110 - 128) and shortness of breath not related to activity. I had anticipated body aches, chills etc and did have those as well. Over the course of 4 - 5 days those resolved but my tachycardia and shortness of breath have not. I waited another week to see if it would improve and when that did not occur I made an appointment to see Cardiologist because quite frankly, I was fearful of my symptoms. My lungs remain clear, I have no difficulty taking a deep breath and my SAO2 is high 90's. I had my annual physical 1/18/2021 and my lab work was normal as was my EKG. I have never had shortness of breath and my heart rate was normally in the 70 - 80's range at rest. Doctor ordered testing and the results are in My Chart. I had a Echo/Stress/Echo which was normal. My EF was 60% and in spite of my extreme shortness of breath on the treadmill, there was no ischemia induced. Bp was elevated initially and during the test but returned to 130's/70's in recovery phase. SAO2 was 97% to 100%. I did a home sleep study on 1/31/2021 with results pending. Doctor stated there was nothing on my testing that would account for my symptoms. At my initial visit (1/26/2021)he started me on low dose Cardezem 120mg to address my heart rate. My heart rate has improved with Cardezem (increased to 240 mg 2/2/2021) but my shortness of breath with minimal exertion has not. I believe Doctor plans to order a PFT next. Because of the timeframe for new onset symptoms and my Covid 19 vaccination, I wanted to reach out to you for guidance. ? Second Covid Vaccination 1/4/2021 ? Shortness of breath and tachycardia 1/5/2021 ? Scheduled appointment with Cardiologist for 1/21/2021 and it was cancelled and rescheduled for 1/26/2021 ? Dr. appointment 1/26/2021, started on Cardezem 120 mg qd ? 1/31/2021 Sleep Study completed, results pending ? 2/2/2021 Echo/Stress/Echo completed, Cardezem increased to 240 mg qd ? PFT order pending ? Follow up with Doctor scheduled for 2/18/2021
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| 66 | 2021-02-08 | fatigue, chills |
Had normal side effects of complete ftigue, body aches, chills for 2-3 days after vaccine. On day 5 ...
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Had normal side effects of complete ftigue, body aches, chills for 2-3 days after vaccine. On day 5 I totally lost my sense of smell and taste. I can find no where else to report this and do not see this listed as a vaccine side effect anywhere.
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| 66 | 2021-02-08 | fatigue, headache | Dizziness, nausea, headache, fatigue |
| 66 | 2021-02-08 | fatigue, influenza like illness | Flu-like symptoms, light-headedness, nauseous, exhausted. No outcome to date - symptoms continue. |
| 66 | 2021-02-08 | headache |
15 min after vaccine had headache and chest pain requiring EC visit. Evaluated in EC without specifi...
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15 min after vaccine had headache and chest pain requiring EC visit. Evaluated in EC without specific intervention and discharge with follow-up precautions with PCP
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| 66 | 2021-02-08 | lethargy |
I experienced a very sore arm, which was swollen and painful to touch. In addition, I felt some let...
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I experienced a very sore arm, which was swollen and painful to touch. In addition, I felt some lethargy. These symptoms lasted 36 hours.
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| 66 | 2021-02-08 | throat irritation | Scratchy throat Wheezing Shortness of breath |
| 66 | 2021-02-09 | chills, fatigue |
sever joint pain hands, arms,shoulders; extreme fatigue; nausea; muscle fatigue; chills for 6 hours;...
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sever joint pain hands, arms,shoulders; extreme fatigue; nausea; muscle fatigue; chills for 6 hours; swollen lymph nodes left side; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration at the left arm on 22Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included heart disorder (heart disease), hypertension, and obesity. The patient was not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. The patient received other medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sever joint pain hands, arms, shoulders, extreme fatigue, nausea, muscle fatigue, chills (for 6 hours as reported), swollen lymph nodes left side all on 23Jan2021 02:00 with outcome of recovering. The patient did not received any treatment for the events.
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| 66 | 2021-02-09 | headache, fatigue, chills |
chills; fatigue; headache; soreness in her arm; This is a spontaneous report from a contactable cons...
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chills; fatigue; headache; soreness in her arm; This is a spontaneous report from a contactable consumer reported for herself. A 66-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: PFREL1283), via an unspecified route of administration on left arm on 13Jan2021 15:00 at SINGLE DOSE for covid-19 immunisation. Medical history included diabetic, highwood pressure, kidney issues. The patient's concomitant medications were not reported. The patient previously took hydrocodone, morphine, oxycontin, metformin, trulicity, all experienced drug allergy. The patient experienced chills, fatigue, headache, soreness in her arm, all on 13Jan2021 16:00 with outcome of recovered on 14Jan2021 16:00. This last for about 24 hrs. No treatment received for these events.
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| 66 | 2021-02-09 | headache |
headache; heart-pounding, racing heart beat,; dizziness; feelings of passing out; This is a spontane...
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headache; heart-pounding, racing heart beat,; dizziness; feelings of passing out; This is a spontaneous report from a contactable consumer. A 66-year-old non-pregnant female received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9262), via an unspecified route of administration in the left arm on 23Jan2021 10:00, at 0.3ml, single for covid-19 immunization.The patient medical history was not reported. Patient is an Rh Neg A blood type and did not have Covid, as she's been isolated for a year. Concomitant medication included gabapentin, paroxetine hydrochloride and atorvastatin. On 23Ja2021, after half an hour (10:30) of receiving 1st dose of the vaccine, patient experienced heart pounding, racing heart beat, dizziness, feelings of passing out. These symptoms lasted up to 3 hours. Patient sat her my car outside of the an emergency parking lot for 3 hours because she couldn't drive home during these symptoms. Patient was on the verge of going into emergency care. For the remainder of the day, patient's sitting heart beat was at 90. The next day, 24Jan201, she felt better but have on and off slight headache. She did not plan on taking the 2nd dose. The outcome of the events was recovering. The patient has not tested positive for Covid-19 post vaccination.
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| 66 | 2021-02-09 | headache |
Pt was brought by wheelchair from Covid Vaccine clinic where rapid response was called; pt reports 2...
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Pt was brought by wheelchair from Covid Vaccine clinic where rapid response was called; pt reports 2nd dose pfizer vaccine given; after obtaining chart pt reports "feeling flushed, and then redness/rash on chest, and blood pressure go up". Pt given epi during rapid response; Pt reported a headache at this time. Pt denies dizziness, nausea, diarrhea, sob, no facial swelling, no lip swelling; no dysphagia; RR equal non-labored; Alert and orientated x4;
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| 66 | 2021-02-09 | headache |
Death. I actually not sure which Covid Vaccine she took. I just know the date and time she took it ...
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Death. I actually not sure which Covid Vaccine she took. I just know the date and time she took it at her local school where she worked. Died in her sleep after complaining of a headache. I talked to her around 5pm on sunday through a videochat and she seemed happy and well. But a local friend commented that she had complained of a headache late in the afternoon.
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| 66 | 2021-02-09 | fever, cough |
fever; persistent cough; This is a spontaneous report from a contactable consumer (patient herself)....
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fever; persistent cough; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 22Jan2021 15:00 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies and was not pregnant. She had not been diagnosed with COVID prior to vaccination. Concomitant medications included metformin 500 mg and hydrochlorothiazide 12.5 mg. The patient experienced fever a persistent cough and fever on 22Jan2021 19:00. No treatment was received for the events. The outcome of the events was recovering. The patient was not tested for COVID post vaccination. Information on the lot/batch number has been requested.
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| 66 | 2021-02-09 | sinusitis, sweating, headache |
Did the adverse event start after the first or second vaccination? both Date and time of vaccinatio...
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Did the adverse event start after the first or second vaccination? both Date and time of vaccination: (list both if they received both shots): 1-6-2021 @ approx 10:15am Pfizer LOT # EL3246 1-27-2021 @ approx 11AM Pfizer LOT # EL9262 Date and time adverse event started: 1-31-2021 at approx 8:30am, cold hands/feet, nausea, HA, pain to bilateral eye, mid lower back aches radiating to upper. today 2-5-2021 losing voice, all symptoms are reported to be intermittent Pfizer LOT # EL3246
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| 66 | 2021-02-10 | chills, fever, headache | Fever 103 Body aches Uncontrollable shaking and chills Headache Nausea |
| 66 | 2021-02-10 | fatigue, headache | Dizziness, headache and fatigue. |
| 66 | 2021-02-10 | fatigue, headache |
Ringing in head to the point of distraction and mild confusion , body aches, headache (worse than us...
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Ringing in head to the point of distraction and mild confusion , body aches, headache (worse than usual), dizziness and some queasiness. Fluctuates very bad for 6-12 hours, then slightly better for a few hours, then pattern repeats. Unusual fatigue occasionally but not too severe.
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| 66 | 2021-02-10 | fatigue |
3rd day I could barely move my limbs. Rash all over my upper torso. Tiny red dots in my skin Extr...
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3rd day I could barely move my limbs. Rash all over my upper torso. Tiny red dots in my skin Extremely tired. Hard time opening my eyes. Moving limbs. Slept 30 hrs.
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| 66 | 2021-02-10 | headache, chills, malaise |
3 hours after severe flu symptoms for 36 hours then severe headache, chills, nausea, malaise , for 8...
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3 hours after severe flu symptoms for 36 hours then severe headache, chills, nausea, malaise , for 8 days after
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| 66 | 2021-02-10 | headache |
This is a spontaneous report received from a contactable consumer (the patient). A 66-year-old femal...
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This is a spontaneous report received from a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 29Jan2021 11:45 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history included high cholesterol, and allergies to medications, food, or other products (unspecified). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jan2021 12:15, the first 8 hours, the patient experienced nausea, dizziness, and slight headache. The patient did not receive any treatment for the events. The clinical outcome of nausea, dizziness, and slight headache was recovered on 29Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 66 | 2021-02-10 | malaise, fatigue | malaise, body aches, fatigue, poor appetite; |
| 66 | 2021-02-10 | malaise, fatigue |
Injection site pain, Tiredness, Muscle pain in L arm, injection site swelling, Nausea, feeling unwel...
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Injection site pain, Tiredness, Muscle pain in L arm, injection site swelling, Nausea, feeling unwell, weakness, brain fog, lasted 40 hours.
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| 66 | 2021-02-10 | throat irritation |
Within fifteen-minutes of vaccination, the patient reported that her lips; tongue; and throat became...
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Within fifteen-minutes of vaccination, the patient reported that her lips; tongue; and throat became "tingly and itchy". She also reported feeling lightheaded. She denied difficulty breathing or pain. EMS assessed patient and found urticaria present on face. Lung sounds were clear with normal respirations. Patient was hypertensive (185/92). Patient remained hypertensive (177/96), but stated the tingling and itching sensations had subsided. They refused transportation to a hospital for evaluation.
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| 66 | 2021-02-11 | cough, chills, throat pain | chills, cough, swollen glands in neck, sore throat, just didn't feel right |
| 66 | 2021-02-11 | headache |
Very bad headache, aches and pains, very thirsty. Could not get out of bed. Stared early morning d...
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Very bad headache, aches and pains, very thirsty. Could not get out of bed. Stared early morning did not get out of bed til 5:30 pm to get something to eat
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| 66 | 2021-02-11 | throat irritation | Tongue and throat itching |
| 66 | 2021-02-14 | chills, headache |
I started with chills at 7 pm went to bed at 9pm at 3:30 I had to go to bathroom and almost fell off...
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I started with chills at 7 pm went to bed at 9pm at 3:30 I had to go to bathroom and almost fell off toilet. Caught myself but laid on floor and slept 30 min until I could get up and go back to bed. Chills were gone at this time. This morning at 10:30 I went to bathroom and blacked out. I was laying on floor but don?t remember what happened except I must have twisted my ankle and knee as they are very sore. I could not get up , no strength and hollered for Alexa to call my husband in the other part of the house. I rested in bed and finally came to couch and then around 3 ate a little but not hungry. I feel better, took a bath and resting but have a terrible headache.
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| 66 | 2021-02-14 | chills, fever |
Both times I felt like I had COVID all over again. My whole body hurt so bad. I missed work both tim...
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Both times I felt like I had COVID all over again. My whole body hurt so bad. I missed work both times. I had COVID in November. I experienced fever, chills, body aches.
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| 66 | 2021-02-14 | fatigue, headache |
Woke up shaking, headache, hurting all over. Lasted about an hour. Feeling tired still on day 6. ...
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Woke up shaking, headache, hurting all over. Lasted about an hour. Feeling tired still on day 6. Day 4 one cold sore started, Day 5, two more cold sores.
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| 66 | 2021-02-14 | headache, chills |
Very sore arm later the day of shot and worse the next day Sudden onset of horrible headache and chi...
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Very sore arm later the day of shot and worse the next day Sudden onset of horrible headache and chills 2/14/2021, 6 AM Still experiencing headache and some chills 2/15/2021
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| 66 | 2021-02-14 | headache | extreme headache |
| 66 | 2021-02-14 | sweating, headache, fever |
No reaction to first dose. However, 12 hours after receiving the second dose, I experienced the foll...
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No reaction to first dose. However, 12 hours after receiving the second dose, I experienced the following reactions, which lasted about 12 hours. Projectile vomiting and dry heaves Nausea Muscle aches, cramps, and spasms Chills Fever Sweats Headache in upper shoulders, neck, and back of head (intense)
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| 66 | 2021-02-15 | chills, sweating, fatigue |
After receiving the 2nd dose of the COVID vaccine on Sunday morning, Feb. 14, my left underarm bega...
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After receiving the 2nd dose of the COVID vaccine on Sunday morning, Feb. 14, my left underarm began to hurt in the evening. I was tired that day but no other symptoms. Through the night I had chills and sweats. In the morning there was a large lump in my left underarm. Swollen lymph glands about 3 inches wide and 2 inches deep. This has continued through Monday and now Tuesday morning it is the same. No sign of it growing larger or smaller.
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| 66 | 2021-02-15 | fatigue, chills, headache, malaise, fever, sleepiness |
Came over me quickly - short of breath at first due to surprise, anxious, achy, fever, chills, tire...
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Came over me quickly - short of breath at first due to surprise, anxious, achy, fever, chills, tired and sleepy. Nausea, weak, headache, feeling unwell. Took a valium to calm down. Felt better around 10 pm on 2/14 but lasted through 2/15. Woke up on 2/16 with my bed soaking wet.
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| 66 | 2021-02-15 | headache |
1 hour after vaccine left arm and hand swelled up. 2 hours after systematic swelling in body. Pants ...
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1 hour after vaccine left arm and hand swelled up. 2 hours after systematic swelling in body. Pants were tight, right hand also swelled and feet sweliing and discomfort. 4 hours after vaccine knee joints swelled and legs wanted to give out upon standing from sitting position. Also, moderate headache. Blood Pressure was normal.
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| 66 | 2021-02-15 | sweating |
pain, swelling and redness of arm; redness and numbness of face, redness and burning sensation of fa...
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pain, swelling and redness of arm; redness and numbness of face, redness and burning sensation of face persists.
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| 66 | 2021-02-15 | lethargy |
patient received covid vaccine. screening questions answered. administered vaccine at 1321pm. pat...
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patient received covid vaccine. screening questions answered. administered vaccine at 1321pm. patient wheeled to vaccine waiting room. patient became lethargic and blacked out. patient not alert and awake for approximately 1 minute. patient came to, pulse 80, blood pressure 93/70, oxygen saturation 98%, husband at side, emergency cart and AED and oxygen brought to location of the patient. oxygen 2L nasal canula placed on patient. EMS called and Dr. came to site. assessment obtained with Dr. at site. patient awake, was able to speak full name but stated she was not aware of where she was. this reaction happened approximately 6 minutes post immunization. within approximately 3 minutes of episode where she states she felt she was going to "black out" she began to shake/ full body involvement. during this episode patient was following nurse commands. momements were rhythmic and lasted approximately 10 seconds then stopped. Patient brought back to exam room. at 138pm- temp 97.5, blood pressure 144/31, pulse 51, respiration 18. patient stated she felt warm and reports she felt she was going to black out. this episode lasted approximately 3 seconds and patient became alert at that time. vitals at 140 pm- blood pressure 124/60, pulse 75, respirations 16. vitals at 144pm- blood pressure 119/75, pulse 75, respirations 16. patient has dialysis 4 times a week for CKD stage 5. patient has lengthy medical history. patient reports her primary care doctor is Dr. who sees her frequently. patient reports she has an issue with internal bleeding with source unknown and at times has to have blood transfusions. no recent illnesses reported. patient states she ate breakfast around 10am today. patient states she has never had a vaccine reaction int he past or reaction to needles. EMS arrived on site approximately 1345. report given to EMS. patient alert with EMT. patient transferred from her personal wheelchair to EMS cot. patients husband left with patient to go to Medical Center. Patient tolerated vaccine well immediately after immunization. She reported no pain at injection site. Paper tape and 2x2 gauze placed at injection site due to allergy to tape. Allergy list was reviewed prior to administration of vaccine. Patient alert and oriented prior to vaccine to person place and time. Husband present in room. Verbal consent obtained by patient to receive covid vaccine today . Vaccine information handout and emergency use handout given to patient. Patient wheeled out of exam in wheelchair.
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| 66 | 2021-02-15 | sleepiness, fever, malaise, sweating, headache, head discomfort, fatigue |
Instantly after receiving the shot I felt pain my arm. On Thursday my arm was real sore and I starte...
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Instantly after receiving the shot I felt pain my arm. On Thursday my arm was real sore and I started feeling bad. I felt tired, real weak, sleeping, wanting to sleep, fever, headache, pressure on my head, sweating, calmly feeling, cold sweats. As of today I started to feel a little better but I still have a grade fever. I have been taking Tylenol for it.
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| 66 | 2021-02-16 | headache |
Within 15-minutes, the patient reported a "pulsating sharp pain" behind their right eye. EMS evaluat...
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Within 15-minutes, the patient reported a "pulsating sharp pain" behind their right eye. EMS evaluated the patient on-site and they were found to be hypertensive (173/88). The patient proceeded to a emergency department. In the ED, the patient remained hypertensive with a mild generalized headache. They reported that their eye pain is constant but comes in waves of higher intensity. Differential diagnosis was possible stroke due to right-sided hemianopsia and right-sided ptosis. Patient was admitted and evaluated. Aspirin was administered and blood pressure was monitored prior to discharge.
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| 66 | 2021-02-16 | runny nose, nasopharyngitis, productive cough |
Day of vaccine symptoms previously recorded cleared up next day. Today, 48 hours after vaccine I now...
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Day of vaccine symptoms previously recorded cleared up next day. Today, 48 hours after vaccine I now have cold symptoms. Watery eyes/nose and spitting up phlegm.
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| 66 | 2021-02-17 | dehydration | Enlarged or inflamed heart, lungs full of fluid, myocarditis, vomiting, dehydration |
| 66 | 2021-02-17 | fever, fatigue, headache, sweating |
Severe Headache; eye pain; earache on side of shot; itching both arms; severe jaw pain; severe chest...
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Severe Headache; eye pain; earache on side of shot; itching both arms; severe jaw pain; severe chest pain; body ache; high fever; fatigue; profuse sweating; belabored breathing; hot; butterfly rash of face; This is a spontaneous report from a contactable physician (patient). A 66-year-old female (Not pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at right arm on 11Feb2021 14:30 at single dose for covid-19 immunization. Medical history included hypothyroidism, hypertension, hypercholesterolemia, breast cancer, osteoporosis, ligamentous RA, degenerative joint disease (DJD). The patient had known allergies to cilantro, cephalosporins, all morphine and morphine derivatives, Herceptin, astralogous mushrooms, gadolinium dye, fentanyl. The patient's concomitant medications reported as other medications in two weeks was yes.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, eye pain, earache on side of shot, itching both arms, severe jaw pain, severe chest pain, body ache and high fever &fatigue - profuse sweating, belabored breathing hot butterfly rash of face on 12Feb2021 at time of 06:00 AM. AEs resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient received Prednisone 80 mg and Benadryl 50 mg as treatment. Prior to vaccination, the patient was diagnosed with COVID-19. Covid was tested post vaccination. The patient underwent lab tests and procedures which included Nasal Swab and PCR test: negative on 09Feb2021. The outcome of events was recovering. Information on Lot/Batch has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 66 | 2021-02-18 | fatigue, chills |
2/13/21 -- c/o fatigue; slept most of the day, cold; warmed with blankets 2/14/21 -- chilled, can't ...
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2/13/21 -- c/o fatigue; slept most of the day, cold; warmed with blankets 2/14/21 -- chilled, can't warm with blankets; no thermometer available 2/15/21 -- somewhat tired, better 2/16/21 -- visited ED for lymphedema treatment (chronic idiopathic condition) of ankles and mid-calf; treated with prednisone
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| 66 | 2021-02-18 | fatigue |
Dizziness and Hot flash surges within the 15 minute time immediately after and occasionally thereaft...
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Dizziness and Hot flash surges within the 15 minute time immediately after and occasionally thereafter for about an hour. Heavy fatigue all afternoon into the evening Extreme muscle fatigue 2 and 3 days afterwards in my legs making it feel like a statin reaction hard to walk with a normal stride.
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| 66 | 2021-02-18 | headache | Flushing, dizziness, nausea, headache, weird taste in the mouth. muscle ache. |
| 66 | 2021-02-18 | headache |
Within 10 minutes of receiving vaccine, caregiver developed tachycardia, lightheadedness, chest tigh...
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Within 10 minutes of receiving vaccine, caregiver developed tachycardia, lightheadedness, chest tightness, and a headache, was taken to the ER and monitored and released.
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| 66 | 2021-02-18 | throat pain, fever |
2/11/21:sore arm 2/12/21: swollen lymph glands in neck, slight sore throat, in evening fever 100.6 F...
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2/11/21:sore arm 2/12/21: swollen lymph glands in neck, slight sore throat, in evening fever 100.6 F maximum 2/13/21: swollen lymph glands in neck, slight sore throat, afebrile, generalized rash over trunk and anticubital area 2/14/21: swollen lymph glands in neck, slight sore throat, afebrile, rash mostly faded 2/15/21 to 2/18/21 swollen glands in neck, slight sore throat, afebrile, no rash 2/19/21 (today): swollen lymph glands in neck, slight sore throat (improving), afebrile, no rash
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| 66 | 2021-02-18 | fever, fatigue, chills |
First 24 hours: Chills, fever, vomiting, unable to keep anything down (even water) for the entire d...
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First 24 hours: Chills, fever, vomiting, unable to keep anything down (even water) for the entire day after the vaccine was given, body aches Second 24 hours: Chills, nausea, fever, body aches Third 24 hours: fatigue, some nausea, occasional chills, body aches Fourth 24 hours: fatigue Finally ALL better!
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| 66 | 2021-02-18 | sleepiness |
dizziness; fall; Swelling in arm; pain in arm; felt sleepy; weakness in the right eye; balance issue...
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dizziness; fall; Swelling in arm; pain in arm; felt sleepy; weakness in the right eye; balance issues (falling into her right side); This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263; Expiration Date: May2021), via an unspecified route of administration in the right arm on 02Feb2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included cancer survivor, type 2 diabetes mellitus, and surgery of the left hand in 2020. Concomitant medications included the second dose of varicella zoster vaccine (shingles vaccine) (MANUFACTURER UNKNOWN) on 12Jan2021 for immunization. The patient previously received the first dose of the varicella zoster vaccine (shingles vaccine) (MANUFACTURER UNKNOWN) on an unknown date for immunization. On 02Feb2021, the patient experienced swelling and pain in arm and felt sleepy. On 03Feb2021, the patient fell on the table due to dizziness. The patient had to use her cane more to get around. On an unknown date in Feb2021, the patient had weakness in the right eye and balance issues (falling into her right side). The clinical outcomes of the dizziness, swelling in the arm, and weakness in the right eye were recovering; while that of the pain in the arm was not recovered. The clinical outcomes of the sleepiness, fall, and balance issues (falling into her right side), were unknown.
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| 66 | 2021-02-19 | chills |
Nausea, vomiting, chills, diarrhea, myalgias. Insomnia during the 3 hours that nausea , vomiting and...
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Nausea, vomiting, chills, diarrhea, myalgias. Insomnia during the 3 hours that nausea , vomiting and diarrhea were occurring. Those symptoms now resolved but myalgias persist.
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| 66 | 2021-02-19 | fever, headache |
Headache - lasted 24 hours Fever (100) - lasted 24 hours Swollen lymph node (under left arm) - laste...
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Headache - lasted 24 hours Fever (100) - lasted 24 hours Swollen lymph node (under left arm) - lasted 12 hours Vomiting - lasted 2 hours
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| 66 | 2021-02-19 | throat irritation |
PATIENT RECEIVED VACCINATION. APPROXMATELY 10 MINS LATER THROAT FELT "STRANGE". BECAME HOT AND HAD M...
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PATIENT RECEIVED VACCINATION. APPROXMATELY 10 MINS LATER THROAT FELT "STRANGE". BECAME HOT AND HAD MINOR CHEST TIGHTNESS. VITAL SIGNS REMAINED STABLE. OBSERVED FOR ADDITIONAL 30 MINS. LEFT ON OWN ACCORD WITH RESOLVED SYMPTOMS.
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| 66 | 2021-02-21 | body temperature increased, chills, sweating |
Resident received the 2nd dose of the Covid vaccine approximately around 1105 by pharmacy through th...
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Resident received the 2nd dose of the Covid vaccine approximately around 1105 by pharmacy through the pharmacy LTC partnership vaccination program. Resident had no adverse effects until around 8:00 pm she began complaining of body aches, and chills, Tylenol was given at this time. Around 9:30pm resident was sleeping in bed. Around 12:00 am the CNA called nurse into room to assess resident as the resident stated she did not feel good. Temperature at that time was 102.2, and vomiting. RN came to assess @ 1220 am She was noted to be vomiting, diaphoretic, pale and having trouble breathing. Temp was 97.3 after vomting, Pulse 53, Resp 20, o2 sats were 40-45%, unable to obtain Blood pressure, Applied 5 L of oxygen at this time and had LPN call 911 immediately. Resident was repsonsive and able to follow staff members instructions but was only answering yes or no simple questions at the time time of assessment. Paramedics arrived at 0040 and resident was sent to Hospital. @ 0130 ER nurse called to nursing facility to notify resident had coded in the ER and passed away @ 0110.
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| 66 | 2021-02-21 | headache, chills, fever, fatigue, malaise |
Body aches, fever 99.8, chills, chattering teeth, general feeling unwell. Pounding headache, fatigue...
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Body aches, fever 99.8, chills, chattering teeth, general feeling unwell. Pounding headache, fatigue, really sore arm. Night sweats. Lasted about 48 hours. I'm still waking up with a pounding headache every morning. Still lingering sense of unwellness.
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| 66 | 2021-02-22 | chills, headache |
Headache in about 20 minutes after Vaccination. Next day had headache and diarrhea and by 3rd day ha...
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Headache in about 20 minutes after Vaccination. Next day had headache and diarrhea and by 3rd day has vomiting, chill and weakness which lasted 6 days
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| 66 | 2021-02-22 | chills | Chills, feeling cold |
| 66 | 2021-02-22 | dehydration |
client says she was in distress prior to taking the vaccine because she had stood for over an hour i...
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client says she was in distress prior to taking the vaccine because she had stood for over an hour in line waiting to be seen and she had a double mask on. She says by then she was dehydrated and feeling faint. She has a history of atrial fib off and on, which she takes medication for. She says she feels like she almost had a stroke and Nurse Pract told her she had a full blown panic attack. She was allowed to sit down and rest and rehydrate and eat and she felt better.
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| 66 | 2021-02-22 | fatigue, chills |
Two days after vaccine: extreme fatigue and chills. Symptoms lasted just that one day. Four-five...
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Two days after vaccine: extreme fatigue and chills. Symptoms lasted just that one day. Four-five days after vaccine, full-body itching. Just thought it was my eczema flaring up (it's worse in the winter). After about 2 weeks, developed red areas on my body (torso, arms, legs and feet) - self-monitored - but got progressively worse. Dermatologist believes it is eczema aggravated by the vaccine. Provided a cortisone injection (right arm). Will monitor for two weeks to determine improvement or lack of improvement.
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| 66 | 2021-02-22 | fatigue, headache |
Injection site pain, tiredness, headache, muscle pain up and down Rt side of body from neck to feet...
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Injection site pain, tiredness, headache, muscle pain up and down Rt side of body from neck to feet, itchy rash all over torso, heart palpitations and pain.
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| 66 | 2021-02-22 | influenza like illness, body temperature increased, head discomfort, fatigue, sweating |
About 8 hrs after shot my mind started feeling foggy and heavy head, i got nauseous and achy joints ...
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About 8 hrs after shot my mind started feeling foggy and heavy head, i got nauseous and achy joints and having breathing problems. i was just sic. or like i had the flu or covid again. went on through the night. was up all night. my arm was just killing me. The next morning i was full on sick. the nausea was intense my temp throughout day was 99.6 and 99.9 . out of breath. That night i went to bed and woke up at midnight and was drenched my hair was soaked Got up at showered. at the 3:30 woke up again totally drenched. yesterday i woke up and 6:00 am i was feeling better but still trouble breathing but everything else was gone. I was tired still. About 10:30 yesterday Everything was fine. I do still have a little trouble breathing but not as bad.
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| 66 | 2021-02-22 | influenza like illness, sleepiness | flu like symptoms, no fever/ chills, sleepy, couldn't stay awake, |
| 66 | 2021-02-22 | lethargy |
This was the second dose in the vaccine series. The patient reported doing well for the first dose. ...
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This was the second dose in the vaccine series. The patient reported doing well for the first dose. A few minutes after receiving her second dose, the patient started to complain of lightheadedness, lethargy, arm weakness. She reported she did have an anaphylactic reaction to the H1N1 vaccine . Patient reported about 10 minutes after she received the vaccine she was starting to feel better- less lightheaded and was gaining arm strength. She was moved to a chair and she could not support her weight. EMS was called to the scene and she was transported to the ER.
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| 66 | 2021-02-22 | fever, nasopharyngitis, headache, chills |
Headache, felt like I was starting a bad cold , chills, low grade fever and every joint ached for 36...
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Headache, felt like I was starting a bad cold , chills, low grade fever and every joint ached for 36 hours. Then it just went away.
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| 66 | 2021-02-22 | throat irritation |
2/17/21-Anaphylaxis-15:17pm (within 30 min waiting period post vaccine), throat scratchy, moved to a...
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2/17/21-Anaphylaxis-15:17pm (within 30 min waiting period post vaccine), throat scratchy, moved to assessment area, HR 100, labored resp, O2 6L NRmask initiated. (ct reports similar reaction as previous anaphylaxis). 15:22pm-911 called, HR 120, Epi 0.5ml admin. 15:37pm transfer via ambulance to hospital. 02/18/2021 evening, f/u call to client by PHN, throat still feels 'weird', ct reports had 2nd Epi in ambulance, 3rd Epi in ER, plus Benedryl gel, Ct then recalled had anaphylaxis reaction in past to bee sting had ER visit, tx w/ steroids at that time. PHN recommended ct talk with PCP re epi pen order.
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| 66 | 2021-02-23 | chills, fever |
The second dose caused the reaction, the first being exactly 3 wks earlier. No major problem to tha...
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The second dose caused the reaction, the first being exactly 3 wks earlier. No major problem to that dose. (Had arm pain and mild chills and fatigue). The day after dose two above noted fullness and discomfort in feet, On the second day after, had early erythematous (non-puritic) rash, mild multi-joint discomfort, 100 deg fever, and shaking chills. Doctor on call said to use judgment on starting Prednisone, since hope that this would stabilize. However, progressed and at 9am on the third day after vaccine started prednisone 40mg. At the worst, had to be dressed by husband due to pain and stiffness in upper extremities, widespread erythematous rash, fullness of skin, joint swelling.
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| 66 | 2021-02-23 | headache | Massive headache |
| 66 | 2021-02-23 | headache |
Tongue feels thick 8:05 slight headache 0819 headache better. Lungs clear b/p 122/78 pulse 68 respi...
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Tongue feels thick 8:05 slight headache 0819 headache better. Lungs clear b/p 122/78 pulse 68 respirations 18. Patient cheerful and talkative, color pink. 0821 Swelling in tongue better. Denies shortness of breath. 0824 left arm feels tight. 0831 patient denies further care. States she going to have a work up for MS. Her sister has MS. Patient refuses further medical care here and states she is feeling ok. Tongue is feeling less thick and arm is less heavy. Patient states she would like to leave with her husband to go home. Patient is talkative and cheerful at this time. Speech is clear(husband states she had anxiety about getting the vaccine) Advised to call MD or 911 if needed.
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| 66 | 2021-02-23 | fever, body temperature increased, chills, cough, headache |
Was diagnosed WITH Covid first symptom on 2/18/2021. Day 1: felt slight fever; Day 2: Extreme headac...
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Was diagnosed WITH Covid first symptom on 2/18/2021. Day 1: felt slight fever; Day 2: Extreme headache (which I never get) low grade fever; Day 3:Hives and itche sin addition to dry cough; Day 4 - Hives deep red, full torso and back, top of legs and pubic areas. Deep and extreme.Chills Steady, Night Hard vomiting, Hives, Soaking Night sweats (never had before), Temp 101.5. Day 5 Morning - rapid test negative, fever 99.9. Started Ibuprofen Day 6 - Hives same - extremely dark and red. itchy. # day swab test was POSITIVE. Put on Prednisone. Day 7 - Fever normal, Hives going down but still ugly. Not sure whether this was really an adverse event as it was a positive test result AFTER the vaccine. I am an allergig person whose eosinophils report for duty quickly and obviously too much! I will assume that they were the result of the virus and NOT the drug as the drug does not have an active virus included. Your call.
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| 66 | 2021-02-23 | fever, fatigue |
fever, aching, spasmodic stabbing pains, teeth hurt, localized tooth pain, underwent emergency root ...
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fever, aching, spasmodic stabbing pains, teeth hurt, localized tooth pain, underwent emergency root canal on day 4 with "dying nerve", butterfly (lupus like) rash on face day 4, "covid arm" day 4 with tennis ball size red knot around injection site that extended down arm over next several days, winded for several days, fatigue and shortness of breath.
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| 66 | 2021-02-23 | fever |
I have a fever of 100.3, is that normal; This is a spontaneous report from a contactable consumer, t...
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I have a fever of 100.3, is that normal; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 26Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient stated, "I have a fever of 100.3 F, is that normal in Jan2021." The outcome of the event fever was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 66 | 2021-02-24 | chills, headache | Dizziness, vomiting, diarrhea, headache, chills. |
| 66 | 2021-02-24 | fatigue, headache, chills |
Sore arm, chills, headache, muscle ache - Two doses of 500mg Tylenol 12 hours apart relieved the sym...
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Sore arm, chills, headache, muscle ache - Two doses of 500mg Tylenol 12 hours apart relieved the symptoms. Fatigue (not able to complete the routine daily walk of 3 miles) the day after vaccination for one day.
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| 66 | 2021-02-24 | fatigue |
morning fatigue - bedrest, recovered by mid-afternoon neck rash, watery eyes - began a week after f...
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morning fatigue - bedrest, recovered by mid-afternoon neck rash, watery eyes - began a week after first shot. took loratadine this morning, now neck not itchy, eyes not watery. also had covid arm a week after first shot - went away in 3 days.
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| 66 | 2021-02-24 | headache |
Throat swelling, racing heart, head throbbing, chest tightness, slight dizziness, and face flushing....
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Throat swelling, racing heart, head throbbing, chest tightness, slight dizziness, and face flushing. These symptoms came in waves and is a normal reaction I get with medication I am sensitive to. However because I not having a normal reaction, I was told to go to an emergency room for a EKG. I knew this wasn?t a heart event, but a reaction to the vaccine. It is a normal reaction for me. I?ve dealt with it most of my life.
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| 66 | 2021-02-24 | nasal congestion, sinus congestion |
Patient received her second dose of Pfizer vaccine today at 1230 today. Approximately 15 minutes la...
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Patient received her second dose of Pfizer vaccine today at 1230 today. Approximately 15 minutes later at 1246 she started to feel a flushed face, nasal and sinus congestion and stated that her throat felt as if it was swelling. Benadryl 50 mg orally was administered. VS were checked BP 128/80, HR 82. Pt stated she was feeling improved at 1315 and stated her throat felt much better, denies feeling swelling in her throat. No evidence of mouth, tongue or lip swelling, no evidence of angioedema. No evidence of respiratory distress, no wheezing, speaking in full sentences. No rash. Reassessment @ 1345: One hour after patient received benadryl she stated she felt much improved aside from mild body itching. Requesting to leave with husband. Advised to continue benadryl 50 mg every 6 hours as needed for symptomatic and follow up with her primary care doctor and allergist.
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| 66 | 2021-02-25 | head discomfort | pressure in temple of head, left eye issues, upper back pain left side,heavy body weight |
| 66 | 2021-02-25 | fever, headache, chills, sweating |
headache; sweats; feverish; chills; low blood sugar symptoms; weakness; This is a spontaneous report...
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headache; sweats; feverish; chills; low blood sugar symptoms; weakness; This is a spontaneous report from a contactable healthcare professional. This 66-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot EL3247) on 24Jan2021 at 11:15 AM at left arm for COVID-19 immunization in hospital. Historical vaccine included first dose for BNT162B2 (lot EK5730) on 02Jan2021 at 11:30 AM at left arm for COVID-19 immunization. Medical history included hypo thyroid, parox afib, high blood pressure (HBP), obesity and allergies: bupropion hydrochloride (WELLBUTRIN), soy. Concomitant drugs included metoprolol, apixaban (ELIQUIS), fluoxetine hydrochloride (PROZAC), losartan potassium (COZAAR), thyroid (ARMOUR THYROID) and more. On the day of injection on 24Jan2021 at 04:00 PM, the patient had low blood sugar symptoms, weakness, which resolved in a few hours. On second day, symptoms of low Blood sugar, sweats, feverish, chills, on third day feverish symptoms of low blood sugar, sweats, feverish, headache. No treatment was received. The outcome the events was unknown.
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| 66 | 2021-02-26 | chills, fatigue, headache | Nausea Achy Chills Headache Sore arm at site Fatigue |
| 66 | 2021-02-26 | chills, fever |
Woke up at midnight with fever, chills, thirst. Tossed and turned all night, cold and thirsty. Drank...
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Woke up at midnight with fever, chills, thirst. Tossed and turned all night, cold and thirsty. Drank about 20 oz of Crystal Light Peach Tea over night. Got up at 5am to get more to drink and find another place to rest. went into my kitchen to fill container and passed out. Woke a few seconds later. Left side of my forehead was bruised and swollen above left eye. Over the last 4 days both eyes an cheeks are bruised. All day felt like I had the flu without the fever. I did not go to the hospital.
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| 66 | 2021-02-26 | headache, fatigue | Headache for 5 days. Extremely sore arm for 5 days. Unusual Fatigue 3 days. |
| 66 | 2021-02-26 | headache | Headaches |
| 66 | 2021-02-26 | headache | Headache Diarrhea |
| 66 | 2021-02-27 | chills, fever | Chills, progressed to fever of 100 F, muscle aches, swelling and discomfort in left armpit |
| 66 | 2021-02-27 | chills |
Insomnia, sleeplessness and brain fog starting one week after vaccine and lasting for one week. Sle...
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Insomnia, sleeplessness and brain fog starting one week after vaccine and lasting for one week. Sleeplessness was worse each night, with inablilty to sleep even with 50 mg of Benadryl and Valium. Did sleep about two hours a night with those meds but continued to be wide awake all day also. My body felt like it hadn't slept but was unable to do so. These symptoms left me suddenly with a severe chill and the brain fog litarally lifted and was gone. The next week following developed mild red itchy skin that comes and goes on hands and torso and that symptom persists. I am now able to sleep.
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| 66 | 2021-02-27 | fatigue |
Spike in blood pressure occurred 3-4 hours after injection (controlled by additional medication) and...
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Spike in blood pressure occurred 3-4 hours after injection (controlled by additional medication) and again the day after. Injection site became red and itchy within an hour of injection; redness has spread down the arm and continues to itch on day 3. This did not occur with first jab. Loss of appetite, fatigue, and brain fog, the day of and next day.
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| 66 | 2021-02-27 | headache, fatigue | Headache Fatigue-minor Sore arm |
| 66 | 2021-02-28 | cough |
Patient presented for COVID vaccine Pfizer dose 1 today. After injection and walked to waiting room....
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Patient presented for COVID vaccine Pfizer dose 1 today. After injection and walked to waiting room. While she was sitting down patient started to complain of itchiness at injection site and felt like needed to scratch arm about 3 times, lasted only a minute. Started to feel lightheaded about 5 minutes after sitting down in waitng arae and notified observer. Felt weak and lighthed. Offered a wheelchair but refused and able to walk back to examination room. Taking Topamax this am for headaches, no other medications. Has COPD. Caring for adult daughter who is disabled and her husband left for a trip last Wednesday and back tonight. Patient often has interrupted sleep and up every couple hours with daughter. She has another daughter who will come and help at times but no one else around due to COVID concerns. Ate granola, blueberries, yogurt for breakfast this am Offered water in exam room, crackers and apple juice but patient refused. States has IBS and not want to eat other things In exam room feeling anxious, but the lightedness disappeared within 10 minutes. B/P decreased to 128/72. No nausea, abdominal pain, SOB. Denies any new illness. Has chronic cough with COPD Patient alert and oriented during entire visit and pleasant in conversation.
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| 66 | 2021-02-28 | cough |
Pt given Pfizer COVID-19 Vaccine (first dose) around 1100. Waited 30 minutes post-vaccination observ...
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Pt given Pfizer COVID-19 Vaccine (first dose) around 1100. Waited 30 minutes post-vaccination observation period and left vaccine clinic. Pt reports she noted SOB going up the stairs to leave the building. Reports she waited upstairs for a while and symptoms did not resolve.. Pt reported back to healthcare facility to report symptoms at 11:45. Brought to observation area, vital signs checked (125/76, HR 60, O2- 99%). Reports SOB/tightness in chest continues at rest- Emergency Response Team is called. 1152- develops thickness in throat and coughing that becomes progressively worsening. Emergency Response Team arrives, Provider advises Epi-Pen. Administered Epinephrine Auto-Injector at 1155. Pt is transported to ER by Emergency Response Team.
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| 66 | 2021-02-28 | fatigue, headache, cough |
Started with extreme exhaustion 1 hour after vaccination, very loose stools X3 days, extreme joint p...
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Started with extreme exhaustion 1 hour after vaccination, very loose stools X3 days, extreme joint pain 1 1/2weeks- pain continues until present, headache for 12hours with headache off & on continues, cough x 5 days
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| 66 | 2021-02-28 | fatigue |
Slight dizziness; body ache; Tiredness; This is a spontaneous report from a contactable nurse (patie...
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Slight dizziness; body ache; Tiredness; This is a spontaneous report from a contactable nurse (patient). A 66-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: unknown), intramuscularly on the left arm on 27Jan2021 at 10:00 at a single dose for COVID-19 immunization. Medical history included diabetes borderline. The patient has no allergies to medications, food, or other products. Concomitant medications included metformin (METFORMIN), and lorazepam (LORAZEPAM). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced slight dizziness, body ache and tiredness on 27Jan2021. No treatment was administered for the events. Since the vaccination, the patient has not been tested for COVID-19. No treatment was administered for the events. The events resolved on an unknown date. Information on the lot/batch number has been requested.
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| 66 | 2021-02-28 | head discomfort |
Face flushing, " rolling hot flashes", head fullness. This lasted about 10 to 15 minutes, intermitte...
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Face flushing, " rolling hot flashes", head fullness. This lasted about 10 to 15 minutes, intermittently then dissipated.
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| 66 | 2021-02-28 | headache, nasal congestion, fatigue |
2/25/2021 9:30am minor pain at injection site upper left arm 2/26/2021 1:30pm dull headache, backsid...
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2/25/2021 9:30am minor pain at injection site upper left arm 2/26/2021 1:30pm dull headache, backside of head and very tired 2/26/2021 5:30pm minor tongue swelling, minor throat and nasal passage constriction 2/27/2021 9:30am increased tongue swelling, increased throat and nasal passage constriction, minor difficulty swallowing, minor facial swelling 2/27/2021 6:30pm treatment at ER/Urgent Care with oral Prednisone tongue swelling started to decrease, released with Rx for Benadryl, Pepcid, Prednisone and EpiPen 2/27/2021 8:00pm started Benadryl + Pepcid. Tongue swelling decreased more, throat and nasal constriction starts to alleviate 3/1/2021 9:00am facial swelling continues with added redness to left side face and spot under right eye socket 3/1/2021 11:20am family doctor visit
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| 66 | 2021-02-28 | headache, fever, chills |
Fever, chills, nausea, vomiting, migraine aura, headache - onset 20 hours after dose. Took Tylenol a...
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Fever, chills, nausea, vomiting, migraine aura, headache - onset 20 hours after dose. Took Tylenol and fever reduced from 99.9 to 98.6. Head ache persisted for 12 hours following onset. Remainder of side effects resolved within 6 hours of onset.
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| 66 | 2021-02-28 | headache, fever, chills |
Headache in the back of my neck radiating up into the back of my head; Headache in the back of my ne...
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Headache in the back of my neck radiating up into the back of my head; Headache in the back of my neck radiating up into the back of my head; Projectile vomiting; Dry heaves; Fever; Chills; Muscle spasms; Swollen glands; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported) on 26Jan2021 (10:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included allergy-induced asthma; Celiac disease; bradycardia; was a pacemaker user (for bradycardia); sulpha allergy; and latex allergy. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), alprazolam, lisinopril, montelukast, and other unspecified medications. The patient previously took cephalexine, and had allergy. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on the left arm on 07Jan2021 (when the patient was 66 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 26Jan2021 (23:00), the patient had headache in the back of the neck, radiating up into the back of the head; projectile vomiting; dry heaves; fever; chills; muscle spasms; and swollen glands. The patient did not receive any treatment for the reported events. The outcome of the events, 'headache in the back of the neck, radiating up into the back of the head', 'projectile vomiting', 'dry heaves', 'fever', 'chills', 'muscle spasms' and 'swollen glands', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
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| 66 | 2021-02-28 | sweating |
Client c/o general flush feeling dryness of mouth and sweating. Client verbalized that symptoms occ...
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Client c/o general flush feeling dryness of mouth and sweating. Client verbalized that symptoms occurred immediately after receiving vaccine. Client seen and assessed by EMS an Vital signs are B/P 147/82, HR 80, O2 100%. Pt. voice that her anxiety level increased when receiving vaccine but now has decreased and symptoms decreased during observation. Second round of vitals B/P 139/82, HR 76, O2 99%. Client then verbalized that she is no longer having the sensation and asked to go home after 45 minutes of observation. Client denied the need to go to or be taken to the hospital and was cleared to go home by EMS. No physical reaction noted.
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| 66 | 2021-02-28 | nasopharyngitis |
Before I left the hospital parking lot I could taste the drug in my moth. By the time I got home ...
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Before I left the hospital parking lot I could taste the drug in my moth. By the time I got home I had the dry heaves. I was also alternating hot and cold. This went from about 7 pm to 8 AM the next day. That day I had a head ache which I normally do not have.
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| 66 | 2021-02-28 | fever, chills, headache |
tenderness under both armpits; Headache; Nausea; Diarrhea; felt like she had a fever that would come...
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tenderness under both armpits; Headache; Nausea; Diarrhea; felt like she had a fever that would come and go; felt like she had Covid again; She got hot; chills; really sick last night; This is a spontaneous report from a contactable consumer, the patient. A 66-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9261), via an unspecified route of administration in the left arm on 27Jan2021 at 11:10 (at the age of 66-years-old) as a single dose for covid-19 immunisation . Medical history included diabetes mellitus from 1995 and ongoing , ongoing hypertension , covid-19 from an unknown date and unknown if ongoing (Had Covid at Christmas). The facility in which the vaccine was received was a Workplace Clinic There were no concomitant medications. No other vaccines were given within 4 weeks. On 27Jan2021 The patient reported she was sick last night, tenderness under her arm pits, headache, nausea, diarrhea and she felt like she had a fever that would come and go. She got hot and then had chills. She felt like she had Covid again. Treatment included Zofran and it helped with the nausea. There was No physician office visit and No emergency room visit as a result of the events The clinical outcome of the events Nausea, diarrhea, was recovered on 27Jan2021, tenderness under both armpits recovered on 28Jan2021, Headache non recovered, Fever was recovering, while felt like she had Covid again, Feeling hot Chills and Sick unknown.
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| 66 | 2021-02-28 | fever |
Running a fever of 100.3; This is a spontaneous report from a contactable consumer (patient). A 66-y...
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Running a fever of 100.3; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) in Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient was running a fever of 100.3 (unit was not reported). The outcome of the event, 'fever', was unknown. The patient would want to know if the fever was normal, and if she could take ibuprofen. Information regarding lot/batch number has been requested.
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| 66 | 2021-03-01 | headache, fever, chills | Headache, fever, chills, body aches, shortness of breath, severe night sweats |
| 66 | 2021-03-01 | headache, throat irritation |
Within 3-5 Minutes, I got severe shooting pains in my left temple that went across my forehead with ...
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Within 3-5 Minutes, I got severe shooting pains in my left temple that went across my forehead with headache, Felt extremely hot and Red rash appeared on my face on both cheeks and when I got up to leave I had weakness in my legs and was dizzy. Was given benedryl by the pharmacist who stated it look liked I had a reaction. Still had pain in left temple, headache, rash and dizzyness the next day along with scratchy throat. Headache and pain in temple mild after 3 days. I am concerned about second dose only because of shooting pains in my left temple.
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| 66 | 2021-03-01 | headache |
My arm was very sore the evening of vaccine and the next day. Later the day after I had a headache ...
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My arm was very sore the evening of vaccine and the next day. Later the day after I had a headache and felt nauseous. I keep getting headaches on and off. Sometimes dizzy. The nausea is almost all the time. It has not improved. It has been one week.
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| 66 | 2021-03-01 | lethargy, sluggishness |
Patient received 2nd Covid 19 Pfizer vaccine shot on 22 February 2021. The patient had a past histo...
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Patient received 2nd Covid 19 Pfizer vaccine shot on 22 February 2021. The patient had a past history of having a reaction to the H1N1 vaccine. patient reports she did well with her first COVID vaccine-reports no issues. A few minutes after the vaccine was injected, it was reported from the nurse the patient was lethargic, sluggish, and the patient complained of arm weakness and lightheadedness. Fire department arrived to the scene first and vital signs were taken, all vitals were WNL. Patient's glucose was 119 on her continuous BG monitor. She reported she was feeling better, but still weak. Her vitals in the ED were BP 174/81 and HR of 53. The patient stated she felt better and decided she did not need treatment in the ED.
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| 66 | 2021-03-01 | throat pain, headache |
With the first shot hands started itching and continued for about a week and half. Did'nt go to Doct...
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With the first shot hands started itching and continued for about a week and half. Did'nt go to Doctor just took otc Bendryl.Arm was a little sore. The second shot about 35 minutes later hands started itching but not as bad as the first shot and I did'nt take any otc Bendryl this time .shot was in same arm (left) it was more sore than the first shot and next day mild headache and sore throat by 3rd day felt better.
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| 66 | 2021-03-01 | throat pain, sleepiness, headache, fever, fatigue |
Day of vaccine: Tiredness, headache, slept for 3 hrs Following evening: aches, fever, sore throat, c...
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Day of vaccine: Tiredness, headache, slept for 3 hrs Following evening: aches, fever, sore throat, coughing, can't sleep for 8 hours, wake up at 3:30 am.
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| 66 | 2021-03-01 | fever, chills, headache | 2/25/21 swelling and redden around arm. On 2/26/21 headache, body aches, chills and fever - 102. |
| 66 | 2021-03-01 | fever, headache |
Pfizer-BioNTech COVID-19 Vaccine EUA Started with some headache 30 minutes after the vaccine and the...
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Pfizer-BioNTech COVID-19 Vaccine EUA Started with some headache 30 minutes after the vaccine and the following day in the afternoon the fever started (high 40/41C), nausea and intense body aches. These symptoms lasted until Monday (2 full days). Today is the 3rd day, and still with body aches a little nausea, very painful and warm arm but no fever. This was the first dose but the patient had Covid in March of 2020 ( at the time all the symptoms mentioned above were present with the addition of having lost taste and having some hallucinations. No problem breathing. Just letting you know for the purpose of statistics.
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| 66 | 2021-03-02 | chills, headache |
Some achey-ness and a bit of chills. Bad migraine with very frequent (every 20-30 seconds) bolts of...
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Some achey-ness and a bit of chills. Bad migraine with very frequent (every 20-30 seconds) bolts of very sharp pain in my head in addition to migraine. This went on for 30 hours. No treatment...just waited it out and used cool packs on head. Also had very enlarged tender nodes under my left arm which are going away.
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| 66 | 2021-03-02 | fatigue, malaise |
terrible gas and bloating - starting 12 hours after injection and lasting 1 day, rapid and irregula...
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terrible gas and bloating - starting 12 hours after injection and lasting 1 day, rapid and irregular heart rhythm - beginning 40 hours after injection - lasting 6 hours, extreme tiredness - day 7 & 8, lower back and hip pain - day 7 and currently day 10, general feeling unwell - most days
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| 66 | 2021-03-02 | headache, fatigue, fever |
Fever 101, aches, awful headaches, nausea, threw up 5 times, very tired, fatigue. Lasted 4 days. H...
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Fever 101, aches, awful headaches, nausea, threw up 5 times, very tired, fatigue. Lasted 4 days. Headaches have not gone away since my first symptoms of Covid on December 24, 2020
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| 66 | 2021-03-02 | sweating |
1020 am Complaint of dizziness, increased heart rate and anxiety with sweaty palms. Patient stated t...
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1020 am Complaint of dizziness, increased heart rate and anxiety with sweaty palms. Patient stated that she did not take blood pressure medication this morning. BP 165/100, T 97.7, P 113, O2 98%. 1050 am T 97.9, P 67, O2 96%, BP 160/90. Patient states symptoms have subsided. Patient educated on taking blood pressure medication as directed by primary provider. Patient discharged from clinic.
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| 66 | 2021-03-02 | fever, chills | Had Fever and chills all day. Seemed to disappear next day |
| 66 | 2021-03-03 | body temperature increased, fatigue, chills, headache |
I had a headache within an hour of the injection. The next day, my left arm hurt (which was to be e...
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I had a headache within an hour of the injection. The next day, my left arm hurt (which was to be expected), muscle aches and pain, headache still, fatigue, shortness of breath and chills. By 8:30 pm I had a temperature of 101.7. I took some Tylenol and took my temperature again at 10:00 pm. It was 100.8. The next morning (3/3/21), I took my temperature again at 6:00 am. It was 101.1. I still had a headache, body aches and fatigue. I took more Tylenol and my temperature was down to 100.8 within an hour. Had a temperature most of the day ranging from 99.5 to 100.0. My normal temperature is usually 97.9. Still very tired. On Thursday March 4th, feeling better. Still a little tired. Temperature is 98.3.
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| 66 | 2021-03-03 | chills, headache, throat pain, fatigue, cough |
Cough; Chills; he came home and said he felt like crap, really bad, she said she did too; they are b...
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Cough; Chills; he came home and said he felt like crap, really bad, she said she did too; they are both so fatigued, so tired/exhausted; sore throat; major headache; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. This consumer reported similar events for two patients. This is the first of two reports. A 66-year-old female patient (wife) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EN5318), via an unspecified route of administration on 27Jan2021 13:00 at single dose on the left upper arm for COVID-19 immunization, reported as "doesn't want to get the COVID". There were no medical history and concomitant medications. The reporter said that she and her husband got first dose of COVID vaccine last week (27Jan2021) and they both got sick, had a major headache in Jan2021, cough and chills both on 27Jan2021, and also she wanted to know if she and her husband can take the second dose, scheduled on 17Feb2021. Patient stated that major headache went in on a "Wednesday". Her husband and her did, and went through vaccination portal, to get an appointment, appointments were very trying, as they were to do all healthcare providers first, which is understandable, and then the vaccine. They were trying to make it available for teachers, as they are going back to school, in school learning in March, so all teachers were the next step and then also anyone over 65 was able to go on the portal with the state to get an appointment to go and get a vaccination. She and husband have a daughter who was a teacher, and she said to go on the portal to get the shot, and they said they didn't have access to it, so she went on the site, and they got it in on 27Jan2021. The headache occurred after the 27Jan2021. Patient stated that as soon as they got home, her husband works full time, she lost her job in October, and she was home and he said "how are you feeling", he went back to work, patient came home and said she felt alright except for her arm then she got a really bad headache. The husband came home and said he felt like crap, really bad, patient said she did too, she was the type of person she never ever gets sick and if he was sick she does not say she was sick. Patient had such a bad headache, she thought her brain was ready to jump out of her head. Headache subsided after two days. She has recovered completely from the headache. Cough started almost immediately (27Jan2021), but patient did not cough today, but did last night, it was usually a deep cough. Today she has not coughed at all. Chills started probably that evening (27Jan2021), when she came home, the shot was around 1PM and chills started in the evening, and went away probably, they had gone back and forth for around two days but they were gone, she has recovered completely. Patient wished to add that they were both so fatigued, so tired, almost like, both she and her husband were very active, when they were down for the count, really exhausted, after this whole vaccination experience, both of them have been exhausted, to the point of going to bed at 8, and they were not 8:00 going to bed people. she doesn't want to be a pain, as she knows people have legit concerns, Patient doesn't want to waste time, her main concern is the second vaccination, if she does not have to, or is suggested to not take it, or her husband, she doesn't want the second vaccination to cause more severe side effects. The patient further reported, that they both experienced major side effects: chills, headaches, sore throat, major cough, fatigue that was "just unbelievable, both of us are exhausted." Her second dose is scheduled on 17Feb2021 and his husband is scheduled on 20Feb2021. Patient was asking "if this was after the first dose, what's going to happen after the second dose?". Outcome of the events headache and chills was recovered in 2021 for cough was recovered on 02Feb2021 while for other events was unknown. Information about Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021105012 same reporter/drug, similar events, different patient
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| 66 | 2021-03-03 | fatigue, headache |
DIZZINESS, DISORIENTATION, UNSTEADY GAIT, SEVERE HEADACHE, NAUSEA WITHIN 10 MINUTES OF VACCINE; THES...
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DIZZINESS, DISORIENTATION, UNSTEADY GAIT, SEVERE HEADACHE, NAUSEA WITHIN 10 MINUTES OF VACCINE; THESE SIDE EFFECTS CONTINUED ALONG WITH EXTREME FATIGUE, NO APPETITE, LOSS OF 6 LBS IN 6 DAYS, WEAKNESS. SYMPTOMS STILL PERSISTING ON DAY 8.
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| 66 | 2021-03-03 | headache |
Ischemic stroke; not hypertensive, but supposedly is now.; Visual disturbances; Headache; This is a ...
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Ischemic stroke; not hypertensive, but supposedly is now.; Visual disturbances; Headache; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EM9810, expiry: unknown), via an unspecified route of administration in the left deltoid on 01Feb2021 14:15 at a single dose for covid-19 immunization at a Physician office. Medical history included asthma, irritable bowel syndrome, pneumonia and borderline high cholesterol. The patient's concomitant medications were not reported. The patient had no prior vaccinations within 4 weeks. The patient had her first COVID-19 vaccine on 01Feb2021 and second one is due on 22Feb2021. On 03Feb2021, the patient had a headache, but didn't think too much because it is a side effect. The headache lasted all through the weekend. Visual disturbances began 04Feb2021. She called her doctor on Monday and was seen by her doctor on Tuesday, 09Feb2021. The patient was referred to the eye center. Her headache was getting a little better. On 10Feb2021, the patient was seen at an institution, her retina and macula looked good, so she was referred to the ED. The patient was told she probably had a stroke. The patient was admitted to the hospital for an ischemic stroke. By looking at the MRI, the onset of the ischemic stroke would have been five to seven days prior, placing the onset on Wednesday, 03Feb2021, which was also the onset of her headache. There is no definitive cause of her ischemic stroke. The patient currently has an arrhythmia monitor on. MRI/MRA showed her vessels looked good. MRI showed evidence of the ischemic stroke. The patient has neurologists since being admitted to the hospital. It was thought that the headache was just because of the COVID-19 Vaccine. Causality was unknown, it was stated that they haven't found anything else as a cause. The patient's doctor stated she was borderline for high cholesterol. She was not hypertensive, but supposedly is now. The patient also had echocardiogram, EKG, manual neuro checks, and blood work but does not have the results. The outcome of the events was unknown. The has trouble reading now since the stroke.; Sender's Comments: Based on available information, the reported events are assessed as unrelated to the vaccine BNT162B2 and can be explained as intercurrent or underlying medical conditions in this elderly patient with excessive weight (BMI=29) and underlying elevated cholesterol. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 66 | 2021-03-03 | headache |
headache; This is a spontaneous report from a contactable consumer (patient). This 66-year-old femal...
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headache; This is a spontaneous report from a contactable consumer (patient). This 66-year-old female consumer received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 26Jan2021 for Covid-19 immunization. Medical history included eczema and lowered the immune system. Concomitant drug included dupilumab (DUPIXENT) for eczema for 1.5 years (as of 02Feb2021) which she gives herself a shot in the stomach every 2 weeks. She stated dupilumab affects the immune system and lowers the immune system. She was previously unaware of this and took the first dose of the Pfizer Covid 19 vaccine and only had a headache as a side effect. She took the dupixent either the day before, day of, or the day after the first dose of the vaccine, so the 25Jan2021, 26Jan2021, 27Jan2021, she had it on the 26Jan2021, and wondering if this impact the efficacy of the first dose. She was scheduled to take dupilumab on 09Feb2021 and second dose of the vaccine on 16Feb2021. Patient had no kind of bad interactions, she had a headache which was her only symptom. Outcome of the event was unknown. Information on the Lot/Batch number has been requested.
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| 66 | 2021-03-03 | headache |
Patient states 30 minutes after vaccine felt dizzy and headache when standing up, no improvement wit...
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Patient states 30 minutes after vaccine felt dizzy and headache when standing up, no improvement with sitting down. Patient alert, denies shortness of breath, or wheezing, but still lightheaded even with monitoring and fluids, so taken to ER
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| 66 | 2021-03-03 | headache | Severe Headache, body aches. Treated with Tylenol, rest |
| 66 | 2021-03-03 | fever |
bled at the injection site; bruised; there are little fever blisters on the arm; her arm also felt h...
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bled at the injection site; bruised; there are little fever blisters on the arm; her arm also felt hot; her arm was hurting; water bubble appear on my arm with fever; fever; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EN6200), via an unspecified route of administration on 16Feb2021 at 09:15 (at the age of 66-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines four weeks prior to the vaccination. The patient was not tested for COVID-19 post vaccination. On 16Feb2021 at 22:00 the patient experienced bled at the injection site; arm is bruised, states there are little fever blisters on the arm, the arm was hurting and the arm felt hot (clarified the whole arm) on 16Feb2021; and water bubble appeared on the arm with fever "later on" on an unknown date in Feb2021. The patient was treated for the bled at injection site, arm felt hot and pain in arm which included cold ice pack and ibuprofen. The events did not require a physician visit or hospitalization. The clinical outcome of the event bled at injection site was recovered on 16Feb2021, the bruising and fever blisters at injection site was recovering, feeling hot and pain in arm was not recovered, water bubble and fever was unknown.
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| 66 | 2021-03-03 | throat irritation, cough |
1:30 pt received vaccine and then walked to observation area without event. 1:45 pt reports feeling...
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1:30 pt received vaccine and then walked to observation area without event. 1:45 pt reports feeling a "tickle in her throat that makes her want to cough". Noted that pt clears throat frequently. No other s/s reaction noted. VSS BP 122/68, HR 82, Resp 12. Pt given water and by 1:47 she reports no longer feeling the tickle. She reports a new autoimmune disorder (erythema nodosum) within the last few months. She is not on any meds for this diagnosis after being treated with prednisone previously. 1:52 Pt reports not needing to cough "tickle just maybe a little there". Pt drinking water and given snack and tickle does not clear. 2:07p pt reports tickle has fully returned, she is clearing her throat and occasionally coughing. Reviewed case with pharmacist. 25mg liquid Benadryl given to pt, drank and tolerated well. 2:15 pt reports "tingle is hardly there", she is no longer coughing or clearing her throat. 2:27 pt reports tingle is no longer there at all. Recommended pt call provider and notify them of potential reaction to the vaccine and discuss if pt should have further consults and/or if the pt should receive the 2nd dose of the Covid vaccine. We also discussed side effects vs signs of reaction. Pt agrees to call 911 immediately if any s/s of reaction. She also agrees to pull off the road if any tiredness develops from the Benadryl. She reports a history of Benadryl making her energetic not tired. 2:35Pt denies s/s reaction. Discharged from observation area.
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| 66 | 2021-03-04 | chills, fatigue |
I got very dizzy at the time of injection and the room was spinning, I sat for 30 minutes and they w...
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I got very dizzy at the time of injection and the room was spinning, I sat for 30 minutes and they watched me and let me go after. I immediately begin to feel very tired and couldn't think, my neck began to hurt and feel stiff and started having chills and still having chills.
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| 66 | 2021-03-04 | chills, headache, lethargy | Chills, headache, stiff neck, lethergy |
| 66 | 2021-03-04 | chills, headache |
Headache, chills, body aches, slight intermittent nausea. Alternated Motrin and Tylenol Q3 hours. Be...
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Headache, chills, body aches, slight intermittent nausea. Alternated Motrin and Tylenol Q3 hours. Began medication at 1145am . Improving as day progresses. ( 2 doses Motrin, 1 dose Tylenol) Currently slight headache and body aches, but much improved.
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| 66 | 2021-03-04 | headache, body temperature increased | Headache, body aches and temp 99.7 |
| 66 | 2021-03-04 | headache | Nausea, Vomitting, Diarrhea, Headache |
| 66 | 2021-03-04 | fever, chills, headache | Fever Chills Headache |
| 66 | 2021-03-05 | body temperature increased, influenza like illness, fatigue, throat irritation |
After the second dose of the Covid-19 vaccine, I had the same mild allergy reactions as I had with t...
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After the second dose of the Covid-19 vaccine, I had the same mild allergy reactions as I had with the 1st dose: mild-moderate numbness of nose, throat - all subsided by taking Benadryl that afternoon/eve. However, for the next 36-48 hrs after this 2nd dose, I experienced mild-moderate "flu-like symptoms": exhaustion, total body aches, scratchy throat, only slightly elevated temperature. This reaction was strong enough to prevent me from going to work for 2 days, sleeping 12-13 hrs at a time.
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| 66 | 2021-03-05 | headache, fever, fatigue |
Low grade fever, headache, body ache, where I have arthritis pain was intensified and unbearable, s...
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Low grade fever, headache, body ache, where I have arthritis pain was intensified and unbearable, somewhat lightheaded, vision slightly blurred-felt like I was in a tunnel, very tired and couldn?t sleep . I had control of my arthritis and as of today (3/6/21) 16 days after shot it is mostly painful, 7 out of 10. Mild lingering headache, and have trouble sleeping.
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| 66 | 2021-03-06 | chills, fatigue, fever |
Shot administered on 3/4/2021 at 10am. Woke up with chills and cold sweats at 3:30 am on 3/5/21. S...
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Shot administered on 3/4/2021 at 10am. Woke up with chills and cold sweats at 3:30 am on 3/5/21. Spend 3/5/21 on couch or in bed, fever spiked at 100.5 around noon. Symptoms disappeared around 4pm. Fatigued day 3 on 3/6/21. All better by Day 4 - 3/7/21
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| 66 | 2021-03-06 | fatigue |
Sore arm starting around 8 pm, and quite tired the following day. After a 2.5 hr nap, I was feeling...
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Sore arm starting around 8 pm, and quite tired the following day. After a 2.5 hr nap, I was feeling much better
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| 66 | 2021-03-06 | headache, fatigue |
I received my shot Thursday and was in bed with severe headache and extreme fatigue for 3 days. On S...
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I received my shot Thursday and was in bed with severe headache and extreme fatigue for 3 days. On Sunday I ate some eggs for lunch and then took a hot shower at about 1:00 p.m. After the shower, I had a moderate/severe rash inside both arms by arm pits, left and right breast, stomach, lower back and above and below my knees. It lessened but by 4:00 p.m. the rash was still not gone.
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| 66 | 2021-03-06 | headache, fatigue |
About 2 hours after the 2nd dose vaccine, I began to have upper leg aches. By 4 hours I was hurting...
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About 2 hours after the 2nd dose vaccine, I began to have upper leg aches. By 4 hours I was hurting very badly in both legs and had a very stiff neck and a headache. I have arthritis all over my body. I am not sure if the vaccine brought on the pain or if my arthritis caused the pain. But, I have not had that much pain with my arthritis before the 2nd dose vaccine. I was in so much pain I could not find a comfortable position in my bed to be able to go to sleep. I was awake until dawn. Finally, the pain became less and I was able to fall asleep and sleep about three hours. Today, 3-8-21, I feel fatigued and still have minor pain in my ankles. Like I said I have never been in so much pain before. The 1st dose vaccine only gave me a very sore arm.
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| 66 | 2021-03-07 | cough |
After observation period, patient went to POV and experienced diffuse pruritic (no hives or rash), c...
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After observation period, patient went to POV and experienced diffuse pruritic (no hives or rash), cough and shortness of breath, hoarseness and feeling of throat closing. Pt. used 5 puffs of albuterol. Pt. was transported via ATV to ED after administration of EpiPen. Pt. given Decadron in ED. Pt. has just started Prednisone taper and was instructed to complete it. Prescribed hydroxyzine and EpiPen. Discharged stable.
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| 66 | 2021-03-07 | fatigue |
I experienced the loss of a sense of taste and exhaustion one day after the shot and could not have ...
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I experienced the loss of a sense of taste and exhaustion one day after the shot and could not have the strength and attention pan to continue cooking. I have also been suffering from Lingering episodes of sudden physical faintness and mental stupor. This is most noticeable after engaging in my normal walks of one mile or less.
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| 66 | 2021-03-07 | malaise, headache, fatigue |
Nausea immediately with injection, injection site pain, tiredness, headache, body aches, dizziness, ...
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Nausea immediately with injection, injection site pain, tiredness, headache, body aches, dizziness, blurred vision, poor appetite, unable to taste food, feeling unwell. day later rash on chest, next day heart racing, breathing shallow and fast, chest hurting. roads were iced over, to unsafe to drive.
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| 66 | 2021-03-07 | malaise |
Pfizer shot on Sunday am - my father noticed my mother c/o not feeling well and unable to explain w...
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Pfizer shot on Sunday am - my father noticed my mother c/o not feeling well and unable to explain why she didn't feel well. She woke up feeling well and then quickly became disoriented and vomited. She was then unable to walk or communicate appropriately. Emergency services was called and she was transported to Emergency room. She was diagnosed with a posterior brain CVA and was treated with tpa and now remains hospitalized in the ICU with expressive aphasia and vision loss.
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| 66 | 2021-03-07 | sleepiness |
Sore at injection site, 2chrs after shot slept 3 hrs than 2 hrs later another 2 hrs, light headednes...
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Sore at injection site, 2chrs after shot slept 3 hrs than 2 hrs later another 2 hrs, light headednes,
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| 66 | 2021-03-07 | throat irritation, headache |
24 hours after the injection I started to flush on my face neck and ears. I itched all over especial...
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24 hours after the injection I started to flush on my face neck and ears. I itched all over especially my eyes and throat. I was very agitated and shaking. I took an allergy Med at 2 pm and again at 7pm. The 2 Nd dose calmed me enough to get to sleep around 11pm. I was very close to going to the ER. In the morning I had a stomach ache like I have experienced before with and allergic reaction. Cramping pain , it lasted all day there was no nausea. The 3 day a headache that seemed appropriate for the vaccine.
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| 66 | 2021-03-08 | chills, headache, fever | Chills, fever, muscle and body aches, headache, naseua |
| 66 | 2021-03-08 | fatigue, chills |
Chills, severe fatigue, weakness, dizziness, unstable on feet , nausea , GUM SWELLING, roof of mouth...
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Chills, severe fatigue, weakness, dizziness, unstable on feet , nausea , GUM SWELLING, roof of mouth burning and pain Tingling in hands and feet, loss of appetite.
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| 66 | 2021-03-08 | fatigue, headache |
Slight arm soreness, tired next day, abdominal muscle sore, groin pain, slight headache, none of the...
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Slight arm soreness, tired next day, abdominal muscle sore, groin pain, slight headache, none of these were bad, just noticeable, and seem to have resolved in 2 days.
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| 66 | 2021-03-08 | fatigue, fever |
12 hours after 2nd shot, for the next 48 hours, fever continuously @ 99.9, severe muscle pain from h...
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12 hours after 2nd shot, for the next 48 hours, fever continuously @ 99.9, severe muscle pain from head to toe, that was not effected by motrin. fever and severe muscle pain had me rolling in bed with pain. Also simultaneously, My left arm, site of injection swelled twice its size, red, and had trouble moving it. Also noticed a swelling in left arm pit, which has improved but a slight swelling is still present . after exactly 48 hours , fever left, muscle pain stopped. Fatigue continued for 5 days. I have had many vaccines in my life, including flu vaccine every year and never experienced such severe symptoms. When I reported this to my PCP, he said it just means your immune system is doing its job no worries
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| 66 | 2021-03-08 | throat pain |
Initial reaction of splotchy, itchy rash over body which diminished but returned on 3/4/21 with seve...
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Initial reaction of splotchy, itchy rash over body which diminished but returned on 3/4/21 with severe pain and swelling in legs and rash from feet to buttocks/back area. Patient went to hospital on 3/7/21; negative for blood clots, lab work was normal; Prescribed Hydroxyzine, PCN-(for mild sore throat), Multi V, Areds 2
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| 66 | 2021-03-08 | fever, headache | Fever , My bones hurt legs and arms low part of my back My head hurt so bad sick to my stomach |
| 66 | 2021-03-09 | chills |
having lots of Gastrointestinal issues/have gastrointestinal stuff going on; up in the middle of the...
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having lots of Gastrointestinal issues/have gastrointestinal stuff going on; up in the middle of the night; body aches/achy; chills (no fever); nausea; got the sore arm; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318 (not clarified further)), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunisation and loratadine (CLARITIN), via an unspecified route of administration from 03Feb2021 at an unspecified dose for unspecified indication. Medical history included ongoing High cholesterol and Sleep disorder, both from unknown date. Concomitant medication included alprazolam (XANAX), calcium (CALCIUM), cyanocobalamin (VITAMIN B12), Multivitamin, taking a statin to prevent high cholesterol and L-methylfolate, stated it is like a folic acid drug. Because the patient really can't take anti-depressant she reacted to them all (Unspecified Medications), so that worked for her and helped her to keep up her spirit. The patient reported her side effects. She didn't want to interfere with anything but she was having lots of Gastrointestinal issues which were inconvenient. She was up in the middle of the night, happened not within 48 hour after the first dose of the Pfizer vaccine but around 60 hours after the vaccine, early this morning (06Feb2021) like around 2 am. The patient was having a reaction after the vaccine but they seemed to be like delayed reactions. Not anything with breathing, she had gastrointestinal stuff going on. The patient had chills, no fever, body aches and she was really going to the bathroom nonstop in the night. It seemed to have been like 2 days after she got the shot like they were worst yesterday (05Feb2021). And she experienced achy, chills, nausea, diarrhea and sore arm in Feb2021. She would like to take TYLENOL and IMODIUM and she didn't know what she could take because she didn't want anything to interfere with that as she had been reading a lot. The patient wanted information on IMODIUM to prevent diarrhea, TYLENOL for body aches, chills (no fever), and FLONASE for sinus. The patient did not receive any treatment for the events. The patient actually didn't even take, that morning that day when she was getting the shot, she called the pharmacist to see if she could spray her nose with the FLONASE for sinus and he told her that he didn't think it was a good idea and that maybe she should just take CLARITIN, so she did. But she took CLARITIN that morning (03Feb2021) and she was hoping that didn't interfere. She was just nervous about it as she didn't want that to interfere with the work that it was. The patient was still suffering, less, like she didn't have the diarrhea anymore. She still had a little achy. She did get the sore arm but only for one day, so it wasn't so bad. The action taken in response to the events for loratadine was unknown. The outcome of event diarrhea and got the sore arm was recovered on an unspecified date in Feb2021, of event achy was recovering, of other events was unknown. Information on the lot/batch number has been requested.
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| 66 | 2021-03-09 | fatigue, headache, chills | Achy, Tired, Chills, Headache for about 12 hours |
| 66 | 2021-03-09 | fatigue | Tired achy upset stomach |
| 66 | 2021-03-09 | headache, chills |
Muscle aches, fuzzy headed, headache, chills and lots of pain in my knee replacement done 9/21/2020...
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Muscle aches, fuzzy headed, headache, chills and lots of pain in my knee replacement done 9/21/2020. That knee pain abated after a few hours.
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| 66 | 2021-03-09 | headache, chills |
injection site pain, redness, and swelling; injection site pain, redness, and swelling; injection si...
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injection site pain, redness, and swelling; injection site pain, redness, and swelling; injection site pain, redness, and swelling; headache; chills; muscle and joint pain; muscle and joint pain; nausea; dizziness; weakness; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EM9809), via an unspecified route of administration in the left arm on 06Feb2021 13:30 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history included slightly elevated blood pressure, not taking medication, and COVID prior to vaccination, on an unspecified date. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included paracetamol (TYLENOL) and vitamin supplements. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Feb2021 16:00, the patient experienced injection site pain, redness, and swelling; headache, chills, muscle and joint pain, nausea, dizziness and weakness. No treatment was received for the events. The clinical outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 66 | 2021-03-09 | headache, fatigue |
Vertigo/dizziness, severe upon arising from bed, lessening as day goes on Slight headache at back of...
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Vertigo/dizziness, severe upon arising from bed, lessening as day goes on Slight headache at back of head Slight tinnitus Fatigue Yawning
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| 66 | 2021-03-09 | headache | watery eyes, dizziness, headache BP 140/61 HR 90 Pulse ox 96%on RA |
| 66 | 2021-03-09 | headache | Headache, dizziness. BPs 156/88 (pulse 60), 142/86, O2 sats 100%. Given juice. |
| 66 | 2021-03-09 | malaise, fatigue, headache |
Fatigue; body aches; headache; general malaise; This is a spontaneous report from a consumer (patien...
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Fatigue; body aches; headache; general malaise; This is a spontaneous report from a consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (lot/batch number and expiration date were unknown) via an unspecified route of administration at left arm on 05Feb2021 13:30 at single dose for COVID-19 immunisation. Medical history included idiopathic hypertrophic subaortic stenosis (IHSS). Unspecified concomitant medication used in two weeks. There was no known allergies. There was no other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient was not pregnant. The patient had fatigue, body aches, headache and general malaise on 06Feb2021 at 08:00 a.m. Patient did not receive any treatment for events. She did not have COVID tested post vaccination. The outcome of events was recovering. Information on batch number has been requested.
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| 66 | 2021-03-09 | nasopharyngitis, headache, fatigue |
My bicep where I was injected was swollen and hard and hurt very badly. I could not elevate my arm, ...
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My bicep where I was injected was swollen and hard and hurt very badly. I could not elevate my arm, I had to keep it my side. I also had a headache. 9 days after the injection I had extreme fatigue and wasn't myself. During the night My right arm/shoulder started throbbing and hurting again. I was cold and lightheaded. When I woke up I was fine!
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| 66 | 2021-03-09 | fever, chills | 12 hours after second dose, fever, aches, and chills |
| 66 | 2021-03-10 | chills, sweating, dehydration, headache | Nausea vomiting aches everywhere extreme headache dehydrated chills sweats |
| 66 | 2021-03-10 | chills, malaise, throat pain, nasal congestion, cough, headache | headache, chills, sore throat and cough, feeling unwell and stuffy nose |
| 66 | 2021-03-10 | fatigue, headache, chills, fever |
Fever for 3 days. 101.2-101.6, chills, body aches, sore arm at injection Severe migraine type headac...
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Fever for 3 days. 101.2-101.6, chills, body aches, sore arm at injection Severe migraine type headache lasted for 4 days Severe exhaustion 4 days No appetite 4 days Day 5 just wiped out!
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| 66 | 2021-03-10 | fatigue |
site of shot got red, warm, painful, and raised in 3" x 3" area 9 days after vaccine. This took 3-4...
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site of shot got red, warm, painful, and raised in 3" x 3" area 9 days after vaccine. This took 3-4 days to go away. Also, I experienced severe fatigue and feelings of arthritis in my hands which both lasted about 24-30 hours.
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| 66 | 2021-03-10 | fatigue |
About 3 hours after vaccine administration I experienced severe numbness and tingling in entire Righ...
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About 3 hours after vaccine administration I experienced severe numbness and tingling in entire Right arm and hand, pain at very top of right arm. Fatigue started the next day (3/3/2021), worsened each day through day 6. Numbness and tingling also lasted 6 days.
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| 66 | 2021-03-10 | fatigue |
As the vaccine was being injected I immediately had a strange taste in my mouth, like 'tin' or like ...
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As the vaccine was being injected I immediately had a strange taste in my mouth, like 'tin' or like being at the dentist. 4 hours later I drank some coffee and it had no taste. I quickly learned I could not taste or smell anything. This went on for 5 days. Very nauseated and my pain medicine I take was not holding 6 hrs. My body pain was magnified x10. I had a hard time staying awake and no appetite. My Dr. office said they had this reported to them from other patients. I don't know if I am to get the second vaccine as no one is getting back to me.
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| 66 | 2021-03-10 | fatigue |
Vaginal bleeding at 3:30 am, bloodied underwear and sheets. Gynecologist gave me an internal ultras...
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Vaginal bleeding at 3:30 am, bloodied underwear and sheets. Gynecologist gave me an internal ultrasound of uterus, ovaries etc. were perfect. Had fatigue and aches for 24 hr. after vaccine. Also had a very bright pink, red rash covering the underside of my right arm and right chest, hot to the touch, some swelling, primary Doctor put me on antihistamines and antibiotics. Bleeding stopped. Rash and swelling is improving, still slight swelling on the underside of right arm 8 days later.
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| 66 | 2021-03-10 | headache, chills, body temperature increased |
About 10 minutes after receiving the vaccine, my left arm started burning. This lasted maybe 15 min...
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About 10 minutes after receiving the vaccine, my left arm started burning. This lasted maybe 15 minutes. I did not have this with the first vaccine. Around 7pm I started to develop chills which over a few hours I started to have shaking from the chills. I also developed a headache, Temperature 101.1, muscle weakness, pain at insertion site and diarrhea. I used Tylenol and Advil. Around 0500 no longer experienced a temperature and chills had lessened. Continued on day two to have slight chills and headache along with weakness. Day 3 minimal weakness
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| 66 | 2021-03-10 | headache, fever | Woke up. Low grade fever. Slight headache. Joint pain and trouble walking. |
| 66 | 2021-03-10 | headache |
pt states that she woke up w/ headache, nauseated, SOB, and pain in left arm. she says these sympt...
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pt states that she woke up w/ headache, nauseated, SOB, and pain in left arm. she says these symptoms come and goes in waves. pt went to urgent Care on 3/8/2021. Pt was ordered Chest X-Ray that came back normal. Rapid Covid Test w/ negative results. All vitals were good. Pt was prescribed an inhaler. Pt also went to her local pharmacy and took another Covid test on 3/10/2021 w/ pending results and then FU w/ PCP.
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| 66 | 2021-03-10 | headache | Racing heart, headache with sudden onset |
| 66 | 2021-03-10 | headache |
Caller says the the pt started having really bad headache the day after taking the vax that lasted a...
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Caller says the the pt started having really bad headache the day after taking the vax that lasted about a week and half. She had 4 hours of amnesia. Pts husband took her to Hospital ER where she had a brain scan and was diagnosed w/ TGA and then admitted.
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| 66 | 2021-03-11 | fatigue, chills |
Extreme chills, could not get warm despite multiple blankets in bed and raising room temp to 78 degr...
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Extreme chills, could not get warm despite multiple blankets in bed and raising room temp to 78 degrees, body aches, extreme fatigue
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| 66 | 2021-03-11 | headache, fever |
Pain left arm and all over body, muscle aches, felt feverish but didn't take temp, headache, lost ap...
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Pain left arm and all over body, muscle aches, felt feverish but didn't take temp, headache, lost appetite.
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| 66 | 2021-03-11 | nasal congestion, fatigue | Fatigue, upset stomach, stuffy nose |
| 66 | 2021-03-11 | throat pain, cough, sneezing |
lost voice, sore throat, coughing, sneezing, dizzy, nauseated all within the two and half weeks sinc...
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lost voice, sore throat, coughing, sneezing, dizzy, nauseated all within the two and half weeks since I received it .
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| 66 | 2021-03-12 | fatigue, chills, fever |
4-5 days post-vaccination: Continued soreness at injection site, itchiness at injection site, and on...
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4-5 days post-vaccination: Continued soreness at injection site, itchiness at injection site, and on day 5 a visible red patch on arm at injection site (Reporting this on day 5 since most information indicates this is more common with Moderna than Pfizer and more common after dose 1 than dose 2.) (Earlier reaction had included 24 hours post-vaccination of chills, fever, fatigue lasting 8-10 hours)
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| 66 | 2021-03-12 | headache, nasal congestion, fever, chills | Chills, Fever, Fatigue, Aches, Headache, Nausea, Very Sore Arm at shot site, stuffy nose |
| 66 | 2021-03-12 | fever, chills |
Fever, chills, Migraine like headache, dizzy upon first arising from bed.,, Loud ringing in ear and ...
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Fever, chills, Migraine like headache, dizzy upon first arising from bed.,, Loud ringing in ear and extreme bright light, feeling of fainting, quick nauseous feeling.
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| 66 | 2021-03-12 | fever | Low grade fever and body aches |
| 66 | 2021-03-13 | chills |
Received second COVID vaccine at 11:30 am on 3/12. Woke up around 3am on 3/13. Heaviness in limbs,...
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Received second COVID vaccine at 11:30 am on 3/12. Woke up around 3am on 3/13. Heaviness in limbs, chills. Took Tylenol. Woke up around 7am. Not feeling any better. The tip of my tongue felt as if it was dipped in hot sauce. Slept most of the day. Chills came back. Took Tylenol. Today (3/14), better, but still weak. Under my tongue is very sore.
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| 66 | 2021-03-13 | fatigue, headache |
Second day: soreness at the site. Fatigue and nausea. Third, fourth and fifth day fatigue and head a...
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Second day: soreness at the site. Fatigue and nausea. Third, fourth and fifth day fatigue and head ache
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| 66 | 2021-03-13 | headache | headache, hard to catch breath. Evaluated by EMS-Cleared |
| 66 | 2021-03-13 | malaise, fatigue |
5-6 days after, my stomach felt pressure, like something pushing in. On the night of the 6th day, I...
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5-6 days after, my stomach felt pressure, like something pushing in. On the night of the 6th day, I wasn't interested in eating, the pressure/discomfort feeling was increasing and I was uncomfortable all over and unable to get to sleep. Around 2 or 3 am, I had an episode of violent vomiting, which did not serve to make me feel any better. From that point on, for the next 24 hours, I continued to feel sick, extremely tired, and ached all over. I couldn't get comfortable, didn't feel like eating or even drinking, and had no energy, even to not being able to sit up and watch TV. As the 7th day continued, I threw up mid-day, was able to sip my way through 2 glasses (water, tea), and eat a few crackers. I felt very dizzy when I walked. I checked my temperature twice and didn't seem to be running a fever, which surprised me. I didn't take any pain relievers, as I felt I would just throw them up. By evening, however, I was able to take 2 ibuprofen, take a hot shower, and slept pretty well that night. By the 8th day, the aches were pretty much gone and I was able to eat soft foods and get rehydrated. I felt a little weak, still tired, and wobbly, but was clearly over the worst of it. By the 9th day, I was back to normal.
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| 66 | 2021-03-13 | runny nose, headache, cough, chills |
Pfizer-BioNTech COVID-19 Vaccine EUA: five days after vaccination patient reports waking up with hea...
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Pfizer-BioNTech COVID-19 Vaccine EUA: five days after vaccination patient reports waking up with headaches starting the day after being vaccinated. Acetaminophen and NSAIDS provide relief. Also reports dizziness, nausea, and photophobia. Patients denies numbness, tingling, or difficulty with speech or word finding. On follow-up visit eleven days after vaccination patient reported an episode of shortness of breath with a dry cough and runny nose with chills that day but headache improving. Symptoms determined to be related to chronic sinus problems and allergies.
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| 66 | 2021-03-14 | chills, fatigue |
Shortness of breath, chest pain, chills, fatigue, pain in back, nausea - Went to ER Feb 28, 2am - sy...
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Shortness of breath, chest pain, chills, fatigue, pain in back, nausea - Went to ER Feb 28, 2am - symptoms continue for another week.
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| 66 | 2021-03-14 | chills |
got my first dose at 12:45 pm on Friday the 12 th of March. At 12:30 am Saturday morning i started...
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got my first dose at 12:45 pm on Friday the 12 th of March. At 12:30 am Saturday morning i started throwing up. I threw up every hour for a total of 3 times. last time was 2:30 am. My stomach was gurgling and it hurt to press on it. and i kept belching. Had no energy. On Saturday was able to sleep 3 hours in my rocker until 2:15pm when i threw up again. Had no energy. Had chills the first day starting about 4 pm Friday after my shot. Called the emergency room to see if I could take antinausea pills I had . Talked to my doctor and he said I was allowed. It was ondansetron 4 mg. I took one at 3 pm and started feeling less weak.
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| 66 | 2021-03-14 | headache, body temperature increased, fatigue |
Five days later. March 2, I had a bout of diahrrea for about 90 minutes I also have the expected one...
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Five days later. March 2, I had a bout of diahrrea for about 90 minutes I also have the expected ones: Headache, some temperature, tireness. Today, March 15,, I had the same problem also about 90 minutes.
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| 66 | 2021-03-14 | headache, cough, chills, sweating |
No adverse reaction until March 1st 2021 Rytuxin Infusion plus (Bendadryl Decadron Zofran) Tues Marc...
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No adverse reaction until March 1st 2021 Rytuxin Infusion plus (Bendadryl Decadron Zofran) Tues March 2nd 2021 Redness Swelling @injection site Wed March 3rd 2021 Prevagen Infusion plus (Benadryl Zofran) Vitamin B12 injection Thursday March 4th 2021 Nerve Block with local anesthesia Saturday March 6th 2021 Headache Cough Sweats Chills Body Aches Monday March 8th Internal Medicine Telehealth Appointment NP Covid Test Rapid & PCR Negative results given for both March 10th Telehealth Appointment with Internal Medicine Dr. cough medicine & antibiotics given at this time
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| 66 | 2021-03-14 | headache, fever |
Intense arm ache evening after the vaccination. Woke the next morning with a splitting headache and...
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Intense arm ache evening after the vaccination. Woke the next morning with a splitting headache and fever. Headache subsided after taking one Tylenol, but fever maintained through 03/10/2021. It took 2 more days before it finally returned to normal.
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| 66 | 2021-03-14 | malaise, fatigue, chills, headache, fever |
I was fine the day I received the shot, the next morning I woke up with a headache and arm pain. My ...
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I was fine the day I received the shot, the next morning I woke up with a headache and arm pain. My breathing started to get worst. I already was having problems since I had Covid in January into February. A week later I woke up and felt very sick, started throwing up all day into the night, had 101 fever and chills. That lasted about a day and a half. I still felt sick for the next two days. I continue using having breathing problems worst than before the shot. I am also very exhausted.
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| 66 | 2021-03-14 | nasal congestion, headache, fever |
Swollen painful lymph node in armpit and another between armpit and elbow; Swollen painful lymph nod...
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Swollen painful lymph node in armpit and another between armpit and elbow; Swollen painful lymph node in armpit and another between armpit and elbow; Fever of 100 degrees; Deep muscle pain in small areas that lasted few seconds, moved from one part on body to another; Headaches; Congestion; This is a spontaneous report from a contactable consumer (patient). This 66-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9269) via an unspecified route of administration on 05Feb2021 at 13:30 (at the age of 66-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included hypothyroidism and pre-hypertensive. The patient had COVID-19 prior to the vaccine on an unknown date. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included HCTZ and levothyroxine sodium (LEVOTHYROXIN) from unknown dates for unspecified indications. The patient previously took penicillin from an unknown date for an unknown indication and experienced allergy. On 05Feb2021 at 14:30 the patient experienced swollen painful lymph node in armpit and another between armpit and elbow, fever of 100 degrees, deep muscle pain in small areas that last few seconds, moved from one part on body to another, headaches, and congestion. The events were reported as non-serious. The patient was not hospitalized for the events and did not receive any treatment for the events. The outcomes of swollen painful lymph node in armpit and another between armpit and elbow, fever of 100 degrees, deep muscle pain in small areas that last few seconds, moved from one part on body to another, headaches, and congestion were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 66 | 2021-03-14 | nasopharyngitis, headache | Severe bone and head pain also cold like symptoms for 5 days |
| 66 | 2021-03-14 | fever, headache, body temperature increased |
full blown auto immune flare/ a great big flare; mild headache; temperature of 102 degrees; This is ...
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full blown auto immune flare/ a great big flare; mild headache; temperature of 102 degrees; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration on 21Jan2021 (at age of 66 years old) at single dose for COVID-19 immunization. The patient's medical history included autoimmune diseases (She had a host of autoimmune diseases. Her body was one big inflammatory responses). Concomitant medications were not reported. The had reactions and was concerned about getting the second dose. She had a host of autoimmune diseases. Her body was one big inflammatory responses. Her doctor figured she would feel it. She started with a mild headache. On the 7th day she was slammed. Her doctor said it was pretty unusual after this long. She had a temperature of 102 degrees. It was like having a full blown auto immune flare that lasted for two days and went away. She was left with a great big flare. She was not able to provide full details as she had an appointment that she had to pay out of pocket for. She was not concerned about the reaction that takes a day or 2 to get over. She was having hell from her usual responses. She was afraid in six months she would be crippled. The outcome of events was unknown. She was due to receive the second dose on Tuesday.
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| 66 | 2021-03-14 | throat irritation |
After receiving the vaccine pt stated she felt her lips swelling, her throat itching, and that she w...
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After receiving the vaccine pt stated she felt her lips swelling, her throat itching, and that she was SOB. Pt assisted to cot, and sat down. pt cont to c/o on swelling in her lips, itchy throat, and sob, she also started breathing more rapidly. At 6:08pm epi 0.3mg given via auto injector, VS HR87, R30, BP140/90, O2SAT 98%, Ambulance call as soon as ambulance called. Pt began to hyperventilate and further c/o of difficulty breathing, sob, and her lips swelling. 2nd dose of epi 0.3m given via auto-injector per protocol. VS P98, R30, BP140/70, O2SAT 98%
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| 66 | 2021-03-15 | body temperature increased, chills |
Chills and body aches at 8pm evening of shot. Temperature 99.6. Hot sweats during the night. Upon wa...
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Chills and body aches at 8pm evening of shot. Temperature 99.6. Hot sweats during the night. Upon waking up temperature was 102. Body aches persist.
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| 66 | 2021-03-15 | fatigue, fever | Tired, had fever, dizziness lasted about 8hours |
| 66 | 2021-03-15 | headache, fever, chills |
I had no reaction after the 1st dose administered on January 26, 2021 other than a slightly sore arm...
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I had no reaction after the 1st dose administered on January 26, 2021 other than a slightly sore arm. After the second dose on Febrary 16, 2021, I expereinced the following in the following order. I did not feel better/normal until March 12. 101 fever for 24 hours, headache for days, chills, slight nausea, pain and aches all over and in joint areas, pain under shot arm in gland areas, black eyes and eye aches, divertiulitus event, brain fog - not being able to have sharp recall, and hives last 7 days.
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| 66 | 2021-03-15 | nasal congestion |
muscle and nerve on both side of her face and the area along the back of both ears on the back head ...
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muscle and nerve on both side of her face and the area along the back of both ears on the back head are very uncomfortable; muscle and nerve on both side of her face and the area along the back of both ears on the back head are very uncomfortable; From thumb finger till middle figure of both hands are numb especially after getting up daily.; The nerve of both front elbows is uncomfortable a lot stronger (e.g. sensation of soreness and distention); Both gums are very soreness and distention; Both gums are very soreness and distention; Stuffy nose; night sweats; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, at the age of 66-year-old, on 20Feb2021, single dose for COVID-19 immunization. Relevant medical history included diabetes. The patient had no known allergies. Patient is not pregnant. Concomitant medications included metformin, thiamine hydrochloride (VITAMIN B1 [THIAMINE HYDROCHLORIDE]) taken for covid-19 immunisation; and cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration (left arm), at the age of 66-year-old, on 23Jan2021, single dose for COVID-19 immunization and experienced muscle and nerve on both side of face (especial jawline area) are uncomfortable. On 21Feb2021 at 07:00 am, her muscle and nerve on both side of her face (especial jawline area, marionette line area, nasolabial folds, both temples and lower eyelid region) and the area along the back of both ears on the back head are very uncomfortable. From thumb finger till middle figure of both hands are numb especially after getting up daily. The nerve of both front elbows is uncomfortable a lot stronger (e.g. sensation of soreness and distention). Both gums are very soreness and distention. Stuffy nose and night sweats in the whole body happen a few times daily after the 2nd dose as well. The patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient did not receive any treatment in response to the events. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 66 | 2021-03-15 | fever |
fever; I have dystonia (OMD)/ my symptoms have been aggravated the last few days; I have dystonia (O...
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fever; I have dystonia (OMD)/ my symptoms have been aggravated the last few days; I have dystonia (OMD)/ my symptoms have been aggravated the last few days; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 17Feb2021 16:45 (batch/lot number: EN 6200) as a single dose for COVID-19 immunisation. Medical history included dystonia (OMD), multi nodular goiter, fatty liver, and uterine fibroids. The patient was not pregnant at the time of vaccination. Concomitant medications included omeprazole, colecalciferol (VITAMIN D), and tonic lemonade with thc; taken for unspecified indications, start and stop dates were not reported. The patient previously took amoxicillin clavulanate and experienced allergies. On 27Feb2021 16:00, the patient has just developed a fever and she really doesn't get fevers. She was normally low at 96.7 and today she was 98.7. She has dystonia (OMD) and her support group was reporting Covid vaccines were making dystonia symptoms worse. Her symptoms have been aggravated the last few days. She had no dystonia reaction until the last 2 days and symptoms might not have anything to do with the vaccine. She was just reporting this because her support group was saying they were worse since the vaccine. She was concerned she has a fever since she never gets them. She hasn't been out of the house since the vaccination. Facility type for the vaccine was a school or student health clinic. No other vaccine in four weeks. No Covid prior to vaccination and was not Covid tested post vaccination. There was no treatment received for the events. The outcome of the events was unknown.
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| 66 | 2021-03-16 | chills, fatigue |
Abdominal cramping and extreme discomfort, diarrhea, loose stool, multiple bathroom trips. Some chi...
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Abdominal cramping and extreme discomfort, diarrhea, loose stool, multiple bathroom trips. Some chills and fatigue. Started about 2 days after the vaccine shot and lasted for about 2 days. Took Pepto Bismol 3 times. It may have helped a little.
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| 66 | 2021-03-16 | fatigue |
I received the vaccination at the clinic. About 24 hours after receiving the vaccination, my urine ...
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I received the vaccination at the clinic. About 24 hours after receiving the vaccination, my urine became very dark (amber) and stayed this way for 9 days. I was not dehydrated. Five days after the vaccination, my stool became very pale (clay color) and stayed this way for 6 days. Both conditions resolved on their own. I was very tired for a couple of days after the vaccination, had some soreness in the vaccination site and my appetite was off a little for a few days. These were the only other symptoms.
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| 66 | 2021-03-16 | nasal congestion |
PATIENT'S RIGHT LIP AND FACE SWOLLEN TO THE NASAL AREA. ADVERSE EFFECT STARTED THE MORNING OF 3/16/...
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PATIENT'S RIGHT LIP AND FACE SWOLLEN TO THE NASAL AREA. ADVERSE EFFECT STARTED THE MORNING OF 3/16/2021. PATIENT NEVER HAD BEFORE. HAD EATEN OATMEAL AAND COFFEE THAT MORNING, PATIENT DID NOT FEEL ANY PAIN, PECULIAR TASTE SENSATIONS, SENSITIVITY TO SOUND, OR DIFFICULTY CHEWING. PATIENT USED BENADRYL AND ICE PACKS . SWELLING SUBSIDED BY BEDTIME.
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| 66 | 2021-03-16 | nasopharyngitis, sweating |
tested positive for Strep yesterday and is on a Z-pak (today is day two for the medicine)/tested pos...
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tested positive for Strep yesterday and is on a Z-pak (today is day two for the medicine)/tested positive for Strep throat; dizzy with sweats; dizzy with sweats; head cold; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3248; Expiration Date: 01Apr2021), via an unspecified route of administration on the right arm on 23Jan2021 at single dose for COVID-19 immunisation . Medical history included patient required acid reducer. Concomitant medication included omeprazole taken as acid reducer.The patient stated that she tested positive for Strep yesterday and is on a Z-pak (today is day two for the medicine). She asked if it is okay if she still gets her vaccine tomorrow. She tested negative for Covid on Feb2021. States she is being treated with Azithromycin, a z-pack, 250mg two tablets to start then one a day. States she just felt like she had a head cold, got up yesterday and was dizzy with sweats and it went away in about 15 minutes on 11Feb2021. The outcome of head cold and dizzy with sweats was recovered on 11Feb2021 and other event was not recovered.
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| 66 | 2021-03-16 | fever, chills |
The evening after patient received vaccine, she started to develop low grade fever and urticarial ra...
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The evening after patient received vaccine, she started to develop low grade fever and urticarial rash at the vaccine site. The urticaria improved the following day, as did the fevers. Then 3/5, the fevers started again, several times per day, as high as 102 at home. In association with the fever she has had some mild nausea, x1 non-bloody emesis last night, as well as rigors/night sweats. She went to urgent care and eventually was admitted to the hospital for the following 9 days. During this admission, she continued to have fevers intermittently as high as ~103. She also developed more generalized urticarial rash (worst on trunk), and lab abnormalities including low platelets and elevated liver function tests. She had extensive testing, ultimately determined likely vaccine reaction, started on prednisone 40 daily and improved for discharge to home on 3/17 without fevers x48 hours and with improving labs.
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| 66 | 2021-03-16 | fever |
Started getting little tiny bumps in random places on my body that would itch extremely and then loo...
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Started getting little tiny bumps in random places on my body that would itch extremely and then look like a hive but it went away in about 20 minutes. Then it might be on my foot or back and do the same thing. Had a low grade fever and started getting fever sores on my lip and took Valtrex.
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| 66 | 2021-03-16 | fever |
Fever up to 100.5 degrees, aches, loss of appetite, lethargy Subsided after 36 hrs No treatment soug...
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Fever up to 100.5 degrees, aches, loss of appetite, lethargy Subsided after 36 hrs No treatment sought
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| 66 | 2021-03-17 | body temperature increased, chills, headache, fever | One week and a day after receiving the vaccine: Fever (101+), chills, headache, body aches. |
| 66 | 2021-03-17 | body temperature increased, fatigue, headache |
temp over 101; severe headache; body aches; neck ache; extreme fatigue; beginning approximately 11P...
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temp over 101; severe headache; body aches; neck ache; extreme fatigue; beginning approximately 11PM on 3/16/21, worsened as the day progressed; loss of appetite
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| 66 | 2021-03-17 | headache |
Bloating; Constipation; Gas; Headache; This is a spontaneous report from a contactable consumer repo...
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Bloating; Constipation; Gas; Headache; This is a spontaneous report from a contactable consumer reporting for himself and his wife. This consumer reported similar events for two patients. This is the second of two reports. A 66-year-old female patient (reporter's wife) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL8982), intramuscular on 26Jan2021 at a single dose on the right arm for COVID-19 immunization. The patient had no medical history and there were no concomitant medications. The patient did not have prior vaccinations within 4 weeks of the COVID vaccine. The reporter called for himself and his wife. He reported that they looked at the at the symptoms on the vaccine fact sheet and they did not have any of those symptoms. They received the first dose of the vaccine on 26Jan2021. The first couple of days they had a little bit of a headache starting on 27Jan2021. The third day, 29Jan2021, they started having constipation and bloating which is not normal for them. They are having a lot of gas and are very bloated. The reporter and patient was asking if anyone else has reported this since it is unusual for them. The patient then stated that she had just a very mild headache. She has been able to go to the bathroom a little bit. Usually she is going to the bathroom a lot. The patient stated that the gas and bloating is unreal. All she had last night was chicken broth and a piece of toast for dinner. She took Tylenol for the headache. She is not taking anything for constipation. She is drinking caffeinated coffee which she never drinks or she would be going to the bathroom all day. She just wishes she could fart. The outcome of headache was recovered on 29Jan2021. The outcome of bloating, constipation and gas was not recovered.
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| 66 | 2021-03-17 | sweating |
Scared of needles. Syncope, flushing/sweating. BP 111/51 (pulse 90). Patient placed in supine positi...
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Scared of needles. Syncope, flushing/sweating. BP 111/51 (pulse 90). Patient placed in supine position - appeared to show signs of convulsion. Taken to the ED.
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| 66 | 2021-03-17 | malaise |
On 3/4 approximately 24 hours after receiving first dose started shaking while standing as if I had ...
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On 3/4 approximately 24 hours after receiving first dose started shaking while standing as if I had parkinsons disease. The heaviest shaking was of the right arm and hand which was where the vaccine was administered. Made my way to bedroom on my walker to tell hubby I was not feeling well, Took blood pressure which was elevated and my heart felt like it was beating out my chest, Bllod pressure was elevated and so was pulse. Shaking continued and breathing was shallow, Waited 10 minutes and retook vitals, BP and pulse up more, Called 911, Paramedics came and monitored my vitals several times which after 20 minutes started declining, Could not say conclusively if was vaccine related. Elected due to Covid not to be transported to hospital and signed off on declination, Was told by paramedics to call 911 again if symptoms reoccurred and go to hospital, In successive days I still continue to have pin-prick feelings and numbness in my right fingers, More difficult to walk than usual,
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| 66 | 2021-03-17 | nasopharyngitis |
All over body pain, cold all day, very very uncomfortable. Advil and two hours later Tylenol eased...
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All over body pain, cold all day, very very uncomfortable. Advil and two hours later Tylenol eased the pain
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| 66 | 2021-03-18 | chills, headache, fatigue |
chills; moderate headache; fatigue; This is a spontaneous report from a contactable nurse, the patie...
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chills; moderate headache; fatigue; This is a spontaneous report from a contactable nurse, the patient. A 66-year-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: unknown), via an unspecified route of administration in the left arm on 08Feb2021 at 15:45 (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included gluten allergies and celiac. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were none. The patient did not have any other vaccines within 4 weeks of the vaccination. On 11Feb2021 at 23:30, the patient experienced chills, moderate headache and fatigue. The events started to resolve on 13Feb2021, but the patient continued to have a very mild intermittent headache. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of chills and fatigue resolved on Feb2021, while moderate headache resolved with sequel on Feb2021. Information on the lot/batch number has been requested
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| 66 | 2021-03-18 | chills, fever, malaise |
Sudden chills with fever 99.4 - body aches and malaise. Fever lasted 16hrs - body aches and malaise ...
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Sudden chills with fever 99.4 - body aches and malaise. Fever lasted 16hrs - body aches and malaise still present 3/19/21.
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| 66 | 2021-03-18 | fatigue, headache |
arm pain; mouth had ulcerations; Unusual taste sensations; tongue felt swollen; tiredness; headache/...
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arm pain; mouth had ulcerations; Unusual taste sensations; tongue felt swollen; tiredness; headache/her head would be pounding; Weird coating on tongue; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318; expiration date: unknown) at 66-year-old vaccination age intramuscularly administered in the left arm on 01Feb2021 as a single dose for covid-19 immunisation. Medical history included obesity just barely qualifies under that began 6 years ago (2015), allergy to one type of Penicillin VK and blood pressure (blood pressure abnormal). The patient has no familial medical history. Concomitant medication included losartan start and stop date were unknown for blood pressure. The patient has no previous immunization with the Pfizer vaccine considered as suspect and did not have other additional vaccines administered on the same day as the covid-19 vaccine. The patient reported that he experienced mouth ulcerations, tongue swelling, arm pain, tiredness and headache. The patient further reported that for the first day or two (02Feb2021 09:00), she had tiredness and headache and that was all resolving. Then on 04Feb2021 06:00, she woke up and the rest of her mouth had ulcerations. Her tongue felt swollen and she had a really weird coating on tongue (also reported to have started on 02Feb2021 06:00), along with really unusual taste sensations that lasted for 4 days and calmed down. It is still continuing on a very reduced level. She is still having weird problems with taste and her tongue feels different. She stated that the tiredness improved on 03Feb2021 and the headache was intermittent until 05Feb2021. The tongue swelling has not resolved all the way, it is intermittent. She will feel ok one day, and the next day, it will be back. She mentioned that the patchy white coating on tongue only lasted about a day, but she still has the feeling intermittently along with the taste sensations, but the white part is gone. The patient also stated that when she would wake up in the morning, her head would be pounding. That is the kind of symptoms she would have if she didn't take her blood pressure medication, but she did take her medication. The patient had arm pain on an unspecified date. The outcome of the event taste abnormality was not recovered, as for the event arm pain was unknown while the outcome of the other events was recovering.
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| 66 | 2021-03-18 | fatigue | No appetite. Feeling tired. |
| 66 | 2021-03-18 | headache, influenza like illness, malaise |
Chronic diarrhea since about a week after the first vaccine. It's been two months now, and no relief...
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Chronic diarrhea since about a week after the first vaccine. It's been two months now, and no relief. I just saw a NP this week about it. Also, one week after the 2nd Pfizer injection, I had a headache all day (very unusual for me) and felt strange, not well, weird, had to go to bed at 6:30 pm because I just felt flu like symptoms. I slept all night and was fine the next day, accept for the diarrhea.
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| 66 | 2021-03-18 | headache |
1:50 pm patient complained of HA, dizziness, nausea. Provided water, elevated legs, observed x 5 min...
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1:50 pm patient complained of HA, dizziness, nausea. Provided water, elevated legs, observed x 5 minutes. Patient's color became very pale. EMS notified. Placed on O2 at 3L NP. SATS on RA 95%; after O2 improved to 98%. Initial VS 182/110 (2:05 pm); p 78; R. 30 - irregular. Glucose - 100dl BP 212/113; p 78. R 30. Nausea better. Sipping water. Refused food. 1415hrs. Fire/rescue arrives at 1420. Assessed patient. She initially refused transport, but later gave her consent. 1438 Transported to ER.
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| 66 | 2021-03-18 | sweating |
12:45 Received Pfizer #2 13:00 Felt dizzy, lightheaded; consumed water and chocolate 13:05 Transport...
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12:45 Received Pfizer #2 13:00 Felt dizzy, lightheaded; consumed water and chocolate 13:05 Transported to EMS area of observation area; in wheelchair lost consciousness and had brief 15-20 second seizure 13:10 Repeated bouts of emesis. Patient had marked pallor and diaphoresis 13:35 EMS transport arrived, placed IV, gave phenergan, and transported via ambulance to Hospital Center
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| 66 | 2021-03-18 | sweating |
On 2/14 started experiencing heart palpitations, tremors, sweating No previous history of anxiety...
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On 2/14 started experiencing heart palpitations, tremors, sweating No previous history of anxiety or depression
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| 66 | 2021-03-18 | influenza like illness, chills, headache | Chills, achiness, headache, flu-like symptoms. |
| 66 | 2021-03-18 | malaise, fatigue, headache |
Extreme pain at injection site, then left arm became paralyzed, unable to move unless assisted by ri...
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Extreme pain at injection site, then left arm became paralyzed, unable to move unless assisted by right hand/arm. Pain spread to left side of head, neck, upper, then lower back. Extreme pain in lower back. General feeling of un-wellness, and wanting to die. Insomnia, and extreme tiredness. Thursday pm pain in left arm subsided, still very tired, severe pain in low back, slept better. Friday, as I write, no more pain in left arm, paralysis subsided, as well as head, neck pain. Low back pain still exists. Did not seek medical help. Took Hydrocodone and Tylenol, iced areas of pain. Not looking forward to next shot. Will contact my allergy doctor regarding if I should get second shot.
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| 66 | 2021-03-18 | malaise |
RLQ pain (without radiation), nausea, malaise and some constipation. Patient reported pain to be pre...
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RLQ pain (without radiation), nausea, malaise and some constipation. Patient reported pain to be pressure, sharp and shooting, and 7/10 in intensity. Acute appendicitis and localized peritonitis. Patient underwent laparoscopic appendectomy.
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| 66 | 2021-03-18 | throat pain |
Possibly coincidental. The next day and for 5 days I had a terrible sore throat with difficulty swal...
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Possibly coincidental. The next day and for 5 days I had a terrible sore throat with difficulty swallowing. The pain moved from left to right in the throat. Also and worse: swollen mouth tissue and gums: agonizing. Lymph nodes in neck very sensitive to touch. *****This was strange because at the beginning of the pandemic, I had these same symptoms three times: March 10, March 22, and April 28. I had a Covid test after 3rd time and it was negative. Consulted with doc, could not go to office for swab of throat because might be Covid. Had Covid test, negative. Started Amoxicillin for one week. Am feeling better.
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| 66 | 2021-03-18 | sleepiness | Slept for 8 hrs 1:00 to 9:00pm |
| 66 | 2021-03-19 | chills, headache | Headache, chills, sore arm |
| 66 | 2021-03-19 | fever, headache, fatigue |
I felt dizzy and lightheaded right after the shot. That night my arm was hurting me very badly. I st...
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I felt dizzy and lightheaded right after the shot. That night my arm was hurting me very badly. I started to feel feverish and extremely fatigued the next day. I also felt achy. I have intermittent very mild headaches and just feel lousy.
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| 66 | 2021-03-20 | chills, headache |
Persistent head ache, starting as mild headache on the evening of March 16, 2021, and increasing in ...
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Persistent head ache, starting as mild headache on the evening of March 16, 2021, and increasing in intensity in the morning of March 17, 2021. I felt chilled and spent much of the day in bed covered with a sleeping bag/quilt, while putting ice packs on my head and neck. The pain lessened by the night of March 17, 2021. There were twinges of headache pain on March 21, 2021. (I have had very few headaches in my life.) There was also some nausea and intestinal distress.
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| 66 | 2021-03-20 | chills, fever | Fever exceeding 102 degrees, extreme muscle pain, chills |
| 66 | 2021-03-20 | fatigue, chills, headache |
tiredness, headache, chills, severe pain in lower left abdominal region, muscle tightness in right c...
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tiredness, headache, chills, severe pain in lower left abdominal region, muscle tightness in right calf, repeated vomiting, constipation
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| 66 | 2021-03-20 | headache, chills | N/v, confusion, headache, chills, weakness |
| 66 | 2021-03-20 | headache, fever |
Headache-muscle aches all over- fever of 102 Took Tylenol overnight was unable to sleep because pain...
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Headache-muscle aches all over- fever of 102 Took Tylenol overnight was unable to sleep because pain from symptoms. Still going and the time is 9;30AM Sunday March 21st
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| 66 | 2021-03-21 | chills, fatigue | Chills, aches, fatigue, nausea |
| 66 | 2021-03-21 | chills, sweating |
Extreme confusion, symptoms similar to stroke, legs weak, could not stand or walk. Difficulty form...
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Extreme confusion, symptoms similar to stroke, legs weak, could not stand or walk. Difficulty forming words. Words were very garbelled. Extremes sweatness. chills.
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| 66 | 2021-03-21 | fatigue, sleepiness |
Day of injection, no adverse affects. That evening after I went to bed, I was woken up by extreme pa...
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Day of injection, no adverse affects. That evening after I went to bed, I was woken up by extreme pain and soreness at the injection site. I had a terrible time sleeping. It radiated into my shoulder and lasted for four days. I didn't sleep well at all the entire time and I was affected by the pain during the day as well. I also had extreme fatigue the next day after the vaccination but that only lasted for that day.
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| 66 | 2021-03-21 | sweating |
Patient was sitting s/p vaccination waiting 15 min. She became diaphoretic, nauseous, and pale. She ...
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Patient was sitting s/p vaccination waiting 15 min. She became diaphoretic, nauseous, and pale. She vomited twice. She stated that she thought she had a panic attack. Her vital signs were normal at all times. Last set of vitals 97.6 po, 126/84, 77, 98%
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| 66 | 2021-03-21 | influenza like illness | Flu like symptoms for 12 hours; just took ibuprofen and drank water |
| 66 | 2021-03-21 | fever, headache | SEVERE PAIN IN THE ARM, SEVERE HEADACHE, MUSCLE, JOIN PAIN AND HIGH HEVER FOR 3 DAYS (38.8 - 39.3 C) |
| 66 | 2021-03-22 | fatigue, chills |
chills x 24 hours, body aches and fatigue x 3 days. Improved x 24 hrs. Then developed stiff neck, ...
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chills x 24 hours, body aches and fatigue x 3 days. Improved x 24 hrs. Then developed stiff neck, joint pain and inflammation in joints with arthritis
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| 66 | 2021-03-22 | fatigue, fever, headache | headache, dizzy, lightheaded, shaking, fatigue, fever |
| 66 | 2021-03-22 | fatigue |
I woke up after a normal night's sleep and found that everything was spinning. Was dizzy and could ...
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I woke up after a normal night's sleep and found that everything was spinning. Was dizzy and could not properly walk. After trying to drink a bit of water, fainted and vomited it all back up. I was weak and tired. Slept or rested all day and by late afternoon was able to hold down some toast and by evening symptoms had resolved. Clearly, I am not sure that this was vaccine related since it occurred 2 wks after vaccination but felt should be reported.
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| 66 | 2021-03-22 | headache, fatigue |
Racing heart, fatigue, headache, felt like fire bursts under my skin mostly in arms and legs. Had t...
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Racing heart, fatigue, headache, felt like fire bursts under my skin mostly in arms and legs. Had these adverse effects on and off for over a week. The second week after the shot felt numbness in my face. After about one month these events are mostly gone. Still have occasional fire bursts under my skin but only one or two not my entire arms or legs.
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| 66 | 2021-03-22 | malaise |
Patient had her shot at 7:23am. She said she didn't feel well and her tongue felt funny. She stated ...
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Patient had her shot at 7:23am. She said she didn't feel well and her tongue felt funny. She stated similar issues with shot 1. She reports hx of anaphylaxis to penicillin. I gave benadryl 50mg po at 7:47am. Her bp was 137/85, pulse 67, and pulse ox was 98%. Patient left at 7:58. She states she just wanted to go home.
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| 66 | 2021-03-22 | fever, headache, fatigue |
Low grade fever, widespread muscle pain (#8 on pain chart) severe headache, mild nausea, fatigue, sw...
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Low grade fever, widespread muscle pain (#8 on pain chart) severe headache, mild nausea, fatigue, swollen , painfull glands in neck, soreness at site of injection that traveled into armpit,
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| 66 | 2021-03-22 | fever, headache, influenza like illness |
Got flu like systems the following day and each day felt weaker with headache and ear and neck pain ...
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Got flu like systems the following day and each day felt weaker with headache and ear and neck pain thought flu ignored. Then felt worse went to urgent care tested negative for corona virus. Seen by dr on site.12/12/21. Double ear infection. Home with antibiotics, got worse. Face extreme pain went to ER at hospital due to left side face dropping and speech slurring was diagnosed with double ear infection and Bell Palsy on 3/14/2021.
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| 66 | 2021-03-23 | headache |
Two weeks after the vaccination I woke up dizzy. Couldn?t walk without balancing assistance, headach...
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Two weeks after the vaccination I woke up dizzy. Couldn?t walk without balancing assistance, headache and nausea. Took Tylenol. Rested 2 hours, still some dizziness, headache, nausea. Improved by 2:30 pm after more rest. I had arm and neck pain , nausea and fatigue for 4 days after the vaccination.
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| 66 | 2021-03-23 | headache |
Approximately 12 hours after shot (during the night), I woke up with debilitating pain in multiple p...
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Approximately 12 hours after shot (during the night), I woke up with debilitating pain in multiple parts of my body: wrists; left groin and leg; neck/shoulders; lower back and had a headache. All of these areas were thrubbing and interrupted sleep. Also was very weak. Was difficult to get out of bed or a chair and to walk. Also had loss of appetite. At no time, did I have a temperature.(Note: I play tennis so was very active early in the week). The course of the symptoms has lasted 96hours but now seems to be subsiding. After 48 hours of inability to do any normal life activities, I contacted my physician who prescribed a cordtisone shot and anti-inflamatory medication, which I've taken for 2 days.
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| 66 | 2021-03-23 | throat pain |
Felt mild sore throat and noticed that my mouth just did not feel right. Looked with flashlight and...
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Felt mild sore throat and noticed that my mouth just did not feel right. Looked with flashlight and saw lesions and white lines on both sides of my mouth. Since I had a dentist appointment schedule for Tuesday (3/23/21), I called them and they said to keep the appointment and they would check it out. The dentist examined me and the diagnosis was Lichen Planus. They recommended that I report this since this is the first time this ever happened to me and the only thing I recall that was out of the ordinary was getting vaccinated.
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| 66 | 2021-03-23 | fever, headache, fatigue, malaise, chills |
Started overnight (after 9:30pm on 3/23/21: Injection site pain,Tiredness,- The following occurred a...
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Started overnight (after 9:30pm on 3/23/21: Injection site pain,Tiredness,- The following occurred around 8am on 3/24/21: Headache,Muscle pain, Chills, Joint pain, Fever, Nausea, Feeling unwell, Dizziness, Fainting
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| 66 | 2021-03-23 | runny nose |
Continuous Post nasal drip started right after vaccine and has not gone away after 11 days. Also, m...
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Continuous Post nasal drip started right after vaccine and has not gone away after 11 days. Also, my body is bloated and that has not gone away. I was very thirsty after the vaccine so I drank a lot of water. The bloat does not seem to be lessening. It is very uncomfortable. I don't want to get the second dose of the vaccine if this does not go away as I am afraid it will get worse. Although you do not have that as a side effect of the vaccine there are a lot of other symptoms you do not have but I have heard many people say they get these symptoms after the vaccine. You do not make it easy for people to report their symptoms so how are you keeping track of the symptoms people are experiencing after the vaccine. Most older people are not computer literate and even though I am it was not easy to find out how to report these symptoms. They gave me some way of reporting it by text message but I have an older phone and it won't work on that. Most older people would not report symptoms on a phone....they are too small. I also have an ipad but it does not do text messages. I suggest you find another way to track symptoms after the vaccine or you are not getting accurate information. This is not the way to do science.
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| 66 | 2021-03-23 | throat irritation, cough |
About two weeks and two days after I had the second vaccine, I felt a little chill and had a very s...
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About two weeks and two days after I had the second vaccine, I felt a little chill and had a very slight scratchy throat and a very slight cough on and off for about five days and I was wondering if what I had experienced was a delayed reaction to the vaccine even though it was two weeks and two days after I had received it? I had associated the reaction to being ?better? than having a cold because when I get colds, it would start with a very bad sore throat and then would become a full-blown cold with very bad coughing and sometimes I would develop bronchitis. I thought that the reaction that I had was quite mild.
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| 66 | 2021-03-23 | throat irritation |
Today at about 11: 30 AM, I took an Amoxicillin for gingival irritation. I have taken this medicine ...
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Today at about 11: 30 AM, I took an Amoxicillin for gingival irritation. I have taken this medicine before , but this was the first time since getting my Covid Vaccine. About one hour later, I began having intense itching of both hands, followed by diffuse flushing and pruritus and slight swelling around my face and eyes and a little feeling of throat irritation, but without SOB, wheezing or tongue swelling. My vital signs stayed stable, including a normal oximeter reading. I took a 180 mg Fexofenidine and used some OTC Hydrocortisone Cream on my hands when the first symptoms started. When the other symptoms progressed , I took 24 mg Methylprednisolone oral tablets and 25 mg liquid Diphenhydramine and my husband drove me to the ER, to be close in case I developed difficulty breathing. After about 30 minutes the symptoms stopped worsening and gradually resolved. I didn't go to ER
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| 66 | 2021-03-24 | fatigue, headache, chills | headache, fatigue, chills, vomitting, Extremely itchy hives, |
| 66 | 2021-03-24 | fatigue |
Pain in the left arm; Atrial fibrillation; Tired; This is a spontaneous report from a contactable co...
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Pain in the left arm; Atrial fibrillation; Tired; This is a spontaneous report from a contactable consumer (patient). A 66 years old female patient (weight: 107.95 kg, height: 165 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the left arm, on 04Mar2021, at 16:50, for COVID-19 immunisation. Relevant medical history included atrial fibrillation from Jan2016 and ongoing and cardiac ablation on an unspecified date, in Feb2020 (she had her 2nd ablation in Feb2020, since then she has had intermittent episodes of atrial fibrillation. She stated prior to the second vaccine she had been in normal sinus rhythm for 8 days). Patient stated that she had a sister who had an arrhythmia problem. The patient previously, on 10Feb2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) in the left arm, at single dose, for COVID-19 immunisation. Patient stated that she had no problem with first dose. The patient received concomitant medications (unspecified). On 04Mar2021, at 21:00, the patient experienced atrial fibrillation and on 04Mar2021 she was tired. On 05Mar2021, she developed pain in the left arm. The patient recovered from pain in arm on 05Mar2021, from tiredness on 07Mar2021, while did not recover from atrial fibrillation. The information on the lot number has been requested.
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| 66 | 2021-03-24 | head discomfort, throat clearing |
9:50 pt c/o mild pressure in middle of forehead and nervousness. Elevated legs and provided water. P...
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9:50 pt c/o mild pressure in middle of forehead and nervousness. Elevated legs and provided water. Pt took her own Tylenol at 10am. Reassessed at 10:15 due to pt coughing and constantly clearing throat, sensation that something was in her throat. NP administered 25 mg Benadryl PO at 10:20. Pt stated head issue resolved after Tylenol @ 10:45. 10:50 symptoms resolved states feels better, denied headache, and throat discomfort. She was able to drink water and eat candy (patient brought the candy). Discharged at 11:03.
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| 66 | 2021-03-24 | headache |
1/13 vaccination I started having HA about 7pm that night. BP was elevated; 170/110. Kept monitoring...
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1/13 vaccination I started having HA about 7pm that night. BP was elevated; 170/110. Kept monitoring. Would come down every day. Valcartin increase per PCM and it took care of the BP increase after 3 days.
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| 66 | 2021-03-24 | headache |
Four days of headaches starting 3/12/2021 (onset 7 days following vaccination) following by rapid on...
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Four days of headaches starting 3/12/2021 (onset 7 days following vaccination) following by rapid onset (~6 hr) nausea, vomiting, and encephalopathy with cortical blindness and altered level of consciousness on 3/15/2021. Found to have diffuse white matter hyperintensities on MRI brain. No spinal cord involvement. CSF analysis with lymphocytic pleocytosis. Negative infectious workup. Started on high dose steroids and plasmapheresis for presumed autoimmune encephalitis. Slow improvement in symptoms for the first 10 days following initiation of steroids (present day).
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| 66 | 2021-03-24 | malaise, headache |
moderately painful herpes simplex virus blister on my lower lip; moderately painful herpes simplex v...
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moderately painful herpes simplex virus blister on my lower lip; moderately painful herpes simplex virus blister on my lower lip; felt mildly unwell; slight headache/mild shooting pains into my left ear and on the left side of my head; mild shooting pains into my left ear and on the left side of my head for a couple of days; mild shooting pains into my left ear; This is a spontaneous report from a contactable nurse (patient). This non-pregnant 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EM-9809) via an unspecified route of administration in the left arm on 11Feb2021 at 14:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis, Hashimoto, nodular thyroid disease, and fever blister with the same shooting pain from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food or other products. Concomitant medications included metoprolol succinate and biotin from unknown dates for unknown indications. On 16Feb2021 at 08:00 the patient developed a moderately painful herpes simplex virus blister on her lower lip 5-6 days after the vaccine injection. She also felt mildly unwell with a slight headache and mild shooting pains into her left ear and on the left side of her head for a couple of days. The pains were reported as peripheral, not deep seated. She reported she had this fever blister before with the same shooting pains, but not after a vaccine. The events were reported as non-serious and did not require hospitalization. The patient was treated with valacyclovir (VALTREX) 2 grams every 12 hours for 2 doses on days 1 and 4. The clinical outcome of the moderately painful herpes simplex virus blister on her lower lip, felt mildly unwell, slight headache, and mild shooting pains into her left ear and on the left side of her head were reported as recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.
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| 66 | 2021-03-24 | throat pain, fatigue, headache |
Neuropathy type sensation in feet, lower legs, hands; difficulty breathing; tongue felt tingly and s...
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Neuropathy type sensation in feet, lower legs, hands; difficulty breathing; tongue felt tingly and swollen; raised red itchy rash on neck, chest and abdomen; swollen lymph glands in throat; diarrhea; sore throat; site soreness; achy joints; headache; nausea; fatigue; Racing heartbeat; throat felt lujeir was closing; tongue felt tingly and swollen; This is a spontaneous report from a contactable healthcare professional (the patient). A 66-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6205), via an unknown route of administration in the left arm on 06Mar2021 at 16:30 (at the age of 66-years-old) as a single dose for Covid-19 immunization. Medical history was included celiac sprue, Crohns, chronic pancreatitis, psoriasis, osteoporosis, and ulcerative colitis, all from an unknown date and unknown if ongoing. The patient was allergic to penicillin and codeine. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9269) on 13Feb2021 at 11:30 in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported however it was reported the patient had other medications in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 at 16:30, within 5 minutes of injection, the patient experienced Racing heartbeat, difficulty breathing, tongue felt tingly and swollen, throat felt lujeir was closing, and neuropathy type sensation in feet, lower legs, hands. The patient also experienced the typical side effects of site soreness, achy joints, headache, fatigue, nausea, sore throat, diarrhea, swollen lymph glands in throat, and raised red itchy rash on neck, chest and abdomen. Treatment of Benadryl was given for the events as recommended by paramedic which was still being taken on day 4. The clinical outcome of the events racing heartbeat, difficulty breathing, tongue felt tingly and swollen, throat felt lujeir was closing, and neuropathy type sensation in feet, lower legs, hands was recovered on 06Mar2021 (reported as 'last about 10 minutes'); outcome of site soreness, achy joints, headache, fatigue, nausea, sore throat, diarrhea, swollen lymph glands in throat and raised red itchy rash on neck, chest and abdomen was not recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 66 | 2021-03-24 | fever, fatigue |
Strange side effect started 5:30 pm 3/13 date of second injection. Felt extremely sad, depressed. ...
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Strange side effect started 5:30 pm 3/13 date of second injection. Felt extremely sad, depressed. Felt like crying but couldn't cry. Didn't know why I felt sad. Otherwise I felt great. Next day extremely tired, slept all day, couldn't move off the couch, had 100 degree fever, had light breakfast in am, light salad at 9:00 pm. Again, extremely sad in the morning, but as other symptoms took over sadness went away. The next day felt fine--no sadness, no symptoms. (Expected other side effects, but didn't expect sadness. I'm finding on facebook several other people felt sadness too, didn't know why. Other symptoms were expected.) No symptoms since.
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| 66 | 2021-03-24 | throat irritation |
Same as first dose, triggered asthma, scratchy throat, no rash, no hives, cleared with 25 mg PO bena...
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Same as first dose, triggered asthma, scratchy throat, no rash, no hives, cleared with 25 mg PO benadryl, her own albuterol inhaler, PO H20, relief, back to normal 25 mg PO benadryl, pepcid PO, 10 mg zyrtec to take home
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| 66 | 2021-03-25 | chills, headache | chills, body ache, headache |
| 66 | 2021-03-25 | fatigue, headache | Vomit headache exhaustion |
| 66 | 2021-03-25 | fatigue, fever, headache | Aches, fever (99) headache, tired lasted 36 hours. |
| 66 | 2021-03-25 | headache, fatigue |
Same day as vaccine administered 3/15/2021 Headache. Tiredness. During the early morning hours on 3...
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Same day as vaccine administered 3/15/2021 Headache. Tiredness. During the early morning hours on 3/16 Big Toe throbbing woke me up. Throbbing stopped in big toe and then moved to right wrist, then stopped at wrist and went to left leg. Throughout the next 24 hours their would be sharp pains in right ankle. Left arm at injection sight very painful. Pains would occur in different body parts next 24 hours. Extreme tiredness to the point of ongoing sleep well passed the 6 hours of regular sleep for me. It took 4 days for me to start to feel I was returning to normal function, the fifth day I felt normal. I thought this was a long time to recover from shot in comparison to what I did hear.
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| 66 | 2021-03-25 | headache, throat pain, fever |
has been feverish, weak, temperature of 99.8 on 3/25 10:33 PM PDT, neck, and throat hurts, sore musc...
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has been feverish, weak, temperature of 99.8 on 3/25 10:33 PM PDT, neck, and throat hurts, sore muscles, very sore at the injection site, diarrhea, nausea, headache, tender scalp These symptoms are unchanged after 24 hours (started approx 10 pm 3/24 is is now after 10pm 3/25.
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| 66 | 2021-03-25 | fever, chills, headache |
About 10am started having chills and fever, took 2 tylenol 10:30-11:30am - threw up 4 times 11:30-23...
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About 10am started having chills and fever, took 2 tylenol 10:30-11:30am - threw up 4 times 11:30-230pm - fever and chills, headache 5pm - fever and chills stopped Very low energy thru Friday 3/26
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| 66 | 2021-03-25 | fever |
I started fever 100.8 the next morning after the second vaccine, then climbed up to 101.2 in the af...
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I started fever 100.8 the next morning after the second vaccine, then climbed up to 101.2 in the afternoon. I also had attacking pain here and there, in joint, or muscles. It moves around every few seconds. I drank a lot of water and slept a lot. All symptom were gone by the evening. And I felt my normal self. But I started feeling a lump in the neck yesterday, feels like swollen lymph node. When i touch it or swallow food I feel the pain. Not sure if it is vaccine related. I feel it is. So I decided to report. Since it is Friday night now I couldn't check with my doctor till at least Monday.
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| 66 | 2021-03-26 | chills, headache | Headache, chills, nausea, rash |
| 66 | 2021-03-26 | cough, headache, fever, nasal congestion, chills |
Day after had chills, fever 101.4 neck ache, back ache both legs ache stuffy nose and cough. Took co...
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Day after had chills, fever 101.4 neck ache, back ache both legs ache stuffy nose and cough. Took covid test at pharmacy on March 24, 2021 and Test came back positive for Covid-19 on March 26,2021. Still have a low grade fever 99.2, stuffy nose, lost sense of taste and smell, ache in neck ,back, and legs head ache on and off.
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| 66 | 2021-03-26 | fatigue, headache, fever |
I don't think this is significant, but my husband encouraged me to report it anyway. Slight headac...
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I don't think this is significant, but my husband encouraged me to report it anyway. Slight headache started evening of March 25 p.m., took 2 aspirin and was fine after. Felt O.K. next morning, March 26, but tired. Went to gym as normal, did a light workout. Came home, didn't do much. Hands felt cold - not normal for me. Went out to dinner around 4:30 p.m., came home around 6:00 p.m. and was tired and freezing, Laid down for a while with two blankets, slept a little. Got up, took my temperature - 100.3. Took 2 aspirin and went to bed. Today, March 27, got up around 9:00 a.m., feeling normal! Temperature is 98.6.
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| 66 | 2021-03-26 | headache, fever, malaise |
high fever, headaches very ill. Neck stiff and the gland were swollen. could not eat or drink and se...
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high fever, headaches very ill. Neck stiff and the gland were swollen. could not eat or drink and severe pain and weakness.
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| 66 | 2021-03-26 | fever, lethargy, headache | I began running a fever of 101F which lasted approx. 36 hours. Also lethargy and slight headache. |
| 66 | 2021-03-26 | throat clearing |
Two hours post injection, experienced excessive, productive clearing of throat with a feeling of con...
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Two hours post injection, experienced excessive, productive clearing of throat with a feeling of congestion in chest which is still present. One week post injection could not sleep due to onset of frequent and bothersome cardiac palpitations with chest tightness which is still present at two weeks post vaccination.
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| 66 | 2021-03-27 | dehydration |
Approximately 32 hours after injection, I began to feel severe gastric bloating. The diarrhea began ...
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Approximately 32 hours after injection, I began to feel severe gastric bloating. The diarrhea began soon after, and then vomiting. Both projectile (I know, eww). I experienced this every 30-60 minutes for about 7 hours. Then the nausea subsided, and the episodes of diarrhea began to happen at longer intervals. I also experienced cold sweats and the next day my body temperature was reading low (96.4 at one point). My brain fog and weakness were probably the result of dehydration.
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| 66 | 2021-03-27 | lethargy, chills, headache, fever |
Extreme chills, low grade fever, nausea, very lethargic, horrible headache - symptoms lasted 2.5 day...
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Extreme chills, low grade fever, nausea, very lethargic, horrible headache - symptoms lasted 2.5 days
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| 66 | 2021-03-28 | chills, fatigue |
peripheral neuropathy in face; Covid-like symptoms; allergic reaction immediately after vaccination;...
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peripheral neuropathy in face; Covid-like symptoms; allergic reaction immediately after vaccination; dizziness; weakness; tingling; increased heart rate; brain fog; fatigue; chills; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; swollen lymph nodes; intermittent heart racing for 3 more days; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration, administered in the left arm on 10Mar2021 at a single dose (at the age of 66-years-old) for COVID-19 immunisation. Medical history included mild asthma, arthritis, known allergies: react to some food, insect bites, and had a bad reaction to shingles vaccine. There were no concomitant medications. The patient had no other medication in the last two weeks and no other vaccine in the last four weeks. On 10Mar2021, the patient experienced an allergic reaction immediately after vaccination which included dizziness, weakness, tingling, increased heart rate - lasting approximately 2 hours; followed by COVID-like symptoms of brain fog, fatigue, chills, muscle and joint soreness and stiffness, peripheral neuropathy in face, swollen lymph nodes and intermittent heart racing for three more days. The patient was not COVID tested post vaccination. No treatment was given in response to the events. The patient was recovering from the events. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-03-28 | headache, chills | chills, dry heaves, dizzy, headache continuing for 13 hours so far |
| 66 | 2021-03-28 | productive cough, chills, fatigue, headache, sweating, lethargy |
feels drugged; fluid in her chest that she didn't have before; Coughing and spitting up white mucous...
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feels drugged; fluid in her chest that she didn't have before; Coughing and spitting up white mucous out of her chest; feels so tired; no appetite, food doesn't taste right; sweating and chills; sweating and chills; feels weak; extremely sick; joints and arms hurt; joints and arms hurt; doesn't feel like walking around/Lethargic; can't hardly even talk to people; Headache; feels like she has been poisoned; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9267), via an unspecified route of administration on Left arm on 09Mar2021 between 15:00 and 16:00 at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient states she took that shot on Tuesday and she is still sick and still doesn't feel good. States that she feels better, but she is coughing and spitting up white mucous started on 10Mar2021. She feels like she has been poisoned in Mar2021. States that she is coughing stuff up out of her chest. States that she took this on Tuesday (09Mar2021) and still feels drugged and tired. She states that it made her extremely sick and she is not taking the second shot. She states she took the shot Tuesday and didn't get sick until three to four hours after, she was down feeling so bad, like an ailment or disease. She states she feels like we gave her the Covid. She states she won't even go to the hospital because can't trust anyone. States that her joints and arms hurt and can't hardly even talk to people on 09Mar2021. States she has fluid in her chest that she didn't have before on 10Mar2021. States that this is the first day she has gotten out of bed. States that she is not taking the second shot. States that she had to sit for fifteen minutes after her shot and she felt fine. Clarified that she couldn't eat, she had sweating and chills for two to three days and she couldn't even get out of bed on 19Mar2021. States she feels better but still feels weak and lethargic on 09Mar2021. States it has improved since yesterday. States that her food doesn't taste right but no appetite on 09Mar2021. States the sweating and chills ended 11Mar2021. She states that she had a headache and it started on 09Mar2021 and it went away 12Mar2021 with treatment of Aspirin. Not sure if she is going to recover. Prior to vaccination, was the patient was not diagnosed with COVID-19. The outcome of events Poisoning; feels drugged, extremely sick was unknown, for Coughing and spitting up white mucous out of her chest was not resolved, for headache it was resolved on 12Mar2021, for feels so tired; no appetite, food doesn't taste right; joints and arms hurt; doesn't feel like walking around; can't hardly even talk to people; feels weak; Lethargic was resolving, for fluid in her chest that she didn't have before was not resolved, for sweating and chills it was resolved on 11Mar2021. Follow-up attempts are completed. No further information is expected.
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| 66 | 2021-03-28 | fever | warmth at site w fever 39 next day |
| 66 | 2021-03-30 | chills, body temperature increased, fatigue |
Nausea; fatigue; chills; 99.6 temperature; This is a spontaneous report from a contactable consumer ...
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Nausea; fatigue; chills; 99.6 temperature; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EM9809; Expiration Date: unknown) via an unspecified route of administration, in right arm on 09Feb2021 13:45 at single dose for COVID-19 immunisation. Medical history included complex regional pain syndrome, CRPS (non-active), fibromyalgia, multiple non-life-threatening allergies to medications and environmental. The patient not-receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient not received within 2 weeks of vaccination; Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 11Feb2021 11:00, the patient experienced nausea, fatigue, chills, 99.6 temperature. On 11Feb2021, the patient underwent lab tests and procedures which included body temperature: 99.6 The outcome of events was not recovered. No follow up attempts are possible. No further information is expected.
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| 66 | 2021-03-30 | chills |
I woke up the following morning (March 5) having chills, vomiting, and very very weak-----but no fev...
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I woke up the following morning (March 5) having chills, vomiting, and very very weak-----but no fever. On Saturday I was better but still weak and that is when cellulitis started in my left leg. On March 7, 2021, I was seen in the ER. I was given a shot and antibiotics and told to return if not better. So on Monday, March 8, I returned to ER and then was admitted to the hospital. I was allowed to go home on Saturday, March 13. Since then I had two sores to develop on my left leg. I had to have wound surgery on them on March 25. I am a lot better but still not completely well.
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| 66 | 2021-03-30 | fatigue, headache, malaise, influenza like illness |
feeling very tired; headache; Muscle pain; Joint pain; Nausea; feeling unwell like the flu; feeling ...
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feeling very tired; headache; Muscle pain; Joint pain; Nausea; feeling unwell like the flu; feeling unwell like the flu/awful; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261) intramuscularly on 21Jan2021 at single dose in left arm for COVID-19 Immunization. Medical history and Concomitant medications were not reported. It was reported that she wanted to report reaction to Pfizer Covid 19 vaccine. stated she was very tired, headache, muscle pain, joint pain, nausea, feeling unwell like the flu. Was injected on 21Jan2021 and this started on 22Jan2021. stated that it has been awful since then. Is her first shot. Stated that since she had such a bad time with the first one should she get the second one. stated that the outcome of feeling very tired and muscle pain varies and cannot be directly determined. Stated that feeling very tired and muscle pain is ongoing. Treatment was reported as none. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-03-30 | fatigue, malaise |
body aches; stomach pains; tiredness; feeling unwell; nausea; Body tingling; dizziness; This is a sp...
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body aches; stomach pains; tiredness; feeling unwell; nausea; Body tingling; dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Formulation: Solution for injection, Lot Number: EL8982, Expiry date: Unknown) via an unspecified route of administration in left arm on 10Feb2021 09:00 as single dose for covid-19 immunisation. Medical history included chronic depression, high cholesterol and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Formulation: Solution for injection, Lot Number: EL3248, Expiry date: Unknown) via an unspecified route of administration in left arm on 21Jan2021 17:15 as single dose for covid-19 immunisation. There was no special history of allergies. Concomitant medications included citalopram 20 mg, aripiprazole 2 mg and rosuvastatin for an unspecified indication. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 10Feb2021 09:00, the patient experienced body tingling and dizziness. 3 days after injection on 14Feb2021, the patient experienced body aches, stomach, tiredness, feeling unwell and nausea. The patient hasn't been tested PCR for COVID-19 since the vaccination. Therapeutic measures were not taken as a result of adverse events. The outcome of the events were reported as recovering.
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| 66 | 2021-03-30 | fatigue, fever, sweating |
she slept unbelievably good the night of 04Mar2021/she wanted to sleep a lot; she had no energy at a...
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she slept unbelievably good the night of 04Mar2021/she wanted to sleep a lot; she had no energy at all; she had achiness; she knewshe had a high fever; Sweating; unbelievable fatigue/she was really tired; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 66-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, administered in the right arm, on 04Mar2021 16:30 (at the age of 66 years old) at a single dose for covid-19 immunisation. This was administered as a pharmacy/drug store. Medical history included asthma for a very long time and overweight. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 via intramuscular route in the right arm on 30Jan2021 (at the age of 66 years old) at a single dose for covid-19 immunization. She did not have any problems with the first dose. The patient had no additional vaccines administered on same date of the Pfizer vaccine. There were no prior vaccinations within four weeks. The patient reported she was really tired after receiving her second COVID-19 Vaccine on 04Mar2021, saying she slept unbelievably good the night of 04Mar2021. On 05Mar2021, the patient experienced she had instantly come down with unbelievable fatigue, she wanted to sleep a lot, she had no energy at all (if she tried to do something, she would have to lay down afterwards), she had achiness, she knew she had a high fever, even though she did not check her temperature, she knew her fever was high because she was sweating but it was nothing she was worried about. She stated she was concerned about the unbelievable fatigue she was experiencing. Her tiredness had improved some, and her achiness resolved about the second day (unspecified date in Mar2021). She stated her fever went away in two days (unspecified date in Mar2021). Reported the pharmacist told her to take TYLENOL after the second COVID-19 Vaccine. She bought a bottle of TYLENOL while she was at the drug store, but she decided not to use the TYLENOL for the symptoms. Reported she didn't take her PROLIA injection in Jan2021 because she didn't want it to interfere with her upcoming COVID-19 Vaccine. She said she self-administered her PROLIA injections, and hadn't restarted it at this time. All the events did not require a visit to emergency room or physician office. Outcome of the events fatigue, she wanted to sleep a lot, she had no energy at all was recovering. Outcome of the events achiness, fever and sweating was recovered on unspecified date in Mar2021. Information on the lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021296202 same reporter, drug and events, different patient
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| 66 | 2021-03-30 | fatigue |
having problems swallowing, she kept getting choked when drinking water; she said the fatigue was ri...
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having problems swallowing, she kept getting choked when drinking water; she said the fatigue was ridiculous, and the fatigue knocked her off her feet; feeling jittery and irritable; feeling jittery and irritable; This is a spontaneous report from a contactable consumer. This 66-Year-old female consumer (patient) reported for herself that she received the second dose of BNT162B2 (Pfizer-Biontech COVID 19 vaccine, Lot number EN6200) at single dose for COVID-19 immunisation on 26-FEB-2021 at 11:30. Relevant history was unknown. The patient previously received Pfizer-Biontech COVID 19 vaccine on 05Feb2021 for COVID-19 immunisation. Past drug included mild blood pressure medication. Relevant concomitant drug was unknown. The patient has fatigue, she kept getting choked when drinking water, feeling jittery and irritable since 28Feb2021. She said the fatigue was ridiculous, and the fatigue knocked her off her feet. The patient asked if there was something she could do for the fatigue she was experiencing. This reaction was really not good. She was having problems swallowing. She said the swallowing problem started at the same time as the fatigue on Sunday, 28Feb2021. No treatment was received for the events. The outcome of event having problems swallowing was not resolved. The outcome of other events was unknown.
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| 66 | 2021-03-30 | head discomfort |
Chest pain; Pressure in head & face; Pressure in head & face; Pains in nape, across the shoulders an...
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Chest pain; Pressure in head & face; Pressure in head & face; Pains in nape, across the shoulders and front/top head; Weakness in arms right worse than left; Tingling in right hand; Nausea; Salty taste in mouth; Elevated blood pressure; Dry mouth; Indigestion; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3246), via an unspecified route of administration in left arm at the age of 66-years (non-pregnant at the time of vaccination), on 01Feb2021 at 08:00 AM at a single dose for COVID-19 immunization. The patient's medical history included osteopenia and allergies to PCN (penicillin) and latex. Concomitant medication included glucosamine, curcuma longa (TURMERIC [CURCUMA LONGA]), fish oil (OMEGA 3 [FISH OIL]), calcium citrate (CITRACAL [CALCIUM CITRATE]), colecalciferol (VIT D3), cranberry, and biotin. The patient previously took first dose of bnt162b2 (Lot number: EK9231), via an unspecified route of administration in left arm at the age of 66-years, on 13Jan2021 at single dose for COVID-19 immunization. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. The patient experienced pressure in head & face, pains in nape, across the shoulders and front/top head, weakness in arms right worse than left, tingling in right hand, nausea, salty taste in mouth, elevated blood pressure, dry mouth, and indigestion on 05Feb2021. The patient also experienced chest pain on 10Feb2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement on 05Feb2021: elevated; nasal swab on 11Feb2021: pending result. The patient received paracetamol (TYLENOL) and ibuprofen (ADVIL) as treatment for the events. The patient also used heating pad and icepack as treatment for the events. The outcome of the events was not recovered.
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| 66 | 2021-03-30 | sweating |
drop in blood pressure; swelling of the face and throat; swelling of the face and throat; fast heart...
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drop in blood pressure; swelling of the face and throat; swelling of the face and throat; fast heart beat; no appetite; exacerbation of existing neuropathy; Palpitations; being lightheaded; sweating; burning mouth syndrome; burning mouth syndrome; especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire; especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire.; especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire.; Some of my reactions look like an allergic reaction; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 66-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL3302, expiry date not reported) via an unspecified route of administration, administered in left arm on 11Mar2021 14:00 at a single dose for COVID-19 immunisation. Medical history included neuropathy from 2006 and ongoing, since she had chemotherapy in 2006 for breast cancer in 2006 and burning mouth syndrome. The patient had no covid prior vaccination. The patient had no known allergies. The patient had other medications in two weeks which included unspecified dietary supplements. The patient had no other vaccine in four weeks. The patient previously took doxycycline from 2010 to an unknown date for Lyme's diseaseand experienced burning mouth syndrome. On 11Mar2021 at 02:00 PM, patient had palpitations, being lightheaded, sweating, exacerbation of existing neuropathy and especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire. These symptoms still continue. Patient stated that people were talking about the second dose being worse. Patient stated that some of the reactions in Mar2021 look like an allergic reaction. They (HCP) only have cautioned the patient about difficulty breathing in Mar2021. They were saying there wasn't anything they can do for it. Patient asked how long the side effects will last and how to go about changing the appointment. If they are going to continue, patient was very concerned about following up with the second shot and asked if they can have that second shot be postponed until patient was not experiencing these side effects to the effect that she was. She completed the self-reporting on Monday (15Mar2021), but because her side effects were not going away she wanted to reach out to someone. She has reached out to her practitioner and had an appointment yesterday. Doctors didn't really know because it was all very new. She had the first vaccination shot on 11Mar2021, almost a week ago. In the 15 minutes that she waited afterwards she definitely experienced palpitations and a feeling of lightheadedness. She has an underlying condition of burning and pain called neuropathy. She has had neuropathy since she had chemotherapy in 2006 for breast cancer. This exacerbated that. She had been very concerned about that prior. Everyone said and the CDC recommends even with neuropathy to go ahead with the vaccine. It also triggered another underlying condition. She had a reaction to a course of Doxycycline in 2010 for Lyme's disease that caused burning mouth syndrome. Both of these things were really acute now, the neuropathy and burning mouth syndrome. Monday (15Mar2021) was a particularly bad day because the symptoms of an allergy which were swelling of the face and throat, fast heart beat, and dizziness were with the burning mouth syndrome. She didn't have difficulty breathing. It was the nerve endings of the tongue that go all the way to the back of her throat and gave the sensation of the whole mouth being involved. Monday was difficult. It was 8 hours of an acute episode then it eased off a little that evening. She had no appetite on Monday and barely ate anything. Yesterday was ok and much better although she was being triggered by environmental thing such as food and toothpaste. Things she normally uses were setting it off. She had an acute reaction this morning to a protein shake she has had every day for 14 years. The reaction this morning, 17Mar2021, was a drop in blood pressure and palpitations. It passed. She has been documenting this and made her provider aware of what she was experiencing. She was participating in the V-Safe through the CDC that checks up on her everyday and asks about symptoms. She didn't know if she was supposed to report this to the vaccine adverse event system or not. Obviously, she didn't want to get COVID. She was struggling with the recommendation to get second shot because she was extremely concerned. She wanted to know how long will the side effects will last and if she can postpone getting the second shot until she gets reasonably well. No practitioner can recommend whether to do it or not to do it. She reported this information online to Pfizer on 15Mar2021. She provided the lot number when she reported it online. The patient was not tested for COVID post vaccination. No treatments received from the events had palpitations, being lightheaded, sweating, exacerbation of existing neuropathy and especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire. The patient recovered with lasting effects from the events had palpitations, being lightheaded, sweating, exacerbation of existing neuropathy and especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire. The outcome of the other reported events was unknown.
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| 66 | 2021-04-06 | fatigue, headache |
After dose 1 on 02/24/2021 in right arm had typical side effects: sore arm, headaches, fatigue, nau...
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After dose 1 on 02/24/2021 in right arm had typical side effects: sore arm, headaches, fatigue, nausea, diarrhea. Nausea & diarrhea stopped after ~ 3 days. Headaches, fatigue continued for about 2 weeks possibly longer. Also began having intermittent facial twitching on right side: cheek, cheekbone. Twitching continued interittently for ~2 wks or more, all on right side of face. After dose 2 on 03/17/2021 in LEFT arm, my dominant arm, side effects included: sore arm, headaches, fatigue, nausea. Nausea ended after ~2 days. Headaches and fatigue continued intermittently for ~10+ days. Adverse event described in on Continuation Page.
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| 66 | 2021-04-06 | fatigue, headache |
After dose 1 on 02/24/2021 in right arm had typical side effects: sore arm, headaches, fatigue, nau...
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After dose 1 on 02/24/2021 in right arm had typical side effects: sore arm, headaches, fatigue, nausea, diarrhea. Nausea & diarrhea stopped after ~ 3 days. Headaches, fatigue continued for about 2 weeks possibly longer. Also began having intermittent facial twitching on right side: cheek, cheekbone. Twitching continued interittently for ~2 wks or more, all on right side of face. After dose 2 on 03/17/2021 in LEFT arm, my dominant arm, side effects included: sore arm, headaches, fatigue, nausea. Nausea ended after ~2 days. Headaches and fatigue continued intermittently for ~10+ days.
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| 66 | 2021-04-10 | fatigue |
Platelets dropped to 3000. Went to ER. Given 2 units of platelets immediately and omitted for 9 day...
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Platelets dropped to 3000. Went to ER. Given 2 units of platelets immediately and omitted for 9 days of treatments. Received a call from my doctor urging me to get to the ER immediately after receiving my quarterly blood work. Other than feeling somewhat fatigue I presented no symptoms. I was a walking time bond and in very serious danger of a bleed out. This was 9 days after my 2nd injection.
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| 66 | 2021-04-11 | fever, malaise, chills |
My mother became very ill-- labored breathing, chills, slight fever, body aches, throwing up and dia...
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My mother became very ill-- labored breathing, chills, slight fever, body aches, throwing up and diarrhea throughout the weekend. By Sunday (48 hours later), she was having black outs and ended up passing away on Monday, March 22, less than 72 hours later. She was fine without symptoms prior to the shot.
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| 66 | 2021-04-12 | fever |
four days after second shot, severe stomach pain, fevers, trouble urinating, chest pain, . turned in...
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four days after second shot, severe stomach pain, fevers, trouble urinating, chest pain, . turned into kidney infection, blood infection and having AFIB, need for pace paker.
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| 66 | 2021-04-15 | body temperature increased |
Received second shot on April 2@ 1130am. Started with diarhhea and vomiting's on April 6 at 3:30 a...
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Received second shot on April 2@ 1130am. Started with diarhhea and vomiting's on April 6 at 3:30 am. Continued to 4:30 am on April 10. Slight elevated temperature at 99.1 . On morning of April 11 couldn't put pressure on right side, leg and arm, facial numbness. Went to er and they said I was having a stoke, transferred to hospital. MRI done verified Stroke with blood clot to Left thalamus Sent home and will be receiving PT and OT.
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| 66 | 2021-04-17 | headache |
seizures; muscle fatigue; hives; rash from head to toe; sore muscles; wrap around headache; This is ...
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seizures; muscle fatigue; hives; rash from head to toe; sore muscles; wrap around headache; This is a spontaneous report received from a contactable healthcare professional (patient herself). A 66 -year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: EN6208; Expiration Date: 30Jun2021) as a single dose for COVID-19 immunisation. She provided a brief history from 2017. She was walking her dog and she fell and suffered a concussion, she had a seizure, then she developed bipolar disorder. She's been taking sodium valproate (DEPAKOTE) for her seizures since 2017. She reports she's very active. She's not an old lady. She can run circles around some 22 year old's. In September of 2017, she had a concussion and had seizures. She's been on sodium valproate (DEPAKOTE) since that time. She's not mentally ill, the concussion she got in 2017 caused her brain to turn bipolar. It's hard for people to understand that. Sodium valproate (DEPAKOTE) was 500mg. She takes 1 tablet in the morning and 2 tablets at night because it can make you sleepy. She reports she was recently hospitalized in Feb2021 for atrial fibrillation with rapid ventricular rate (RVR). Her heartrate was 181 beats per minute, her blood pressure was dropping, she tested positive for rhinovirus and the doctor thinks the atrial fibrillation with RVR was caused from the rhinovirus. She was allergic to bee venom and carries an EPI PEN. Medical history also included ongoing high blood pressure from an unspecified date (controlled with medication). Concomitant medications included ongoing metoprolol tartrate (LOPRESSOR) taken for blood pressure; ongoing lisinopril; ongoing valproate semisodium (DEPAKOTE) taken for seizure from 2017; ongoing hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) taken for blood pressure; paracetamol (TYLENOL) from an unspecified date in 2021. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Mar2021 (Batch/Lot Number: EM9810; Expiration Date: 30Jun2021). The patient did not receive any recent vaccines for any other conditions or any recent vaccines for any other conditions prior to the event being reported; or any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient reported that with the second Covid 19 vaccine she had two seizures on 27Mar2021. The seizures were back to back. The seizures resolved within 2 minutes. She had fatigue from an unspecified date, sore muscles and a wrap around headache on 26Mar2021. The wrap around headache felt like she was going to have a stroke even though her blood pressure was fine. She monitored her blood pressure at her home. She feels it's weird that they publish that the second Covid 19 vaccine is going to be worse. She thought she'd have muscle soreness and fatigue but not seizures. She looked it up and the wrap around headache and seizure are the rarest things that can happen after receiving the Covid 19 vaccine. She stayed in bed from Friday afternoon after she received the second Covid 19 vaccine on 26Mar2021 and started to feel better Sunday afternoon, 28Mar2021. Her blood pressure and pulse were both fine with her wrap around headache. She had fatigue with both Covid 19 vaccines. She also developed hives, which she still has. She has a rash from her head to her toes. It looked like she rolled around in an ant bed. The hives were clearing up. She was using an anti-itch cream. The hives and the rash started midday on Saturday, 27Mar2021. She only has around 5 hives now on her chest. She hasn't taken Benadryl. She doesn't like to take it. Her doctor didn't want her to open the hives and cause impetigo. She never had any soreness in her arm. She doesn't think the headache was serious because she had a blood pressure cuff at home. She just knew the hives and the rash were a reaction to the Covid 19 vaccine. She didn't go to the hospital for her seizures. She was not seen in the Emergency Department, hospitalized, or admitted to an Intensive Care Unit. She tries to do holistic medicines and treatments. She doesn't run to the hospital every time something happens. She tries to stay out of the hospital. She's fine now and she loves Pfizer. If she can get a medicine she needs that Pfizer makes she tries to get it. She tries to see every side of things. Outcome of seizures was recovered on 27Mar2021 and sore muscles was recovered on 28Mar2021; of remaining events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and seizure cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 66 | 2021-04-23 | chills, headache, fever |
Fever of 100.8; chills; headache; This is a spontaneous report from a contactable consumer (patient ...
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Fever of 100.8; chills; headache; This is a spontaneous report from a contactable consumer (patient sister). A 66-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) second dose via unspecified route of administration, administered in left arm on 02Feb2021 13:30 and first dose via unspecified route of administration, administered in left arm on 12Jan2021 3:00 PM as single dose for COVID-19 immunization. The patient medical history included prior breast cancer. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. Patient does not for underwent lab test and procedures which included COVID-19 test for post vaccination. On 10Feb2021 03:00 PM patient experienced Fever of 100.8, chills, headache. This report was for reporter's sister who received the second dose of the Pfizer COVID vaccine. The reporter reported it on the day she told me about it also reported that within 24 hours of learning of her reaction as required under our reporting policy. The outcome of the events was recovered. Follow-up (19-Feb2021): This is a follow-up spontaneous report in response to mail trail sent regarding confirmation of reporter and awareness date. This report included the awareness date. Information about lot and batch number was requested.
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| 66 | 2021-04-23 | fever, headache |
fever of 101.3; full body muscle pain; headache; vomiting; This is a spontaneous report from a conta...
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fever of 101.3; full body muscle pain; headache; vomiting; This is a spontaneous report from a contactable consumer or other non hcp. A 66-year-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: 9809; Expiration Date: unknown) via an unspecified route of administration, in Arm Right on 09Feb2021 08:15 for COVID-19 immunization.The patient previously took first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: 3247; Expiration Date: unknown), via an unspecified route of administration, in Arm Right on 19Jan2021 08:15 for COVID-19 immunization. The patient previously took Levaquin and bnt162b2.Medical history included neuropathy peripheral, rosacea, drug hypersensitivity to levaquin. Concomitant medications included vitamins (MULTIPLE VITAMIN), ciclosporin (RESTASIS), calcium and omega 3 taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Feb2021 22:00, the patient experienced fever of 101.3, full body muscle pain, headache, vomiting. The patient underwent lab tests and procedures which included body temperature: fever of 101.3 on 09Feb2021. The outcome of the event was recovered.
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| 66 | 2021-04-23 | fever |
Lost her sense of taste and smell; Lost her sense of taste and smell; Tested positive for Covid afte...
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Lost her sense of taste and smell; Lost her sense of taste and smell; Tested positive for Covid after receiving first dose of vaccine; Tested positive for Covid after receiving first dose of vaccine; Fever; body aches; Diarrhea; stomach symptoms abdominal discomfort; This is an initial spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNTl62B2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL8982; Expiration Date: 20May2021) first dose via an unspecified route of administration and administered in right arm on 23Jan2021 14:00 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Past drug included When she gets the flu shot, she gets a low grade fever and body aches for about 1 night. No Lot/NDC/Expiry for any of those Flu shots. States that this happens every year. On 08Feb2021 patient underwent lab test and procedures which included COVID-19 test and tested positive for first dose vaccine. Patient about the Covid-19 Vaccine. States that she doesn't know if there is something for self reporting, but her mom and her husband both got the vaccine, then 16 days later got symptoms of Covid, then on the 17th day, tested positive for Covid; and this was after the first dose of the vaccine. States that her mom, is on day 12 of Covid and still having symptoms. States that she was tested for Covid-19 on 08Feb2021, and it resulted on 10Feb2021 as positive. She started having symptoms such as body aches on 07Feb2021 to 08Feb2021, and the fever started 08Feb2021 to ongojng. She still had a fever yesterday. Caller states that the fever would disappear for a day or two, then come back, and this has been going on for the last 10 days. She also lost her sense of taste and smell about a week ago, and got it back about 1.5 days ago. Also had stomach symptoms as well, had diarrhea on 06Feb2021 and 17Feb2021, resolved that day 17Feb2021. The outcome of the events like Drug ineffective and SARS-CoV-2 test positive were unknown, pain, Ansomia, Ageusia and Diarrhoea was recovered and fever was not recovered.
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| 66 | 2021-04-24 | fatigue |
Erythema multiforme; asthma attack/shortness of breath/cough; Rash started on legs on the 03Apr2021 ...
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Erythema multiforme; asthma attack/shortness of breath/cough; Rash started on legs on the 03Apr2021 late morning buy next day (04Apr2021) full body rash from shoulders to top of feet; extreme exhaustion; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER 8730), via an unspecified route of administration, administered in left arm on 02Apr2021 09:15 as single dose for covid-19 immunisation. Medical history included heart disease, high blood pressure, asthma, drug hypersensitivity and wasp stings. Concomitant medication(s) included amlodipine; aspirin and atorvastatin. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 09:45 late morning, the patient experienced rash started on legs by next day (04Apr2021) full body rash from shoulders to top of feet. Later on 03Apr2021, extreme exhaustion and dry cough that went into shortness of breath and asthma attack. Visit to ER and later sent to dermatologist. Possible Erythema multiforme. As of 09Apr2021 still have rash and exhaustion and dry cough. It was unknown whether patient received any treatment. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-04-24 | nasal congestion, runny nose, sneezing |
Allergic reaction/Reaction or allergies; Stuffy head; nose began to run and began to sneeze; sneeze;...
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Allergic reaction/Reaction or allergies; Stuffy head; nose began to run and began to sneeze; sneeze; Nasal stuffiness; Seasonal allergies; Rheumatoid arthritis; Joint and muscle pain that are worse; Joint and muscle pain that are worse; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on 29Mar2021 as single dose for COVID-19 immunization; and treprostinil sodium (TYVASO), via resp inhalation from Feb2021 to an unspecified date, at 18-54mug (3-9 breaths), 4x/day for secondary pulmonary arterial hypertension. Medical history included ongoing secondary pulmonary arterial hypertension, ongoing arthralgia, ongoing myalgia, seasonal allergy, and hypertension from an unknown date. Concomitant medications included sildenafil citrate taken for an unspecified indication; and amlodipine besilate taken for hypertension. The patient previously took meloxicam for joint pain. On an unspecified date in 2021, the patient experienced joint and muscle pain that are worse, rheumatoid arthritis and seasonal allergies. The patient had joint and muscle pain for a while, but was worse since starting treprostinil sodium. The event of rheumatoid arthritis was considered as medically significant. The patient had joint and muscle issues (arthralgia, myalgia, and rheumatoid arthritis) that could be debilitating, reported that they were getting better with the Nabumetone. On 29Mar2021, the patient had nasal stuffiness that started when she went on an outing. She felt like she was doing better this week than last week (at time of report). On 31Mar2021, the patient reported that she was having a reaction or allergies. She received her first COVID vaccine on 29Mar2021 and felt fine but woke up on Tuesday (30Mar2021) with stuffy head, nose began to run, and began to sneeze. The action taken in response to the events for treprostinil sodium was unknown. The outcome of the events arthralgia and myalgia was recovering, for rheumatoid arthritis was not recovered, and for other events was unknown. The reporter's causality for the event of myalgia and arthralgia with IH Tyvaso was considered to be possibly related. The reporter did not provide causality for the events of rheumatoid arthritis and seasonal allergy. Case Comment/Senders Comment: The company has assessed the serious adverse event of drug hypersensitivity and rheumatoid arthritis as not related to IH treprostinil and TD-300/A device. Drug hypersensitivity was likely due to administration of COVID vaccine. Rheumatoid arthritis was likely an underlying medical condition in this 66-year-old patient based on an implausible time to onset for the reported event. Information on the lot/batch number has been requested.
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| 66 | 2021-04-24 | sinusitis |
prone to sinus infections; Tested positive for COVID; This is a spontaneous report from a contactabl...
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prone to sinus infections; Tested positive for COVID; This is a spontaneous report from a contactable Nurse. A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EL9262), dose 1 via an unspecified route of administration, administered in left deltoid on 08feb2021 at 3:15 PM as single dose for covid-19 immunisation. Medical history included sinusitis, diverticulitis. Concomitant medication(s) included levothyroxine sodium (LEVOXYL) taken for thyroid disorder, docusate sodium (COLACE) taken for diverticulitis; calcium carbonate, Vitamin D 2000 units, colecalciferol (vitamin d 2000). Her husband started not feeling well 1.5 weeks post vaccination. She specified her husband was also sneezing and she didn't have symptoms beside maybe a sinus congestion when waking up in the morning, which she has regularly. She said they are both prone to sinus infections (non serious), and her husband had a "sinus infection" with a "negative covid-19 test back in november. Due to having contact with her husband who had tested positive for COVID she also got tested for COVID. She mentioned she only goes out walking 3-4 miles each day, or bicycle 6-7 miles a day in the gym downstairs in their apartment complex. She has no symptoms whatsoever. She was not sleeping a lot with her husband because he was already in a different room due to his sleeping habits. She had a rapid COVID test done on 20Feb2021 and it was negative. On Saturday at the Urgent care she asked were the Rapid PCR test could be done. The rapid test was done via nasal swab. She had an oral COVID test done yesterday 21Feb2021 and it was positive. She has not had the second dose of the vaccine yet. The event assessed as medically significant. The outcome of the events was unknown.; Sender's Comments: Based on the temporal relationship, A possible contributory role of the suspect product to the development of Sinusitis cannot be excluded.,Linked Report(s) : US-PFIZER INC-2021218654 same reporter/drug, similar event, different patient
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| 66 | 2021-04-26 | fatigue, headache, fever |
terrible headaches; fever; nausea; terrible stomach pain; colitis; fatigue; diarrhea; she was sick; ...
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terrible headaches; fever; nausea; terrible stomach pain; colitis; fatigue; diarrhea; she was sick; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included sore arm as a side effect when she had a pneumonia shot. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation and had a sore arm for 2 days and joint pain for over a week.On an unspecified date after 2 dose of vaccine, patient experienced terrible headaches, fever, nausea, terrible stomach pain, fatigue, diarrhoea, colitis which she had never had before and she was sick. It was reported that at the end of the week patient started feeling better, however she started with diarrhea again and its been for over a week. If she eats anything she had to go right to the bathroom (banana, rice, turkey, eggs (8 pounds to begin), she was trying to hydrate herself. She started eating lightly trying to heal, and after a week she thought she was better, now her stomach was a wreck. Patient wanted to know the duration of these symptoms and if vaccine could have been contaminated and if she was going to have this gastric symptom for a long time or the whole time.She would like to know how the vaccine works and how does it leave your system. She says that the minute she got home she had the runs, it went right through her. She says she started eating lightly trying to heal, and after a week she thought she was better, now her stomach was a wreck. She says she had done a report before. Caller says that she would like to report that and ask question, since the vaccine was in her, would this always be a problem, it feels like she had colitis which she has never had before. She said she could not get to her doctor for an appointment for a few days, and she would like to know if it could be her IBS. She said with a normal medication she could drink a lot to get it out of her system, but with a vaccine she was not sure of what she could do. She says after the second time she did an online report and then she was starting to feel much better then her stomach exploded again. Caller says she can't eat much, and she was wondering how the vaccine works, since it was still in her and irritating her. The outcome of the event's terrible headaches, fever, nausea, terrible stomach pain, fatigue, colitis and she was sick were reported as unknow and the outcome of diarrhoea was not recovered. Information on batch number has been requested.
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| 66 | 2021-04-26 | headache, fatigue |
nervous; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels li...
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nervous; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Constipated; Doesn't sleep through the night; Headache lasted for days and days; No appetite, lost 6 pounds in a week; No appetite, lost 6 pounds in a week; Tired; Diarrhea; Nausea; felt like Dumping Syndrome; Stiff neck, like an iron claw; Anxiety reared up; Blacked out; Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 17Mar2021 at 11:30 AM (at the age of 66 years old) (Lot Number: EN6205, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included ongoing anxiety (40 years or more), ongoing depression (46 years ago, at the age of 20), ongoing acid reflux (maybe 25 years), ongoing GERD (maybe 25 years), ongoing Barrett's esophagus (for 12 years), mild to moderate COPD since 2011, gastric bypass (a year and a half ago), and lost 120 pounds. Concomitant medications included bupropion for anxiety depression and omeprazole for acid reflux, both ongoing. The patient previously received flu and tetanus on unspecified dates for immunization and both experienced hard red welt on arm (welt was hard and lasted for 5-7 days). The patient reported no side effects for 12 hours, but a little soreness at injection site on 17Mar2021 at 20:00 (8:00 PM). Her arm wasn't heavy, but she had an awareness of the soreness. She has had life-long anxiety and depression. Several weeks ago (on 26Mar2021), her anxiety reared up, and it could have been due to a family situation. On the 9th day after the first shot, she was having a therapy appointment on the phone and talking about her anxiety, and she got a stiff neck, like an iron claw (26Mar2021 at 10:00 am). It lasted for a couple of 5 minutes and she laid down on the couch then on the floor. Her therapist said to call 911. Emergency medical technicians came to her house and they said all of her numbers looked good. She went to the hospital, and was in the emergency room for several hours, but she only remembers one hour of it. She also had diarrhea and nausea on 26Mar2021 at 11:30, and it felt like Dumping Syndrome, that one can have from a gastric bypass. She was only aware for one hour at that point and blacked out (on 26Mar2021). With regards to nausea, she mostly saw bile in the bag, all she had that day was a protein drink. She was back home and the next day, she did not remember how she got home. She hasn't had blackouts anymore but feels it may be from heightened anxiety. On 27Mar2021 at 09:00, she had no appetite, lost 6 pounds in a week, and was tired. She had headache lasted for days and days on 29Mar2021 at 09:00 AM. She is slowly improving but she still doesn't sleep through the night on 29Mar2021 at 16:00. It was like a feeling like she was resetting her surgery, like she didn't care about eating. The also experienced back pain, butt and legs hurt, feels like sciatica on 31Mar2021 at 16:00 and was constipated. She is using a stool softener and is back in her routine. She called her primary doctor and could not tell her what happened, and she went in a loop trying to get information and authorizations for her to make a determination of what had happened. Her doctor felt like she should have an MRI. Her heart and all of her numbers looked good, as the emergency medical technicians said. Her primary doctor recommended her to get the second shot. She had cancelled the second shot for this week, and she has rescheduled it for another date. She was afraid that she will black out again, after the next vaccine, and is not sure if that is how her anxiety manifested. The main reasons she is calling is that she had no concerns of side effects prior to the vaccine, and a couple of her neighbors said they had read about side effects of the vaccine, but she was not worried. When the patient started to read about side effects of the vaccine, she understood that on the 10th day, the vaccine starts to be in a person's system and that maybe is why she didn't have initial side effects, but then she had side effects several days later because the vaccine was in her body. By day 10, the vaccine is in effect in the body and she is nervous. Her second vaccine is scheduled on 26Apr2021. The patient would like to know if there is any information on people that have had a gastric bypass. The patient has no prior vaccinations within 4 weeks. The events resulted in emergency room visit (except nervous). The patient recovered from soreness at injection site on 18Mar2021; recovered from diarrhea, nausea, felt like Dumping Syndrome on 26Mar2021; recovered from stiff neck on 26Mar2021 at 10:05am; recovered from constipation on 02Apr2021; and recovered from no appetite and lost 6 pounds on unspecified dates. The patient also recovered from headache with sequelae on unspecified date; and recovered from blacked out on 27Mar2021 with sequelae. The patient had not yet recovered from anxiety reared up; tired; doesn't sleep through the night; back pain, butt and legs hurt, feels like sciatica. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-04-26 | headache |
Temp dropped to 94.3; Had a very sore arm for two days; swelling in gland under the arm; Strong head...
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Temp dropped to 94.3; Had a very sore arm for two days; swelling in gland under the arm; Strong headaches were common & continue; She had lost a week of her life trying to keep warm; This is a spontaneous report received from a contactable other healthcare professional (patient). A 66-year-old female (non-pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown) via an unspecified route of administration in left arm on 10Feb2021 at 09:00 AM (at the age of 66-years-old) as a single dose for COVID-19 immunization in Public Health Clinic/Veterans Administration facility. Medical history included allergic to dust, mold, mildew, hay, cat & rabbit hair. Concomitant medications included atorvastatin, cetirizine, amlodipine, all received in two weeks. No other vaccines received in four weeks. The patient previously took moxifloxacin hydrochloride (AVALOX) and had allergies (Bayer wide spectrum antibiotic). The patient had not been tested for COVID prior vaccination. It was reported that 10 hours after receiving the vaccine Temperature dropped to 94.3 on 10Feb2021 at 08:00 PM. For next 8 days it has varied as sub-normal from 95 to 97.6, mostly ranging from 95.4 to 96.5. Had a very sore arm for two days with swelling in gland under the arm. Strong headaches were common & continue. Eight days out that swelling is still going down. The doctor visit was a waste of time & money. They knew little & couldn't offer any suggestions. She was afraid to get the second shot because the doctor did tell her side effects would be worse with that one. She had lost a week of her life trying to keep warm. Her temperature did go up to normal & past on day 8 after she was in a very hot vehicle for 1/2 hr. Events resulted in visit to Doctor or other healthcare professional office/clinic. No treatment received for events. The patient had not been tested for COVID post vaccination. The outcome of events was recovering. Information on lot/batch number has been requested.
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| 66 | 2021-04-30 | sweating |
flushed hot face; sweaty head; BP 160/90; This is a spontaneous report from a contactable consumer, ...
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flushed hot face; sweaty head; BP 160/90; This is a spontaneous report from a contactable consumer, reporting for herself. A 66-year-old non-pregnant female patient received the second dose (Lot Number: ER8732) of the bnt162b2 (BNT162B2), via an unspecified route of administration in the left arm on 30Mar2021 at 13:30 at a single dose for covid-19 immunisation. Medical history included sleep apnea, asthma, obesity, anxiety (antidepressants for 35 years), and allergy to lemon, lime, green peppers, mushrooms, walnuts. Concomitant medications included fluticasone furoate/vilanterol trifenatate (BREO ELLIPTA); tiotropium bromide (SPIRIVA); albuterol [salbutamol] (MANUFACTURER UNKNOWN); duloxetine hydrochloride (CYMBALTA); vitamin d3 (MANUFACTURER UNKNOWN); vitamin c [ascorbic acid] (MANUFACTURER UNKNOWN). The patient previously received furosemide (MANUFACTURER UNKNOWN) and theophylline (MANUFACTURER UNKNOWN) and experienced drug allergy to both on unspecified dates. The patient previously received the first dose of the bnt162b2 (Lot Number: EN6206) on 09Mar2021 13:00 at a single dose in the left arm at 66 years of age for covid-19 immunisation. There were no other vaccinations within 4 weeks prior to vaccination with bnt162b2. There was no covid-19 prior to or post vaccination with bnt162b2. On 30Mar2021 at 14:00, the patient experienced 30 minutes after shot, while still sitting in the post-shot waiting area: flushed hot face, sweaty head, BP 160/90, which were non-serious. BP was 130/72 just before going to the get the shot on 30Mar2021. There was no therapeutic measures were taken as a result of the events. The clinical outcome of the events was recovered after about 30 minutes on an unknown date. The patient fully recovered within an hour. No follow-up attempts are needed. No further information is expected.
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| 66 | 2021-04-30 | sinus disorder, nasal congestion, cough |
sinus issues; stuffy nose; cough; hoarseness; soreness in both arms; This is a spontaneous report fr...
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sinus issues; stuffy nose; cough; hoarseness; soreness in both arms; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in right arm on 08Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Vaccination facility type was Clinic. Medical history included Parkinson's from an unknown date and unknown if ongoing. The patient's concomitant medications were none. The patient previously took the first dose of BNT162B2 via intramuscular administration administered in left arm on 18Mar2021 for COVID-19 immunisation and experienced sore arm, and took a Flu shot probably 25 years ago. The patient experienced cough on 09Apr2021 with outcome of recovering, hoarseness on 09Apr2021 with outcome of recovering, sinus issues on 09Apr2021 with outcome of recovering, soreness in both arms on 08Apr2021 with outcome of recovering, stuffy nose on 09Apr2021 with outcome of recovering. Patient had sinus drainage on 09Apr2021. AEs did not require a visit to Emergency Room and Physician Office. Clincial course reported as follow: Patient stated that it may be obvious by the sound of her voice that after the second dose of COVID vaccine on 08Apr2021, by the time patient woke up on 09Apr2021, she had developed a cough. The cough was getting better but her voice was very hoarse, and has also had sinus issues with it, stuffy nose and sinus drainage. Patient stated that the cough was worse last night and her husband was concerned because she had Parkinson's. Patient believed her height was 4'10" or 4'11" and her weight 80-85 pounds right now, she had Parkinson's and for that reason she carried a low weight. Patient stated that with the second COVID vaccine, it was weird because she could feel the pain in her left arm even though she got the dose of COVID vaccine in the right arm so both arms hurt after the second dose. The hoarseness, sinus issues, cough all started 09Apr2021 in the morning when patient woke up. She stated that those symptoms were improving. The pain in both arms after second dose was improved, the pain started on 08Apr2021 and that the pain started right when she was giving me the vaccine. Patient stated that after a flu shot that was probably 25 years ago. Patient stated that within 3 minutes of getting that flu shot her left sinus blocked up and stayed blocked up for 3 weeks (no treatment). When she told her doctor, the doctor recommended not getting any other flu shots. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 66 | 2021-05-02 | headache, fatigue | Tired, headache. |
| 66 | 2021-05-04 | malaise, sleepiness, fever, headache |
Malaise; short lasting fever & chills; short lasting headaches; nausea w/o vomiting; loss of appetit...
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Malaise; short lasting fever & chills; short lasting headaches; nausea w/o vomiting; loss of appetite; sleepy; upper body aches; This is a spontaneous report from a contactable consumer (Patient). A 66-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer Covid-19 vaccine, solution for injection, Lot# unknown) via an unspecified route of administration, administered in left arm on 11 Feb 2021 at 01:30 PM (at the age of 66-years), as a single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (Pfizer covid-19 vaccine, solution for injection, Lot# unknown) via an unspecified route of administration, administered in left arm on 19 Jan 2021 at 02:30 PM, as a single dose for Covid-19 immunization. Medical history included polymyalgia rheumatica. Patient was allergic to ibuprofen and opiates. Concomitant medication was not reported. On 11 Feb 2021 at 01:00 AM, patient experienced short lasting fever & chills, malaise, sharp but short-lasting headaches, nausea w/o vomiting, very sleepy, loss of appetite and upper body aches. The events were long term side effects which were from 2-9 days post second dose of vaccination. Patient did not receive treatment for events. Patient did not receive any other vaccine in four weeks prior vaccination. Patient does not have Covid prior to vaccination and was not tested for it post vaccination. The outcome of all the events of was not recovered. Information on the lot/ batch number has been requested.
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| 66 | 2021-05-12 | fever |
pleurisy symptoms/pain couldn't turn over, couldn't take a deep breath; fever; arm was really sore; ...
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pleurisy symptoms/pain couldn't turn over, couldn't take a deep breath; fever; arm was really sore; pain in her chest whenever she would take a deep breathe; This is a spontaneous report from a contactable Nurse (patient). A 66-year-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Batch/Lot Number: EN5318, Expiration date unknown) at 10 AM via an unspecified route of administration on 04Feb2021 at 10:00 as single for covid-19 immunization. Medical history included ongoing Psoriatic arthritis and first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Batch/Lot Number: EL8982, Expiration date unknown) via an unspecified route of administration on 14Jan2021 for Covid-19 immunization and minimally sore arm. Concomitant medication included methotrexate (Injection) at 0.4 mL, weekly taken for Psoriatic arthritis. It was reported that, pain in her chest whenever she would take a deep breathe and described the symptoms as pleurisy symptoms on an unspecified date in 2021. Stated that the pain has "definitely subsided and it was gone within a week. Reports that her oxygen saturations were lower than normal, and stayed around 94%. With her second injection she had what she thought was some interesting side effects from the vaccine. She says the first one she got she only had a minimally sore arm, she got that first one on the 14Jan2021 and then got the second vaccine on 04Feb2021 and the first 24 hours her arm was really sore on an unspecified date in 2021, but she thought that was nothing to worry about. She got the second dose at 10 am and the next day after 10 AM at about 1 or 2PM she noticed that it was sore for her to take a breath and she thought hmm okay. That night she had a low grade fever which she expected and she took Tylenol. On an unspecified date in 2021, the next morning she woke up Saturday at 5 AM in severe she pain couldn't turn over, she couldn't take a deep breath, she had fever of 102, she managed to get up and she took Tylenol and she had to sit in a chair, she couldn't take a deep breath. She was not short of breath, she just couldn't expand her lungs and she went to a clinic at about 3PM because she was scared she had a pulmonary embolism, they did a chest x-ray and didn't see anything, and they said it sounds like pleurisy, she has never had that in her life ever and they just gave Toradol and said if it gets worse come back the next day or if it does not go away come back Monday. She says it did not end up getting better she was the same way the next morning. Her O2 sats were staying around 94 which was not bad but for a healthy person they should be a little but higher than that, but she couldn't take a deep breath. She says that Monday she thought maybe she got Corona and didn't know it so she went back to the Clinic and asked for a test and she tested negative for the corona virus and they just said they did not feel like it was vaccine related. They sent her home and did not do anything else. It took her until Friday of the week after the vaccine. She says she got the vaccine on a Thursday and on Friday she started feeling bad and it took until the following Friday and Saturday to be fever free and feeling like a human being. She has been on hold for 2 hours so she can answer some questions. She confirm it was the second dose that she was calling about. She got the second dose 04Feb2021 and she had minimal slight soreness when she took a deep breath starting the next day. She says it did not present it self as sever until 5 AM the next morning after she had been asleep all night. She says initially it was pain in both sides of her chest but it wound up setting on the right side, the right lung, she says she keeps saying lung but it she would say right chest. She takes Methotrexate injection once per week for psoriatic arthritis and she contacted her rheumatologist and he okayed her to get the vaccine. She says it was a small dose. It comes in bottle of 50 mg per 2ml and she only takes 0.4 ml once weekly. She has been on it for about a year and half. She would says it was medically significant because she doesn't normally get ill with anything hardly. She does not even go to the doctor but once per year to get a check up. She asks has anyone else reported symptoms like this, pleurisy like symptoms. She asks if it was not long she would be interested to see. The outcome of the events was unknown and Causality was reported as related. Follow-up activities completed. No further information expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event pleurisy and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-01-03 | cough, chills |
On my way home from receiving the vaccine, I felt slight numbness in my lips (no further swelling, e...
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On my way home from receiving the vaccine, I felt slight numbness in my lips (no further swelling, etc.). Noticed some circumoral cyanosis around my lips after arriving home. Had a fine afternoon (sleeping following vaccine and 16 hr. shift). Had dinner and usual evening. Upon going to bed about 11pm, I experienced chills for several hours, and shortness of breath. Very weak. Called 911 about 3 am - went to hospital ER - O2 sat. 90% enroute. Vital signs stable in hospital ER. Had neg. CXR, EKG, and labs. Also had slight cough and slight bronchial congestion. Received some IV fluids in ER. Left ER at 7am. Went home and slept all day, slight nausea in am. Awoke at 7pm - had good breakfast for dinner. Fine evening and night. Off the next day from work - usual day. It was like having Covid all over again (positive X2 in April - out of work for 5 weeks). Although the symptoms began about 12 hrs. following the injection and subsided about 24 hrs. later). My colleagues (work as a nurse in long term care - rehab) who had Covid in the past have experienced similar symptoms following the vaccine, even though we had Covid back in the spring. Dreading vaccine number 2 on Jan. 19th - hopefully I will be ok.
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| 67 | 2021-01-03 | runny nose |
about 1 hour and 15 minutes post injection (I waited in area as recommended for thirty minutes becau...
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about 1 hour and 15 minutes post injection (I waited in area as recommended for thirty minutes because of hx), I had the sudden onset of itchy runny nose and chest tightness and wheezing of significant intensity that I needed to use inhaler then and again later in the day. Noteworthy, I had as a precaution taken prednisone 20mg p.o about 2 hours before the injection. I had to take more later that afternoon because of symptoms. I then seem better but several times since the vaccine I have needed to uses the inhaler and take prednisone more than I have except after an infection about 6 years ago that precipitated similar symptoms to now. Today I had a flare significant enough that except for covid I might have gone to the ER or urgent care.
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| 67 | 2021-01-04 | chills |
flushing; lightheadedness; chills; tongue numbness; dry mouth; cold hands and feet; This is a sponta...
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flushing; lightheadedness; chills; tongue numbness; dry mouth; cold hands and feet; This is a spontaneous report from a contactable physician (patient herself). A 67-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration on 24Dec2020 13:15 in left arm at single dose for covid-19 immunization. Medical history included none. The patient was not allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included methylphenidate hydrochloride (RITALIN) and one-a-day ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS), both from Dec2020 for an unspecified indication. Immediately after vaccine, patient experienced flushing, then lightheadedness, and waves of flushing and chills every minute for several hours; tongue numbness, dry mouth, cold hands and feet; no rash, no breathing difficulty - normal vital signs on 24Dec2020 13:30. Patient received iv diphenhydramine hydrochloride (BENADRYL) and famotidine (PEPCID) and iv hydration after symptoms were not improving 3 hours later - several hours after this treatment, the flushing and chills continued, as did numbness of tongue and dry mouth. Symptoms were still present 22 hours after injection-waves of flushing and chills. The events were reported as non-serious and the events resulted in Emergency room/department or urgent care. Outcome of events were not recovered.
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| 67 | 2021-01-05 | headache, fatigue | Headache Fatigue; Arm soreness |
| 67 | 2021-01-05 | fever, chills, headache |
severe headache, fever, nausea, frequent bowels, injection site pain, chills, joint pain - it felt l...
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severe headache, fever, nausea, frequent bowels, injection site pain, chills, joint pain - it felt like 36 hours of bad flu
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| 67 | 2021-01-06 | chills, fever |
100 degree fever, body aches, chills, insomnia overnight. Other symptoms still persist . I was unabl...
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100 degree fever, body aches, chills, insomnia overnight. Other symptoms still persist . I was unable to work today as scheduled due to these symptoms.
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| 67 | 2021-01-07 | malaise, headache | headache, nausea, light sensitivity, neck pain, general not feeling well, not sleeping well |
| 67 | 2021-01-08 | sweating |
welty rash appeared Friday night. very uncomfortable and itchy, clothing swapped, was gone by mornin...
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welty rash appeared Friday night. very uncomfortable and itchy, clothing swapped, was gone by morning. Later in the morning, reappeared, mainly on back of thighs and rear end. took 2 tablets of 25mg Benadryl. took a n ap, and rash is gone again.
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| 67 | 2021-01-08 | fever | Fever Narrative: |
| 67 | 2021-01-11 | cough, headache, productive cough |
phlegm in throat; Headache; Dry cough; It just made her uncomfortable; This is a spontaneous report ...
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phlegm in throat; Headache; Dry cough; It just made her uncomfortable; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL1284), intramuscular on the left arm on 04Jan2021 15:01 (she would say 15:01 because they told her to wait 20 minutes after receiving the vaccine and she left at 15:21) at SINGLE DOSE for COVID-19 immunization. The patient stated that she might be a little obese. There were no concomitant medications. When she got the vaccine on Monday (04Jan2021), she felt okay. The next day, it seemed like she had phlegm in her throat. She also had a horrible cough and headache. She don't know if it's the vaccine or what. It was mentioned that the phlegm in her throat was no longer horrible went away by the same day of 05Jan2021. The patient also stated that she took two acetaminophen (TYLENOL) for the headache and it went away last night (05Jan2021). However, she has the headache again by 06Jan2021. It was also mentioned that her dry cough that just won't go away, it's persisting. She can't cough, because people don't like that- they get uncomfortable. The patient mentioned that she didn't see any of these side effects on the paper she was given. It just made her uncomfortable, she didn't know what was going on with her body. Outcome of the events of productive cough and headache (initial occurrence) were recovered in 05Jan2021; recovering from dry cough; not recovered for headache (recurrence) while unknown for the remaining event.
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| 67 | 2021-01-11 | malaise |
symptoms began as patient was leaving post vaccination, patient began to have a vagal response with...
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symptoms began as patient was leaving post vaccination, patient began to have a vagal response with feeling like her heart was racing, HR 80. Patient was observed for 15 minutes. Patient states feels normal. As patient was leaving states she doesn't feel so good. Staff spoke with patient re: symptoms, Patient was observed for 30 minutes. HR was 60 at time patient left. Patient states she feels normal.
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| 67 | 2021-01-12 | fatigue, sleepiness |
arm is sore; Fatigue; eyes are still heavy; a metallic taste in her mouth; sleepy/eyes are still hea...
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arm is sore; Fatigue; eyes are still heavy; a metallic taste in her mouth; sleepy/eyes are still heavy/she is yawning a lot more; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 06Jan2021 at single dose in her left arm for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient had no investigation assessment. It was reported that it had been 24 hours, she received her first bnt162b2 (reported as Pfizer COVID vaccine), yesterday (on 06Jan2021), and she was wondering, her arm was sore on 07Jan2021, which she thought was normal and fatigue on 06Jan2021, she got right away, she didn't know if that was normal, but she got a metallic taste in her mouth on 06Jan2021. It felt like a metallic taste when she swallows, a little metallic taste, yesterday (on 06Jan2021) was more than today, it was after the vaccine, about 7 hours after. She thought in her head, like the aluminum chewing gum, when kids chew it, it had a metallic taste, like the (company name withheld) wrapper she used to chew on it. Provides she was shrinking. Provide she was wearing stretch pants when providing weight. She Googled and didn't see the metallic taste, the only thing she saw with metallic taste is if you have the actual virus, she didn't have it, she was fine. Maybe it was all in her head. Arm was sore not right away, it built up, like when you stretch like with the flu shot, she lifted and it's sore, and she felt sleepy. It was like with the flu shot, it took a few days to go away. Last night on 06Jan2021, she was very sleepy, she was kind of sleepy, but it could be watching the Capitol and insanity, but she was yawning a lot more, her eyes felt heavy, she was ok, she had an appetite and is fine, she would drink (company name withheld) now. Thought she was peaking with it, she would go to sleep early today (07Jan2021), her eyes were still heavy, she wanted to close them and took a nap, but couldn't. It was like her saliva has a metallic taste in her mouth, it may be in her head, she googled to see side effects and when they start, it may be going soon, who knows, she was just wondering. The taste was worse yesterday (06Jan2021), and it wasn't IV or anything like that, the patient wanted to know how can that be. She had to go back on the 27th for her second dose. She had been tested and retested on an unspecified date, and it was offered for those 65 and over, and she was lucky to get an appointment. The outcome of the event metallic taste was recovering; the events fatigue and eyes heavy was not recovered; the outcome of the rest events was unknown.
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| 67 | 2021-01-12 | fatigue | Developed fatigue, chills, body aches |
| 67 | 2021-01-12 | head discomfort |
I IMMEDIATELY FELT LIGHT HEADED WITH A FAST HEARTBEAT AND UNSTEADY. MY HEAD FELT VERY HEAVY AND MY B...
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I IMMEDIATELY FELT LIGHT HEADED WITH A FAST HEARTBEAT AND UNSTEADY. MY HEAD FELT VERY HEAVY AND MY BLOOD PRESSURE ( WHICH IS NORMALLY LOW WENT TO 160/86). AFTER ABOUT 45 MINUTES I FELT WELL ENOUGH TO DRIVE HOME. MY LAST BP READING WAS 150/75. AGAIN TODAY ( 1 DAY LATER ) AT MID-MORNING I GOT UP FROM DESK AND FELT LIGHT-HEADED AND JUST A BIT UNSTEADY. NOT SURE IF THIS IS AN ALLERGIC REACTION BUT ACCORDING TO PFIZER'S FACT SHEET "FAST HEARTBEAT AND DIZZINESS / WEAKNESS" ARE CONSIDERED SEVERE ALLERGIC REACTIONS!
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| 67 | 2021-01-12 | fever |
Fever; pregnant at the time of vaccination; pregnant at the time of vaccination/Other vaccine same d...
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Fever; pregnant at the time of vaccination; pregnant at the time of vaccination/Other vaccine same date; pregnant at the time of vaccination; Other vaccine same date; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient (pregnant: yes) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: EH9899 and Expiration Date unknown) via unspecified route of administration on 06Jan2021 10:30 AM (Right arm) at single dose for COVID-19 immunization. No other vaccine in four weeks. The patient's medical history included Diabetes mellitus. No covid prior vaccination, no covid tested post vaccination and no Known allergies. The concomitant drug was reported as atorvastatin (LIPITOR), Metformin, clonazepam. After getting the vaccine (on 07Jan2021 15:00) patient was experiencing fever as a side effect. Patient had other vaccine same date. Patient was pregnant at the time of vaccination. No treatment was received. The outcome of event fever was not recovered. Information on Lot/batch number has been requested.
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| 67 | 2021-01-12 | throat irritation |
Within 10 minutes started itching on arms, within 45 minutes hives started first on arms, then trunk...
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Within 10 minutes started itching on arms, within 45 minutes hives started first on arms, then trunk, neck and ears. During this time throat began to get scratchy. Took two 50mg of benadryl then 1 hour later took one more 50mg of benadryl. Within 3 hours hives and scratchy throat was gone.
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| 67 | 2021-01-13 | body temperature increased, headache, chills |
Temperature , chills, body aches, headache Took 1 Tylenol,Symptoms improved . Only a light headache ...
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Temperature , chills, body aches, headache Took 1 Tylenol,Symptoms improved . Only a light headache is left .
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| 67 | 2021-01-13 | body temperature increased |
Resident had been monitored and had shown no signs or symptoms of any kind until 2 pm on 1/14/2021. ...
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Resident had been monitored and had shown no signs or symptoms of any kind until 2 pm on 1/14/2021. Resident was found in the floor of her room. She had fallen and was having a seizure, temperature was 99.7F and Oxygen saturation was 82%.
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| 67 | 2021-01-13 | headache, malaise, chills, fever | Low grade fever, severe headache, chills, malaise |
| 67 | 2021-01-13 | headache |
Within 15 minutes after the shot left upper arms and forearm felt cold; followed by neck (left side)...
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Within 15 minutes after the shot left upper arms and forearm felt cold; followed by neck (left side) feeling cold; patient began to have a headache and left lower jaw felt numb. This was also experienced on lip & cheek. Patient was coherent. not dizzy. Patient was being checked on and stayed to about 2:40 PM when patient could feel the numbness subsiding. At 5:40 PM. Patient has a little numbness and a headache on left side of the head. Patient shot was administered on left arm.
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| 67 | 2021-01-13 | malaise, chills |
5 min post injection- nauseous for a few minutes 9 hrs post injection- severe stomach pain and ...
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5 min post injection- nauseous for a few minutes 9 hrs post injection- severe stomach pain and sudden onset vomiting lasting for several hours. Chills and malaise throughout next day.
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| 67 | 2021-01-14 | chills, malaise, sweating, headache |
received Pfizer vaccine on 1/11/2021 in Right arm at 9:40 am. Awoke at 12 midnight unable to hersel...
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received Pfizer vaccine on 1/11/2021 in Right arm at 9:40 am. Awoke at 12 midnight unable to herself out of bed, needed to wake husband for assistance due to employee being unable to use Right arm. Developed headache, chills, sweats, joint pain Stated "it felt like I was hit by a bus" felt like I got beat up. Wednesday Headache was gone, R arm swollen, lymph nodes at axilla and R neck large as grapes, painful. No appetite, effort to move .Arm was swollen and reddened at injection site.
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| 67 | 2021-01-14 | fatigue, lethargy, head discomfort |
2nd dose: no ae events 1 nd dose:12/24/20 07:30 PM Heavy head at awakening 4:30 AM, spouse drove p...
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2nd dose: no ae events 1 nd dose:12/24/20 07:30 PM Heavy head at awakening 4:30 AM, spouse drove pt to work; brain fogginess, fatigue arriving home; pt did not eat for 2 days, lethargic; forced self to hydrate; missed work for 4 days. Large lesion roof of mouth l side to larger two front teeth, very painful, Veltrax PCP. Pt regained appetite as lesion went down in mouth. Lesion has resolved, all other symptoms have resolved.
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| 67 | 2021-01-14 | headache, chills |
INJECTION WAS ADMINISTERED IN THE CLAVICULAR SECTION OF THE L DELTOID: TINGLING AND HEAVINESS AT SIT...
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INJECTION WAS ADMINISTERED IN THE CLAVICULAR SECTION OF THE L DELTOID: TINGLING AND HEAVINESS AT SITE RADIATING DOWN THE ARM TO HAND AND INTO THE L SHOULDER (I BELIEVE IT WAS GIVEN TOO CLOSE TO THE NERVE: THIS RXN R/T VACCINE DELIVERY TECHNIQUE; RXN TO VACCINE ITSELF: 32 HOURS AFTER ADMIN, CHILLS, SEVERE ARTHRALGIAS THAT LASTED 12 HOURS AS WELL AS SUSTAINED HEADACHE AND SACRUM ACHE FOR 4 DAYS
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| 67 | 2021-01-14 | headache, head discomfort |
Vertigo started after lying down the same night of getting the vaccine. Vertigo continued every nig...
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Vertigo started after lying down the same night of getting the vaccine. Vertigo continued every night and was accompanied by nystamus upon waking each morning. Symptoms continued for the first several hours after awakening then would gradually get better and was much lighter during the day. Would return every night and next morning and this continued for the next 7 days. My head felt like it was in a fog and it seemed harder to think. It was also very sinus like. No nasal congestion, no post nasal drip, no cough, but my head felt thick and full. I had headaches which I never get. I took my blood pressure to be sure and it was normal. I took Claritin (without the D), Flonase alone and then also Dymista, did the Neti pot, and took Ibuprofen. Headache got better but still had the head fog. Today is post vaccine day 8 and I finally woke up this morning feeling better. Hope it lasts but I answered "Unknown" to Item 20 below because it's too soon to tell.
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| 67 | 2021-01-14 | headache, fever, fatigue |
Fatigue/lassitude, mild mild headache diarrhea start 8 am on 1/12/21 end 8 am on 1/13/21 approx 6 ...
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Fatigue/lassitude, mild mild headache diarrhea start 8 am on 1/12/21 end 8 am on 1/13/21 approx 6 episodes; 2 doses of peptobismol taken no fever
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| 67 | 2021-01-15 | fatigue, headache | Headache, Myalgia, fatigue |
| 67 | 2021-01-15 | malaise |
About 15 minutes after injection, my scalp began to itch all over. Have basically felt unwell for t...
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About 15 minutes after injection, my scalp began to itch all over. Have basically felt unwell for the last three days.
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| 67 | 2021-01-16 | fatigue, chills, fever | sore arm redness at the site chills and fever-101.3 fatigue |
| 67 | 2021-01-17 | fatigue |
States was very fatigued day of vaccination. Day after vaccination states bilateral feet were numb a...
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States was very fatigued day of vaccination. Day after vaccination states bilateral feet were numb and hands felt weak. Did not seek any medical attention. Entirely resolved day of reporting this (1/18/21).
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| 67 | 2021-01-17 | headache | Horrible headache for 30 hours Bad body aches |
| 67 | 2021-01-18 | headache, cough, sinusitis, respiratory tract congestion |
I got Covid from my husband which he tested positive on 12-26-2020. On 12-26-2020 I tested positiv...
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I got Covid from my husband which he tested positive on 12-26-2020. On 12-26-2020 I tested positive for Covid. I developed headaches, cough, congestion along with a sinus infection and had left arm soreness. I also received my 2nd dose injection on 01-06-2021 at 9:30am.
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| 67 | 2021-01-18 | sweating |
After receiving the vaccine, client verbalized she feels hot and sweaty. Client was evaluated by Fi...
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After receiving the vaccine, client verbalized she feels hot and sweaty. Client was evaluated by Fire Rescue on site. Client's symptoms resolved and released to go home per Fire Rescue at 10:28 am.
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| 67 | 2021-01-19 | fatigue |
Presented to ED 1/12 with primary complaint of Fatigue starting that AM. Being treated for Stage IV ...
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Presented to ED 1/12 with primary complaint of Fatigue starting that AM. Being treated for Stage IV Sacral Decubitus Ulcer w/ possible osteomyelitis, Still admitted
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| 67 | 2021-01-19 | headache |
aprox 15 minutes after receiving the vaccine, client started c/o headache and tingling from head to ...
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aprox 15 minutes after receiving the vaccine, client started c/o headache and tingling from head to hands, denied difficulty breathing. 11:25 client denies any tingling at this time. She was released to her husband and told to monitor her symptoms.
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| 67 | 2021-01-20 | fatigue |
Sore muscle at injection site, fatigue, joint pain; Sore muscle at injection site, fatigue, joint pa...
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Sore muscle at injection site, fatigue, joint pain; Sore muscle at injection site, fatigue, joint pain; Sore muscle at injection site, fatigue, joint pain; Sore muscle at injection site, fatigue, joint pain; This is a spontaneous report from a contactable nurse (patient). A 67-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via an unspecified route of administration on 07Jan2021 09:45 at single dose for covid-19 immunization. Vaccine location was left arm. Patient received the first dose on 17Dec2020 08:45 AM (lot number EK5730) at right arm for covid-19 immunization. Patient is not pregnant. The facility type vaccine was hospital. Medical history included hypertension, elevated cholesterol. Known allergies included Sulfa. Concomitant medication included losartan, hctz, atorvastatin, zinc, ergocalciferol (VIT D). Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore muscle at injection site, fatigue, joint pain on 07Jan2021 10:00 AM. Patient didn't receive treatment for the adverse events. The outcome of events was recovered in Jan2021.
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| 67 | 2021-01-20 | fever |
She began to have twitching on the day of vaccine 1/12/2021 but does have a history of seizures seco...
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She began to have twitching on the day of vaccine 1/12/2021 but does have a history of seizures secondary to cancer, low grade temp of 99.4 for which she was given tylenol. After the tylenol her fever broke but the lip twitch persisted and her body began to twitch intermittently. She continued to have the twitching throughout the evening and then became unresponsive. She was sent out EMS to our local hospital. She was admitted and returned from the hosptial on 1/19/2021 and state she feels fine. New Diagnosis of Metabolic Encephalopathy
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| 67 | 2021-01-20 | throat irritation | Itchiness to both hands, sensation of scratchiness in throat |
| 67 | 2021-01-20 | throat irritation |
Pt identified as needing 30 min observation due to previous severe allergies. Pt reports she is feel...
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Pt identified as needing 30 min observation due to previous severe allergies. Pt reports she is feeling anxious: about the vaccines, long lines, and wait. RN spoke with her she stated that she experienced an allergic reaction to codeine in the past when she was in the hospital. Pt alert, oriented and calm. 3:20 pt reported she thought her throat was feeling itchy. RN called for assistance to observation room EMS called. Pt agreed to receive benadryl IM and 6L O2; and administered benadryl into left deltoid. EMS/FF arrived, pt declined transport. BP 168/104 taken 138/97, went home with daughter in law.
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| 67 | 2021-01-21 | body temperature increased, chills, headache |
6PM FELT HOT, DEVELOPED CHILLS. TEMP OF 100.6--TOOK 2 TYLENOL TABS. 5: 30a HAD HEADACHE AND DIZZINES...
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6PM FELT HOT, DEVELOPED CHILLS. TEMP OF 100.6--TOOK 2 TYLENOL TABS. 5: 30a HAD HEADACHE AND DIZZINESS-STILL HAD CHILLS. TYLENOL 2 TABS, WATER AND GATORADE.
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| 67 | 2021-01-21 | chills, influenza like illness, headache | 1/7 6:30PM TO 1/8 1PM: ARM PAIN FLU-LIKE SYMPTOMS CHILLS, HEADACHE, BODY ACHES WEAKNESS TOOK TYLENOL |
| 67 | 2021-01-21 | headache, headache | HA, SEVERE NAUSEA |
| 67 | 2021-01-21 | malaise |
General malaise with burning sensation inside the body, no fever registered; inflammation of right a...
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General malaise with burning sensation inside the body, no fever registered; inflammation of right arm and hand/wrist, migratory joints pains, muscle pain, stabbing pains sudden, neuralgic pain in the extremities. Pain was so severe that cause limitation for walking around the house. The last event on the 7th day was inflammation of the right foot and ankle with severe pain with no history of sprain or trauma.
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| 67 | 2021-01-22 | fever |
Left Arm reddness and hot to touch, red circle 5 inches wide - Approx 4 hr following injection (5:30...
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Left Arm reddness and hot to touch, red circle 5 inches wide - Approx 4 hr following injection (5:30PM 1/21/21) Fever 102 at 10PM : Aleve 2 gelcaps for fever and arm discomfort , also used heating pad on Left arm discomfort Woke at 5 AM TEMP 102.2 , arm much better, vertigo significant, took mezcalin anti vertigo RX (had from from weeks virus) took 1 Aleve gelcap Temp assessed at 2PM - 99.2 Temp assessed at 5PM - 98 No anti pyretic taken after5am
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| 67 | 2021-01-23 | sweating, fever, fatigue, chills |
Within 2 hours of receiving my second Covid 19 vaccine I developed fever, chills, nausea, vomiting, ...
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Within 2 hours of receiving my second Covid 19 vaccine I developed fever, chills, nausea, vomiting, myalgias, arthralgias which persisted for 36 hours. After 36 hours, the acute symptoms improved, but I have had persistent daily fever, sweats, chills. The fever has been as high as 102 degrees F orally. The night sweats have been extremely drenching. I also have had ongoing fatigue and have been unable to work or perform my usual activities.
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| 67 | 2021-01-23 | malaise, fever |
In the middle of night started feeling dizzy and developed soreness in arm at injection site.. Over ...
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In the middle of night started feeling dizzy and developed soreness in arm at injection site.. Over the next few days, I developed symptoms: slight fever of 99.4 F, diarrhea, unable to eat much, malaise, still dizzy and sort of "blanking out" at times. Arm pain lessened in 2 1/2 days.
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| 67 | 2021-01-23 | throat irritation |
Irritation on inside of upper and lower lips with some swelling. Very dry and scratchy throat. ...
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Irritation on inside of upper and lower lips with some swelling. Very dry and scratchy throat. By 11:00 PM the lower lip was much better. This morning 1/24 lower lip not an issue but upper lip still irritated and swollen on inside of lip. Very dry but no sore throat
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| 67 | 2021-01-24 | chills, headache |
The first 3 days i had chills weakness headache and small pimples on my tongue. My arm was soar .aft...
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The first 3 days i had chills weakness headache and small pimples on my tongue. My arm was soar .after the 3 days i went back to normal on Jan 22 i wake up with pain in left arm i thought it was due to my neck issue Sunday the 24 th noticed that my Arm is swollen and red check with a primary care provider and been told that i hv cellulitis that he thinks it is from the injection . The Physician prescribed immediately doxycycline 100 mg twice a day for 10 days .. on the 25 i informed my care provider . I started the Antibiotics Jan 24th at 8:00 pm.
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| 67 | 2021-01-24 | chills, fever, chills, fever | Chills and fever |
| 67 | 2021-01-24 | fatigue, chills, fever | fever (100.4 - 100.9). chills, achy joints, fatigue, nausea |
| 67 | 2021-01-24 | headache |
yesterday I got a really, really bad headache, that I still have; sore arm; This is a spontaneous re...
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yesterday I got a really, really bad headache, that I still have; sore arm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246), via an unspecified route of administration in the left arm on 06Jan2021 at a single dose for COVID-19 immunization. Medical history included lung condition, sarcoidosis, immune system problems, ongoing headache and migraines. Concomitant medication included topiramate for headache and to ward off migraines. States it is in a white bottle, but a pharmacy bottle from (Pharmacy name). She provides discard after 18May2021. Now clarifies it is Topiramate, the generic, 50 mg, it helps ward off migraines. She sees a neurologist for this, not by her internist, she sees the internist who prescribes it twice a year, actually, it is so her headaches don't turn into a migraine, this is just a worse headache, she doesn't know what this is from, hopefully it will just get better. The patient previously took codeine and experienced drug allergy. It was reported that she received the first dose of the vaccine on Wednesday, 06Jan2021. Patient reported that "she's a headache person and gets them all the time." Per the reporter, late yesterday on 10Jan2021, she got a really, really bad headache, that she still have. Could this be vaccine related this far out? The only thing she got right after the vaccine was a sore arm. It's not debilitating (the headache). She is going through a few stressful situations with a friend and her son going through a divorce. She do have a lung condition that's now in remission. She was being followed by a pulmonologist and she is taking something. She is allergic to codeine. She will continue to take Tylenol and will continue to just deal with it." She said that her husband believes the current headache is related to stress. It was further reported that she got the vaccine last Wednesday, on 06Jan2021, she is a headache person, she gets headaches all the time, and takes Topamax (later clarified as the generic, topiramate) on a daily basis, but yesterday on 10Jan2021, late afternoon, she got a really really bad headache, that is still there today, but she didn't get it right after the vaccine, she wondered is that related, or would she have gotten it right away, the headache? States it is not horrible bad, it's just a bad headache, she still wants the second vaccine, and she doesn't want this to interfere, she has a lot of medical conditions, this is why she was afraid to call. Her husband doesn't think this has to do with the vaccine, but she felt like, let her just call. She still has it (headache), she is a headache person, it got better then she got it again, and it also could be stress related, she has been dealing with a few things: she has a friend giving stress, her son is going through a divorce. But she did not get it right after the vaccine, the vaccine was early Wednesday, which is why her husband doesn't think it has to so with anything. Also, she has a lung problem, and thank god she is in remission, she has sarcoidosis, and she has immune system problems, so she has medical reasons. But the issues most important are the lung. She is having blood work done tomorrow, so it has nothing to do with it. States this is good to tell about the stress: she has a friend, a toxic friend, she lives in (State Name), the friend lives in (City Name), and she is a negative person, and she is ending a longstanding friendship, which is not like her, so that is weighing on her mind, and that is, could be, adding to it, and even hurts a little, that's stress, but since she had the vaccine, she thought to call and see. She can definitely get the second dose, right? This report doesn't affect her getting the second dose? After reviewing the call recording, there is no mention of the friend getting the vaccine. The reporter said her friend is giving her stress, and in regards to the statement "weighing on her mind, and that is, could be, adding to it, and even hurts a little, that's stress, but since she had the vaccine", the reporter was referring to herself. Additionally, the statement "But she did not get it right after the vaccine, the vaccine was early Wednesday" the reporter was also referring to herself. The outcome of the event 'headache' was not recovered while unknown for the other event.
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| 67 | 2021-01-25 | cough, sinus disorder |
but tested covid positive; but tested covid positive; had sinus; a little diarrhea; cough; The initi...
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but tested covid positive; but tested covid positive; had sinus; a little diarrhea; cough; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 13Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer, reporting for herself. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration at the right arm at on 30Dec2020 11:15 at a single dose as the patient works for a medical retirement facility. Vaccination was done in a hospital. Medical history included was reported as none. The patient's concomitant medications were not reported. It was reported that the patient got her first shot on 30Dec2020, but tested COVID positive on 13Jan2021, had sinus, a little diarrhea, and cough. She was on quarantine with her husband as of today. She did not receive any other vaccines that day or 4 weeks prior. No history of any other vaccines or events. She was asking if she can take the second dose of the COVID vaccine. The patient underwent lab tests and procedures which included COVID virus: positive on 13Jan2021. The outcome of the events was unknown.
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| 67 | 2021-01-25 | sleepiness, chills | Exaggerated chills, sleepiness, no fever, slept under 3 blankets for interrupted 15 hrs. |
| 67 | 2021-01-26 | chills, headache, fatigue |
The day after receiving the COVID vaccine, patient had headaches, body aches, chills and fatigue. Pl...
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The day after receiving the COVID vaccine, patient had headaches, body aches, chills and fatigue. Plans to treat with ibuprofen and/or tylenol
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| 67 | 2021-01-26 | chills |
7 hours after shot I had severe vomiting and diarrhea and chills; 7 hours after shot I had severe vo...
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7 hours after shot I had severe vomiting and diarrhea and chills; 7 hours after shot I had severe vomiting and diarrhea and chills; 7 hours after shot I had severe vomiting and diarrhea and chills; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly into the left arm on 11Jan2021 02:45 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly into the left arm on 21Dec2020 03:00 at a single dose for covid-19 immunization at the age of 67-year-old as well. On 11Jan2021 09:45, 7 hours after the shot she had severe vomiting, diarrhea and chills. The patient received no treatment for the events reported and was not pregnant at the time of administration of the vaccine. Outcome of the events recovered on an unspecified date in Jan2021. Information on lot number/batch number was requested.
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| 67 | 2021-01-26 | fatigue, influenza like illness |
January 8th, I experienced flu like symptoms (aching, tiredness) which I understand this is normal. ...
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January 8th, I experienced flu like symptoms (aching, tiredness) which I understand this is normal. These symptoms lasted only aprox. four hours. The other reaction, the one I am concerned about is that my bottom lip began to swell. The swelling continued throughout the night, swelling 3x normal size. It began to recede back to normal within 48 hours. Also, my lymph nodes under my right arm ( the injection arm) was very sore for 48 hours as well.
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| 67 | 2021-01-26 | throat irritation |
Generalized pruritus associated with itchy throat and sensation of throat tightening. Epinephrine 0...
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Generalized pruritus associated with itchy throat and sensation of throat tightening. Epinephrine 0.3mg IM and Benedryl 50mg. Symptoms resolved. Refused transport to ED
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| 67 | 2021-01-27 | chills, headache |
SINTOMES 3 DAYS , CHILLS,HEADACHE ON RIGHT SITE,PAIN ON RIGHT EAR THIS WAS ON 01/26. ON 01/27/2021 ....
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SINTOMES 3 DAYS , CHILLS,HEADACHE ON RIGHT SITE,PAIN ON RIGHT EAR THIS WAS ON 01/26. ON 01/27/2021 . SHE HAD A DEVATION OF THE MOUTH TURN TO HER LEFT SIDE SHE HAD FACIAL PARALISIS CONTINUE WITH SINTOMES HAS APPOINMENT WITH PHYSIATRIST 01/28/2021.
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| 67 | 2021-01-27 | chills | Chills for 3 days after the shot |
| 67 | 2021-01-27 | fatigue, headache |
Nausea; muscle pain; joint pain; headache; tiredness; This is a spontaneous report from a contactabl...
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Nausea; muscle pain; joint pain; headache; tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 67-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248 and expiry date: Apr2021), via an unspecified route of administration on the left arm, on 12Jan2021 13:45 at a single dose for COVID-19 immunization. Medical history included high blood pressure; patient was not pregnant at time of vaccination. Concomitant medications were unspecified (received within 2 weeks of vaccination). The patient experienced nausea, muscle pain, joint pain, headache and tiredness on 13Jan2021 14:00. Treatment was not received for the events. Patient was recovering from the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
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| 67 | 2021-01-27 | fatigue, headache |
Spoke with Patient regardingside effects following her #1 Covid Vaccine on 1/15/21. She stated that ...
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Spoke with Patient regardingside effects following her #1 Covid Vaccine on 1/15/21. She stated that about 12 hours later developed extreme fatigue, all over weakness, headache, she also c/o intermittent numbness & tingling in bilateral lower extremities (mid-calf to toes) she states that she also has Resless Leg Syndrrome that is untreated. Has been in contact with her PCP. Encouraged her to "Self-Report" to the Vaccine's web-site listed in the Vaccine handout. Encouraged her to call back if she has further concerns or questions.
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| 67 | 2021-01-27 | fatigue, malaise |
Pt called the Covid Triage Line wanting to report adverse reactions to the Phizer Covid vaccine she ...
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Pt called the Covid Triage Line wanting to report adverse reactions to the Phizer Covid vaccine she received. Pt states she was Covid positive on 12/8/21 and received the Covid vaccine on 1/20/21. Later that day she reported feeling "woozy" and started to feel like she was "drunk" (pt states she has not had a drink since 2005). On 1/21/21 she felt "sick as a dog" and started "violently vomiting". She had a compazine suppository at home that she used which stopped the vomiting. She reports she remained extremely nauseated and fatigued for the next 24 hours. The nausea was only relieved when she would sleep or lie down flat. Pt states she slept the rest of the day on 1/21/21 to "about noon" on 1/22/21 and started to feel better during the late afternoon. She was able to eat dinner 1/22/21. Pt reports she still feels tired but that she is better on 1/23/21. Notified pt's PCP of events who followed up with pt with no further orders. Last note from PCP on 1/27/21. Spoke with pt 1/28/21 and pt states she remains without any further symptoms.
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| 67 | 2021-01-27 | fever |
10 minutes post-vaccine, patient developed itchy rash on right cheek. Symptoms include itching, burn...
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10 minutes post-vaccine, patient developed itchy rash on right cheek. Symptoms include itching, burning, tingling at rash site. Patient also felt thirsty (was then given water). Benadryl oral was given, but symptoms did not resolve and patient began to feel feverish and dizzy. Itch worsened and spread throughout body. Dexamethasone oral was given 15 minutes later. Itching started in mouth. EpiPen was administered intramuscularly to left vastus lateralis. Hypertension was noted post administration. Itching in mouth subsided, but patient began to feel shaky and still felt dizzy. Monitored for additional 20 minutes. After, patient was stable, walked out via wheelchair enroute home.
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| 67 | 2021-01-28 | cough |
7:07 Started coughing then became nauseated proceeded to vomit. Nurse suggest after about 10 mins t...
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7:07 Started coughing then became nauseated proceeded to vomit. Nurse suggest after about 10 mins that she should take me to ED for Zofran. Upon getting to ED I was wheezing badly and trying to find inhaler in purse; wheezing and unable to catch a breath I was placed in a room, by then my body was turning red and wheezing worse. I was given epinephrine and prednisone immediately for anaphylaxis. They reacted immediately upon my arrival. Time I unsure. I just say thank God for them. Meds Given- Tylenol Duoneb, Decadron, Benadryl, Epinephrine, Pepcid, Nss
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| 67 | 2021-01-28 | fatigue, sweating |
Night 3 of vaccine woke in am with right mild thigh gnawing, a sensation never experienced before....
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Night 3 of vaccine woke in am with right mild thigh gnawing, a sensation never experienced before. Duration 1-2 hours. Night 4 woke 2 am with more intense discomfort left knee, again not like anything experienced before but did not require Tylenol. It was gnawing and annoying, Night 5 woke around 4 am with left lower leg/ side of foot mild ache which lasted a few hours. Stretching, changing positions had no effect on any of three nights. Day after vaccine while exercising I perspired more than usual and was tired. Did not concern me in any way and would not have reported unless had above symptoms. Question- Do any of the above symptoms indicate I should not get dose 2? Thank you
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| 67 | 2021-01-28 | fatigue |
Injection site pain, mild, 1day; Fatigue 2 days, mild; pain to the touch and lifting arm, in right a...
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Injection site pain, mild, 1day; Fatigue 2 days, mild; pain to the touch and lifting arm, in right armpit, started 24 hrs post vaccine, still occurring; no treatment for anything
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| 67 | 2021-01-28 | headache, fatigue, chills | shaking chills body aches headache fatigue red sore arm |
| 67 | 2021-01-28 | headache |
Almost immediately after taking the vaccine for covid19, I felt extreme dizziness (vertigo). The nu...
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Almost immediately after taking the vaccine for covid19, I felt extreme dizziness (vertigo). The nurse had me drink some water and eat some nuts. I had drunk some glucerna that morning for breakfast with my medication. The RN had me wait for about an hour. I then called my primary care doctor who told me to go home and rest. He said that I did not need to go see him or go to a clinic or Emergency Room unless I felt worse. (I have progressively felt better). I left his number and contact information under the contact information above. However, I had received the shot from the Hospital site. I am providing this as you were a little vague in your question about contact address. Anyway, my husband took my temperature about 6 pm. I had a temperature of about 93.8. I normally have a temperature of 98.6 F. He used a digital thermometer. However, I did not feel as if I had asthma. I did have a slight headache then and my arm was a little bit sore. Today (the 29th) my temperature is about normal. I do not have any breathing problems, but my arm is a little bit sore where I got the shot. I still have a slight headache, but it's not too bad. I don't need to take medication for it. There is no redness at the site of the injection. I should mention that one of the RN's did look at my fingernails and the color was normal which I assume means no problems with oxygen levels. I am only reporting this because of the extreme dizziness! I felt a lot better after about an hour after taking the shot, drinking the bottle of unflavored (still) water and eating the nuts. My A1C is back to normal today. (and remember I am not currently needing or taking any form of insulin but my doctor has my blood checked regularly and has for many years). I am only putting no on the item number 20 below because I still have a slight headache and a little bit of soreness in the injection site. Today the site of the injection is not red either.
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| 67 | 2021-01-28 | malaise |
redness and swelling at injection site; redness and swelling at injection site; muscle pain; muscle ...
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redness and swelling at injection site; redness and swelling at injection site; muscle pain; muscle and joint pain; not feeling well; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) at the 1st dose on 22Dec2020, at the 2nd dose on 12Jan2021; both via an unspecified route of administration at left arm at single dose for covid-19 immunization. Medical history included diabetic and allergies to sulfur drugs. Concomitant medications included other medications in two weeks. The patient was not pregnant. The patient had no other vaccine in four weeks. The patient experienced redness and swelling at injection site, muscle pain, muscle and joint pain, and not feeling well on 24Dec2020. No treatment was received for events. The patient had no COVID prior vaccination. The patient had Covid test post vaccination by Nasal Swab on 11Jan2021 with negative result. Outcome of the events was unknown.
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| 67 | 2021-01-29 | chills, headache, fever | Headache, muscle ache, severe chill, fever |
| 67 | 2021-01-30 | headache, fatigue, malaise |
Shot administered 6:08pm. About 6:18pm I felt very tired and wanted to close my eyes. I told my husb...
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Shot administered 6:08pm. About 6:18pm I felt very tired and wanted to close my eyes. I told my husband 'I don't feel well'. Immediately my eyes rolled back and convulsions started. Then I passed out. EMTs were called over to car and started to administer oxygen. I woke up about 6:30pm cognizant of surroundings. BP was normal. No fever, no rash, no chills. I was just tired. Then 2 hours of vomiting started. Last vomit about 8:15pm in ambulance. EMT unable to administer IV. After waiting in ER waiting room for 45+ minutes, a bed was available (around 9pm). ER doctor gave me ondansetron ODT 4mg Once. Released at 10:12pm to go home. Next 3 days symptoms of lightheadedness and dull headache.
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| 67 | 2021-01-30 | headache | mild periodic headache in crown of head for couple of days |
| 67 | 2021-01-30 | fever, chills | fever, chills, nausea, vomiting |
| 67 | 2021-01-31 | fatigue |
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Exhaustion...
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Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Exhaustion-Severe, Systemic: Other- mild chest pain, dizziness, feeling like she was going to pass out or fall asleep-Medium
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| 67 | 2021-01-31 | fatigue |
fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 67-year-o...
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fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302, expiry date: not reported), intramuscularly, on 14Jan2021 11:15, at a single dose on the left arm for COVID-19 immunization. The vaccine was administered a clinic, not a facility vaccination. There were no additional vaccines administered on same date of the bnt162b2. The patient did not receive other vaccinations within 4 weeks prior to receiving bnt162b2. Medical history included high blood pressure, obesity (has obesity but does not have diabetes), and menopause (10 years). Family history was none. Concomitant medications included metoprolol succinate (METOPROLOL SUCCINATE) for high blood pressure (been taking for 10 years). The patient experienced fatigue on 17Jan2021 10:00 after receiving the first dose of the covid vaccine on Thursday 14Jan2021 11:15. She received her first shot on Thursday (14Jan2021) and everything was fine. She was just experiencing a little bit of fatigue. She would like to know if you would get side effects immediately or after a few days. She wants to know when the side effects typically start after receiving the vaccine. Outcome of the event was recovering.
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| 67 | 2021-01-31 | headache |
Severe chest pain, pain in jaw, brow bones and headache (may have been due to GERD- acid reflux dise...
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Severe chest pain, pain in jaw, brow bones and headache (may have been due to GERD- acid reflux disease), symptoms started at 11:30PM while in bed and lasted 1-2 hours; sudden onset and dissipation
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| 67 | 2021-01-31 | nasopharyngitis, headache |
day 13, 14, 15 mild headache, feel like early onset of head cold: low energy, heavy chest; constipat...
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day 13, 14, 15 mild headache, feel like early onset of head cold: low energy, heavy chest; constipated with only small soft BM after product use; self care
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| 67 | 2021-02-01 | chills, headache, fever |
nausea; vomiting; rigors; temperature greater than 100 degrees topical; headache; muscle ache; This ...
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nausea; vomiting; rigors; temperature greater than 100 degrees topical; headache; muscle ache; This is a spontaneous report from a contactable health care professional nurse, the patient. A 67-years-old non-pregnant female patient (nurse) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot Number: EK9231,), intramuscular in the left arm on 07Jan2021 16:00 as a single dose, for COVID-19 vaccination. Medical history included gastrooesophageal reflux disease. Concomitant medication included diltiazem (DILTIAZEM). Patient has no known allergies. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number EH9899, on 18Dec2020; 16:00, Intramuscular, right arm,. On 08Jan2021 at 04:00 the patient experienced nausea, vomiting, rigors, temperature greater than 100 degrees topical, headache, muscle ache. The events resulted in a Physician office visit. Lab tests included body temperature: greater than 100 degrees on 08Jan2021. Treatment given include zofran, APAP, fluids, and rest. The clinical outcome of nausea, vomiting, rigors, temperature greater than 100 degrees topical, headache, muscle ache was recovering.
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| 67 | 2021-02-01 | fatigue, chills |
Itching at injection site within 3 minutes or less from time of injection, After two to three minute...
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Itching at injection site within 3 minutes or less from time of injection, After two to three minutes of the itching episode, heart racing followed by palpitations. Followed by chest tightness over heart area. Followed by shaking in upper torso and arms and hands. Became nauseous followed by weakness and a need of a wheel chair to get to my car. A few hours after arriving at home, itching started all over my body and nausea persisted through the night. Itching became stronger. The morning after the shot explosive diarrhea. Fatigue, chills and hot and cold feelings the following day as well as itching persisted. Now, two days later, itching remains with intermittent mild chest tightness which is abating and taking zytrec for the itching
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| 67 | 2021-02-02 | body temperature increased |
temp max 102.6 24 hr after vaccine. Low grade temps to 100.7 daily for 7 days. Worst symptom: severe...
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temp max 102.6 24 hr after vaccine. Low grade temps to 100.7 daily for 7 days. Worst symptom: severe insomnia days 3 thru 7.
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| 67 | 2021-02-02 | head discomfort, fatigue | Swollen eyelids Intense fatigue Swollen tongue Pressure in head Tinnitus |
| 67 | 2021-02-02 | headache | headache, weakness, body aches, high blood pressure |
| 67 | 2021-02-02 | malaise, fever, fatigue, headache |
Beginning 4 hours after administration of 2nd dose: headache, malaise, fatigue By 10 hours after dos...
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Beginning 4 hours after administration of 2nd dose: headache, malaise, fatigue By 10 hours after dose: worsening headache, low grade fever, body pain By 24 hours after dose: above symptoms continued, but now had bone pain By 48 hours after 2nd dose was "back to normal"
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| 67 | 2021-02-02 | throat pain |
This is a spontaneous report from a contactable consumer reporting for self. This 67-year-old female...
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This is a spontaneous report from a contactable consumer reporting for self. This 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 29Dec2020 around 10AM at left arm at single dose for COVID-19 immunization. Medical history included allergic to penicillin. She also had an allergy to anesthesia but was told this was irrelevant to the shot, this allergy was over 20 years ago. Ongoing acid reflux, she had a problem with acid reflux for a year (it was controlled on medication) but they made changes to her medication and started to come back. She stated it was not real bad and that this wasn't a side effect because she has been dealing with it for a year. Concomitant medications were none. No other vaccinations within 4 weeks. The patient stated she received her first dose of the vaccine and didn't have any problem with it, just that her arm was sore and ached but by the next morning it was gone. The arm soreness happened maybe 12 hours later after she took the shot. She didn't experience it immediately after getting the injection. The soreness lasted overnight and by mid morning of 30Dec2020, she recovered completely. She stated this morning (18Jan2021) she woke up with a sore throat and her ear started to throb and she asked if it is safe for someone to receive the second dose if they are not feeling their very best? She is scheduled for her next dose tomorrow. The events did not require a visit to emergency room or physician office. Patient stated she was not sure about her weight because she lost a lot of weight dealing with the acid reflux she had had lately. Lab data included she had two COVID tests because of work previously, but these were negative. The outcome of arm soreness was recovered on 30Dec2020, outcome of other events was unknown. Information on the LOT/Batch number has been requested.
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| 67 | 2021-02-03 | chills, fever |
one of the nurses at the outpatient clinic where she works was positive for covid; Nausea; she start...
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one of the nurses at the outpatient clinic where she works was positive for covid; Nausea; she started feeling a little warm; Low grade fever; Chills; This is a spontaneous report from a contactable nurse reporting for herself. A 67-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302), intramuscularly on 19Jan2021 11:03 on right arm at single dose for COVID-19 immunization. Vaccination Facility Type was at Clinic. Medical history included just had rotator cuff repair surgery last Thursday (11Jan2021), pain, muscle relaxer. Concomitant medications included acetaminophen; hydrocodone as pain medicine, methocarbamol as muscle relaxer. Historical Vaccine included first dose of BNT162B2 (Lot number: EK9231) intramuscularly on 28Dec2020 at 9:52 am for COVID-19 immunization on right arm and experienced right arm soreness at the injection site. It was reported that last night (19Jan2021) she had a low grade fever and chills, then it went away, she was not having the chills earlier today and the fever went away. The fever had come back and she was chilled even though it was hot. She tested negative for coronavirus that Monday (08Jan2021) prior to the surgery. She was being told that one of the nurses at the outpatient clinic where she worked was positive for covid. She clarified that the fever and the chills go together and started last night. The fever did get better and she was not feeling feverish or chilled during the day. About 2 or 3 hours ago (20Jan2021) she started feeling a little warm, nauseated and she checked her temperature 30 minutes ago and it was 99.4. She always run low and did not have a fever. No treatment received for all events. The outcome of event low grade fever was resolving, outcome of events chills and nauseated were not resolved, outcome of other events were unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events low grade fever, chills and nausea cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-02-03 | cough |
cough; started with a temperature; This is a spontaneous report from a non-contactable consumer (rep...
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cough; started with a temperature; This is a spontaneous report from a non-contactable consumer (reporting for her mother). This 67-year-old female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date unspecified) on unspecified date in Jan2021 (at 67 years of age) as single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. On Jan2021, the patient experienced cough and started with a temperature. Outcome of event 'cough' was unknown and 'started with a temperature' was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 67 | 2021-02-03 | fatigue, fever |
Do not believe he gave it IM, I believe he gave it subQ; Redness; Swelling; heat coming out; Skin le...
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Do not believe he gave it IM, I believe he gave it subQ; Redness; Swelling; heat coming out; Skin lesions 4.5 to 7cms/Red spot on my arm; Low grade temperature elevation; Fatigue; This is a spontaneous report from a contactable physician (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899, reported as "SARS-COV-2 then it says Pfizer EH9899", expiry date: Unknown), subcutaneous on 05Jan2021 at single dose for COVID-19 immunization (reported as "To not get COVID 19"). Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID) 25mcg, once a day for hypothyroidism. The patient got the vaccine last Tuesday (05Jan2021). When she got the vaccine, the gentleman was from military who gave the vaccine. The patient does not believe that he gave it intramuscular (IM), she believed that he gave it "subQ" because she had no muscle tenderness and "skin a 4.5 by 7cm skin reaction", and it was nowhere near the deltoid muscle. The patient had a high degree of suspicion that he gave it "subQ" (subcutaneous). When asked for the anatomical location of administration, the patient stated that "He gave it on my right arm but it was not into the deltoid, I think he gave it subcutaneously. I am not positive of that but missed the deltoid, it was lower, it was below the deltoid, it was in between the deltoid and the bicep and I am assuming it was subQ because none of my muscles were sore at all after getting the vaccine, accept that big red spot on my arm". Patient asked "Now my question to you is because I looked through all your literature and I can't find anything about this". Since then the skin lesion within a couple of days it was up to about 4.5 to 7cms. It was still about that size however the redness has gone way down, "the not redness", just pink, the swelling was almost gone. The heat coming out of it was almost gone. The patient mentioned that the actual skin region was much better, it was still about the same size though. Patient was not too worried about that and stated "what am concerned about is what I've also have is a low grade temperature elevation and some fatigue. If I got it on 3 O'clock on Tuesday the 5th that would be day 9. Is the 9 days post injection for dose 1 to still have a low grade temperature elevation and some fatigue. Is that acceptable or does that indicate a problem?". Patient stated the she went to her internist and he had a look at it and he said "I had no idea, he said that they just don't have experience like this. Do you have a phone number that I can talk to somebody?". The patient was about 5' 7" (height) and about 175 pounds (weight) approximately. The patient stated that fatigue and temperature elevation started one or two days after the vaccine (Jan2021). Patient reported that she still have it. The fatigue was much less but it was there and low grade temperature elevation was still there. There was no investigation assessment. The patient assessed that the events swelling, redness, skin lesions, temperature and fatigue were related to COVID-19 vaccine, also reported as "Yes, because I never had that before and I am not taking anything now. So, it is like yes. It is definitely because that. The two main symptoms I am asking about are the fatigue and the low grade temperature elevation". Outcome of the events fatigue and skin lesion, redness, swelling and heat coming out was recovering, for low grade temperature elevation was not recovered.
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| 67 | 2021-02-03 | fever, cough |
Temperature of 100.1; cough; This is a spontaneous report from a contactable consumer. who is the pa...
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Temperature of 100.1; cough; This is a spontaneous report from a contactable consumer. who is the patient. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982, expiration date unknown), via an unspecified route of administration in the left arm on 16Jan2021 (at the age of 67-years-old) as a single dose for COVID-19 vaccination. Medical history included blood pressure, restless leg syndrome, cholesterol, triglycerides, unknown rash, Vitamin B-12 deficiency and Viamin D deficiency. Concomitant medication included olmesartan medoxomil (BENICAR) for blood pressure, fenofibrate (FENOFIBRATE), doxepin (DOXEPIN), levocetirizine dihydrochloride (XYZAL), clonazepam (CLONAZEPAM), colecalciferol (VITAMIN D3) and cyanocobalamin (VITAMIN D12). It was unknown if the patient has any allergies to medications, food, or other products. It was unknown if the patient had received any other vaccines within four (4) weeks prior to the vaccine. The patient stated that she started yesterday, 19Jan2021, with a cough and today, 20Jan2021, the patient developed a temperature of 100.1. After taking Tylenol "at 12" her temperature was 99.6. She noted that her normal temperature is 96.8. Treatment information included Tylenol. The clinical outcome of cough was not recovered and the clinical outcome of fever was unknown.
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| 67 | 2021-02-04 | chills, fever |
Fever; Ache; Chills; Feeling miserable; Fever/Ache/Chills/Feeling miserable; This is a spontaneous r...
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Fever; Ache; Chills; Feeling miserable; Fever/Ache/Chills/Feeling miserable; This is a spontaneous report from a contactable consumer. This 67- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EL3246), via intramuscular route of administration, on 19Jan2021 at 10:30AM (at the age of 67-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The medical history included: Blood pressure high, Diabetes, Hypothyroidism, High cholesterol, all from unspecified dates and ongoing. Patient's Medical History (illness at time of vaccination): States that she was concerned because she thinks she has had a sinus infection for the last week; hasn't been feeling well. She told her doctor about it and asked if it was still okay to get the vaccine and was told that it would be fine. Concomitant medications included FLUTICASONE PROPIONATE (FLONASE) and montelukast sodium (SINGULAIR), both for Allergy. The patient received first dose BNT162B2 on 28Dec2021, (Lot: EJ1685, Expiry/NDC: Unknown), in right arm (Her arm hurt for about a week). Patient's Medical History (illness at time of vaccination): States that she was concerned because she thinks she has had a sinus infection for the last week; hasn't been feeling well. She told her doctor about it and asked if it was still okay to get the vaccine and was told that it would be fine. Prior vaccination included: Pneumonia vaccine - States that her arms swelled up and turned red the day she got the vaccine. The next day she had chills, fever, and body aches; and she had a rash on her arm that started the day after the vaccine. Her doctor told her not to get the vaccine again. She does not have the Lot/NDC/Expiry to provide because it was many years ago. Prior vaccination: Flu shot - She swells up and turns red at injection site; she also gets fever, chills, and body aches with it as well. She does not have the Lot/NDC/Expiry to provide; she got it back in Oct2020 at the Hospital where she works. On 20Jan2021 03:00 AM, the patient experienced fever, aches, chills, and feels miserable. States that she reacts to the flu shot too, but nothing like this. Stated that all the events started in the early hours of the morning, around 3:00AM. She pushed herself to go to work, and it just got worse throughout the day. States that she has been alternating Tylenol and Ibuprofen since early this morning. The outcome of events fever, aches, chills, and feels miserable was not recovered, got worse through the day was unknown. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-02-04 | fatigue |
bilateral feet were numb and hands felt weak; bilateral feet were numb and hands felt weak; fatigued...
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bilateral feet were numb and hands felt weak; bilateral feet were numb and hands felt weak; fatigued; This is a spontaneous report from a contactable Nurse (the patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1685, expiration date unknown), intramuscularly in the left arm, on 28Dec2020 as a single dose for COVID-19 vaccination. Medical history was not reported. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 28Dec2020 the patient experienced fatigue. On 29Dec2020 the patient states that her feet were numb bilaterally and her hands felt weak. The patient did not seek any medical attention and no treatment of the events was reported. The clinical outcome of fatigue, numbness of feet and weakness of hands was recovered (reported as "resolved entirely on its own") on an unspecified date.
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| 67 | 2021-02-04 | fever, chills |
Chills; Fever; cool; Night sweats; Soreness in arm; This is a spontaneous report from a contactable ...
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Chills; Fever; cool; Night sweats; Soreness in arm; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EK9231), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Blood pressure, ongoing Cholesterol. Concomitant medication included nifedipine (ADALAT) for Blood pressure and ongoing, atorvastatin (ATORVASTATIN) had been on this medication 6-7 year and ongoing for Cholesterol. Historical Vaccine included flu and had Soreness in her arm. The patient experienced soreness in arm on 20Jan2021; chills, cool, fever, night sweats on 21Jan2021. She woke up drenched. She imagined the fever was breaking. She woke up, and did not have a fever, and was fine other than that; She just couldn't warm up. She was cool, and the chill wouldn't go away with clothes or blankets or the fire place. The event outcome of soreness in arm was recovering, outcome of other events was recovered on 21Jan2021.
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| 67 | 2021-02-04 | throat irritation |
Face got red and warm and a burning sensation in her throat. Gave Benadryl PO. Continued to monitor ...
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Face got red and warm and a burning sensation in her throat. Gave Benadryl PO. Continued to monitor for 30mins and patient still complained of burning and tightness in throat. Called her family and they drove her to the ER. I have spoken with patient and she has had to go to the ER a total of 3 times.
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| 67 | 2021-02-04 | throat irritation |
Itchy throat - helped with Benadryl 25 mg PO. O2 sat 100%. BP: 172/76, 151/77. Pulse 63. Discharged ...
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Itchy throat - helped with Benadryl 25 mg PO. O2 sat 100%. BP: 172/76, 151/77. Pulse 63. Discharged to home.
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| 67 | 2021-02-05 | headache, fatigue | Headache, light headedness, spike in blood pressure of 180/106, fatigue, racing heart rate |
| 67 | 2021-02-05 | fever, headache, chills |
Fever of 100, chills, muscle and joint aches and a headache began about 2:00 am, throughout the day ...
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Fever of 100, chills, muscle and joint aches and a headache began about 2:00 am, throughout the day on Friday the aches increased. Slept quite a lot. Took Tylenol and Advil, alternating them and then at bedtime took 1 of each. Joint aches have decreased on Saturday, but the fever and chills are still coming and going.
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| 67 | 2021-02-06 | headache, chills, fever | Fever, headache, muscle pain, chills, joint pain, fever. |
| 67 | 2021-02-06 | malaise |
Swollen glands in upper right neck, under jaw Tightness in chest; shortness of breath Malaise I fee...
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Swollen glands in upper right neck, under jaw Tightness in chest; shortness of breath Malaise I feel like I have the mumps
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| 67 | 2021-02-07 | headache, malaise |
Within 2 minutes of receiving the COVID19 vaccine I became moderately mentally foggy with mild dizzi...
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Within 2 minutes of receiving the COVID19 vaccine I became moderately mentally foggy with mild dizziness and headache. I then experienced tightness in the center of my chest and a generally mild shakiness. After waiting my 20 minute observation time, I recovered enough to drive home. However, mild mental fogginess, headache, tightness in chest and generally feeling unwell remain for 24 hours.
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| 67 | 2021-02-07 | headache, fever | I had a fever of 103 and headache that lasted 4 days. |
| 67 | 2021-02-07 | fever, fatigue, headache |
Medical history included systemic lupus; Medical history included systemic lupus; Fever; Vomiting; D...
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Medical history included systemic lupus; Medical history included systemic lupus; Fever; Vomiting; Diarrhea; Abdominal pain; Joint/muscle pain; Joint/muscle pain; Nausea; Fatigue; Severe headache; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249, via an unspecified route of administration in the right arm on 15Jan2021 13:00 at SINGLE DOSE (first dose) for COVID-19 immunization. Medical history included systemic lupus, "hypothyroid", Leiden Factor V. Patient's known allergies: penicillin, erythromycin and tetracycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included hydroxychloroquine, clopidogrel bisulfate (PLAVIX), acetylsalicylic acid (ASPIRIN), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and experienced drug hypersensitivity, tetracycline and experienced drug hypersensitivity. On 15Jan2021 16:00, the patient experienced fever, vomiting, diarrhea, abdominal pain, joint/muscle pain, nausea, fatigue, severe headache and sore arm. Outcome of events was fever, vomiting, diarrhea, abdominal pain, joint/muscle pain, nausea, fatigue, severe headache and sore arm not recovered. Outcome of the other events was unknown. Patient did not receive any treatment for the events. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
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| 67 | 2021-02-08 | chills, fatigue, malaise, headache |
8 hrs post vaccine, got headache, chills, no fever, felt like the worst flu I ever had for 12 hrs, ...
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8 hrs post vaccine, got headache, chills, no fever, felt like the worst flu I ever had for 12 hrs, felt slightly better but still quite ill, tired, joint ad body aches, headache. Could not eat or get out of bed
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| 67 | 2021-02-08 | fatigue, headache |
Nausea, a bit of headache immediately after receiving vaccine. The next day extreme fatigue, some pe...
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Nausea, a bit of headache immediately after receiving vaccine. The next day extreme fatigue, some periods of weakness, muscle ache, joint ache, a bit of nausea and headache; soreness, swelling, and redness at injection site; intermittent itching at injection site and upper body
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| 67 | 2021-02-08 | headache |
Day 2 - Had a bad headache but that went away by day 3. Day 4 I started to notice a tenderness in m...
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Day 2 - Had a bad headache but that went away by day 3. Day 4 I started to notice a tenderness in my right thigh and a rash started to appear. The entire front of my thigh is very tender. Plus my body just seems to feel achy.
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| 67 | 2021-02-08 | malaise, chills |
Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unw...
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Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unwell; Difficulty sleeping; Dizziness; Weakness; Joint pain neck; Joint pain neck; Mild injection site pain; This is a spontaneous report from a contactable nurse reporting for self. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history included Covid, Hypothyroidism, Arthritis, Chronic Neck R shoulder pain, Migraines, Submaxillary gland removal, Tubal ligation. Concomitant medication included amitriptyline, ibuprofen, levothyroxine sodium (LEVOTHYROXIN), ibuprofen (MOTRIN [IBUPROFEN]), vitamin d3. Patient received first dose of bnt162b2 on 30Dec2020 and experienced injection site pain. Patient had allergies to Amoxicillin, Duricef, Mobic, Nexium. The patient experienced severe chills, feeling unwell, difficulty sleeping, dizziness and weakness, passed out, laceration to back of skull requiring staples, joint pain neck, mild injection site pain, on 22Jan2021 01:00 AM, 24 hours later rash on torso. Patient underwent CT head neck, EKG, Chest XRAY, Labs, results all unknown. Events resulted in Emergency room/department or urgent care. Outcome of event rash was unknown, of other events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for passed out and chills. Laceration is subsequent to passed out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 67 | 2021-02-09 | chills, fatigue, malaise, headache |
Very bad arm pain on injection arm; tiredness; mild headache; chills; feeling unwell; This is a spon...
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Very bad arm pain on injection arm; tiredness; mild headache; chills; feeling unwell; This is a spontaneous report from a contactable consumer (patient herself). A 67-year-old female patient received bnt162b2 (BNT162B2 also reported as COVID 19 vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration in arm on 16Jan2021 10:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included allergy to latex, iodine, motrin. No other vaccine in four weeks. There were no concomitant medications. On 16Jan2021 15:00, the patient experienced very bad arm pain on injection arm, tiredness, mild headache, chills, feeling unwell overall for 4 solid days. No treatment was given. The outcome of events was recovered on 20Jan2021. Information about lot and batch number was requested.
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| 67 | 2021-02-09 | chills, fatigue |
chills; weak; feeling very tired; This is a spontaneous report from a contactable consumer (patient)...
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chills; weak; feeling very tired; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 67-year-old female patient received first dose of bnt162b2 (lot/batch number not provided), via an unspecified route of administration on 21Jan2021 at 1:00 (unspecify AM/PM) at SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her 1st dose of vaccine, on the 4th day (25Jan2021) she feels weak, have chills and no fever. It was reported that it has been four days since she had her first Pfizer injection of Covid vaccine. Stated that she is feeling very tired, weak and has no chills (pending clarification). Stated that she is four days into it. Stated that she had the vaccine at 1:00 on 21Jan. Stated that she has the list with chills which says that they are normal. Wanted to know if this is normal. The outcome of the event was unknown. Information on the lot/batch number has been requested.
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| 67 | 2021-02-09 | headache |
On a scale of 1-10, 10 being the greatest, I had a little slight, may be like a little slight headac...
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On a scale of 1-10, 10 being the greatest, I had a little slight, may be like a little slight headache like I will give that a 2; This is a spontaneous report from a contactable consumer. This 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EE3247), via an unknown route, on 23Jan2021 (at 11:20) at a single dose for COVID-19 immunisation. Relevant medical history included high blood pressure. Relevant concomitant medications included amlodipine. The patient stated, 'on a scale of 1-10, 10 being the greatest, I had a little slight, may be like a little slight headache like I will give that a 2' that night, the night I had got the injection". The outcome of the event was unknown.
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| 67 | 2021-02-09 | headache |
Side effect was headache, which I do not normally have headaches. Lasted about 30 hours. Tylenol a...
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Side effect was headache, which I do not normally have headaches. Lasted about 30 hours. Tylenol and Aleve helped but did not get rid of it.
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| 67 | 2021-02-09 | sweating, fatigue |
Got a bumpy itchy rash on both legs which is still present; sweating; arm began to hurt then throb a...
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Got a bumpy itchy rash on both legs which is still present; sweating; arm began to hurt then throb and go numb a bit; arm began to hurt then throb and go numb a bit; The patient was cold; clammy; the first blood pressure was 90 over something/second blood pressure was 70 over 40 something; diarrhea; tired; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: 3247), via an unspecified route of administration in the left arm on 18Jan2021 10:00 at a single dose for COVID-19 immunization. The patient's medical history was none. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 18Jan2021 10:10, the patient's arm began to hurt then throb and go numb a bit. On 18Jan2021 10:15, the patient started sweating. She stood up to try and feel better. The patient's husband called the nurse over and they called the paramedics because they said the patient was cold, clammy, and still sweating. The patient sat down again and they put leads on me to check her heart rate, blood pressure (BP), and oxygen on 18Jan2021. Her heart rate and oxygen were fine but the first BP was 90 over something. A few minutes later, she closed her eyes and could have fallen asleep right there. Her second BP was 70 over 40 something. She opened up her eyes and tried to stand up again. After a few more minutes, her BP came up and was OK. They refused an ambulance and went home. She had diarrhea at home on 18Jan2021. She ate, walked and felt better. She just experienced the normal tired and hurt arm in the afternoon on 18Jan2021. She rested the balance of the day. On Wednesday (20Jan2021), she got a bumpy itchy rash on both legs which is still present but with cream, it was OK. No treatment was received for the adverse events. Outcome of the "the first blood pressure was 90 over something/second blood pressure was 70 over 40 something" was recovered on 18Jan2021 and of the remaining events was recovered on Jan2021.
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| 67 | 2021-02-09 | malaise |
COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a Pfiz...
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COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for herself. A 67-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 09Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 virus test positive on 18Jan2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 18Jan2021. She was still sick. The information on the Lot/Batch number has been requested.
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| 67 | 2021-02-10 | chills, headache | HEADACHE THE FIRST EVENING CHILLS BUT NO FEVER THE SECOND DAY |
| 67 | 2021-02-10 | fatigue, headache |
Symptoms: soreness at injection site, headache, tiredness Timing: came on by 6pm on day of injection...
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Symptoms: soreness at injection site, headache, tiredness Timing: came on by 6pm on day of injection, gone by 10am following day
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| 67 | 2021-02-10 | fatigue |
Pfizer-BioNTech COVID-19 Vaccine On 2nd day 8 am was very very tired and took several naps. Lasted...
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Pfizer-BioNTech COVID-19 Vaccine On 2nd day 8 am was very very tired and took several naps. Lasted for about 8 hours. Took ibuprofen at 10 am.
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| 67 | 2021-02-10 | headache, fatigue |
Headache, nausea, fatigue, generalized body aches lasting for 7 days. Symptoms mostly resolved after...
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Headache, nausea, fatigue, generalized body aches lasting for 7 days. Symptoms mostly resolved after 7 days, still feeling fatigued
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| 67 | 2021-02-10 | headache |
12/22 arm soreness, 12/23 headache, dizziness, body ache, abdominal pain. symptoms lasted until 1/2/...
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12/22 arm soreness, 12/23 headache, dizziness, body ache, abdominal pain. symptoms lasted until 1/2/21. Ibprofen and increased fluid whiched helped alliviate some of the symptoms
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| 67 | 2021-02-10 | sweating, fever, fatigue |
The same day as receiving the vaccine, I started getting nervous and restless around 11pm after I we...
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The same day as receiving the vaccine, I started getting nervous and restless around 11pm after I went to bed. I started having generalized pain, all my muscles became achy and my R arm was so sore I could not move it. About 1 am the next morning, I became nauseated and retching. I stared sweating and chilling, my body was shaking so bad I could not hold my thermometer. That lasted possibly 5 minutes, fever 100.8. Episodes of sweating alternating with cold chills occurred the remainder of the night. Exhaustion set in and I could not get out of bed. I was on bedrest all morning and I began to feel better around 4-5pm the next day.
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| 67 | 2021-02-11 | body temperature increased, cough, headache, malaise |
On Christmas day I was working and then you started feeling like a pinching in my chest, like when y...
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On Christmas day I was working and then you started feeling like a pinching in my chest, like when you are going to catch a cold, that went on through the afternoon. In the afternoon I started with light headache and dry cough (intermittent), no temperature. I did not take anything for it and continued working. When I got home, I felt weak and was supposed to join my family for Christmas and decided not to go. And went to sleep. The next day (Sat) I was still not feeling well, weakness on my limbs, I went to the hospital to see if I could get checked and they told me to return on Monday because Occupational Health was closed on the weekends. I went home and treated myself with Tylenol and Vitamin C. On Monday I got tested and was positive. By then, I was coughing, limbs weak, had temperature (101F). I started to get weaker an weaker and Tuesday or Wednesday my work called me and asked me if I would like to come see a doctor. Wednesday I started with shortness of breath. I called my PCP and he prescribed me an albuterol inhaler. It helped me but my cough got worse by Saturday. My doctor then told me to go to the hospital (I live by myself). At my choice I went to Medical Center and were admitted and was hospitalized for 6 days. They kept treating me with inhaler and oxygen. They wanted to send me to rehab but I told them I wanted to go home. I came home with oxygen and with albuterol inhaler and the ambulance had to bring me home. I still was feeling very weak, had cough, and had the shortness of breath. And I have been home since then. I have home health and a therapist that come check on me 2X a weekly.
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| 67 | 2021-02-11 | chills | Diarrhea, vomiting, rash, mild hives, chills, episode of delirium |
| 67 | 2021-02-11 | fatigue |
she felt so tired; her breathing was heavy and felt tight; This is a spontaneous report from a conta...
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she felt so tired; her breathing was heavy and felt tight; This is a spontaneous report from a contactable nurse. A 67-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EL9262), at age 67 years, injection into the left upper arm/deltoid, first dose on 27Jan2021 14:00 at single dose, for COVID-19 vaccination. Ongoing medical history included diabetes diagnosed more than 10 years ago and high cholesterol diagnosed around 10 years ago, maybe longer. The patient's concomitant medications were unspecified maintenance medications because she is diabetic and has high cholesterol. She said that she has been taking these medications for a long time though already. Patient was a retired registered nurse that was calling about the COVID-19 vaccine and reported that she had the first dose injection on 27Jan2021 at 14:00 and 2 hours after she got home, she felt so tired that she did not feel like moving and her breathing was heavy and felt tight. Patient said that her breathing feeling heavy and tight did not last too long, maybe an hour then went away. Her tiredness, felt so tired lasted through the day and whole night and she was fine and completely recovered after waking up in the morning. For breathing feeling heavy and tight: She clarified that it lasted from like 14:00-17:00 yesterday 27Jan2021. Patient wanted to know with the symptoms she had is it contraindicated to get the second dose? She was reading the information about the injection and seemed like the symptoms are part of it. The outcome of the events was recovered, for felt so tired was on 28Jan2021 and for breathing was heavy and felt tight was on 27Jan2021. Case was reported as serious with other medically important condition as seriousness criteria. The reporter assessed the events she felt so tired and her breathing was heavy and felt tight as related to the suspect drug COVID-19 Vaccine. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
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| 67 | 2021-02-14 | chills, fatigue, headache | Myalgias, fatigue, headache, weakness, nausea, chills, decreased appetite and easy bruising. |
| 67 | 2021-02-14 | chills, fatigue, fever |
Saturday, 2/13/21 7;00 am. chills, fatigue, nausea 11:00 am-3:00pm, vomiting 3 times, fever of 10...
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Saturday, 2/13/21 7;00 am. chills, fatigue, nausea 11:00 am-3:00pm, vomiting 3 times, fever of 100 degrees ( normal temperature is 97.5) 6pm - 6:00 am. Fever spiking to 102.7 throughout night Sunday, 2/14/21 Fatigue and weakness. Increased pain at injection sight.
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| 67 | 2021-02-14 | chills, headache |
During screening, patient stated she has tested positive while in Ohio in early January, had symptom...
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During screening, patient stated she has tested positive while in Ohio in early January, had symptoms of headaches and loss of taste. Upon returning to CA, tested positive again Feb. 1st and was diagnosed as a "long-hauler". Denies any symptoms at this time except for loss of taste. Approximately 10 minutes after injection in monitoring area, patient began complaining of dizziness, headache, nausea and feeling hot. After about 10 minutes more, patient then began complaining about chills and stated she felt the need to throw up, spit up a small amount of sputum. Offered to call for ambulance, patient stated she did not want to go to the hospital, just wanted to go home. Approximately 10 minutes later, patient felt stable enough move her to a wheelchair and assisted outside so that she could remove her mask. 02 applied at 2L via nasal cannula, patient stated immediate relief of nausea and dizziness once outside. After another 10 minutes, patient stated headache was now a dull ache and she felt well enough to go home. Spouse provided nurse call number for local hospital, patient transported to vehicle via wheelchair.
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| 67 | 2021-02-14 | chills, sweating, fatigue |
I was felling a bit dizzy upon awakening the day after the vaccination. Once in the bathroom I becam...
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I was felling a bit dizzy upon awakening the day after the vaccination. Once in the bathroom I became very dizzy and started sweating profusely. I tried to walk back to the bedroom but fainted. I came to sitting on the floor. My husband brought me some water and stayed with me. It took quite a while for those symptoms to subside enough that I could get up and go back to bed. For the next 7 or 8 hours I felt chilly and somewhat tired. Normal by late afternoon and evening.
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| 67 | 2021-02-14 | chills, fever |
8 hours post the vaccine the pt experienced severe nausea, vomiting, diarrhea, fever , chills and ac...
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8 hours post the vaccine the pt experienced severe nausea, vomiting, diarrhea, fever , chills and aches
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| 67 | 2021-02-14 | headache |
On 2/5/21, started with headache, brain fog which seem to be getting worse rather than better. This...
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On 2/5/21, started with headache, brain fog which seem to be getting worse rather than better. This still has continued since it's onset. Has taken Advil. Called her provider and they asked her to go to V-safe. Is scheduled to receive the 2nd vaccine on Thursday, 2/18/21.
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| 67 | 2021-02-14 | fever | Nausea, fever |
| 67 | 2021-02-15 | chills | High heart rate, hard to breath, shivers, sore at injection site and general weak feeling |
| 67 | 2021-02-15 | headache | HEADACHE, BODY PAIN FIRST THREE DAYS; DAY FIVE: BELL PALSY-PARTIALFACIAL DROP |
| 67 | 2021-02-15 | headache | ER last night blood pressure 198/106 headache dizzy |
| 67 | 2021-02-15 | sweating |
Patient reported numbness of the left vaccinated arm, "passed out" for a few seconds and became diap...
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Patient reported numbness of the left vaccinated arm, "passed out" for a few seconds and became diaphoretic. Cold packs applied. (BG = 126, BP180/100, T 97.2, HR 60, R 18, 18:16 time O2 was 94% room air, EKG Normal Sinus Rhythm Alert and Oriented. Repeat BP 98/78. Patient taken to ER or Clinic for further observation unknown if was a ER or clinic
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| 67 | 2021-02-15 | fever, fatigue, chills, headache |
I received the shot on Feb. 13, 2021. My side effects started on February 14 before bedtime and cont...
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I received the shot on Feb. 13, 2021. My side effects started on February 14 before bedtime and continued through the day on February 15. I felt much better on Tuesday, symptom free. Pain at shot site and in muscles beginning about 1 hour after the shot and got worse for the next several hours. I began to be very tired before bedtime and started a headache, a fever of about 99.6, and chills. Chills throughout the night on Feb. 14 until morning the 15th. Felt achy in back and general aches all day the 15th and headache. Fever Feb. 15 when I got up in the morning was 100.2. Just sat around very tired and achy throughout the day on Feb. 15. Still a slight fever that night (99.3), but I began to start feeling better close to bedtime on Feb. 15. Feb. 16- I feel fine, just a bit tired, but doing my normal activiites.
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| 67 | 2021-02-16 | fatigue, headache |
One and a half hours after I received my injection, while driving home, my mouth, lips and face bega...
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One and a half hours after I received my injection, while driving home, my mouth, lips and face began to tingle. This lasted for almost two hours. I experienced some brief tingling of the skin on my chest as well and on the skin of my upper thighs. I did not have trouble breathing, and did not develop a rash anywhere on my body. The tingling remained localized to my face and the upper part of my mouth. There was no swelling of my lips or redness of my lips. Immediately after I received my injection I briefly felt the slightest bit of light headedness, but this resolved before I left the vaccination site. I felt tired later in the evening and then began to experience headache and nausea, the typical side effects that I had anticipated and previously heard about.
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| 67 | 2021-02-16 | fatigue |
Possible flare of RA. Symptons include fatigue, pain and stiffness in joints; parficularly right sh...
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Possible flare of RA. Symptons include fatigue, pain and stiffness in joints; parficularly right shoulder.
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| 67 | 2021-02-16 | headache |
Vaccinated 2/11 and symptoms started 2/13 at noon. Sudden bronchial spasms, obstructive apnea, cyano...
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Vaccinated 2/11 and symptoms started 2/13 at noon. Sudden bronchial spasms, obstructive apnea, cyanosis. EMS gave a breathing tx, O2 sats WNL. Declined transfer to hospital at that time for fear of Covid. Client exhibited confusion, oriented x 0, short term memory loss. Bronchial spasms resumed, EMS again called, transported via EMS to MC. Diagnosed with transient global amenesia and hypercapnia. Client was transported to MC for CT and MRI for r/o stroke. Stroke was ruled out. Client with c/o severe H/A, nausea, dizziness, myoclonic seizures. Severe h/a which lasted 4 days. Still experiences mild memory loss, confusion, and h/a are becoming less severe. Client states that sensory processing is slowed
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| 67 | 2021-02-16 | fever, chills | Very weak, fever 39.9, chills for three days |
| 67 | 2021-02-16 | throat irritation |
Within 15-minutes of vaccination, the patient reported nausea, pruritus on bilateral feet, her throa...
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Within 15-minutes of vaccination, the patient reported nausea, pruritus on bilateral feet, her throat "feeling itchy and weird", and that it was hard to swallow. EMS evaluated patient on-site and was found to be hypertensive (182/133). Administered 4mg Ondansetron PO and 50mg Benadryl IV. Patient was transported to ED for evaluation. In the ED, patient was hypertensive (191/85) but noted feeling better after Benadryl IV. No evidence of worsening allergic reaction or respiratory distress. Patient was discharged from ED with instructions to follow-up with PCP.
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| 67 | 2021-02-18 | headache |
She was sitting and got a slight HA, light headed a little bit also per report. She stated she knew ...
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She was sitting and got a slight HA, light headed a little bit also per report. She stated she knew her b/p was high because this is how she always feels every time hr b/p is high. she states she struggle with high and low b/p so she didn't take any of her meds today. Pt took a prn clonidine that was in her purse for b/p 200/100 hr-120 @ 1415. 1445 b/p 180/98, hr-99 pt report HA and dizziness is resolved. Pt instructed to stand up and see how she feels. States she feels fine and is ready to go home. Pt escorted to car with her daughter. Instructed to follow up with MD as needed.
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| 67 | 2021-02-21 | chills |
dizziness. Patient felt normal after drinking water. Sx resilved monitored for about 15-20 minutes ...
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dizziness. Patient felt normal after drinking water. Sx resilved monitored for about 15-20 minutes after symptoms resolved. PSOB, palpitations, chills, ED Precautions discuseed. BP 160/90 Hx High Blood Pressure T98.0 New BP 151/81 HR 78 #21 allowed to go home advised to contact pcp if symptoms recur or
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| 67 | 2021-02-21 | fatigue |
I received the 2nd Covid injection. I went to the 15-minute waiting area. The waiting area was ful...
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I received the 2nd Covid injection. I went to the 15-minute waiting area. The waiting area was full, so my husband and I were standing. I stand and work every day, so this was not difficult. I texted my daughter, who is a hospital employee, and told her that we had a super experience with no wait and had already received our 2nd dose. However, 5 to 7 minutes after the injection, I SUDDENLY felt dizzy and weak and had to sit down. Within a minute or so, I could not stand or open my eyes. The weakness made it difficult to breath or talk. My husband had to lift me up into a wheelchair. I was taken to the ER. For the longest time, I could not even open my eyes or talk above a whisper. After 4 hours, I was able to get my eyes open and talk better. I, gradually, was able to move my hands and feet. Last of all, I could move my hips and walk. It was as if my body had been put to sleep. I could feel everything but my body wouldn?t move. As it wore off, my face and limbs felt slightly tingly. I was, basically, fine after 5 hours other than being tired from the experience. The doctors had no explanation for what happened and said it must be an emotional response to getting the shot. They wrote that I was not exerting enough effort to move my body. One said that I was hyperventilating when I pulled my mask up to breathe after he told me to hold my leg in the air. Though I tried, I was too weak to hold my leg up and it fell to the bed. The doctor told me that I should not tell anyone about what had happened or people would not come to get the Covid vaccination. He obviously knew that SOMETHING had happened that I couldn't control but he didn't put that in his report!
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| 67 | 2021-02-21 | headache | Full body aches Insomnia Headache Difficulty concentrating Temp low |
| 67 | 2021-02-21 | sweating, chills, headache |
Too dizzy to pen eyes, nauseous, diarrhea, headache, chills, sweating, duration about 6 hours, recov...
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Too dizzy to pen eyes, nauseous, diarrhea, headache, chills, sweating, duration about 6 hours, recovery within 10 hours
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| 67 | 2021-02-21 | fever, cough | 103 fever, difficulty breathing, chest cough, not coherent |
| 67 | 2021-02-21 | sleepiness |
Blurred vision, benign vertigo, immediately after vaccine given. Corrected itself over the next hou...
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Blurred vision, benign vertigo, immediately after vaccine given. Corrected itself over the next hour. But at 4:30 am 2/22/2021 I was awakened by intense itching on my left arm and hand. Over the next 2 hours the itching increased in intensity and progressed to my right arm and hand, over my upper back and shoulders, and along the back of my thighs and buttocks. I took 2 Benadryl allergy tablets (25mg) and used Benadryl GEL extra strength on the affected areas. This resulted in my sleepiness for the remainder of the day. Contacted my physicians office for an appointment to resolve the issue.
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| 67 | 2021-02-22 | fatigue |
I got very tired and I felt achy. I started feeling a tingle and numbness in my hands and fingers. I...
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I got very tired and I felt achy. I started feeling a tingle and numbness in my hands and fingers. I had pain around the base of my thumb on my left hand.
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| 67 | 2021-02-22 | fever, fatigue |
Note: this was a POSITIVE effect worthy of study! I was resigned to being a long hauler after 8 werk...
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Note: this was a POSITIVE effect worthy of study! I was resigned to being a long hauler after 8 werks of 100 degree fever and fatigue, but on 3rd day after first Pfizer vaccine, I woke up totally symptoms free. Did the vaccine give me something my body couldn?t produce, or just push my immune system to kick out a new round of fresh antibodies? This could be extra good news for longhaulers. Should be studied.....
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| 67 | 2021-02-23 | cough |
Patient complained of chest tightness, shortness of breath "tongue feels funny", cough, weakness. P...
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Patient complained of chest tightness, shortness of breath "tongue feels funny", cough, weakness. Patient monitored for 30 minutes by EMS, VSS, lung sounds clear, SPO2 100%. Patient remained on-site for an additional 15 minutes then went home.
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| 67 | 2021-02-23 | fatigue, malaise, fever, headache |
Bitter taste in mouth immediately after shot. A few hours later bad headache, nausea, injection sit...
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Bitter taste in mouth immediately after shot. A few hours later bad headache, nausea, injection site pain and redness and swelling , tiredness, muscle and joint pain, slight fever, feeling unwell. Lasted 5 days.
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| 67 | 2021-02-23 | fatigue |
nausea; felt tired; Rash is red and she can feel bumps; rash is red and she can feel bumps; pain at ...
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nausea; felt tired; Rash is red and she can feel bumps; rash is red and she can feel bumps; pain at the injection site; itching going on in my face, my left arm, in the elbow / stomach about 2 inches to the left where they made the incision for the cancer removal; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL9269), via an unspecified route of administration into left arm on 06Feb2021 (at the age of 67-years) as a single dose for COVID-19 immunization. Medical history included allergic to peanuts, allergic to Penicillin, cancer and hysterectomy. There were no concomitant medications. The patient previously took vancomycin, cefalexin (KEFLEX) and zelnorm and was allergic. On 06Feb2021, the patient had pain at the injection site, but that was gone now. She also experienced rash, which was elaborated as an itch, like a rash that started since she got the shot. She had the itching rash going on into her face, left arm, the elbow, and also 2 inches from naval on the left side where she had incision from cancer removal, hysterectomy. The rash was started in the area of the hysterectomy. The patient elaborated that the rash was red and she can feel bumps. The patient was taking diphenhydramine hydrochloride (BENADRYL) which usually stop the itching. Last night 06Feb2021, the back of her left elbow and her face started itching as well and at 23:30 the patient experienced nausea and felt tired. The patient is scheduled for second dose on 27Feb2021. The clinical outcome of event rash is red and she can feel bumps was not recovered. The outcome of pain at the injection site was recovered in Feb2021. The clinical outcome of other events was unknown.
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| 67 | 2021-02-23 | headache |
Pt. from tent 16 in observation lane complained of fluttery chest, difficulty swallowing, headache, ...
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Pt. from tent 16 in observation lane complained of fluttery chest, difficulty swallowing, headache, dry mouth. Paramedics assessed pt. once symptoms subsided paramedic released pt. to leave.
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| 67 | 2021-02-23 | fever, head discomfort, cough, chills, lethargy, sneezing, malaise, influenza like illness |
2/7: By 7:00 pm, I had fever which rose to 102+ before midnight. 2/8: Low-grade fever, flu-like fee...
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2/7: By 7:00 pm, I had fever which rose to 102+ before midnight. 2/8: Low-grade fever, flu-like feeling, "heavy head", lethargic 2/9-2/10: Pretty much back to normal with the addition of an injection site "hot spot"- raised, rashy and feverish 2/11: Began feeling general malaise in the afternoon. Low grade fever, pain behind collarbone on both sides. By 7pm, severe chills. 2/12: Called PCP and advised of symptoms. Went and got a Covid19 PCR test just in case. Negative 2/13-2/15: Still had low-grade fever (usually around 100*) which often didn't present until 2pm and then stayed until bedtime. Glands became swollen, bad night sweats. Pain behind collarbone worse when sneezing, coughing, yawning, burping, etc. Additional information for Item 18: Almost like a "catch" rather than constant pain. 2/16: Went to local medical center for drive-thru rapid Covid 19 and flu test. Both came back negative as did the PCR Covid test they also ran. 2/17-2/20: Symptoms pretty much the same....no fever in the am and thought I was finally getting better, then it would spike again around 1:00-2:00. Never over 101*. On the morning of 2/21, the "catch" around the collarbone had moved down to the bottom of my ribcage. 2/22: Contacted PCP again and made appointment for bloodwork, chest x-ray, and further tests. "Sick and tired of feeling sick and tired!"
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| 67 | 2021-02-24 | chills, fever | Fever (101) chills, body aches lasting about 12 hours |
| 67 | 2021-02-24 | fever |
running fever; This is a spontaneous report from a contactable consumer reporting for herself. A 6...
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running fever; This is a spontaneous report from a contactable consumer reporting for herself. A 67-years-old female patient received bnt162b2 (BNT162B2) vaccine, via an unspecified route of administration in the right arm on 06Feb2021 15:30 at single dose for covid-19 immunisation . Medical history included blood pressure abnormal and blood cholesterol increased. The patient experienced running fever on 08Feb2021 20:00 with outcome of not recovered. The patient was hospitalized on an unknown date for running fever . The patient underwent lab tests and procedures which included body temperature: still running temp on Feb2021, Sars-cov-2 test: negative on 12Feb2021. The patient has received antibiotics as a treatment for pyrexia. At the time of the vaccination the patient was not pregnant and after being vaccinated she was tested negative to Sars-Cov-2 Information on the lot/batch number has been requested.
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| 67 | 2021-02-25 | chills, fatigue |
Muscle aches, chills and severe joint pain 9:05PM Treatment: went to bed at 10:00 P Following day 2/...
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Muscle aches, chills and severe joint pain 9:05PM Treatment: went to bed at 10:00 P Following day 2/25/2021: 7:45 AM extreme fatigue, loss of appetite, taste buds off Treatment: naps, fluids 02/25/2021 9:00PM mild muscle aches and joint pain
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| 67 | 2021-02-25 | chills |
Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed 3rd Attempt to call patien...
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Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed 3rd Attempt to call patient for follow up via phone. No answer. Progress Notes (Nurse Practitioner) ? ? Family Medicine 2nd Attempt to call patient for follow up via phone. No answer. Progress Notes (Nurse Practitioner) ? ? Family Medicine Attempt to call patient for follow up via phone. No answer. Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand All Collapse All 2/24/2021 Patient Date: 2/24/2021 Subjective is a 67 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience itchy, shaky, hot, chest tightness. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, drooling, hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH includes none. She does not take any medications but is on Vyvanse.none. She denies any medial hx. Not on any medications. She did drink a protein shake this am. ALLERGY REVIEW OF SYSTEMS: Patient complains of chills, chest tightness and itching of skin (to R shoulder/injection site area) Patient denies fever, malaise/fatigue, nasal sores, sneezing, sore throat, frequent throat clearing, cough, shortness of breath, wheezing, rash, hives, eczema, abdominal pain, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/24/21 1024 02/24/21 1029 BP: (!) 180/73 (!) 150/90 Pulse: 71 SpO2: 97% Blood Sugar 108 collected at 1050 Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Neck supple. Skin: General: Skin is warm and dry. Findings: No rash. Comments: Injection site and R arm without erythema or swelling. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood is anxious. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines, water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) PT monitored and improving. Pt ambulates well without dizziness. Chest tightness resolved and itchiness improving. Precautions discussed with patient. Pt aware of what to monitor and when to go to ED. Pt voiced understanding and appreciated. Pt able to ambulate out of the facility with ease. APRN Electronically Signed 2/24/2021 12:27 PM
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| 67 | 2021-02-25 | headache, fatigue, chills, fever |
Chills, low-grade fever (99 - 100), headache, body ache, fatigue - lasted for two days, then lifted....
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Chills, low-grade fever (99 - 100), headache, body ache, fatigue - lasted for two days, then lifted. One day of feeling fine, then the next day starting getting stomach cramps in waves, then more chills and fatigue, which lasted through that day; by afternoon of the next day I felt fine.
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| 67 | 2021-02-25 | headache, malaise |
itching on the skin of the back; Headache; malaise; This is a spontaneous report from a contactable ...
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itching on the skin of the back; Headache; malaise; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 04Feb2021 at 09:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unspecified date in Jan2021 (age at vaccination: 67 years) at 09:00 on the left arm for COVID-19 immunization. Prior to vaccination, was the patient has not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced itching on the skin of the back, headache and malaise on 05Feb2021 at 07:00. It was unknown if the patient received treatment for the events. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 67 | 2021-02-25 | headache |
I really hurt so bad all over; I hurt all over like right leg, left leg, upper body; Headache; My ar...
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I really hurt so bad all over; I hurt all over like right leg, left leg, upper body; Headache; My arm was just little uncomfortable; patient with fibromyalgia was given Pfizer Covid-19 Vaccine; patient with fibromyalgia was given Pfizer Covid-19 Vaccine; I am getting nightmares, it's like I am struggling; Fibromyalgia/never have 'flare-up' this bad; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL1283; expiration date: unknown) at 67-year-old age of vaccination via an unspecified route of administration in the left arm on 21Jan2021 at a single dose for covid-19 immunization. Medical history included fibromyalgia. The patient's concomitant medications were not reported. The patient reported that she got her vaccine on a 21Jan2021 (Thursday) and on Friday (22Jan2021), her arm was just little uncomfortable but its fine. On Saturday by 4 o' clock (23Jan2021), she really hurt so bad all over and with headaches. By Sunday (24Jan2021), it went down a little bit and it was going away but last night (unspecified date in 2021), it hit again it just waking her up and she was getting nightmares, it's like she was struggling. She mentioned that she has a history of Fibromyalgia, but she never has 'flare-up' this bad on unspecified date in 2021. It was reported that the patient with fibromyalgia was given Pfizer Covid-19 Vaccine. She further stated that she hurt all over like right leg, left leg, upper body. The patient received treatment of acetaminophen (TYLENOL). The adverse events did not require an emergency room/ physician office. She mentioned that she has read all literature, it says you can get side effects, but this isn't normal. The outcome of the events limb discomfort, pain and headache were recovering while the outcome of the other events was unknown.
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| 67 | 2021-02-25 | sinusitis |
sinus infection; This is a spontaneous report from a contactable consumer (patient). A 67-year-old f...
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sinus infection; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date was unspecified) via an unspecified route of administration on 23Jan2021 (at the age of 67 years old) in a single dose for COVID-19 immunisation. No Medical history or concomitant medication reported. The patient experienced sinus infection on an unspecified date. The patient was prescribed Cefdinir 300mg, twice daily and Methylprednisolone 4mg once daily for 7days. The patient wanted to check about the medications that her doctor has given her for the sinus infection to see if it will override the effects of the COVID vaccine. Outcome of event sinus infection was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
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| 67 | 2021-02-26 | chills, headache | Chills, muscle aches, headache. Gone in 12 hours. No treatment other than rest. |
| 67 | 2021-02-26 | headache, fatigue |
Dose was injected at 9:30 am and around 1 pm, my neck started to stiffen up and get sore on both sid...
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Dose was injected at 9:30 am and around 1 pm, my neck started to stiffen up and get sore on both sides and up into occipital region. It was very painful and difficult to turn my head in either direction. It started to ease after 5 or 6 hours but my neck still feels somewhat sore now which is 3 days later. My injection site was throbbing and painful from elbow to shoulder from about 1 pm until about noon the next day. I did not experience any fever but felt tired.
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| 67 | 2021-02-26 | fever, chills |
Fever, aching, (severe) chills, (a little) nausea, unable to get out of bed for 30 hrs, symptoms con...
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Fever, aching, (severe) chills, (a little) nausea, unable to get out of bed for 30 hrs, symptoms continued for 48 hrs toatal.
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| 67 | 2021-02-27 | headache, fatigue, chills, fever, malaise |
Started with Chills approx 8 pm same day as vaccine given. Developed general weakness/tiredness, fe...
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Started with Chills approx 8 pm same day as vaccine given. Developed general weakness/tiredness, fever, headache, muscle/joint pain, nausea, dizziness with made it difficult to walk to the bathroom d/t the dizziness, general unwell feeling. I took tylenol. I applied ice packs to my neck and core body area. I was confined to the bed until Friday apprx 11:00 am until I could get up. I continue to feel "funny" in the head at times. I did not seek any Dr or hospital visit.
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| 67 | 2021-02-28 | chills, influenza like illness, headache, fatigue | Mild flu symptoms: headache, chills, fatigue, aches |
| 67 | 2021-02-28 | fatigue, body temperature increased, sleepiness, headache |
felt very sleepy; very tired; Headache; elevated temperature; This is a spontaneous report from a Pf...
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felt very sleepy; very tired; Headache; elevated temperature; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable consumer (patient herself) reported that a 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL1283, UPC/NDC number and expiration date were unknown), via an unspecified route of administration in the left deltoid (also reported as left shoulder) on 16Jan2021 at a single dose for COVID-19 immunization. Relevant medical history included hypertension, for which she was taking medication for it and had a torn redness on her rotator cuff; from an unknown date and unknown if ongoing. Concomitant medications included cortisone injection as she had a torn redness on her rotator cuff, as she guessed and she was taking an unspecified medication for hypertension. The patient just wanted to report that after taking the vaccine (Covid-19 Vaccine) on the 16Jan2021, she felt very sleepy and then very tired, slightly headache and she had elevated temperature. The patient further stated that she had elevated temperature and lastly, after she had the injection, she got really, really sleepy. The patient stated that before she had the injection, she had a cortisone injection, so she didn't know. The events did not require any visit to the physician office or to the emergency room. Therapeutic measures were taken as a result of felt very sleepy, very tired, headache, and elevated temperature, which included paracetamol (TYLENOL). The outcome of all the events was unknown.
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| 67 | 2021-02-28 | head discomfort, headache, cough |
not thinking straight; very very intense headache; felt an ungodly pressure in my head; My vision wa...
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not thinking straight; very very intense headache; felt an ungodly pressure in my head; My vision was off; foggy; confused; coughing; felt severe tightness in left side of my chest and that moved to the center of my chest and started to like move up higher, more towards my throat and then it stopped; severe tightness in left side of my chest and that moved to the center of my chest and started to like move up higher you know more towards my throat; rapid heart rate, 100bpm and 102bpm and lasted for couple of days.; my head was more clear but still had some pressure and woozy; Trouble concentrating; ALT High; Test: Cholesterol; Result: Little High/Cholesterol 207 was high; This is a spontaneous report from a contactable consumer, the patient. A 67-years-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9269), via an unspecified route of administration on 07Feb2021 (at the age of 67-years-old) as a SINGLE DOSE for Covid-19 Vaccination. Medical history included ongoing asthma, type 2 diabetes mellitus, seasonal allergy (told to take Zyrtec for seasonal allergies prophylactically). Facility in which the vaccine was received was a clinic at a high school through the local hospital. Concomitant medication included fluticasone propionate, salmeterol (WIXELA INHUB), glipizide (GLIPIZIDE). On 07Feb2021, the patient received the first dose and while walking to the observation area (about two minute after receiving the vaccine) the patient experienced very very intense headache, felt an ungodly pressure in my head, vision was off, and trouble concentrating. When she sat down got real foggy, confused and was not thinking straight, was coughing and experienced severe tightness in left side of my chest and that moved to the center of my chest and started to like move up higher, more towards my throat and then it stopped. Patient began taking deep breath. It went back over to left side of my chest and the tightness (stayed in my left chest for probably 3 days but not to the same degree). The fogginess and the intense pressure in my head, it was bad to the point she thought she would not be able to drive home, waiting for 30 minutes, and because she was not thinking clearly she didn't even ask anybody for help. When she got to the car she waited 15 minutes more before driving home. Patient stayed like this for 2 days. When she reached home, she experienced a rapid heart rate, 100bpm and 102bpm and lasted for couple of days. Each day got gradually better, her head was clearer but still had some pressure and woozy. The patient did visit the physician, he did an EKG and other test. The doctor did not think what I had was an anaphylaxis reaction. Physician recommended she make sure to take her inhalers, for asthma and told me to take Zyrtec (for seasonal allergies) ahead of time. Consumer inquired if she should receive the second dose. The patient underwent lab tests and procedures which included blood cholesterol: little high 207 on Feb2021, blood thyroid stimulating hormone: normal on Feb2021, electrocardiogram: normal on Feb2021, full blood count: normal on Feb2021, hemoglobin: 6.9 on Feb2021, heart rate: 100 bpm on Feb2021, heart rate: 102 bpm on Feb2021, metabolic function test: Alt high on Feb2021. No treatment was given for the events. The clinical outcome of the events not thinking straight, pressure in my head, foggy, confused, coughing, tightness in the left side of my chest , it then moved to the center of my chest then moved up towards throat, rapid heart rate, Woozy, intense headache, vision was off and trouble concentrating was recovering while ALT High, and Cholesterol; Result: Little High was unknown.
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| 67 | 2021-02-28 | headache |
About six hours after the injection I experienced discomfort in my throat, mild swelling in both han...
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About six hours after the injection I experienced discomfort in my throat, mild swelling in both hands and face, some tingling in face, and head ache.I took Zyrtec 10 mg, Pepcid AC 20mg. Then I started to have tightness in my chest and used my albuterol inhaler. I was still having symptoms an hour later so took Benadryl 25 mg. During the night I woke up with mild wheezing and used my inhaler again. Throughout the next 2 days, I continued to have these symptoms (except for wheezing) off and on. Today, I still have some symptoms but not as often or severe.
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| 67 | 2021-02-28 | headache |
Multiple joints( wrists, elbows, shoulders, and hand fingers) excruciating pain, swelling with han...
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Multiple joints( wrists, elbows, shoulders, and hand fingers) excruciating pain, swelling with hand and shoulder movement limitation. Last two days chest discomfort with some difficulty in breathing. Last night first time developed severe skull pain at posterior area. Symptoms mainly during night time and unable to sleep due to the intensity. Treatment: Voltaren Gel 1%, Generic Mobic 7.5 mg and Sombra Warm Therapy Natural Pain Reliving Gel, Acetaminophen 500mg. Most of the symptoms have been for the last three weeks.
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| 67 | 2021-02-28 | sweating |
Approximately 5-10 minutes after receiving the vaccine, patient began sweating, feeling dizzy and dr...
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Approximately 5-10 minutes after receiving the vaccine, patient began sweating, feeling dizzy and dry heaving. BP was normal as well as HR. This has happened before with vaccines and other needle sticks like blood draws. Patient was given and ice pack to help her cool down and after about 10-15 more minutes, patient was calm enough to leave the vaccine observation area.
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| 67 | 2021-02-28 | lethargy |
Loose bowels 2nd day after shot; Rapid heart beat for about an hour second day, but could be thyroid...
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Loose bowels 2nd day after shot; Rapid heart beat for about an hour second day, but could be thyroid as well; Rapid heart beat for about an hour second day, but could be thyroid as well; Sore arm, not severe; Lethargic for a day; This is a spontaneous report from a contactable other health professional, the patient. This 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 26Jan2021 at 09:00 AM in the left arm (at the age of 67 years-old) for COVID-19 vaccination. Medical history included hypothyroidism, autoimmune disease, allergies to penicillin and many foods. Concomitant medications included etanercept (ENBREL), levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and losartan potassium (LOSARTIN). The patient receive did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 at 09:00 AM, the patient experienced sore arm, not severe and was lethargic for a day. On 27Jan2021, the patient had loose bowels the second day after the shot and rapid heart beat for about an hour second day, but could be thyroid as well. No treatment was received for events, sore arm, lethargic, loose bowels, rapid heart beat and thyroid. The events were reported as non-serious. The clinical outcome of sore arm, lethargic, loose bowels, rapid heart beat and thyroid was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 67 | 2021-02-28 | throat irritation |
Patientreported tingling hands, face and itchy throat on the outside not on the inside. 50mg of Bena...
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Patientreported tingling hands, face and itchy throat on the outside not on the inside. 50mg of Benadryl was given and patient was observed for an hour and stated she felt better when she left. Patient was not driving the car.
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| 67 | 2021-03-01 | fatigue, cough, chills, fever |
Day 1: uncontrollable coughing spasms for several minutes, piercing joint pain in left shoulder cap...
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Day 1: uncontrollable coughing spasms for several minutes, piercing joint pain in left shoulder capsule and right ankle, 101 degree fever lasting 6 hours Day 2: chills, exhaustion/weakness, inability to concentrate, lack of appetite Day 3 &4: waves of muscle aches and exhaustion
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| 67 | 2021-03-01 | headache, fatigue | headache tiredness back and shoulder ache treated with ibuprofen |
| 67 | 2021-03-02 | chills, fever |
Fever to 102, chills, body aches. Palpitations headache, nausea everything started the day after sym...
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Fever to 102, chills, body aches. Palpitations headache, nausea everything started the day after symptoms lasted until 3/2/2021
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| 67 | 2021-03-02 | fatigue, headache, malaise |
injection site pain; headache; joint pain; nausea; feeling unwell; tiredness/tired; swollen lymph no...
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injection site pain; headache; joint pain; nausea; feeling unwell; tiredness/tired; swollen lymph nodes under left arm; achy; This is a spontaneous report from a contactable consumer reporting for herself. This 67-year-old non-pregnant female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Jan2021 at 09:30 AM, in left arm, for COVID-19 immunisation. Medical history included allergies to sulfa and COVID before vaccination. Concomitant medications included calcium, glucosamine/chondroitin and unspecified multivitamin. On 30Jan2021 at 16:00 the patient experienced injection site pain, headache, joint pain, nausea, feeling unwell, tiredness, swollen lymph nodes under left arm and achy. The events got progressively worse the following day. On 01Feb2021 the patient was too tired and achy to go to work. The events did not require any treatment and were resolving at the time of report. COVID was not tested post vaccination. No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
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| 67 | 2021-03-02 | fatigue |
Migraines 3 days, vomiting 1day, nausea 4 days. Muscle aches 4 days, joint pain 5 days. Exhaustion 5...
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Migraines 3 days, vomiting 1day, nausea 4 days. Muscle aches 4 days, joint pain 5 days. Exhaustion 5 days
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| 67 | 2021-03-02 | headache, fatigue |
Heart palpitations to the point where I could not sleep; Heart palpitations to the point where I cou...
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Heart palpitations to the point where I could not sleep; Heart palpitations to the point where I could not sleep; Extreme fatigue; Slight headache; sore arm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (brand=PFIZER), via an unspecified route of administration (vaccine location=right arm) on 28Jan2021 15:45 at a single dose for COVID-19 immunization. Medical history included breast cancer and mitral valve prolapse. She had no known allergies. Concomitant medications included celecoxib (CELEBREX). No other vaccine in four weeks. No covid prior vaccination. The patient experienced heart palpitations on 28Jan2021 10:00 PM to the point where she could not sleep - started 6-8 hours after receiving vaccine. Some better the next day but still having palpitations. Day 2 after vaccine about the same. Extreme fatigue, slight headache & sore arm but not too bad on an unspecified date in 2021. No treatment received for the events. No covid test post vaccination. The patient was recovering from heart palpitations to the point where I could not sleep while outcome of other events was unknown. Information on the lot/batch number has been requested.
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| 67 | 2021-03-02 | headache |
face and jawline went absolutely numb; Headache; Swelling arm; This is a spontaneous report from a c...
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face and jawline went absolutely numb; Headache; Swelling arm; This is a spontaneous report from a contactable consumer reported for herself. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 16Feb2021 10:15 (at the age of 67-year-old) from lot # EN6200 at single dose for COVID-19 immunization via intramuscular route at the left arm. The caller stated she had a half an hour of sitting afterwards and then they let her go. Concomitant medications included loratadine (CLARITIN) for sinusitis and insulin for Type 2 diabetes mellitus. Relevant medical history included type 2 diabetic (Diagnosed about 17 years ago), allergic to some food, allergic to sulfa, she had a number of allergies and she had an anaphylactic reactions in the past, asthma diagnosed around the age of 40, sinuses, high blood pressure after a D&C, she had a miscarriage, uterine dilation and curettage, one headache before this in her entire life. The patient had received Flu vaccine on unknown date. The patient, on 16Feb2021 had headache that lasted for 5 minutes. It was right after the first shot of the Pfizer COVID-19 vaccine, her face went numb and she couldn't breathe through her nose. She was only able to breathe through her mouth. Her jaw got really numb. It happened when she was driving home from the vaccination center and she had to pull over because she might go into an accident. She wasn't sure if she was having a stroke or not but she was scared since her sister had histories of multiple strokes. She wanted to know Pfizer's recommendations for the second dose considering her adverse events. He had a really short headache tonight, He stated "it hit me out of the blue right in my temporal; I got on the floor it was so bad. 5 minutes after I left my face went totally numb" She stated she also had the second headache she had ever had in her entire life. She also mentioned she had some swelling in her arm but she didn't think that was unusual. She clarified as she was driving home after receiving her shot, her entire face went numb and her jawline went numb. It scared her so bad. She thought she was having a stroke or something. She confirmed she recovered completely from this, the numbness cleared up in 10 minutes. The Outcome of the event swelling arm was unknown while the outcome of the other events was recovered on 16Feb2021.
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| 67 | 2021-03-02 | headache | Adverse event is constant ringing in ears and continuous headache. |
| 67 | 2021-03-02 | influenza like illness, fatigue, fever, chills |
After my second injection, I , the day after, had severe flu like conditions, aches, chills, feveris...
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After my second injection, I , the day after, had severe flu like conditions, aches, chills, feverish, extreme fatigue. The second day after my reaction, two days after I received it, I had so much fatigue that I could do nothing, but lie in bed. The third day, I felt a little better but was again fatigued and could not do anything but rest. I began to feel a little better after the third day but two weeks later I still have fatigue but can still function. The Saturday after I received the injection on Sunday I slept 11 hours.
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| 67 | 2021-03-02 | nasopharyngitis, chills |
Chills; Injection site pain; flu; cold; Joint pain; Muscle stagnant; Where they gave me the shot the...
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Chills; Injection site pain; flu; cold; Joint pain; Muscle stagnant; Where they gave me the shot the muscle goes jumping up and down; Not feeling well; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL9262 expiry date not reported, via an unspecified route of administration from 28Jan2021 at single dose for COVID-19 Immunization. Medical history included High blood pressure and Pre-diabetic. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) 12.5 mg, metformin (METFORMIN) 1000 mg, twice a day, lisinopril (LISINOPRIL) 20 mg at night, pravastatin (PRAVASTATIN) 20 mg, acetylsalicylic acid (BABY ASPIRIN) and atorvastatin calcium (ATROSTAT). The patient experienced joint pain, not feeling well and muscle stagnant; where they gave me the shot the muscle goes jumping up and down all on 29Jan2021 and chills, injection site pain, flu and cold all on unspecified date. Consumer stated, "I am having a joint pain and chills and not feeling well, I had it Thursday evening, I took it Thursday evening. I am not feeling well from that Friday night and last night I mean the joint pain, the muscle pain you know, it's just you have to deal with." Consumer added, "I have been taking pain medicines, Ibuprofen and Tramadol for pain and Mucinex for cold and flu." Therapeutic measures were taken as a result of joint pain, injection site pain, flu and cold. Outcome of the events was unknown.
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| 67 | 2021-03-02 | throat pain |
throat is still sore; Vomiting; Migraine; This is a spontaneous report from a contactable consumer (...
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throat is still sore; Vomiting; Migraine; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261 and expiry date: unknown) via an unspecified route of administration on the left deltoid, on 27Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included ongoing type 2 diabetic for at least 15 years. There were no concomitant medications and no prior vaccinations within 4 weeks. On 28Jan2021, patient got a migraine and on 29Jan2021, the vomiting started which was so bad her throat was still sore. The migraine resolved as of the morning of 01Feb2021. The vomiting lasted 3-4 hours and resolved the same day (29Jan2021). It was done at a clinic at a local church. There were no treatment, she just waited it out and rehydrated. Outcome of the event throat was still sore was not recovered.
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| 67 | 2021-03-02 | fever, influenza like illness, chills | Chills, fever, body aches, nausea, diarrhea, dizziness, feels like I have the flu |
| 67 | 2021-03-03 | chills, fever |
Shot in left arm. No side effects until three days later began having nausea, fever, chills, aches....
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Shot in left arm. No side effects until three days later began having nausea, fever, chills, aches. Next day noticed heat, redness, increased swelling, tenderness of RIGHT arm that has Lymphedema. Called doctor today and was prescribed Keflex 500 4x a day for 7 days for suspected cellulitis.
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| 67 | 2021-03-03 | chills, fever |
3/2 - sore arm, chills, low grade fever 3/3 - woke up with heart palpitations. Apple watch recorded...
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3/2 - sore arm, chills, low grade fever 3/3 - woke up with heart palpitations. Apple watch recorded range between 59 and 166. 3/4 - itchy rash near injection site ( have photo)
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| 67 | 2021-03-03 | chills, runny nose, fever, sweating, headache |
Chills; Headache; Severe sweats; Nausea; Runny nose; Fever; Vomiting; It was positive for Covid and ...
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Chills; Headache; Severe sweats; Nausea; Runny nose; Fever; Vomiting; It was positive for Covid and negative for the antibodies the Nurse told me; It was positive for Covid and negative for the antibodies the Nurse told me; It was positive for Covid and negative for the antibodies the Nurse told me; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation. Medical history included diabetes mellitus. The patient's concomitant medications were not reported. The patient experienced positive for covid and negative for the antibodies on 02Feb2021, chills, headache, severe sweats, nausea, runny nose, fever, vomiting on an unspecified date. The outcome of events was unknown. Information about lot/batch number has been requested.
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| 67 | 2021-03-03 | fatigue, fever | fever - lasted one day fatigue persistent strange (flowery) taste and smell |
| 67 | 2021-03-03 | fatigue |
Severe pain in hands and knees where I have arthritis, tiredness low. Grade temp fluid retention doe...
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Severe pain in hands and knees where I have arthritis, tiredness low. Grade temp fluid retention doesn?t go down,
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| 67 | 2021-03-03 | headache, cough, fever |
low grade fever (99.4F); really bad headache with aches all over/aching all over; feeling like she h...
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low grade fever (99.4F); really bad headache with aches all over/aching all over; feeling like she had been run over by a truck; really bad headache with aches all over/head has been hurting really bad; cough; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received her first dose bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262; expiration date: unknown) at vaccination age of 67-year-old via an unspecified route of administration in the left arm on 29Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included blood pressure (blood pressure abnormal), cholesterol (blood cholesterol) and several bypass surgeries. She mentioned that she was pretty healthy for her age. Family history included father died of heart disease and her sister has heart disease. Concomitant medication included unspecified blood pressure and cholesterol medication. The patient has no previous vaccination within 4 weeks and did have other vaccines given on the same day. The patient reported that she did not feel bad on the first day, but she started getting a cough on Saturday night (30Jan2021) and on Sunday (31Jan2021), she started getting a really bad headache with aches all over. This morning (02Feb2021), she is running a low-grade fever (99.4F). She added that now she was sick, she has a low-grade fever, chills, is hurting all over, all the things on the list. She inquired if these are common side effects of the vaccine and was asking if she should get tested to see if she's diagnosed with COVID-19. She inquired will her getting the shot effect the results of the COVID test, would she test positive for COVID now that she's had the shot. It is confirmed she has not tested positive for COVID. She did have 2 tests previously in Dec2020 before and after traveling. She further explained that she didn't feel bad until Saturday night and that is when she started with nagging cough. The aching all over started on Sunday (31Jan2021), feeling like she had been run over by a truck. She hadn't had a fever until this morning (02Feb2021), she woke up with a low-grade temperature of 99.4. She has been taking acetaminophen (TYLENOL) that helps. The call also notes later in the call that her head has been hurting really bad and this started yesterday (01Feb2021 [also reported as 31Jan2021]). It is remarked that she will probably be tested if the vaccine doesn't affect the results. The adverse events did not require emergency room or physician office. The outcome of the events was not recovered.
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| 67 | 2021-03-03 | sweating, fatigue, throat irritation |
Immediately after medicine went in my arm I felt a warm flush from my neck all the way to my toes (t...
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Immediately after medicine went in my arm I felt a warm flush from my neck all the way to my toes (the same as when I have had radioactive dye), during my 15 minutes of observation my hands and feet were cold and sweaty and I felt a little shaky. I waited 20 minutes and went to the restroom and had diarrhea (very rare for me). I went to my car and looked in the mirror and my face was bright red and the whites of my eyes were red and my eyes were glassy. I went back in to the observation area and was given oral Benadryl. and monitored for 45 minutes. Right after I took the Benadryl my throat felt itchy (not sore - itchy). My blood pressure was 157/62 when I first sat down but came down to 130/ 60 by the time I was sent home. My bp is normally about 106/60. I was really tired at home for the rest of the day so went to be early. The next day I felt fine and my arm was only slightly sore. The doctor at the immunization clinic told me not to get the 2nd shot. I called my GP, and he too told me not to get the 2nd COVID shot and wait until more information has come out about adverse reactions to the vaccine. I did not have any difficulty breathing. I don 't know if the redness on my face went down my neck to my chest. I didn't look. I did not have a fever.
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| 67 | 2021-03-03 | sweating | pt felt dizzy, diaphoretic. |
| 67 | 2021-03-03 | fever, chills, headache, malaise |
Yesterday I received my 2nd Pfizer vaccine at 9AM. My first dose was a non-event. About 50 minutes a...
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Yesterday I received my 2nd Pfizer vaccine at 9AM. My first dose was a non-event. About 50 minutes after the jab, I broke out in hives on my upper thigh and stomach. By 7 PM, I felt really sick, my arm felt as though the strongest person in the world punched me, and by 8, I was shivering and wrapped in a ton of blankets, by 10, every muscle in my body ached beyond its capacity and my fever was 101.8. It got to 102.1. My head was weighed down with an unrelenting headache. Finally, an hour ago, my fever broke. I have Systemic Lupus and CRPS and do not vaccinate because my body is always attacking itself. But this year I got my first ever flu vaccine. Same results. So sick.
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| 67 | 2021-03-04 | body temperature increased, chills, headache, influenza like illness | achy flu like symptoms, bad headache, chills temp 101-103.6 |
| 67 | 2021-03-04 | chills, fatigue |
Woke up feeling fine, a few hours later started with fatigue, extreme chills, achy, and my arm was v...
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Woke up feeling fine, a few hours later started with fatigue, extreme chills, achy, and my arm was very sore swollen some at injection site, however, I had swelling under my armpit that was very tender and sore to touch. These symptoms lasted for 2 days, the armpit tenderness lasted for 4 days. I could t keep my blood sugar levels low, as they remained high almost 400. I was taking additional insulin to try and bring it down and I wasn?t eating.
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| 67 | 2021-03-04 | chills |
elevated transaminase measurement; Severe abdomen pain; abdomen swelling; chills; nausea; vomiting; ...
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elevated transaminase measurement; Severe abdomen pain; abdomen swelling; chills; nausea; vomiting; This is a spontaneous report from a contactable consumer. A 67-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el 3247), via an unspecified route of administration on the left arm on 28Jan2021 10:15 at a single dose (at the age of 67-years-old) for COVID-19 immunization. The patient was administered in a public health clinic/administration facility. Medical history included asthma, diabetes, high blood pressure and anxiety. The patient had unspecified concomitant therapy. The patient preciously took enalapril and sulfur and experienced drug allergies: "Allergies to medications, food, or other products: Sulfur, Enalapril". The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 at 21:30, the patient experienced severe abdomen pain, abdomen swelling, chills, nausea, vomiting and elevated transaminase measurement. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received unspecified treatment for the adverse events. The patient underwent lab tests and procedures in 2021 which included CT scan, comprehensive metabolic, Random amplification of polymorphic DNA (Rapd) and ultrasound all with unknown results; on 30Jan2021 elevated transaminase; and on 31Jan2021 a negative nasal swab (SARS-CoV-2 test). The events were considered non-serious by the reporter: not resulted in death, not life threatening, did not cause or prolong hospital, not disabling/incapacitating and not a congenital anomaly/birth defect. The patient has not recovered from the events.
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| 67 | 2021-03-04 | headache, fatigue, fever |
Severe headache, fever high at 101, aches in joints, nausea and vomiting,fatigue. Started at about 1...
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Severe headache, fever high at 101, aches in joints, nausea and vomiting,fatigue. Started at about 1 am on 3/5/21. Fever has dropped to 100 as of 4 pm. Severe headache persists. Advil every 6-7 hours, fluids regularly
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| 67 | 2021-03-04 | headache |
Friday around 5:30pm a headache began and then tongue swelling began around midnight Then the sw...
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Friday around 5:30pm a headache began and then tongue swelling began around midnight Then the swelling of tongue went away around 3pm on Saturday afternoon. On Saturday The nausea and diarrhea started around 7:30am and subsided by 9am. The headache went away by Sunday afternoon.
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| 67 | 2021-03-04 | fever | Continuous low grade fever since injection |
| 67 | 2021-03-05 | chills, fatigue |
Within 3 hours - Fatigue, injection site pain Within 6 hours - Fatigue, injection site pain, chills ...
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Within 3 hours - Fatigue, injection site pain Within 6 hours - Fatigue, injection site pain, chills Within 24 hours - Fatigue, increased injection site pain Within 4 days - injection site redness
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| 67 | 2021-03-05 | fatigue |
I found that I had tiredness for about 8 days after. The second dose. I could function, but couldn?t...
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I found that I had tiredness for about 8 days after. The second dose. I could function, but couldn?t get through exercises that I regularly do. Just tired a little achy.
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| 67 | 2021-03-05 | fever, cough, headache, throat pain, chills |
1. Sore Arm the next day. Expected because the first shot made the same arm a little sore. 2. Low...
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1. Sore Arm the next day. Expected because the first shot made the same arm a little sore. 2. Low Grade Fever and Chills. (can't take anything else due to PE caused by DVT.) 3. Light cough. Not a sore throat but not right. 4. Terrible headaches. But Tylenol takes it away in time. 5. All over Achy body. What is most concerning is the oxygen level Because of my PE I watch my levels at night. Average for me with PE I'm around 94-97 saturation But from Wednesday Night March 3 my levels are lower. Dropping to 88-85. My finger montor goes off at 88 so I cake a couple of deep breaths to bring it back up.
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| 67 | 2021-03-05 | fever, fatigue |
Fever of 104 Extreme tired Swollen and very sore Lymph Nodes under left arm I took Tylenol for feve...
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Fever of 104 Extreme tired Swollen and very sore Lymph Nodes under left arm I took Tylenol for fever and pain
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| 67 | 2021-03-06 | chills, headache, fatigue |
An hour after vaccine, my arm got very sore, then neck pain and headache. Followed by fatigue and ch...
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An hour after vaccine, my arm got very sore, then neck pain and headache. Followed by fatigue and chills for about 6 hours. It was tolerable and manageable with Ibuprofen and lots of water.
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| 67 | 2021-03-06 | chills, fever, headache |
Severe muscle and joint pain Severe body aches Skin pain Severe headache Nausea Vomiting Fever S...
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Severe muscle and joint pain Severe body aches Skin pain Severe headache Nausea Vomiting Fever Severe chills Left arm pain Injection site swelling, redness hives around left upper arm Left axillary lymph node swelling
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| 67 | 2021-03-06 | fatigue, chills | Severe chills. Severe achiness severe fatigue |
| 67 | 2021-03-06 | fatigue, headache |
mild headache possible start when sleeping approx. 12hrs after injection, tired with body aches that...
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mild headache possible start when sleeping approx. 12hrs after injection, tired with body aches that increased as day progressed
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| 67 | 2021-03-06 | headache, fever | Bone and joint pain, fever. Joint pain severe. Headache. Lasted 48 hours. |
| 67 | 2021-03-06 | influenza like illness, fatigue, chills, headache |
Severe chills, joint aches, headache, fatigue. Took some Aleve which improved symptoms, but felt li...
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Severe chills, joint aches, headache, fatigue. Took some Aleve which improved symptoms, but felt like mild flu symptoms for about 12 hours. Felt better about 12 hours later, then felt completely normal by the next morning.
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| 67 | 2021-03-06 | throat irritation |
At 30 min observation time pt. Advised medics that she had hoarseness and scratchy throat. Medics i...
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At 30 min observation time pt. Advised medics that she had hoarseness and scratchy throat. Medics in obs. lot did initial eval, and FIre/Rescue EMS summonsed (SMFRA) via 911 for potential allergic/anaphylactic reaction. Vital signs were BP 180/100, P82, Pox99% on RA and R20. Pt was evaluated also by fire/EMS and patient encouraged to seek medical attention via ambulance. Pt. refused transport to facility but agree to go POV. Pt. had total time pre obs/post obs of approx one hour with no worsening of s/s. Pt. was release AMA with advisement of not seeking medical attention could lead up to death. Pt. accepted risks. Pt. also advised to advise PCP.
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| 67 | 2021-03-07 | chills, fatigue |
The day after receiving the vaccine (Wednesday 3/3/21) I noticed extreme sensitivity to sunshine whi...
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The day after receiving the vaccine (Wednesday 3/3/21) I noticed extreme sensitivity to sunshine while driving, even while wearing shades. Remind me of when I get my pupils dilated by the ophthalmologist. Also muscle pain, chills, and fatigue. All these symptoms disappeared by the next day, but the fatigue remained through the weekend. Today, 3/8/21 I feel back to normal. I had Covid 19 in May 2020, so I recognize some of the symptoms, except for the light sensitivity, which scared me. I will consult with my ophthalmologist before my second dose scheduled for 3/23/21.
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| 67 | 2021-03-07 | chills |
Extreme chills, aches body and head, swollen lymph node in left arm. Very sore left arm and difficu...
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Extreme chills, aches body and head, swollen lymph node in left arm. Very sore left arm and difficulty lifting it. Fatigue. LARGE RED CIRCLE ON UPPER LEFT ARM NEXT TO INJECTION SITE. The red spot is warm and tender and has persisted for 3 days.
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| 67 | 2021-03-07 | fatigue, influenza like illness | flu like symptoms for 48 hours, fatigue, sore arm at injection site, rash possibly related. |
| 67 | 2021-03-07 | headache, chills, fatigue, malaise |
Chills; pain wasn't constant it was jumping to different parts of her body; difficulty in breathing/...
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Chills; pain wasn't constant it was jumping to different parts of her body; difficulty in breathing/labored breathing; tightness in the chest/chest felt tight there was a heaviness just like a feeling of discomfort; joint pain started in her right elbow, right thumb, right knee, left ankle and left instep; Feeling unwell; Muscle pain; Injection site pain; Headache; has not felt normal; Tiredness; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261), intramuscularly on 22Jan2021 09:35 at 0.3 ml single dose for COVID-19 immunization. Medical history included ongoing High cholesterol, allergies to penicillin and sulfanized antibiotics, allergies to latex, Shingles since 2007, post herpetic neuralgia, mild shingles pain from the neuralgia, changes in temperature, the temperature and the weather going up and down. No other condition was reported. Concomitant medication included rosuvastatin (strength: 10mg) from 18Jan2021 to 24Jan2021 at 10 mg for High cholesterol. Past drug event included doxycycline allergy (she had a reaction to that she was sweating profusely and had very rapid heartrate and elevated BP and unable to sleep), Ibuprofen allergy, Levaquin allergy, Valium allergy and omeprazole allergy, took sulfanized (SULFA) antibiotics allergy (she had rapid heartbeat, sweating). Patient stated she said that she had received the first dose of the COVID-19 vaccine and did experience some side effects of the COVID-19 vaccine. She said she did not have an anaphylactic reaction but had difficulty in breathing 2 days after having the first dose. She said she experienced 30 hours of labored breathing. She wanted to know if there is "sulfa dioxide" in the lipid/mRNA portion of the COVID-19 vaccine. She said she is highly allergic to "sulfanized compounds". She is also allergic to all forms of penicillins. Caller wanted to know if the second dose of the vaccine has the same ingredients as the first dose. She wanted to know if the ingredients have the same amounts as the first dose or if the actives are stronger. She based this question from "most people having more reaction on the second dose of the vaccine" and also from what Pfizer second line told her "the first dose primes the system while the second dose strengthens the system". She wanted to know what ingredient causes the anaphylactic reactions for this vaccine and if it is penicillin. On 22Jan2021 she learned that there is a small amount of Sulfa Dioxide in the lipid portion of mRNA and she is highly allergic to sulfa compounds. With her side effects she would also like to add that she had a severe case of shingles in 2007 that was not diagnosed until the end of the 7th week. She had seen 8 doctors, her family doctor, she had 3 ER visits so prior to the vaccine she had post herpetic neuralgia and so a week and half before the vaccine there were changes in temperature, the temperature and the weather going up and down so she was having mild shingles pain from the neuralgia going into the vaccine which was given on 22Jan2021. The other thing is she had high cholesterol and her cardiologist put her on a statin she does not have high BP but she has high cholesterol so she was started on a statin, it was Crestor 10 mg, actually it says it is Rosuvastatin Calcium 10 mg and she took that 18Jan2021 and the 19Jan2021 and then on the 20Jan2021 her doctor told her to stop it before her vaccine so she did and she felt okay just had mild reactions so she took the Rosuvastatin that Friday night 22Jan2021 and she took it 23Jan2021 then she took her self-off of it on 24Jan2021. She called her doctor on 25Jan2021 and he said yes stop the Rosuvastatin and stay off it until after your second dose of the vaccine. So she was having an allergic reaction in Jan2021 she has had a lot of side effects from being post shingles and all the side effects from COVID vaccine and being post shingles and the statin all of the possible side effects mirror one another. As far as the reaction she got a headache about 35 minutes after she took the shot Friday morning at about 9:35 AM and she took Tylenol twice that day, once that morning and she took it also around 4:30 PM when she was having medium pain at the injection site and that is when she took her statin and she woke up on 23Jan2021 and until late in the afternoon she had tightness in the chest so she took one more Tylenol then that was mid-morning, so total she had 3 doses of 325 mg Tylenol. Then on 24Jan2021 at about 4:30 AM in the morning she woke up with labored breathing, it wasn't normal. She did not have a closed throat but her breathing was labored, her chest felt tight there was a heaviness just like a feeling of discomfort. Then around 5 pm that same day the joint pain started in her right elbow, right thumb, right knee, left ankle and left instep and the pain wasn't constant it was jumping to different parts of her body and she still felt the tightness in her chest and heaviness all day. Then around 4PM on 24Jan2021, Saturday the labored breathing dissipated around 8pm and she did not take the statin that night then on 25Jan2021 her breathing was normal but she still had tightness in her chest. She had injection site pain on the 22Jan2021, 23Jan2021 and the 24Jan2021 and it was almost totally gone on 25Jan2021. Tiredness began on the evening 22Jan2021 the day she had the shot and it comes and goes. Headache- she had mild headache and she had took Tylenol so it was mitigated a little but it started 22Jan2021 and she had a headache through the 23Jan2021, 24Jan2021 and the 27Jan2021 so around 3:25PM yesterday she took another Tylenol yesterday 27Jan2021. Muscle pain she has had since 23Jan2021 and it has been ongoing but less today, she doesn't know if it will come back or not. It is mainly in the in the rhomboids which is the shoulder wings. She had it on both sides. Chills she had 25Jan2021, 26Jan2021 and 27Jan2021 and they come on mid-day-late afternoon they go on up until early evening, a little past supper/dinner time. Joint pain was 23Jan2021, 24Jan2021, 27Jan2021 and pain in her rhomboid muscles. She has had no fever, no swelling or redness at the injection site, no nausea. Feeling unwell- she would say from 23Jan2021 to the present she has not felt normal on 22Jan2021, it comes and goes She has not had swollen lymph nodes. Difficulty breathing 24Jan2021 at 4:30 am it woke her up and she had labored breathing, no closed throat and she stopped the Statin that day, tightness in her chest started 24Jan2021 in the morning and she had that 25Jan2021 26Jan2021 and it has been present on and off mainly in her back discomfort. She says the tightness is not really in the front around the heart but it is like a total tightness in the chest area. Muscle pain on the 27Jan2021 mainly in her back, the rhomboids. Fast heartbeat- She was sound sleep this morning at about 12:45AM and it woke her up her heartrate was 87, her BP was 135/81 (2021) and she did an ice pack for 16 minutes on her head and then she went back to sleep at 4:45 AM she woke up again her BP 131/87 pulse was 80 temp was 97.8 (2021). She didn't take her temp the first time she woke up she just did an ice pack for 16 minutes and she as up for a while typing side effects at that point. Then she went back to sleep from 6:20-7:20 and then when she woke up again her BP was 122/75 and pulse was 64, temp 98.3 (2021). For someone look at at her BP they may say that's not high but for someone post shingles, the pain, the nerve endings are already on edge she can feel it working on her body. They say reactions are proof that the vaccine is working but her issue with the joint pain, it disappeared when she stopped the Statin and then there is the labored breathing, she has had 2 new drugs that went into her system at the same time and she doesn't know, one has the documented side effects and the other one it is so unknown at least the mRNA part she does not know if she is just having a reaction to Sulfa. She says that blood pressure doesn't seem high but for someone whose body is stressed and with her pulse to go up when she is sound asleep, normally when her body is sleeping and she wakes up she would be about 117/70 (2021), she would have low numbers she doesn't have high BP. She took the statin for 2-3 days and then stopped it her doctor told her she could start and stop it and her doctor told her to stay off of it but she started it because she felt okay she only had a headache and injection pain so she said she is going to take it and then things intensified so she decided to stay off it. She has a history of having delayed serious side effects. She is allergic also to Penicillin and that is probably in the records already because she called and asked when she was thinking about taking it. It dates way back with her allergies with her, it is extensive Doxycycline, Ibuprofen, Levaquin, all forms of Penicillin, sulfanized antibiotics, Valium, latex, Omeprazole. She had shingles so bad after about 7.5 weeks of it going undiagnosed she had the 2 worse reaction and they asked her they went through her history and asked what are the 2 worst things she had and that was with Doxycycline they gave her that because they thought she had a bacterial infection and didn't realize it was shingles and she had a reaction to that she was sweating profusely and had very rapid heartrate and elevated BP she was unable to sleep literally she could feel the blood coursing through her veins. and then the other one she knows is Sulfa she has had that allergy since a child but she had rapid heart beat, sweating and there may have been other symptoms but she does not remember she was a child. She has been given Sulfa drugs since then and she is highly sensitive to Sulfa. Outcome of the event muscle pain was not recovered; injection site pain was recovered on 25Jan2021; labored breathing was recovered on 24Jan2021, while other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-03-08 | chills, fever, fatigue, cough |
First 48 hours reports felt fine. Sunday am felt achy and tired. Took advil and aspirin. Reports the...
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First 48 hours reports felt fine. Sunday am felt achy and tired. Took advil and aspirin. Reports the next 8 days she felt sleepy and achy. Reports felt ok couple of days. Friday 3/5/2021 she had a fever, loss of appetite, chills, for 24 hours. Sunday night had trouble breathing SOB. used humidifier. Chest felt tight. minor cough, symptoms similar to asthma.
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| 67 | 2021-03-08 | chills |
vomiting, diarrhea, chills Thursday 9:00 PM to Friday 9:00 AM rash over entire body, pins and needle...
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vomiting, diarrhea, chills Thursday 9:00 PM to Friday 9:00 AM rash over entire body, pins and needles effects Friday 8:00 PM to Saturday 10:00 rash continues but not as severe to currently Tuesday at noon Jaundice, elevated liver enzymes, and elevated billirubin started Saturday to currently Tuesday at noon
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| 67 | 2021-03-08 | fatigue, cough, fever, nasal congestion, chills |
Intense pain at injection site but no swelling or redness Intense body and joint pain and muscle cra...
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Intense pain at injection site but no swelling or redness Intense body and joint pain and muscle cramps. Difficulty walking. Fatigue. Chills and Fever 102.2 degrees. Brain fog and off-balance could not sleep but no headache. Nausea —no appetite. Nasal congestion and mild cough. Symptoms woke me at 2 am with chills. Took 500 mg acetominophin at 10 am. Forgot to take medication resulted in high heart rate and blood glucose. Symptoms started to decrease after 2 pm 2/28/21. Took 500 mg acetominophin around 3 pm. Fever 100. 5 on 3/1. Fever 100 on 3.2 Felt better but cancelled morning appointment on 3/3. Went for short walk outside on 3/5/21. Did not seek medical care. Still have muscle pain fatigue and brain fog.
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| 67 | 2021-03-08 | fatigue, fever |
Extreme tiredness 8 hours after the vaccine. Fever over 100 that evening continuing intermittently f...
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Extreme tiredness 8 hours after the vaccine. Fever over 100 that evening continuing intermittently for four days after vaccine. On the fourth day, I woke up with a reddish purple rash over most of my body. My doctor advised me not to take the second dose.
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| 67 | 2021-03-08 | headache, fatigue |
No symptoms until 8:30 PM on fifth night after injection. Headache, unable to sleep fifth night aft...
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No symptoms until 8:30 PM on fifth night after injection. Headache, unable to sleep fifth night after injection. Dizziness beginning 9:00 AM and lasting all day sixth day after injection; Nausea and shortness of breath beginning 7:00 PM on sixth after injection; able to sleep sixth night after injection. Fatigue and shortness of breath beginning 8:00 AM and lasting all day seventh day after injection until 8:00 AM eight day after injection. Side effects were moderate, subsided on their own.
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| 67 | 2021-03-08 | sweating |
Patient felt woozy after receiving the vaccine while sitting in the waiting area. She was lowered to...
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Patient felt woozy after receiving the vaccine while sitting in the waiting area. She was lowered to the floor and her blood pressure was taken, at 104/85. She was sweaty and clammy. Patient stated that she was anxious about the vaccine and something like this had happened before. After laying on the floor she felt better and soon after sat up in her chair. Her blood pressure was taken again and rose to 133/66. She was observed in the waiting area and started feeling better after 15 minutes.
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| 67 | 2021-03-08 | sweating | chest pressure/pain, mild hypoxia to 92%, became diaphoretic |
| 67 | 2021-03-08 | runny nose, sinus congestion, fatigue, nasopharyngitis |
migraine next 2 following days after shot. Tiredness the day of the shot and the following day. Col...
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migraine next 2 following days after shot. Tiredness the day of the shot and the following day. Cold/allergy symptoms including nasal sinus congestion and runny nose all the way up until today. Also paying on the side of injection on the day of the shot and following day
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| 67 | 2021-03-08 | sinus disorder, headache, throat irritation, runny nose, fever |
Rec'd 1rst shot @ noon Friday 2/26/21. By Monday afternoon my head started to ache & skin of extremi...
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Rec'd 1rst shot @ noon Friday 2/26/21. By Monday afternoon my head started to ache & skin of extremities started stinging, nose running & feeling feverish. My ears started ringing too & got vertigo. Also I started having trouble breathing with a slight ache/pain in my lungs. A noticible itch started in my nose & a tickle in my throat and I had extreme muscle pain, especially in extremities affected by previous carpal tunnel injuries & sciatica. Tuesday afternoon all symptoms were worsening so I used Zicam Gel swabs in my nose, made chicken garlic soup & tea with honey & went to bed. It took 3 days for the sinus, headache & respiratory symptoms to resolve. The neuropathy (skin stinging) pain in my arms, hands & lower legs persists and is very painful.
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| 67 | 2021-03-09 | chills, headache, fever, fatigue |
bone ache; body shaking chills; no appetite; exhaustion; headache; occasional nausea; incapacitating...
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bone ache; body shaking chills; no appetite; exhaustion; headache; occasional nausea; incapacitating fever; This is a spontaneous report from a contactable consumer, the patient. This 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9265), dose 2 , single dose via an unspecified route of administration in the left arm on 02Feb2021 at 14:00 (at the age of 67 years-old) for COVID-19 vaccination. The patient was not pregnant. Medical history included primary immunodeficiency, diabetes, irritable bowel disease, gastroesophageal reflux disease (GERD), high cholesterol and allergy to cefazolin (ANCEF). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248, dose 1 on 12Jan2021 at 2:15 PM in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included famotidine, lansoprazole, pioglitazone and rosuvastatin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 03Feb2021 at 09:00 AM, the patient experienced bone ache, body shaking chills, no appetite, exhaustion, headache, occasional nausea and incapacitating fever. Treatment was not received for the events. The clinical outcome of bone ache, body shaking chills, no appetite, exhaustion, headache, occasional nausea and incapacitating fever was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 67 | 2021-03-09 | fatigue |
Fatigue. I am never that tired and did nothing the days before to warrant that kind of wiped out ...
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Fatigue. I am never that tired and did nothing the days before to warrant that kind of wiped out feeling. Got that wiped out feeling all day long. Took 4 hours total in naps, and still slept like a rock all night. The day after that, (March 5th) I felt super great. Just wanted it to be known.
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| 67 | 2021-03-09 | headache, chills, body temperature increased, malaise |
4 hours after injection felt like I had Covid coming back on me. Felt sever headache, elevated tempe...
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4 hours after injection felt like I had Covid coming back on me. Felt sever headache, elevated temperature, chills flurry vision. Lack of appetite. Just general malaise?. Laid on couch after taking Tylenol Extra Strength 2 tablets and napped.
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| 67 | 2021-03-09 | headache, fever, chills | Fever, chills, aches, headache |
| 67 | 2021-03-09 | nasal congestion, chills, fever, fatigue, headache |
Violent entire body chills approximately 12 hrs after vaccine. Chills lasted an hour with 3 blanket...
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Violent entire body chills approximately 12 hrs after vaccine. Chills lasted an hour with 3 blankets and heating pad. Then switched to fever for next 8 hours. Fever recorded 102 the only time I checked. Nausea, body aches, plugged nose making it slightly difficult to breathe, headache, and exhaustion. Unable to sleep through the night due to fever, aches, and breathIng discomfort. Slept off and on all following day. Able to eat minimally at dinner next day. Strong taste of food, ie chicken soup seemed way strong. Third day tired but appetite slightly returning and other side effects seem subsided.
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| 67 | 2021-03-10 | chills |
On Saturday-Sunday, March 6-7 I had diarrhea, nausea, chills and body aches. Beginning Wednesday, ...
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On Saturday-Sunday, March 6-7 I had diarrhea, nausea, chills and body aches. Beginning Wednesday, March 10 and continuing to the present, I have had an itchy rash over much of my body--arms, stomach, and back of legs.
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| 67 | 2021-03-10 | cough |
increased cough, difficulty breathing, anaphylaxis; received IM EpiPen, IM Benadryl, and IV Solumedr...
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increased cough, difficulty breathing, anaphylaxis; received IM EpiPen, IM Benadryl, and IV Solumedrol 125mg Symptoms improved; did not need repeat Epi dosing. did not receive Famotidine because has documented allergy to Ranitidine.
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| 67 | 2021-03-10 | head discomfort, lethargy, fatigue |
Before i arrived at the waiting area, which had no attendant on duty though intake personnel were wi...
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Before i arrived at the waiting area, which had no attendant on duty though intake personnel were within sight range, i had an extreme pressure sensation on the right side of my head. I lessened the effect by holding my nostrils and blowing when reminded to do so by my husband when i returned to the car after 15 minutes. Sensations that reminded of bugs crawling beneath my scalp began shortly thereafter, and continue to a lesser degree to this day. I had lethargy, fatigue and brain fog.until Wednesday. My right eye remains challenged as i do have an ongoing eyelid issue for the last 8 years. No arm soreness.
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| 67 | 2021-03-10 | headache | Headache, nausea, patch of hives on face. |
| 67 | 2021-03-10 | headache |
On 3/4 patient received 1st dose of COVID vaccination. She states that she drove home afterward and ...
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On 3/4 patient received 1st dose of COVID vaccination. She states that she drove home afterward and decided to sit and watch TV. She immediately began noticing that the words on her TV screen were not legible - her vision had become blurry. This blurriness was accompanied by severe eye pain and pain in the temples of her head. When shutting eyes and keeping them closed for a few hours, the blurriness would subside. However she continues to experience this blurriness 'on and off' to date. Also experienced some mild headaches but they have subsided as of two days ago. Hasn't taken anything to alleviate the symptoms. Patient is extremely concerned that she may permanently lose vision and refuses to get 2nd dose.
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| 67 | 2021-03-10 | throat irritation, chills |
syncope; feeling of heat rising into throat; feeling of heat rising into throat; lightheaded; chills...
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syncope; feeling of heat rising into throat; feeling of heat rising into throat; lightheaded; chills; mild pain at injection site; This is a spontaneous report from a contactable pharmacist reported for self. This 67-year-old female patient (no pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 13:45 PM on Arm left via Intramuscular at single dose (Lot # EL9269) for covid-19 immunisation. Medical history included Osteoporosis, known allergies: Sulfa, flu vaccine for immunisation. No COVID prior vaccination. Concomitant medications included alendronate sodium (FOSAMAX), ergocalciferol (VITAMIN D), calcium, magnesium, biotin, bifidobacterium lactis (PROBIOTIC). No other vaccine in four weeks. Past similar reaction from Flu vaccine 8 years ago (2013) for immunisation and treated in ED, had no problems with any other vaccine such as HepB (Hepatitis B), DTAP, pneumococcal 23, Shingrix all for immunization. On 17Feb2021 14:15 PM, feeling of heat rising into throat, then lightheaded- EMT on-site monitored BP, heart, oxygen then administered IV Benadryl and zofran - signed out in 2hr, developed chills and syncope for next 4 days and mild pain at injection site. Self treated with Tylenol/ advised by MD to not get 2nd dose. Events resulted in emergency room/department or urgent care. Treatments were received for the events. Treatment included IV Benadryl and IV Zofran. Outcome of the events was recovering.; Sender's Comments: Based on a temporal association, a causal relationship between the events of feeling of heat rising into throat, lightheaded and syncope, and BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 67 | 2021-03-11 | fatigue, fever, headache |
Had low grade fever 0n 3/11/2021 along with slight headache and slight body aches. Sore arm at injec...
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Had low grade fever 0n 3/11/2021 along with slight headache and slight body aches. Sore arm at injection site. Still felt tired on 3/12/2021 but fever gone.
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| 67 | 2021-03-11 | fatigue, fever, headache | Fever, fatigue, headache |
| 67 | 2021-03-11 | headache |
Headache, sore injection site, pain all over my body Started @ 8 am and continued all day until abou...
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Headache, sore injection site, pain all over my body Started @ 8 am and continued all day until about noon the 2nd day
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| 67 | 2021-03-11 | lethargy |
right sided facial numbness that started same night of vaccination about 8-9 hours after, lethargy t...
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right sided facial numbness that started same night of vaccination about 8-9 hours after, lethargy that started right away
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| 67 | 2021-03-12 | body temperature increased | Nausea after 6 hours. Temperature rise of 2 degrees at 12 hour mark that lasted for 36 hours. |
| 67 | 2021-03-12 | fatigue |
Arrived home after vaccination - felt very tired and fell asleep. When I woke around 3:30pm I was ...
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Arrived home after vaccination - felt very tired and fell asleep. When I woke around 3:30pm I was experiencing a very rapid heart beat (tachycardia) and my heart was skipping a beat every 10 seconds or so (arrhythmia). I took my blood pressure several times, while seated and at rest and it fluctuated between 180/87 with a heart rate of 74, to 150/94 with a heart rate of 111, to 143/98 heart rate 107 and then to 118/77 with a heart rate of 105. To verify the machine was working, both my husband and son used the same device and their readings were steady and did not fluctuate. I called my GP, who told me to drink lots of water, rest and wait to see with my heart doctor. She also said if my condition got worse to go to the ER. I made an appointment with my heart doctor but he cannot see me until April 7. The adverse event lasted until bedtime. (about 6-7 hourse). I haven't had a problem after that. I since discovered that the CDC changed its recommendation a couple days before I got the vaccine to avoid the shot if I'm allergic to Polysorbate due to PEG being present in the mRNA vaccines.
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| 67 | 2021-03-12 | headache |
Suddden onset of feeling very hot in my face and neck.. I went to bathroom and looked at my face n...
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Suddden onset of feeling very hot in my face and neck.. I went to bathroom and looked at my face no swelling noted. My neck had a pouch of fluid accumulating with small redden areas on my neck and upper chest area. No other symptoms noted. My breathing was good.
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| 67 | 2021-03-13 | body temperature increased |
Pain at injection site 12:44pm 4:25 pm high temperature of 102 took tylenol. Swelling and pain und...
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Pain at injection site 12:44pm 4:25 pm high temperature of 102 took tylenol. Swelling and pain under left armpit. Felt a lump in my left breast. Feels like someone punched me real hard in my armpit. Took Ibuprofen for swelling. Swelling and pain lasted 3-4 days then subsided and now there is no longer any pain. Don't feel the lump any longer in my left breast.
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| 67 | 2021-03-13 | fatigue, headache, sweating, throat irritation, body temperature increased |
ongoing symptoms of headache, muscle aches, fatigue, insomnia, elevated temperature( no fever above ...
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ongoing symptoms of headache, muscle aches, fatigue, insomnia, elevated temperature( no fever above 99 degrees) joint aches, swollen lymph nodes, sweats, scratchy throat, red irritated eyes, bowel cramps and nausea
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| 67 | 2021-03-13 | headache, fever |
3/9/21 PM headache, 3/10/21 AM fever, generalized achiness, 3/11/21 bilateral hand swelling and rash...
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3/9/21 PM headache, 3/10/21 AM fever, generalized achiness, 3/11/21 bilateral hand swelling and rash on hands, diffuse itching. 3/14/21AM swelling around eyes. continues itching. continued fever. swelling in hands improved.
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| 67 | 2021-03-13 | fever, chills, fatigue, headache | Low grade fever, chills, headache, tires, weak |
| 67 | 2021-03-14 | body temperature increased, lethargy | ELEVATED TEMP 100.3, SHORTNESS OF BREATH, LOW OXYGEN SATURATION LEVEL, LETHARGY |
| 67 | 2021-03-14 | chills, sweating |
Vomiting; Diarrhea; Sweating and shivering all night; Sweating and shivering all night; This is a sp...
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Vomiting; Diarrhea; Sweating and shivering all night; Sweating and shivering all night; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL1283) in the left arm, at single dose, on 03Feb2021 at 07:15, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included hypertension. No known allergies were reported. The patient had not experienced Covid-19 prior vaccination. The patient previously, on 12Jan2021, at 07:00 AM, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK9231) in the left arm, for COVID-19 immunisation. Concomitant medications included metoprolol, simvastatin, telmisartan and buspirone hydrochloride (BUSPAR). On 05Feb2021, at 10:00 PM, the patient experienced vomiting and diarrhea, sweating and shivering all night. Post the vaccination, the patient has not been tested for COVID-19. No treatment was received. The patient recovered from the events on an unspecified date.
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| 67 | 2021-03-14 | chills | Nausea muscle aches chills very painful left arm |
| 67 | 2021-03-14 | cough, throat irritation |
Started having SOB, cough and scratchy throat. She then transported to the ER and treated. Given ben...
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Started having SOB, cough and scratchy throat. She then transported to the ER and treated. Given benadryl 25mg IM.
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| 67 | 2021-03-14 | cough |
Three days after the second dose of the vaccine I started coughing, wheezing and having shortness of...
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Three days after the second dose of the vaccine I started coughing, wheezing and having shortness of breath on exertion. This symptoms did'nt alarm me at first since I have this asthma for couple years. Then after a week from receiving my second dose vaccine in 02/28/21, my symptoms got worst. In additon to having SOB, wheezing , coughing I developed generalized hives. I started taking steroids started 03/13/21 to ease my symptoms. Today I started feeling better and able to walk for 30 minutes without any problems. Hives also subsided. I had no asthma or hives attack for the last three years.
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| 67 | 2021-03-14 | fatigue | Joints extremely sore, body aches, fatigu |
| 67 | 2021-03-14 | headache, chills |
nausea; dizzy; chills; body aches; headache; trouble concentrating; very sore arm; This is a spontan...
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nausea; dizzy; chills; body aches; headache; trouble concentrating; very sore arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 67-year-old non-pregnant female patient (Patient was not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: E1823886, Expiry date: unknown), via an unspecified route of administration on 09Feb2021 at 10:00 (age at the time of vaccination was 67-year-old) on right arm at single dose for covid-19 immunisation. Medical history included allergy to Sulfa. Concomitant medication patient received within 2 weeks of vaccination included Hydrochloride, potassium chloride (K-DUR), vitamin d3, irbesartin. The patient experienced nausea, dizzy, chills, body aches, headache, trouble concentrating and very sore arm on 09Feb2021. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient was recovering from the events.
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| 67 | 2021-03-14 | headache, fever, fatigue |
Approximately 24 hours after vaccine, had symptoms very similar to when I had Covid in January - tir...
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Approximately 24 hours after vaccine, had symptoms very similar to when I had Covid in January - tired, queasy stomach, headache, no appetite. Thought I was doing better after 48 hours but had a relapse last night with fever and chest pains. When I take a deep breath, feel pain in my chest.
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| 67 | 2021-03-14 | headache |
Abdominal cramps/really bad cramps in my abdomen; a bit of a headache; This is a spontaneous report ...
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Abdominal cramps/really bad cramps in my abdomen; a bit of a headache; This is a spontaneous report from a consumer. A 67-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no:EN9581, expiration date:31May2021) as first dose, on left arm, via an unspecified route of administration on 28Jan2021 15:30 at single dose for covid-19 immunisation. Medical history included Kidney transplant recipient from 1995 and ongoing. There were no concomitant medications was not reported. This consumer reported that she was administered the first dose of Pfizer-BioNTech COVID-19 Vaccine 28Jan2021 about 15:30. On 28Jan2021 about 19:30 she had onset of abdominal cramps. Patient also reported that she received the Pfizer shot yesterday at around 3:30, then at around 7:30 she experienced really bad cramps in her abdomen, along with a bit of a headache. She asked if that is one of the side effects of the Pfizer-BioNTech COVID-19 Vaccine. She was a little concerned because she heard that if you had a reaction or side effects to the first dose of the Pfizer-BioNTech COVID-19 Vaccine that they would be worse with the second dose. She had abdominal cramps all night long off and on. She reported outcome as ongoing but a little bit better. She did better if she just stays still. When she gets up and starts doing things the abdominal cramps occur more. She described the abdominal cramps as being kind of like menstrual cramps, which she has not had in a long time, but they are low like that in the abdomen; not like stomach cramps that are up higher. Usually with something like this kind of abdominal cramps she would have diarrhea but she was not having any diarrhea. The abdominal cramps are weird feeling. Outcome of the event abdominal cramps/really bad cramps in my abdomen was recovering and outcome of other event was unknown.
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| 67 | 2021-03-14 | headache |
About 30 minutes post vaccination patient complained of headache and palpitations and was hypertensi...
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About 30 minutes post vaccination patient complained of headache and palpitations and was hypertensive. VS were taken and she was given water but symptoms did not resolve
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| 67 | 2021-03-14 | sweating, headache |
Headaches & dizziness a few times on 1st & 2nd days. Soaked bed from sweating all night on 1st & 2n...
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Headaches & dizziness a few times on 1st & 2nd days. Soaked bed from sweating all night on 1st & 2nd days. Off-balance and dizziness on & off since 3-2-21. Blurry vision/ can't focus, which bothers me more than the other adverse events.
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| 67 | 2021-03-14 | fever, chills | Fever, chills, nausea, body aches. |
| 67 | 2021-03-14 | fever, headache, malaise |
My arm did get sore and it had stayed sore; I am also experiencing nausea; headache; not feeling wel...
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My arm did get sore and it had stayed sore; I am also experiencing nausea; headache; not feeling well; felt feverish; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982), via an unspecified route of administration on her arm on 25Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included raynaud's phenomenon. She was told that she could not donate plasma because of it but she have raynauds, she stated she is not taking medications or anything for it, it's just she get chills in her hands and feet from anything if she drink anything cold or get chilled or whatever, white they turn white. It was reported that patient had Covid 19 and was tested positive for antibodies back in June. The patient's concomitant medications included estradiol (Cream, its a hormone cream), vaginally at 13 micro grams, twice a week for unknown indication and acyclovir for unknown indication. In Jan2021, patient reported that her arm did get sore and it had stayed sore and she is also experiencing nausea, she had experienced nausea that night, a headache, not feeling well and felt feverish didn't recorded fever but her concern is that it's not going away. The patient received treatment just advil (as reported). The events were considered as non-serious. The outcome of the event felt feverish was not recovered and outcome of other events unknown.
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| 67 | 2021-03-15 | fatigue |
Five days after the vaccine she was on the phone, sitting in a chair and she lifted her arm up and i...
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Five days after the vaccine she was on the phone, sitting in a chair and she lifted her arm up and it felt heavy and it just dropped. She then started to raise the arm and she was not able to do it. She then suddenly lost sensation in her left arm. She then could not control it, would raise when it wanted to but was not able to feel it or control it. (had the feeling that it was not connected to her body and it was just floating around). Then started having involuntary muscle spasms in her mid torso region. The same thing then happened again and the muscle spasms were more intense and she waited around and lasted for minutes. She never lost consciousness, but then it happened again and was spreading on her left side. It then encompassed from her hip up to her shoulder. The involuntary muscle spasms were moving from the side toward her chest to where she felt it would impact her breathing. She then went to the ER and they started doing testing, and she had more spasms, and then started having double vision. In talking with the doctor about all of this she had a CVA with complex partial epilepsy with recurrent seizures and that the double vision was related to the infarct in her brain and that the stroke triggered the seizure that she had. She did not lose any memory, loss of consciousness, no weakness or loss of sensation. These episodes only lasted minutes and a refractory time of minutes and when she got to the ER she the other episode when they were trying to test her. They were not able to do the EKG or EEG due to the involuntary movements and these resolved. She is now completely recovered other than the fatigue with no residual. She saw a neurologist on 2/24/21 who felt like that she had a stroke and put her on Keppra and is going to FU in 3 months at IU. It was ruled out that there was no relationship of her transplant to this reaction. She is now on Keppra, Atorvastatin for the swelling in her brain, and also put on aspirin 81 mg. Her blood tests that were done were all drawn and were all within normal limits except for kidney function, but is only a minor #'s for her secondary to the transplant. She then had some titers drawn for CMV and that was also negative. Then she had a COVID test that was negative. Then she had spinal tap that came back normal results.
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| 67 | 2021-03-15 | headache |
2/23/21- Redness swelling to Rt side of face - Rt eye red and swollen and headache Rt entire arm swo...
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2/23/21- Redness swelling to Rt side of face - Rt eye red and swollen and headache Rt entire arm swollen and redness from shoulder to elbow w/a sting 2 weeks after 2nd dose
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| 67 | 2021-03-15 | sweating, fatigue, headache |
Sore arm for the rest of the day after receiving the shot. On 2/27 fatigue. On 3/4 possible low gr...
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Sore arm for the rest of the day after receiving the shot. On 2/27 fatigue. On 3/4 possible low grade temperature with periods of feeling very warm and sweating. Lasted approximately an hour. On 3/6 again periods of feeling warm and sweating. Rotating achiness in muscles. Brief feelings of discomfort in axillary region but unable to palpate lymph node. Lasted half the day. On 3/14 headache across the front of my face above my eyes with left side neck discomfort. On 3/15 again experienced periods of warmth and sweating throughout the day. In between headache, Not as severe as headache on 3/14. Contacted doctor by email.
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| 67 | 2021-03-15 | fever, lethargy, chills | Fever lethargic chills |
| 67 | 2021-03-15 | fever |
Arm has been burning for 2 2/2 weeks. The injection was given up high. Also woke up with nausea whi...
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Arm has been burning for 2 2/2 weeks. The injection was given up high. Also woke up with nausea which has lasted over a week. Spent first day after injection in bed. Felt feverish and had absolutely no energy. Felt that way for about two or three days. For about a week had very little energy. My arm through the shoulder blade and in the back still has a burning sensation.
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| 67 | 2021-03-15 | fever |
Nausea; Diarrhea; Fever; This is a spontaneous report from a contactable consumer (patient). A 67-ye...
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Nausea; Diarrhea; Fever; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EM9810), via an unspecified route of administration on 05Feb2021 at a single dose on left arm for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient was asking if Pfizer had people, about 3 or 4 days later, get nausea and diarrhea after getting the COVID shot. She had a real bad fever 3 hours after the shot but felt fine the next day. But now she has nausea and diarrhea that started yesterday (08Feb2021). She normally does not that have that. Her nausea has improved because she took a nausea pill, ondansetron (ZOFRAN) 2 mg. Therapeutic measures were taken as a result of nausea. The outcome of the event fever was recovered on 06Feb2021, nausea was recovering, and diarrhea was recovered on 09Feb2021.
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| 67 | 2021-03-16 | cough |
67 year old female with PMH of HTN, HFpEF, history of DVT, obesity, migraines, gastroparesis, Sicca ...
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67 year old female with PMH of HTN, HFpEF, history of DVT, obesity, migraines, gastroparesis, Sicca symptoms, asthma, chronic bronchitis, and GERD who presents with anaphylactic reaction s/p COVID vaccine administration. Received COVID vaccine across the street (<1 minute EMS ride) C/o itching, cough, and wheezing shortly after No respiratory distress or hypoxia en route Received IM epi (2 weeks expired) and Benadryl PTA Symptoms improving now Has extensive allergy list Review of Systems 10 point ROS completed and negative except noted in HPI above Physical Exam/Objective Vitals & Measurements last 24 hours VITAL SIGNS Temp C: 36.3 DegC Heart Rate: 87 bpm Resp Rate: 16 br/min BP #1: 139 / 59 mmHg SpO2 (%): 99 % O2 Device: Room air Height CM: 152.4 cm Ideal Body Weight: 45.5 kg General: NAD, well-nourished Eyes: No scleral icterus, EOMI HENT: Normocephalic, atraumatic, no airway edema Neck: Supple, intact range of motion Respiratory: Lungs CTAB, symmetric chest wall expansion, no wheezes, speaking in full sentences Cardiovascular: RRR, no murmur, +2 peripheral pulses Abdomen: Soft, NTTP, non-distended Musculoskeletal: No gross deformity Integumentary: Intact, warm, dry, no rashes Neurologic: A&O x 3, no focal deficits Psychiatric: Cooperative, appropriate mood and affect Medical Decision Making 67 year old female with extensive PMH including asthma, chronic bronchitis, and GERD who presents with anaphylactic reaction s/p COVID vaccine administration. Has long list of allergies. On exam, airway intact, no respiratory distress, no wheezing, speaking in full sentences, C/o subjective itching and cough that is starting back up. IV methylprednisone IV famotidine Albuterol PRN Benadryl PRN Observe Rx EpiPen upon discharge Re-Assessment Observed for >4 hours Symptoms resolved Counseled patient on EpiPen use and gave strict return precautions Has albuterol and Benadryl in her purse Has had many reactions in the past and is very familiar with how to manage them Discharge home with daughter
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| 67 | 2021-03-16 | nasopharyngitis, runny nose, throat pain, headache |
Top of roof throbbing sore throat, headache very cold and runny nose. Just started today these feeli...
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Top of roof throbbing sore throat, headache very cold and runny nose. Just started today these feelings
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| 67 | 2021-03-16 | fever, malaise |
Day 2 diarrhea, fever and upset stomach Day 2 broke out all over my chest and stomach and just don't...
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Day 2 diarrhea, fever and upset stomach Day 2 broke out all over my chest and stomach and just don't feel good
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| 67 | 2021-03-16 | fever |
I believed I had received the full and appropriate dose of the Pfizer vaccine. Four days later the ...
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I believed I had received the full and appropriate dose of the Pfizer vaccine. Four days later the pharmacist contacted me telling me I had only received a saline solution and would need to get vaccinated again. I inquired how they knew this and received sparse information saying they couldn't tell me ... privacy etc. Then on March 10th I went to another one of their locations and received the first vaccine of Moderna ... I have been super sick since then.. I have had fever, delirium, cognitive impairment ( forget vocabulary MID sentence) severe covid arm, ( worse than the images on line) pain in my left hand, stiffness in my left fingers ( what I assume arthritis might be like) I WANT TO KNOW what WAS IN THE FIRST PFIZER INJECTION: I AM DEMANDING... to find out what was in the first shot, why it was reported to me 4 days later, How the facility knew it was only saline... WAS it TRULY ONLY SALINE or have I been injected with two different doses of vaccines within a 9 day period? I really need to know what it going on.
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| 67 | 2021-03-17 | headache, chills, malaise, fatigue |
Sore arm at injection site, bad headache, chills, fever, aches in joints, back pain, nausea, tiredne...
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Sore arm at injection site, bad headache, chills, fever, aches in joints, back pain, nausea, tiredness Treatment, sumatriptan for headaches, Advil for aches , pain and fever. I was in bed for 2 1/2 days because I felt so sick and was very tired Most of my symptoms were better after 3 days but the headaches and tiredness are still bothering me today 3/18/21.
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| 67 | 2021-03-17 | headache |
My face went numb; Headache; This is a spontaneous report from a contactable consumer. A 67-years-o...
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My face went numb; Headache; This is a spontaneous report from a contactable consumer. A 67-years-old non-pregnant female patient received BNT162b2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration, in the left arm, on16Feb2021 at 10:15 (at the age of 67 years-old) as a single dose for covid-19 immunisation. Medical history included headache, anaphylaxis reactions to food allergies, Spinich, cabbage, sulfa based drugs diabetes, and asthma. The patient had not received any other vaccinations within 4 weeks and was not diagnosed with COVID-19. Concomitant medication included diabetes meds and insulin glargine (BASAGLAR). The patient reported on 16Feb2021, at 10:45 after waiting 30 as instructed, I had a reaction 5 - 10 minutes later. My face went numb, and then a headache started. I have had only 1headache in my life prior to this. The patient was not hospitalized for the events nor was treatment received. The clinical outcome of the event was recovered
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| 67 | 2021-03-17 | malaise, headache, fever | Fever, headache, weakness, malaise, muscle aches |
| 67 | 2021-03-17 | malaise, fever |
Four days after, I noticed a soft "lump" right axilla. Cancer Institute did an ultrasound. "No enla...
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Four days after, I noticed a soft "lump" right axilla. Cancer Institute did an ultrasound. "No enlarged lymph nodes." No sign of cancer The lump in my axilla got very large. "Not as big as a baseball but larger than a golf ball." I could wrap my fingers around it. Hard as a rock. Within a week my whole entire chest wall on the right (from side to sternum) was scarlet red. And I was getting another "lump" in the fold of tissue where my upper chest meets my upper arm. I was put on Keflex 500 mg four times a day. The redness in my chest wall subsided. Five days after being on Keflex, the lump on my chest was hard, red, very painful, "angry." Fevers, feeling "pretty sick." (Very uncharacteristic of me. I didn't miss a day of work through months of multiple rounds of chemo, 5 weeks of radiation.) February 7 PCP requested I go the ER. Suspecting an abscess. They did an I&D. Expressed "lots of puss" and left a drain in. To be removed in 5 days. Placed on Bactrim twice a day for 5 days.
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| 67 | 2021-03-17 | throat pain, cough, lethargy, fever |
Severe rash covering entire lower back, severe sore throat and mouth with sores, cough, some shortne...
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Severe rash covering entire lower back, severe sore throat and mouth with sores, cough, some shortness of breath, low grade temp., extreme lethargy, nausea, bloating, peeling of the tips of my fingers on the palm side, loss of appetite.
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| 67 | 2021-03-17 | throat pain, headache, fatigue, body temperature increased |
3/14/21: 10:00 pm violent hand tremors - 3 hours 3/14/21: 10:30 pm nausea 3/14/21: 11:00 pm vomiti...
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3/14/21: 10:00 pm violent hand tremors - 3 hours 3/14/21: 10:30 pm nausea 3/14/21: 11:00 pm vomiting every hour - 7 hours and off and on the next 48 hours 3/15/21: 10:00 am extreme joint pain 48 hours 3/15/21: 10:00 am headache off and on 72 hours 3/16/21: 3:00 am 102.4 temperature (couple of hours?)16 3/16/21: 12:00 pm sore throat 24 hours 3/16/21: Fatigue Continues 3/16/21: Very dizzy 3/17/21: 3:00 pm injection side tenderness and slight swelling 48 hours 3/18/21: 3:00 pm first time able to get out of bead and shower - slight light headedness
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| 67 | 2021-03-17 | productive cough, sneezing, chills, headache, runny nose, cough |
post injection patient reported chills headache, runny nose sneezing and coughing for 2 weeks. at da...
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post injection patient reported chills headache, runny nose sneezing and coughing for 2 weeks. at day 15 reported coughing up sputum with bright red blood for last 2 days of coughing
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| 67 | 2021-03-17 | fever, chills | Migraine, chills, nausea, dizziness, fever |
| 67 | 2021-03-17 | fever, chills | Fever and chills lasting 8 hours Vomiting |
| 67 | 2021-03-17 | fever, headache, fatigue |
About 12hours after the vaccination I had a 101.3 fever (normally 98.1) Body aches; when I got up...
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About 12hours after the vaccination I had a 101.3 fever (normally 98.1) Body aches; when I got up about 9am the next morning I was dizzy and then fainted. The fever persisted until mid afternoon that day, as did the body aches, and a headache. I spent the day dozing or sleeping. I did eat some oatmeal and have a cup of black coffee about noon. That helped the headache. That evening I was more tired than usual, but no fever or aches. The next day I was also very tired, but I did go to work. The rest of the week I had no energy, but that was the only other side effect. After the first shot, I had only had an achy arm at the injection site that persisted for 2 or 3 days.
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| 67 | 2021-03-18 | chills, fatigue | Nausea, emesis, chills, and fatigue. |
| 67 | 2021-03-18 | chills, fatigue |
Rash; Joints and fingers swelling/hands were swollen; Joints and fingers swelling; wrist was sore; F...
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Rash; Joints and fingers swelling/hands were swollen; Joints and fingers swelling; wrist was sore; Freezing and chills; Felt like would pass out/felt so faint; Ate dinner but food came back up; Shortness of breath; Cheeks flushed; Achy; felt draggy/feeling tired; This is a spontaneous report from a contactable. A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCIN) lot number: GL9266, via an unspecified route of administration, administered in left arm on 21Feb2021 as single dose for COVID-19 immunisation. Medical history included rheumatic fever (occurred age 7), vulvovaginal dryness and sore joints. The patient was negative on Covid test on an unspecified date. Historical vaccine included BNT162B2 on 28Jan2021 for COVID-19 immunisation and flu shot. Concomitant medications included estradiol (IMVEXXY) taken for vulvovaginal dryness; vitamin C [ascorbic acid] (VITAMIN C); colecalciferol (VITAMIN D); calcium. On Monday, 22Feb2021, the patient felt draggy, but did not think it was a big deal. She just thought it was from the shot and was feeling tired. The draggy feeling lasted a few days, but she was unable to clarify outcome further. On Tuesday, she started to feel achy and felt like that too was to be expected. The achiness went away on 25Feb2021. On Wednesday, 24Feb2021, she was really busy. She was still achy but was busy. She also did not drink much water for several hours. It dawned on her later when she was not feeling good. Late Wednesday afternoon it was like everything cratered and she felt horrible. She was feeling bad. She was freezing and had chills. It was a horrible feeling. She helps with her grandkids since she is retired. They were home from school and had to sit on the couch. She felt cold, yucky, and achy. It was a yucky feeling. She went home a couple of hours later. She told her husband she had to lie down on the couch because she felt horrible. She could not further describe horrible feeling. Her daughter had called her as well and was unable to describe how she felt to her daughter. She could only say she felt so sick but could not explain further. She felt awful and could not put her finger on it. She was laying down and when she got up, she felt like she would pass out. At that time, she had not eaten dinner yet. She ate dinner, took one bite and the food came back up. For a few moments she felt so faint, she felt shortness of breath, but it was only for a few seconds. After that, her and her and her husband took a drive to go to hospital. However, by the time she got to hospital she was feeling better. She was also talking to a friend at that time who said all of this was probably form the shot as well. Since she was feeling better decided not to go into the hospital and went back home. At the time she was thinking this was all from the shot and no big deal. On Wednesday night, things got crazy and worse. That evening Wednesday she was getting ready for bed and noticed her cheeks were flushed. On Thursday she got up and noticed rash. She was covered all over her body. It did not itchy really, but it was a rash. Not a bumpy rash, it reminds her of Roseola. Her joints and fingers were starting to swell. Her hands were swollen. It started with her knuckles, it went to her fingers, up to her hands, wrist. Her wrist was sore. Her joint swelling was worse. On Friday, she tried to see her doctor, but could not be seen by the doctor. However, she got in with the PA. When she saw the doctor, it could be seen her hands were swollen. However, the main reason she went to the doctor was due to the rash. However, her joints were sore and swollen. Treatment for rash included Hydroxyzine, for joints and fingers swollen/ wrist was soreincluded prednisone 10mg one tablet every day for five days. The patient recovered from the event felt like would pass out/felt so faint and shortness of breath on 24Feb2021. The outcome of the events joints and fingers swelling/hands were swollen, wrist was sore and cheeks flushed was not recovered.
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| 67 | 2021-03-18 | chills, nasal congestion, headache |
1AM Sat. March 6: Woke up shivering, lasted on and off throughout the day) Also had a Severe migra...
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1AM Sat. March 6: Woke up shivering, lasted on and off throughout the day) Also had a Severe migraine, severe nausea, lower leg cramps, and vomited 5 times until nearly 5PM ( last 3 times was water that was sipped but "heaved") mild diarrhea. Family offered to take me to hospital at since I had trouble "holding down" sips of water. Dozed off about 11PM and woke up at 1AM feeling better. Nausea and headache had subsided greatly, Congestion lasted until Sat. Took a 24 hour non drowsy Sudafed on Thursday and Friday. Rested Sunday and ate very light (toast; applesauce).
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| 67 | 2021-03-18 | fatigue, headache |
feeling light headed; mild headache; fatigue; erratic bp/ spike in her blood pressure; feeling nause...
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feeling light headed; mild headache; fatigue; erratic bp/ spike in her blood pressure; feeling nauseous; accelerated HR; she had body shakes/body was trembling; to the point she thought she was going to pass out; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EL1284) at vaccination age of 67-year-old via an unspecified route of administration on 28Jan2021 at a single dose to prevent COVID19 (covid-19 immunisation). Medical history included interstitial lung disease and overactive thyroid (She was treated for overactive thyroid, but it has been stable for five years). Concomitant medication included nitrofurantoin for interstitial lung disease and fluticasone. The patient previously took prednisone [prednisone acetate] (She did ten weeks of Prednisone and has been off Prednisone since the middle of Nov2020. She started at 30mg and tapered down to 20mg then to 10mg and then to 5mg until she was done). The patient experienced feeling lightheaded, mild headache, fatigue, erratic bp 01Feb2021 11:30, feeling nauseous on an unspecified date in 2021. Took Pfizer Covid 19 vaccine last week. Began feeling lightheaded, mild headache, fatigue, erratic BP on Monday, 4 days after receiving the vaccine. Went to Emergency department on Monday evening. Has been continuing off and on since Monday. Can these symptoms occur after 4 days patient questioned. Has already reported to DSU. She got Pfizer's COVID19 Vaccine a week ago today. She was doing fine and then Monday she started with mild headache, erratic blood pressure readings. She ended up in the ER because it was so high. It stabled out and she went home. She was feeling ok on Tuesday, but not quite normal. She was fine yesterday until last night then it started again with erratic blood pressure, fatigue, mild headache and lightheadedness. The headache is never pounding. The lightheadedness won't go away. Is that normal to have that many days after receiving the vaccine? It was four days before she started experiencing it. Now she feels kind of normal as long as she is laying down except for headache. As of 15Feb2021, the patient reported that she called a couple weeks ago and reported adverse side effects and she needed a couple questions answered. She mentioned that she was due to have the second vaccine this weeks (18Feb2021). She was extremely worried about doing it because even some of the effects she had after 4 days in the first vaccination have not subsided. She added that it landed her in emergency room a couple of times (also reported as ended up in the ER twice). She inquired if should she take the second one at this point or can she wait and if she can wait for how long. She mentioned that she had a spike in her blood pressure (BP), she had accelerated HR on an unspecified date in 2021, she was very lightheaded to the point she thought she was going to pass out on an unspecified date in 2021. The second time around, her body was trembling on an unspecified date in 2021, she had body shakes. It was not fun. All of these effects have returned to somewhat normalcy, but she is still experiencing lightheadedness. She has seen her own physicians, but she is not sure if she should proceed with the second vaccine. The outcome of the event lightheadedness was not recovered while the outcome of the other events was recovering. Follow up (15Feb2021): New information received from a contactable consumer (patient) included: lab data, new event (accelerated HR, to the point she thought she was going to pass out, body shakes/trembling) and clinical course of the events.
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| 67 | 2021-03-18 | fatigue, headache |
Losing her mind/ mental fog; No appetite and went 32 hours without eating/He stated she's lost her a...
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Losing her mind/ mental fog; No appetite and went 32 hours without eating/He stated she's lost her appetite; heard in the background stating the COVID-19 Vaccine screwed up her mind; Headache; Eyes hurt/Her eyes felt like they were going to pop out; Feels tired and weak; Feels tired and weak; can't think straight; pain in head and stomach; change of mood; altered mental status and nightmares; altered mental status and nightmares; she is so mean to everybody / not acting normal; her eyes felt like they were going to pop out; Suicidal thoughts/thinking of committing suicide; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program. A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL267, expiry date 31May2021) via an unspecified route of administration, at the age of 67-year-old, on 24Feb2021, as SINGLE DOSE (0.3mi as reported) for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and ongoing allergy to penicillin. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL9265, expiry date 31May2021) via an unspecified route of administration, on 03Feb2021, single dose for covid-19 immunisation wherein the patient had to got to Emergency room and it was found that her magnesium and potassium were low. The patient had a super bad reaction to the Pfizer vaccine. Patient's mind has not been normal ever since and she is so mean to everybody. The patient was fine until she got the vaccine. The reporter has had the ambulance and police up there to try and help but the caller wouldn't go out to the hospital. The patient had a normal mind before she got the shot. The patient has a bad headache that will not go away (8 days) and her eyes are hurting really bad/eye pain/ eyes hurt. She feels so tired and weak. The second COVID-19 Vaccine messed the patient up. She had the same symptoms for both first and second dose (unspecified symptoms), but the second dose has really messed up her mind. Patient probably won't have a mind. It was reported that the patient's mind was alright, but the second COVID-19 Vaccine did her in. Now patient is saying she won't get her mind back. It has messed up her mind. Clarified when caller states it messed up her mind, he is referring to the patient being mean. Stated patient did have a headache, but wasn't hateful. Stated patient's mind is so bad, she is just mean. If patient doesn't get help soon she is going to tell herself good night. Patient stated in background "If I don't get my mind back I'm going to end up killing myself because he made me." At 11PM last Wednesday (24Feb2021), patient starting losing her mind. Confirmed with caller that patient is currently having suicidal thoughts. Patient used to be a real nice lady and blames this on the COVID-19 Vaccine. Patient is afraid she is not going to get her mind back. Advised caller to seek emergent medical attention for the patient. Patient is against everybody now because of the crazy COVID-19 Vaccine. Patient heard in the background stating the COVID-19 Vaccine screwed up her mind. Caller stated patient is quite upset with everybody. Patient is not acting normal. Patient doesn't think her mind will ever get straightened. The medicine was too much for her body. After getting the second dose, the patient lost her mind, she's lost her appetite/ No appetite and went 32 hours without eating, can't think straight, altered state of mental, mental fog, pain in head and stomach, change of mood, nightmares, her eyes felt like they were going to pop out. Her doctor said it was probably an overdose. The patient was not like this prior to second dose. Outcome of the event was unknown. The reporter believes her mental fog is due to second dose of vaccine.
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| 67 | 2021-03-18 | fatigue, lethargy, fever, chills |
Aches, chills, fever about 7 hours after receiving the dose. Lethargic, tired the next day. Same sym...
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Aches, chills, fever about 7 hours after receiving the dose. Lethargic, tired the next day. Same symptoms but less but less severity than the night before. Slept all day the second day. The third day almost back to normal except for a little listlessness. Took Tylenol the first night and the next morning.
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| 67 | 2021-03-18 | fatigue |
Patient is being hospitalized for COVID-19 pneumonia. The patient has had a pulse ox reading in the ...
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Patient is being hospitalized for COVID-19 pneumonia. The patient has had a pulse ox reading in the low 90s and feels short of breath. She had a positive COVID-19 test collected on 3/16/21. She has fatigue and nausea/vomiting. The patient received Regeneron antibody infusion and dexamethasone. In ED, patient is requiring 2 L of O2 to maintain O2 saturation of 96%. Patient is being admitted.
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| 67 | 2021-03-18 | sweating, fatigue |
Discussed vaccine ADE after first dose with patient. Pt reports having existing lung disease for whi...
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Discussed vaccine ADE after first dose with patient. Pt reports having existing lung disease for which she uses oxygen and CPAP overnight. She reports feeling fatigued and increased SOB on exertion and increased O2 requirement for 2d after receiving vaccine. She also reports intermittent sweating and feeling hot on her head and scalp but without chills or bodyaches for 3 weeks now. When she checked her temperature at home, she reports temps of 98 or 99. Based on discussion, her reaction is not likely to be an allergic reaction and more likely an immune response to vaccine. Patient agrees to proceed with 2nd dose and will continue to monitor symptoms.
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| 67 | 2021-03-18 | fever, headache |
Day 1 none noted Day 2 extreme overall body aches, headache, fever (101.2) chills. Took Tylenol o...
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Day 1 none noted Day 2 extreme overall body aches, headache, fever (101.2) chills. Took Tylenol one time -30 hrs. after injection Day3 fever and aches began subsiding *now noted itchy, red, hive-like rash, warm to touch- around upper and inner arm around injection site as well as sore and swollen lymph node in armpit of same arm. Took Tylenol 2 times Ice to arm Day 4 fever, aches, headache subsided. Red rash on arm larger, red, itchy, warm and node still sore (no fever) Ice to arm and took 10 mg Cetirizine
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| 67 | 2021-03-18 | throat irritation |
Pt developed facial flushing, throat itchiness and "chest tightness" post-vaccination. Pt with repor...
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Pt developed facial flushing, throat itchiness and "chest tightness" post-vaccination. Pt with reported history of anaphylaxis. No shortness of breath or chest pain. - Pt given 25mg diphenhydramine - Sxs gradually resolved without further intervention
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| 67 | 2021-03-18 | throat irritation |
Patient received 2nd dose at 1226 on 3/19/2021. At approximately 1240, she felt itchiness on her thr...
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Patient received 2nd dose at 1226 on 3/19/2021. At approximately 1240, she felt itchiness on her throat both inside and outside. She then took 25mg of Benadryl. The itchiness didn't subside and she requested another 25mg of Benadryl at 1255. She took a total of 50mg of Benadryl. Her neck was visibly red and she was scratching it. After 5 minutes, she said she felt better. When she left at about 1315, she said she felt nearly 95% normal. She was with her husband, sister and daughter. She was given instructions to call 911 if her throat felt like it was closing. Compared to her first dose of the vaccine, this was a more mild reaction.
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| 67 | 2021-03-19 | chills, fatigue, headache, fever |
I had somewhat similar results the 1st does. Same symptoms w/o fever 1st does. Chills, headache mu...
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I had somewhat similar results the 1st does. Same symptoms w/o fever 1st does. Chills, headache muscle aches joint pain fatigued. 2nd does, all the symptoms listed. I took tums and Advil which helped. This time had fever which lasted 24hrs. Stomach pains the time along with the other symptoms. Not unlike the actual virus I had!
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| 67 | 2021-03-19 | cough, fever, malaise, fatigue, chills |
I woke up, and could not get out of bed because I was sick. Aches and pain on entire body, tired, m...
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I woke up, and could not get out of bed because I was sick. Aches and pain on entire body, tired, malaise, and sick. Then I got the chills, accompanied with a fever. My everyday temperature is 96.7 and I had a 99.7 fever. My eyes were glassy and grey. I was like this until the next day. I had COVID19 on 11/18/2020 - I did not have the above symptoms of aches and pains or a fever or the chills. My breathing and coughing finally was 99% better by February 2, 2021. My taste and smell is not back yet. Are there studies on how people react to vaccination if they had the COVID19? Is there research comparing prior COVID19 symptoms with adverseReactions symptoms?
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| 67 | 2021-03-19 | fatigue, headache |
Pulsatile Tinnitus in left ear started 5 days after 2nd dose administered and is ongoing. Other eff...
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Pulsatile Tinnitus in left ear started 5 days after 2nd dose administered and is ongoing. Other effects post 2nd dose had resolved before tinnitus began. Other effects experienced were headache, nausea, itching at injection site, diarrhea, fatigue
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| 67 | 2021-03-19 | headache, fever, chills, fatigue |
I got a headache at the base of my skull (very unusual for me and it lasted for 36 hours) within an ...
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I got a headache at the base of my skull (very unusual for me and it lasted for 36 hours) within an hour of the shot and became quite fatigued a couple hours later. Approximately 8 hours after injection I began having severe chills with teeth chattering and muscle cramps and aches. which lasted for three exhausting hours. Then suddenly I had a fever of 101 degrees and body aches and nausea with extreme fatigue until 4:00 PM the next day. The fatigue and brain fog continued until 48 hours or so after the shot. My arm did not hurt at all by the way. Nurse had me pull my arm down in an exaggerated way as she gave me the shot and it seems to have helped.
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| 67 | 2021-03-19 | headache | Nausea headache sore arm |
| 67 | 2021-03-19 | sweating |
Patient became diaphoretic and cold 10 minutes after vaccination. Vital signs: BP 170/90 , Repeat a...
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Patient became diaphoretic and cold 10 minutes after vaccination. Vital signs: BP 170/90 , Repeat after 15 mins 165/90 HR 74, SPO2 100% RR 28 She denied chest pain, syncope, difficulty breathing, itching. Preferred to go home, refused offer to be transported to Emergency room.
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| 67 | 2021-03-19 | fever, headache, chills | Severe chills, low grade fever, headache, body aches, sore arm at injection site |
| 67 | 2021-03-20 | fatigue, chills, headache, fever |
Pain in left arm, fatigue, headache, muscle aches starting at about 4 hours after the vaccine was ad...
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Pain in left arm, fatigue, headache, muscle aches starting at about 4 hours after the vaccine was administered and lasting for about 36 hours. Chills and mild fever starting about 12 hours after the vaccine was administered and lasting about 8 hours.
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| 67 | 2021-03-20 | fatigue, chills |
I became very dizzy. My heart rate was very fast. My blood pressure was 157/82. My normal blood pres...
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I became very dizzy. My heart rate was very fast. My blood pressure was 157/82. My normal blood pressure is 120/70 I had chills, and tired
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| 67 | 2021-03-20 | fatigue, headache |
-About 20-25 minutes after received vaccine, had already left the facility felt a surge tightness wr...
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-About 20-25 minutes after received vaccine, had already left the facility felt a surge tightness wrap around my diaphragm up to my collar bone, as if my breath was being taken away. I yelped out but the three people in the car with me did not here me. I remained calm took a deep breath- feeling went away. - Had vaccine on Saturday. Woke up in the night on Sunday night, feeling like my tongue was swelling and my throat was closing up. I took 1/2 Benadryl and used Albuterol enhaler. Temp was 99.8 (my average at home is 96.5)Fell back asleep. Woke up the next day and was fine. - other symptoms were tiredness, headaches, achy joints, which went away fairly as quickly. -since the vaccine I have had a bad outbreak of do
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| 67 | 2021-03-20 | fatigue |
Bad taste in mouth followed by increasing chest pain. B/p 200/100 (nl low) increase chest pain gradu...
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Bad taste in mouth followed by increasing chest pain. B/p 200/100 (nl low) increase chest pain gradually better over 45?. Tried to leave didn?t get out of bldg, collapsed in chair bad chest pain felt really bad. Ambulance called, gradually progresses to weak r side hi b/p slurred stammering speech inability to swallow tongue thrusting to Uc health ct w contrast ok. Gradually improved discharged at 1700. Saw doctor following Monday. Cardiac work up scheduled 4/5/21 She does not want 2nd vaccine until cleared by cardiologist. I have had bouts of chest pain. Hospital tadmitted me as Jane doe. Severe fatigue sleeping 12-14 h/ d for 5-6 d no fever flu sx. Low energy. Hospital never took he from me once better discharged as migraine but I don?t have migraines
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| 67 | 2021-03-20 | headache, chills, fever | Fever 101.5, headache, chills, 1 1/2 day |
| 67 | 2021-03-20 | headache, chills |
severe headache; body pain/ aches; Chills; temperature; This is a spontaneous report from a contacta...
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severe headache; body pain/ aches; Chills; temperature; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3302; Expiration Date: May2021), via an unspecified route of administration, in Arm Left on 04Feb2021 around 09:00 AM as SINGLE DOSE for covid-19 immunization. The patient (age was 66-year-old) first dose was LOT: EK4176 with EXP Mar2021 and was injected 14Jan2021, in her left arm around 09:00AM for covid-19 immunization. She says she did have a flu shot in Sep (unspecified year, NDC/LOT/EXP unknown). Medical history included fibromyalgia from 2009, lyme disease and Arthritis from an unknown date; all unknown if ongoing (reported as diagnosis of fibromyalgia/Lyme disease depends on what specialist she sees, but she was diagnosed first with fibromyalgia in 2009. She says that she also has severe osteoarthritis, but not the one that does the bones, just put arthritis, since it is not the type that deteriorates the bones, it does cartilage). There were no concomitant medications. The patient says she has not had any other recent vaccinations or started any new medications. It was reported by the patient, who says she had her second vaccination on 04Feb2021 and had a pretty strong reaction for about 36 hours. She says she had a severe headache, body pain, and a temperature with no chest involvement. She says she has experienced this every 3 hours for days now after, in waves. She says she would like to know if anyone else has reported a similar thing as what is happening to her. She says she goes 3-4 hours with a headache and chills today, and aches, and she didn't know if that was typical or not. She says she has not spoken to her health care provider about this. The patient reported that she got the vaccines from pharmacists that came to the care center where her mother lives. For the treatment the patient says she took Ibuprofen last night, which seemed to give her some relief. She says that the Ibuprofen (EXP Jan2022, LOT: 63650291AA, UPC: 1387402032). She says that the Ibuprofen is 200mg and she just took one dose, one time only, she tried it yesterday. She says when it started and hit again today she thought she should call someone and talk about it. The outcome of the events was unknown.
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| 67 | 2021-03-20 | headache, fever, chills |
Fever 103°, chills, muscle aches, joint pain, headache, difficult breathing, weakness, ringing in e...
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Fever 103°, chills, muscle aches, joint pain, headache, difficult breathing, weakness, ringing in ears
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| 67 | 2021-03-21 | chills, fever, fatigue, sweating |
Pain in arm at the injection site. fever of 100 degrees, sweats and chills, extreme tiredness, tota...
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Pain in arm at the injection site. fever of 100 degrees, sweats and chills, extreme tiredness, total body aches for about 36 hours
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| 67 | 2021-03-21 | chills, fever |
Arm sore when I got home that evening. Up at 4:00 with chills and fever which last 4 days. Diarrhea...
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Arm sore when I got home that evening. Up at 4:00 with chills and fever which last 4 days. Diarrhea stated at 6:00 am the day after my second shot and lasted 10 days.
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| 67 | 2021-03-21 | head discomfort |
4 days after my first vaccine I started to have numbness, pressure and tingling in my upper lip and ...
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4 days after my first vaccine I started to have numbness, pressure and tingling in my upper lip and lower face, which varies in how uncomfortable it is. I have had sinus issue in the past and some previous issues with facial pressure, but this seems different. I have not previously had this kind of pressure or numbness in my upper lip, lower face, unless I was having an allergic reaction to a medication
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| 67 | 2021-03-21 | headache, chills, fatigue, sweating, fever | Extreme exhaustion, chills, low grade fever, headache, sweats |
| 67 | 2021-03-21 | headache, fatigue |
1. Very tired, fatique, no energy which has never subsided. I sleep alot. 2. Headache sporadically...
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1. Very tired, fatique, no energy which has never subsided. I sleep alot. 2. Headache sporadically, now daily. 3. Back pain near kidney developed a week after vaccine. 4. Thirsty and for 3 days unquenchable thirst. 5. Had spurts of joint pain all over for several days. Did not have these symptoms with 1st vaccine, this has been progressing for 2 weeks, as of tomorrow, and got worse as time passed. I am very active and healthy and this has certainly impacted my routine. I still work. Visit to Dr. about back pain resulted in negative test and Dr. blamed it on vaccine.
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| 67 | 2021-03-21 | headache |
2nd shot caused dizziness, loss of balance, nauseous, unable to eat, diahera, headache. Going on sin...
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2nd shot caused dizziness, loss of balance, nauseous, unable to eat, diahera, headache. Going on since evening of day of injection.
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| 67 | 2021-03-21 | headache | vomiting, dizziness, headache, |
| 67 | 2021-03-21 | headache |
Patient feeling very anxious, shortness of breath, headache, and palpitations. Patient was trembling...
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Patient feeling very anxious, shortness of breath, headache, and palpitations. Patient was trembling. She denied any history of diabetes. Patient stated that she has many severe allergies (did not verbalize to what specifically even when asked) and even carries her own epi pen. She acknowledged that this did not feel like an allergic reaction and more like symptoms of anxiety. Patient refused EMS and stated she wanted to wait to see if she could calm down. Second RN and Pharmacist were called for assistance. Pulse ox was placed on patient and O2 Sats ranged from 94-97%, HR 90's. Patient stated she had history of HTN and asked for her BP to be taken d/t her headache. BP was 128/85. After about 20 minutes of close monitoring, patient stated that she was starting to feel better and trembling decreased. Patient remained in observation area for 30 more minutes and left in stable condition after all symptoms had subsided.
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| 67 | 2021-03-21 | influenza like illness, chills, headache |
About 9 1/2 hours after receiving the vaccine I began to experience flu-like symptoms : Full body ac...
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About 9 1/2 hours after receiving the vaccine I began to experience flu-like symptoms : Full body aches, chills and a headache. Also my armpits felt swollen and hurt a great deal. The symptoms lasted about 30 hours. By 7 am on the second day after the shot I felt fine however, both of my armpits are still hurting. I am assuming it is from swollen lymph nodes. (After the first shot I went for my annual mammogram and one lymph node in my left arm was still swollen.)
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| 67 | 2021-03-21 | fever |
Patient was hospitalized with fever, body aches, inability to transfer and SIRS. Increased liver en...
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Patient was hospitalized with fever, body aches, inability to transfer and SIRS. Increased liver enzymes as well
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| 67 | 2021-03-22 | fatigue, chills, headache, fever | Chills, low fever, achey muscles, achey joints, fatigue, headache, |
| 67 | 2021-03-22 | fatigue, chills |
About 3 days after the first vaccination I started to notice a slight humming or buzzing in my ears...
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About 3 days after the first vaccination I started to notice a slight humming or buzzing in my ears at night. Mostly noticeable when I go to bed not enough after the first shot to keep me from sleeping so didn't think much of it. After the second shot it is more noticeable even during the day. Not so much to be disabling but I do notice it and I have never had this happen before. I had normal side affects for first and second shots otherwise, sore arm, some fatigue and slight chills more so after the second shot as it these symptoms lingered for almost a week but nothing too severe and those are gone now but the humming/buzzing noise is still there in the background. Is there something I can do to help alleviate this or will it go away on its own?
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| 67 | 2021-03-22 | fatigue, headache, body temperature increased |
Temperature read 99 degrees upon arising. Elevated through out the day to a high of 100.2 at 9pm. Le...
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Temperature read 99 degrees upon arising. Elevated through out the day to a high of 100.2 at 9pm. Left armpit swollen & itchy. Dull headache all day. All joints in entire body ached entire day. Tired feeling all day and night. Slept 4-6:30 pm and 9:30 pm to 1:30 am the following morning. Temperature down to 99.2 degrees at 1:30 am. Difficulty raising left arm more than 45 degrees.
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| 67 | 2021-03-22 | fatigue | Shingles.......given Valtrex.......still having some fatigue......diagnosed on 02/09 |
| 67 | 2021-03-22 | headache, fatigue, sweating, chills, fever |
Fever, chills, severe nonstop headache, including my entire face, nausea, complete body ache, fatigu...
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Fever, chills, severe nonstop headache, including my entire face, nausea, complete body ache, fatigue, weakness, sudden sweating and severe nausea, extreme weakness disableing my ability to walk upright to even get to the bathroom. This lasted 3 days 03/16/2021 through 03/18/2021. Sever symptoms decreased to managable levels by 03/19/2021, except for off and on nausea. Fatigue, lack of energy and weakness still remain as of the report 03/23/2021
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| 67 | 2021-03-22 | malaise, throat pain |
I am writing this on behalf of my mother. She received the first round of the vaccine (Pfizer/EL9269...
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I am writing this on behalf of my mother. She received the first round of the vaccine (Pfizer/EL9269) on 2/18/21. That evening she reported not feeling "right". Over the next two days after receiving the vaccine on Thursday she reported to family that she didnt feel well. She had no fever but muscle aches, an earache and sore throat (this was on Friday and Saturday). On Sunday her breathing became a bit labored. She still had previous symptoms reported and labored breathing -- she stated she thought she would have to go to the Dr the next day (Monday, Feb 22, 201) if she did not feel better. Sometime in the night of Feb 21st and Feb 22nd my mom passed away. My mom had many health problems. Heart disease, diabetic, she was on dialysis and had sleep apnea. However, she definitely seemed to be having some difficulty with the affects of the first vaccine. Please let her life be counted.
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| 67 | 2021-03-22 | fever, headache, chills | Fever of 101.7 with severe body aches, headache, chills, nausea |
| 67 | 2021-03-22 | fever | fever started at midnight Patient took Tylenol which has subsided fever |
| 67 | 2021-03-22 | fever | Fever, aches pains, rash brain fog sleep |
| 67 | 2021-03-22 | sleepiness |
I was very sleepy and slept hard (which I do not usually do) all afternoon. Later, I developed red r...
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I was very sleepy and slept hard (which I do not usually do) all afternoon. Later, I developed red raised spots on my inner arms. They have scabbed over and are fading. I think they are called ? Lichenoid drug eruption ? according to my daughter who is a pediatrician and my son in law who is an ER physician.
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| 67 | 2021-03-23 | fatigue, headache, fever | Bad headache Fever Fatigue Nausea Rash |
| 67 | 2021-03-23 | malaise, chills, headache, fever | chills, fever of 101.6 with Tylenol on board, headache, chest tightness, nausea, malaise |
| 67 | 2021-03-23 | malaise, chills |
I had chills; feeling of being unwell; arm, it was swollen looked like Popeyes arm; warm to touch/ T...
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I had chills; feeling of being unwell; arm, it was swollen looked like Popeyes arm; warm to touch/ The arm she got the vaccine in; arm she got the vaccine in, left arm, really hurt; arm, it was swollen looked like Popeyes arm, blotches,; her adverse reaction turned out to be cellulitis/cellulitis from the injection.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration left arm on 03Mar2021 14:15 (Batch/Lot Number: EN6203),at the age of 67-years at vaccination, as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose on vaccine on 10Feb2021, LOT:EL9266 to Upper Left Arm. On 03Mar2021 at 2:15PM; patient received the second dose of the Pfizer covid vaccine, in her left arm; her adverse reaction turned out to be cellulitis, Patient states, it could have been happening two days or a day before she actually noticed it when she took off the Band-Aid, she had chills and didn't feel well on day 3 of the vaccine she still didn't feel well it was still hurting, she looked at the arm, it was swollen looked like Popeyes arm, blotches, warm to touch, she didn't have a temperature but she knew something was wrong. She got an antibiotic started from a doctor, and Famciclovir , that she took one day. She thought all of this stressed her out and she would end up with shingles. the medications are Doxycylcine, Hyclate, and Famciclovir, A doctor over the phone said that she had cellulitis, and told me to go into the ER, so early in the afternoon, she went to urgent care and they said she had cellulitis, and that's when she got the prescriptions. They wanted to see her on 07Mar2021 to check, and it is doing better. The patient was also asking, should she be somebody to get an antibody test, to see if it did it's job. Does she need to re-do the vaccine? The patient asked, was the bacteria in the vaccine or in the needle? She feel like there was something in the vaccine, maybe the bacteria was in the vaccine. LOT EN6203 - She has a Band-Aid from the site kept in a freezer at home. The vaccination Center. She stated she feel really fortunate, she was just scared to death of getting covid. For some reason, she got a bacterial infection that day, she have no way of knowing if it was the health care worker and bad technique, or bad vaccine. Psychologically, there's something about not knowing if the vaccine is protecting me because she took these medications, she was not sure I have the protection, and it creates a level of anxiety. Patient states that she believes she had an adverse reaction from her second dose on 03MAR2021. She states that three days later after the shot, she had already had chills and a feeling of being unwell. The arm she got the vaccine in, left arm, really hurt and she looked in the mirror and could see red blotches from her shoulder to the elbow and it was swollen and warm to touch. Patient states that she called around Saturday morning asking if this was typical or to be expected. She states at one point she called an ER and the doctor there said right away cellulitis and said that someone needed to see her. Patient states that she has no transportation so she had to wait until the afternoon and her son took her to Urgent care to be seen and she was diagnosed with cellulitis from the injection. The patient states she noticed when her arm felt unusual, thinks 6MAR2021. Treatment: Patient states that she was given an antibiotic, Doxycycline HYCLATE, 100mg twice a day for 7 days. She started taking it on Saturday 06Mar2021. Patient states the doctor asked her to come back the following day and looked at it again and thought it was improving and sent her home. Patient states that she also took a one day dose Samciclovir Sunday 07MAR2021. Patient clarifies that she had shingles in past and feels stress is going to cause this to occur again for her. She did take one day dose. She states that she does not have a shingles breakout nor did she have one. States that it prevents shingles breakouts and she took it as a preventative dose. Patient states the actual injection site is still warm and painful. Patient states, because she is on the antibiotic and also took the samsivocloir, a total of 2000mg, she is wondering does that make the vaccination ineffective, would she have to redo it? The outcome of the event was not recovered. Information on lot/batch is requested
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| 67 | 2021-03-23 | throat irritation |
Scratchy throat, facial hives, increased work of breathing after second dose of Pfizer mRNA COVID-19...
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Scratchy throat, facial hives, increased work of breathing after second dose of Pfizer mRNA COVID-19 vaccine IM right arm. Took patient to ED for monitoring. Gave albuterol, prednisone 60 mg PO, and diphenhydramine 50 mg PO. Monitored until symptoms resolved and discharged from ED in stable conditions.
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| 67 | 2021-03-24 | body temperature increased, chills, headache | Chills, headache, temperature 101, nausea, |
| 67 | 2021-03-24 | chills, fever, headache, fatigue |
Minimal reaction the first 2 days after receiving the shot. on the 3rd day I became fatigued but not...
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Minimal reaction the first 2 days after receiving the shot. on the 3rd day I became fatigued but noticed some lower abdominal discomfort. 4th day had loose stools and noticed some burning when urinating.. Late in the day had a splitting headache, i never get headaches, took Tylenol and felt better. At 2 am that night woke up with teeth chattering and limbs shaking. Urinated and noticed a pink tinge. My husband took me to the ER ( He had had a similar reaction to his first Pfizer shot) Found to have a fever, increased heart rate and a raging bladder infection (significant amount of blood in urine). Treated with Keflex via IV . Went home with a presciption for Keflex They are running a culture. I HAD COVID IN NOVEMBER AS DID MY HUSBAND IT APPEARS THAT MAYBE ONE DOSE WOULD HAVE BEEN SUFFICIENT FOR US. I HOPE THIS WILL BE EVALUATED AND THE PUBLIC INFORMED OF BEST PRACTICE
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| 67 | 2021-03-24 | chills, fever | swelling, soreness, fever, chills, aches |
| 67 | 2021-03-24 | fatigue, chills |
Severe chills, migraine, some nausea, zero appetite, body muscle pain and joint ache, soreness at va...
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Severe chills, migraine, some nausea, zero appetite, body muscle pain and joint ache, soreness at vax site and extreme tiredness. Symptom onset was 12 hours after the shot.
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| 67 | 2021-03-24 | fatigue |
Patient received first dose of COVID vaccine on 2/23/2021. Presented to clinic for 2nd dose on 3/16/...
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Patient received first dose of COVID vaccine on 2/23/2021. Presented to clinic for 2nd dose on 3/16/21. Reported that she had swelling on the left side of her neck x3 days after first dose and also had fatigue. Reports s/s resolved after 3 days. Did not seek medical care. Clinic staff contacted medical advisor to discuss before giving 2nd dose. MD recommended to vaccinate with 2nd dose. Patient agreeable. Received 2nd dose without incident.
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| 67 | 2021-03-24 | headache, fever, chills |
Severe nausea, temperature 102, aches, chills, severe headache, light sensitivity On 03/19/2021, con...
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Severe nausea, temperature 102, aches, chills, severe headache, light sensitivity On 03/19/2021, consulted with Dr and given Rx for Ondansetran, 8mg Symptoms receed over the next few hours
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| 67 | 2021-03-24 | headache, fever, fatigue, body temperature increased |
Started with loss of taste on Tuesday p.m.. Just after 4am, I awoke my husband because I was about t...
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Started with loss of taste on Tuesday p.m.. Just after 4am, I awoke my husband because I was about to vomit. From there I was going in and out of consciousness. My husband took my temp and it was just over 104 degrees. He wanted to call an ambulance to take me to the ER, but I refused not realizing how bad off I was. This went on for about 4 hours. My husband applied ice cold wash cloths to my forehead and back of my neck for hours. He finally was able to bring my temp down some. I used the cold cloths for just over two days. I was so fatigued I was unable to walk without help. Had a bad headache too. My husband gave me Tylenol off and on for days. My fever finally broke on the 5th day. I am still left with bad fatigue and some headache. Have also had diarrhea. My husband kept fluids in me which also included Ensure. I had terrible fever blisters on my lower lip and the inside of my mouth was sore. I am due to have my 2nd shot in about a week, but because I still have some lingering symptoms, was advised to not have 2nd shot.
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| 67 | 2021-03-24 | headache |
No symptoms first dose 2nd dose: 18 hours- headache 24 hours-joints ache, sore arm 52 hours- diarrh...
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No symptoms first dose 2nd dose: 18 hours- headache 24 hours-joints ache, sore arm 52 hours- diarrhea, sore arm 74 hours- diarrhea
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| 67 | 2021-03-24 | headache | Headache 3 days tightness in upper chest from shoulder to shoulder for 3 days |
| 67 | 2021-03-24 | headache |
1st shot could lift arm all day and very dizzy felt sick for 3 days only, 2nd shot I went home and t...
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1st shot could lift arm all day and very dizzy felt sick for 3 days only, 2nd shot I went home and took a IB 800 like the guy told me because I told him about my reactions with the first one, I had no problems until the 4th or 5th day after the shot now I have continuing Joint aches,. pains in legs wrists. neck. its like my fibromyligia has came back in full force. I feel like crap! Headaches and hurt all over in my joints back just like I used to 20 years ago, I is very crappy!!
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| 67 | 2021-03-24 | fever |
Feverish and woozy/dizzy starting 3/6/21 following 3/2/21 vaccine. Continues (today is 3/24/21). Pre...
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Feverish and woozy/dizzy starting 3/6/21 following 3/2/21 vaccine. Continues (today is 3/24/21). Pretty much bed-ridden. App't with naturopath will be 3/31/21.
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| 67 | 2021-03-24 | throat irritation, headache |
Couldn?t swallow good, itchy ears and throat, blood pressure 170/87 , elevated heart rate, numb lips...
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Couldn?t swallow good, itchy ears and throat, blood pressure 170/87 , elevated heart rate, numb lips, bad headache. I received a shot of benedryl and steroids.
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| 67 | 2021-03-25 | chills, body temperature increased, fatigue |
Day of Vaccine, typical sore arm. Day2 sore arm & feeling out of sorts. Day3 started in the early am...
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Day of Vaccine, typical sore arm. Day2 sore arm & feeling out of sorts. Day3 started in the early am with N&V, chills, fatigue & later in the day diarrhea. Slept off & on throughout the day, drank nothing but Gatorade, Gingerale & water. That night had a temp of 100.8 took Tylenol. Day 4 fever broke able to stomach dry toast & later Chicken Noodle soup but still continued with diarrhea. Day 5 starting to feel a little better, tried to eat normally, but later continued to have diarrhea. From Day 6 to today (Day 12) I still continue to have some nausea & diarrhea & fatigue.
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| 67 | 2021-03-25 | chills, fatigue, headache, fever |
fatigue, headache 6 hrs after vaccine (same as 1st dose), ~11 pm, severe chills, nausea, joint pai...
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fatigue, headache 6 hrs after vaccine (same as 1st dose), ~11 pm, severe chills, nausea, joint pain, short of breath ~ 2 am increased heart rate (112, usually in 80's) fever over next 3 days fever, joint pain, injection site redness and area on arm below -day - continued redness in arm
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| 67 | 2021-03-25 | headache, chills | Chills Headache Muscle and Joint pain Trouble sleeping |
| 67 | 2021-03-25 | headache |
10 pm of 3/23 I started feeling headache and muscle pain. By 4:30 3/24 I was in great pain across m...
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10 pm of 3/23 I started feeling headache and muscle pain. By 4:30 3/24 I was in great pain across multiple locations across my body. I also had a heaviness in my chest, making it uncomfortable to breath.
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| 67 | 2021-03-25 | headache |
Vaccinated 2/11 and symptoms started 2/13 at noon. Sudden bronchial spasms, obstructive apnea, cyan...
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Vaccinated 2/11 and symptoms started 2/13 at noon. Sudden bronchial spasms, obstructive apnea, cyanosis. EMS gave breathing tx, 02 sats WNL. Declined transfer to hospital at that time for fear of Covid. Client exhibited confusion, oriented x 0, short term memory loss. Bronchial spasms resumed, EMS again called, transported via EMS to hospital. Diagnosed with transient global amnesia and hypercapnia. Client was transported to medical center for CT and MRI for r/o stroke. Stroke was ruled out. Client with c/o memory loss, confusion, and h'a are becoming less severe. Client states that senrory processing is slowed.
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| 67 | 2021-03-25 | headache |
Pt arrived at observation area. at around 8:45 am. At 08:53, the patient stated 'I feel dizzy" Pati...
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Pt arrived at observation area. at around 8:45 am. At 08:53, the patient stated 'I feel dizzy" Patient lower extremities elevated on a chair. V/S obtained BP 152/88, P-61, SaO2 100%. Pt denied anu other concerns but stated B/P usually 120/70.. POC glucose obtained by EMT. Result 103. Apple juise and Graham crackers given to patient. Pt. stated she has eaten this am but was thirsty. 0905- Pt remains stable with c/o dizziness at same level. VS 151/86, P-60 Sats 100%. Pt. given small bottle of water. Pt. stated she had been under moderate stress due to a recent release from employer. She denied any chronic conditions other than HTN. 09:20- Pt. states she is 'still dizzy' this is what happened last time" EMY and writer continue to monitor Monitoring patient at present.. VS improving. Pt states level of dizziness unchanged. BLE remain elevated on chair. Stated she 'felt a headache coming on'. VS 140/81, P-62, Sats 100% 09:46- Recheck of vital signs- 145/87, P-61, Sats 100% Pt stats she is starting to 'feel better' juice pak, small bottle of water and @) graham crackers consumed. 10:00- Pt has felt 'well' and wants to leaved. VS stable. B/P 147/68, P-61, Sats 100%. Writer walked with pt. to elevator. Tolerated well. Denies any issue of dizziness.. Pt. discharge to home. All questions answered. Impression- vertigo and elevated blood pressure related to anxiety. Pt advised to follow up with her MD. Also advised to call 911 if symptoms return. Pt verbalized understanding of all information.
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| 67 | 2021-03-25 | headache |
Client complained of pain on the left side of her head. She stated began having a headache five mins...
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Client complained of pain on the left side of her head. She stated began having a headache five mins after receiving vaccine. Assessment revealed no hives, no rashes, and no difficulty breathing, no chest pain or other signs of anaphylaxis. Client reported a 7/10 pain on the left temporal region. She denied pain or swelling upon palpation. She denied any allergies and has a history of hypertension with prescribed meds. Client declined any other pain throughout her body. She was given water, and vitals were taken at 5mins intervals. She was observed for an additional 30mins, After 20 mins she reported that she "much better" and her headache was gone. She decided to leave 10mins before her 30mins of observation were completed. She was in no apparent distress when leaving. She was given ER precautions. Pfizer fact sheet was provided.
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| 67 | 2021-03-25 | sweating |
presents to the ED with SOA that began at midnight tonight while getting ready for bed. Following th...
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presents to the ED with SOA that began at midnight tonight while getting ready for bed. Following the onset of the SOA she began to have diaphoresis, lightheadedness, and a burning sensation in her chest that radiates to her back. No nausea or vomiting. She reports checking her heart rate and was tachycardic. She tried to bare down and walk off the tachycardia, with no relief. While she was driving to the ED, her symptoms gradually resolved
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| 67 | 2021-03-25 | influenza like illness, headache, fatigue |
Couldn't get warm- very cold, her skin was very cold; Nausea; Pretty severe headache; Generalized ac...
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Couldn't get warm- very cold, her skin was very cold; Nausea; Pretty severe headache; Generalized aching; Fibromyalgia flare up; No energy been very tired; No energy been very tired; Felt like she was going to faint; Dizziness; Vision blurred; Loss of appetite; Flu-like symptoms; Hands feel warm to touch, but she still feels cold; She cannot sit or stand without discomfort in her spine; She cannot sit or stand without discomfort in her spine; Sick; Her bones and muscles hurt; Her bones and muscles hurt; Wheezing; This is a spontaneous report from a contactable Other HCP, the patient. A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE,Lot Number: EM9809; Expiration Date: 30Jun2021), intramuscularly, on 01Mar2021 at 13:45 (at the age of 67 years old) as a single dose in the left deltoid for COVID-19 immunization. Medical history included having become disabled in 2009, arrhythmia from 2014 and ongoing which was diagnosed after she took a Hep C treatment (Sovaldi, Ribavirin, Olysio). She had to take these medications for five months, where most people have to take it for three, ongoing allergic asthma - allergic to "everything." She has had this her whole life, diagnosed when she was 5. Started treatment with steroids at 16 , Hepatitis C from 1996 to 2014 diagnosed 4 years after blood transfusions Could have already gotten it as a nurse, was much more resistant than the average person 5 weeks to go negative, ongoing hepatic failure from 2013- she went into liver failure from Hep C. An event occurred- exposure of a deadly toxin that came from China, ongoing fibromyalgia from 1992 -Immediately after blood transfusions when her son was born- Gave her the correct blood but her body reacted. Flu shot in Early Oct2020 Fibromyalgia flare up, 4 times the dose (as reported)- Onset Age 66, Seizure disorder which was diagnosed in 2016 after disseminated shingles; after 2.5 months started having black outs where she did things and said things no memory of, the only way she knew it happened is if there were consequences. Doesn't know if she still has those, but she is getting an MRI and EEG. She lost vision in her right eye 2 years ago due to retina surgery macular pucker. She thinks her liver was stealing Vitamin A from her eye. Medical history also includes she ran over herself with her car, blood pressure abnormal, hepatic encephalopathy, autoimmune thyroiditis, and anxiety all from unknown dates and unknown if ongoing. The patient has had cataracts since an unknown date prior to the vaccination. The patient was diagnosed with "Rocky Mountain" in 2009. She also mentioned that when she got the vaccine she did not tell them that she was on steroids and an antibiotic. She commented that she was not in good shape when she took the vaccine to begin with. She is immunosuppressed and thinks that she should not have received the vaccination. But she also stated that she took the vaccine because she is a severe asthmatic and does not have a strong immune system so if she got COVID, she would die. Concomitant medication included benazepril (BENAZEPRIL) for blood pressure abnormal from an unspecified start date and ongoing; amlodipine (AMLODIPINE) for arrhythmia from 2014 and ongoing; rifaximin (XIFAXAN) for hepatic encephalopathy from 2014 and ongoing; lactulose (LACTULOSE)for hepatic failure, ammonia abnormal from 2014 and ongoing; levothyroxine sodium (SYNTHROID) for autoimmune thyroiditis from 1984 and ongoing; omeprazole (PRILOSEC [OMEPRAZOLE]) for reflux gastritis, chronic gastritis from an unspecified start date and ongoing; alprazolam (XANAX) for anxiety, post-traumatic stress disorder from 2009 and ongoing; albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) for asthma from an unspecified start date and ongoing; ranitidine (RANITIDINE) for an unspecified indication, start and stop date were not reported.The patient previously took flu vaccine vii, olysio for hepatitis c and experienced histamine level increased, lyrica and experienced weight increased. Ten minutes after the vaccine was administered the patient experienced generalized aching on 01Mar2021 at 13:55 with outcome of not recovered. After twenty minutes she developed a pretty severe headache on 01Mar2021 14:05 with outcome of recovering. After 30 minutes she stared to feel nausea on 01Mar2021 at 14:15 with outcome of recovered. She stated that when she stood up to leave felt like started to feel dizzy on 01Mar2021 with outcome of unknown, and felt like she was going to faint on 01Mar2021 with outcome of unknown, her vision blurred on 01Mar2021 with outcome of not recovered and she had trouble getting into the elevator. She also experienced a loss of appetite on 01Mar2021 with outcome of recovering. The patient continued to describe her experiences noting that "things changed daily" and mentioning that she experienced fibromyalgia flare up on 01Mar2021 with outcome of not recovered, no energy been very tired on 01Mar2021 with outcome of not recovered , no energy been very tired on 01Mar2021 with outcome of not recovered , couldn't get warm- very cold, her skin was very cold on 02Mar2021 01:30 with outcome of not recovered, flu-like symptoms on 01Mar2021 with outcome of recovering, hands feel warm to touch, but she still feels cold on 01Mar2021 with outcome of unknown, she cannot sit or stand without discomfort in her spine on 01Mar2021 with outcome of unknown, she cannot sit or stand without discomfort in her spine on 01Mar2021 with outcome of unknown, sick in Mar2021 with outcome of unknown, her bones hurt in Mar2021 with outcome of unknown, her muscles hurt in Mar2021 with outcome of unknown, wheezing on an unspecified date in Mar2021 with outcome of unknown. Lab tests and procedures included cardiac output: over 50 percent, echocardiogram: her heart was good and clear, electroencephalogram with unknown results, magnetic resonance imaging with unknown results, all on unknown dates. Therapeutic measures were taken as a result of pretty severe headache; Sender's Comments: Based on the available information, the company considers that a causal relationship between generalized aching, severe headache, feel dizzy, going to faint, vision blurred, no energy been very tired, very cold, her skin was very cold, wheezing and bnt162b2 vaccine cannot be excluded due to plausible temporal association. The Company considers the reported event fibromyalgia flare up is unrelated to bnt162b2 vaccine but more likely due to underlying medical history of ongoing fibromyalgia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 67 | 2021-03-25 | nasal congestion, sneezing, fatigue, runny nose |
Very rapid onset of severe nose congestion, slight runny nose and sneezing. Lasted about 12 hours. S...
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Very rapid onset of severe nose congestion, slight runny nose and sneezing. Lasted about 12 hours. Severe skin sensitivity ( pain when touched) on right side of back and eventually stomach area. Took two different over the counter allergy pills over 2 days (claritin was one) , two Advil cold and Sinus pills and eventually before bed a decongestant nasal spray. The spray was the most effective. By next day symptoms were better but not gone. By third day this had cleared up. I was also tired and a bit achy for two days.
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| 67 | 2021-03-25 | fever, chills, headache, sweating, fatigue |
Within an hour of the shot I felt very tired and took a long nap. Around 5 pm I began to feel a lit...
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Within an hour of the shot I felt very tired and took a long nap. Around 5 pm I began to feel a little achy and a slight headache. During the night, I ached all over, had a terrible headache, the muscles in my neck felt like they were drawing up, I had fever, but didn't get up to check it, my joints and bones ached, I had chills and it was a miserable night. The next morning I got up to make my breakfast and I kept trying to pass out and would have to sit down. I was sweating real bad and finally went to lay down. My husband fixed my lunch and I began to feel like my eyes were getting black, and then I slumped over and he said my head was bobbing on his shoulder. I could hear him saying my name, but I couldn't respond. Right after I cam to, I began to throw up at the table. He called an ambulance and they came and check me out. My blood pressure, blood sugar, EKG, and pulse ox were all normal. I refused going to the hospital, but I didn't know what the hospital could do for me. I called my family physician's office, but never heard back from them. I hear the second shot is worse than the first, so I am not sure if I should take the second shot. Also, strangely enough, my arm wasn't sore. Every time I have the flu shot I feel bad for a couple of days. I also felt bad after my Shringrix shot and pneumonia shots.
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| 67 | 2021-03-25 | fever |
A few hours after the shot, I experienced a mild bout of diarrhea. Then began to run a fever. The...
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A few hours after the shot, I experienced a mild bout of diarrhea. Then began to run a fever. The injection site and right arm became extremely heavy and painful. Overnight, I experienced fever, extreme muscle cramping and a burning sensation in all of my joints. Took a Tylenol at midnight which helped. Fever remained at 99.8 which is high for me. This lasted for the next 24 hours. Today, Friday the 26th, I am finally feeling better and fever is gone.
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| 67 | 2021-03-26 | fatigue, headache, malaise |
Muscle pain (all body muscles). Joint pain (including jaw & fingers) Headache (persistent - especia...
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Muscle pain (all body muscles). Joint pain (including jaw & fingers) Headache (persistent - especially forehead after tylenol or ibuprofen) Tiredness Feeling very unwell Treatment: Tylenol (650 mg, 2 tabs tid); and Ibuprofen (200 mg, 2 tabs qid) Outcome: All events, except headache & tiredness resolved following 9 days of treatment (3/25/2021). Headache & Tiredness finally get to bearable level on Day 11 (today; 3/27/2021).
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| 67 | 2021-03-26 | fatigue | Very sore arm, body aches, lack of appetite, and extreme tiredness |
| 67 | 2021-03-26 | fever, headache |
Fevers 104.0-102.6, day 22 and still fevers over 101.0. Severe diarrhea, vomiting, and crushing head...
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Fevers 104.0-102.6, day 22 and still fevers over 101.0. Severe diarrhea, vomiting, and crushing headache since the second vaccine. Vaccine card shows two different Covid vaccines. Nurse wrote in my medical record that I received two of the same, we had witnesses that the second wasn?t a moderna
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| 67 | 2021-03-26 | sleepiness |
1st shot: the following morning felt like I had a cold. symptons over by noon 2nd shot: felt good ...
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1st shot: the following morning felt like I had a cold. symptons over by noon 2nd shot: felt good and got sleepy early and am sleepy the next day, sore arm for 24hrs then all good!
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| 67 | 2021-03-27 | chills, fatigue, headache | Body aches, chills, extreme fatigue, weak, headache |
| 67 | 2021-03-27 | chills, fever, headache |
Woke up the next morning with body aches, 101 fever, chills, migraine. As the day worn on fever clim...
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Woke up the next morning with body aches, 101 fever, chills, migraine. As the day worn on fever climbed to 103., nauseous and vomiting. Slight headache and diahhrea on 3rd day following vaccine
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| 67 | 2021-03-27 | malaise | I was fine for a few days then got really sick on 5 th day & have felt bad since then. |
| 67 | 2021-03-27 | fever, chills |
3 phases- within 24 hrs of shot - low grade fever and chills lasting 24 hours; during the following ...
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3 phases- within 24 hrs of shot - low grade fever and chills lasting 24 hours; during the following 2 weeks, strong pain in arm muscle that travelling under arm into lymph nodes. Approximately 30 days after injection experienced a mild heart attack and unexplained pericarditis. Symptoms at onset were major pressure in chest and elevated blood pressure 210/99. Prescribed blood pressure medication, blood thinners and 4 does of indomethacin for pericarditis
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| 67 | 2021-03-28 | headache, throat irritation |
something in her throat; rash/bumpy rash; nausea; vomiting; started having a taste in her mouth; tic...
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something in her throat; rash/bumpy rash; nausea; vomiting; started having a taste in her mouth; tickle in her throat, and she kept trying to clear her throat, and then her voice was gone; it felt like her throat was closing up.; rash/red rash; lost of voice; dizziness; headache; This is a spontaneous report from a contactable consumer. A 67 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6200, expiration date: 30Jun2021), via an unspecified route of administration on 04Mar2021 (at the age of 67 -years-old), single dose for COVID-19 immunisation. Medical history included diagnosed in 1978 with Gestational Diabetes, and that went away, but it came in 1995 and has been active and progressing ever since; Diabetes, Type Two; allergies to various medications; food allergy. Caller had concomitant medicines of unspecified anxiety medicine, pain medicine,anti-inflammatory, diabetic, blood pressure medicines, the statins. After getting the first dose of the Pfizer BioNTech COVID-19 vaccine, caller had adverse events that made her become hospitalized. She said she had developed dizziness, light headedness, headache, something in her throat, lost of voice, rash nausea, and vomiting. She was in the hospital for 5.5 hours. She originally has the appointment for the second dose of the vaccine on 25Mar2021 but it got cancelled. Caller got the vaccine on 04Mar2021, and the guy gave her the shot, and then said the would check on her in 10 minutes, because of the caller's history of allergies to various medications and foods. Caller reports that she started having a taste in her mouth, and then she got lightheaded, she was dizzy, she got a headache, she felt sick to her stomach and that progressively got worse to where she ended up throwing up twice at the hospital. Caller was given a Bendaryl, and some anti-nausea pills under her tongue, but she did not know she was rashy, until she got home, there was a rash on her chest, arms, back, and legs that was all bumpy and red. Caller started to feel a tickle in her throat, and she kept trying to clear her throat, and then her voice was gone. An ambulance was called, but her husband took her to the hospital because it was right across the street, because her doctor had advised her to get the shot at a site near the hospital because of her history of allergies. Caller reports that she was in the ER for like five and a half hours, and when she started to feel better, she said she wanted to go home and lay in her own bed if she is just going to be puking her guts out. Caller states that she went home and crashed and burned for a few days, with no voice, and she was still coughing to try and clear her throat, it felt like her throat was closing up. Caller confirms she was not admitted to the hospital for this reaction. All events started 04Mar2021. Treatment was given for all events. The outcome of the events was unknown. Caller had no other vaccines on the same day.
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| 67 | 2021-03-29 | headache, chills |
Extreme nausea; My symptoms were so severe I felt like I was going to die; I mean literally die; I t...
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Extreme nausea; My symptoms were so severe I felt like I was going to die; I mean literally die; I thought I am going to have a stroke; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; Chills; Headache; The chest pain was horrible; The joint and muscle pain were so severe; I am still little real nauseous; I feel like I mean like acid coming up constantly making me more nauseous; Unable to eat; The joint and muscle pain were so severe; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Deltoid Left on 19Mar2021 (Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient previously had first dose of BNT162B2 for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication includes supplements and multivitamins. The patient stated "I wanted to ask you and I have some horrible concerns I got my second COVID shot last Friday, and by Saturday night, I am not exaggerating, my symptoms were so severe I felt like I was going to die I mean literally die on 20Mar2021. I couldn't get to emergency room, I figured out I am just going to die, I just laid down and let my door open down so somebody could find me, the symptoms I was having was extreme nausea, chills, headache, the chest pain was horrible, horrible, the headache I mean I thought I am going to have a stroke, the joint and muscle pain were so severe. So I have been taking Tylenol, Advil (Treatment) finally this morning, yesterday was tiny, tiny bit better, this morning its little bit better but I am still little real nauseous and I feel like I mean like acid coming up constantly making me more nauseous and almost like unable to eat. Ever since Saturday all I will have been doing is three bites of chicken soup three times a day. What in the world is going on with this vaccine that it would cause those severe symptoms and my chest is still tight I still feel low congestion having hard time taking a deep breath in Mar2021". The outcome of the event "my symptoms were so severe I felt like I was going to die I mean literally die" was recovered on unspecified date. The outcome of the event unable to eat was unknown. The outcome of the rest of the events was recovering. Information on lot/ batch number has been requested.
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| 67 | 2021-03-29 | lethargy, fever |
Patient presented 8 days after her vaccine with fevers and lethargy. She subsequently developed DVT,...
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Patient presented 8 days after her vaccine with fevers and lethargy. She subsequently developed DVT, PE, and severe thrombocytopenia consistent with ITP. She has also developed encephalitis.
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| 67 | 2021-03-29 | fever, fatigue |
Initially--fatigue, fever, muscle aches. On day 4--parethesia and numbness causing imbalance on le...
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Initially--fatigue, fever, muscle aches. On day 4--parethesia and numbness causing imbalance on left side. lasted a brief time--less than 20 minute. Day 5 paresthesia and numbness on waking up on left side, increased in intensity during the day. Difficulty walking and using left side. Muscle control lacking and balance very poor. The intensity of this fluctuates--there are days that improvement seems to be happening and then very bad days. Admitted to the hospital on Wednesday, March 24, 2021, via the ER. MRI, CAT scan, heart monitor, --these did not show evidence of a stroke as suspected at the time. The neurological symptoms persist, at times including numbing on the left side of my face.
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| 67 | 2021-03-30 | dehydration, fever, influenza like illness, headache |
passing out; she was 155 lbs before when she was in the hospital - and now 160 lbs; States that she ...
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passing out; she was 155 lbs before when she was in the hospital - and now 160 lbs; States that she was dehydrated in hospital and did not eat a thing; stayed dizzy; confused; She had felt disoriented; foggy; it was like the flu shot; sleeping a lot; her vision would get very narrow; thumb pink; erratic body temperature; horrible headache; bodyaches; dry heaves; slight fever/ body temperature 104.4; injection site sore; lymph nodes swollen; This is a spontaneous report from a contactable consumer (patient). The 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 04Feb2021 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer - stage 2 from Jan2008; 29Jan2008 surgery, breast cancer. First surgery for breast cancer removal and lymph node removal, then the cancer went around the first and second lymph nodes so they had to go back in because they had to take out a bunch more and she had to give them permission to take out more lymph nodes. Concomitant medication(s) included ongoing simvastatin for High cholesterol; ongoing bifidobacterium bifidum, bifidobacterium longum, lactobacillus gasseri (PHILLIPS COLON HEALTH) she has high pain tolerance, had stomach cramp did not know what it was and one a day vitamin. The patient previously took bnt162b2 (BNT162B2), dose 1 intramuscular administered in Arm Right on 14Jan2021 (Batch/Lot Number: EL8982) as SINGLE DOSE for covid-19 immunization and experienced Injection site sore. The patient experienced passing out on 28Feb2021, injection site sore, lymph nodes swollen on 04Feb2021, thumb pink on 26Feb2021, erratic body temperature, horrible headache, bodyaches, dry heaves on 05Feb2021, she was 155 lbs before when she was in the hospital - and now 160 lbs on an unspecified date. The patient was hospitalized for passing out from 01Mar2021 to 02Mar2021. The event passing out leaf to emergency room visit. The patient lab tests and procedures which included cat scan/ cat scan groin area with contrast: normal; EKG: normal; blood workup: normal; Blood culture:normal, all on 01Mar2021; cat scan head and neck with contrast: normal and cat scan head and neck without contrast:normal on 02Mar2021. The outcome of the event thumb pink was recovering, erratic body temperature was not recovered, horrible headache, bodyaches, dry heaves recovered on 26Feb2021, and was unknown for the rest events. Reported as: Caller states that on 04Feb2021 she received her 2nd vaccine at around 3:30 pm, and then around 10 pm she had injection site soreness. The morning after the second injection around 4 am, she had site on her arm soreness, erratic body temperature with slight fever, horrible headache, bodyaches, and dry heaves. Her lymph nodes also swelled up again. Caller clarifies that this also happened after her first injection of the Pfizer Covid19 vaccine and on a similar timeline. Caller clarifies that 2 weeks later on 26Feb2021 she had ended up with horrible headache, dry heaves, headache, body temperature 104.4. She states that this lasted Friday night and Saturday night and Sunday she was feeling better. Clarifies that was the week of 26Feb2021. Caller states that her events were on a similar timeline and that her first vaccine was 14Jan2021 at 3:30 pm on Thursday. States that by 10 o'clock that night, injection site was sore. At 4 am, injection site was very sore. A couple of days later, her lymph nodes were swollen in her left leg, groin area, right arm under armpit. Adds that area under armpit was the size of her thumb. Also, on the left underneath her chest wall. She states that she has had breast cancer in that left breast. She states that the swelling went away completely, but that the groin area swelling took 2 weeks to go away. Unable to verbalize exact dates. Confirms that this was after the first vaccine and also occurred after the second vaccine. Caller then adds that she was feeling better Sunday, 28Feb2021 but that her husband then found her on the floor Sunday night at 8:45 pm. She states that she passed out. Monday she passed out again and was taken to the hospital where she stayed until 02MAR2021. Healthcare Provider also provides information that her son ran her to emergency room, and she is not familiar with the doctors there. Also, a doctor that she does not remember the third physician but it was a neurologist. Caller states that she was 155 lbs before when she was in the hospital - and now 160 lbs. States that she was dehydrated in hospital and did not eat a thing. Normally she runs around 160 lbs. States she had breast cancer so left arm cannot be used, so they used her right arm for both vaccines. caller adds that she had a cruise she was going to go on but refused to go on in 2020. States that she heard you will need to have a vaccination passport to travel in the future so she wanted to get vaccine. States she did not want to get covid. States that so many people have died. Caller clarifies that she was admitted to (Hospital Name) on 01Mar2021. Caller adds that she went to the hospital 2 weeks after the second dose. She states that is what makes them wonder if it is from the Covid vaccine. Adds that she is not saying that is what caused all of this, but that it is just a coincidence that it was exactly 2 weeks after the vaccine, exactly 2 weeks out when this happened. She states that she has been thinking if she should be wasting Pfizers time reporting this but it could be a coincidence or maybe a reaction. Caller adds maybe it is because she had 34 radiations, 8 chemo treatments, 1 year of Herceptine, and breast cancer. States that maybe she can save somebody else, or if a possibility, people can be prepared two weeks early. She adds that she is lucky she did not break an arm, leg. or bone. States that she doesn't know if maybe she can save some other person by sharing this information. Injection site sore: States that this was after both first and second vaccine. It stayed sore for about a week, and was just tender after that. If she touched it, she noticed, but it didn't hurt her from doing anything. With the first vaccine, injection site soreness started 14Jan2021 around 10 pm and completely resolved after about a week. She adds that with the second vaccine she also noticed injection site soreness that same day on 04Feb2021 around 10 pm also. She adds that it lasted about six days or seven days or so. It was the same way, tender the first day and then at 4 am was when it got really bad. That Friday 05Feb2021 was when it hurt worse. Adds that she went into hospital on 01Mar2021 on Monday. States she was feeling okay, stayed dizzy and confused and thought she was getting Alzheimer's or dementia but it cleared. At 11 pm on Sunday felt completely different, like the old her. States she was fine yesterday 15Mar2021. She had felt disoriented but is now feeling better and back to normal. Eratic Body Temperature: States that she started watching and recording her body temperature on 09Mar2021. She states that it was 104.5 on Friday, and Saturday and Sunday night she used a wet washcloth to her forehead. States that her body temperature initially was variable starting on 26Feb2021. She adds that it continued until Sunday 28Feb2021. On 26Feb2021, her body temperature was 104.5. She states that it was then low on Sunday 28Feb2021 and was 98 or 99. Adds that it had been erratic but that once the fever broke it has been between her normal which is 98.6 to 98.7. Adds that her and her husband know for sure that when she passed out the three times, her temperature was 94.4. States that her husband gave her aspirin for the temperature. Adds that her temperature has been between 97.9 to 94.9 and dropped to its lowest on Saturday 13Mar2021 at 10:35 am. She states that it is still doing this erratic behavior and that this morning it was 96 at 1 am and then 96.8 at 8 am. While on phone today, it is 97.1. Lymph nodes swollen: States noticed swelling at 4 AM 16Jan2021. States this occurred 4 am after both first and second injection. Occurred to groin area, right arm, and left arm. It was there for a couple of days and then it would just remind her it was there. The arm lymph node swelling went away after a few days, maybe before a week or so. The one in the groin was there for about two weeks. On a scale of 1 to 10, it was a 1.5 and was not something that people need to take an Advil or something for. Clarifies it was in the armpit except in the left side because they took those lymph nodes out during surgery in 2008. Also, she noticed lymph node swelling in the chest area. Lymph Nodes at second vaccine she also noticed them starting at about 4 am after the vaccine and it started hurting again. Caller reiterates both shots were given at 3:30 pm and then at 10 pm injection site gets sore.Then 4 am injection site gets more sore. She's been telling everybody to get the vaccine in the morning. Her symptoms lasted two weeks and then she was fine. Caller adds that her husband never felt a thing from receiving the vaccine. She states that the injection site was tender on her husband but gone the next day. Investigations: stated they looked at her in the hospital and said she was fine. The girl came back up and did more cultures and nothing grew. They were confused and so was she and she has been debating whether to call and waste time reporting but thinks that Pfizer needs to know what happened to her. Simvastatin: Adds that asked doctor if this caused her symptoms and he said no. Phillips colon: doctor 6 to 9 months later did scan, the next day was in emergency surgery and it was her appendix. It enlarged and had grown into the other organs. Doctor said it was a mess and it was ready to rupture as a precaution they wanted to remove it. Bayer product Code above expiration date states 0C09C and expiration is Mar2023. Thumb pink: thumb nail to finger print past where you bend it was where she noticed it was pink. States it is now 98% better. Friday 26Feb2021 afternoon at 1 pm, right thumb turned pink. She took a pen and marked where it was vertical and horizontally pink to scarlet in color. She put herself on antibiotics. She was not sure if maybe she cutting chicken and cut it, or closed finger in drawer. It swelled up twice the size, turned purple. Went all around the finger and it was hot. She thought it was going to pop off. She kept wondering what she was going to do to her thumb. She did jam it and cut herself 2 months ago. Clarifies it was right hand thumb. Treatment: took antibiotics, which she states they kept her on in the hospital in IV form. She started the antibiotics on Friday 26Feb2021. Took it Friday afternoon, Friday night, and Saturday and Sunday. She thought it was doing better Sunday night before she passed out. Clarifies Cephalexin, 500 mg daily (Keppra) three times a day and by mouth. Adds that she keeps this medication on her because she travels the world and it is good to have on hand since it is broad-spectrum. Passing out: 28Feb2021 Sunday night noticed the volume on television was driving her crazy and it was irritating. Around a quarter to 9 she got up to brush her teeth and go to the bathroom. She went pee and then fell off toilet. She got really really dizzy, and her husband was standing over her yelling asking what happened. She saw the wall and she did not know what happened. States she was out cold and he was calling her name but she did not hear him. She heard him asking what happened but it was in the distance. He got her to bed and about 20 minutes later (husband reports 30 minutes later) she was so dizzy and passed out again. She adds that this may have happened Saturday also because she was sleeping a lot and it was like she was seeing words repeat themselves over and over again and her vision would get very narrow. Her husband was note sure if she passed out on Saturday also, but said both times Sunday she was out cold. Monday 01Mar2021 she called her husband's office and woke up to the nurse on the other line screaming. She dropped the phone and heard her name being screamed over and over on the phone and when she picked it up the nurse said that she must have passed out even though she thought she was sleeping. The nurse got ahold of her husband in his office. She believes she passed out again Monday morning and was then in the hospital Monday and Tuesday. Hospitalization: On 01Mar2021, her husband is a physician and suggested she go to the hospital. She was trying to get ahold of her son and daughter in law. She sent them a text and called and they did not answer. Her sons phone was charging and when he looked at it he was on his way to her. She states that when she came to all three times, she was extremely dizzy foggy and confused. Adds that the nurse at her husband's office alerted her husband and he told her to stay in bed and her son came to help her and then drove her to ER. States she was there Monday 01Mar2021, and discharged Tuesday night 02Mar2021 about 4:30 to 6 pm. Caller does not want to file a report for her husband regarding the injection site soreness. She states it was like the flu shot. She clarifies that it was not his arm, it was the injection side. She states that these people who are going on and on about their arm hurting, it is the injection site. She states it is the injection site and will not be the arm. States that it is like the flu shot. States she does not want to file a report regarding her husband because it was injection site soreness and went away. Provides no additional information. Adds that this is a new drug and new disease and we do not know what the future holds Caller adds that she keeps a diary and started a diary so that she has everything recorded in terms of medical history. States that it is important that everybody do so. Family Medical History Relevant to AE(s): callers dad passed out at age 85. He found out he was diabetic and had heart issues. Also had a stroke at age 87 and passed away. Adds that between ages 85 and 87 he passed out every few months, he would do one of his passing out things. Caller also had a brother who passed out sitting at table and went forward into table. She states at that time her brother didn't realize he had stage 4 lung cancer, and her brother passed away 1 and a half years later. Caller adds that he smoked from ages 15 to 64, and quit at age 63 because the doctor told him to. No follow-up attempts possible. No further information expected.
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| 67 | 2021-03-30 | fatigue |
pt states she started feeling very bad and everything hurt the day after getting the vax. She has a...
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pt states she started feeling very bad and everything hurt the day after getting the vax. She has a lot of hair loss. She had to stay in the bed for the next couple of days because she had fatigue and body aches. 5 weeks after taking the vax she has swollen lymph nodes in both arm pits and he developed sore knots under the skin on the outside of her thighs. Her BP has become uncontrollable. She was on 10mg of bp medicine and then it was upped to 20 mg. About 7 days ago a diuretic and her BP is still very high. on 3/20/2021 it was 180/89. she checked it again a couple of hours later and it was 165/92. She has had symptoms of GERD since 3/22/2021. Blood work she had on 3/18/21 shows way too much carbon monoxide in her CO2. Her anxiety has increased since she was vaccinated. She has an appt w/ her PCP on 4/9/21. She is very concerned that she is going to die from taking this vax.
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| 67 | 2021-03-30 | headache, fatigue |
fatigued/ extremely tired; nauseated; severe headache behind my eyes; This is a spontaneous report r...
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fatigued/ extremely tired; nauseated; severe headache behind my eyes; This is a spontaneous report received from a contactable consumer (patient). A 67-Year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EK9231), via an unspecified route of administration on right arm on 25Jan2021 13:15 at single dose for COVID-19 immunisation in hospital. The patient medical history included chronic migraine and brain aneurysm (surgery 2016). Concomitant medications included unspecified Multivitamins (Vitamins NOS) within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021, the patient experienced somewhat fatigued the first day after the vaccine, but the second day It was extremely nauseated, had a severe headache behind her eyes, and was so exhausted that she could barely get out of bed to use the bathroom. she felt better the following day but have since had some days when she is extremely tired. No treatment was received for the events. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient has not been tested for COVID-19 Since the vaccination. The outcome of the events was reported as unknown.
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| 67 | 2021-03-30 | headache, fever |
fevers/ gone as high as 102. I don't know if it's part of the side effect or not. It's usually in th...
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fevers/ gone as high as 102. I don't know if it's part of the side effect or not. It's usually in the evening and night. but during the day having temperature of 99.1. It came down from 102 to 99.1; I had a headache; This is a spontaneous report from a contactable Nurse (patient herself). A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247, Expiration date: not provided), intramuscular, administered in Arm Left (Anatomical Location) on 02Feb2021 14:22 as single dose for COVID-19 immunisation. The patient medical history included ongoing psoriatic arthropathy. Concomitant medication included ongoing ixekizumab (TALTZ, injection) at 80mg monthly for psoriatic arthropathy. The patient historical vaccine includes BNT162B2 from 12Jan2021 to 12Jan2021 for COVID-19 immunisation. she got her 2nd Pfizer vaccine on Tuesday 02Feb2021 She was fine on Tuesday. Wednesday evening, she had a headache and a little bit of a fever. This all went away by Thursday. Then, Friday, Saturday and Sunday, she had a fever again. She doesn't know if its related to the vaccine or if something else is going on. Wednesday evening into Thursday I had a headache and a low grade fever of 100.4. On Friday, Saturday and Sunday I've gone as high as 102. I don't know if it's part of the side effect or not. It's usually in the evening and night. But during the day having temperature of 99.1. It came down from 102 to 99.1 in a few hours. she did take 2 Tylenol at 8am within an hour, her fever came down. Last night or earlier this morning, it was higher than it had been on Saturday. On Saturday, it was like 101 degrees and earlier this morning, it was 101.9 which was almost a degree more than on Saturday. The patient underwent lab tests and procedures which included body temperature: 100.4 on 03Feb2021, 102 on 05Feb2021 she have gone as high as 102 , 101 degree on 06Feb2021, 101.9 degree on 08Feb2021, 99.1 on Feb2021, came down on Feb2021, higher than it had been on Saturday on Feb2021. The outcome of the event Fever was unknown and other event was recovered on 04Feb2021.
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| 67 | 2021-03-30 | malaise, headache, fatigue, sleepiness |
also had a headache; her eyes have been really sore, red and she has several broken blood vessels in...
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also had a headache; her eyes have been really sore, red and she has several broken blood vessels in her eyes; her platelet levels dropped; having muscle pain or some kind of pain, maybe joint pain that is in her hips; has had nausea and she has generally felt unwell; muscle pain; she slept for almost two days; felt unwell; diarrhea; abdominal pain; her eyes have been really sore, red and she has several broken blood vessels in her eyes; her eyes have been really sore, red and she has several broken blood vessels in her eyes; tiredness; eyes were yellow when she woke up that morning; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6200), first dose via an unspecified route of administration, administered in Arm Left on 09Mar2021 11:45, single dose as SINGLE DOSE for covid-19 immunisation. Medical history included lung transplant from May2011, immunodeficiency from May2011 and ongoing, strokes. The patient had dtap vaccine before Jan2021. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN); prednisone acetate (PREDNISONE); tacrolimus monohydrate (TACROLIMUS). Patient reported that it has been about a week and a half of maybe more since her first COVID vaccine and she gets new symptoms almost everyday. Most of the symptoms aren't like put-you-down sick, horrible symptoms, they can be dealt with, but she has had a lot of them. She never got injection site pain and her arm never got sore. She had tiredness on the second day after her COVID vaccine, she slept for almost two days. She has a headache almost constantly. She is having muscle pain or some kind of pain, maybe joint pain that is in her hips. She doesn't have chills, a fever, injection site swelling or redness. She has had nausea and she has generally felt unwell all the time for a week and a half now. She is immunocompromised because she has had a lung transplant, that is the one thing that probably sets her apart is that she is immunosuppressed. She had the lung transplant almost 10 years ago now and she has been doing well. She is not on blood thinner medicine but she does take a baby aspirin everyday. Those are the only two things that she can think about. She doesn't know if all of that would make the symptoms from the COVID vaccine different for her. Most people she knows who have received the COVID vaccine have only had a couple days of tiredness and a sore arm. But she has a headache, been achy, and she just doesn't feel good. She also had a headache then and slept a lot, she was really tired. Later in the report caller clarified the first dose was actually 09Mar2021. She is not tired right now but she does still have a headache today, it is a pretty good headache. Her tiredness was Sunday and Monday of this week, confirmed to be 14Mar2021 and 15Mar2021. She says that she has recovered completely from the tiredness even though she feels like she could nap right now but she can't since she has a blood draw later. It is like she wakes up and every day she gets new symptoms. She had two symptoms that are not on the sheet of symptoms. The two she experienced are weird. On Saturday, a week and a day after her vaccine, her eyes were yellow when she woke up that morning. Confirmed date to be 13Mar2021. It was only that one day. She thinks that she has recovered completely. Also, her eyes have been really sore, red and she has several broken blood vessels in her eyes. Some of this is normal in the winter for her, but the yellow isn't normal for her. Normally, when she does get the blood vessels in her eyes they will heal in a day or so but the ones now have lasted much longer. They have been much slower to go away. It is not like there is a red spot, but it looks kind of red and kind of weird. The other symptom that is strange is that her platelet levels dropped. She was at 49 before her COVID vaccine and now her platelet level is down to 29. She does have normally very low levels for platelets but they are usually around 50. They have dropped substantially since her COVID vaccine. They dropped from 50 to 33 and then 5 days later her level went to 29. She is getting another platelet level drawn today, confirmed to be 16Mar2021. Her eyes being sore, red, and having broken blood vessels occurred probably a couple of days after she received the COVID vaccine. Specifically, her left eye felt like it had something in but she doesn't believe that it did. She used eye drops. Her eye just felt gritty. This is not like she had pink eye and she didn't wake up with this eye shut. It wasn't pink eye she knows what that is like. Her eyes had broken blood vessels and then they turned yellow then they turned red and have remained red. They are not sore today and she doesn't feel like she has gravel in her eye but the whites of her eyes don't really look clear. She says so far it has improved some but she will see since she wakes up every day and something new has happened, or something different or something has come back again. The good news is that she doesn't have all of these symptoms at the same time. She can't the remember the day pain in hips began but it is ongoing. She noticed this morning that the pain in her hip was not as bad when she had gotten out of bed. That pain has lessened there but the pain went to her head. Nausea and generally not feeling well: Probed for when this began and caller says that it has occurred for several days after she eats dinner, her stomach will be growling loud and that comes along with abdominal pain which doesn't really fit in with muscle or joint pain, she has no muscle there unfortunately she jokingly says. Sometimes this is all accompanied with diarrhea. It is not ongoing as of now, no date provided. She noticed that it comes and goes and sometimes she can eat and she is fine and sometimes she gets really sick feeling. It seems like if she doesn't eat then she doesn't get the symptoms but she knows that she needs to eat. Investigations: Her doctor has been having her do platelet blood tests about every 5 days since she took the COVID vaccine. She does not remember the dates of these tests off of the top of her head. She had a blood draw at the clinic the day before her COVID vaccine and her platelet count was 49 on 08Mar2021. For the result of 29 that was either last Thursday or last Friday, 11Mar2021 or 12Mar2021. Te outcome of the event scleral discoloration was recovered on 13Mar2021, tiredness was recovered on 15Mar2021, headache was not recovered, pain in hip was recovering, other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021299104 similar report from same reporter
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| 67 | 2021-03-30 | throat irritation, headache, throat pain |
Sore throat; Headache; Something sharp going down her leg and it felt like it was in the area of the...
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Sore throat; Headache; Something sharp going down her leg and it felt like it was in the area of the vein; Abdominal pain; It is rawish and hard to swallow; Her throat felt scratchy when she laid down; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in upper right arm on 03Feb2021 12:35 (Batch/Lot Number: EN9581; Expiration Date: 31May2021) as SINGLE DOSE for covid-19 immunisation (reported as "her health. She has a heart condition and is scared to get COVID"). Medical history included heart condition (Verbatim: heart condition/caller states she doesn't know what her heart condition is), blood cholesterol abnormal, blood pressure abnormal. Concomitant medications included irbesartan (AVAPRO) taken for blood pressure abnormal (she has been on it for some time); evolocumab (REPATHA) taken for blood cholesterol abnormal (been on it a year. She gave herself a shot yesterday), two heart pills and a blood pressure pill. The patient previously got flu shot back in November. History of all previous immunization with the Pfizer vaccine considered as suspect was None. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Prior Vaccinations (within 4 weeks) was No. The patient experienced sore throat on 04Feb2021 with outcome of not recovered (reported as worsened), headache on 04Feb2021 with outcome of not recovered, something sharp going down her leg and it felt like it was in the area of the vein on 04Feb2021 with outcome of recovered, abdominal pain on 04Feb2021 with outcome of recovered, it is rawish and hard to swallow on 04Feb2021 with outcome of not recovered, her throat felt scratchy when she laid down on 04Feb2021 with outcome of not recovered. The patient underwent lab tests and procedures which included body height: 152.4 cm on an unspecified date, weight: 165 lbs on an unspecified date. The clinical course was reported as follows: She went and had the vaccine. She got a horrible sore throat. It is rawish and hard to swallow. She had a headache last night (04Feb2021). When she laid down last night it felt like something sharp going down her leg and it felt like it was in the area of the vein: it happened through the night off and on. It hasn't done it today (05Feb2021). She had abdominal pains really bad yesterday(04Feb2021). She didn't have a sore throat prior to the vaccine, so she is sure it is related. Her throat felt scratchy when she laid down. Today (05Feb2021) it has been raw. She has not wanted to eat, but she took her medicine. The headache was just dull at the time of reporting. She had only got the first dose. She only got a sheet with the side effects. 24Feb2021 was when she gets the second. No Emergency Room and Physician Office required. The sharpness down her leg was gone. Other than her throat and dullness in her head she was doing ok. Caller declined to be transferred to a facility. She states she was just going to gargle with warm salt water.
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| 67 | 2021-04-06 | headache |
Rash in her mouth/break out on her lips and her ear; Rash in her mouth/break out on her lips and her...
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Rash in her mouth/break out on her lips and her ear; Rash in her mouth/break out on her lips and her ear; Shingles; Pain; Ramsay-Hunt syndrome; Loss of hearing; Itchy on the left side of the face; Blisters on face, temple, ear; Left side of her face is scorched bright red and painful; Left side of her face is scorched bright red and painful; Numbness; no feeling in her mouth on the left, cheek, temple; Numbness; no feeling in her mouth on the left, cheek, temple; Blisters in her mouth; Pain, teeth started hurting went to her temple; Pain, teeth started hurting went to her temple; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 20Feb2021 (09:30) as a single dose, with route of administration unspecified, for COVID -19 immunization at the pharmacy/drug store (not a military facility). Medical history included shoulder surgery in Aug2020; ongoing abnormal blood pressure; ongoing heart disorder; and was in a pacemaker and defibrillator. Concomitant medications included carvedilol for abnormal blood pressure from 2012 and ongoing; losartan for heart disorder from 2012 and ongoing; and furosemide from 2017 and ongoing. On 05Mar2021, the patient had Ramsay-Hunt syndrome and loss of hearing. On 21Feb2021, the patient had pain/teeth started hurting and went to her temple. On 22Feb2021, the patient had blisters in the mouth; left side of the face was scorched bright red and painful; and numbness/no feeling in the mouth on the left, cheek and temple. On 23Feb2021, the patient had blisters on face, temple and ear. On 25Feb2021, the patient was itchy on the left side of the face. On an unspecified date, the patient had rash in her mouth/broke out on her lips and ear; shingles; and pain. The events, 'pain/teeth started hurting and went to her temple', 'blisters in the mouth', 'blisters on face, temple and ear' and 'pain', had resulted into physician's office visit. The patient's ENT had the patient put on treatment with valaciclovir (VALTREX) and prednisolone for the 'blisters in the mouth', 'blisters on face, temple and ear'; treatment for 'pain/teeth started hurting and went to her temple', 'left side of the face was scorched bright red and painful', 'itchy on the left side of the face', 'rash in her mouth/broke out on her lips and ear', 'shingles' and 'pain'; and unspecified ear drops for 'loss of hearing'. The outcome of the events was not recovered for 'Ramsay-Hunt syndrome', 'loss of hearing', 'pain/teeth started hurting and went to her temple', 'left side of the face was scorched bright red and painful', 'numbness/no feeling in the mouth on the left, cheek and temple' and 'itchy on the left side of the face'; was recovered on 04Mar2021 for 'blisters in the mouth' and 'blisters on face, temple and ear'; and was unknown for 'rash in her mouth/broke out on her lips and ear' and 'pain'. The patient had received the second dose of vaccination on 20Mar2021. Information about batch/lot number has been requested.
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| 67 | 2021-04-12 | fatigue, fever |
My MOTHER had a health condition, diabetes and heart problems, she was at home with palliative care,...
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My MOTHER had a health condition, diabetes and heart problems, she was at home with palliative care, due to her condition, she was fine in the last month she was able to walk, shower, eat alone, she felt happy to be able to recover, she got the vaccine because the doctor advised her, the same day she got fever, and began to feel fatigued, 3 days later my mother died, she had heart attack from shortness of breath.
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| 67 | 2021-04-12 | throat pain |
Glands in her throat swelled up; her throat was inflamed; Painful to swallow; Throat pain, sore; her...
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Glands in her throat swelled up; her throat was inflamed; Painful to swallow; Throat pain, sore; her neuropathy, since the vaccine, has acted up.; her neuropathy, since the vaccine, has acted up.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in upper left arm on 15Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation (did not want to get Covid). Medical history included hypertension (she has been on medications for it, and she doesn't know how long), Cancer (Cancer Survivor. for probably 8 years), ongoing Neuropathy (since she had chemotherapy 7.5 years ago), chemotherapy. Concomitant medication included telmisartan tablet at 80 mg once a day taken for hypertension (stated she has been taking it for a couple of years). The patient experienced her neuropathy, since the vaccine, has acted up on an unspecified date in 2021, glands in her throat swelled up on 20Mar2021, her throat was inflamed on an unspecified date 2021, painful to swallow on an unspecified date in 2021, throat pain, sore on an unspecified date in 2021. Caller stated she was the recipient of the Pfizer vaccine. Caller stated her first shot was 15Mar2021, and in 5 days, all of a sudden her glands in her throat swelled up, and asks, is that normal, Reclarified, caller stated the Pfizer vaccine, she was not sure but as she gets older, she shrinks. Caller stated that she was due to get her second shot next week and was a little leery. Glands in throat swelled up: Start: caller stated she did not know than stated 20Mar2021, she thought. Stated it was resolved, she did not feel it, it resolved 2-3 days later, maybe on the 23Mar2021. Caller stated it was weird, her throat was inflamed and it was painful to swallow. She did not know, it was hard to tell, it feels a little sore. Caller stated she did not know she has no idea. Throat inflamed caller did not the same day, maybe that Saturday, or the night before, she did not remember. She reports she did a lot of gargling with salt water and her throat was sore, what the heck. She stated she feels much better. Recovered. Caller stated she did not remember. In 2021, painful to swallow caller Stated probably the same day as the glands or the night before. She Stated no, it was not difficult to swallow anymore. She did not know the end date, it was better 3 days later. Throat pain and sore in 2021, caller stated no, it was all together around the same time. Caller stated she woke up with it. Caller stated the pain has gone, and she did not know the date, once it went away, she didn't think about it. She was not sure, if it was recovered, or recovered completely. Caller stated she has neuropathy because of chemotherapy, but reports that her neuropathy, since the vaccine, has acted up. Stated the vaccine must have been given between 1 and 1:30, she had the appointment at 12:45, but didn't get in after 1:00. Caller stated all she saw was N534, she thinks, it was an E or Z the way that they wrote it. Caller gave ZPN534, reclarifies, she stated she thinks they wrote it so sloppily.. She did not know if that was an E or ZPN534. I was having hard time reading it. It could be a E or it could be a Z, P, I think it was N 534. For events, her neuropathy, since the vaccine, outcome was not recovered, glands in her throat swelled up, outcome was recovered on an unspecified date in 2021, her throat was inflamed outcome was recovered on an unspecified date in 2021, painful to swallow, outcome was recovered with sequelae, throat pain, sore outcome was recovered on an unspecified date in 2021. Information on the lot/batch number has been requested.
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| 67 | 2021-04-13 | malaise |
Patient presented to ED with difficulty walking, falls, right sided chest pain, lower extremity edem...
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Patient presented to ED with difficulty walking, falls, right sided chest pain, lower extremity edema, generally felling unwell
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| 67 | 2021-04-16 | fever |
entered room drooling . right sided neglect BP elevated . not following command send to ER A...
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entered room drooling . right sided neglect BP elevated . not following command send to ER Admited to hospital with CVA PCP Note upon return - Patient is a 67-year-old female with past medical history of hypertension, MS, dementia, CHF, chronic kidney disease and hyperlipidemia who was sent from the facility to the emergency room for altered mental status and possible CVA. In the emergency room, blood pressure was elevated at 170/100 and she was noted with more pronounced weakness in left upper extremity and lower extremity and left gaze. Neurosurgery was consulted and deemed patient a poor candidate for TPA due to recent GI bleed. Stroke workup was negative for acute findings and a brain MRI ×2 was negative. EEG was ordered to rule out seizure and it was normal and neurologist recommended to start patient on Keppra. Patient was initially started on aspirin which was stopped due to drop in H&H. Patient was also noted with low-grade fever and infectious workup including blood cultures, UA and extensive imaging did not have evidence of infection and COVID-19 was negative. Social services spoke to patient's sister who is the POA regarding advanced directives and she requested to change advanced directives to DNR/DNI/no PEG and orders noted in chart. Patient's symptoms progressively improved and discharged back to the facility and resting in bed comfortably in no acute distress
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| 67 | 2021-04-17 | headache |
Hallucinations; Headache; sharp pain through arm come and go and arm sore; This is a spontaneous rep...
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Hallucinations; Headache; sharp pain through arm come and go and arm sore; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 04Mar2021 10:00 (Batch/Lot Number: EN6200; Expiration Date: Jun2021) as SINGLE DOSE for COVID-19 immunization at the doctor'ss office. Medical history included arthritis and was diabetic. Concomitant medications were not reported. It was reported that right after the first dose probably first, second, or third night in Mar2021 the patient had hallucinations. The patient also had headaches and sharp pain through arm/arm sore a couple of days after the first dose (probably started the next day or even the same day) which come and go. The patient recovered from the events in Mar2021 (a week or week in a half maybe two weeks before getting second dose). Follow-up attempts are completed. No further information is expected.
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| 67 | 2021-04-17 | headache |
Chronic obstructive pulmonary disease exacerbation; hypertension; vaccination complication; really s...
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Chronic obstructive pulmonary disease exacerbation; hypertension; vaccination complication; really sick; nausea; headache; The patient had decreased breaths from 12 to 10 breaths; This is a solicited report received from pharmacy. A contactable other healthcare professional and a consumer (patient) reported that a 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as a single dose for COVID-19 immunization; treprostinil sodium (TYVASO, concentration of 0.6 mg/ml), resp inhalation (reported as via inhalation (IH) route) from 23Sep2020 (batch/lot number: 2101929; expiration date: 31Jan2022) to an unspecified date, delivered by Tyvaso inhalation device (TD-300/A) at 18-54 ug, QID (3-9 breaths), then via an unspecified route of administration from an unspecified date (batch/lot number was not reported) to an unspecified date, at 72 ug to 60 ug (12 to 10 breaths) for secondary pulmonary arterial hypertension. Medical history included ongoing secondary pulmonary arterial hypertension and ongoing chronic obstructive pulmonary disease. Concomitant medication included tadalafil taken for an unspecified indication, start and stop date were not reported. On 25Mar2021, the patient experienced events of chronic obstructive pulmonary disease exacerbation (chronic obstructive pulmonary disease, hospitalized), hypertension (hypertension, hospitalized) and reaction to COVID vaccine (vaccination complication, hospitalized). On an unreported date, the patient experienced events of really sick (illness), nausea (nausea) and headache (headache). On an unreported date, the patient had decreased breaths from 12 to 10 breaths (off label use). It was also reported that the patient had decreased breaths from 72 ug to 60 ug (12 to 10 breaths). The patient was really sick, nausea and headache. On 25Mar2021, 6 months and 3 days after initiating IH Tyvaso, the patient was hospitalized for reaction to coronavirus disease (COVID) vaccine, chronic obstructive pulmonary disease exacerbation, and hypertension. The patient was discharged from the hospital on 28Mar2021. The action taken in response to the events chronic obstructive pulmonary disease, hypertension and vaccination complication for treprostinil sodium was not reported, and dose was decreased due to the events illness, nausea and headache. At the time of reporting, the outcome of chronic obstructive pulmonary disease, hypertension, vaccination complication, illness, nausea and headache was unknown. The reporter did not provide causality for the events of chronic obstructive pulmonary disease, hypertension, and vaccination complication. The reporter's causality for the events illness, nausea and headache with IH treprostinil sodium was considered to be possibly related. Case Comment/Sender's Comment: The company has assessed the serious adverse event of chronic obstructive pulmonary disease, hypertension and vaccination complication as not related to IH treprostinil and TD-300/A device. Chronic obstructive pulmonary disease and hypertension were likely due to exacerbation of underlying COPD and Hypertension respectively. Vaccination complication was due to COVID vaccine. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is based on the company causality assessment. Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event chronic obstructive pulmonary disease, hypertension, vaccination complication, illness, headache, nausea and the suspect drug BNT162B2 , TYVASO cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-04-17 | headache |
bradycardia; fainting; Head and neck ache; Head and neck ache; first dose received on 09Mar2021; sec...
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bradycardia; fainting; Head and neck ache; Head and neck ache; first dose received on 09Mar2021; second dose received on 15Mar2021; first dose received on 09Mar2021; second dose received on 15Mar2021; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the right arm, on 15Mar2021 15:00, as single dose, for COVID-19 immunisation. Medical history included psoriasis, high blood pressure, scoliosis and low thyroid. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); sertraline; sertraline hydrochloride (ZOLOFT); and levothyroxine sodium (LEVOTHYROXINE), all taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported) received at age 67 years, via an unspecified route of administration in the right arm, on 09Mar2021 14:45, for COVID-19 immunisation. On 15Mar2021, the patient experienced bradycardia, was fainting, and had head and neck ache. One week after the second vaccine, in Mar2021, the patient was taken to the hospital due to the events. Treatment for the events included "had to have a pacemaker put in". The patient reported that she never had heart problems before, and she was curious if these could have ben side effects from the vaccine. The events resulted to physician office and emergency room visits, and hospitalization. The duration of the hospitalization was reported as 4 days. The events were reported as life-threatening illnesses. The patient was recovering from the events. Information about Batch/Lot number has been requested.
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| 67 | 2021-04-17 | sweating, chills, influenza like illness, headache |
Blurred vision; Headaches; Chills; Itching rash on arms, back, neck and chest; Fainted at home, fell...
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Blurred vision; Headaches; Chills; Itching rash on arms, back, neck and chest; Fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black; Fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black; busted her lip and it was bleeding real bad; Weakness/ feeling weak; Feel weak in her arms and legs; Sweating profusely; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Foggy Brain; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) intramuscularly, administered in the left arm on 11Mar2021 (batch/lot number: EN6205) at 67 years old as a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Pharmacy/ drugstore. The patient's medical history included compromised immune status; respiratory illness, genetic /chromosomal abnormalities; endocrine abnormalities (including diabetes) and obesity; asthma diagnosed since childhood; diagnosed allergies, allergies (seasonal and food); food allergies included gluten, dairy, artificial sweeteners including Sorbitol and Xylitol, broccoli, cauliflower, cabbage, brussel sprouts, asparagus, all "percifirous"/ cruciferous vegetables; she also has allergies to cats, pollen, trees, grass, ragweed, mold, mildew, and dust; and allergies to Codeine, Penicillin, Sulfa, Iodine, Epinephrine, Morphine, and Clindamycin (patient does not have a manufacturer, lot or expiration to any of these medications). The patient had no family medical history. Concomitant medications included unspecified prescription medications for years which she did not feel they were relevant. On 11Mar2021, the patient experienced "weakness/ feeling weak" (weakness), "feel weak in her arms and legs" (weakness of limbs), "fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black" (faint), "fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black" (fall), "busted her lip and it was bleeding real bad" (bleeding lips), sweating profusely (excess sweating), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (Flu-like symptoms), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (Joint pain), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (muscle pain), and foggy brain (foggy feeling in head). On 12Mar2021, the patient experienced headaches, chills, itching rash on arms, back, neck and chest (itchy rash). On13Mar2021, the patient experienced blurred vision. It was reported that after the first shot, on 11Mar2021, patient experienced weakness, then she got home and she fainted, fell, and busted her lip and it was bleeding real bad. Then she began sweating profusely. She started feeling weak 30 minutes after getting the shot. Someone took her there because she would not have been able to drive. They brought her home and she was in the kitchen. While over the sink, she started to feel weak in her arms and legs. Before she could tell her husband that she was feeling weak, she dropped to the floor and everything was turning black. She fell face first and busted her lip and it was bleeding real bad. The weakness gradually started getting a little better on 30Mar2021. She is having to walk with a cane now because of the weakness. She was not using a cane before. Two days later on 13Mar2021, she was in the kitchen again and she felt that feeling coming and her husband was able to grab her and sit her down and she did not faint but she could tell it was coming. Patient also reported that from 12Mar2021, she is getting headaches every day off and on and in different spots of the head. Sometimes it is in the forehead, top, side and back. For about a good week, she had chills and it tapered off after the first dose. Also, on 12Mar2021, she experienced itching rash on arms, back, neck and chest. They were fine bumps and they just itch. The patient was recovering from the events faint, fall, bleeding lips, excess sweating, and itchy rash; and has not recovered from the events weakness, weakness of limbs, flu-like symptoms, joint pain, muscle pain, foggy feeling in head, headache, chills, and blurred vision. Follow-up attempts are completed. No further information is expected.
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| 67 | 2021-04-19 | fever |
Pt presented with abd pain, dark stool, altered mental status, febrile, hypotensive, septic, cardiog...
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Pt presented with abd pain, dark stool, altered mental status, febrile, hypotensive, septic, cardiogenic shock, progressed to multi organ dysfunction.
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| 67 | 2021-04-20 | headache, fatigue |
Severe headache on night of shot and every day since Tiredness daily causing sleep of up.to 20 ...
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Severe headache on night of shot and every day since Tiredness daily causing sleep of up.to 20 hours per day
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| 67 | 2021-04-24 | sweating, fever, headache, fatigue, chills |
Shaky; Muscles and nerves seemed to be locking up like almost paralyzed; swollen lymph nodes; inject...
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Shaky; Muscles and nerves seemed to be locking up like almost paralyzed; swollen lymph nodes; injection site redness; severe allergic reactions; slight dizziness; severe headache; nausea; weak; tired; feverish; sweat; had pain at the Pfizer Covid 19 Vaccine injection site; right arm started to swell; chills; extreme muscle pain; certainly extreme and joint pain; Heart beat seemed to speed up; Has not been able to walk or move body in normal fashion; This is a spontaneous report from a contactable consumer (patient herself) A 67-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EP7533) a week ago via an unspecified route of administration on 02Apr2021 at 13:45 hrs on the right upper arm as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.When caller was 18 they required a booster for Small pox and caller received the small pox booster on the leg in the same site where it was given at age 5. Caller's leg swelled up to 5 times the normal size, at the time caller was 18 years old.Took a long time for swelling to go away, a couple weeks. Caller requires it hindered sports activities during this time. On 02Apr2021, the patient started reported slight dizziness, severe headache, Shakiness, nausea, weakness, tiredness, have been feverish, pain at the injection site and stated that her right arm started to swell. The patient stated that through out the night of 02Apr2021, she had extreme muscle pain, certainly extreme and joint pain that was also extreme and heart beat seemed to speed up within the first hour and by the end of the hour. On 03Apr2021, the patient stated that her muscles and nerves seemed to be locking up like almost paralyzed. The patient described the events she experienced slight dizziness and didn't worry because it wasn't major and caller was driving herself and with in an hour the dizziness got worse. Caller had severe headache and had to drive home a significant distance and the time the caller got home, she reports being shaky, dizzy, had headache, nausea, was weak and tired and must have been feverish. Caller reports she must have been feverish because she was drenched in sweat by the time she got home and it was a 2 hour drive home from the vaccine administering facility. Caller had pain at the Pfizer Covid 19 Vaccine injection site, and caller's right arm started to swell.Caller clarified that the injection site was in the right upper arm, doesn't know what the muscle is called. Caller says she couldn't see if her arm was getting red, caller has some discs out in her neck and is unable to look at the arm. Caller could feel the injection site on her right arm was swollen and swelling. Caller reports fever was gone and fever got replaced with chills later on. Caller reports there was progression of the symptoms after the first hour. Caller states the information provided thus far was the first hour of her experience and through the night a lot of other things changed and added.Through the night caller had extreme muscle pain, certainly extreme and joint pain that was also extreme. Muscles and nerves seemed to be locking up like almost paralyzed: By the next morning, after caller had the Pfizer Covid 19 Vaccination, states she was not a doctor but all of her muscles and nerves seemed to be locking up like caller was almost paralyzed. Caller reports she couldn't move, couldn't get out of bed. It took a long time to get caller's fingers and toes moving and the rest of the body, but fingers and toes were the first ones. Caller was able to kind of release from muscle cramping. Whatever was going on, caller says can't tell exactly what was going on, does not have a Doctor in the home. States the information given should cover that part of the experience. Through the night had extreme muscle pain, certainly extreme and joint pain that was also extreme: Reports since the morning after receiving the Pfizer Covid 19 Vaccine, caller has had continued muscle pain, although not as extreme, its pretty extreme, and join pain. The patient has not been able to walk or move body in normal fashion. The patient stated that she had every side effect listed on the fact sheet at the top minus the swollen lymph nodes and injection site redness and she had two of the side effects listed under the severe allergic reactions. The patient wanted to know whether it is safe to receive the second dose of the vaccine. The patient lives in an isolated area where all through COVID-19 she tried to get information from the local medical clinics and they did not seem to stay informed. Caller states she has a doctor's appointment, and she will let them know the side effects she experienced after the first dose but she is not confident in the recommendations they might provide. Patient was given a list of side effects to look for, ones they were assuming, doesn't know if the hand out was published by Pfizer or not.The hand out listed emergency kind of side effects people were experiencing.Caller reports they are over age 65 range and knew a lot of people before her who had the Pfizer Covid 19 Vaccine and said they only had injection site soreness. Caller was expecting the same reaction, caller was told by the Doctor she was in pretty good shape. Caller reports she had most all of the reactions except anaphylactic reaction of not breathing after receiving first dose Pfizer Covid 19 Vaccine. Caller is nervous about going for the second round of the Pfizer Covid Vaccine, is not sure how to proceed and would like that information. The case was assessed as serious medically significant for the event paralysis. It was reported that patient took Aspirin as treatment medication for pain. The outcome of the events was resolved for fever and nausea, resolving for swelling arm, unknown for swollen lymph nodes, Chills , Vaccination site pain, injection site redness, severe allergic reactions, sweat, shaky feelings, heartbeat increased, movement disorder and not resolved for all other events.
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| 67 | 2021-04-24 | fever, fatigue, malaise |
kidney was not functioning properly; GFR was 41 (stage 3)/ low GFR; Stage 3B Kidney disease; 100.2°...
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kidney was not functioning properly; GFR was 41 (stage 3)/ low GFR; Stage 3B Kidney disease; 100.2°F fever; whole body was aching; tired; right kidney started aching and then the left kidney; leucocytes in her urine; high creatinine; bladder symptoms; oil bubbles in my pee/bubbles in her pee; I don't at all feel well; I have got lots of fluid in my body around my middle; put on about 5 or 6 pounds; cystitis; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot no. PEL9261, via an unspecified route of administration on 05Feb2021 as single dose for prevention of COVID 19 virus. No relevant medical history and no concomitant medications. The patient previously took the first dose BNT162B2 for COVID-19 immunisation (lot no. batch/lot number: EL1284). The patient received the first dose of the BNT162B2 on 15Jan2021. She had a reaction to the vaccine, had a mild reaction with first one she felt like if her heart warmed up and a burning sensation in her left side of the neck and face. She received the injection on her left side. She was kept for half an hour and then she had a mild headache and slept. She also had fever, pain at the injection site and felt very tired. She received the second dose of the vaccine 5 weeks ago. Several days after second dose on Saturday mornings, started having 100.2°F fever for two days and her whole body was aching. When the fever disappeared, she was very tired that week. Her right kidney started aching and then the left kidney, there were also bubbles in her pee and it went worse (no blood in the pee). A few weeks ago, she went to the urgent care, because a week before there were leucocytes in her urine and she took antibiotic. On Monday, she saw the urologist and the urologist sent her a CT scan and a blood test. The blood test results were abnormal so she didn't have a CT scan done because it could be dangerous. Her creatinine was high and her GFR was 41 (stage 3), she didn't know her kidney disease stage until they have the results (Monday). She was very healthy, didn't take drugs and there's no history of kidney disease in her family, also she exercised every day. She would like to know if something similar has been reported with the Pfizer-BioNtech Covid-19 vaccine because she's trying to understand these symptoms that came from nowhere. She knew the Covid-19 could cause kidney problems. She would like to know if there's any live virus in the Pfizer-BioNtech Covid-19 vaccine. She was normally completely fit and healthy. She did not have any abnormality whatsoever and no big medical history. She had the 2nd Pfizer job about 4-5 weeks ago and in the last 3 or 4 weeks at least, she has been having aching kidney, kind of oily bubbles in her urine and she went to see a doctor, a specialist to send her for some test. Today, she discovered that she got a high creatinine and low GFR so that meant have got at the moment, the picture was stage 3B Kidney disease. She had no family history of that. She never had any problems before. She just wondered whether there was any other case report like vaccine should be toxic to her kidneys. This was so out of the loose. Just so uncharacteristic. She stated that probably more than that, she thinks it started because she did not realize at first, it just made her feel tired, her kidney was aching because she was working too hard. It has developed over, it was hard to say. She had the second shot and she had fever for two days. She was so tired anyways. So, she was not exactly sure whether it began exactly when she had it but she certainly did not have it before or whether it came on a few days after or a week after, she was not sure but she knew that it has got worse and now, she was in a situation where she had a CT scan today (19Mar2021). So, she went to the doctor probably on Monday or Tuesday to find out exactly what was going on but she had absolutely no history of anything like this. She had no family history. She was completely healthy. She normally exercised, aerobic exercise most days. She was a healthcare professional (nutritionist). This had come as a complete shock to her today. She was phoning because she wanted to know if there were any other case reports. She knew it was very early and there was not much research on the vaccine but she did not know whether anybody else had reported having kidney problem. She knew you can get kidney problem with the actual disease, with the virus rather but she did not know if the vaccine could cause that. She knew it had something to do with the vaccine and obviously, it may be temporary and she can deal with it. She just needed tab a little bit insight of what to do next. She was not on her normal weight because she has put on about 5 or 6 pounds in the last few weeks. So, she thinks she had got so much fluid. She was normally 5 foot 5 (inches) and her weight was normally about 130 pounds. Actually, it was less than that so it was 127 or 128 pounds but at the moment she was 134. She had got lots of fluid in her body around her middle. When she had the second shot, she had the fever for two days on the Saturday and Sunday and got really tired on Monday and Tuesday and she went there and felt a little bit better but she cannot remember when her kidney started aching. She did not know if it was immediately or whether it was the next week. It started gradually and it had got worse in the last couple of weeks. So, the ache had got so much worse and the amount of bubbles in her pee and urinary symptoms had got worse in the last, at least probably 2 to 3 weeks or so. She had nothing at all before the second vaccination. She would say that it was shortly after she carried on feeling tired and then her kidney started aching and then she developed urinary symptoms. So, that was within a week to 2 weeks of having the shot. She definitely noticed that she had the symptoms and it may have been sooner. She was not entirely sure. It may have been the same week. She honestly cannot remember because it began gradually and she started to feel like she was getting cystitis and she did not think anything over it and then it got progressively, her kidney started hurting and she got really tired and then she just started having oily bubbles in my pee. When probed for the LOT# of vaccine, the first one looked like as EL1284, and the second one, it looked like PEL9261. It could be 4916. She had got the card but she did not know exactly. It was terrible writing. She was not sure it was hard to read. The first one was in her left shoulder and the second one was in her right shoulder. She felt it was related. It has taken incident from when she had the vaccine. Well, she was obviously not a 100 percent sure that was why she was phoning to ask if there is any other similar case report. When probed for the treatment, she stated no, not yet. She only found out today that what happened was she went to see a neurologist this week and on Monday and they organized her to have a CT scan today and some blood work and when she got to the CT scan center today and they looked at the blood work and they said that her levels were too abnormal to have the CT scan with the contrast dye. It would be dangerous. So, that was when she found out it was an abnormal result. So, it just happened today. So, she had not even seen the results of the scan yet and had not seen the doctor but she just knew that her blood was abnormal and her kidney was not functioning properly and trying to find out whether it was related to the vaccine because she needed to find out how to manage it going forward. She was hoping if it was due to the vaccine she can, it has been toxic stroke to her kidney and then she can workout how to deal with it hopefully reverse the situation but she had no Idea but she was just trying to get the feeling for what this could be. She did not have the results of the CT scan yet. She only got the results of the blood which said her kidney, when she went to have the scan her doctor asked her to have the scan and then to have a second scan to what they call a contrast dye and the technician said that when he looked at her blood results he said she cannot give her the contrast dye it was too dangerous. She needed to phone the doctor and so he phoned the doctor and the doctor said just do the scan without the contrast dye and they told her what the blood results were. So, she looked online and she can see that it was Stage 3B Kidney disease and she was in the stage of shock and she was feeling before she went to have this test that this was related to the vaccine because it has come since she has had the vaccine, so close to her having it so now she was more convinced and she just wanted to see anybody else has had this. Obviously, the doctor would not know about this because this was so new and so she needed to workout on how to deal with what has happened to her. Her creatinine was 2 and GFR was 41. With second one she had the fever for few days and she felt very tired, and then she developed some bladder symptoms, and she thought maybe she just had something like cystitis, and then she was very tired, her kidney started aching and particularly on the right hand side but on the left as well, it's got worse and worse to point that she got oil bubbles in her pee and she went to see neurologist on Monday, she had the blood test and today she got scan, a CT scan and she meant to have a consult after the scan with the scan but when they saw the blood result, which she has not seen, they said that was so abnormal they could not get her the contrast dye, so they said because of the result, she suddenly got out of nowhere and stage 3B kidney disease, and she had not gotten the result of the scan yet but she has sent in on stay, but she didn't at all feel well, haven't felt well since she had the vaccine she personally felt it had something to do with the vaccine because she did not have any family history of kidney disease or anything related to that and she never had an issue, never even had kidney infection so, she phoned up today to off Pfizer whether there have been any other case reports, because she had to go back and see her Urologist now and he won't know because it's obviously such early days with the vaccine and there not any proper Clinical Trials to, she would think to reflect this. She was concerned about the side effects and she just wanted to know because now, she knew had to deal with it, and she was, obviously that came as big shock to her that she just wanted to, if there have been any, she knew that the Covid virus can cause kidney disease, but I didn't know whether the vaccine has been showing to do that in any other individual. Results of tests and procedures for investigation of the patient on 15Mar2021: blood test, result: creatinine 2 and GFR 41. The outcome of fever and tired was recovering, while outcome of other events was unknown. Information on the lot/batch number has been requested.
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| 67 | 2021-04-24 | fever, sweating, headache, chills, sinusitis, sinus headache |
cramps; her stiff neck; She couldn't move her neck, it was very painful; She was breaking out in swe...
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cramps; her stiff neck; She couldn't move her neck, it was very painful; She was breaking out in sweats; She is still cold/She is freezing cold; She is loosing her hair. clumps of hair falling out.; sinus headache; had issues with her thyroid; sinusitis like when she had COVID; palpitation; nausea; feeling achy like you have a flu/ aches and pain; fever; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of BNT162B2, via an unspecified route of administration, administered in arm left on 26Mar2021 15:00 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included atrial fibrillation on an unknown date. Caller added she takes medication for Atrial Fibrillation. She had Covid at the end of Dec2020. She was sick and out of work for 6 weeks. She had a headache since she was diagnosed with Covid. Caller had a funny sensation in her sinuses after the injection. It was a weird feeling, just like when she had Covid. She had breathing issues with her Covid diagnosis. Her headache, cough, and breathing issues kept her out of work for 6 weeks. She had a lot of allergies. The patient's concomitant medications were not reported. The patient experienced headache on 26Mar2021 with outcome of recovered with sequelae on 27Mar2021, achy, chills, fever, nausea on 27Mar2021 with outcome of recovered with sequelae on 29Mar2021, palpitation, sinusitis like when she had covid, cramps, stiff neck, couldn't move her neck, it was very painful, she was breaking out in sweats, still cold/ freezing cold, loosing her hair/ clumps of hair falling out, sinus headache and had issues with her thyroid on an unspecified date with outcome of unknown. The clinical course reported as follows: Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 26Mar2021 and scheduled to get the 2nd dose on 16Apr2021. Patient experienced headache, sinusitis like when she had COVID, nausea, feeling achy like you have a flu, fever chills, cramps ,aches and pain, palpitation. Patient had tested positive for COVID last 28Dec2020 that lasted for 6 weeks. Asking if 2nd dose will be more intense when it comes to reactions and if she can safely have the 2nd dose. She will see her cardiologist due to chest palpitations. She worked and had her first Pfizer Covid-19 vaccine 26Mar2021. She had Covid at the end of Dec2020. She was sick and out of work for 6 weeks. She had a headache on Friday immediately after her injection. Then was okay. On Saturday morning after waking up, she felt achy, nauseous, had a fever, chills, and a headache. On Sunday she was not feeling great. Even into Monday, she had fever and chills and felt the same as when she had Covid. Caller added she is not supposed to get sick. Caller states weighs 160 pounds, which she shouldn't be. After the shot she felt a sinus headache. Funny sensation in her sinus's just like it was when she had COVID. Once she had the shot, the original headache went away along with her stiff neck. She couldn't move her neck, it was very painful, it still happens. And she had breathing issues with her Covid diagnosis. Her headache, cough, and breathing issues kept her out of work for 6 weeks. Caller had lasting effects from Covid, but didn't know if these symptoms were related to the shot. She was breaking out in sweats. She was still cold. There was something going on. She was having her Vitamin D level and thyroid checked. She was loosing her hair, clumps of hair falling out. She had issues with her thyroid. Caller wondering if the vaccine was the cause. She was freezing cold. She hadheart palpitations and was seeing her Cardiologist next Thursday. Caller received the vaccine because she had Covid and didn't want to get it again. She was pretty sick. She worked around people and didn't want to be in a situation because not everyone wants to get the vaccination. Treatment of events included: She had not been to the doctor for this, she just jumped into bed and took Tylenol. The events didn't require a visit to emergency room or physician office. No follow-up attempts are needed. No further information is expected.
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| 67 | 2021-04-24 | fever, sleepiness, headache, fatigue |
sleeping for 3 days; weak; really thirsty; tired; Fever; real achy; terrible headache; left arm hot,...
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sleeping for 3 days; weak; really thirsty; tired; Fever; real achy; terrible headache; left arm hot, red, and swollen at injection site; left arm hot, red, and swollen at injection site; left arm hot, red, and swollen at injection site; This is a spontaneous report from a contactable Nurse (patient). A 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 09:00 (Batch/Lot Number: ER8734) as SINGLE DOSE (at the age of 67 years) for covid-19 immunisation. The patient had the first dose of BNT162B2 for COVID-19 immunisation in the left arm lot number EP7534 and the patient experienced peripheral swelling in left leg and blood clot. Medical history included ongoing thalassaemia beta Caller stated she was diagnosed with this in her later 20s or early 30s. The patient's concomitant medications were not reported. The patient experienced fever (disability) on 06Apr2021 20:00 with outcome of recovered, real achy (disability) on 06Apr2021 with outcome of recovered, terrible headache (disability) on 06Apr2021 with outcome of recovered, weak (disability) on 07Apr2021 with outcome of recovering, really thirsty (medically significant) on 07Apr2021 with outcome of recovered, tired (disability) on 07Apr2021 with outcome of recovered, sleeping for 3 days on an unspecified date with outcome of unknown, left arm hot, red, and swollen at injection site on 06Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included body temperature: 102, body temperature: 101.9, body temperature: 106, body temperature: 101.6. Therapeutic measures were taken as a result of fever, real achy, terrible headache, weak. Treatment: Advil. The patient is not in a study or programme. No Additional vaccines administered within last 4 weeks. Events were considered related for real achy, terrible headache, weak, really thirsty, tired, and left arm hot, red, and swollen at injection site. Follow-up attempts completed: case closed.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for fever and other reported events. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 67 | 2021-04-24 | sinusitis, fatigue |
face swelled up, numbness and red on left side; face swelled up, numbness and red on left side; sinu...
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face swelled up, numbness and red on left side; face swelled up, numbness and red on left side; sinus infection; Shortness Of Breath; pounding in my chest/throbbing in her chest; ringing in ears; flared up some digestive issues / digestive disturbances; flared up some digestive issues / digestive disturbances; red on left side/face redness; exhausted all the time; This is spontaneous report received from contactable female consumer (patient) reported herself. A 67 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199) on 10Mar2021 17:30 at age of 67 years old at single dose in right upper arm for COVID-19 immunisation. Medical history included: last year February, she was really sick with bad sinus infection not knowing about COVID at the time. Sometime later she got these horrible digestive attacks, ended up in her stomach and esophagus, horrible attacks where she couldn't breath, she has had acid reflux in the past. digestive problems stayed with her a really long time, they did and endoscopy and put her on amitriptyline 10mg daily, continuing to take this medication for hypersensitivity. She tested in April last year, it was negative (not detectable). There was no history of all previous immunization with the Pfizer vaccine considered as suspect. Concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). No adverse events (AE) following prior vaccinations. Patient had first Pfizer covid vaccine on 10MAR2021, approximately 10 days to 14 days after the vaccine her face swelled up, numbness and red on left side, went to see my doctor, he treated her with steroid and antibiotic for sinus infection, at the same time she had some shortness of breath and pounding in my chest, and had and still have ringing in ears since then, it kind of flared up some digestive issues she had last year. If she back up to last year February, she had a bad sinus infection, went to see allergist, family doctor and ENT, all treated her for sinus' before covid testing was even a thing, they didn't think of covid testing at the time. It ended up in her stomach and esophagus, horrible attacks where she couldn't breath, they did and endoscopy and put her on amitriptyline 10mg daily, continuing to take this medication for hypersensitivity. In March2020 her husband came home with covid, after that, talking to his doctor, she brought him meals outside of the door, it occurred to her that queried if this could have been covid. She tested in April last year, it was negative (not detectable), they were still not sure if it could have been covid. She was supposed to get the second vaccine, she postponed it, the numbness and swelling of face is gone, next shot was tomorrow. Since this was a delayed reaction, typically one to three days would be a reaction to the vaccine. she didn't associate it with the vaccine, asked if it could have been from the vaccine. She wanted to make sure that she was safe to get the second one. Response: Spoke from EUA factsheet for Recipients and Caregivers: LAB-1451-4.0 Revised: 06 April 2021: Sections: who should not get the PFIZER-BIONTECH COVID-19 VACCINE and what the risks of the PFIZER-BIONTECH COVID-19 VACCINE were. Spoke from attached VR Consumer- Pfizer cannot assess causality (i.e., cannot assess if what you described/are experiencing is associated with the Pfizer BioNTech Covid 19 vaccine). Your doctor/healthcare provider is in the best position to assess and advise you as your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case. Patient calling about the COVID vaccine. She states that she had the first vaccine 10MAR2021, and 10 days afterwards her face swelled up. She had numbness in it and redness. She went to the doctor and the doctor thought that maybe it was a sinus infection. So she was treated for that. She states that she did have a few other symptoms. To make a long story short, she was suppose to have the last vaccine last Friday. She postponed it for a week (postponed getting the second shot for a week). She wants to know what Pfizer thinks about her getting her second vaccine and her side effects. She says that somewhere between the 10th and 14th day, after receiving the vaccine the symptoms started and that was why she did not think she had a reaction to the vaccine. She has not had anything like that before, it was sort of a delayed reaction. She states she is better now. She had a few symptoms after the face things started and the only thing that she still has now is ringing in her ears. She states it all started around the same time as her face issues, or might have started a little after that. She confirms everything but ringing in her ears have completely resolved. She states that she did have some digestive disturbances, shortness of breath, and throbbing in her chest after receiving the vaccine. She asks if she can go back a little bit to explain. She states that last FEB2020 she was really sick with bad sinus infection not knowing about COVID at the time. She went to her allergist, then her family doctor, and then an ENT. She states that it was nothing like she has ever had, it was really bad. Sometime later she got these horrible digestive attacks, she has had acid reflux in the past but it was nothing like this. In March her husband had COVID and tested positive for COVID. She decided to get tested and she tested negative. She wonders if she had COVID earlier but at that time they were not testing for COVID. Her digestive problems stayed with her a really long time, and she was still on the medications her gastrointestinal doctor put her on. They are hypersensitive esophageal medication. She states that she has been exhausted all the time. The rest of the story she has told already. She states that after the face thing happened she started getting those digestive issues again. Her friend suggested that she call Pfizer, so she is doing that. She confirms that the vaccine card does not have an expiration date, NDC, or dosing information. She states it says 0.3 ml, but she cant see a point, so she doesn't know if its just 03. She states she got the vaccine to lessen her chances of getting a severe disease, in case she ends up in the hospital. Also, to keep herself safe from other people. She states she wants the second one because husbands works with the public and she wants to be protected when he comes home. She states that she has those gastrointestinal disturbances and is on amitriptyline 10 mgs for that. She states she also takes something for her thyroid but she has no major health issues. She states that she had a endoscopy and a colonoscopy as well as blood work done but she doesn't have any of the results because they are in her Beaumont chart where she actually got the vaccine. All of this was pre-vaccine so she doesn't know how relevant it is. The patient did not require a visit to Emergency Room, but visit to Physician Office. The only thing similar had a sister who reacted to a shingles vaccine, She has no information about her sisters reaction to the vaccine. Outcome of event ringing in ears was not recovered, for others was recovered. No follow-up attempts are needed. No further information is expected.
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| 67 | 2021-04-26 | chills | Diarrhea, joint aches, chills |
| 67 | 2021-04-26 | malaise, chills, headache, sleepiness |
hot and cold; very ill; felt horrible; Clammy; feeling odd, kind of wonky, woozy; Diarrhea; Fall; pr...
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hot and cold; very ill; felt horrible; Clammy; feeling odd, kind of wonky, woozy; Diarrhea; Fall; pretty badly bruised / bruise has gone above her knee to her ankle; Weak and could not get out of bed; Sleeping a lot; Dizziness; Headache; Chills; Vomiting; Queasy; This is a spontaneous report from a contactable consumer reporting for herself. A 67-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 16Mar2021 11:05 (Batch/Lot Number: EP7534; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation . Medical history included hypersensitivity , immune system disorder , respiratory disorder , cytogenetic abnormality , endocrine disorder Endocrine abnormalities , diabetes mellitus , obesity , anxiety, hypersensitivity. Concomitant medication(s) included alprazolam (XANAX) at 5 mg daily, taken for anxiety, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) at 60 mg daily taken for anxiety, start and stop date were not reported. The patient experienced fall on 05Apr2021 with outcome of recovered with sequelae , pretty badly bruised / bruise has gone above her knee to her ankle on 05Apr2021 with outcome of unknown , headache on 16Mar2021 with outcome of recovering , chills on 16Mar2021 with outcome of not recovered , vomiting on 16Mar2021 with outcome of recovering , queasy on 16Mar2021 with outcome of not recovered , diarrhea on an unspecified date with outcome of recovering , weak and could not get out of bed on 17Mar2021 with outcome of recovering , dizziness on 16Mar2021 with outcome of not recovered , sleeping a lot on 17Mar2021 with outcome of not recovered , hot and cold on an unspecified date with outcome of unknown , very ill on an unspecified date with outcome of unknown , felt horrible on an unspecified date with outcome of unknown , clammy on an unspecified date with outcome of unknown , feeling odd, kind of wonky, woozy on an unspecified date with outcome of unknown. The events fall and contusion were considered Important Medical Events. The remaining events were non serious. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-04-27 | fatigue |
She was 'bouncing off the walls'.; unsteadiness; Nausea; extreme dizziness; fatigue/bad enough that ...
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She was 'bouncing off the walls'.; unsteadiness; Nausea; extreme dizziness; fatigue/bad enough that for 3 days she couldn't work; This is spontaneous report received from Pfizer Sponsored Program Support from a contactable consumer (patient). This 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in upper left arm on 15Mar2021 09:30 (Lot Number: EN6207) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were none. The patient experienced nausea on 15Mar2021 18:00, extreme dizziness on 15Mar2021 18:00, fatigue/bad enough that for 3 days she couldn't work on 15Mar2021 18:00, she was 'bouncing off the walls' on an unspecified date, unsteadiness on an unspecified date. She went on 15Mar2021 to get her first shot and then she was went for her second vaccine this past Saturday. Patient stated they denied giving her the 2nd dose of the covid vaccine after hearing about her side effects form the 1st one. She would like to know whether she needs to get the 2nd dose. She had pretty bad reactions to the first shot. She got the shot around 09:30 in the morning and by 6 pm she felt the reactions. Patient reported the following side effects form the 1st dose of the covid vaccine: nausea, extreme dizziness and fatigue, bad enough that for 3 days she couldn't work. She was 'bouncing off the walls', unsteadiness and spent the next three days in bed due to fatigue. There was no event require a visit to emergency room and physician office. There was no prior vaccination (within 4 weeks) and no adverse event following prior vaccinations. The outcome of event nausea was recovered on 16Mar2021, extreme dizziness and fatigue/bad enough that for 3 days she couldn't work was recovered on 18Mar2021, She was 'bouncing off the walls' was recovered on an unspecified date, unsteadiness was unknown. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-04-27 | pneumonia |
multiple er/admissions from february through april 27. pt deceased on 4/27/21 2/25/21 known past m...
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multiple er/admissions from february through april 27. pt deceased on 4/27/21 2/25/21 known past medical history of hypertension and hypothyroidism. Status-post spinal decompression due to stenosis. The patient then developed worsening issues with a surgical site infection. Patient has had numerous bouts of C diff. Staff notes patient is to have GI consult in the near future. Patient is seen today in her room. Patient was once again diagnosed with C diff and is currently being treated with antibiotics. Patient notes no bowel movements today. Patient has not had any issues with intake recently. The patient's weight has declined partially due to likely diarrhea. Patient's blood pressure continues to be monitored closely as it has been on the lower side of normal. Patient's potassium 2.9 on CMP. Patient's other care and therapies were reviewed. 2/28/21 Patient was admitted the hospital after found to be anemic at skilled care facility where she is being treated for C diff infection recurrent Lea. Patient was transfused. Patient was also found to have pneumonia/lung mass. Patient has struggled with electrolyte dysfunction. Patient had to be transfused a second time. Patient did well with second transfusion. Patient was found to be hypokalemic. Patient did well with potassium replacement. The patient was advised will have to do outpatient PET scan. Patient was found to have positive blood cultures as well 4/26/21 68 y.o. female who presents from nursing home with complaints of elevated white blood cell count. According to nursing home records patient had CBC checked on Saturday 04/24/2021 and her WBC count was found to be 50,000. At that point in time no other orders were given and patient was not sent in for evaluation. CBC was repeated this morning and WBC count found to be in the 70,000s. Patient was sent in for evaluation this morning. In talking with the patient, she denies any runny nose, sinus drainage or cough. Patient does report shortness of breath. Patient denies any chest pain or palpitations. Patient denies any dysuria, hematuria, fevers, or chills. Patient denies any nausea or vomiting. Patient does report diffuse pain across the lower abdomen. She does report chronic diarrhea. Patient had C diff stool checked on 04/13/2021 and was negative. (4/26 cdiff positive) Of note patient does have known lung mass that was seen on chest x-ray and PET scan. Patient reports that she does not want anything done and understands it could be cancer. And continuing to question patient, she reports she wants to be a DNR and does not want any aggressive measures.
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| 67 | 2021-04-28 | headache |
slight ache in left arm; headaches; surgery is hopefully a mitral valve repair; This is a spontaneou...
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slight ache in left arm; headaches; surgery is hopefully a mitral valve repair; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6203) intramuscular, on left arm, at the age of 67-year-old, on 26Feb2021 5:45pm, single dose, for covid-19 immunisation. Medical history included asthma and Allergies. Concomitant medications were not reported. On 27Feb2021, the next morning when she woke up, she had like a slight ache in her left arm and then everything was fine. She clarifies she was getting headaches after the first injection but she didn't know if it was from the vaccine or not. The headaches were not that severe. She took Tylenol and the headaches kind of went away. The patient found out that she had to have a surgery on 29Mar2021 and was subsequently moved on 15Apr2021. It was determined her surgery was going to happen after receiving the second vaccine. The surgery is hopefully a mitral valve repair. Outcome of headache and slight ache in her left arm was recovered in 2021 while it was unknown for mitral valve disease. No follow-up attempts are needed. No further information is expected.
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| 67 | 2021-04-28 | headache |
collapsed, head hit the tile floor of bathroom; collapsed, head hit the tile floor of bathroom; righ...
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collapsed, head hit the tile floor of bathroom; collapsed, head hit the tile floor of bathroom; right arm was bruised; corner of her eye was purple/bruised; feeling nauseated; Headaches off and on; pain; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6208) intramuscular, administered in Arm Left, at the age of 67-year-old, on 19Mar2021 11:00, as SINGLE DOSE for covid-19 immunisation. Medical history included asthma and Allergies. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6203) single dose, at the age of 67-year-old, on 26Feb2021, for covid-19 immunisation and experienced slight ache in her left arm, headaches, and mitral valve disease. On 20Mar2021, the patient had headaches off and on and the patient mostly woke up with them. The patient doesn't know if the headaches were from pollen in the air since it is Spring time or mold. On 24Mar2021 at 4am, the patient got out of bed because she had to use the restroom. As soon as the patient took the first step into the tile floor of the bathroom, the patient collapsed. The patient didn't fall, the patient collapsed on the file floor. Her head hit the floor. Her head was killing her when she was laying there. The patient used the restroom and went back to bed. The patient got out of bed because her head was killing her. The patient guesses she threw her right arm out to brace herself, because she noticed her right arm was bruised the morning of 24Mar2021 when she went to shower. The patient took Equate 500MG for the events head hit the tile floor of bathroom, headache, and right arm was bruised and used a wash cloth with cold water as a cold compress and applied it by her eyebrow, the corner of her eye was purple/bruised. It looked like she had eyeshadow on. On 24Mar2021, she was feeling nauseated. Thankfully, she had the next 2 days off (Thursday and Friday) because she didn't feel so hot. On 26Mar2021, the patient called her PCP and was asked if she wanted to come in/ make an appointment. Since, the caller was planning to meet with the surgeon about her upcoming surgery on 29Mar2021, it didn't really fit into her schedule. She was undergoing all these tests, etc. It was determined her surgery was going to happen after receiving the second vaccine. The surgery is hopefully a mitral valve repair. The patient mentioned that her provider is aware of her experience with the COVID vaccine. The patient saw the surgeon on 29Mar2021, and she told him all about her experience. He advised the patient to call her PCP and schedule an appointment with them. She saw her PCP on 01Apr2021. She told her PCP what happened and her PCP asked why she didn't go to urgent care. The patient doesn't really know why she didn't, she just thought she was going to feel better. The patient thought she would work through the pain since Mar2021. Plus, she had everything going on with her surgery- like finding out she had to have the surgery and going under other tests. Her PCP wanted her to go to radiology to have a MRI of the head/brain done. She had the MRI done at 3:00PM on 06Apr2021 and the results were negative. Up until last weekend, she still felt "headachy". The patient has headaches too because of stress knowing her surgery was scheduled in a matter of 2 weeks, so she didn't know if the headaches she was experiencing was because of the COVID vaccine, stress, allergies, etc. The patient was certain the headache she experienced the day after she collapsed, was due to the collapse. The patient clarified that she knew it was more of a "collapse" instead of a fall because all the furniture leading to the bathroom, like the loveseat, lamp, cedar chest, etc, were all intact with no marks. It was like all of a sudden she collapsed. Her bruising is all gone, but there might be a slight mark that is like yellow and green (because the bruising changes colors) on her arm. Her eye was okay. The patient will have her planned surgery on 15Apr2021. The events required physician office visit. The patient underwent unspecified lab test and procedures relevant to her upcoming surgery but no other testing in regards to her symptoms after the COVID vaccine. Outcome of headache was not recovered, the events corner of her eye was purple/bruised and right arm was bruised recovered in 2021, while it was unknown for the other events.
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| 67 | 2021-04-28 | nasal congestion |
she still had a hard time with her breathing when she was doing anything that was exerting herself t...
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she still had a hard time with her breathing when she was doing anything that was exerting herself to get things done/ short of breath; she started to feel like her lungs were starting to close up; her nose closed up completely; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 09Mar2021 at 08:30 (batch/lot number: EN6199) as a single dose for COVID-19 immunisation. The patient has no medical history and no concomitant medications. Historical vaccine included flu shot for immunization and got sick on an unspecified date. No prior vaccination (within 4 weeks prior). No family history related to adverse events. The patient experienced she started to feel like her lungs were starting to close up and her nose closed up completely on 09Mar2021. She said that she wanted to let Pfizer know about the symptoms she had gone through when she got the shot. She received her first shot 09Mar2021 and it was at 08:30 am and then around mid-afternoon that same day she started to feel like her lungs were starting to close up and her nose closed up completely. She has a nebulizer machine and she used that and it opened up her lungs but it didn't open her nose up at all. So she sat up for a couple of nights with her nose not working right and she had to breathe out of her mouth. Days later here nose finally opened up and it was breathing good but she still had a hard time with her breathing when she was doing anything that was exerting herself to get things done. She would become short of breath. It was kind of that way when she went in for her second one, she was better at that time but she wasn't the greatest. When she had went in for second shot and told them about what she experienced after the first shot, they didn't do anything and they said that was what should be happening which was scary. They gave her the second shot even though she was very reluctant on it and she did it anyways. With that, what she experienced was even worse than what she experienced with the first shot. She got her second shot on 30Mar2021 in the morning and then the same thing pretty much happened as the first one, only it was a lot worse with her lungs and her nose. Her lungs did the same thing where they had closed and her nose did the same thing where it closed as well. She already had everything ready to use for nebulizing and that opened her lungs but it didn't open her nose for at least 3 days or maybe it took longer for her nose to open. She had sat up for 4 nights trying to sleep. She was breathing through her mouth because she couldn't breathe through her nose. It was a horrible time trying to breathe. It was unreal. It was kind of scary when you're trying to breathe and you're not getting any air. She had went to her clinic and she was put on a heavier nebulizer and that that one kind of opened up her lungs and her nose and then her doctor also put her on prednisone. Besides that she was given another nebulizer that wasn't as harsh or intense for her to use for all of her reactions or if she needed it during the night. Finally she was getting back on the mend now to where at least she can breathe through her nose and her mouth. Her provider thought that she should report this because she just cant figure it out. She knows that when she gets flu shots she gets sick and the same thing happens like now. The first time she got a flu shot she was sick like that for a week and she thought that maybe it was just a fluke so she did it a second time and the same thing happened. With this shot, she didn't know if she would want to get it again or not but people say that you should so she thought to give it a chance and then it turned out the same way with the second shot. It was not good. She doesn't know if there was something in those that was not a good thing or her to have or what. She didn't end up in the hospital even though she was pretty close to going up there. Probed for names, , lot numbers and expiry dates for all previously mentioned medications such as the different nebulizers, prednisone, and the flu shots from previously and she says that they were fairly new, she doesn't have the box now because she used them and when she was done she tossed it. The products weren't old and they didn't have old expiry dates. Probed for information such as , lot number and expiry dates for previously administered flu shots and she declined to provide and said that was many years ago. Provided mailing address and then caller stated that she doesn't want to be bombarded with anything if it has nothing of importance but she doesn't want it really. She doesn't want a lot of stuff to read through if it was not of importance. Informed caller that all information was voluntary in what we ask and she does not have to provide her mailing address was if she was not comfortable doing so and she asked this agent to remove her mailing it's because she always hears stuff on the news. Caller confirmed that this was her first time speaking to someone about what she has experienced. Probed if her side effects began on the same day she received her vaccine, 09Mar2021 and 30Mar2021 and caller said that for the first dose of the COVID vaccine on 09Mar2021 the side effects started mid-afternoon and for the second dose on 30Mar2021 the side effects started a little later and it wasn't on the same day. She had started feeling it that day but she really felt them the next day. She could tell it was kind of starting to do it at a slower process but when it happened it was really worse then the first time. Caller confirmed dates of 09Mar2021 and 31Mar2021 for when her side effects began and she says she was still feeling a little bit like she did with the side effects. She still has where if she was doing a little more exertion stuff then it seems like she still was having to sometimes stop and get her breath but it was getting better now. She doesn't want to go through that again, that was horrible. Caller said it seemed like if you didn't get the COVID vaccine then you couldn't go out in public without a mask on for the rest of your life or even if you go to some places, like a concert or an event, if you didn't have the COVID vaccine then they were going to card you and if you didn't, you know what. She has a friend who went to get it because he was working and he was around people and she thought that was important too with her being around him and that was the other reason she got the COVID vaccine. She didn't really want to but she did it anyways. She probably should of just taken her chances and if she got COVID then she got it and it probably wouldn't be as bad as putting something into her system that doesn't even like her. It was hard. That was just how she was feeling. It was a bad thing, you know. Her mom couldn't (well, she has been gone since 2000) but anyways, her mom could never get flu shots either years ago. The caller doesn't know if there was something with that that she doesn't know. All she knew was that these shots don't like her. Probed for relevant test results, concomitant products and medical conditions and caller says no, she was not sick and she didn't take anything before. She wasn't sick, if she was sick she would have thought that maybe she felt like not from the sock but she didn't feel sick. She takes her temperature every day and she has been for the better part of this whole last year and she never had a fever. She couldn't take her temperature during all this because she couldn't breathe when her mouth was shut. She said that the only thing what she doesn't really understand was that if you can still get COVID after getting the shots, then why were people still doing the shots. It just makes her wonder why was everything doing something like this and it can still happen. To her it didn't really make sense. After she found out that you can still get COVID after this thing she thought well what's the point. She just thought that she would let Pfizer know about what she experienced and that this was a lot worse than when she had the flu shot with the side effects. The flu shot was minor compared to this thing, the COVID vaccines, she felt like she almost could of died. This was most definitely by far a lot worse. She would rather have the flu shot and have a minor thing than this one this was bad. She doesn't know what was in it or what caused her to have this total reaction where she couldn't breath and it was bad. She really doesn't want to do this again either. She doesn't know if there was something in this one or whatever, but it doesn't like her big time. She doesn't know if Pfizer has heard of this where people had trouble breathing after they got this done but she kind of wonders. She listens to the news and on there you don't really hear any side effects caused or how people are dealing with the symptoms. Vaccine was not administered at military facility. Vaccination facility, it was a clinic, well it was between that and the hospital that was connected to the clinic so kind of right inside the hospital area going to clinic, maybe it was the hospital. The adverse events required a visit to a physician's office because she got to the point to where she couldn't breathe. She was even having trouble walking across the parking lot so she ended up going in because she couldn't breathe. No relevant tests done. The outcome of the events "she started to feel like her lungs were starting to close up and her nose closed up completely" was recovering and unknown for the other event. Follow-up attempts are completed. No further information is expected.
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| 67 | 2021-04-28 | nasal congestion |
Her lungs did the same thing where they had closed; Her lungs did the same thing where they had clos...
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Her lungs did the same thing where they had closed; Her lungs did the same thing where they had closed/her nose did the same thing where it closed as well/only it was a lot worse with her lungs and her nose; her nose did the same thing where it closed as well; She was breathing through her mouth because she couldn't breathe through her nose.; She had sat up for 4 nights trying to sleep.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8733) via an unspecified route of administration into left arm on 30Mar2021 (at the age of 67-year-old) in the morning as single dose for COVID-19 immunisation. The patient's medical history were not reported. There were no concomitant medications. Historical vaccines include: INFLUENZA VACCINE on an unspecified date for immunization where she got sick for a week and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) into left arm on 09Mar2021 08:30 AM (at the age of 67-year-old) for COVID-19 immunization and feeling like her lungs were starting to close up and her nose closed up completely, hard time breathing when doing anything that was exerting herself, she still had a hard time with her breathing and short of breath. It was reported that patient got her second dose on 30Mar2021 in the morning and on 31Mar2021 almost the same thing pretty much happened as the first one, only it was a lot worse with her lungs and her nose. Her lungs did the same thing where they had closed and her nose did the same thing where it closed as well. She already had everything ready to use for nebulizing and that opened her lungs but it didn't open her nose. It was further reported that since 31Mar2021 she had sat up for 4 nights trying to sleep and she was breathing through her mouth because she couldn't breathe through her nose. The patient went to her doctor's clinic where she was given treatment for the events reported; she was put on a heavier nebulizer; that kind of opened up her lungs and her nose and then her doctor also put her on prednisone. Outcome of events "she was breathing through her mouth because she couldn't breathe through her nose" and "she had sat up for 4 nights trying to sleep" was unknown while for all other events was recovering.
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| 67 | 2021-04-28 | fever, fatigue |
This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient re...
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This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 10:00 (Lot Number: ER2613) (age at vaccination: 67-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history was reported as no, and no known allergies. The patient was not pregnant. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). On 23Mar2021 13:00, the patient was tired and slept, 25Mar2021 through 31Mar2021, had Low grade fever and fatigue. On 31Mar2021, thumbs turned purple and looked bruised Went to emergency room. All fingers were turning purple and swelling, could not bend fingers. Hurt to touch anything, couldn't open containers. Spent 2 nights (31Mar2021-01Apr2021) at hospital. Infectious disease doctors both agreed it was a reaction to the Pfizer Covid shot. Also CT scan at hospital showed a small nodule in the right lung. There was no nodule in the CT scan from 09Feb2021. Saw pulmonary Dr 14Mar2021 she and her colleague also believe the nodule was from the vaccine and she need to have another CT scan early May to see if it is gone. Skin peeling off thumbs and first fingers. On 02Apr2021 fingers less purple and moving some. Saw Dr 05Apr2021 wanted pulmonary appointment as soon as possible. 03Apr2021 through 12Apr2021 afternoon the patient had fatigue. The events resulted in: Emergency room/department or urgent care. No treatment received for events. Covid test (Nasal Swab) on 31Mar2021 showed Negative result. The outcome of the events was not recovered.
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| 67 | 2021-05-06 | headache |
fainting; Severe head, neck and back pain; Severe head, neck and back pain; Severe head, neck and ba...
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fainting; Severe head, neck and back pain; Severe head, neck and back pain; Severe head, neck and back pain; nausea; vomiting; This is a spontaneous report from a contactable consumer, the patient. This 67-year-old non-pregnant female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8737) via an unspecified route in the right arm on 19Apr2021 at 14:45 (at the age of 67-years-old) as a single dose for COVID-19 immunization. Medical history included chronic severe tension headaches and allergies to some antibiotics (unspecified products). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination. Concomitant medications included unspecified supplements and herbals. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) on 27Mar2021 at 14:45 in the right arm as a single dose for COVID-19 immunization. On 20Apr2021 at 02:30, the patient experienced severe head, neck and back pain, combined with nausea, vomiting and fainting. There was no treatment received for severe head, neck and back pain, combined with nausea, vomiting and fainting. The clinical outcomes of severe head, neck and back pain, nausea, vomiting and fainting was recovering. The patient was not tested for COVID post vaccination.
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| 67 | 2021-05-06 | headache |
stroking; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; th...
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stroking; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; This is a spontaneous report from a contactable nurse reporting for herself. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW01B1/expiration date: not provided), via an unspecified route of administration, on 19Apr2021 (at the age of 67 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included ongoing hypertension (HTN) and COVID-19 on an unspecified date. The patient had known allergies to ciprofloxacin (CIPRO), latex and iodine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included losartan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Apr2021 at 12:00AM, the patient reported that after having her first vaccine on 19Apr2021, the next morning her blood pressure went up to 210/110 and HR 130 with a pounding headache and reported "thought I was stroking". The patient received treatment for these events which included extra medicine: an extra dose of losartan, clonopin and two acetaminophen (TYLENOL) and slept 24 hours. The outcome of the events blood pressure went up, heart rate increased, headache and "thought I was stroking" was recovering. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on chronological connection to the vaccine, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 67 | 2021-05-06 | malaise |
seizure; Feel woozy; felt even weaker; jittery feeling; shaky; doesn't feel well; It has left her wi...
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seizure; Feel woozy; felt even weaker; jittery feeling; shaky; doesn't feel well; It has left her with a stutter; This is a spontaneous report received from contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6198), dose 1 via an unspecified route of administration on 02Mar2021 (at the age of 67years) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got her first shot on 02Mar2021 and the second shot 25Mar2021. She took the first shot and she wanted to say a day or so after that she got up and did some things around the house and she went to the cloth store. She clarified that she went to the fabric store and came out she had a jittery feeling. Then she began to feel woozy and stated she may need to eat. She drove up to by (withheld) and there was a cookout restaurant in the same vicinity as (withheld). When she went to turn into the lot, she was "shaky" and pulled into the parking space. She added that the best thing is for her to go home. She didn't want to take the interstate and went to the back way just in case something happened. She went home and it was approximately 10 miles away. When she got home, she felt even weaker. Her husband was outside because he fishes and was working on his boat. She told him that she doesn't feel well and was shaky. He told her to go in the house and he would come in. She went in through the basement and when she got to the step her foot wouldn't come up, so she crawled up the steps. When her husband came in, she went into a seizure and had no control. She could hear her husband speaking but couldn't speak so he called. They told him to give her four 81 mg of aspirin. So, he gave her some aspirin. She could hear them when they came in to get her, but she couldn't respond. They took her to the hospital. At the hospital they did two CAT scans and another unspecified test. The patient added that she was concerned because she is a very active person, and this is not her normal talk. Before the shot she did a lot of sewing and that's her business. But a few days after the shot she began to have a lot of seizures and went to the hospital. And when she came home it continued. Before she left the hospital, she had not spoken to anyone. When her husband came in, she couldn't get her words out. It has left her with a stutter, and she decided to go to speech therapy. She went in and a few days it seemed like it had helped. The patient further stated that she is not getting back to normal and needs a walker or cane and she's 68 and healthy. The outcome of events was unknown. Information on lot/batch number was available. Additional information has been requested.
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| 67 | 2021-05-07 | headache |
Hot flash; Headache; severe body aches over whole body/ localized around rib cage; severe body aches...
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Hot flash; Headache; severe body aches over whole body/ localized around rib cage; severe body aches over whole body/ localized around rib cage; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EM9810) via an unspecified route of administration at left arm on 03Feb2021 17:45 (67-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included high blood pressure, COPD, and allergies to Penicillin, various blood pressure meds. Concomitant medications included ongoing atenolol (TENORMIN) for high blood pressure, ongoing ergocalciferol (VIT D), ongoing acetylsalicylic acid (BABY ASPIRIN), ongoing Multi Vitamin (unspecified). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9231, the second letter need to read) via an unspecified route of administration at right arm on 13Jan2021 17:50 (67-year-old at time of vaccination), at single dose, for COVID-19 immunization. There was not prior vaccination. On 04Feb2021 02:00, the patient experienced hot flash (Seriousness criteria: Not Serious). She had headache on 04Feb2021 in middle of night and severe body aches (Seriousness criteria: Not Serious) on 04Feb2021. Next day severe body aches over whole body then by end of day pain was localized around rib cage. Adverse events did not result in emergency room visit or physician office visit. Patient did not have COVID-19 prior vaccination. Patient did not test COVID-19 post vaccination. No therapeutic measures were taken as a result of the events. The outcome of the event hot flash was recovered on 04Feb2021; headache and "severe body aches over whole body/ localized around rib cage" were recovered on 05Feb2021. Follow-up attempts are completed. No further information is expected.
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| 67 | 2021-05-13 | malaise |
left hand was edematous and cold; left hand was edematous and cold; left hand pain; blood clot; swol...
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left hand was edematous and cold; left hand was edematous and cold; left hand pain; blood clot; swollen submandibular gland that got bigger/could feel her mouth getting bigger; ill with something not related to the vaccine; This is a spontaneous report from a contactable nurse (patient) via Medical information team. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 03Mar2021 15:00 (Lot Number: EN6201) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included stroke on 2007, COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included clopidogrel bisulfate (PLAVIX) taken for stroke from 2007 to an unspecified stop date; and acetylsalicylic acid (ASPIRIN (E.C.)) taken for stroke from 2007 to an unspecified stop date. The next day on 04Mar2021, the patient had a swollen submandibular gland that got bigger. She could feel her mouth getting bigger. The patient was admitted into the hospital on 07Mar2021 and released on 09Mar2021. She was readmitted to the hospital on 11Mar2021 until 18Mar2021. The patient went back into the hospital on 21Mar2021 and released 20Apr2021. The gland was removed on 13Apr2021. She developed a blood clot. She went to the emergency room and was sent home on Xarelto. The patient mentioned that she received the 1st dose of the vaccine on 03Mar2021 and came down ill with something not related to the vaccine. She was hospitalized for 4 weeks and ended up missing her 2nd dose appointment on 24/Mar/2021. She would like to get her 2nd dose but she is now 5 weeks overdue for it. She mentioned the hospital is recommending that she restart her vaccination. She is looking for guidance from Pfizer. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent had CT and MRI of left arm/wrist which she does not have results to provide. Event relatedness to vaccine was unknown for events, swollen submandibular gland that got bigger, left hand was edematous and cold, left hand pain and blood clot. The outcome of the event blood clot swollen submandibular gland was recovered with sequel on unspecified date, the outcome of ill feeling was unknown and the outcome of the rest of the events was recovering.; Sender's Comments: The 67-year-old female patient had medical history of stroke. Based on information available, the reported thrombosis and other events were unlikely related to the vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2020-12-31 | fatigue, headache, chills |
on dec 22 I felt some myalgias, chills, fatigue, HA --quite normal. That evening, noted small amoun...
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on dec 22 I felt some myalgias, chills, fatigue, HA --quite normal. That evening, noted small amount swelling R hand --I iced and took acetaminophen. By Dec 25, hand very swollen and painful with decreased ROM all fingers
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| 68 | 2021-01-02 | cough, throat irritation | After receiving vaccine, c/o burning throat, coughing, face itching, hot flashes. |
| 68 | 2021-01-02 | sleepiness, fatigue | Exhaustion Sleepiness Dizziness Joint pain |
| 68 | 2021-01-03 | fever | Low Grade fever, Diarrhea |
| 68 | 2021-01-04 | chills, nasal congestion, headache, fever, throat pain |
arm was hurting/very sore arm; have a really bad headache; teeth ache; muscle and joint pain; muscle...
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arm was hurting/very sore arm; have a really bad headache; teeth ache; muscle and joint pain; muscle and joint pain; chills; low grade fever 99.7; sore throat; congestion; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 3 ug/ml) Batch/lot number: EL1284, on 29Dec2020 12:33 single dose on left arm for COVID-19 immunization. Medical history included Blood pressure high which diagnosed a long time ago, probably when she was 45 years old, though it could have been when she was 42 or 43, probably earlier, 25 years ago, so put when she was 42; hemochromatosis diagnosed about 25 years ago; Arthritis; Cluster headaches; low thyroid and she didn't take medication for this, it wasn't low enough; COVID-19 in Mar2020. Concomitant medication was none. The patient received the Pfizer covid vaccine yesterday (29Dec2020) and she called the line to report the side effects today. She said she had covid around the Easter time and donated her plasma also for antibodies. She said after getting the vaccine yesterday she was feeling worse, have a really bad headache, teeth ache, arm was hurting woke up due to that in the night, really bad headache, muscle and joint pain, chills , low grade fever 99.7 , sore throat and congestion. The patient received the vaccine through work, and was not prescribed it from a provider. She had her shot at 12:33PM yesterday (29Dec2020), after lunch. Her vaccine was given to her at the hospital where she worked, which was not a military hospital. Her side effects were that she developed a headache, also her teeth were aching, and then last night around 04:00AM in the morning she woke up with a very sore arm and worse headache. She said she also had muscle and joint pains, chills, and fever. She said now she still had a headache, and still didn't feel good. Treatment received for the events included Ibuprofen and Tylenol. Ibuprofen was clarified to being generic Ibuprofen prescription in a pharmacy bottle with EXP 3 09Mar2021 and NDC: 67877032005. She said that the strength of this medication is 600mg, and she just took one last night by mouth at about four in the morning. She says she also took Tylenol before bed, 500mg, this is the name brand product. UPC/LOT/EXP: unknown, she didn't have it with her she said it was in date and was brand new, in to go packs. She said that her teeth aching was gone, she still had her headache, muscle pain, fever, and her arm hurt. She said she did take another Tylenol a half hour ago or 45 minutes ago. Her low grade fever temperature was 99.7 degrees Fahrenheit. She had COVID-19 before, she tested positive for COVID at Easter time, this was in March, they did a PCR nasal swab. She had two positive tests and then a negative test because they had to retest her to get plasma, she had to be negative before she could get plasma. She also had an antibody test a couple months after she had COVID, that showed she had 27 antibodies. She had COVID, then a couple of weeks later she gave plasma, and then a few weeks later had the antibody test that showed she had the 27 antibodies. The outcome of teeth ache was resolved. The outcome of headache, muscle pain, fever, and her arm hurt was not resolved. The outcome of other events was unknown.
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| 68 | 2021-01-04 | headache, chills, fever, fatigue |
headache; nausea; vomiting; chills, rigor; fever; fatigue; This is a spontaneous report from a conta...
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headache; nausea; vomiting; chills, rigor; fever; fatigue; This is a spontaneous report from a contactable other hcp. A 68-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscularly in the left arm on 24Dec2020 at 07:30 (at the age of 68-years-old) as a single dose for COVID-19 vaccination. Medical history included penicillin allergy from an unknown date and unknown if ongoing, latex allergy from an unknown date and unknown if ongoing and a thyroid disorder from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took iodine for an unknown indication and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Dec2020 at 15:30, the patient experienced headache, nausea, vomiting, chills, rigor, fever and fatigue. No therapeutic measures were taken as a result of the events. The clinical outcome of the headache, nausea, vomiting, chills, rigor, fever and fatigue was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 68 | 2021-01-04 | throat pain, cough |
positive for Covid with symptoms; positive for Covid with symptoms; positive for streph; positive fo...
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positive for Covid with symptoms; positive for Covid with symptoms; positive for streph; positive for influenza; This is a spontaneous report from a contactable physician and nurse. A 68-year-old female patient received bnt162b2, via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced positive for COVID with symptoms, positive for streph and positive for influenza in Dec2020. Additional Context: caller stated that she had a patient that got Covid vaccine on 17Dec2020 who was complaining of muscle aches, no fever, sudden loss of taste and smell in the last 24 hours, sore throat and a cough. Stated that she cannot attribute the cough to the vaccine. Stated that she was screened for COVID, streph and influenza. Stated that she was positive for covid and streph. Stated that she does not think that and wanted to know if the vaccine would cause a positive from a rapid test. Outcome of the events was unknown. The Lot/Batch and expiry date has been requested.; Sender's Comments: The reported positive for COVID with symptoms after immunization with BNT162B2 is considered related to the suspect, BNT162B2.
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| 68 | 2021-01-07 | fatigue, cough, runny nose |
I tested positive for COVID 9 days after receiving the vaccine; I tested positive for COVID 9 days a...
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I tested positive for COVID 9 days after receiving the vaccine; I tested positive for COVID 9 days after receiving the vaccine; Rhinorrhea; aches; fatigue; cough; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the first of the two reports. A 68-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the left arm on 21Dec2020 at 09:30 at a single dose for COVID-19 immunization. Medical history included hypertension. The patient had no known allergies. Concomitant medications included losartan (LOSARTAN), amlodipine (AMLODIPINE), and atorvastatin (ATORVASTATIN). On 28Dec2020, the patient had rhinorrhea, aches, fatigue, and cough. The patient had no COVID prior vaccination, and when tested post vaccination showed a positive result. It was reported that the patient was tested via nasal swab (PCR SARS) and showed positive for COVID on 30Dec2020, 9 days after receiving the vaccine. The patient had no other vaccines in four weeks. No treatment was administered for the events. The events had not resolved. Information on the lot/ batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events drug ineffective and SARS-COV-2 test positive cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021001246 Same reporter, same drug, similar events, different patients.
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| 68 | 2021-01-07 | fatigue |
In the evening on the day of the vaccine and the following day my arm was sore and then my entire bo...
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In the evening on the day of the vaccine and the following day my arm was sore and then my entire body. Body was so sore that I had to take med to sleep. It is early Friday morning now and I have been so tired and hurting that I have slept most of the week (4 days). I don't often take immunizations as they kick in my rheumatic/psoriatic arthritis so badly and I hurt so badly and can't do anything. I was hoping that this immunization would be different as it's action is supposed to be different. I am still planning on getting the second shot as it is so important:especially due to my age and other conditions.
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| 68 | 2021-01-07 | headache, chills, cough, fatigue, nasal congestion |
Initial right arm soreness. Second day after initial dose. chills, headache, fatigue, stuffy nose, c...
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Initial right arm soreness. Second day after initial dose. chills, headache, fatigue, stuffy nose, cough, with lots of mucus and cough. Taking Tylenol, OTC cold medication and inhaler as needed. Waiting it out with rest, fluids, medication.
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| 68 | 2021-01-07 | headache, chills, malaise |
1-2 minutes after injection: lip tingle, bi-lat side back of tongue, some neck discomfort, slight he...
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1-2 minutes after injection: lip tingle, bi-lat side back of tongue, some neck discomfort, slight headache, eyelid drop-bi-lat. Lasted 30 minutes. Day 2- symptoms returned approx 10:30 am - 3:00 pm. Nore intense included dizziness, shakes, overall malise, chest tightness. Later that day, mild diarrhea, mikd nausea. Day 3- woke with wheezing. Symptoms all continued for next 10 days off and on. The lip, tongue seemed to get shorter and shorter in duration. Also has mouth watering. Afternoon would bring on overall malaise issues. 2nd and 5th day, the worst. On 3 day went to urgent care, prednisone 40 mg x days, pepcid, zyrtec. Back to urge t care day 6, Ed day 8. Day 14 abd 15 awful chills, muscke ache and shaking.
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| 68 | 2021-01-07 | headache, productive cough, fatigue, chills |
Immediately sore right arm lasting approximately 1 day. Then after initial dose on the second day af...
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Immediately sore right arm lasting approximately 1 day. Then after initial dose on the second day after first injection, I began with chills, headache, fatigue, body aches. By the second day after initial dose, I began with mucus cough and same symptoms with chills, headache, fatigue and body aches. I took Tylenol, cold and cough medication. It is the third day after injection, symptoms same, but slightly better, still extreme fatigue and body aches and chills and I took an Proventyl inhaler as needed. Note, I do not take Proventyl inhaler on a regular basis, I just felt the need as I was beginning to have a lot of bronchial mucus. The inhaler seems to help. I am waiting it out and did not contact my family physicians. I am hoping I will feel better soon. Still taking OTC medications and Tylenol, fluids and rest.
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| 68 | 2021-01-07 | headache |
Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left...
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Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; This is a spontaneous report from a contactable consumer, the patient. A 68 -year-old elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0142), via an unspecified route of administration in the left arm on 29Dec2020 at 02:30 PM, (at the age of 68 -years-old) as a single dose, dose number=1 for COVID-19 vaccination. Medical history included hypothyroidism and osteopenia. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included levothyroxin and citalopram within 2 weeks of the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 02Jan2021, the patient woke up with a red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea. The patient was treated for red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea with diphenhydramine (BENADRYL) 50 mg x 1. The clinical outcome of red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 68 | 2021-01-07 | fever, chills, headache |
woke up with 100.5 fever, head ache, chills , generalized body aches, stomach ache, Called my work,...
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woke up with 100.5 fever, head ache, chills , generalized body aches, stomach ache, Called my work, they ordered, rapid Covid 19 test, waited for 3 hours and came back negative, but I'm having fever 100.3 for two nights and 99.0 at day time, with head ache and stomach ache,
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| 68 | 2021-01-09 | fatigue, chills |
Pain at injection site (resolved within 48 hours). Chills, lightheadedness, warm (not feverish), ab...
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Pain at injection site (resolved within 48 hours). Chills, lightheadedness, warm (not feverish), abdominal cramping, loose stool x 5 over 48 hours. Extreme fatigue (over 5 days)
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| 68 | 2021-01-10 | chills, fever | Chills nausea body aches dizziness fever |
| 68 | 2021-01-10 | throat pain, sleepiness, cough, throat irritation |
Burning/pain in throat, itching around mouth, wheezing, coughing, and BP 195/100. Taken to the ER, ...
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Burning/pain in throat, itching around mouth, wheezing, coughing, and BP 195/100. Taken to the ER, received epinephrine breathing treatment and Benadryl Observed for 2 hours then discharged. Slept most of the following day.
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| 68 | 2021-01-11 | malaise, chills, fatigue |
moderate, and intermittent nausea; lack of appetite; fatigue; malaise; sometimes chills; This is a s...
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moderate, and intermittent nausea; lack of appetite; fatigue; malaise; sometimes chills; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. A couple of hours after she received the Pfizer-BioNTech Covid-19 Vaccine last 21Dec2020, she started to experience moderate, and intermittent nausea, lack of appetite, fatigue, malaise, and sometimes chills; all on 21Dec2020. She said that the worse of all side effects she's experiencing was nausea. HCP also said that she was still experiencing the side effects until now. She also mentioned that she got tested for Covid, and results came back negative. However, she said that she will get tested again just to make sure she did not have the virus. The events were reported as non-serious. The outcome of events was not resolved. Information on the Lot/Batch number has been requested.
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| 68 | 2021-01-11 | fever, chills |
developed fever, aches, chills in the middle of the night after receiving the vaccine. did not repo...
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developed fever, aches, chills in the middle of the night after receiving the vaccine. did not report to work the following day
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| 68 | 2021-01-11 | fever |
Sore arm Low grade fever between 101-102 F Really bad body aches Nausea and vomiting that lasted 24 ...
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Sore arm Low grade fever between 101-102 F Really bad body aches Nausea and vomiting that lasted 24 hours Fever has continued in the afternoons
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| 68 | 2021-01-12 | fever, chills, headache |
Itching of tongue, face, under arms & groin, headache, intense chills & shakes, fever 101.9, stom...
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Itching of tongue, face, under arms & groin, headache, intense chills & shakes, fever 101.9, stomach pain, diarrhea Still experiencing fever and diarrhea.
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| 68 | 2021-01-13 | fatigue, chills |
Most concerning was dizziness to the point of almost fainting. This happened 2 times. Once on the fi...
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Most concerning was dizziness to the point of almost fainting. This happened 2 times. Once on the first day after injection and once on the second day after injection. Other S.C. were fatigue, muscle aches, chills, indigestion and sore arm. No fever noted.
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| 68 | 2021-01-13 | fatigue, fever | Tired, low grade (100.9) temp |
| 68 | 2021-01-13 | fatigue |
Ten minutes after the vaccine was administered, I began to taste it in the back of my mouth, a metal...
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Ten minutes after the vaccine was administered, I began to taste it in the back of my mouth, a metallic-type taste and felt tingling around my mouth. I had been sitting in the post-vaccine observation area during this time looking at my telephone. I approached the nurse's desk and reported what I was experiencing and was taken to another room where I was put in a wheelchair and vital signs were taken. By now I think I became very anxious and fearful and my heart felt like it was pounding at 104. My BP went to 188/79 which is high for me and I felt SOB. I truly think the VS symptoms were related to anxiety, but I continued to have the taste in my mouth and my tongue felt like sandpaper. I was given 50 mg BENADRYL and observed for 30 minutes. After that amount of time, I felt better and safe to leave the hospital. Today, 1/14/2021, I have felt excessive tiredness and mentally dazed with diarrhea. No temperature, slight nausea this morning, and no vomiting. My left arm is only moderately sore. Now, at 7:30 pm I am feeling better and feel that I can work tomorrow. Honestly do not know if it was an adverse reaction or excessive anxiety. I do not have anxiety disorder.
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| 68 | 2021-01-13 | fatigue | Severe abdominal cramps moving up towards diaphragm. Complete exhaustion. Nausea |
| 68 | 2021-01-13 | sweating, chills | 1) Ice cold toes & feet, sweat in toe area of socks 2) confusion, 3) chills |
| 68 | 2021-01-13 | productive cough |
neck stiffness; coughing with production of white mucous; felt like she couldn't breath with tightne...
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neck stiffness; coughing with production of white mucous; felt like she couldn't breath with tightness for about a half hour; felt like she couldn't breath with tightness for about a half hour; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot /batch and expiration date unspecified), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got the vaccine yesterday (07Jan2021) and that a couple of hours later she began to experience neck stiffness, coughing with production of white mucous and felt like she couldn't breath with tightness for about a half hour. The patient was asking if this was normal. Outcome of events was unknown. Information on the lot/batch number has been requested.
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| 68 | 2021-01-13 | fever, headache |
Stomach (Abdominal pain); Nausea, headache, feverish, but no temp; minor Body aches. Began around 9:...
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Stomach (Abdominal pain); Nausea, headache, feverish, but no temp; minor Body aches. Began around 9:00 A.M. (2 hrs After injection). Nausea & other symtoms gone by A.M. 12-29-20.
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| 68 | 2021-01-16 | fever, headache, chills |
chills, headache, body aches, spaced out feeling, loss of appetite, sick stomach, 100.5 fever for 2 ...
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chills, headache, body aches, spaced out feeling, loss of appetite, sick stomach, 100.5 fever for 2 days-this felt similar to how I felt when I had Covid 19 March-April.
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| 68 | 2021-01-17 | cough, respiratory tract congestion |
eosinophil count is 12.2%; Congestion; rhinitis; Cough; This is a spontaneous report from a contacta...
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eosinophil count is 12.2%; Congestion; rhinitis; Cough; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration on 21Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient who is an MD received the COVID vaccine on 21Dec2020. She quickly developed rhinitis, cough, and congestion which have persisted. Her eosinophil count is 12.2%. She received a Medrol pack, but it did not relieve her symptoms. She has delayed her second injection for now. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 68 | 2021-01-17 | headache | severe headache soon after vaccination, vomiting, nausea and diarrhea also |
| 68 | 2021-01-18 | fatigue, headache, chills |
Started with uncontrollable chills that lasted 1 hr , Fever. The next day ( saturday)tiredness , h...
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Started with uncontrollable chills that lasted 1 hr , Fever. The next day ( saturday)tiredness , headache joint pains , muscle pains , chest pains and nausea as well as Fatigue . I started taking Tylenol 500mg po q 6 hrs and that improve the sxs. The site of the injection was extremely red and swollen as well as lymphadenopathy underneath the left arm ( site of injection). The next day ( sunday) I noticed a swelling underneath the axilla going on top of the bra with blood exudate and looked as if I had bumped an object. The weakness continued during the next week and slowly the tiredness got better ( TOOK AT LEAST 7-10 DAYS).
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| 68 | 2021-01-19 | fatigue, body temperature increased, headache, chills |
1/15 - HAD SLIGHT HEADACHE AND BODY ACHES IN LATE EVENING AND CHILLS AND TEMP 100.1 AT 10PM. 1/16- ...
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1/15 - HAD SLIGHT HEADACHE AND BODY ACHES IN LATE EVENING AND CHILLS AND TEMP 100.1 AT 10PM. 1/16- 6AM HEADACHE; 10AM TEMP 100.2 WITH BODY ACHES AND VERY TIRED; 12 NOON VOMITED; 3PM TEMP 101.2. BODY ACHES, TIRED AND CHILLS. HAD SMALL AMT OF BLOOD IN STOOL (STOPPED ADVIL); 5PM TEMP 100.1 1/17 - 10AM TEMP 99; 11AM TEMP 98 AND REMAINED AFEBRILE WITH HEADACHE. 1/15 2:40PM- ADVIL 200MG+TYLENOL 500MG; 9:30PM 400MG ADVIL 1/16 6AM ADVID 400MG; 3PM TYLENOL 500MG 2 TABS 1/17 7AM TYLENOL 500MG 2 TABS
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| 68 | 2021-01-20 | fatigue, fever, chills | Nausea, joint pain, fever, chills, fatigue. 2 days duration |
| 68 | 2021-01-20 | fatigue | Exhausted Light headed |
| 68 | 2021-01-20 | malaise, headache |
Severe posterior headache and lower midline back pain. 68 yo female with PMH cognitive changes since...
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Severe posterior headache and lower midline back pain. 68 yo female with PMH cognitive changes since admission for Sepsis (6/2020), chronic headaches, right sided HL, GAD, NA fatty liver disease, Osteoporosis p/w headache back of her head after receiving the COVID immunization. Per Daughter CO reported feeling unwell while leaving the vaccination clinic. They wet back to the clinic and CO laid down for a while and was given a snack. She then reported she felt well and wanted to go home. Between the clinic and the car she felt unwell again and was directed to the ED. Per CO HA at back of head along with mild dizziness initially. Dizziness has now resolved. She took Tylenol at 1100 today for HA but does not remember if she took any more Tylenol since then. CO does not remember when she last ate. Per Daughter she last ate at 1030 today. She was supposed to have lunch at one but someone forgot. CO has a family member with her at all times since her cognitive impairment this past summer. She reports regular HAs are usual for her ever since her "brain injury" (CO hospitalized for Sepsis July 2020) Denies dizziness, denies visual changes, no photophobia. Given Acetaminophen and some food. RBS: 94 CO reports that the headache is now at the front of her head. CO eating a sandwich, calm, in a good mood. Feels much better. Headache resolved prior to discharge.
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| 68 | 2021-01-20 | malaise, headache |
Severe posterior headache and lower midline back pain. 68 yo female with PMH cognitive changes since...
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Severe posterior headache and lower midline back pain. 68 yo female with PMH cognitive changes since admission for Sepsis (6/2020), chronic headaches, right sided HL, GAD, NA fatty liver disease, Osteoporosis p/w headache back of her head after receiving the COVID immunization. Per Daughter Pt reported feeling unwell while leaving the vaccination clinic. They wet back to the clinic and Pt laid down for a while and was given a snack. She then reported she felt well and wanted to go home. Between the clinic and the car she felt unwell again and was directed to the ED. Per Pt HA at back of head along with mild dizziness initially. Dizziness has now resolved. She took Tylenol at 1100 today for HA but does not remember if she took any more Tylenol since then. Pt does not remember when she last ate. Per Daughter she last ate at 10:30 today. She was supposed to have lunch at one but someone forgot. Pt has a family member with her at all times since her cognitive impairment this past summer. She reports regular HAs are usual for her ever since her "brain injury" (Pt hospitalized for Sepsis July 2020) Denies dizziness, denies visual changes, no photophobia. Given Acetaminophen and some food. RBS: 94 Pt reports that the headache is now at the front of her head. Pt eating a sandwich, calm, in a good mood. Feels much better. Headache resolved prior to discharge.
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| 68 | 2021-01-21 | chills, fever, malaise, fatigue |
Chills, fever to 100.7, mild nausea, malaise, fatigue all resolving in 24 hours. A transient light r...
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Chills, fever to 100.7, mild nausea, malaise, fatigue all resolving in 24 hours. A transient light rash (hives) noted at bedtime 48 hours after injection, totally resolving by morning. Not sure this were real adverse advents,but very happy to have had a robust reaction indicating it's working! !!
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| 68 | 2021-01-21 | headache, fatigue, chills | headache( did not take anything yet) chills tiredness muscle/joint pain injection site pain |
| 68 | 2021-01-21 | headache | LOSS OF TASTE, HA |
| 68 | 2021-01-21 | throat pain |
my face started to feel tight, feeling as through I was getting a sore throat, lips and tongue start...
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my face started to feel tight, feeling as through I was getting a sore throat, lips and tongue started tingling. All symptoms were minor and lasted about 3 hours.
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| 68 | 2021-01-21 | fever, headache |
I immediately sat down for 1 hour, felt I had something , like i felt possible slight chest tightnes...
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I immediately sat down for 1 hour, felt I had something , like i felt possible slight chest tightness. I say I was fine until 3-4 hours later, I had extreme headaches. At 430pm, I still had the headaches and I took Tylenol 500mg. At night my headache got worse and it felt like I had the flu. I then went to bed and when I woke up my left arm felt intense like hornets and it was swollen. I then took another Tylenol and Ibuprofen 600mg. At 4am, I felt awful and horrible. I had joint pain with aches, felt nauseated. I called my PCP and he told me to take Prednisone 10mg. My fever was 101.4F. By the night my fever was gradually coming down and it was 102F. By the next day I felt much better. I also had Covid-19 on March 2020 and also got tested for antibody test in July 2020. I spoke with my PCP and he is recommending I do not take the 2nd dose injection.
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| 68 | 2021-01-22 | malaise, chills |
30 minutes after the vaccine was administered, as I was walking in the parking lot, I all of a sudde...
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30 minutes after the vaccine was administered, as I was walking in the parking lot, I all of a sudden felt weak, lightheaded, trembly, with chest tightness and a need to lay down. The biggest problem was that my eyes became strangely affected, like there were shutters being opened and closed in rhythmic waves inside my eyes. They were also very photosensitive and blurry. My whole head felt wrong. drove me home, (I could not have driven). This lasted several hours. I had chills and stayed laying down with my eyes closed. By the end of the day I felt mostly recovered. This series of events recurred 6 days later, on Jan. 20th. This time it also lasted most of the day, but I continued feeling moderately unwell the next day, and today it continues. I feel weak and unsteady. My eyes are better but not entirely. They ache and feel insecure. I am not currently feeling up to any activities besides resting.
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| 68 | 2021-01-23 | malaise, fatigue | Malaise and fatigue x 48 hours |
| 68 | 2021-01-24 | chills, headache, body temperature increased, cough, fatigue |
The only reaction I had with the first vaccine on 12/18/20 was fatigue the second day following the...
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The only reaction I had with the first vaccine on 12/18/20 was fatigue the second day following the vaccination. 12/18/20. On 12/2820 I developed a deep cough and a temperature of 100.6. I tested positive for Covid. I quarantined for 10 days and was ill for approximately 5 of those days. I contacted my pulmonologist who researched the data and determined if I was afebrile and did not have body aches and was feeling ok I could take 2nd vaccine. If not I should wait a week. Since I was not experiencing S&S of Covid and felt fine I took 2nd vaccine on 1/8/2021. Late the night of the injection 1/8/2021 I developed a deep consistant cough, a temp of 100.2, chills, headache, and fatigue. By the second day my temp was 99.8 , cough was unchanged and fatigue was unrelenting. My temp continued to decrease with time until I was afebrile the week of the 18th. By the 22nd the fatigue was much improved and the cough was not as persistent. Today, 1/25/2021 my only complaint is the deep cough .
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| 68 | 2021-01-24 | chills | chills,diarrhea,body,aches,no appetize |
| 68 | 2021-01-24 | headache |
Patient is a 68yo female with a PMH s/f of osteoarthritis, CHF, TIA with right limb weakness and aph...
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Patient is a 68yo female with a PMH s/f of osteoarthritis, CHF, TIA with right limb weakness and aphasia and HTN presenting with a 1 week history of bilateral upper and lower extremity pain, stiffness and weakness. Patient states that she received the Pfizer COVID vaccine on 1/14 last week at pharmacy. At the time of inoculation, she did not experience any symptoms and went home after the 15 minute waiting period. The next day, she developed a generalized headache that started in her neck and continued over her head. She states that this continued to get worse throughout the day and on Saturday, she woke up and described a constant, 10/10, dull-aching pain that started at her neck/back of head and extended down to her shoulders to the tips of her fingers. She also stated that she had the same pain starting around her groin extending down to her knees and ankles. Patient initially tried taking Tylenol and ibuprofen to treat the pain, and said that those treatments normally work for her osteoarthritis, but that her pain did not improve afterwards. In addition to the pain, she also states that she developed worsening weakness to the point where she could not walk around her home. She stated that she thought moving around and being active had helped her fight through the pain and tolerate it, but that laying down and resting actually seemed to make it worse. With her symptoms worsening and her inability to walk, she decided to come to the hospital to get further treatment. She denied ever having an adverse reaction to other vaccines she has received previously. She receives the flu vaccine every year, and received measles, polio and other childhood vaccinations that she could not recall. She was diagnosed with polymyalgia rheumatica and started on 20mg prednisone daily. She had a remarkable response to the steroids and her symptoms resolved within 24 hours. She was discharged on her 3rd day of admission. On ROS, she denies fevers, chills, night sweats, SOB, changes to vision, eye pain, cough, chest pain, sputum production, nausea, vomiting, diarrhea, dysuria or hematuria. She affirmed weight loss, headache, neck stiffness, dizziness, lightheadedness, muscle stiffness/pain, reduced ROM, and urinary urgency and incontinence.
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| 68 | 2021-01-24 | headache |
My reaction did not require medical attention, but I happened to have an appt. with my doctor and me...
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My reaction did not require medical attention, but I happened to have an appt. with my doctor and mentioned it to her. She thought I should mention it to you in case it is part of a larger pattern. I had normal reactions of arm pain and headache (not serious) since I had the shot. I have also been experiencing sporadic numbness and tingling in my arm down to my fingers. It does not last long but it comes and goes. It has been three days since the shot and all symptoms have decreased.
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| 68 | 2021-01-25 | chills, fatigue, cough, headache |
Chill, headache Saturday and Sunday the 1 /24/21 and 1/25/21. Coughing began on Sat the 24 along wit...
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Chill, headache Saturday and Sunday the 1 /24/21 and 1/25/21. Coughing began on Sat the 24 along with terrible aches through out my whole body. Very weak and tired. Today is Tuesday, 1/26/21 and my symptoms are the same. My 95 year old mother had a bad cold and I thought I had gotten a cold from her. Now I believe it is a reaction from my first covid shot. No symptoms til 3 days after injection. My aches throughout my whole body have only been this bad when I was diagnosed in 1994 with derma-polymiostis. An arthritis that attaches the skeletal muscles in your whole body. A question is: What should I possibly expect when I get my 2nd covid injection? How long are these current symptoms going to last?
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| 68 | 2021-01-25 | chills, sweating, sleepiness |
Patient self-reported through the hospital. In her own words, "After 2nd dose of Pfizer COVID-19 Vac...
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Patient self-reported through the hospital. In her own words, "After 2nd dose of Pfizer COVID-19 Vaccine 1/15/21 @ 0630, at 2030 developed generalized aching, chills, weakness and sleepiness. Woke up at 0300, went to bathroom and passed out returning to bed. Awakened soaked in perspiration. Had dry heaves and 1 loose stool. Felt weak and sleepy until 0700, then felt mostly normal. Symptoms relieved by 1000. No other symptoms after that".
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| 68 | 2021-01-25 | fatigue | No appetite. Diarrhea fatigue Lasted 7 days.Then normal. |
| 68 | 2021-01-25 | headache, chills, fatigue, fever |
About 12 hours after injection I developed a fever, body aches, chills, and severe arm soreness, hur...
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About 12 hours after injection I developed a fever, body aches, chills, and severe arm soreness, hurt to lift my arm. Also had some slight nausea and headache. Took Ibuprofen helped some. Next day still felt off, arm still extremely sore, body aches, headache, fatigue. I continued with the Ibuprofen alternating with Tylenol. Finally felt better by Sunday and was able to return to work on Monday.
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| 68 | 2021-01-25 | sweating, headache, fatigue |
Mild headache within 1 hour of vaccine. Fatigue in evening necessitating early to bed. Slept thro...
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Mild headache within 1 hour of vaccine. Fatigue in evening necessitating early to bed. Slept through the night and awake in am without symptoms. Getting out of bed sudden drop in BP with weakness, feeling faint, nausea, sweating. Drop in BP to 68/52. Unable to go to work. Improved with upright resting in am with BP at 10:30 am 119/69 (low as my usual BP averages 130's/mid 80's). Still slightly nauseous. Able to have toast and tea. Felt better as am progressed and able to drive to work at 11:45 am. Worked until 6 pm without further symptoms.
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| 68 | 2021-01-26 | chills, throat pain |
chills; Sore throat; some aching, like body aches; joint tenderness; some swelling at the injection ...
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chills; Sore throat; some aching, like body aches; joint tenderness; some swelling at the injection site; arm tenderness; This is a spontaneous report from a contactable consumer reported for self. This 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 13:30 on Arm Left at single dose (lot: EK9231, Expiry: 30Apr2021) for covid-19 immunisation. Give her a follow up appointment for a second dose, that will be 02 Feb at 1:20 PM. Medical History included arthritis and had surgery for right knee replacement 6 years ago (2015). They are trying to figure out, she has water in her ear she has had CT scans recently trying to check for any problems that could be corrected surgically and that was all clean. She has had a mammogram, she was not sure about the mammogram yet but she thinks they would have called her if there was a problem with that. Historical vaccine included Just mild stuff with the flu vaccine for immunisation on occasion she has had similar reactions that were very mild with the flu vaccine and last year she had none of that at all. She says when she has had any other vaccine, she had no reaction other than maybe a slightly sore arm. No other products. She did have some mild side effects. She was really glad she got this shot. She said she had experienced some chilling on 13Jan2021, these are all very mild symptoms. She had a sore throat on 13Jan2021, some aching, like body aches on 13Jan2021 and joint tenderness on 13Jan2021. She just got chilled every once in a while. It was not very bad. She said the sore throat had persisted about the same, but the coffee helped. She was having some swelling at the injection site that was about the same as when it began on 13Jan2021. She was having some arm tenderness on 13Jan2021. She did not have any adverse reactions yesterday (12Jan2021) she was so excited to get it. Outcome of the events was not recovered.
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| 68 | 2021-01-26 | fatigue, headache |
immediate dizziness and elevated heart rate after vaccine, and somewhat elevated blood pressure afte...
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immediate dizziness and elevated heart rate after vaccine, and somewhat elevated blood pressure after an hour felt better, went home to bed with fatigue, slight nausea and headache
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| 68 | 2021-01-26 | headache, fever, fatigue |
6 days after vaccine I had fever, nausea, headache, stiff neck, fatigue. Symptoms lasted 2 days and...
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6 days after vaccine I had fever, nausea, headache, stiff neck, fatigue. Symptoms lasted 2 days and are improving.
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| 68 | 2021-01-26 | headache |
.On the way home after receiving vaccine, began to have feeling of facial flushing and swelling. No ...
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.On the way home after receiving vaccine, began to have feeling of facial flushing and swelling. No outward sign. Symptoms continued throughout the rest of the day. Mild headache, some nausea. No difficulty breathing, no fever, no hives or rash. General uneasy feeling. Next morning awoke with "fullness "in ears, with some ringing. Facial symptoms would come and go. On Sunday, two days after vaccine, I felt much better, facial symptoms better, ears still felt plugged. Could ear fine. On Monday , symptoms pretty much gone. I was in contact with primary physician through email/phone message. No treatment was necessary.
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| 68 | 2021-01-26 | throat irritation | Burning sensation in upper stomach, chest, throat. Rapid heartbeat |
| 68 | 2021-01-27 | body temperature increased | Temperature 99.5 - usually run in 96 to 97 range. Body aches. Eyelids swelled and were red. |
| 68 | 2021-01-27 | chills, headache | Debilitating headache, nausea, chills, aches, pains, light-headed, disorientation, diarrhea, more |
| 68 | 2021-01-27 | cough |
Patient presented to the ED on 1/21/21 for evaluation of SOB stating her husband tested positive for...
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Patient presented to the ED on 1/21/21 for evaluation of SOB stating her husband tested positive for COVID earlier that week and she has been around him. The patient states her symptoms started 3-4 days prior to presentation. She admits to cough, nausea, and an episode of vomiting the day of presentation. She had been intermittently using her husband's oxygen prior to presentation which she says has helped with her symptoms, but does not use oxygen at baseline. Upon presentation the patient's oxygen saturation rate on room air is 89%. Patient was placed on 2L oxygen via nasal cannula and then was saturating in the mid 90s. CXR demonstrated bilateral patchy infiltrates in the ED which the ED physician felt to be consistent with COVID infection. The patient's rapid COVID test resulted as positive. The patient was admitted to the hospital for further management of hypoxia related to COVID infection. The patient remains hospitalized on the day of report submission (1/28/21)
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| 68 | 2021-01-27 | fatigue, chills |
Back pain; tired; whole body trembled; nervous; facial tingling; immediate pain in arm from injectio...
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Back pain; tired; whole body trembled; nervous; facial tingling; immediate pain in arm from injection; couldn't lift her arm at all; left eye twitching; Chills; Nausea; no appetite; whole body ache; This is a spontaneous report from a contactable consumer reporting for herself. A 68-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 11Jan2021 5:15 PM at a single dose on arm for COVID-19 immunization. Medical history included ongoing shellfish allergy from 1975 (she carries epi pen), ongoing iodine allergy from 1975 (she carries epi pen), ongoing Mitral valve prolapse (for 20 years), blood pressure high, and cholesterol. The patient had mitral valve prolapse for about 20 years now. They are just watching it now. She just saw the cardiologist, and had an echo done. If the symptoms worsen, they will proceed. Concomitant medications included diltiazem for blood pressure high and atorvastatin for cholesterol, both from an unspecified date and ongoing; she has been on these medications for 30 years now. On 11Jan2021, the patient experienced facial tingling, immediate pain in arm from injection, couldn't lift her arm at all, left eye twitching, chills, nausea, no appetite, whole body ache, tired, whole body trembled, nervous. On 12Jan2021, the patient experienced back pain. The patient explained that on 11Jan2021, evening at 5:15pm, she received her first COVID 19 vaccine. The Pfizer vaccine was being given out at that time. She has shellfish and iodine allergies. So, they made her sit and wait 30 minutes after being injected. One of her daughters took her. On the drive home, a few minutes after leaving she developed facial tingling. At first, she thought nothing of it. She did have immediate pain in her arm from the injection. By the time she got home, she couldn't lift her arm at all. It was that painful. The next morning, she couldn't lift arm, and if she tried, she would be in pain. Also, her left eye started twitching right away also. That night she really noticed it. It was not a constant twitching. She thought at first it was because she was tired or from the pain in her body. But then she noticed the next day it was still doing that. It was still twitching. It is not constant, but it was here and there. She still had it on 13Jan2021, but so far nothing at the day of report (14Jan2021). She also had chills. She had on double clothes, and coverings on her feet and hands. The chills wouldn't go away. Her whole body trembled. On 13Jan2021, Wednesday morning, they went away. She experienced nausea and no appetite. Her whole body ached. It was so brutal. The problem was with her left eye. It didn't twitch constantly, but it got her nervous. She is pretty sure she is going to refuse the second dose. She has heard that the 2nd part is when most people have the worst side effects. So, she is not comfortable getting it. She also got back pain. It wasn't severe, but it was there. She is against getting the second shot. She stated that she is a medical assistant at a pediatric office. She doesn't have a prescribing doctor. She got it (vaccine) because of her age. She was advised to get it as she was around patients. Work gave them the option. The inability to move her arm ended in the middle of night at 4 am 14Jan 2021. She noticed she could move her arm. Her second dose is scheduled for 01Feb2021 at 8:45 am. She does work in a pediatric office. If the second part of side effects are worse, then she doesn't want to take the chance. The eye has her concerned. Outcome of the events were as follows: facial tingling recovered on 11Jan2021, immediate pain in arm from injection recovered on 13Jan2021, chills recovered on 13Jan2021, nausea recovered on 13Jan2021, no appetite recovered on 13Jan2021, whole body ache recovered on 13Jan2021, couldn't lift her arm at all recovered on 14Jan2021, back pain was recovering, while outcome for events left eye twitching, tired, whole body trembled, and nervous, was unknown. Information about lot/batch number has been requested.
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| 68 | 2021-01-28 | headache, fatigue |
tiredness; headache; muscle aches; nausea; dizziness; This is a spontaneous report from a contactabl...
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tiredness; headache; muscle aches; nausea; dizziness; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283), via an unspecified route of administration on 11Jan2021 at 11:00 AM at a single dose on the left arm for COVID-19 immunization. Medical history included Barret's esophagus and glaucoma both from an unknown date and unknown if ongoing. Concomitant medication included dorzolamide;timolol maleate (manufacturer unknown) and pantoprazole (manufacturer unknown). The patient did not have COVID-19 prior to vaccination. The patient did not have other vaccines in four weeks. The patient previously took codeine and experienced allergies. The patient experienced tiredness, headache, muscle aches, nausea and dizziness all on 12Jan2021 at 03:30 PM. The patient did not receive any treatment for the events. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
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| 68 | 2021-01-28 | headache | Shakes, tongue and lip sweeping, pain in stomach and headache |
| 68 | 2021-01-28 | fever, chills | shore arm, fever chills body aches nausea and vomiting |
| 68 | 2021-01-29 | headache |
Experiencing headache and shortness of breath every day, for the last 5days. Using albuterol; had n...
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Experiencing headache and shortness of breath every day, for the last 5days. Using albuterol; had not been necessary for months.
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| 68 | 2021-01-30 | headache | Headaches Nausea Dizziness Aches |
| 68 | 2021-01-31 | headache, fatigue, fever |
Fatigue; joint discomfort; mild fever; mild headache; This is a spontaneous report from a contactabl...
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Fatigue; joint discomfort; mild fever; mild headache; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via an unspecified route of administration in left arm on 15Jan2021 at 08:30 AM at single dose for COVID-19 immunization. Medical history included CAD (coronary artery disease), mild COPD (chronic obstructive pulmonary disease) and GERD (gastroesophageal reflux disease). Patient had Covid prior vaccination. Patient was not pregnant. Patient has no known allergies. No other vaccines in four weeks. Concomitant medications included rosuvastatin calcium (CRESTOR), carvedilol (COREG) and vitamins (unspecified). On 16Jan2021 at 01:00 PM, the patient experienced fatigue, joint discomfort, mild fever, and mild headache. Patient did not receive treatment for the events. Patient was not tested for Covid post vaccination. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 68 | 2021-01-31 | malaise, headache |
feeling a little woozy/dizzy; My head was sideways and every time I would raise my head the room was...
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feeling a little woozy/dizzy; My head was sideways and every time I would raise my head the room was spinning; there is not enough spit in my mouth. It's very dry; I walked very slowly; slight headache; My blood pressure now is 137/93. It was high this morning; felt lousy like I had the flu; felt like I was fainting; This is a spontaneous report from a contactable consumer. A 68-years-old female patient started to receive received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Medical history included transient ischaemic attack (I had a TIA prior). The patient's concomitant medications were not reported. The patient experienced "feeling a little woozy/dizzy" on an unspecified date with outcome of unknown, "my head was sideways and every time I would raise my head the room was spinning" on an unspecified date with outcome of unknown, "there is not enough spit in my mouth, it is very dry" on an unspecified date with outcome of unknown, I" walked very slowly" on an unspecified date with outcome of unknown, "slight headache" on an unspecified date with outcome of unknown, "my blood pressure now is 137/93. it was high this morning" on an unspecified date with outcome of unknown, "feelt lousy like I had the flu" on an unspecified date with outcome of unknown, "felt like I was fainting" on an unspecified date with outcome of unknown. Reaction description by the reporter:" I had no pain, slight headache. My blood pressure now is 137/93. It was high this morning when I talked with the triage nurse. I had the shot/vaccine (first dose) on Friday. I feel better today than yesterday. Friday I felt fine. I got symptoms yesterday. When I woke up yesterday. I was feeling a little woozy, I always stretch slowly in bed. I slowly raised myself on the bed but before I got up my torso fell backwards. I felt like I was fainting. The room was spinning. All day yesterday I did not drive. I walked very slowly. I was holding onto the wall. I felt lousy like I had the flu. I would lay down for 20 minutes, watching tv. My head was sideways and every time I would raise my head the room was spinning. Also there is not enough spit in my mouth. It is very dry. I had a slight headache. So I did not bother but no headache today. I supposed to get my 2nd dose on 02Feb2021. The action taken was not applicable. Information on the Lot/Batch number has been requested.
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| 68 | 2021-02-01 | headache |
Swelling under the left side of left breast; Mild headache; minor muscle pain in left and arms below...
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Swelling under the left side of left breast; Mild headache; minor muscle pain in left and arms below elbow on top of arm; minor soreness at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL-1283 (also reported as "FL-1283"), intramuscular on left arm on 19Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included known allergies to penicillin and dust molds. The patient is not pregnant at the time of vaccination. No other vaccine in four weeks. Concomitant medications included Atorvastatin, ergocalciferol (VIT D), Biotin and Glucosamine with MSM. The patient previously took first dose of BNT162B2 (lot number: EK92316) on 29Dec2020 12:45 intramuscular on left arm for COVID-19 immunization. On 19Jan2021 at 16:45, the patient had swelling under the left side of left breast, mild headache, minor muscle pain in left and arms below elbow on top of arm and minor soreness at injection site. Patient was most concerned about swelling. No treatment for the events. The patient had no COVID prior vaccination and not COVID tested post vaccination. The outcome of the events was not recovered.
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| 68 | 2021-02-01 | influenza like illness |
Flu like symptoms; This is a spontaneous report from a contactable consumer reported for herself. A ...
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Flu like symptoms; This is a spontaneous report from a contactable consumer reported for herself. A 68-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration at Left arm on 12Jan2021 16:00 at SINGLE DOSE for covid-19 immunization. Medical history included Hypo-Thyroid and gastrooesophageal reflux disease. No known allergies, not allergies to medications, food, or other products. The patient received other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced non-serious flu like symptoms three days after vaccine on 15Jan2021 at 04:00 PM, lasted for 4 days. No treatment received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid (Nasal Swab) tested on 19Jan2021 post vaccination but the result was pending. The outcome of the event was recovering.
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| 68 | 2021-02-01 | nasopharyngitis, nasal congestion, cough, fatigue, fever |
Was exposed to a COVID + person on the 12/20/2020, took a COVID test on 12/23/2020 negative results,...
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Was exposed to a COVID + person on the 12/20/2020, took a COVID test on 12/23/2020 negative results, on 12/26/2020 started feeling feverish at night, just did not feel good, felt tired, felt different. Then the next day started developing a cough in the afternoon, no fever during the day, took my temperature and it was 99.8F and it was later on the afternoon. On the 27th I started coughing a lot more, it kinda hurt a little bit like Bronchitis, not productive at all, I coughed a lot. Did not feel bad at all but the cough was very present. On Tuesday evening it felt like I was coming down with a cold and Wednesday my taste buds started changing, I could not taste as well and then my cough got better. Just had a stuffy nose like a cold, I was feeling fine, was able to do all my normal activities as usual. It might have lasted overall 7 days and I was completely fine.
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| 68 | 2021-02-01 | fever, chills, malaise |
Developed a slight fever late at night the same day f the vaccine. Had chills, was freezing at night...
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Developed a slight fever late at night the same day f the vaccine. Had chills, was freezing at night, had lots of blankets, electric heater could not feel warm. Did not take anything. Next morning woke up and still felt a little bit of general malaise, took Tylenol and that is it, it was all over in 24 hours.
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| 68 | 2021-02-01 | fever, chills |
101.2 fever, chills, body aches, nausea, diarrhea, very sore left arm. Symptoms started early morni...
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101.2 fever, chills, body aches, nausea, diarrhea, very sore left arm. Symptoms started early morning of 01/29/2021 and lasted until midday on 01/30/2021.
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| 68 | 2021-02-02 | fatigue, fever, headache, chills |
1.23~starting with stomach ache and lots of elimination which turned into diarrhea. 1.24~awful diarr...
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1.23~starting with stomach ache and lots of elimination which turned into diarrhea. 1.24~awful diarrhea and stool was black for a few eliminations. Fever, Chills, Nausea, arm sore, headache, fatigue, body ache 1.25 ~ symptoms continued 1.26 ~ more black stool. Dr. advised me to go to ER. They did find blood in stool. 2.1~finally had normal bm and started to feel better
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| 68 | 2021-02-02 | headache, chills, fatigue | hyperesthesia, myalgia, chills, fatigue, headache |
| 68 | 2021-02-03 | headache | Hives arm soreness and a headache |
| 68 | 2021-02-03 | headache |
2nd dose COVID-19 vaccine (Pfizer EK4176) received on Thursday 1/28/21. approxx 8 hours later devel...
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2nd dose COVID-19 vaccine (Pfizer EK4176) received on Thursday 1/28/21. approxx 8 hours later developed headache which increased in intensity and eventually triggered a migraine, severe dizziness making it impossible to sit/stand, muscle aches,nausea. no temperature or chills. The headache lasted all day lasted all day Friday and decreased in intensity by Saturday. With rest, the dizziness resolved by Friday evening. The muscle aches remained mildly for a few days.
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| 68 | 2021-02-03 | malaise, chills, headache |
Fuzzy; Unsteady; Weak/Not very energic/Fatigued; Lightheaded/Dizzy; Chest tight; My eyed began swimm...
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Fuzzy; Unsteady; Weak/Not very energic/Fatigued; Lightheaded/Dizzy; Chest tight; My eyed began swimming with a sensatoin of shutters being opened and closed in front of me/could not see very well; Eyes very photosensitive; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unknown route, on 14Jan2021 (at 08:30) at single dose on the left arm for COVID-19 immunization. Relevant medical history included orthostatic intolerance, myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS). Relevant concomitant medications included hydrocortisone (CORTEF), levothyroxine sodium (SYNTHROID), fludrocortisone acetate (FLUDROCORTISON) and pyridostigmine. No other vaccine was received in four weeks. On 14Jan2021, after vaccination, she began to feel unsteady, weak, lightheaded, chest tight, and dizzy. Her eyed began swimming with a sensation of shutters being opened and closed in front of her. She could not see very well, eyes were very photosensitive. Layed down and slept, rested in a dark room most of the day. She had also chills and headache. But nightfall she felt mostly recovered, although not very energetic. About one week later, on 20Jan2021, it all happened again, all at once. She also rested for the day and slowly recovered. But this time it hasn't all gone away. She is still weak, fuzzy, unsteady, fatigued, she had headache, and 'my eyes are not right' (as reported). Pre-vaccination and post-vaccination COVID tests were not performed. No treatments were given for the events. The outcome of the events 'unsteady', 'weak/not very energic/fatigued', 'Lightheaded/Dizzy', and 'chest tight' was not recovered while the outcome of the remaining events was unknown.
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| 68 | 2021-02-03 | fever, fatigue, headache, chills |
Jan. 29 (evening): mild headache, mild chills, pain at injection site Jan. 30 (all day): moderate he...
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Jan. 29 (evening): mild headache, mild chills, pain at injection site Jan. 30 (all day): moderate headache, chills, aching (muscles), fatigue, low-grade fever (100.2), mild nausea, sore upper arm Jan. 31: mild headache, mild muscle/joint ache, chills, fatigue, pain at injection site, loss of appetite Feb. 1: mild pain at injection site Feb. 2: all symptoms resolved
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| 68 | 2021-02-03 | throat irritation |
Patient called into PCP office reporting red rash surrounding her mouth, extending to her chin and d...
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Patient called into PCP office reporting red rash surrounding her mouth, extending to her chin and down her neck. Patient also described throat as "scratchy".
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| 68 | 2021-02-04 | chills, headache |
6 hrs after injection swelling began and headache (About 9PM). Next morning swelling from shoulder t...
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6 hrs after injection swelling began and headache (About 9PM). Next morning swelling from shoulder to elbow & headache, chills, tool Tylenol. No appetite, very loose bowels at 10:00 am, (NOTE: NO fever) headache, chills continued all day & dizziness was added only when I moved my eyes like to glance at something or trying to read . Woke up, all symptoms were gone except a little swelling around injection site. 48 hours after injection, only very little swelling at injection site.
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| 68 | 2021-02-04 | chills, malaise | Intestinal pain, chills, generally feeling unwell |
| 68 | 2021-02-04 | fever, chills |
The night of the vaccine she woke up with: Diarrhea, black stools, weakness, fever, chills, stomach ...
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The night of the vaccine she woke up with: Diarrhea, black stools, weakness, fever, chills, stomach ache, nausea, rash on abdomen
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| 68 | 2021-02-04 | fever | Resident had fever of 103.1 with body aches but has been resolved afterwards. |
| 68 | 2021-02-05 | body temperature increased |
Low grade temp. 100.2 All over body aches tired/no energy I took 1250mg. Tylenol, 2x's on 2/5/2021 a...
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Low grade temp. 100.2 All over body aches tired/no energy I took 1250mg. Tylenol, 2x's on 2/5/2021 and slept most of the day. Today, 2/6/2021 I feel fine. No further symptoms and no further need for Tylenol.
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| 68 | 2021-02-05 | fatigue |
Lightheaded initially. Felt a little nauseous and tired Then went home and experienced vertigo when...
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Lightheaded initially. Felt a little nauseous and tired Then went home and experienced vertigo when I turned my head or bent forward. Still having vertigo off and on since vaccine. I have had vertigo before but usually never lasts this long or has felt quite like this.
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| 68 | 2021-02-05 | headache, sweating |
Early morning after vaccine started with headache then nausea and chilling. Chilling all day and ev...
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Early morning after vaccine started with headache then nausea and chilling. Chilling all day and evening Fever must have broke about 24 hours or so after with breaking out in a sweat. Symptoms just keep getting worse as the day progressed . Almost 24 hours after the bones just hurt. Today, 2/6/21, two days after vaccination still have nagging headache
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| 68 | 2021-02-05 | headache |
Headache beginning 5 hours after time of vaccination continuing until 16 hours after vaccination Arm...
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Headache beginning 5 hours after time of vaccination continuing until 16 hours after vaccination Arm soreness from 5 hours after vaccination until 36 hours after time of vaccination
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| 68 | 2021-02-05 | fever, chills, fatigue, headache, influenza like illness, nasal congestion |
Started with chills fever. Had flu like symptoms,joint pain headaches fatigue achy Just SICK all ove...
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Started with chills fever. Had flu like symptoms,joint pain headaches fatigue achy Just SICK all over. Nasal congestion.
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| 68 | 2021-02-06 | chills, fever, throat pain, sweating |
After 72 hrs extreme sore throat/ fever as high as 102.8 , muscle aches , chills and sweating still ...
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After 72 hrs extreme sore throat/ fever as high as 102.8 , muscle aches , chills and sweating still continuing after 3 days . Called on call doctor and she put me on zpac antibiotics 7pm Feb 6 . With Tylenol and ibuprofen able to get temperature down to 100.1 but goes back up in evening, 102 temp . I feel a little better this morning, temp . 99.8 , still extreme sour throat. On call doctor told me if systems get worse to go to immediate care
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| 68 | 2021-02-06 | headache, malaise, fever, fatigue, chills |
Beginning about 12 hours after injection, for apporximately 36 hours after injection, I had a fever ...
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Beginning about 12 hours after injection, for apporximately 36 hours after injection, I had a fever (high of 101), chills, pounding headache, body aches, vomiting, diarrea. I felt incredibly tired and slept, restlessly, on and off for 24 hours. I was unable to even drink anything for about the first 15 hours. Finally I was able to eat two crackers and tea and take tylenol which took the edge off the headache. All of these sympoms persisted for 36 hours. It was miserable and I honestly have never felt so sick. That is coming from someone who has been through labor, childbirth, c- sections, and several major surgeries. I don't think I could do another vaccine without being supervised in a health care facility to help manage the side effects for the first few days. Also, I had a mild case of Covid beginning November 9, 2020 that lasted about 2 weeks. I was only exposed to one person who had covid that I am aware of. When I was with that person for about 15 minutes, we were masked and 6 feet apart. I do not go anywhere but work and am always masked, as is everone else I work with and we are always at least 6 feet apart.
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| 68 | 2021-02-06 | influenza like illness, headache | Headache. site of Injection. slight nausea. Flu like feeling. |
| 68 | 2021-02-06 | fever, chills | Dizziness, Fever, Chills |
| 68 | 2021-02-07 | chills |
blood shot right eye; Allergic reaction; Chills; Her lips are a pinkish color as if she is still hav...
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blood shot right eye; Allergic reaction; Chills; Her lips are a pinkish color as if she is still having some type of reaction; She did have nausea this morning; This is a spontaneous report from a contactable consumer reporting for herself. A 68-years-old female patient received bnt162b2 (BNT162B2; Lot # EL1283) , via an unspecified route of administration on 21Jan2021 at single dose for Covid-19 immunisation . Medical history included cataract operation on 10Nov2020, oedema , swelling , brain operation on 2016 , aneurysm (aneurysm that did not rupture and there are 8 coils protecting that) , implantable cardiac monitor insertion , hypertension. Concomitant medication included lisinopril dihydrate (LISINOPRI)Lacetylsalicylic acid (ASPIRIN BAYER), amlodipine besilate (AMLODIPIN) pravastatin sodium (PRAVASTATIN) The patient experienced chills on 21Jan2021 with outcome of not recovered , her lips are a pinkish color as if she is still having some type of reaction on 21Jan2021 with outcome of not recovered , she did have nausea this morning on Jan2021 with outcome of unknown , blood shot right eye on 22Jan2021 with outcome of not recovered , she thinks she had an allergic reaction on 21Jan2021 with outcome of not recovered. The patient received Benadryl, Prednisolone and Ketorolac as treatment. Follow up information has ben requested.
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| 68 | 2021-02-07 | fatigue, chills, headache, fever |
pain down left arm to wrist and hand (still there); pain down left arm to wrist and hand (still ther...
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pain down left arm to wrist and hand (still there); pain down left arm to wrist and hand (still there); unable to open & close left hand until next morning; Headache; occasional chills; fever; fatigue; Mild facial swelling; This is a spontaneous report from a contactable consumer (patient) reported that a 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9263; expiry date: unknown) via an unspecified route of administration in the left arm, on 21Jan2021 at 14:00, at a single dose, for COVID-19 immunization. Medical history included allergies to Sulfa. The patient did not have other chronic health conditions. Concomitant medications included turmeric [curcuma longa rhizome], and ashwagandha. The patient previously took doxycycline and experienced allergies. On 21Jan2021, the patient had mild facial swelling 20 minutes after inoculation, at 14:30 the patient had pain down left arm to wrist and hand (still there), unable to open and close left hand until next morning, headache, occasional chills, fever and fatigue. The patient did not receive treatment for the events. The events were considered non-serious. The patient was recovering from the events.
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| 68 | 2021-02-07 | fatigue, headache, malaise |
joint pain; dizzy; face a little swollen; splotches on both cheeks; burned; Feeling sick; Injection ...
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joint pain; dizzy; face a little swollen; splotches on both cheeks; burned; Feeling sick; Injection site pain; Headache; Muscle pain; tired; This is a spontaneous report from a contactable consumer reporting for herself. A 68-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration in the left arm, on 13Jan2021 14:30 at single dose for Covid-19 immunisation . Medical history included cyclic neutropenia from 1998, thyroid disorder from 2001. There were no concomitant medications. The patient experienced feeling sick on 13Jan2021 with outcome of recovering , injection site pain on 13Jan2021 with outcome of recovering , headache on 13Jan2021 with outcome of recovering , muscle pain on 13Jan2021 with outcome of recovering , tired on 13Jan2021 with outcome of recovering , splotches on both cheeks on 14Jan2021 with outcome of recovering , dizzy on 16Jan2021 with outcome of recovering , face a little swollen on 16Jan2021 with outcome of recovering , joint pain on an unspecified date with outcome of recovering , burned on 13Jan2021 with outcome of recovering. The patient received ibuprofen 400 mg to treat headache, muscle pain, joint pain. The patient is not sure if LOT number is EL1283 or EC1283. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 68 | 2021-02-07 | fatigue, fever |
Fever; Fatigue; This is a spontaneous report from a contactable consumer (patient's spouse). A 68-ye...
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Fever; Fatigue; This is a spontaneous report from a contactable consumer (patient's spouse). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. Medical history included covid-19 in 2020 wherein the reporter and the patient had it last year. The patient's concomitant medications were not reported. The patient experienced fever with outcome of recovering. She already took TYLENOL to treat her fever. It was queried if the patient can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The patient was a nurse, she got the Pfizer vaccine yesterday on 21Jan2021, that at 3am this morning (22Jan2021), she had a 101 degree temperature, a 100 degree temperature at 8AM and a while ago it was 99.9 degrees at around 9:30 this morning. The reporter wanted to known if these were expected and what they should do. The reporter mentioned that his wife's case was not so bad, states that he himself was in the unit for some weeks. The patient also had fatigue 22Jan2021 with outcome of not recovered. Information about Lot/Batch has been requested.
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| 68 | 2021-02-07 | headache, chills, fatigue | Side effects profound fatigue, incessant chills, headache |
| 68 | 2021-02-07 | headache |
Pt states she developed a headache aproximatley 15-20 minutes after receiving the vaccine at 12:15. ...
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Pt states she developed a headache aproximatley 15-20 minutes after receiving the vaccine at 12:15. Pt states her headache has not gone away and would like to have her vitals taken. Pt's vitals are stable. Pt requested to sit with the crew and monitor her vitals. At 13:10 Pt states her headache is gone. Pt refused transport to hospital.
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| 68 | 2021-02-07 | headache |
Patient initially felt dizziness and headache within 15 mins of receiving the vaccine. Blood pressu...
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Patient initially felt dizziness and headache within 15 mins of receiving the vaccine. Blood pressure was 180's/96. About 1 hour after vaccine, patient's blood pressure was 160's/90. Around 1pm BP was 201/102. Patient went to EC and was treated with Klonopin and Benadryl. After Klonopin, BP was 150's/80's. Patient was discharged home from EC. BP on 12/23/2021 was 110/60.
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| 68 | 2021-02-07 | malaise |
Approx 5-10 min after receiving the injection patient c/o not feeling well, lightheaded, visual migr...
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Approx 5-10 min after receiving the injection patient c/o not feeling well, lightheaded, visual migraine (has history of. Assisted to private location and removed some of her winter garments to cool her. She also took in water as she had not drank much that day she stated. Ice pack to the back of neck also applied. Vitals taken and wnl. Affter approx 10 min patient states headache resolved and was feeling slightly better. Observed till symptoms resolved. Denies any resp symptoms during entire process. No swelling anywhere on person.
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| 68 | 2021-02-07 | nasal congestion, sinus congestion, head discomfort |
Head fullness, sinuses dried, nose stuffy, weak, spacey, rapid pulse, Felt as if I would pass out, ...
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Head fullness, sinuses dried, nose stuffy, weak, spacey, rapid pulse, Felt as if I would pass out, ashy/pale complexion. Felt extremely weak in the evening.
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| 68 | 2021-02-08 | fatigue |
6 hour run of AFib. I am a physician. I did not go to the hospital but had an irregularly irregular ...
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6 hour run of AFib. I am a physician. I did not go to the hospital but had an irregularly irregular pulse with light headedness, mild shortness of breath, and after spontaneous conversion felt tired.
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| 68 | 2021-02-08 | headache |
Severe migraine and head pain. Onset 24 hours after vaccine. Generalized itching from top of head ...
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Severe migraine and head pain. Onset 24 hours after vaccine. Generalized itching from top of head to toes. Both lasting about 48 hours
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| 68 | 2021-02-08 | headache |
suspect polymyalgia rheumatica; bilateral proximal muscle stiffness; weakness/ could not support her...
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suspect polymyalgia rheumatica; bilateral proximal muscle stiffness; weakness/ could not support herself to walk around in her home; pain in her upper and lower extremities/ this bilateral upper and lower extremity pain; stiffness and weakness beginning at the shoulders and hips; dull headache; This is a spontaneous report from a contactable healthcare professional. A 68-year-old female (not pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 14Jan2021 at single dose for COVID-19 immunization. Medical history included HTN (hypertension), COPD (chronic obstructive pulmonary disease), previous TIA (Transient ischemic attack) with some residual right sided weakness, CHF (congestive heart failure), osteoarthritis. Had a childhood vaccination history. No Known allergies. Concomitant medications included albuterol, aspirin, atorvastatin, fluticasone, furosemide, hydralazine, ibuprofen, lisinopril, metoprolol, multivitamin, all above were in two weeks (as of 25Jan2021). The patient previously received influenza vaccine yearly, and received her pneumonia vaccines over the last several years, both for immunization and never had a reaction to a vaccine. The patient was not pregnant at time of vaccination. No other vaccine received in four weeks. The patient developed a dull headache on 15Jan2021, one date after the vaccine, but that it resolved after 24 hours on 16Jan2021. On 16Jan2021 at 8:00 AM, the patient developed bilateral proximal muscle stiffness, weakness, and pain in her upper and lower extremities over the course of 1 week. The patient started experiencing this bilateral upper and lower extremity pain, stiffness and weakness beginning at the shoulders and hips and extending distally over several days. Her symptoms started out relatively mild and progressively got worse over the course of 7 days. She presented to the reporting healthcare professional 8 days after her vaccination and she was extremely weak and could not support herself to walk around in her home, the reporting healthcare professional suspect polymyalgia rheumatica. All the events (except dull headache) resulted in emergency room/department or urgent care, hospitalization. The patient was hospitalization due to all the above events for 3 days. The patient had a remarkable response to the treatment of prednisone during her hospitalization. It was unknown if covid prior vaccination. The patient underwent lab tests and procedures, which included COVID tested (COVID test type: Nasal Swab, SARS-COVID19 PCR) post vaccination on 23Jan2021: Negative. Outcome of event headache was recovered on 16Jan2021 and all the events was recovered on an unspecified date. Information about lot/batch number was requested; Sender's Comments: A possible contribution role of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded, considering the temporal relationship. However, it is worth noting that the 68-year-old female patient had pre-existing osteoarthritis, which could be one of the causes of joint symptoms. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2021-02-08 | headache |
Left arm itching, swollen and skin on entire left arm was red and across shoulder to neck. Neck pain...
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Left arm itching, swollen and skin on entire left arm was red and across shoulder to neck. Neck pain and headache. Early evening I developed hoarseness and trouble breathing. Went to Emergency room. They administered IVwith Benedryl; Prednisone; and Pepcid. After an hour my breathing was better and some of the redness on arm was better. I went to physician on 2/5/2021 because of neck pain and was prescribed MethylPrednisolone Tablets, 4 MG. 6 day pack and was on day 3 when the symptoms started.
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| 68 | 2021-02-08 | sweating |
Pt c/o felt nausea, sweaty, ears became tingling and then went number. Was in placed in a wheelchair...
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Pt c/o felt nausea, sweaty, ears became tingling and then went number. Was in placed in a wheelchair and assisted to private location. C/o eyes feeling funny and tearing. next c/o chest pressure and tingling started down legs. Breathing labored and flushed skin. Epi administered and assisted to ER.
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| 68 | 2021-02-08 | fever, chills | CHILLS, FEVER UP TO 101 DEGREES, BODY ACHES, NAUSEA, WEAKNESS LASTED FOR 24 HRS THEN WEAKNESS |
| 68 | 2021-02-09 | headache |
Nasty taste in mouth , Headache, started 25 min. after shot. Nausea and stomach pain started at 10 P...
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Nasty taste in mouth , Headache, started 25 min. after shot. Nausea and stomach pain started at 10 PMon the 6 Feb. 2021. body aches. On 7th the same. Nausea went away on 8th. arm sore. went away on 9th. the nasty taste still have it on 10th. No headche stopped on 9th. Just feel week. going away on 9th of Feb.
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| 68 | 2021-02-09 | headache |
Pin prickly feeling in different areas of her body; Headache; Funny feeling on the top of her head a...
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Pin prickly feeling in different areas of her body; Headache; Funny feeling on the top of her head and down her forehead and around her right eye, like a numbing sensation; Stinging feeling in sinus cavity; This is a spontaneous report from contactable consumer (patient) A 68-years-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from lot#292673 on left deltoid (reported as left shoulder) on 25Jan2021 11:21 at SINGLE DOSE for covid-19 immunisation . Medical history included diabetes from 11Sep2001 and ongoing , ongoing cardiac pacemaker insertion Put in about 7 years ago , ongoing blood cholesterol increased Diagnosed about 24 years ago , ongoing blood triglycerides increased. She is allergic to statins. Concomitant medication included alirocumab (PRALUENT) 1 mL at 1ml injection every 14 days for High cholesterol (Injection on side or top of her leg. She has been taking for about 4 year).The patient experienced headache on 25Jan2021 with outcome of recovered , funny feeling on the top of her head and down her forehead and around her right eye, like a numbing sensation on 25Jan2021 with outcome of unknown , stinging feeling in sinus cavity on 25Jan2021 with outcome of recovered , pin prickly feeling in different areas of her body on an unspecified date with outcome of unknown. Clincial course reported as follows:She got the first dose of the vaccine today and while she was sitting in the observation area, she started getting a headache. It was close to noon and she just blew the headache off since she was a diabetic. She started getting a funny feeling on the top of her head and down her forehead and around her right eye, like a numbing sensation. When the feeling hit her sinus cavity, it was like a stinging. She started drinking water and she had lunch. Within an hour it started getting better and within 3 hours it was a lot better. She has a pin prickly feeling in different areas of her body but did not have the numbness sensation. She tried to report this online. She only had one virtual visit with her doctor. Treatment: declines any, she was drinking plenty of water to try and flush some it out of her system.
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| 68 | 2021-02-09 | fever, headache |
woke up with burning in her ears; fever; Low grade headache/worse headache; This is a spontaneous re...
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woke up with burning in her ears; fever; Low grade headache/worse headache; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (BNT162B2), on Jan2021 07:30 PM at single dose in Right arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Systemic Lupus Erythematosus. Concomitant medication received within 2 weeks of vaccination included denosumab (PROLIA), trazodone, ezetimibe, simvastatin (VYTORIN), duloxetine, hydroxychloroquine sulfate (PLAQUENIL), cevimeline. Low grade headache occurred the day after the vaccine on 22Jan2021 04:30 AM and has lasted until now. But 24Jan2021 the patient woke up with burning in her ears, a worse headache, and a fever. The outcome was Recovering. No treatment received for the adverse event. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. All the events were assessed non-serious. Information on the lot/batch number has been requested.
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| 68 | 2021-02-10 | fatigue, respiratory tract congestion, pneumonia, malaise |
arm soreness; community acquired pneumonia; COPD; shortness of breath; chest congestion; weakness; f...
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arm soreness; community acquired pneumonia; COPD; shortness of breath; chest congestion; weakness; fatigue; Muscle aches and pains; she became ill; This is a spontaneous report from a contactable nurse from a Pfizer-sponsored program Pfizer First Connect. A 68-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on 06Jan2021 at single dose on right deltoid for covid-19 immunisation. Medical history included blood pressure high and seasonal allergies. There were no concomitant medications. The patient previously received first dose of bnt162b2 (Lot: EJ1685) on 16Dec2020 for COVID-19 immunization. The patient experienced community acquired pneumonia, shortness of breath, chest congestion, weakness, fatigue, COPD, muscle aches and pains, she became ill, all on12Jan2021; arm soreness on an unspecified date. Events required Emergency Room visit. Clinical course reported as: she got the second dose of the pfizer covid vaccine on 06Jan2021 and on 12Jan2021 she experienced shortness of breath, chest congestion, weakness and fatigue. Nurse stated ER doctor thought she had COPD or community acquired pneumonia. Nurse further stated she had the second COVID-19 vaccine on 06Jan2021. A week later on 12Jan2021, she became ill. She had all the symptoms of COVID. She was short of breath, very fatigued. She couldn't get any air, she was at work. She had muscle aches and pains. The shortness of breath, fatigue and weakness lasted several days. She also had severe chest congestion. She confirmed she got better. It actually took 4 or 5 days. By that Sunday (17Jan2021) she was better. She wanted it noted she had no reaction right after the shot. She stated she only had arm soreness, it was just a little sore, not even worth mentioning. It was only when she moved her arm a certain way. This was with either vaccine (first or second vaccine). She went to the doctor and somebody thought it might be a reaction, but the nurse thought it was too late for a reaction. The ER doctor thought it was COPD and community acquired pneumonia. Her primary doctor thought it was COPD. The patient underwent lab tests and procedures which included COVID-19 test: negative on 12Jan2021. Outcome of arm soreness was unknown, others was recovering.; Sender's Comments: Based on the drug-event time interval and the vaccine's safety profile, the community acquired pneumonia is possibly intercurrent condition, unrelated to vaccine BNT162B2 administration, which is not the disease that the vaccine BNT162B2 can prevent from. While the COPD is more likely underlying condition, unrelated to vaccine BNT162 injection. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2021-02-10 | throat pain | sore throat |
| 68 | 2021-02-10 | fever, chills, headache | Uncontrollable shaking chills, fever, headache stomach pain |
| 68 | 2021-02-10 | fever, chills, headache | Headache, fever, chills, body aches. Symptoms were intense. |
| 68 | 2021-02-10 | fever, chills, sweating, headache, fatigue |
6 hours after 2nd shot ran 202 degree fever, had head ache, muscle aches, chills, sweats, and fatigu...
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6 hours after 2nd shot ran 202 degree fever, had head ache, muscle aches, chills, sweats, and fatigue for well over 48 hours.
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| 68 | 2021-02-11 | headache, chills, fever, malaise, fatigue |
I was fine except for soreness in the arm and a mild headache from the time I got the vaccine (Wedn...
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I was fine except for soreness in the arm and a mild headache from the time I got the vaccine (Wednesday 1:20 p.m.) through the evening, but woke up (Thursday morning about 6:00) very sick . I had a worse headache, extreme tiredness, nausea , vomiting (dry heaves as I couldn?t eat or drink the whole time), fever and chills. The bouts of vomiting fever and chills came in three through the day. I felt extremely unwell the whole time and just kept reminding myself that it would be over soon, but it lasted throughout Thursday. I fell asleep around 5:00 p..m. Thursday afternoon and woke up around midnight feeling that the symptoms had passed. Now it?s Friday morning (5:30 a.m.) and I feel completely well again.
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| 68 | 2021-02-14 | chills, fatigue, headache |
Sudden fatigue, chills, headache, painful arm from injection site to fingers, tingling in left hand ...
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Sudden fatigue, chills, headache, painful arm from injection site to fingers, tingling in left hand and fingers
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| 68 | 2021-02-14 | headache, fever, malaise, chills, fatigue | infection site pain, tiredness, headache, chills, joint pain, fever, foggy thinking, feeling unwell |
| 68 | 2021-02-14 | sweating, headache, fever, fatigue |
Immediately following the injection and till the next morning, my arm was tender at the injection si...
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Immediately following the injection and till the next morning, my arm was tender at the injection site. The following morning my arm was more painful at injection site. Around noon the day after the 2nd shot, I began to feel achy all over and couldn?t get warm. By 2:00 a headache began. At 3:01 I had a fever of 101.7*, at 4:02 it was 102.*, at 6:23pm it was up to 103.1*. The body aches and headache worsened. At 9pm I called a nurse advocate who said all symptoms were normal and to take 2 ibropfen for the fever. I slept most of the afternoon and evening. By 10:30, I woke up all sweaty and the fever had broken. On Feb. 11th, my arm was only slightly painful, I had no fever or aches, just felt tired. On the 12th, I was fine.
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| 68 | 2021-02-14 | fever, chills | Chills, Fever, Body aches |
| 68 | 2021-02-15 | fatigue |
Sudden onset tired, exhausted, noted to be tacky cardiac. Check my pulse (retired RN, BSN,OCN.) ov...
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Sudden onset tired, exhausted, noted to be tacky cardiac. Check my pulse (retired RN, BSN,OCN.) over 150., peripheral and attempted to reck apical w stethoscope, Hard to count. Noted pulse 156 on Fitbit. Called local Urgent Care, Staff noted I sounded SOB on the phone, I was. Drove self to Urgent Care Office, EKG done -tacky, VS done, labs drawn. All labs WNL except D Dimer as >2. ++, (do not have in front of me). Was recommended that I go to ED- to be r/o for PE. Went to ED repeat EKG, Labs, CT scan w contrast and negative for PE. Discharged to home.
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| 68 | 2021-02-15 | respiratory tract congestion, fever |
After both doses had soreness around injection site on arm, lasting 3 days. After dose 1, 5 days aft...
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After both doses had soreness around injection site on arm, lasting 3 days. After dose 1, 5 days after I had itching, prickly tingly sensations everywhere, especially arms, legs, neck, and back. These lasted for 11 days after that, finally subsided. But then I got dose 2, and had sore arm, and next day, aches in muscles, low fever, congestion but all mild. Took ibuprofen and went away after 24 hours. 5 days later, the itching, tingling started up again and was more intense and everywhere. Have had some redness, swelling, red bumps in itchy areas, they come and go. Worse when I have hot flash. Itching is keeping me awake along with anxiety and restlessness. Hope this won't last for another 10 days, very uncomfortable.
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| 68 | 2021-02-16 | sleepiness, sluggishness, runny nose |
out like a 'light' and this stuff knock her out; whole entire face her head, down her back her neck ...
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out like a 'light' and this stuff knock her out; whole entire face her head, down her back her neck was numb/Numbness in leg/jaws are numb; I'm feeling my teeth are still and my jaws are numb; felt very odd sensation as she was swallowing; was closing up but much wasn't closing up/it was not full open; swelling on her throat; Muscle pain in my left arm where they gave me injection and it hurts my neck area across my back down my arms specially my left side; it hurts my neck area across my back; it hurts my neck area across my back; Stumbling; face was swollen; eyes looks like little switch; thirsty; felt very sluggish; nose started to running; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first single dose BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (anatomical location: arm left) on 29Jan2021 15:00 for COVID-19 immunization. Medical history included insomnia and asthma. The patient's concomitant medications were not reported. Patient stated, "I got the vaccine yesterday about 3 pm and I came home and I had dinner and sat down to watch TV at 9 O' clock, I turn the program on and I was out like a 'light' and this stuff knock me out (onset date: 29Jan2021). My dog has to wake me up licking my face at 3:15 this morning. I normally don't sleep long 4 hours and that's it. I'm 68 years old and I have insomnia (History) but when I woke up I was stumbling around, still have to sleep (onset date Jan2021), I took the dog out to walk and came back and saw myself in mirror, my face was swollen and my eyes looks like little switch. I noticed, I was thirsty and I went to get and drank, some coke because I felt very sluggish and I drank some coke and when I was swallowing the coke I felt very odd sensation as I was swallowing, I noticed that after swallowing. I have asthma (History) to begin with so I'm anticipated on having some of the symptoms it start showing up a bit, my nose started to running and I noticed that my whole entire face my head, down my back my neck was numb along with swelling on my throat, I felt okay but I felt it wasn't being, it was closing up but much wasn't closing up you know what I mean it was not full open. I also had muscle pain in my left arm where they gave me injection and it hurts my neck area across my back down my arms specially my left side. I also noticed I went to a lovely person and when I went to bathroom I pull my pants down I felt numbness on my legs. So, my whole body was kind of having that not tingling sensation but numb and when I ran my fingers across my leg you know how you feel numbness when you run your fingers across a part of your body when it's numb that's exactly how I felt and that was about 3:30 this morning that happened I woke up by but I also want to ask question because I got to go back to my second shot. I'm wondering if I go back to my second dose am I going to have even more intense reaction to the stuff that I get this time." Patient further added "I was still trying to eat something but I'm feeling my teeth are still and my jaws are numb and this I got since yesterday (29Jan2021)." The outcome of events was unknown. Information on the lot/batch number has been requested.
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| 68 | 2021-02-17 | chills, fever |
This is a spontaneous report from a contactable consumer reported for herself. This 68-year-old fema...
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This is a spontaneous report from a contactable consumer reported for herself. This 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number EL9265), via an unspecified route of administration at single dose in the left arm on 31Jan2021 11:30 for covid-19 immunisation. Medical history included liver disorder, kidney disease, asthma, allergies to PCN, Sulpr, Iodine dye, pineapple, spinach. Concomitant medications were not reported. On 01Feb2021, the patient experienced achy, fever, chills and neck muscle sorenesswith. No treatment required. The outcome of the events was recovered on an unspecified date in Feb2021. The vaccine was administered at Health Clinc and facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. The patient had not been diagnosed with COVID-19 prior the vaccination.
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| 68 | 2021-02-18 | cough |
Feb 5, 2021 at 8:45 started coughing as if having an allergic reaction to a cat. We stopped and g...
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Feb 5, 2021 at 8:45 started coughing as if having an allergic reaction to a cat. We stopped and got me some Claritin, cough drops, and water. Called my PCP and left message. Coughed an asthmatic cough Friday, Saturday, Sunday and Monday. On Monday, Feb. 8 called PCP again. We had a virtual visit. He said, it was not an allergic reaction. He prescribed Prednisone and Alburetol inhaler. On Thursday Feb . 11 I got a rash all over my body that came and went and I got Hives on the palms of my hands. Virtual visit with my PCP. He said that he retracted his statement from Monday and evidently I was having a reaction to the Vaccine. I kept taking the Steroid which I finished on Monday. The rash and hives bothered me till Monday. Tuesday and Wednesday rash and hives gone. On Thursday morning I woke up with a burning pain across my left side of my chest to the backside and pain on my knees. On Friday the pain was also on the backside of my waist. It felt like shingles. Went to see the NP at Dr. office. They don't think I have shingles. This is all still a reaction to the vaccine.
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| 68 | 2021-02-18 | malaise, headache, fever |
I had a serious case of COVID-19 in 3/2020. After the vaccine, I felt like I had the illness all ov...
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I had a serious case of COVID-19 in 3/2020. After the vaccine, I felt like I had the illness all over again. I got a fever of 101, loss of appetite, slept 16 hours a day, headache, slight nausea, some pain at injection site. This lasted about 48 hours. I took two Tylenol 20 hours after the vaccine as the headache was so bad. I got better within 48 hours. No medical help was sought.
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| 68 | 2021-02-18 | fever, chills |
Received shot at 6:00 am. At 4pm started to experience chills, then fever and body aches. Gone by...
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Received shot at 6:00 am. At 4pm started to experience chills, then fever and body aches. Gone by 7 am the next day.
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| 68 | 2021-02-21 | chills, fatigue, fever |
Got up the next morning after 1st vaccination with crusty eyes, itchy and watering. Self care till ...
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Got up the next morning after 1st vaccination with crusty eyes, itchy and watering. Self care till sunday 3rd day went to UC. Said I had pink eye. Gave medication. Later in the day started with fever, fatique, chills by day 5 after vaccination was told to get a Covid test which came back negative. They felt I had a late immune response. Was in good health for 2nd vaccination and the same thing happened with my eyes. Pink eye. We are 20 days out from 2nd vaccination and have pain in eyes, and watery. Spoke with Opthamologist office and they suggested 1st I try Refresh for 2 weeks if my eyes are not better will need to be seen. could be a response from the vaccine.
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| 68 | 2021-02-21 | chills, headache |
injection site pain, body ache , headache, stiff neck, dizziness, chills, swollen lymph glands in un...
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injection site pain, body ache , headache, stiff neck, dizziness, chills, swollen lymph glands in underarm area. acetaminophen 1000mg every 8 hours was effective for pain relief . bed rest
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| 68 | 2021-02-21 | chills, productive cough, headache, body temperature increased |
That evening, 2/17/21, I got home ate some soup in bed soon after, slept 10 hours! The next morning...
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That evening, 2/17/21, I got home ate some soup in bed soon after, slept 10 hours! The next morning went to work and then around 9:30 the chills started, checked my temp 99.8 decided to take myself home, at took temp again, 101.7 then an hour later 102.7 where it remained for the rest of 2/18/21. By the next morning no more chills and temp 97.6. I do have a lingering headache on both sides of my head which meanders down my neck. The site of the injection is still sore and seems to have moved 3 inches down my arm. And there is also a lingering phlegm problem building up at the back of my throat.
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| 68 | 2021-02-21 | headache, fatigue |
Chest pains by heart once in the car; Itching by neck, shoulders, upper arms, legs, back; Throat clo...
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Chest pains by heart once in the car; Itching by neck, shoulders, upper arms, legs, back; Throat closed up a bit; Sore upper left arm at injection site; Headache; Fatigue; Later on sharp pains in left calf upon walking; Numbness in left facial cheek and left side of tongue; Numbness in left facial cheek and left side of tongue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 13:30 at single dose for COVID-19 immunization. Medical history included allergies or hypersensitivity. Concomitant medication was not reported. The patient was not pregnant at the time of vaccination. The patient was vaccinated at a health facilty. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received second dose of varicella zoster vaccine (lot number and expiry date not reported) on 18Jan2021 at single dose for immunization. Five minutes after first shot of Pfizer Covid 19 vaccine, on 02Feb2021 13:35, it began itching by neck, shoulders, upper arms, legs, back; throat closed up a bit. The patient was administered 50 mg Benadryl, but itching continued. The patient had sore upper left arm at injection sight. They waited at the vaccination facility under care of 3 nurses for one hour. The patient was offered Epi-pen, but did not administer Epi-pen. The patient's husband drove her home. She had chest pains by heart once in the car. The patient had headache, fatigue, and later on sharp pains in left calf upon walking, numbness in left facial cheek and left side of tongue and difficulty swallowing. Clinical outcome of the events was not recovered.
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| 68 | 2021-02-21 | headache |
Intense headache from temple across eyes to temple. Severe eye pain. Totally unlike my migraines. La...
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Intense headache from temple across eyes to temple. Severe eye pain. Totally unlike my migraines. Lasted two days Also body aches. Lasted two days
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| 68 | 2021-02-21 | headache |
Pt. in tent 4 at 2:31 at observation lane was reporting throat tightness and headache. Paramedics a...
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Pt. in tent 4 at 2:31 at observation lane was reporting throat tightness and headache. Paramedics assessed vitals. Bp 210/115. Paramedics and Pt. wanted her to go to the hospital. Emergency services was called. She was transported.
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| 68 | 2021-02-21 | throat irritation | Scratchy throat. given Benadryl and relieved. No respiratory symptoms. |
| 68 | 2021-02-22 | chills, fatigue |
I got the shot at 10:30am. My arm was mildly painful at the injection sight. During the next early ...
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I got the shot at 10:30am. My arm was mildly painful at the injection sight. During the next early morning (~2:00am Friday, Feb 19) I had the chills for about 2 hours. I had intermittent muscle pain, nausea, and fatigue. These symptoms resolved during the day Friday, February 19th.
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| 68 | 2021-02-22 | chills | Chills & body aches Chills lasted about 8 hours Aches lasted 3 days |
| 68 | 2021-02-22 | fatigue, fever, chills | Fever, chills, fatigue, ache, at injection site minor soreness. This went on for about 32 hours |
| 68 | 2021-02-22 | headache, cough, runny nose |
About four days after the shot I started having a runny nose and a cough with lots of clear mucus ...
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About four days after the shot I started having a runny nose and a cough with lots of clear mucus from both. Then it went down to my lungs and my lungs really hurt . I do have asthma so maybe that?s a part of it? It just seems strange that I was coughing so much and gave me a headache. Then about six days later I got an attack of IBS. I haven?t had an attack like that for two years. Maybe it?s all a coincidence? Also about 3-4 days after shot I had a herpes outbreak.
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| 68 | 2021-02-22 | sweating | Dizziness, weakness, sweating, confusion,stumbling when trying to walk. |
| 68 | 2021-02-23 | chills, fatigue | Body aches, chills, tired, nausea, started next morning, lasted a day and a half. |
| 68 | 2021-02-23 | nasal congestion, cough |
After receiving her vaccine, client stated she started to cough. Client stated she has a stuffy nos...
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After receiving her vaccine, client stated she started to cough. Client stated she has a stuffy nose for the past 3 days.
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| 68 | 2021-02-24 | headache, fatigue |
After first shot on 1/28/21: Very slight headache next two mornings and very slight arm at site of s...
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After first shot on 1/28/21: Very slight headache next two mornings and very slight arm at site of shot. After second shot on 2/20/21: Almost imperceptible arm soreness day after (when driving and arm touched driver door), slight nausea (extremely unusual for me) on afternoons of 2/21, 2/22 & 2/23 along with moderate afternoon fatigue those days (I napped which is extremely unusual for me). Alka Seltzer didn't help but CupOSoup eliminated the nausea completely.
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| 68 | 2021-02-24 | headache, malaise, fever |
2.5 inch redness, swelling, itching, painful with a couple of hive looking spots at injection site ...
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2.5 inch redness, swelling, itching, painful with a couple of hive looking spots at injection site Also headache, fever, malaise
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| 68 | 2021-02-24 | sweating, fever | Body aches joint pain, sweats, fever |
| 68 | 2021-02-24 | malaise, chills, headache, influenza like illness |
Symptoms: chills, joint pain, severe headache with blurry vision, injection site soreness, muscle pa...
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Symptoms: chills, joint pain, severe headache with blurry vision, injection site soreness, muscle pain, feeling unwell - very sick, fatigue. I woke up 2/23/2021, Tuesday, with injection site tenderness upper left arm. Tuesday midday the headache began. By evening, I had chills, pronounced joint and muscle soreness, with further progression of headache to severe with vision changes, and a general malaise and feeling very ill. Like having the flu without fever or congestion. I did not seek medical treatment. Symptoms were treated with over the counter medicines and perscriptions medicines on hand, plus bedrest.
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| 68 | 2021-02-24 | malaise, sweating |
Pt received her first Pfizer COVID vaccine today at approximately 1305. She stated approximately 10...
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Pt received her first Pfizer COVID vaccine today at approximately 1305. She stated approximately 10 minutes into observation she developed abdominal pain and felt like she needed to have a BM. She sat on the toilet and had an episode of diarrhea and started to feel flushed, diaphoretic and stood up to go to the sink. She then felt nausea, dizziness and lightheaded and placed her head down leaning over the sink. EMT arrived to bathroom and sat patient down in a wheelchair. I arrived on scene shortly thereafter and the patient was pale and diaphoretic stating she did not feel well. EMS was activated. She was placed on the cardiac monitor and her HR was NSR in the 80's. BP 114/61, 96% on RA. Denied CP, SOB, rash, mouth, lip or tongue swelling. She was brought back to the observation area and was assisted to the gurney. Cool compresses were placed on her forehead and behind her neck. Medics arrived to scene to assess the patient. She stated she was feeling improved and did not want to go to the ED. She signed the AMA form. She was given water and crackers. She was monitored for 1 hour and stated she felt improved. She denied dizziness, lightheadedness, nausea or abdominal pain. I assisted her to the bathroom and she had one more episode of diarrhea. She stated she felt improved after that. She was monitored for 15 more minutes and stated she would like to go home. She was able to get up off the gurney without assistance, stated she felt well. She was ambulatory with a Steady gait and assisted outside. Prior to discharge I recommended she follow up with her PCP. Advised that she rest for the remainder of the day and to activate 911 should she develop any new or worsening symptoms. Advised that if she does get the second dose of vaccine she should be laying down at the time of administration and for 30 minutes after the injection for observation.
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| 68 | 2021-02-25 | chills, headache, fatigue |
Fatigue, Chills, Headache, sore arm at injection site. Took x2 extra strength Tylenol and took a na...
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Fatigue, Chills, Headache, sore arm at injection site. Took x2 extra strength Tylenol and took a nap. All signs and symptoms relieved by next day
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| 68 | 2021-02-25 | chills, fever, headache, malaise |
high fever, swollen face, rash in face, headache, nausea, swollen lymph nodes, joint pain, chills, w...
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high fever, swollen face, rash in face, headache, nausea, swollen lymph nodes, joint pain, chills, weakness, overall feeling not well.
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| 68 | 2021-02-25 | cough |
Patient started with slight cough while waiting 15 minutes. Patient then walked to make next appoint...
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Patient started with slight cough while waiting 15 minutes. Patient then walked to make next appointment and started wheezing and having trouble breathing. Patient given Epinephrine 0.3 mg IM and Benadryl 50 mg IM, and sent to ER for further evaluation and treatment.
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| 68 | 2021-02-25 | headache |
sustained high blood pressure; Have 2 aneurysms; Continuous headache; some dizziness; This is a spon...
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sustained high blood pressure; Have 2 aneurysms; Continuous headache; some dizziness; This is a spontaneous report from a contactable 68-year-old female consumer reported for herself. A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL9262), via an unspecified route of administration (right arm) on 26Jan2021, 17:15 at SINGLE DOSE for covid-19 immunisation, at 68 years old. Medical history included allergies: Penicillin from an unspecified date. Patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is taking unspecified concomitant medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EH 9899, at 68 years old), on 05Jan2021, 16:30, right arm for COVID-19 immunization. The patient experienced sustained high blood pressure, have 2 aneurysms, continuous headache, and some dizziness on 26Jan2021. Therapeutic measures were taken as a result of the events which include 3 different blood pressure medications, still not under control; medications and monitoring of pressure. She mentioned she has 2 aneurysms so she needs to keep her pressure normal. Outcome of the events was not recovered. The event was considered non-serious by the reporter.
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| 68 | 2021-02-25 | fever, chills, headache, fatigue |
Tues 2/23/2021: fever no greater than 101, chills, fatigue, body ache, headache all day, very sore a...
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Tues 2/23/2021: fever no greater than 101, chills, fatigue, body ache, headache all day, very sore arm. Fever treated with tylenol Wed 2/24/2021: No fever in morning, but headache, body ache, mild fatigue all day, sore arm, then fever of 102 in evening (about 5 pm). Treated with Tylenol successfully, fever abated pretty quickly. Thursday 2/25/2021: No fever or headache, but arm still pretty sore without tylenol. Friday 2/26/2021: feeling fine, arm is very slightly sore.
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| 68 | 2021-02-25 | fever, headache, chills | Sore arm, low grade fever, chills, headache |
| 68 | 2021-02-26 | cough, throat irritation |
Pfizer-BioNTech COVID- 19 Vaccine EUA Approx 5 minute post vaccination, patient began reporting itch...
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Pfizer-BioNTech COVID- 19 Vaccine EUA Approx 5 minute post vaccination, patient began reporting itching. Shortly after, developed a dry cough and reported that her throat "felt funny." Patient began vomiting and having difficulty breathing, speaking in 1-2 word sentences. Pt received epi pen to left thigh, with some resolution of symptoms. Pt continued to have cough and nausea, chest pain. Gave 25 mg benadryl IM at 08:27 am. Patient received 2nd dose of Epi for increased SOB, difficulty breathing, and increasing cough, with some resolution of symptoms. Patient reported increased chest pressure. Began having seizure like activity at 08:30, lasting approx 20 seconds with no post ictal period noted. EMS arrived after 2nd dose of epi. Second "seizure like" activity after EMS arrival, lasting approx 20 seconds. During transport to ambulance, patient had 2 more episodes of seizure like activity with no post ictal phase. ED note states low suspicion for true seizure since patient was awake during episodes of tonic clonic movements, answering questions during, and did not have post ictal state.
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| 68 | 2021-02-26 | headache, chills |
Severe & debilitating chills, headache, muscle and joint pain 16 hours after injection and lasting a...
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Severe & debilitating chills, headache, muscle and joint pain 16 hours after injection and lasting approximately 8 hours before tapering down to moderate pain level approx 30 hours following injection.
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| 68 | 2021-02-26 | sweating, headache, cough |
11:20 Eggy taste in throat, 11:45 on standing slight racing of heart, 1pm still noted eggy taste, 2:...
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11:20 Eggy taste in throat, 11:45 on standing slight racing of heart, 1pm still noted eggy taste, 2:30 eggy taste, slight shot ache, 4:30 light headache, 02/13/2021 2:30am woke with a rush feeling of med, started coughing, burst (spread) of warmth in center of chest, slight perspiration; 3:30am heart racing, warmth in chest, modest itchiness(arm, face & torso), soreness at injection site. 02/14/2021 7am burning/ itching injection site, & chest/torso arm red and square blotch about 1 1/2 inch very itchy and burning for several days. 02/23/2021 itchinesss better. Brown square area at site of injection. There is still a slight itch at times as if healing.
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| 68 | 2021-02-26 | fever | Daily fever to 101., which resolves in the afternoon |
| 68 | 2021-02-26 | fever | Anxiety and Pyrexia . Negative all other symptoms. Pt held for observation and provider released |
| 68 | 2021-02-27 | chills, headache |
Several hours after injection my arm hurt down to almost the elbow. Not bad. Next day same until a...
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Several hours after injection my arm hurt down to almost the elbow. Not bad. Next day same until about 3:30 and I started to get chills, body aches and pains then nausea and headache. Shivering for 4-5 hours under the covers in bed with extra blankets and clothes. Can?t say I?m overly concerned as searching online I?ve seen reports of similar reactions but best to report. Today feeling a bit better, not shivering but still achy but not as bad and still a little nauseous.
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| 68 | 2021-02-27 | chills | chills, shakiness, shortness of breath, body aches |
| 68 | 2021-02-27 | fatigue, lethargy, chills |
Night sweats, chills horrible muscle bone aches diahrrea, no appetite, had to crawl to the bathroom ...
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Night sweats, chills horrible muscle bone aches diahrrea, no appetite, had to crawl to the bathroom the last 3 days on hands and knees. Lethargic . Tired. Fatigue. 4 days now. And I am getting worse. Heaviness on chest
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| 68 | 2021-02-27 | fatigue, fever, head discomfort, headache, chills |
First shot only chills and mild muscle aches gone by the next morning. Second shot aftereffects wer...
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First shot only chills and mild muscle aches gone by the next morning. Second shot aftereffects were very different. Received the shot around noon on Tuesday , February 23, 2021. Later in the afternoon experienced muscle aches and chills. My head felt kind of weird. Hard to describe except I once had a morphine shot that made me feel close. I spent the next ~60 hours in bed. Fever, severe joint and muscle pain, migraine like headache, and brain fog is about all I remember. It could have been 2 hours or 60 hours, I don't remember. On Wednesday and Thursday my sedentary heart rate was 101 and 95 according to my Apple watch up from 77 on Tuesday. Couldn?t eat. Food tasted and smelled differently but not in a good way. Woke up this morning,Friday, with a mild headache and very fatigued but mostly back to normal.
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| 68 | 2021-02-27 | headache, malaise |
In one hour, extremely dry month, tongue and throat. Sharp pain on left side of forehead that would ...
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In one hour, extremely dry month, tongue and throat. Sharp pain on left side of forehead that would come and go. Overall, not feeling well. A few hours later (about 4 hours), tingling and numbness (neuropathy) in my lower legs and arms. Some neuropathy on left side of face.
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| 68 | 2021-02-27 | fever, fatigue | Fever 99.9 and shaking, after that 102.7 fever and tiredness. |
| 68 | 2021-02-27 | sleepiness, fever, fatigue |
Next day could not stand up without vomiting, fever 101, progressively worse as day went on to the p...
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Next day could not stand up without vomiting, fever 101, progressively worse as day went on to the point I could not lift my head off pillow. Could not eat, even sips of water or coke. Hard to breathe Day 2 fever 100 and slept most of day, still nauseous and dizzy with no appetite. Hard to breathe. Day 3 slept 12 hours and normal is 7 hours. Able to eat clear broth and drink lots of water. Fever 99.9 but went down to just 99. Normal for me is 96 and sometimes 96. Hard to breathe. Day 4 Teeth look off color. Able to eat egg, but no sense of taste. Sleep almost back to normal, but no energy. Sudden movement or bending I get out of breath.
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| 68 | 2021-02-28 | chills, fever, headache |
Bad headache, chills, fever, nausea, redness at injection site, stomach ache, weakness. The injecti...
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Bad headache, chills, fever, nausea, redness at injection site, stomach ache, weakness. The injection was on Friday and Saturday we woke up with the side effects. Sunday we were much better and Monday better.
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| 68 | 2021-02-28 | fatigue, chills | Chills, dizziness, nausea, vomiting, diarrhea, fatigue |
| 68 | 2021-02-28 | fatigue, cough, throat irritation |
intense itching/burning in throat within one hour of vaccination causing incessant coughing; lasting...
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intense itching/burning in throat within one hour of vaccination causing incessant coughing; lasting 2 days wheezing and shortness of breath beginning 8 hours after vaccination and lasting at least through Monday Mar1. conjunctivitis and light-sensitivity beginning Saturday (24 hours after vaccination) lasting at least through Mar 1 fatigue commensurate with what others describe as having and worse than many have reported lasting at least through mar 1
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| 68 | 2021-02-28 | fever, headache, fatigue |
SEVERE Body pain - just like when I had COVID in October (sick 9 days) Fever: 103.2. Broke la...
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SEVERE Body pain - just like when I had COVID in October (sick 9 days) Fever: 103.2. Broke last night. When I had COVID it was 103.2 for 3 days Very light head Exhaustion skull pain
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| 68 | 2021-02-28 | sluggishness, fever, headache |
Started with severe headache Continued with all over body aches Next day woke up with fever Even wh...
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Started with severe headache Continued with all over body aches Next day woke up with fever Even when treated with Tylenol, fever got as high as 102. 4 Within 24 hours I was better but very sluggish and still a little light headed
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| 68 | 2021-03-01 | chills |
More of an administration error.. It was given by a distracted national guardsman who was waving a...
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More of an administration error.. It was given by a distracted national guardsman who was waving around syringe and talking to someone else as he grabbed my arm---I saw him expel a sizable amt of vaccine from the TB syringe before administering (I'm a retired NP) so was concerned that I had gotten a suboptimal dose---really have no idea how much I got and didnt point out his error b/c I was pretty sure they wouldnt draw up another dose for me . Anyway--just reporting this b/c I was asked to and am hoping for the best! I did have a sore arm, muscle aches and chills so I know that I got some.
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| 68 | 2021-03-01 | cough |
Beginning 3 days after my vaccination I began to experience chest pain and tightness sporadically th...
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Beginning 3 days after my vaccination I began to experience chest pain and tightness sporadically throughout the day and night for the next 5 days. No fever. Then at the end of those 5 days, it seemed my lungs, right one in particular, had pain and I developed a cough. I had a small amount of pain when breathing, especially breathing in. It felt very similar to an episode of Pleurisy I had quite a few years ago. I do have seasonal allergies and had been sneezing off and on in the days previous to the vaccination and also afterward. Symptoms have since lessened considerably and have almost disappeared. I am curious to know if this was in any way related to the vaccination, or purely coincidental.
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| 68 | 2021-03-01 | fatigue, chills, headache, sweating |
Starting the first day I had muscle aches, swollen glands, headache, tiredness and chills, this la...
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Starting the first day I had muscle aches, swollen glands, headache, tiredness and chills, this lasted for three days. Then I did feel better for a few days but had some tiredness. Then Sunday the 28th my body seemed over whelmed with sweats and chills, I developed a rash in my groin area and realized that I had a yeast infection that was affecting my vaginal area, groin, and mouth. I have been treating this with a natural yeast complex and Monistat. I am starting to do better today but felt that I needed to report it to see if others were having the same problem. I feel that the injection adversely affected my body's normal hemostasis and the yeast was the results. I am not looking forward to getting the next shot. I think I did have Covid 19 in late January or early February before it was widely known and there were no tests. I will keep treating myself with natural remedies as chemicals will just inflame the yeast at this time. This is not life threatening but wanted to report the abnormal reaction I have experienced.
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| 68 | 2021-03-01 | fatigue | Extreme fatigue, sudden of onset. Mild nausea. |
| 68 | 2021-03-01 | headache, fatigue |
soreness @ injection site initiated 2 hours later & persisted for days: fatigue & sleepiness initia...
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soreness @ injection site initiated 2 hours later & persisted for days: fatigue & sleepiness initiated after 2 hours & persisted for days after 16 hours of sleep; dull headache at base of skull initiated after 4 hours & dissipated after 48 hours.
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| 68 | 2021-03-01 | sweating | "woozy" diaphoretic. Waited an extra 15 mins. Evaluated by EMS-Cleared |
| 68 | 2021-03-01 | influenza like illness, headache |
My heart rate and b/p increased evening after injection. My heart rate and b/p have been maintaine...
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My heart rate and b/p increased evening after injection. My heart rate and b/p have been maintained at normal ranges for years! B/P usually 122/76 and heart rate 76-80. Since I got that vaccine, each evening my heart rate has been 97, 87, 94, 90. B/P 133/85, 145/84. I had flu-like symptoms, headache, injection site pain and joint pain. They subsided.
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| 68 | 2021-03-01 | lethargy, chills | chills, lethargic, right side of face swollen |
| 68 | 2021-03-02 | chills, malaise |
Soreness in injected arm, chills, dizziness, headache, muscle pain, joint pain, nausea, general mala...
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Soreness in injected arm, chills, dizziness, headache, muscle pain, joint pain, nausea, general malaise, lasting almost 2 days
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| 68 | 2021-03-02 | fatigue, fever |
she has a cold sweat or something right now; She has not eaten anything.; her right arm felt like it...
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she has a cold sweat or something right now; She has not eaten anything.; her right arm felt like it was going to fall off it hurt so bad; she has ran a temperature and that finally broke but the highest was 102.4; She has been so weak she hasn't been out of bed hardly.; tired; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9265), via an unspecified route of administration from 29Jan2021 14:45 (2:45 PM) at single dose on right arm (as she was left handed) for COVID-19 immunization. Medical history included COVID (recovered) on an unspecified date. There were no concomitant medications. No additional vaccines administered on same date of Pfizer suspect. Patient previously got her flu and shingles shot at the end of "October". Patient took the vaccine last Friday (29Jan2021) at the age of 68 years old (reported as "68 and a half"). She does not know if that makes a "different" but her right arm felt like it was going to fall off it hurt so bad, on a scale of 1-10 it was about a 20. It was really tender she put a heating pad on it, she has been sleeping on the heating pad and it was mild now. It was only about a 3 now and it has come down, but it hurt like the dickens. Also she has ran a temperature and that finally broke but the highest was 102.4. Patient has slept around the clock and she has not been out of bed but like 30 minutes out of the last 24 hours (hrs) just to go the potty or drink something. Patient stated "almost gave up holding it was so long". She has been so weak she has not been out of bed hardly. Patient said that she has eaten since, "lets see Saturday night, Sunday, Monday". Patient has not eaten since Saturday night (30Jan2021) or gotten out of bed. She has not eaten anything. Patient has had COVID and recovered so she did not want to catch that again. She confirmed that she had COVID prior to received the vaccine. She called her primary care and she has a viral phone call tomorrow or visual phone call, whatever its called, she was trying to get over this mess, she feels warm, she was not registering a temperature right now but she had a cold sweat or something right now (01Feb2021). Patient has a call with him tomorrow so he will know about this incase Pfizer calls. Patient stated that she knows with a normal vaccine she might have an ache or something but this one hurt bad, maybe they pushed it in too hard or something she does not know. When asked for vaccination facility type, the patient answered that they had a vaccine clinic they had set up there in a conference room, they had an elaborate set up, go through certain places and there were several steps. Vaccine was not administered at facility (reported as "No hospital"). Patient further reported that her arm on 29Jan2021 (Friday evening) was tender. Patient lives by herself, she came home and does not know if she event ate. All she knows was she was real tired that Friday evening, it was tender and it got worse. Events did not require emergency room and physician room visit, reported as "Not to date but tomorrow she does not know if he will have her come in unless she spikes another fever or if he will do anything she may just ride it out". When asked for adverse events prior vaccinations, the patient answered "no none that she can remember. Sometimes she will have a sore arm that is why she gets it in the right arm because she is left handed thinkin her dominant hand will not have any problems but this one hurt really bad. Have they had many calls where this is really effecting arms really bad?". Patient also reported that her sister had the shot the same day and her arm was a little sore but that was all, she does not have NDC lot expiration for her sisters dose of the vaccine. She went to a different facility in a different location. Outcome of "her right arm felt like it was going to fall off it hurt so bad" was recovering, while for other events was unknown.
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| 68 | 2021-03-02 | headache, chills, fever | Fever, headache, body aches, nausea, chills |
| 68 | 2021-03-02 | headache, chills | Severe body aches, chills, headache. Tylenol didn't help. Can't take Ibuprofen. |
| 68 | 2021-03-02 | headache | Severe headache, extremely high blood pressure 220/120, low blood sugar, anxiety, insomnia |
| 68 | 2021-03-02 | headache |
About an hour after I received the vaccine my entire head was in pain including upper jaw and back o...
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About an hour after I received the vaccine my entire head was in pain including upper jaw and back of neck. My face was flushed and my throat began to tighten a little The headache and flush lasted about an hour. (I had taken Tylenol right after getting the vaccine.) The throat symptoms lasted longer ,lessening slightly after about an hour and a half. Never had trouble breathing, talking, eating or drinking. But the feeling has lasted into the late evening to a very mild degree; as if something is caught at the back of the throat, or the back of the tongue feels a little fuzzy.
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| 68 | 2021-03-02 | malaise, headache, fever |
I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ach...
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I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; Unable to eat, loss of appetite.; Not feeling too well; very sick; can hardly move; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL9069), via an unspecified route of administration at single dose on 10Feb2021 for covid-19 immunisation. Medical history included diabetes, thyroid removed. Concomitant medication included influenza vaccine, metformin, levothyroxine, ferrous sulfate, atorvastatin. The patient stated that experienced: I got fever, I got diarrhea. I got body ache, headache, unable to eat, loss of appetite, not feeling too well, very sick, can hardly move , all on an unspecified date in Feb2021 with outcome of unknown. The patient was hospitalized for these events from Feb2021 to an unknown date. The patient underwent lab tests and procedures which included investigation: unknown results in Feb2021.
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| 68 | 2021-03-02 | malaise, sweating, fever | Was sick for 2 weeks. Ran low grade fever and sweat profusely drenching hair and clothes. |
| 68 | 2021-03-03 | body temperature increased, fatigue, headache |
I received the vaccine at 9AM on March 1st in my right arm. Everything was fine until 3 PM when my ...
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I received the vaccine at 9AM on March 1st in my right arm. Everything was fine until 3 PM when my right arm started swelling. I ran a temperature of 100.1, had fatigue and a headache, in addition to aches and pains. By Tuesday morning my right arm from the injection site to the elbow was twice it's normal size. My chest and underarm area were both significantly swollen. I had an 8:30 AM appointment on Tuesday with an allergist who advised me to take Benadryl, which I did. By Wednesday, my chest and abdominal area were both swollen. I had a lymphedema therapy appointment because I have lymphedema on my left side due to node removal. The therapist measured both arms and they were both swollen, including my chest and abdomen. The therapist advised me to see my oncologist as swelling in the Right Arm, (where i received the shot) was normal for COVID shots, but she could not explain the swelling in the chest or abdomen. Other than that my lymphatic system was working overtime. I called my oncologist on Thursday March 4, and they fit me in. Doctor examined me and he couldn't explain to me why I was swelling up the way I was. He has only seen arm swelling in his breast cancer patients. He is referring me to get a PET scan and advised me to see a breast surgeon as maybe the surgeon would know more about the lymph nodes.
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| 68 | 2021-03-03 | fatigue, chills |
chills; very fatigued; sore arm; This is a spontaneous report from a contactable consumer (patient)....
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chills; very fatigued; sore arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) solution for injection, via an unspecified route of administration on left arm on 01Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient got her second shot of COVID vaccine yesterday, 01Feb2021, and was asking if she was infectious to anyone. She had some chills, was very fatigued and was a having sore arm. The sore arm started last night (01Feb2021) and when she woke up this morning (02Feb2021), she was with the chills and fatigue. The patient stated that they could be related to the fact that she got up at about 3:00 in the morning. The outcome of the events was not recovered.
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| 68 | 2021-03-03 | fatigue, malaise | Malaise, fatigue, red rash over entire abdomen, inner arms, chest and inner thighs |
| 68 | 2021-03-03 | sleepiness |
Patient is a 68 y/o female who enrolled in program on 9/19/2018 who began monotherapy treatment with...
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Patient is a 68 y/o female who enrolled in program on 9/19/2018 who began monotherapy treatment with Pioglitazone 15mg PO on 10/5/2018. Patient called study team stating that she received her second Pfizer COVID-19 vaccination on 02/19/21. Afterwards, she had a sore arm and slept most of the next day. On 02/21/21, she experienced severe right-sided leg weakness and fell while attempting to go to the bathroom. She was unable to ambulate and her son took her to the emergency room. She was hospitalized overnight for a serious adverse reaction to the second Pfizer COVID-19 vaccination. Multiple sclerosis exacerbation was ruled out after extensive testing. Then, she was transferred a Rehab facility on 02/22/21 for physical therapy and occupational therapy. She continues study medication without any missed doses. She will most likely be in Rehab for another week. She was able to walk 80 feet on 2/25/2021 with a walker and gait belt and ambulatory assistance. This is unrelated to study drug. We consider this to be a Non-UP SAE. As of 3/4/2021 the patient is still in rehab.
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| 68 | 2021-03-04 | chills, headache, fatigue |
general moderate joint pain, chills, moderate headache, fatigue mostly gone by the morning of 3/5/2...
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general moderate joint pain, chills, moderate headache, fatigue mostly gone by the morning of 3/5/2021
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| 68 | 2021-03-04 | chills, fever, headache |
6-8 hours after the injection noted chills, fever and chills alternating, weakness, headache, joint ...
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6-8 hours after the injection noted chills, fever and chills alternating, weakness, headache, joint pain and stiffness., muscle soreness. Noticed voice hoarseness. Attempted to sleep after taking Advil with nightmares and restlessness. Felt this overall feeling of crying and uncontrolled sobbing. I had COVID in May of 2020 with hospitalization, Remdesivir IV. Pneumonia . July I was feeling better with noted Shortness of Breath not brought on by activity. I was able to resume my exercise activity. I walked but no longer able to walk 3-4 miles per day. I am walking 2 miles w strengthening exercise. The headache comes and goes with the addition of Advil and Tylenol alternating takes the edge off. I take a Zyrtec but it does not help
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| 68 | 2021-03-04 | cough, throat clearing |
30 minutes post vaccination, patient's voice was hoarse, face flushed, appeared restless. Patient w...
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30 minutes post vaccination, patient's voice was hoarse, face flushed, appeared restless. Patient was coughing and clearing throat. Fluids were offered and patient was moved to a more private area, vitals were taken. Pulse ox 96% RA, blood pressure was elevated, HR was 86 bpm. Rapid response team was notified and took the patient to the hospital's emergency department.
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| 68 | 2021-03-04 | headache |
week after the 1st dose, her Blood pressure went up to 210/101/noticed some spikes in her blood pres...
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week after the 1st dose, her Blood pressure went up to 210/101/noticed some spikes in her blood pressure; felt a weird sensation; Tingling in her head and her face; pain in the head and got increasing worse/scalp felt on fire/light headache; scalp felt on fire; she felt a little soreness in arm/12 hours my arm hurt; This is a spontaneous report from a contactable consumer (patient's cousin). A 68-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/Lot number: EL9262), via an unspecified route of administration on the left arm, at age 68 years first dose on 20Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included ongoing anxiety from an unknown date. Ongoing concomitant medication included escitalopram 5 mg for anxiety, calcium and an unspecified multivitamins. The patient had flu vaccine in Oct2020. Patient's cousin called on behalf of cousin and reported that patient was very ill for having severe reaction to the COVID Vaccine. Patient was physically fit and thin received first dose of COVID vaccine on 20Jan2021, 10:30 AM. After her 1st dose, she felt a little soreness in arm, 12 hours her arm hurt and light headache the same day. Patient went to bed a little earlier than normal and slept a little longer since she was 69 years, its her body and it needed more sleep and woke up at noon and her arm was fine and very grateful to have the shot. Two nights later, on 22Jan2021, patient woke up in the middle of the night with tingling and pain in the head and got increasing worse, her scalp also felt on fire and had tingling sensation in her face for 3 weeks. Then, a week after the 1st dose on 27Jan2021, her blood pressure went up to 210/101. She went to the hospital, they controlled her pressure and put on a pressure pill 1 a day (amlodipine). She mentioned she had felt a weird sensation on an unspecified date and as she noticed some spikes in her blood pressure, her MD told her to take another 2.5 mg amlodipine if needed (once or twice a day as needed). She confirmed she had no heart rate problems but she actually experienced high blood pressure instead. She never had numbness, instead she had a tingling sensation still present. The outcome of the event 'eek after the 1st dose, her blood pressure went up to 210/101/noticed some spikes in her blood pressure' and 'tingling in her head and her face' was not recovered, for event 'she felt a little soreness in arm/12 hours my arm hurt' was recovered on 21Jan2021, while for the other events, it was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187054 same patient/drug, different event
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| 68 | 2021-03-04 | sweating |
Woke up feeling quite clammy as if I had been sweating. Our bedroom is rather cold. Also felt nauseo...
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Woke up feeling quite clammy as if I had been sweating. Our bedroom is rather cold. Also felt nauseous. Didn't last long. Wiped my face and upper body with washcloth soaked in cool water for relief. Messaged my cardiologist and internist but haven't gotten response yet.
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| 68 | 2021-03-04 | fever, fatigue | fever, 100.8, achy, very tired. Took advil felt better within 24 hours. |
| 68 | 2021-03-04 | fever |
found by husband with AMS on 3/4/21, not responding to questions or following commands. taken to the...
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found by husband with AMS on 3/4/21, not responding to questions or following commands. taken to the ER- fever 101.2, HR elevated, decreased BP
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| 68 | 2021-03-04 | fever |
pt stated that she had a sore arm and low grade fever the night after receiving the 2nd dose of the ...
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pt stated that she had a sore arm and low grade fever the night after receiving the 2nd dose of the covid vax. She started having vision problems about an hour after receiving the vaccination. She stated that her vision is blurry and she has to blink a lot so she can see anything. Today 3/5/2021 the only symptom she is having blurred vision. Pt will contact her PCP if her symptoms persist.
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| 68 | 2021-03-05 | headache, chills, fever, lethargy | Fever, chills, lethargy, body aches, headache, loss of taste |
| 68 | 2021-03-05 | headache, fever, fatigue |
Lightheaded, nausea, headache, eyes dry with itchiness and pain; joint and muscle discomfort; low gr...
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Lightheaded, nausea, headache, eyes dry with itchiness and pain; joint and muscle discomfort; low grade temp, fatigue, hair and scalp hurt. Symptoms lasted about 36 to 48 hours.
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| 68 | 2021-03-05 | headache |
Bad chest pain, hard to take a deep breath, headache, dizziness, diarrhea. By the end of the day, be...
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Bad chest pain, hard to take a deep breath, headache, dizziness, diarrhea. By the end of the day, because of chest pain and dizziness my doctor sent me to the ER. I was then referred to a cardiologist, who indicated he thinks these symptoms are from the second dose of vaccine. He has seen several patients with the same symptoms after the second vaccine dose. My family doctor now thinks the same thing for the same reasons.
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| 68 | 2021-03-05 | headache |
shot given at 1045 am. arm soreness at injection site. ltook two 500 mg tyleno at 1 pm and laid dow...
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shot given at 1045 am. arm soreness at injection site. ltook two 500 mg tyleno at 1 pm and laid down for a nap, woke up at 1:30 pm with heavy headache at top of head about 3 inches in circumference. at 4:30 pm began to have body aches, more in my legs but generally all over. temp went up 1 degree. had these symptoms till the next day which began lessening about noon and by 4 pm they were gone except I had arm soreness and I have continued to have heavy headaches every day which is somewhat relieved by scalp massage and tyleno.. lingering effects of vaccinenone
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| 68 | 2021-03-05 | malaise, chills, headache |
rash on lower back within an hour after vaccine. It disappeared soon. At 2:00 am on March 4th - wo...
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rash on lower back within an hour after vaccine. It disappeared soon. At 2:00 am on March 4th - woke with severe headache, musle and joint pain, chills, nausea, genarlly feeling unwell.
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| 68 | 2021-03-06 | chills |
About 11 hours after receiving vaccine vomited repeatedly, had chills and then short periods of feel...
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About 11 hours after receiving vaccine vomited repeatedly, had chills and then short periods of feeling very warm. Taste was off- many foods just did not taste good. General body aches, ambulation unsteady, blood sugar went up to over 700. This lasted until about 11 the next morning.
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| 68 | 2021-03-06 | chills | Severe shaking, muscle aches, chills |
| 68 | 2021-03-06 | fatigue, headache, chills |
Tightness in chest, chills, sore throat, fatigue extreme, headache, bodyaches and joints, blurry eye...
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Tightness in chest, chills, sore throat, fatigue extreme, headache, bodyaches and joints, blurry eyes, nausea, no appetite.
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| 68 | 2021-03-07 | chills, fever, headache |
Fever, chills, joint pain, headache, swelling at the injection site. All but swelling resolved afte...
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Fever, chills, joint pain, headache, swelling at the injection site. All but swelling resolved after 48 hours. Injection site continues to have redness and swelling about 3 inches in diameter, 72 hours later.
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| 68 | 2021-03-07 | chills | Dizzy, chills, nausea - came on suddenly (7 days after shot) and lasted about 4 hours. |
| 68 | 2021-03-07 | headache, fatigue |
Woke at 5AM and felt like I had been hit with a ton of bricks. Headache/dizzy/tired/unable to proces...
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Woke at 5AM and felt like I had been hit with a ton of bricks. Headache/dizzy/tired/unable to process thoughts logically. Arm somewhat sore, but not horrible. This lasted until I went to bed Friday night at 11:00 PM
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| 68 | 2021-03-07 | headache, fatigue | Headache Extreme fatigue Body aches All lasted 18 hours |
| 68 | 2021-03-07 | headache |
Pt received 1st dose of Pfizer Covid vaccine 3/5/2021 at the Health Dept at approx 9:35AM; pfizer lo...
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Pt received 1st dose of Pfizer Covid vaccine 3/5/2021 at the Health Dept at approx 9:35AM; pfizer lot number EL9269. Patient has hx of widespread rash from Penicillin; no history of anaphylaxis. Pt alerted the medic at 10:05AM that she was experiencing nausea and body weakness. No other symptoms noted at that time. BP 138/76 P84 O2RA 98%. At 10:35AM pt experiencing worsening nausea, body weakness, generalized prickle sensation, sudden left-sided headache, & dry heaving. Epi 0.3mg auto injector(Lot 0FM534) administered right leg 10:40AM; BP 178/104 P90. Paramedics called 10:42, arrived at 10:46AM and assumed care of patient. Patient transported to Hospital.
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| 68 | 2021-03-07 | sweating, headache, chills, lethargy |
Within 3.5 hours of receiving my 1st Pfizer COVID 19 vaccination injection, I developed a headache, ...
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Within 3.5 hours of receiving my 1st Pfizer COVID 19 vaccination injection, I developed a headache, EXTREME lethargy, initial chills and later on sweats, cold sensation at the roof of my mouth, and within 6 hours a sore arm at the injection cite. I ended up sleeping off and on for the next 29 hours. The headache, the lethargy and sore arm persisted past 24 hours. The headache was gone after about 28 hours. The sore arm was gone by the morning of the 2nd day (Monday). The lethargy lasted for 36 hours but was completely gone by the morning of the 2nd day (Monday).
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| 68 | 2021-03-07 | fever, chills |
Vile scary nauseating metallic taste in my mouth, still Here a week later! Fever and chills were n...
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Vile scary nauseating metallic taste in my mouth, still Here a week later! Fever and chills were no match for this awful taste I felt like I was poisoned!
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| 68 | 2021-03-07 | fever |
SITE WAS SORE FOR A COUPLE OF DAYS; SLIGHT FEVER THE FIRST AND SECOND DAY; TEMPERATURE ROSE BUT NOT ...
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SITE WAS SORE FOR A COUPLE OF DAYS; SLIGHT FEVER THE FIRST AND SECOND DAY; TEMPERATURE ROSE BUT NOT MUCH. UPON WAKING DAY TWO, I HAD A VERY PRONOUNCED ACHE IN THE BACK OF LEFT SHOULDER AND THE ACTUAL SHOULDER BLADE WAS SORE AND PAINFUL TO THE TOUCH. I DID NOTHING THE FIRST DAY OF THE DISCOMFORT (THINKING IT WOULD GO AWAY). I NOW APPLY CBD/THC BALM ON THE AREA 3 TIMES A DAY AND I'VE BEEN TAKING EXTRA STRENGTH TYLENOL , TWO TABLETS, THREE TIMES A DAY. I AM SLEEPING IN A ZERO-GRAVITY MODE ON MY SLEEP NUMBER BED...OTHERWISE I CAN'T SLEEP AT ALL. I HAD A HOLE IN MY ROTATOR CUFF SURGUCIALLY REPAIRED ABOUT 18 MONTHS AGO AND THE PAIN I HAVE NOW ACTUALLY FEELS LIKE MY SHOULDER FELT BEFORE AND FOR AWHILE AFTER THE SURGERY! I AM BEGINNING TO WONDER IF THERE IS A RELATIONSHIP TO THE TWO EVENTS.
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| 68 | 2021-03-08 | headache, chills, fatigue, fever | Severe body aches, fever, chills, severe headache 3 days now, nausea, exhaustion |
| 68 | 2021-03-08 | headache, fatigue | Next day I had a headache, slightly achy, noticeable fatigue. Continued for a 2nd day, then abated. |
| 68 | 2021-03-08 | headache |
Client reports being "very sick" the next day with vomiting and headache. She has a history of havi...
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Client reports being "very sick" the next day with vomiting and headache. She has a history of having COVID 19 on 12/25/2020.
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| 68 | 2021-03-08 | headache |
Vasovagal Syncope Sudden drop in blood pressure. occurred day after vaccination 9:00pm Called my c...
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Vasovagal Syncope Sudden drop in blood pressure. occurred day after vaccination 9:00pm Called my cardiologist. Encouraged to monitor and keep them informed reduce blood pressure meds until stable. Discontinue chlorthalidone until BP is stable Blood pressure seems to be stable today (3-9-10). Still slight headache and mild dizzy spells
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| 68 | 2021-03-08 | fever, fatigue, headache, throat pain |
I received the first vaccine around 10:00 in the morning. Symptoms hit about Midnight. Started wi...
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I received the first vaccine around 10:00 in the morning. Symptoms hit about Midnight. Started with a headache, a mild sore throat, fever 100.1, body and joint aches, chills, and then a few times the next day of being extremely tired, only lasted for about 24 hours. After the second vaccine, I had all of the previous symptoms again but this time the chills lasted for about 3 hours which was a lot longer. Lasted again about 24 hours and then a few times of feeling extremely tired the next couple of days. I should also let you know that I did test positive for COVID around November 6, 2020, and had mild symptoms for a full week.
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| 68 | 2021-03-08 | sleepiness, headache | couldnt stay awake, headache, disorientation, swollen and pain at site |
| 68 | 2021-03-09 | chills, headache, fever |
A week after second dose I had chills, slight fever, headache and body aches for 24 hours. Today, I ...
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A week after second dose I had chills, slight fever, headache and body aches for 24 hours. Today, I had my bi monthly allergy shot that I have been receiving for 2 years and had chills, body ache and headache one hour after shot for about 3 hours.
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| 68 | 2021-03-09 | fatigue |
Gastrointestinal issues; Had occasional zaps of pain in toes and tiredness; Had occasional zaps of p...
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Gastrointestinal issues; Had occasional zaps of pain in toes and tiredness; Had occasional zaps of pain in toes and tiredness; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318) via an unspecified route of administration on 02Feb2021 at 16:00 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included pancreatic cancer. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included levothyroxine; pancreatin (CREON); famotidine; latanaprost; and calcium carbonate, vitamin b12, vitamin D (CALCE) from unknown dates for unspecified indications. The patient did not have any known allergies. On 03Feb2021 at 18:00 around dinner time, the patient started with gastrointestinal issues and also had occasional "zaps" of pain in toes and tiredness. These lasted into Saturday night (06Feb2021). The patient did not receive any treatment for the events. The outcome of gastrointestinal issues, zaps of pain in toes, and tiredness was recovering. It was also reported that the patient had not been tested for COVID-19 after the vaccination. No follow-up attempts are needed. No further information is expected.
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| 68 | 2021-03-09 | headache |
At 8pm began having headaches. At 10pm lost taste and smell, started experiencing body aches, abdomi...
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At 8pm began having headaches. At 10pm lost taste and smell, started experiencing body aches, abdominal pain and nausea for 3 days. Took Tylenol for pain and Famotidine and Pepto Bismol for nausea. As of 3/1/21 all symptoms relieved except for smell and taste.
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| 68 | 2021-03-09 | headache |
2nd Pyzer Shot 2/8/2021 2:54 PM I believe I had an allergic reaction the first night: Arm twitched s...
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2nd Pyzer Shot 2/8/2021 2:54 PM I believe I had an allergic reaction the first night: Arm twitched several times approx. 6-7pm,Light headache approx. 8pm Anxiety increased between 8pm-2am,Woke 3:49 am with bad headache in rear of head, went to bathroom and turned over. Woke up with bad headache a little while later, Several times woke up struggling to swallow. Last time I woke up with Difficulty breathing and pressure on chest Decided I needed to wake my husband, but that is my last thought or action until I woke up 9AM. I take a generic Zyrtec at supper time each night. I think had I not had Zyrtec these symptoms could have been serious. Was OK until 3 – 11pm 3/9/2021 Slight headache & Shortness of breath.
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| 68 | 2021-03-09 | sweating |
Patient received the Covid-19 vaccine. She reports symptoms of dizziness, high heart rate, sweaty. ...
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Patient received the Covid-19 vaccine. She reports symptoms of dizziness, high heart rate, sweaty. 1145: Patient states she feels like she has a sensation of swelling, itchy legs. Patient is requesting Benadryl. 1147 Benadryl 25mg given by RN. Phone call made to patient's son to come to the clinic to accompany patient home. 1217 Patient states she feels much better, slight dizziness. 1244 Patient's son arrived. Patient states she feels better and wanted to walk herself out of the clinic. Patient will contact her PCP if she has anymore questions or concerns. Vitals taken: 1135: 158/98 120 96% RA 16R 1142: 162/98 110 99% 2L 18R 1152: 160/92 83 98% 2L 18R 1244: 150/80 108 98% RA 18R Treatment/intervention patient was given: 25mg Benadryl PO
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| 68 | 2021-03-09 | fever, fatigue, runny nose |
Fever, fatigue, runny nose the day after the 1st dose. . Pt deceased from COVID less than one month ...
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Fever, fatigue, runny nose the day after the 1st dose. . Pt deceased from COVID less than one month after 1st dose of vaccine
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| 68 | 2021-03-10 | body temperature increased, headache, chills | 101.3 Temperature, Chills Headache, Dizziness, Aching. |
| 68 | 2021-03-10 | fatigue, chills |
She still has fatigue; The extreme pain, mental fog, and disconnect that came with it has all subsid...
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She still has fatigue; The extreme pain, mental fog, and disconnect that came with it has all subsided; The extreme pain, mental fog, and disconnect that came with it has all subsided; Cytokine storm; extreme chills with teeth chattering; This is a spontaneous report from contactable consumer. A 68-year-old female patient the second dose of BNT162B2 (Batch/lot number: EN5318) on 04Feb2021 at 1:00 on Left arm for covid-19 immunization. Medical history was ongoing Arachnoiditis (this is a spinal cord disease). Concomitant drugs were not reported. Historical Vaccine was 1st dose of BNT162B2 (Lot Number: EL1283) on 15Jan2021 administered in left arm for covid-19 immunization. She was calling to report a severe reaction that occurred after the second injection. On 05Feb2021 she started to have extreme chills with teeth chattering at 3 AM. She knew this could be part of the symptoms. At 6 AM on 05Feb2021 she got up and with her husband's assessment who is also is a doctor it was determined by her husband she was in a cytokine storm that attacked her spinal cord disease. The extreme chills ended within a couple of hours on 05Feb2021. The cytokine storm has pretty much resolved. It is still there, but better. She still has fatigue. However, the extreme pain, mental fog, and disconnect that came with it has all subsided. Caller stated she knows from research and talking to other people most people might have the chills after the COVID Vaccine. The chills is not the severe side effect she is referencing as severe. The Cytokine storm reaction for her wit her spinal cord disease is unexpected and not normal. This was the severe event. No Emergency Room visited. Physician's Office visited for Cytokine Storm. She should have gone to the hospital, but she did not want to go. Seven days after event started, she went to her physician. This was as soon as she was able to get up and get out of the house. Treatment was mainly self-treating. Her husband is a doctor and they did what they needed to do at home. These side effects were pretty horrific. Outcome of the event cytokine storm was recovering, for fatigue was not recovered, for other events was recovered. No follow-up attempts are possible. No further information expected.
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| 68 | 2021-03-10 | headache, dehydration |
Three days after dose 1 I experienced dizziness and violent vomiting (for 8 hours). Taken to emergen...
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Three days after dose 1 I experienced dizziness and violent vomiting (for 8 hours). Taken to emergency room. Admitted to hospital for hospital for 1 day. Was given anti-vomiting/dizziness drugs, CT scan, IV for dehydration, pain and anxiety medicine. Diagnosis was vertigo. Upon release from hospital, consult with internist further diagnosed condition as labarynthitis. Headache and slight dizziness continued for a couple of weeks . After second dose dizziness, light-headedness and headache are significant enough to take Tylenol regularly. These effects are still in place 12 days after 2nd dose. Will see internist if symptoms continue after 2 weeks.
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| 68 | 2021-03-10 | headache |
Slight headaches that come and go throughout the day, but never last very long. Strange as they onl...
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Slight headaches that come and go throughout the day, but never last very long. Strange as they only last 1 or 2 minutes and then subside.
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| 68 | 2021-03-10 | influenza like illness, cough, chills |
Within 30 minutes started a dry cough which lasted for 3 weeks. (Had a dry cough off and on before ...
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Within 30 minutes started a dry cough which lasted for 3 weeks. (Had a dry cough off and on before but had gotten better, possible long haul from flu last Feb/March that lasted 3 weeks. Not tested, so could have been Covid 19.) Severe chills and joint pain and fever like symptoms through out the night. - Better in the morning but still slight flu like symptoms, but only lasted 48 hours. However, the dry cough lasted 3 weeks.
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| 68 | 2021-03-10 | malaise, headache |
late evening of injections date, felt sick at stomach. early nxxt morning started vomiting thick ...
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late evening of injections date, felt sick at stomach. early nxxt morning started vomiting thick yellow bile. felt nausiated all day, "foggy" headache and lack of appetite. night sweats for 2 nights. no fever.
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| 68 | 2021-03-11 | chills, sweating, fever, sluggishness |
Fever as high as 102.4 (took Tylenol at 1:30 a.m. on 3/11/2021), shaking chills, elevated heart rat...
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Fever as high as 102.4 (took Tylenol at 1:30 a.m. on 3/11/2021), shaking chills, elevated heart rate (up to 107) (all overnight on 3/10-11/2021). Felt sluggish during day of 3/11/2021 with low grade fever, mild chills (took Tylenol one more time at 11:00 a.m. on 3/11/2021). Rested most of day. Overnight of 3/11-12/2021 woke up at 4:30 a.m. completely drenched, but no further fever, chills or elevated heart rate. Have felt fine on 3/12/2021.
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| 68 | 2021-03-11 | chills, pneumonia, fever |
Patient hospitalized on 3/9/21 with one week history of fever, chills, and shortness of breath. Tes...
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Patient hospitalized on 3/9/21 with one week history of fever, chills, and shortness of breath. Tested positive for COVID-19. Respiratory status worsened on 3/11 requiring transfer to ICU and intubation. Currently intubated in ICU.
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| 68 | 2021-03-11 | dehydration |
Diarrhea (usually 4+ times per day) began on 2/20/2021, and continues to today (3/12/2021). Fainte...
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Diarrhea (usually 4+ times per day) began on 2/20/2021, and continues to today (3/12/2021). Fainted 2/26/2021. To Urgent Care and then ER 2/27/2021. Suspected dehydration.
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| 68 | 2021-03-11 | fatigue, headache |
Sore arm began on afternoon of shot, the next day was very tired and a headache. Overnight, woke up ...
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Sore arm began on afternoon of shot, the next day was very tired and a headache. Overnight, woke up with vertigo. All symptoms went away within the next 24 hours.
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| 68 | 2021-03-11 | fatigue |
Extreme soreness at injection site left arm Noted at approximately 8:00 AM 03/07/2021; difficulty l...
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Extreme soreness at injection site left arm Noted at approximately 8:00 AM 03/07/2021; difficulty lifting left arm at same time. Wave of extreme fatigue at approximately 10:30 AM 03/07/2021 fell asleep in chair until approximately 12:00 PM 03/07/2021. Upon awakening, could not lift my left foot until approximately 2-3 minutes later on 03/07/2021. My left foot was not asleep, I know the difference; it was like my left foot was paralyzed. When I was able to get up out of the chair I looked in a mirror to check for signs of stroke-SMILE. No signs, checked one eye at a time; equal vision in both.
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| 68 | 2021-03-11 | headache, chills | Severe headache, chills and slight nausea and severe diarrhea (causing me to lose 2 lbs.). |
| 68 | 2021-03-11 | headache |
3 hrs after 1st vaccine developed bad headache, lasted about 36 hrs and then completely resolved. 1...
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3 hrs after 1st vaccine developed bad headache, lasted about 36 hrs and then completely resolved. 12 hrs after 2nd vaccine, same headache last about 24 hrs then completely resolved Feb 28 same headache suddenly redeveloped and have been chronic since that time along with new dx of HTN. Seen by doctor 2 times and ER that did CT of head/EKG/labs all normal so final discharge dx was migraines with HTN. I have never had headaches or HTN in my past medical history. Rx Lisinopril 10mg and Medrol 6 day dose pack have done little to relieve these symtoms.
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| 68 | 2021-03-11 | fever, chills |
Injection Friday 2/16, Saturday 2/27 afternoon, common symptoms, fever, chills, muscle aches. Sunday...
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Injection Friday 2/16, Saturday 2/27 afternoon, common symptoms, fever, chills, muscle aches. Sunday 2/28 through Monday Tuesday 3/2 nausea; Wednesday 3/3 vomiting, Thursday 3/4 nausea, Friday 3/5 nausea, Saturday vomited 2 times went to emergency room, Sunday 3/7 - Wednesday 3/10 nausea, Thursday vomiting, still nauseous.
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| 68 | 2021-03-11 | fever, fatigue, malaise |
Fever, general malaise, extreme fatigue, aches in muscles and joints. Began late evening the day of...
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Fever, general malaise, extreme fatigue, aches in muscles and joints. Began late evening the day of the injection, about 6-7 hours after. Lasted a little over 24 hours.
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| 68 | 2021-03-11 | fever, headache, chills | fever 100 chills achy joints mild headache |
| 68 | 2021-03-12 | chills, headache, sleepiness |
Fushing of face by 4:15pm Slight headache by 5:30 No fever Slept from 7pm to 6:00am the next day. 3/...
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Fushing of face by 4:15pm Slight headache by 5:30 No fever Slept from 7pm to 6:00am the next day. 3/12/21 Headache intensified around 10am Slept on and off all day No fever During the night had a few chills 3/13/21 Headache has lessened Body is weak
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| 68 | 2021-03-12 | fatigue, headache |
Throbbing headache - top of head and back of head that was barely touched by any medicine. Severe fa...
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Throbbing headache - top of head and back of head that was barely touched by any medicine. Severe fatigue. Symptoms still ongoing. Today the 10th day
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| 68 | 2021-03-12 | fatigue |
I initially felt tired. As the day progressed I noticed discomfort in my joints. I also noticed wh...
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I initially felt tired. As the day progressed I noticed discomfort in my joints. I also noticed what I would describe as discomfort in the lymph system. Also, I have difficulty thinking clearly. Tasks that I usually complete easily such as online banking have been more difficult. I'm making mistakes. As I write this I am now three days from the inoculation. I have burning pain under my right arm. I have burning pain in tops of my feet. My hip joints are stiff. My eyes are sore. I feel generally fatigued. This is not my normal level of functioning.
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| 68 | 2021-03-12 | headache |
Started with very sore arm evening of shot. Next day - queasy stomach, headache, all over achiness,...
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Started with very sore arm evening of shot. Next day - queasy stomach, headache, all over achiness, continued sore arm but better than prior pm. Arm still a little sore following day but all other symptoms gone.
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| 68 | 2021-03-12 | paranasal sinus discomfort, throat irritation, sinus congestion, sinusitis, head discomfort, headache |
Headache, aches within 8 hours. Within 20 hours developed severe vertigo and nausea. Movement caused...
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Headache, aches within 8 hours. Within 20 hours developed severe vertigo and nausea. Movement caused room spinning and broke out in cold sweat. Severe vertigo continued through second day (Feb 22), but seemed to diminish somewhat toward evening. Day 3 still had moderate vertigo/nausea but better than previous day. Went on a long walk. Day 4 moderate vertigo/nausea continued. Tried doing Epley exercises for vertigo. Vertigo/nausea became severe again, so severe I vomited several times. After vomiting got the shakes and felt very cold. Checked blood pressure and it was very high (170/98), but pulse rate was in low 30s. After a few hours blood pressure and pulse rate became closer to normal. Almost decided to go to ER clinic, but decided to wait until my daughter came home from work because I was way too dizzy to drive. After I calmed down I decided it wasn't an emergency. Severe vertigo continued through evening of day 4. On day 4 I called primary care doctor to see if there was anything I could do for the vertigo. She prescribed meclizine, but hearing that it is an antihistamine, I declined it (antihistamines make my heart race and make me very anxious). Severe vertigo/nausea continued through day 5 and day 6. (Severe vertigo/nausea being that I could not move around at all other than to sit still staring forward without the room spinning.) All this period I also had a headache, a feeling of pressure through my whole head/sinus area, and my vision was blurred. I also felt as though I could not focus my eyes or concentration. I tried using some over-the-counter nasal decongestant spray for 2 days to relieve congestion in head, but they made me feel very anxious, so I stopped. I also tried taking some Aleve a couple of times. It helped a little, but made me feel woozy, so stopped. Day 6 the vertigo/nausea improved to moderate, but I could still not walk straight. I felt unsafe to drive. Day 7 continued to improve, but still moderate vertigo/nausea. Day 8 I noticed a lot of improvement in vertigo/nausea. Kept improving day 9. By evening on day 10 I was noticing a rawness and lump in the back of my throat. Called primary care office day 11 to see someone. Drove car, but felt marginally safe driving. Was diagnosed with a sinus infection and prescribed a 10 day course of Amoxicillin/Clavulanic Acid (875-125 mg for 2 pills a day for 10 days). Felt improvement in throat and sinus over next few days. Day 15 I felt greatly improved with head ?fog? and vertigo. Had an appointment with an ENT clinic on day 15 to see what was causing vertigo. All tests were good for hearing, and visual examination of ears. Was checked for BPV but that was ruled out. Said vertigo was probably caused by viral infection or inflammation of vestibular nerve or canals. Recommended waiting for improvement and coming back if it persisted. Began doing more normal activities even though I still had mild vertigo. Day 16 felt still better in morning, then in afternoon bent over quickly to catch something and got a terrible wave of spinning again. Moderate/severe vertigo continued that evening. Improved to moderate on day 17 and 18. All along, when vertigo was worse, so was the ?fog? (blurry vision, inability to focus mentally). At day 19 I feel like I did on day 15, but I have noticed the pressure/lump around my ear and on left side of head is improved. Brain ?fog? is improved too, very mild and the vertigo is mild. I finish my antibiotic tomorrow.At present vertigo is not gone. Its mild today, but this is only one of maybe 2 1/2 days in which its been this mild (out of almost three weeks since I was vaccinated). I have been drinking a lot of water every day, and ginger tea when I get nauseous. I had my 2nd dose of the COVID Pfizer vaccine scheduled for Mar 15. I?ve cancelled it and intend to wait to see how long it takes for vertigo to finally resolve before considering a 2nd dose.
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| 68 | 2021-03-13 | fatigue, headache |
Almost immediate fatigue that lasted about 5 hours. Slight headache. Later that night while sleepi...
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Almost immediate fatigue that lasted about 5 hours. Slight headache. Later that night while sleeping I woke up and could not breathe and my chest hurt. It lasted about 15-20 minutes. I would like to know if it is safe for me to take the second dose as I have heard from friends that it was a little bit more difficult if you had side effects.
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| 68 | 2021-03-13 | fatigue | Pain in left armpit, swelling and soreness at injection site, fatigue |
| 68 | 2021-03-13 | headache, fatigue | Headache, achy, very tired /took Tylenol every 4 hours / gone within 24 hours |
| 68 | 2021-03-13 | headache, fatigue |
Headache - AM 3/9/21 - took Tylenol, which helped to reduce it. Headache went away completely later ...
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Headache - AM 3/9/21 - took Tylenol, which helped to reduce it. Headache went away completely later in the day Fatigue - not severe but I wasn't as energetic as usual. Lasted until next morning (3/10/21)
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| 68 | 2021-03-14 | chills, respiratory tract congestion, fatigue, fever |
chills, fever, congestion, extreme tiredness, swelling and pain at injection site, swelling of finge...
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chills, fever, congestion, extreme tiredness, swelling and pain at injection site, swelling of fingers, swelling under arm
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| 68 | 2021-03-15 | chills |
I had chills. I was very cold and shivered continuously for about 30 minutes. After the shivering ...
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I had chills. I was very cold and shivered continuously for about 30 minutes. After the shivering stopped, I went to sleep and slept normally. I had no lingering adverse effects and did not see a doctor related to this event.
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| 68 | 2021-03-15 | fatigue, body temperature increased, chills |
chills all night , arm somewhat sore, when I got up to use the bathroom my heart pounded vey hard an...
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chills all night , arm somewhat sore, when I got up to use the bathroom my heart pounded vey hard and could feel below the esophagus area, March 12 at 6:30 am T 99.9, BP 151/85 achy , took tylenol and at 8:40 am BP 128/ 74 P 93, my back ached all day, 3:45 pm BP 141/74 P 90, Took tylenol for achy body, 6:00pm BP 158/82 P 84, 8:08pm BP 138/73 P82 . Felt very tired and slept in my chair 3:30- 6:00 pm, felt really exhausted and went to bed early : slept 9:00pm-7:00 am . Saturday 3/13 /21 felt better T 97.3 BP124/69 P 64 felt fairly good all day but tired
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| 68 | 2021-03-15 | fatigue, chills |
2:00 AM awoke with joint pain. Took 2 Advil and went back to bed. This medication aleviated the pai...
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2:00 AM awoke with joint pain. Took 2 Advil and went back to bed. This medication aleviated the pains. Slight chills during the day (put on extra sweater), fatigue all day, napped off and on all day. Symptoms gone by next morning.
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| 68 | 2021-03-15 | fatigue, headache |
68 yo WF in excellent health with prior history of intermittent benign positional vertigo for seven ...
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68 yo WF in excellent health with prior history of intermittent benign positional vertigo for seven years and a cerebral concussion two years ago from which she recovered uneventfully in 6 weeks with no residual neurologic or physical issues. Patient received first dose 1/19/2021 with only mild fatigue and arm soreness at injection site. 16 hours after the second dose, Patient developed a dull total cranial headache and fatigue , retiring to bed , taking no medicines. She had taken only her premarin 0.625 mg for the last week. Patient awoke at 4:30 am with severe headache, nausea and vertigo, being unable to stand without assistance. urinary incontinence also occurred, but most likely occurred as she was unable to to get to the bathroom due to vertigo and pronounced vomiting of clear yellow fluid. incontinence never occurred again throughout the illness. examination at this time showed nystagmus on bilateral lateral gaze and vertical nystagmus. no other neurological signs or symptoms were present. On return to bed, Patient continued to have vertigo headache and nausea even supine with eyes closed. Vetigo and standing instability did not respond to epley manuvers. Headache remained mild to moderate, along with persistent vertigo and nystagmus for 4 days, becoming slightly less each day. On the fifth day, Patient was able to ambulate unaided by holding onto walls furniture etc. vomiting did hot reoccur after her initial bout. Headache abated on the fifth day. Patient remained "fuzzy" and imbalanced for the next 14 days with occasional mild posterior cranial headache. Rotary nystagmus abated on the 7th day. Note is made that no abnormalities of the tympanic membranes were noted. no cardiac symptoms or irregularities were noted HR 60 BP 110/70 several attempts at epley manuvers only resulted in symptom worsening. Patient felt well enough to traveled by airplane day 8 post dose, having still some "fuzziness 'and slight imbalance, being unable to walk briskly due to gait instability..symptoms worsened slighty after air flight, and on return to home, slight barotraumatic changes were noted in the tympanic membranes, slight fluid levels and some small streaky membrane hemorrhages noted. her gait became slighty more unstable, but she was able to walk unaided. symptoms improved daily and by day 14 symptoms seemed to be much lessened, no nystagmus being noted. vertigo was present only on rapidly standing , position change and vertical looking up., vertigo abating quickly after each motion at rest. Patient traveled by plane on 3/4/21-3/8/21, vertigo escalateed to mild to moderate..no response to epley manuvers. Vertigo worsened daily and Patient again developed mild gait instability and nystagmus bilaterally and vertically. Ear exam was unchanged. no headache was present during this time. Patient was taken for balance training to a specially trained Physical therapist on 3/10/21 for evaluation , Patient being markedly symptomatic, examination showing both right and left ear abnormaities as well as vertical nystagmus. driving was prohibited. The constellation of symptoms for the even are most consistent with acute vestibular neuronitis or central vertigo.. Neuologic localizing signs suggestive of cerebral thrombosis, etc were not present , so MRI was not performed. Patient had Had a Notmal CT scan with here cerebral concussion two years prior. As the symptoms weer worsening and the result of the balance training session on 3/10/21 resulted on significant worsening on awakening on 3/11/21 with moderate gait instability, bilateral horizontal and vertical nystagmus, Prednisone 40MG po was administered. Approximately 8 hours after the prednisone dose, Patient was able to stand unaided, and vertigo was almost totally cleared. 30mg prdnisone was administered on 3/12/21 with Patient being totally asymptomatic. No nystagmus could be detected and epley manuvers done by the physical therapist resulted in no symptons or evoked nystagmus. Predinsone dose was deescalated by 10 mg daily, Patient remaining totally asymptomatic. today 3/16/21 Patient will take 5mg of prednisone, still assymptomatic, prednisone to be discontinued tomorrow.
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| 68 | 2021-03-15 | headache, head discomfort |
Light-headed; Pressure in my chest; Pressure on my jaw and shoulder, my left shoulder; pressure on m...
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Light-headed; Pressure in my chest; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Arm was sore; Had light headache; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982) via an unspecified route of administration on 22Jan2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]) taken daily. The patient experienced light headedness and pressure in her chest that went to her left shoulder and jaw. Patient had light headache, pain in chest, and pain in jaw. She woke up this morning feeling better but still had slight pain in jaw. Wondering if side effects are from vaccine and will she be ok. Patient stated, "I have the first dose of the vaccine on 22Jan2021, I didn't have any side effect, my arm was sore but nothing big. But yesterday I feel light headed, like pressure in my chest, kind of pressure on my jaw and shoulder, my left shoulder, and my vitals were okay like my blood pressure, my heart rate and everything was normal. Further she explained this morning I felt better I didn't have pressure on my chest or anything but the pressure on my jaw that go up to my head. Is that related to the vaccine or is something that I have to worry about?" Consumer stated, "The second one is going to be on 12Feb2021, this Friday." Patient stated, "No, I was calling because today I feel better, I don't have the pressure on my chest. But I still have the pressure on my jaw and on my kind of my head. But no I have not called anybody. It's not like an emergency, I am calling because I was not sure about this is related to the vaccine." For treatment consumer stated, "No, today I took some Tylenol, that's all." No investigation assessment. The outcome of the event 'Light-headed' was recovering, the patient recovered from the event 'Pressure in my chest' on an unspecified date, was not recovered form Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head and was unknown for other events. No follow-up attempts needed. No further information expected.
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| 68 | 2021-03-15 | headache | Headache, sore arm, joint aches |
| 68 | 2021-03-15 | fever, chills, influenza like illness |
Flu like symptoms. Nausea with vomiting. Low grade fever of 100 for 3 days. Aches, pains and chil...
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Flu like symptoms. Nausea with vomiting. Low grade fever of 100 for 3 days. Aches, pains and chilling. Nausea treated with Zofran.
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| 68 | 2021-03-15 | fever, chills |
First three days regular side effects, chills, fever, nausea and occasional dizziness (reported on a...
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First three days regular side effects, chills, fever, nausea and occasional dizziness (reported on app to CDC). Day 4 pain in right hip began. By day 7 rash had appeared on right buttocks and hip and below waist on right side. Day 12 formerly diagnosed with shingles.
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| 68 | 2021-03-15 | fever, chills |
Lightheaded and weak 11 am March 15th fever of 100.2 with Tylenol all day shaking chills with hot an...
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Lightheaded and weak 11 am March 15th fever of 100.2 with Tylenol all day shaking chills with hot and cold spells, rattling chills so I could not even text with my fingers, extremities cyanotic, but that is usual for me when I am very cold. Got into a very hot tub of water and stayed until my core warmed up. Spell lasted about 2 hours and then resolved. Felt much improved on 3/16/21
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| 68 | 2021-03-16 | fatigue, chills, headache |
Stomach cramps, vomiting, chills 4 hours Sleep disturbance and fatigue for 6 days Headaches 4 days. ...
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Stomach cramps, vomiting, chills 4 hours Sleep disturbance and fatigue for 6 days Headaches 4 days. Handled by Ibuprofen or aspirin
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| 68 | 2021-03-16 | fatigue |
she was so tired; Rash on both arms and inside arms/Rash on Face/rash on front and back of knees; bu...
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she was so tired; Rash on both arms and inside arms/Rash on Face/rash on front and back of knees; burning and itching with bleeding; swelling in lips; Blood in stool/she had blood in her stool, leaking blood around rectum and it had like a burning itch; Blood leaking around rectum/she had blood in her stool, leaking blood around rectum and it had like a burning itch; Face and Neck Burning/hot face and neck was flushed; hot face and neck was flushed; Tingling in tongue, lips, face; Tingling in tongue, lips, face; throat felt tight; lips were puffy; thought she was starting to shake; anaphylactic event; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration in left arm (left shoulder area) on 06Mar2021 17:45 at SINGLE DOSE for COVID-19 immunisation. The patient had no additional vaccines administered on same date of the Pfizer vaccine. The patient had no prior vaccination within 4 weeks. Medical history included upset stomach after eating banana's last year (2020). There were no concomitant medications. The patient had no family medical history relevant to events. The patient previously took bactrim and pneumonia vaccine and experienced anaphylactic reaction to both. On 06Mar2021, the patient experienced anaphylactic event, allergic reaction, face and neck burning, hot face and neck was flushed, tingling in tongue, lips, face, swelling lips, throat felt tight, and lips were puffy. On 07Mar2021, the patient experienced rash, blood in stool, blood leaking around rectum, burning and itching with bleeding. The patient further reported that she had a 'serious life threatening event' after first dose of the Pfizer Covid 19 vaccine on 06Mar2021. Hospital papers say 'anaphylactic event.' Tingling in lips tongue and face, hot face and neck after vaccine, swelling in lips, rash started yesterday evening (07Mar2021), bloody stools for a few hours yesterday evening (07Mar2021) but has resolved. The patient was seen in emergency room (ER) via ambulance. The patient asked if there was a chance the preservative in the vaccine caused her reaction and if the potassium in the vaccine causing her anaphylactic reaction. Additionally, the patient reported that she had a severe allergic reaction this past Saturday to the Covid Vaccine, stated the nurse sent her back to the pharmacist who told her she was having an allergic reaction to the vaccine. The patient reported having a hot face and neck was flushed, after the vaccine, she stated she had tingling in her tongue, lips, and face. And she stated her throat felt tight also, her lips were puffy, and a lot of heat of neck and face, thought she was starting to shake. The patient reported the pharmacist gave EpiPen in thigh and 20 mg tablet of Benadryl and called 911, and took her to the local hospital. Patient also reported that she has not seen this doctor yet she asked to see her and has an appointment with her. The patient also stated that her new PCP was not aware of the reaction to the vaccine at this time. The patient further mentioned that she was still having a rash that broke out. She reported that her tongue was tingling and she still has some swelling in her lips. Patient continues to clarify she still has swelling and some tingling on the tip of tongue and half back on her tongue. She stated that the swelling was persisting and that Benadryl or Prednisone does give some relief but it comes back. Patient mentioned being on a 4 day cycle of Prednisone, takes two in the morning with food. The patient clarified the location of the rash as a rash on both arms that was inside of both of the arms, like a pink rash, she states it was on face and on knees around the front and back of her knees like a red rash. She continues it was on the neck down to the collar bone around the back of her neck, like if she was a bust statue it would be all in that area from the collar bones at that point up and around the back of the shoulder blades. It goes all the way around face and neck. Patient also further reported that she had a scary reaction last night (07Mar2021), she said she had blood in her stool, leaking blood around rectum and it had like a burning itch, when she wiped it was blood, she continued to say when she wiped it was like 'giblets.' She stated was stool, blood, and giblets. Patient stated this lasted for about and hour and half or 2 hours until the stool stopped and it was about 1:30 am before she finally went to sleep, she was so tired on an unspecified date. She stated she took Benadryl right away. She continued to report the bleeding has resolved completely as of this point and reported a regular bowel movement today (08Mar2021). She has two Epi Pens from the drug store that was prescribed but she was afraid to use it, and she thought to see what happens if she uses the Benadryl. She received the Epi shot at the drug store, at (pharmacy), when her reaction broke out, on 06Mar2021, in her thigh, for the allergic reaction. This was her first time ever receiving EpiPen (Lot 029F20AA, expiration Mar2022, and NDC is 0093-5986-27). The ER doctor prescribed her 0.3 mg every 5-15 minutes as needed for anaphylaxis, and not to exceed 3 doses. She received the Benadryl at the drug store, 120mg tablet, first dose was given at drug store. Patient reported she was given prednisone IV in hand through IV at ER, she doesn't know how much that was, then was given Prednisone to go home with- 20mg tablets take 2 a day for 4 days, which she started Sunday morning, 07Mar2021. She was told she experienced a life threatening allergic reaction. Patient was taken to the ER in the ambulance, the paramedic who was with her said she was his first COVID reaction patient. ER doctor told her not to take the second dose of Pfizer vaccine, and to be cautious if taking the EpiPen, she states her heart was racing because of the EpiPen and was told it was because she was not younger that her body did not handle the Epi like younger people do and was told she could have a heart attack from the EpiPen. She was scared because she was not covered fully, since she can't get the second shot of Pfizer, and she was afraid of the Epi Pen, so she was really in a tough spot. ER doctor stated she may be able to take the Johnson and Johnson vaccine, as the second, but she needs to talk to her Primary care about that. The ER doctor continued to tell her it would have to be a special case where she was in a hospital setting in case she has another serious reaction, she was concerned for not receiving the second dose because that means she was not completely covered with one vaccine. She was afraid of the Epi-Pen since she can get a heart attack from it because of her age. The patient mentioned she was tested in Oct (clarified as 14Oct2020) for Covid due to having a viral infection at that time but was negative. Added the ER paper work says ED anaphylaxis. The patient wanted to ask about finding out the ingredients in Pfizer vaccine and the ingredients in the Johnson and Johnson vaccine. She saw the list on the fact sheet of Pfizer's ingredients and in a few places it says Potassium, 3 different ingredients, and several months ago, she quit eating bananas, bananas have potassium, and they were giving her stomach upset, diarrhea, she used to eat them all her life, she noticed that there was a lot of potassium in the medicine. Doctor wanted to know if she would be able to take the Johnson and Johnson vaccine. He said if she got the second shot, of the Johnson and Johnson, that it would have to be a special case, like in a hospital setting, and there would have to be medical people in a medical center, to take care of her was she has a reaction to it as well. He advised that she take the Johnson and Johnson than not taking it, because by not taking it, she was very vulnerable to catching COVID 19. And patient wanted to know was it a preservative that was causing the reaction. It was reported that rash began around 10PM, bloody stool began between 11 PM and 12:30 AM, all other symptoms within 15-20 minutes, it began around 6PM, maybe sooner 5:55 PM, she was in denial, it felt like tongue and lips tingling, she did have a reaction before to a different shot. The anaphylactic reaction required emergency room visit. Patient was not hospitalized and was in observation in ER. On 08Mar2021, the patient recovered from blood in stool, rectal bleeding, and burning and itching with bleeding. The patient had not yet recovered from severe allergic reaction, hot face and neck was flushed, tingling in tongue, lips, face; lips were puffy, and rash. The outcome of throat felt tight, thought she was starting to shake, she was so tired, and swelling in lips was unknown.
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| 68 | 2021-03-16 | headache |
About 14 hours after first dose I woke with a moderate headache that lasted 36 hours and continued m...
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About 14 hours after first dose I woke with a moderate headache that lasted 36 hours and continued mild/moderate since (i.e. nine days) most intense in the early hours. I've taken aspirin intermittently for the pain.
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| 68 | 2021-03-16 | nasopharyngitis, headache, chills |
Got shot at 8:15am on 3/8/2021. Felt fine all day other than arm slightly tender & sore at shot site...
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Got shot at 8:15am on 3/8/2021. Felt fine all day other than arm slightly tender & sore at shot site. Went to bed around 11:30pm, woke up at 1am chilling & aching, freezing cold, couldn't get warm, added another blanket & went back to sleep. Woke around 6:30am on 3/9/2021 still achy & chilling & feeling headachy, took a Tylenol & went back to bed for an hour. Got up again around 7:30m, felt better & continued to slowly feel better throughout the day but just a little out of sorts all day. Felt much better on Wednesday 3/10/2021 but not completely 100% until Thursday 3/11/2021. I had the virus in January & the effects felt just like when I had the virus. I also understand the vaccine contains the virus to allow your system to make itself immune to it. I am a small person = 5' tall, 110 lbs. I wondered if the amount of the dosage I received was too strong for a small person. I understand that the same amount of dosage is given to each patient, but I'm sure it can affect smaller people differently than someone of more body mass. Anxiously awaiting my 2nd shot scheduled for March 29 and wonder if I will have adverse effects again. I will certainly watch for any next time. Hope this info helps.
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| 68 | 2021-03-16 | fever, chills, lethargy, headache | Fever, chills, headache, vomiting, diarrhea, lethargic and SOB |
| 68 | 2021-03-17 | chills, body temperature increased |
Arm swollen and black and blue at the site, 101 temperature for 5 hours, chills - took Tylenol and...
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Arm swollen and black and blue at the site, 101 temperature for 5 hours, chills - took Tylenol and iced arm as of this date arm is start to go down bruise getting bigger starting to itch
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| 68 | 2021-03-17 | chills, fever |
Injection site pain12 hours after then chills fever up to 100 for almost 36 hours. Body aches especi...
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Injection site pain12 hours after then chills fever up to 100 for almost 36 hours. Body aches especially back hips neck . Itchy rash at end of fever andafter fever subsided lasted for five days. I typically with fever get a rash. Nausea, body aches all over swollen neck glands
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| 68 | 2021-03-17 | fatigue, chills |
Chills for approximately 24 hours after Dizziness, overall weakness, and tiredness with inability to...
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Chills for approximately 24 hours after Dizziness, overall weakness, and tiredness with inability to sleep (ongoing, 6th day) Swelling of the face, particularly left side more affected (noticed on 6th day after injection) Bad taste in mouth and dryness Eye sockets darkened, more so in the left eye (noticed on the 4th day after injection; ongoing)
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| 68 | 2021-03-17 | headache, throat pain |
a significant headache this morning with pain focused at the front of her head; Weak feeling; feelin...
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a significant headache this morning with pain focused at the front of her head; Weak feeling; feelings of weakness in her legs when walking; sore throat; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263) solution for injection, intramuscular on left deltoid on 26Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medication was reported as none. The patient received the first dose of COVID vaccine on 26Jan2021 and reported a significant headache this morning with pain focused at the front of her head after she was up for a while, she also had a weak feeling, feelings of weakness in her legs when walking and a sore throat, all on 02Feb2021. Her headache was very bad, but after treating with 2 tablets of extra strength paracetamol (TYLENOL) 500 mg, her headache was not as bad as it was. This happened suddenly. Her sore throat started the same time as the headache which was currently gone. She wanted to know if these events could be from the vaccine, a week later; if she should get a COVID test; and how long will the headache last if it came back. The outcome of the headache was recovering and recovered on 02Feb2021 for all other events.
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| 68 | 2021-03-18 | chills, fatigue | Chills, body aches, dizziness, fatigue lasted 48 hours |
| 68 | 2021-03-18 | fatigue, headache | Nausea joint pain muscle pain headache tiredness |
| 68 | 2021-03-18 | fatigue | One day of extreme fatigue Two following days of diarrhea No treatment beyond Kaopectate |
| 68 | 2021-03-18 | fatigue |
She had the vaccine at the facility where she lives. She fainted less than 24 hours after the vacci...
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She had the vaccine at the facility where she lives. She fainted less than 24 hours after the vaccine, got up from that and had dry heaves, lost her speech and had loose stools. The aide caught her as she was fainting as she would have fallen on the floor. She said it was weird, she looked at people and it looked like they were 2 dimensional and knew something was wrong, but couldn't figure out what as they attended to her. They asked her questions, but she was not able to speak to them. They apparently spent 2 hours with her, but she doesn't believe it was that long, and then they knew she wanted to go to one Hospital and not the other. She had been loosing words before this happened, but not as bad as this one. This was about the same reaction that she had when she got the COVID virus in January. She was then taken to the hospital where she was given fluids and hydrated her and checked her heart, saw a cardiologist and a neurologist to see if those things caused the fainting and had blood work done. They also did a CAT Scan of her head and neck. They told her that she was fine and was discharged back home after 5 days, which was 3/11/21. Since then she has been very tired, she does have GERD and her stomach has been hurting a lot as well.
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| 68 | 2021-03-18 | headache |
RECEIVED SECOND DOSE OF PFIZER ON TUESDAY (3/16) AND HAD SLIGHT HEADACHE THRU THE NIGHT, BUT TOOK NO...
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RECEIVED SECOND DOSE OF PFIZER ON TUESDAY (3/16) AND HAD SLIGHT HEADACHE THRU THE NIGHT, BUT TOOK NOTICE OF ITCHING ON RIGHT CALF ON THURSDAY. DISCOVERED I HAD A VERY RED RASH/HIVE? FROM MY RIGHT KNEE MOST OF THE WAY TO MY ANKLE AND SEVERAL SMALLER BLOTCHES. THEY WERE ITCHY AND HOT. USED SUNBURN LOTION WHICH HELPED SOME WITH ITCHING. IT SEEMS TO BE FADING BUT STILL ITCHY. THOUGHT IT SHOULD BE REPORTED...BUT CERTAINLY BETTER THAN COVID.
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| 68 | 2021-03-18 | headache |
Extreme nausea, abdominal cramping, diarrhea, dizziness. Also headache and warm face (low fever) occ...
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Extreme nausea, abdominal cramping, diarrhea, dizziness. Also headache and warm face (low fever) occurring for 2 hours , beginning 4 hours after vaccination. Then a little less severe for the following 2 hours. Then further diminishing over the next four hours. Felt OK after 12 hours.
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| 68 | 2021-03-18 | sweating, headache |
Within two hours had headache, violent diarrhea, clammy skin and sweating. Light headed to the point...
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Within two hours had headache, violent diarrhea, clammy skin and sweating. Light headed to the point of almost fainting. I called 911 which I never would do normally but there was no one but me and I wasn?t sure what was happening. Medics took vitals and all was ok. By the time they arrived I was shaky but all other symptoms had gone.
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| 68 | 2021-03-18 | fever, chills, headache | Low grade fever, muscle aches, severe headache, chills |
| 68 | 2021-03-18 | fever, fatigue, chills |
Fever (101); aches; chills; fatigue; This is a spontaneous report from a contactable consumer (patie...
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Fever (101); aches; chills; fatigue; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9269) via an unspecified route of administration on 15Feb2021 at 11:00 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included diabetes and osteoporosis. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient had not been diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not have allergies to any medications, food, or other products. The patient previously received dose 1 of BNT162B2 (lot EL9261) on 25Jan2021 at 15:00 as a single dose in the left arm for COVID-19 immunization. On 15Feb2021 at 19:00 after the second dose of BNT162B2 the patient experienced fever of 101, aches, chills, and fatigue all night and into the morning. The events were reported as non-serious. The patient was not hospitalized for the events. The outcomes of fever of 101, aches, chills, and fatigue all night and into the morning were recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 68 | 2021-03-18 | throat irritation, chills, fatigue |
Heart flutters and tickling in bronchial tube for several hours. In the past when I had this reacti...
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Heart flutters and tickling in bronchial tube for several hours. In the past when I had this reaction to a different combination of medications, it progressed to spasms and I couldn't get my breath for several minutes. My reaction to the covid vaccine didn't progress to that degree, so I didn't report it. A friend suggested that I contact you to see if it is safe for me to take the second shot since the reaction is often stronger after the second dose. I am scheduled to receive that second shot Monday. My only other reactions to the first dose were chills and fatigue, and minor soreness at site of injection.
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| 68 | 2021-03-19 | fatigue, chills, fever, headache |
Severe chills for 1.5 hr despite multiple heated blankets, comforter, etc.; high fever, severe heada...
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Severe chills for 1.5 hr despite multiple heated blankets, comforter, etc.; high fever, severe headache (pain in ears and eyes as well as head), severe muscle and joint pain body-wide, skin painful to touch. Symptoms so severe that sleep was impossible for most of night. Headache severity lessened by 8a.m. 3/20, but is still present, and widespread joint pain, myalgia and fatigue continue up to the time of this report (24 hrs after injection).
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| 68 | 2021-03-19 | fatigue |
Mild Body aches and fatigue that lasted 18 hours. Took Tylenol at 7:30 am and ibuprofen at 11:40 a...
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Mild Body aches and fatigue that lasted 18 hours. Took Tylenol at 7:30 am and ibuprofen at 11:40 am on 3/19/21. Better by mid afternoon 3/19/21.
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| 68 | 2021-03-19 | lethargy, fever, chills |
3:00 am woke up and vomited, Continued to wake up with 3 bouts of diarrhea, had chills & fever of ...
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3:00 am woke up and vomited, Continued to wake up with 3 bouts of diarrhea, had chills & fever of 101, slept in until 10:00, got up and took 1st dose of ibuprofin, felt achy and very lethargic all morning and afternoon, Continued to take doses of ibuprofin, Fever came down and some achiness went away due to ibuprofin, felt better by evening (24 hrs. after shot) but still had slight fever and still fatigued. By morning of 3/20 I felt much better.
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| 68 | 2021-03-19 | paranasal sinus discomfort, headache | 2/10 headache, patient feels like a sinus pressure headache. No other c/o pain or symptoms. |
| 68 | 2021-03-20 | chills, fever |
First 48 hours fever 101 degrees, chest pain, aches, chills, unable to sleep due to pain everywhere ...
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First 48 hours fever 101 degrees, chest pain, aches, chills, unable to sleep due to pain everywhere Approximately 6 days later severe vertigo.....now still soon 4 weeks later, off and on vertigo mild to moderate. Blood work on 3/10/21 my basophils is high and my mean corpus all hemoglobin concentrate low. Two months before this shot, everything was normal
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| 68 | 2021-03-20 | chills |
cramping real bad; sick all night; Chills; hurting; could not keep the Tylenol down, it came back up...
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cramping real bad; sick all night; Chills; hurting; could not keep the Tylenol down, it came back up; stayed in the bathroom, you know I was just dribbling sometimes; This is a spontaneous report from a contactable consumer for herself. A 68-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9269, Expiration date: Unknown) on 08Feb2021 via an unspecified route of administration at single dose for COVID-19 Immunization. The patient's medical history included cholesterol and thyroid from an unknown date and unknown if ongoing. The patient's concomitant medications included vitamins. The patient stated she took medications for her thyroid and cholesterol, and vitamins. On 08Feb2021 at 19:30 the patient had cramping "real bad." The patient was sick all night, had chills, stayed in the bathroom, "you know I was just dribbling sometimes and hurting." The patient could not keep the Tylenol down, it came back up. There was no investigational assessment. The reporter stated she had her first dose of vaccine "yesterday" about 11. The patient was told that the second dose would probably make her sick, but "last night" at about 7:30 she started cramping "real bad," was sick all night, had chills, and just "now" really feeling quite normal. The patient asked if "this in anyway could have affected her kidneys." The patient stayed in the bathroom and "was just dribbling sometimes, was getting normal then she just dribbling and tried Tylenol (taken as treatment) but could not keep the Tylenol." The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 68 | 2021-03-20 | fatigue, headache | Sore arm, headache, fatigue |
| 68 | 2021-03-20 | headache, fatigue |
Next day nausea; severe back pain./Back pain lasted two days; Within 2 hours experienced dizziness; ...
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Next day nausea; severe back pain./Back pain lasted two days; Within 2 hours experienced dizziness; severe headache./After a week still have a headache.; Slight arm soreness; Severe exhaustion and slept 12-15 hours the first three days after shot.; Severe exhaustion and slept 12-15 hours the first three days after shot.; This is a spontaneous report from a contactable consumer. a 68-year-old female patient (consumer) received first dose BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection) via an unspecified route of administration (anatomical location: arm left) on 03Feb 2021 at 12:15 pm at single dose for COVID-19 immunisation. Patient Medical history included low thyroid. The patient's concomitant medication included levothyroxine. It was reported that no other vaccine was given within Four weeks prior to the vaccination. On 03Feb 2021 at 02:15 PM (same day of vaccination) Within 2 hours patient experienced dizziness and severe headache. Slight arm soreness. Next day nausea and severe back pain. Back pain lasted two days. Severe exhaustion and slept 12-15 hours the first three days after shot. After a week still have a headache. The patient prescribed treatment with Ibuprofen, tylenol and meloxicam. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event headache was not recovered and other events was Recovering. Information on Lot/Batch number has been requested
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| 68 | 2021-03-20 | headache, sinus pain, fever, fatigue |
Fever - 101; Muscle aches; Joint aches; Headache; Sinuses hurt; Chest hurt; Tired (All side effects ...
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Fever - 101; Muscle aches; Joint aches; Headache; Sinuses hurt; Chest hurt; Tired (All side effects were gone the next day with the exception of fever - I keep running a very low-grade fever 99.5 into day 3) 2nd day after injection - Injection site had redness going down to my elbow, very warm, and felt swollen
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| 68 | 2021-03-20 | headache |
patient complained of stabbing pain in left temple at time of departure. BP 176/81 82 16. BP taken...
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patient complained of stabbing pain in left temple at time of departure. BP 176/81 82 16. BP taken two times again, 5 minutes apart continue to be 185/ 87. Encouraged to call Primary regarding HTN. No further vaccine reactions noted.
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| 68 | 2021-03-20 | lethargy, headache |
Minimal soreness at injection site; headache; some lethargy; This is a spontaneous report from a con...
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Minimal soreness at injection site; headache; some lethargy; This is a spontaneous report from a contactable consumer reported that: A 68-years-old female patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: EL3248; Batch/Lot Number: EK9231), dose 1 via an unspecified route of administration, administered in Arm Left on 16Jan2021 as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 06Feb2021 as single dose for covid-19 immunisation. Medical history included type 2 diabetes mellitus, patient is allergic to sulpha, tetracycline, shellfish, IV dye. The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient received concomitant medications from unspecified date at unspecified dose frequency and an unspecified indication included: sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]), hydrochlorothiazide (HYDROCHLOROTHIAZIDE) phytosterols nos (CHOLESTOFF ORIGINAL), colecalciferol (VITAMIN D [COLECALCIFEROL]), acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID; ASCORBIC ACID]). On 16Jan2021 08:PM, the patient experienced minimal soreness at injection site, headache, some lethargy. Outcome of the events were recovered.
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| 68 | 2021-03-20 | fever, headache, fatigue |
Fever/chills, headache, weakness, dizziness, fatigue, loss of appetite. Woke feeling feverish around...
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Fever/chills, headache, weakness, dizziness, fatigue, loss of appetite. Woke feeling feverish around 1:30 am (about 16 hours after vaccination). Began feeling better around 5:30 pm (about 34 hours after vaccination). Symptoms not as bad as after first dose and didn't last as long. As of 8:30 am on second day after vaccination (49 hours), feel about 90% back to normal.
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| 68 | 2021-03-21 | chills, sweating | Chills Sweating temperature |
| 68 | 2021-03-21 | fatigue, headache, fever | bad headache, fever, fatigue, body ached, hips hurt (hard to lay down or sitting) for about a day. |
| 68 | 2021-03-21 | fatigue | Great fatigue, double vision, droopy eyelids for 2 weeks now and still ongoing. |
| 68 | 2021-03-21 | fatigue |
severe rashes, hives, swollen joints, fatigue (sleeping 19-20 hrs/day), pending biopsy results expec...
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severe rashes, hives, swollen joints, fatigue (sleeping 19-20 hrs/day), pending biopsy results expected to confirm Sweet's Syndrome.
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| 68 | 2021-03-21 | headache, fatigue | fatigue, nausea, headeache, extreme cold and pain in arm. |
| 68 | 2021-03-21 | headache |
pain in arm, mild bruising, headache. Headache got worse on Wednesday , it is getting better today...
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pain in arm, mild bruising, headache. Headache got worse on Wednesday , it is getting better today. Patient has been taking Tylenol PM patient no longer has headaches, feeling much better. Taking Tylenol PM as needed.
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| 68 | 2021-03-21 | influenza like illness | flu like symptoms |
| 68 | 2021-03-21 | fever, chills, fatigue |
I had chills, a low grade fever, and vomiting, and was extremely fatigued, which lasted about 2 days...
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I had chills, a low grade fever, and vomiting, and was extremely fatigued, which lasted about 2 days. NOTE: The same symptoms occurred with my first vaccine on February 26, 2021.
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| 68 | 2021-03-21 | fever, chills, headache |
Chills, fever and intense headache. Started at 9:30 PM and lasted through the night. 8:00 Am next ...
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Chills, fever and intense headache. Started at 9:30 PM and lasted through the night. 8:00 Am next day felt much better but did have the upper teeth sensitive to cold and heat. This lasted half a day.
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| 68 | 2021-03-21 | runny nose |
Runny nose and prickly skin like hives were going to occur. I took an eighth of 25 mg Atarax and Cla...
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Runny nose and prickly skin like hives were going to occur. I took an eighth of 25 mg Atarax and Clariton D. Again at night. The site was itchy. I used Benadryl cream and massage, which was affective. At no time did I feel sick or unable to go through my normal, retired life. Today is Monday. I am fine.
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| 68 | 2021-03-22 | headache |
I had difficulty walking after approximately 27 hours of vaccination, severe pain in groin on both s...
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I had difficulty walking after approximately 27 hours of vaccination, severe pain in groin on both sides. Within approximately 48-72 hours I developed a severe bursitis on my left elbow, approximately 6 inches from the vaccination site - I had never had a bursitis before. The difficulty walking lessened after a few days, but I am still sore, possibly due to bursae by joints. I had a severe headache after approximately 48 hours which lasted for approximately 5 days. My arm is still sore at the injection site more than 2 weeks after the vaccination.
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| 68 | 2021-03-22 | influenza like illness |
Had the injection 3/21/2021 at 2:30. On 3/22/2021, the next morning after the injection had nausea,...
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Had the injection 3/21/2021 at 2:30. On 3/22/2021, the next morning after the injection had nausea, flu-like symptoms, and slept all day. Took two advil and one tylenol at 6:30 am, 2:00 pm and again at 10 pm. On 3/23/2021, woke up 7 am in the morning and felt fine.
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| 68 | 2021-03-22 | influenza like illness | severe flu-like symptoms for 24 hours post vaccine |
| 68 | 2021-03-22 | sinus disorder, headache |
very painful arm for a week, nausea, muscle pains and weakness, sharp pains in knees, dizziness, bra...
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very painful arm for a week, nausea, muscle pains and weakness, sharp pains in knees, dizziness, brain fog, all my skin felt like it a bad sunburn its still not back to my normal state, cronic sinus issues for about 2 weeks with headaches,
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| 68 | 2021-03-23 | chills, fever, fatigue |
The evening of the inkection I felt nauseated. The next morning I had fever and chills (100 F) and f...
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The evening of the inkection I felt nauseated. The next morning I had fever and chills (100 F) and fatigue. The next morning I had lymphedema on the rt side of my jaw and down my anterior neck. The next day I developed a large ulcerated area at the back of my throat on the right with intense ear pain. I went to the clinic and a covid test was done (I don't have the results yet). Today (7days after the injection) I returned to the clinic because my throat ulcer had gotten larger and spots were appearing on the roof of my mouth. I again ran a low grade fever. I was again diagnosed with either a viral infection or an unusual immune response to the vaccine.
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| 68 | 2021-03-23 | fatigue, chills, headache, fever | Fatigue all day, chills12:00 pm - 7:00 pm, headache and body aches, fever of 101.5 12-7 |
| 68 | 2021-03-23 | fatigue, dehydration, fever, headache |
Was at home, felt Dizziness,fainting,fever,strong headache,fatigue,cold sweat,body ache,clammy skin,...
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Was at home, felt Dizziness,fainting,fever,strong headache,fatigue,cold sweat,body ache,clammy skin,nausea, short of breath ,dry mouth ,dehydrated, very bad I though Iwas going to pass out at any time,weak.
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| 68 | 2021-03-23 | fatigue, headache, fever, chills |
Headache, sore arm, fatigue, muscle pain, racing heart rate, difficulty breathing Fever (high of 101...
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Headache, sore arm, fatigue, muscle pain, racing heart rate, difficulty breathing Fever (high of 101.9) Body ache Chills Upset stomach/ no appetite
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| 68 | 2021-03-23 | fatigue |
Exacerbation of chronic fatigue, "burning" eyes, "brain fog", chills, metallic taste in mouth, mouth...
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Exacerbation of chronic fatigue, "burning" eyes, "brain fog", chills, metallic taste in mouth, mouth sores, decreased appetite.
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| 68 | 2021-03-23 | fatigue | Excessive fatigue, severe arthritic body pain to entire body |
| 68 | 2021-03-23 | fever, fatigue |
Low grade fever(100.6) for 20 hours, controlled by Tylenol; upset, queasy stomach and very tired for...
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Low grade fever(100.6) for 20 hours, controlled by Tylenol; upset, queasy stomach and very tired for same time frame. No other symptoms.
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| 68 | 2021-03-24 | headache, sweating, fatigue, chills, body temperature increased |
Nausea, vomiting, bad vertigo, (fell) sweating, chills and freezing, temp 101, headache, eyes blurry...
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Nausea, vomiting, bad vertigo, (fell) sweating, chills and freezing, temp 101, headache, eyes blurry and could not focus on anything- trouble standing up and not falling over- started at 6:30 Sunday morning and gone by 1 - except very fatigued, (slept mostly for 3 days) shaky (trembling) , no appetite , headache and chills- lasting thru to Thursday morning. Was very scary!
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| 68 | 2021-03-25 | cough, throat irritation, fever |
a few hours after getting the vaccine, my throat started burning, hard to swallow, then cough, low f...
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a few hours after getting the vaccine, my throat started burning, hard to swallow, then cough, low fever, body aches which continued from the 15th untill today 26th. lost 12 lb during this time, Weakness. Have never been this sick! My husband also had the same shot, same day, and started getting ill 5 days later, Cough, fever, nausea, unable to sleep. He is still ill today with dry heaves.
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| 68 | 2021-03-25 | fatigue, chills |
Felt exhausted, sciatic nerve in left buttocks flared up badly, felt a slight, brief chill like a fe...
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Felt exhausted, sciatic nerve in left buttocks flared up badly, felt a slight, brief chill like a fever for about 5 minutes, dizzy, felt out of it.
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| 68 | 2021-03-25 | fatigue |
Tiredness; sore arm; stomach and intestinal issues; Diarrhea; very unsettled stomach; This is a spon...
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Tiredness; sore arm; stomach and intestinal issues; Diarrhea; very unsettled stomach; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 12Feb2021 at 13:45 (at the age of 68-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included breast and colon cancer, thyroid surgery, controlled blood pressure (BP), and diabetic. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine the patient was not diagnosed with COVID-19. Concomitant medications included trastuzumab (HERCEPTIN) infusions every 3 weeks from an unspecified date for cancer, pertuzumab (PERJETA) from an unknown date for cancer, anastrozole from an unknown date for cancer, levothyroxine sodium (SYNTHROID) from an unknown date for thyroid surgery, nadolol from an unknown date for controlled blood pressure, linagliptin (TRAJENTA) from an unknown date for diabetic, pantoprazole (PROTONIX) from an unknown date for an unknown indication, cetirizine (ZYRTEC) from an unknown date for an unknown indication, and "vita" from an unknown date for an unknown indication. The patient previously received penicillin, aspirin, and medications from yew pine tree from unspecified dates for unspecified indications and experienced allergy. On 06Feb2021 (as reported) the patient experienced tiredness. On "day 2" the patient experienced sore arm, stomach and intestinal issue, diarrhea and very unsettled stomach. The event were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of tiredness and sore arm were recovered on an unspecified date. The outcomes of stomach and intestinal issues, diarrhea and very unsettled stomach were recovered on "day 5". It was also reported that since the vaccine, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 68 | 2021-03-25 | fever, chills | Chills body aches headache fever 102.8 no appetite very thirsty |
| 68 | 2021-03-26 | chills, sleepiness, fatigue |
All adverse effects have lasted for six (6) plus days post-injection unless otherwise indicated: inj...
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All adverse effects have lasted for six (6) plus days post-injection unless otherwise indicated: injection site arm sore, fatigue, sleepiness, joint pain, diarrhea, bad nightmares for four (4) nights and bad dreams (unusual for me) for two plus nights after (I had nightmares after the first covid shot, too), minor dizziness for three days, chills, depression.
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| 68 | 2021-03-26 | headache, fatigue | Extreme Fatigue, brain fog, nausea, headache, body aches for 5 days |
| 68 | 2021-03-26 | headache, influenza like illness, fever |
Fever, headache, flu-like aches and pains--joint pain, miscellaneous stabbing/throbbing pains, nause...
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Fever, headache, flu-like aches and pains--joint pain, miscellaneous stabbing/throbbing pains, nausea, loss of appetite
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| 68 | 2021-03-26 | headache |
Paralysis of arm and hand on side (L) where vaccine was administered. Extreme pain (Fire -like) shoo...
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Paralysis of arm and hand on side (L) where vaccine was administered. Extreme pain (Fire -like) shooting up and down the leg on the opposite side (R) with very bad joint pain. This went off & on through the night/early morning in the first 22 hrs after vaccination. Woke with most pain gone, L hand red and sore, minor headache. Through out the following week I have experienced difficult pain and instability of some joints.
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| 68 | 2021-03-27 | chills |
For the first 3 days, intermittent chills and muscle aches in legs. On the 4th day, I felt back to ...
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For the first 3 days, intermittent chills and muscle aches in legs. On the 4th day, I felt back to normal. On the 5th day, I noticed a distinct increase in the volume of tinnitus in both ears, day and night. It sounds like constant high pitched white noise.
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| 68 | 2021-03-27 | fatigue, headache | Double vision, droopy eyelids, fatigue, headache, cramps ( all within first 24 hours after shot) |
| 68 | 2021-03-27 | headache, fatigue | Extreme fatigue, headache, muscle aches, reduced sense of smell & taste |
| 68 | 2021-03-27 | malaise |
symptoms of liver failure. Liver seems to be shutting down.; began to feel ill, illness continued ov...
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symptoms of liver failure. Liver seems to be shutting down.; began to feel ill, illness continued over time; Jaundice; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 68-years-old via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on an unspecified date for covid-19 immunisation. It was reported that within 24hrs of receiving the vaccine on 20Feb2021, the patient began to feel ill, illness continued over time, eventually when to doctor and presented symptoms of liver failure. Liver seems to be shutting down. Jaundice has set in over the past 5 days. It was unknown if the patient received any treatment for the events. The patient did not recover from the events. Information on the lot/batch number has been requested.
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| 68 | 2021-03-27 | fever, fatigue, headache | Fever 101 for one day, headache/body aches/joint pain for 3 days, fatigue for 4 days |
| 68 | 2021-03-27 | fever |
2 days: sore arm, fever, aches, extensive sleep days 3-10 vaccination arm swollen lymph nodes with ...
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2 days: sore arm, fever, aches, extensive sleep days 3-10 vaccination arm swollen lymph nodes with low grade fever
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| 68 | 2021-03-28 | throat pain, cough, fever, chills |
body ache from head to toe; chills; sore throat worsening; sore throat worsening; fever of 101.8F; d...
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body ache from head to toe; chills; sore throat worsening; sore throat worsening; fever of 101.8F; dry cough; weakness; This is a spontaneous report from a contactable nurse reporting for herself. A 68-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number reported as "G or E N6202"), intramuscular in left arm on 27Feb2021 (age at vaccination 68-year-old) at 11.30 at single dose for COVID-19 immunization. She is due to take the second dose of the vaccine on 20Mar2021. Medical history included: she has history of AFIB but has been in regular rhythm and has not taken any medications since 3-4 years ago. Her blood pressure is so low and she was falling all the time, was dizzy and bumping into wall. The doctor said it was a good thing she is off. Her blood pressure is still 90's/60/s. She got shingles two shots and she got it last fall. Those were pretty awful. She had a lot of local tenderness, trouble lifting arm up and the next two days, she felt blah and had pain in clavicle and scapula on left side. That pain in the bone lasted about a week afterwards; diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, she has had low white cell all of her adult life (she has gone between 3.5 and 4.0). Family medical history: Cardiac history. Concomitant medication included: eye vitamins and that kind of stuff. She did not take Tylenol or aspirin two days prior. On 09Mar2021, 11 days after getting the first dose of the vaccine, she had symptoms namely sore throat, chills, body ache from head to toe, dry cough, fever and weakness. She said that it lasted for 36 hours. She felt so crappy on 09Mar she did not take her temperature. She did not take it until 10Mar2021 when it reached a maximum of 101.8 degrees. Patient said she now feels pretty good except she has no energy at times. She wondered if she had COVID, so she got a test on 10Mar2021 and it was negative. Patient reported that she actually had a sore throat for about a year. That may not have been started with the vaccine, but it may have been exacerbated. She thinks she may have Reflux. She made an appointment with her gastroenterologist. She said her throat was red when she went to Urgent care to get the COVID test. She has had a dry cough for about a year. That could be related as well to the reflux. That did not seem to increase since the vaccine. Reporter considered events fever, chills and ached from head to toe as medically significant. Outcome of events sore throat worsening, asthenia was not recovered, chills, ached from head to toe, fever was recovering, of event cough was unknown. Information about Batch/Lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events Fever, Ache, and Chills cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2021-03-29 | body temperature increased, influenza like illness |
Within 60 seconds, my heart stated racing, my throat swelled and my tongue grew in size and became l...
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Within 60 seconds, my heart stated racing, my throat swelled and my tongue grew in size and became like sandpaper. I had a cold drink with me that I guzzled quickly and forced fluids, taking benadryl. I spiked a temperature to 99.5F within the hour. After that resolved I had 48 hours (still going) of flu like symptoms with temps up to 101.
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| 68 | 2021-03-29 | fatigue |
pt states that immediately after taking the vax she got light headed and her limbs felt very very he...
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pt states that immediately after taking the vax she got light headed and her limbs felt very very heavy. Her BP was up to 192/90. They had her sit to monitor her BP and she became nauseas. She went to the ER. They continued to monitor her BP and she was given IV Benadryl. The heaviness in her limbs lasted many hours. Once her dizziness, heaviness in limbs, and her BP was 141/67 and still coming down she went home. Walking to her vehicle she had the dizziness, heaviness and was light headed again. When she got home she went to bed. Pt woke up having heart palpations. No chest pain or SOB. These palpitations lasted about 15 minutes. On 3/30/2021 she has some fatigue and a tightness around the top of her head. Pt has a FU appt w/ PCP on 3/31/2021.
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| 68 | 2021-03-29 | malaise, fever, headache |
"covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking s...
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"covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; headache; slight fever; malaise; This is a spontaneous report from a contactable other health professional (patient herself). A 68-years-old contactable female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA, formulation: solution for injection. lot number: EN6202) vaccine via an unspecified route of administration, in left arm on 23Feb2021 18:45 as single dose for covid-19 immunisation. Medical history included hypersensitivity (allergies) to medications, food, or other products. The patient was not diagnosed with COVID-19 before vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included vitamin D and calcium. On 24Feb2021 at 15:00, the patient experienced "covid arm"-2.5-inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site, headache, slight fever, malaise. The reporter classified the events as non-serious. Treatment received for the adverse event was ibuprofen, ice and Benadryl. The outcome of events was not recovered.
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| 68 | 2021-03-30 | chills, headache |
Bad taste in my mouth (like bad feta cheese); Chills; then hot 98.7; (normal is 97.4); total body mu...
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Bad taste in my mouth (like bad feta cheese); Chills; then hot 98.7; (normal is 97.4); total body muscle aching; headache; This is a spontaneous report from a contactable consumer (patient herself) of 68-year-old female (age at the vaccination) received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 28Jan2021 09:00 AM as single dose for covid-19 immunisation. Vaccine was administered at facility. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient did not diagnose with covid-19 prior to vaccination and had not been tested for covid-19 since the vaccination. Patient medical history was included Stage IV breast cancer, hypo thyroid, elevated BP, pernicious anemia, low K, glaucoma BP and allergies to fish, shellfish, phenothiazines, cipro, cytoxin, morphine, demerol, codeine, sulfa, ampicillin, vancomycin, xylatan, alphagan. Patient's concomitant medications were included eribulin mesilate (HALAVEN) denosumab (XGEVA), amlodipine besilate (AMLODIPINE BESILATE), levothyroxine sodium (SYNTHROID), potassium (POTASSIUM K 20). On 28Jan2021 10:30 am the patient experienced bad taste in my mouth (like bad feta cheese), chills, total body muscle aching, headache. Patient underwent lab tests included body temperature results as hot 98.7 (normal is 97.4) on 28Jan2021 10:30. Patient had not received treatment for the events. The outcome of event was recovering.
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| 68 | 2021-03-30 | fatigue |
MS/Optic Neuritis; MS/Optic Neuritis; sore arm; fatigue; overslept; Color fading/washed out symptoms...
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MS/Optic Neuritis; MS/Optic Neuritis; sore arm; fatigue; overslept; Color fading/washed out symptoms left eye/decrease color discernment; poor vision left eye/vision from 20/30 to 20/60 corrected in left eye/decreased vision; This is a spontaneous report from a contactable physician. A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198) intramuscularly administered in the right arm on 02Mar2021 08:00 as single dose for COVID-19 immunisation. Medical history included addison's disease, hypertension and optic neuritis from Aug2020 to Aug2020. Patient was not pregnant. Concomitant medications included hydrocortisone (HYDROCORTISONE), metoprolol (METOPROLOL), fludrocortisone (FLUDROCORTISONE), amlodipine (AMLODIPINE), estradiol (ESTRADIOL) and olmesartan (OLMESARTAN). Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9265) intramuscularly administered in the right arm on 09Feb2021 02:00 PM as single dose for COVID-19 immunisation. On 03Mar2021 07:00, patient had multiple sclerosis (MS), optic neuritis, sore arm, overslept and fatigue. It was also reported that when the patient woke up on 03Mar2021 07:00, she had poor vision in the left eye and experienced color fading; further reported as washed out symptoms in the left eye. She went to the ophthalmologist and saw that she had decreased vision, further reported as from 20/30 to 20/60 corrected in left eye and decrease color discernment. Patient was treated with Methylprednisolone 250mg intravenous (IV) every 6 hours x 12 doses for the events multiple sclerosis (MS) and optic neuritis. The events resulted in physician office visit. The patient underwent lab tests and procedures which included CT angiogram: negative for arteritis on an unspecified date, fundoscopy: normal on an unspecified date, intraocular pressure (IOP): normal on an unspecified date, lumbar puncture: increased protein 79 ms panel pending on an unspecified date. Outcome of events was recovering.; Sender's Comments: The events most likely intercurrent conditions and unlikely related to suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198). This case will be reassessed when follow-up information is received.
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| 68 | 2021-03-30 | fatigue |
extreme fatigue; body aches; very sore arm; This is a spontaneous report from a contactable consumer...
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extreme fatigue; body aches; very sore arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown and Expiration date: Unknown), via an unspecified route of administration in Left arm on 29Jan2021, 09:15 AM (at the age of 68-year-old) as a single dose for COVID-19 immunisation in Public Health Clinic/facility. The patient's medical history included Type 2 Diabetes, High BP (blood pressure), High Cholesterol, Asthma. List of any other medications the patient received within 2 weeks of vaccination: Yes (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. About 48 hours after injection, on 31Jan2021 09:00 am, the patient experienced extreme fatigue, body aches, very sore arm. The reporter assessed the events as non serious. The patient did not receive any treatment for the adverse events. The outcome of the events was recovered in 2021. Information on the lot/batch number has been requested.
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| 68 | 2021-03-30 | headache, chills |
Nausea; Vomiting; Chills; Stomach pain; Slight headache; Uncontrollable shaking; This is a spontaneo...
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Nausea; Vomiting; Chills; Stomach pain; Slight headache; Uncontrollable shaking; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 68-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiry date: unknown) via an unspecified route of administration, administered in Left arm on 28Jan2021 at 14:00 (at the age of 68-years-old) at a single dose for covid-19 immunisation. Medical history included bronchiectasis and dysthymia. Allergies to medications, food, or other products included Rash with amoxicillin. Concomitant medication patient received within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT) and ovata (METAMUCIL [PLANTAGO OVATA]). The patient previously took amoxicillin and experienced rash. The patient experienced nausea, vomiting, chills, stomach pain, slight headache and uncontrollable shaking on 28Jan2021 at 21:30 PM. The event was considered as non-serious. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient was recovering form all the events.
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| 68 | 2021-03-30 | malaise, fatigue |
It became very hot and it became black and blue; it bleed and went black and blue; It became very ho...
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It became very hot and it became black and blue; it bleed and went black and blue; It became very hot and it became black and blue; it bleed and went black and blue; It became very hot and it became black and blue; it bleed and went black and blue; My arm had gotten very swollen; I wasn't feeling well but I was light headed; I felt very fatigue; I wasn't feeling well but I was light headed; I felt very fatigue; I wasn't feeling well but I was light headed; I felt very fatigue; I might have a Strep throat for me; I began to feel my throat bothering me as of today my throat feels raspy; This is a spontaneous report from a contactable consumer (reporting for herself). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205, expiration date: unknown), via an unspecified route of administration in her right arm on 05Mar2021 as single dose for COVID-19 immunization. The patient medical history included allergy and had prosthetic left knee. Concomitant medications were not reported. The patient previously took tobramycin (NEBRACIN) for unspecified indication and experienced sensitivity. On an unspecified date, the patient reported that when she took the inoculation at that moment she developed a form of a response or reaction rather and they had to put her into the medical cubicle for observation and to treat her at that moment. Her arm had gotten very swollen. It became very hot and it became black and blue, it bleed and went black and blue and she was sitting in the medical cubicle for approximately an hour and a half until the medical staff said that she was really not to be and when she did leave she wasn't feeling well and she was light headed, her breathing was not anyway affected but she felt very fatigue. That itself now was not an issue. They started giving her ice on that particular area where the inoculation took place and she consistently for that an hour and a half used the ice on her right arm until she finally left an hour and a half later. As the weekend preceded, the patient began to feel that her throat bothering her as of today and her throat felt raspy. It was reported that she might and she was not sure because she has not gone to the doctor yet that she might have a Strep throat when she has an allergic reaction to something that her body does not accept very well. The outcome of the events was not recovered.
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| 68 | 2021-03-30 | sleepiness |
Somnolence; Dizziness; Imbalance; High blood pressure; This is a spontaneous report received from co...
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Somnolence; Dizziness; Imbalance; High blood pressure; This is a spontaneous report received from contactable consumer (patient). A 68-year-old female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. E19266) single dose, in the left arm, on 20Feb2021, for COVID-19 immunisation. Relevant medical history included penicillin allergy, aortic valve replacement and diabetes. The patient previously, on 30Jan2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. E105318) single dose, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. Concomitant medications were unknown. On 20Feb2021, the patient experienced somnolence, dizziness, imbalance and high blood pressure. No treatment was received. The patient did not recover from the events at time of this report. The case was assessed as non-serious. Post the vaccination, the patient has not been tested for COVID-19. Futher information has been requested.
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| 68 | 2021-04-02 | fatigue |
Fatigue; soreness at injection site; warmth at injection site; diarrhea; This is a spontaneous repor...
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Fatigue; soreness at injection site; warmth at injection site; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EL9269) via an unspecified route of administration, administered in left arm on 07Feb2021 14:15 (at the age of 68-years-old) as single dose for COVID-19 immunization. The patient medical history included Hypertension, Atrial fibrillation, Mitral Valve Prolapse. No known allergies. The patient concomitant medications included Lisinopril, Metoprolol, Eliquis, Calcium, Biotin. On 08Feb2021 09:00 AM patient experienced fatigue, soreness at injection site, warmth at injection site, diarrhea. No other vaccine in four weeks. No COVID tested post vaccination. No COVID prior vaccination. No treatment received. The outcome of the event was not recovered.
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| 68 | 2021-04-06 | fatigue |
pulse went up; Itchy all over her body; blood pressure was elevated; Very tired/fatigue; This is a s...
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pulse went up; Itchy all over her body; blood pressure was elevated; Very tired/fatigue; This is a spontaneous report from a contactable physician. A 68-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 20Mar2021 at 11:20 (at the age of 68-years) as single dose for COVID-19 immunization. Medical history included multiple allergies. There were no concomitant medications reported. Her cousin had a similar reaction to flu vaccine. On 20Mar2021, The patient experienced pulse went up, blood pressure was elevated, very tired and fatigue on 20Mar2021.On 22march, the experienced itchy all over her body. The patient was hospitalized for pulse went up from 20Mar2021 to 21Mar2021. The other events (blood pressure elevated, tired/fatigue, itchy) were reported as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: it was 132/86 on 20Mar2021. At 18:15 pm elevated to 146/91, heart rate: pulse went up to 125 and stayed up for many hours on 20Mar2021 pulse of 118, at 18:15 pm pulse of 153. Therapeutic measures were taken as a result of pulse went up. The outcome of increased heart rate was recovered, elevated blood pressure and pruritus was recovering and fatigue was not recovered Additional information on lot/batch number has been requested.; Sender's Comments: Based on the information currently available and plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events pulse went up, blood pressure was elevated, very tired and fatigue, and itchy all over her body cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 68 | 2021-04-06 | malaise, chills, fever |
Fever chills nausea from 10.30 pm 23 march 2021. Wednesday same. Wednesday evening extreme nausea vo...
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Fever chills nausea from 10.30 pm 23 march 2021. Wednesday same. Wednesday evening extreme nausea vomitting fever severe trembling and chills. During the night nightmares and migraine woke me up. Tried to go to the bathroom but collapsed and knocked my head on the wall. Could not get up crawled to the bathroom and tried to pull myself up but fell headfirst and hit my nose and cheek on the toilet. Cut nose and hurt cheek bone. Felt terrible head spinning and unable to get up/ Crawled to bed; Live alone. Could not even find the telephone; Woke up and tried to get up. Freezing cold. Finally called Ambulance Their doctor refused to send an ambulance and said " go to your GP its not an emergency". I was disgusted barely could walk but somehow drove to the GP. he was closed so went to emergency. the Dr in charge of the vaccination center was there but did not accept it was the vaccine; Finally on the verge of collapse another lady took me to the entrance of emergency. I was finally seen:; Same thing. Dr there told me its not an emergency and to go and see my GP. I was so sick and told him th eGP was not there; His reply " There are plenty of others to see" It was the nurse who persisted and even thought may be I had covid and did the PCR test. I started uncontrollably shivering and was freezing. I had a fever. they did blood tests lung x ray and finally a urine test, Full of blood leucocytes and protein. The same wonderful nurse said its bad. I was by then vomitting again and thought I would die; Uncontrollable shivering ; taken to the lab or a pelvic cat scan;Couldnt even get to sip water. SEVEN hours later the same DR who told me I was not an emergency came in and said " You will have to be hospitalised as you have a serious kidney infection. Acute pyelonephritis. I vomitted on him! Taken to a ward 25 March until 29 March. Rocephin antibiotics. Allergy to that too with migraines and skin rash; They changed the antibiotics. After five horrible days I finally went home on antibiotics Ofloxacine
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| 68 | 2021-04-07 | fever, cough, fatigue |
Patient transferred from outlying hospital on 3/30/21 due to increasing oxygen demands and increased...
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Patient transferred from outlying hospital on 3/30/21 due to increasing oxygen demands and increased level of care. Patient was admitted to outlying hospital with COVID-19 infection with shortness of breath, cough, fever, weakness, fatigue with decreased oral intake on 3/28/21. Patient required oxygen and was treated with remdesivir, steroids, and antibiotics. Patient was discharged to home with oxygen.
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| 68 | 2021-04-08 | fatigue |
called back to schedule her second appointment but is was past 42 days so they said she could not sc...
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called back to schedule her second appointment but is was past 42 days so they said she could not schedule; tested positive for Covid/Got COVID; tested positive for Covid/Got COVID; Tiredness; achiness; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 19Feb2021 13:00 (at the age of 68 years) (Batch/Lot Number: EN6200) as a single dose to prevent getting COVID (COVID-19 immunization). Ongoing medical history included high blood pressure (started about 10 years ago) and varicose vein (At least probably about 20 years). Family history includes both of her parents had heart problems, Mother had a stroke (she doesn't know when, she took medications for heart problems) and Father died of a heart attack. Concomitant medications included hydrochlorothiazide taken for hypertension. It was reported that the patient had the first dose on 19Feb2021 and was due to have second dose on 13Mar2021 and two days before that (11Mar2021) she ended up being sick having symptoms (cold) so she had to cancel the appointment and was tested for COVID. On 17Mar2021 the patient found out she got COVID. She called back to schedule her second appointment but is was past 42 days so they said she could not schedule. It was reported that she was not sure when she had COVID-19, it would have been in the evening when she started feeling like she had a cold. She's still having a little bit of tiredness since 11Mar2021 but no cough. Her tiredness is not as bad now. The patient also experienced achiness on an unspecified date in 2021. The patient received the following treatment for the events: Vitamin C, not sure if helped, Vitamin D, not sure if helped, and Advil, helped with achiness. The outcome of the event tiredness was not recovered, while unknown for the rest of the events.
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| 68 | 2021-04-12 | fever |
68 y.o. female who presents with FEVER, ALTERED MENTAL STATUS, URINARY INCONTINENCE. DAUGHTER STATE...
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68 y.o. female who presents with FEVER, ALTERED MENTAL STATUS, URINARY INCONTINENCE. DAUGHTER STATES INCONITNENCE STARTED Friday 4/9 AND FEVER AND CONFUSION STARTED TODAY WITH SHORTNESS OF BREATH. PT WAS SEEN AND SWABBED FOR COVID AND FLU BUT REFERRED TO ER FOR FURTHER EVAL AND WORKUP. PT IS DIABETIC BUT DAUGHTER REPORTS NOT KNOWING WHERE ACCUCHECKS ARE AS THEY HAVE NO MONITOR AT HOME. Admitted Inpatient 4/13/21
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| 68 | 2021-04-14 | throat pain, chills, fatigue, cough |
This is the patient's spouse reporting. The day following the vaccination, wife began to suffer mil...
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This is the patient's spouse reporting. The day following the vaccination, wife began to suffer mild, common vaccination symptoms such as fatigue, hills, and joint pain. In the days following, in addition to those symptoms, she began to cough and had a sore throat. By March 8th, she had lost her sense of taste and sense of smell. We realized we needed to have her tested for COVID-19. We went to a testing area. She was seen and tested. She tested positive for COVID-19 (as did I). The belief was that our illness was uncomplicated and we were sent home with instructions to monitor our symptoms. On 03/14/2021, I took her to the hospital because her condition was worsening.
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| 68 | 2021-04-17 | fatigue |
feels tired; She did have palpitations overnight that woke her up in her sleep for 15 minutes; head ...
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feels tired; She did have palpitations overnight that woke her up in her sleep for 15 minutes; head feels tight, like there is a band around it/head feels tight, like there is a band around it; Nausea; severely lightheaded; her limbs felt heavy; her blood pressure went way up and lasted a good 7 hours/blood pressure at this time was elevated to 190/86; it was hard to lift her arms; This is a spontaneous report received from a contactable two nurses (one nurse reported for herself). This 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6205 and expiration date: 30Jun2021), via an unspecified route of administration right arm on 29Mar2021 at 10:15 as single dose for COVID-19 immunization. Medical history included anaphylaxis (recovering), hypertension ongoing, gastroesophageal reflux disease (GERD), anemia (her hemoglobin dropped to 6.9 and ferritin was low), hiatal hernia surgery (had mesh), a latex allergy (her lips would start swelling) and food allergy (tuna fish). Family history included lung disease (her dad was diagnosed). Concomitant medications included hydrochlorothiazide (HCTZ) 25 mg, daily (been on it for 10 years) taken for high blood pressure from an unspecified start date and ongoing; losartan 100 mg, daily (for about 10 years) taken for hypertension from an unspecified start date and ongoing; iron (Tablet) 65 mg, daily (about 10 years ) taken for anaemia, cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication; The patient previously took cefalexin (KEFLEX) and experienced swelling on face and mouth, epipen, acetylsalicylic acid (ASPIRIN) (6 years ago aspirin sensitivity took place) and experienced haematuria, tolectin as nonsteroidal anti-inflammatory drug (NSAIDS) (about 30 years ago (received steroids, breathing treatments and benadryl) and experienced anaphylactic reaction, flu vaccine taken for flu (at 19 years old). The patient got first vaccine on 29Mar2021 and had an event. On the same day, she was severely light headed and her limbs felt heavy and her blood pressure went way up and lasted a good 7 hours. They had her in the emergency room. She did have palpitations overnight that woke her up in her sleep for 15 minutes but she had no chest pain or shortness of breath and then it went away. At first, she didn't feel anything, but then as soon as she got up to go to the sitting area where she was supposed to wait for 15 minutes, she became very very light headed, almost like there was a band around your head. there was no dizziness, but she was lightheaded and all four of her limbs felt really heavy, it was hard for her to move her limbs, she experienced nausea while sitting in the waiting area as well. She did not throw up and it started about an hour after the vaccine and describes the nausea as fleeting and states it lasted about a couple of hours, but not as long as the light headedness and heavy limbs. her blood pressure at this time was elevated to 190/86. the doctor there told them to send her to the ER. The reporter stated that the vaccine was given at the hospital, so they just wheeled her to the emergency department within the hospital, the doctor in the emergency room told her they didn't think it was an allergic reaction. after about 6 hours around 1600 her blood pressure finally came down to 141/67. She was discharged from the emergency room around 16:00 on 29Mar2021. At the time of discharge, the heaviness of limbs and light headedness had went away, but when she was walking to get to her car in the parking lot the lightheadedness and heaviness of her limbs returned. it was hard to lift her arms. she went home and went to bed, the lightheadedness and heaviness of her limbs went away after she was able to lay down and rest. Last night around 2:30 or 3:00am she woke up with heart palpitations. Caller states that these palpitations went away after 15 min and that she hasn't had this experience in years since hiatal hernia surgery. she felt much better next day, the only thing she felt today was tightness in her head but not a headache and just felt tired. The outcome of the events severely lightheaded, her limbs felt heavy, her blood pressure went way up and lasted a good 7 hours/blood pressure at this time was elevated to 190/86 and head feels tight, like there is a band around it were recovered in 2021; nausea was recovered on 29Mar2021; palpitations was recovered on 30Mar2021 and other events were unknown. As reported causality : Feeling light headed; Limbs felt really heavy; high blood pressure Related; head feels tight, like there is a band around it; heart palpatations Related. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported events and the administration of the suspect COVID19 vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 68 | 2021-04-17 | headache |
her MS symptoms exploded; head became foggy; blurred eyes; slight headache; This is a spontaneous re...
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her MS symptoms exploded; head became foggy; blurred eyes; slight headache; This is a spontaneous report by contactable consumer(patient) from Pfizer Sponsored program. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 17Mar2021 at single dose for COVID-19 immunization. Medical history included Multiple Sclerosis (MS) for 20 years and autoimmune disease. Concomitant medications included interferon beta-1a (AVONEX) for MS. The patient previously took Avelox for MS. Caller also states she would like to report that she has a history of Multiple Sclerosis (MS) and she goes to the clinic. Caller states since no studies were done on people with MS, she would like to report her experience. Caller states she received her first dose of the vaccine on 17Mar2021 and hours afterwards her MS symptoms exploded. Caller states she has had MS for 20 years and she doesn't even realize she has it because she is able to walk the dogs at the pound and she does 3600 steps a day and it doesn't keep her from doing anything. Caller states after the shot she has torn meniscus in her knees and her knees were so tight and she has heel spurs, and they were burning and hurt. Caller states she hurt her hand previously and her hand was tight, and it felt like it was going to explode. Caller states every injury she has ever had it felt like it was exacerbated and got worse. Caller states she was instructed by the Clinic to take Tylenol every 6 hours and these symptoms lasted for 12 days. Caller states she takes a medication called Avelox for MS once a week and she didn't take it after the shot because it is known to cause flu like symptoms, but she is back taking it now. Caller states she was working on the computer and her head became foggy and this lasted for six or seven days. The caller has MS and is on Avonex, it's a beta 1 interferon injectable that she has been taking for over 20 years. The caller's doctors told her it was okay to get the shot. Because of the caller's autoimmune disease, the caller's doctors don't know how effective the shot will be with an autoimmune disease. The caller has done well with Multiple Sclerosis; her Multiple Sclerosis was really good she was walking 3600 steps a day. The vaccine seems to have flared up everywhere the caller has been hurt. It made those spots worse. The caller had a torn meniscus and it felt like her knee was stiff like a board. The caller had a bone spur in her foot that it began to hurt where that was removed. The caller broke her left hand and then it felt like it was going to explode. The caller also had head fog and blurred eyes. It took 6-7 days for head fog to get better. The other symptoms it was 12-13 days to get better. The caller also had a slight headache. The clinic said there were no studies in someone with MS who took the covid vaccine, they only reported to them about the autoimmune disease. Someone on the thing said the second dose was 10 times worse than the first one. Then the caller was told if she gets those symptoms with the first shot then the second one will be better because your body is used to it and knows what to do. It is kind of like a trial by fire and no one knows what to expect. The caller wants to know if Pfizer had any information on Avonex interfering with MS. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 68 | 2021-04-17 | malaise |
19 second pause of no heartbeat and in third degree heart block; 19 second pause of no heartbeat and...
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19 second pause of no heartbeat and in third degree heart block; 19 second pause of no heartbeat and in third degree heart block; Awoke to throw up; Thinks she fainted; Oxygen level of 93 on oximeter; she wasn't feeling well; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 22Mar2021 at 15:00 (Lot Number: EN6198) as single dose for covid-19 immunization. Medical history included mild stroke from 18Jan2020 and not ongoing, suspected she had atrial fibrillation and she had a heart monitor placed 21Feb2020. Her heart monitor never showed Atrial Fibrillation after one year of being monitored. Ongoing low thyroid/hypothyroidism and blood cholesterol increased from an unknown date. Concomitant medications included levothyroxine taken for low thyroid/hypothyroidism from an unspecified start date (started probably been 10 years) and ongoing; atorvastatin taken for reduce cholesterol from 2020 (started right after she had stroke, either Jan2020 or Feb2020) and ongoing. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations (within 4 weeks). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 01Mar2021 (at age of 68 years old, Lot Number: EN6200) as single dose for covid-19 immunization. She was fine right after the first dose. She only had a sore arm for 3 days. Just last week, she had a severe adverse reaction right after her vaccine. With the second dose, she had everything possible. Twelve hours after, on 23Mar2021 at 03:00, she awoke to throw up. She thinks she fainted. She had to throw up 2 more times that night. She had been wearing a heart monitor. On 24Mar2021 her cardiologist called her and told her she had a 19 second pause of no heartbeat and was in a 3rd degree heart block. The very next morning, they put in a pacemaker. She was overall healthy and athletic. She was a runner and golfs all the time. She had an outpatient procedure for the pacemaker placement at the hospital on 25Mar2021. She was still recovering but improving. Caller added it was scary when your heart stops. Caller added she did not see this as a possible related side effect, but that evening when she was not feeling well, 22Mar2021, she checked her oxygen level with her oximeter. It was 93 and usually runs around 99. It is back to normal now. She checked it the night she was vomiting. Stated this was before the third degree heart block by a few hours. She did not think it was related. All her symptoms are gone other than the placement of her pacemaker. The outcome of the events " 19 second pause of no heartbeat and in third degree heart block" was recovering. The outcome of the event " Oxygen saturation decreased" was recovered. The outcome of other events was unknown.
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| 68 | 2021-04-17 | pneumonia |
second vaccine on 16Mar2021 and tested positive for covid on 21Mar2021.; Second vaccine on 16Mar2021...
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second vaccine on 16Mar2021 and tested positive for covid on 21Mar2021.; Second vaccine on 16Mar2021 and tested positive for covid on 21Mar2021; pneumonia; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Feb2021 (Batch/Lot Number: EN6200), and dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 (Batch/Lot Number: EN6202), both as a single dose for covid-19 immunization. The patient's medical history included blood pressure high and diabetes from an unknown date, and brain aneurysm from 2006. Patient has no family history. The patient's concomitant medications were not reported. On 21Mar2121, the patient experienced on the second vaccine on 16Mar2021 patient tested positive for covid on 21Mar2021. It was further reported that the patient took the 2 shots and the last shot was on 16Mar2021. In-between 16Mar2021 and 21Mar2021 the caller developed a cough (given Quercetin to take for it) and went to the urgent care on 21Mar2021. From the urgent care the patient was sent to the hospital and admitted because she was covid positive. Patient was admitted in the hospital from 21Mar2021 to 23Mar2021. The patient underwent lab tests and procedures which included chest x-ray: pneumonia on 21Mar2012 (pneumonia of left lower lobe due to infectious organisms). The outcome of the events was unknown
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| 68 | 2021-04-18 | headache, fatigue |
01/12/21 Brief pricking pain in left hip with mild cramping in left foot. 01/16/21 4 days later I e...
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01/12/21 Brief pricking pain in left hip with mild cramping in left foot. 01/16/21 4 days later I experienced discomfort with burning,tingling radiating sensations in both knees,lower legs and feet for a few minutes. 01/22/21 symptoms returned and remained or more than 24 hours. After subsiding for several hours they returned 01/24/21 but progressed overnight up thighs to buttocks with 4 soft BM during night.01/25/21 I walked in to see PCP to report symptoms,exam and lab work drawn.01/27/21 tingling was experienced to upper thighs buttocks,perineum ,scapulae ,and fingers bilaterally,lasted briefly. 01/29/21 tingling in face. 02/01/21 pain in both arms. 02/02/21 weakness in legs,burning and cramping in both feet.02/04/21buttocks and thighs feeling heavy,tightness,numbness around nose,eyes and ear lobes,fatigue. 02/10/21 burning and tingling in 4th and 5th fingers of both hands radiating to elbows,hands unsteady. 02/12/21 MRI of brain and spine done,admitted to Hospital for worsening of symptoms including unsteadiness on feet, discharged 02/13/21. 02/14/21 Tingling in lips,tongue,speech halting and stuttering,head jerking,face twitching,shortness of breath,pounding heart. Speech abnormality returned on at least 6 different occasions. Mild headache,blurred vision,tightness in face,around eyes are occasional and transient since 03/22/21.Tingling and burning in feet and lower extremities and sporadic joint pain continue on and off with unsteadiness on feet and fatigue
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| 68 | 2021-04-19 | sleepiness, headache, fatigue, sweating, paranasal sinus discomfort |
A few days after my shot I started feeling very tired and groggy. My head was dizzy most of the day...
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A few days after my shot I started feeling very tired and groggy. My head was dizzy most of the day. Five days after the vaccination I started to go into a sweat if I exerted myself too much. I continued to have a dizzy head and my stamina was greatly reduced. I used to ride my exercise bike for 90 -150 minutes a day but after the vaccine I could only go 20 minutes the first week and then I got progressively weaker and more dizzy. I could barely walk a half block. I also experienced some shortness of breath and a racing heart at times. The third week out was the worse. I could hardly care for myself. I started to get a lot of pain behind my eyes and other sinus pressure. Also the lymph gland under my ear was swollen and painful. I was extremely tired for a couple of days at that point but have found it hard to sleep on most other nights. I have strange dreams that are almost like an hallucination. I also have head aches but they seem to have improved as the weeks have gone by, especially since I have been taking Aleve every day. I am unable to exercise and have very little energy still. The dizzy head continues to persist even 6 weeks out. I had this same kind of dizzy head in August when I had Covid but it went away in a week or two. I get dizzy just reading a book or looking at my piano music also. Having had Covid twice I am very confident that these symptoms were caused by this vaccination. It also seemed to make my blood sugar more volatile. The sad thing is that I was feeling perfectly normal when I went in! I am devastated by these symptoms and they have completely altered my life. I am so discouraged that they never go away. Some days I feel like I am improving and then they pop up again. I was a very active person and now I can hardly do anything. I think I got the shot too close to when I had covid and that it has triggered an immune response that is overwhelming my body. Will it ever get better? I can't stand to go on like this!
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| 68 | 2021-04-20 | malaise |
Received 2nd COVID vaccine on 4/19/21. Apparently hadn't been feeling well since. Presented to the...
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Received 2nd COVID vaccine on 4/19/21. Apparently hadn't been feeling well since. Presented to the ED on 4/21/21 with hypotension, bradycardia, hypoxia and a GCS of 3. Does have a history of ESRD on HD, but no missed dialysis sessions. Found to have a potassium of 8.7. There was concern for pulmonary embolism but was not hemodynamically stable enough to undergo imaging. Went into PEA arrest x 3 in the ED and ultimately died. Of note, patient did have a recent ankle fracture recently and apparently has been non-ambulatory for at least the past few days.
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| 68 | 2021-04-21 | runny nose, throat pain, nasopharyngitis |
Bitter, metal, tinny taste in mouth within one hour or less of vaccination. I am not sure of exact t...
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Bitter, metal, tinny taste in mouth within one hour or less of vaccination. I am not sure of exact time because we ate directly after the fifteen minute waiting period. I didn't notice the sensation until right after we ate. It lasted about three days and then was gone. It was strong enough for me to notice immediately and think how weird, and it was strong enough for me to notice it off and on the next three days-gradually lessening. I have also had a sore throat the whole week since the vaccination-it started the day after. It hasn't turned into a cold-maybe a little drippy nose occasionally so not sure if sinuses etc, but the sore throat is persistent. Occasionally I feel it up higher in the nasal-pharynx also. I didn't report to my doctor or treat in any way. And for statistics, my arm was sore for about two days. The worst was that evening and pretty mild after that.
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| 68 | 2021-04-24 | fatigue, chills, headache, fever |
fever 103.4; Injection site pain; tiredness; headache; chills; joint pain; nausea; This is a spontan...
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fever 103.4; Injection site pain; tiredness; headache; chills; joint pain; nausea; This is a spontaneous report from a contactable consumer reporting for herself. A 68-year-old non-pregnant female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 30Mar2021 at 10:45 (Batch/Lot number was not reported) as a single dose (at the age of 68-years-old) for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing, and high cholesterol from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included pravastatin at 40mg taken for an unspecified indication, start and stop date were not reported; benazepril at 20mg taken for an unspecified indication, start and stop date were not reported; and esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) at 40mg taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever 103.4 on 31Mar2021 at 20:30, injection site pain on 31Mar2021 at 20:30, tiredness on 31Mar2021 at 20:30, headache on 31Mar2021 at 20:30, chills on 31Mar2021 at 20:30, joint pain on 31Mar2021 at 20:30, and nausea on 31Mar2021 at 20:30 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 103.4 on 31Mar2021. Treatment was not received for any of the events. The outcome of the events fever 103.4, injection site pain, tiredness, headache, chills, joint pain, and nausea was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 68 | 2021-04-24 | fatigue |
chest pain; palpitations; experiencing consistent PVC's which is abnormal because I do not have any ...
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chest pain; palpitations; experiencing consistent PVC's which is abnormal because I do not have any Cardiac history; have a D-Dimer lab result of 758ng/ml as well as other abnormal labs; have a D-Dimer lab result of 758ng/ml as well as other abnormal labs; irregular heart rate and am going to have to more cardiac work up; extreme shortness of breath with minimal exertion; weakness; dizziness; very tired; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7533), second dose via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:15 (at 68 years old, not pregnant), single dose for covid-19 immunisation. Medical history included hypothyroidism, arthritis, all from an unknown date. The patient had her first dose of bnt162b2 for Covid-19 Immunization on Mar2021. The patient was taking unspecified concomitant medicines. The patient experienced within 5 minutes after receiving her second injection, she began having chest pain and palpitations. The paramedics ran a 4 lead EKG and she was experiencing consistent PVC's which is abnormal because she does not have any Cardiac history. She went to the emergency room and was noted to have a D-Dimer lab result of 758ng/ml as well as other abnormal labs. Still continue having PVC's and irregular heart rate and was going to have to more cardiac work up. Also have experienced other symptoms associated with actual COVID such as extreme shortness of breath with minimal exertion, weakness, dizziness, very tired. And muscle aches 2 days as of Friday 09Apr2021. All the events also reported as started 07Apr2021 14:15. The outcome of the events was not recovered. Treatment for the events was observation and medication. Patient was hospitalized due to the events for 1 day. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies.
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| 68 | 2021-04-24 | fatigue |
appendicitis; sore; tired; with in 12 hours I started with nerve pain on the level of shingle pain e...
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appendicitis; sore; tired; with in 12 hours I started with nerve pain on the level of shingle pain except it didn't stay in one part of the body.; This is a spontaneous report from a contactable consumer (reported for herself). A 68-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6199), administered in right arm via an unknown route of administration on 22Mar2021 at 09:00 am as SINGLE DOSE for covid-19 immunization. The patient previously took first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6200), administered in right arm via an unknown route of administration on 27Feb2021 at 08:00 am. The patient medical history included blood pressure measurement. Concomitant medications in two weeks included Olanzapine 2.5mg, Olmesartan 20mg and Zetia 10mg. The patient had drug allergies for Codeine and Demerol. On 22Mar2021 within 12 hours, the patient started with nerve pain on the level of shingle pain except it didn't stay in one part of the body. The whole body was affected. Next day on 23Mar2021, the patient was sore and tired. On 26Mar2021 at 3:30 pm, the patient had abdominal pain and went to hospital at 09:00pm because of pain and was diagnosed with an appendicitis. The treatment for the events included appendectomy surgery to remove the next morning. There was no other vaccine in four weeks. On 26Mar2021, the patient was tested for covid with nasal swab post vaccination which was negative.The patient was hospitalized for 2 days for all the events. The outcome of the events was recovering.
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| 68 | 2021-04-24 | sneezing, cough |
has pain in the right side of her stomach when sneezing and coughing; has pain in the right side of ...
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has pain in the right side of her stomach when sneezing and coughing; has pain in the right side of her stomach when sneezing and coughing; pain in the right side of her stomach when sneezing and coughing, and a very deep pain upon movement; slight dizziness; This is a spontaneous report from a Pfizer-sponsored program. A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in deltoid left on 06Apr2021 at 12:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (had coronavirus last year) on an unspecified date in 2020, blood pressure and blood cholesterol abnormal, sleep disorder, prophylaxis for heart disease, hypertension and premature ventricular contractions (PVCs) from an unknown date and unknown if ongoing. Concomitant medications included amlodipine; olmesartan medoxomil taken for hypertension; acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) taken for prophylaxis; atorvastatin calcium taken for blood cholesterol; metoprolol taken for hypertension; melatonin taken for sleep disorder, all from an unspecified start date and ongoing. She has taken medication for blood pressure and cholesterol for years and never had this type of pain. She takes amlodipine, olmesartan medoxomil and was taking Bystolic before and it was working ok but she would have PVC's and that was discontinued, and she was placed on metoprolol. The PVC's are better, better control over the PVC's. Clarified she had the PVC's before the medications. The patient previously received a flu vaccination for influenza immunization and got soreness at the injection site. Reporter stated that on her right side when she presses down in the area, she feels it a lot, has pain in the right side of her stomach when sneezing and coughing, and a very deep pain upon movement. These started mildly several hours after the vaccine on the same day and then progressively got worse over the last 2 days, 07Apr2021 was very bad and 08Apr2021 also and she still has it this morning. It let up a bit this morning. The slight dizziness started the same day as the vaccine a few hours later and has stayed about the same, it may be improving a little she thinks as she didn't really evaluate it this morning, but she thinks it might be a little better. The dizziness she knows you can have light dizziness as a side effect from the vaccine and it is not serious, it can be a normal side effect for people, that most people she has spoken to didn't have dizziness. The pain is a little less today, she is moving around now, and it has lessened to some degree, it is not as severe as yesterday or the day before. She didn't know if her liver was being affected or what, it is in that area. She feels her symptoms are 100% related to the vaccine. Consumer stated, "I took Pfizer COVID vaccine on 06Apr (06Apr2021) and after that I started feeling dizziness and pain in my stomach area or abdomen area and now the third day it is really bad. All I had was the Pfizer COVID Vaccine." When paraphrased the concern, consumer stated, "Yes, It is in my stomach area." The events coughing, sneezing and stomach pain were considered medically significant by the reporter. The outcome of the event slight dizziness was recovering, while of the rest was not recovered.
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| 68 | 2021-04-26 | chills | chills, dizziness. shortness of breath developed a few hours later . |
| 68 | 2021-04-27 | fatigue, influenza like illness, headache, fever, cough |
Asthma flare up; dry, hacky cough; pain and tightness in her chest; pain and tightness in her chest;...
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Asthma flare up; dry, hacky cough; pain and tightness in her chest; pain and tightness in her chest; nausea feeling in her chest; She gets this laryngitis; has trouble talking; She wants to make sure its not going into like a viral pneumonia; Flu-like symptoms; fever; achy; fatigue; Sore arm; Headache; This is a spontaneous report received from a contactable pharmacist (patient). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: CER230) via an unspecified route of administration on 24Mar2021 at 11:30 (at the age of 68-years-old) as a single dose in the right arm for COVID-19 immunisation. The medical history included flu and suspected COVID-19 both in Jan2020 to an unspecified date (she had a bad flu back in Jan2020, which could have been COVID because it was such a bad flu, over a year ago), ongoing asthma from an unspecified date (mild asthma) and chest nausea in Jan2020 to an unspecified date. The patient had no history of any adverse events following prior vaccinations. Medical history (including any illness at time of vaccination) was also reported as none. Family medical history relevant to the adverse event included an uncle that had asthma, but no one else had breathing issues. Concomitant medications included fluticasone propionate/salmeterol xinafoate (ADVAIR) and ipratropium bromide/salbutamol sulfate (DUONEB), both ongoing and taken for asthma on unspecified dates. Other products were also reported as "no". The patient did not receive any prior vaccinations within 4 weeks prior to the COVID-19 vaccine and did not receive any additional vaccines on the same date as the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: 3N6202) via an unspecified route of administration on 24Feb2021 at 11:30 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunisation. On 24Mar2021 the patient experienced sore arm and headache; on 25Mar2021 the patient experienced flu-like symptoms, fever, achy, fatigue; on 02Apr2021 the patient experienced asthma flare up, dry, hacky cough, pain and tightness in her chest, nausea feeling in her chest; on unspecified dates in Apr2021 the patient experienced she gets this laryngitis, has trouble talking and she wants to make sure its not going into like a viral pneumonia. The reporter classified the events headache and flu-like symptoms as non-serious. The patient called to report that she had an asthma flare up 10 days (as reported) after her second dose of COVID-19 vaccine on 24Mar2021. The patient stated that she did not get a flare up often, she had mild asthma. She usually got mild flare-ups since she did not have severe asthma. She stated it could be something else, but she had not had a flare-up like this since she had a bad flu back in Jan2020, which could have been COVID-19 because it was such a bad flu. That was over a year ago. She received her second vaccine on 24Mar2021, and the asthma flare up and hacking cough started on 02Apr2021. On the night of 24Mar2021, she started with a headache. She had the shot at 11 something and by that evening before she went to bed, she had a headache and a sore arm, but that was no big deal. Then on 25Mar2021, she started with flu like symptoms/fever. The headache persisted through that as well. At that point, she did not have tightness or the dry, hacky cough. By the middle of the day on 27Mar2021, her flu-like symptoms were gone. She would consider these to be "non-serious", it was what she expected, as it was seen from the paperwork of the vaccine. By 28Mar2021, all of her symptoms were gone prior to the flare-up. She had typical flu-like symptoms: fever, headache, achy, fatigue on the 2nd, 3rd, and into the 4th day but then they cleared up. By the evening of the 4th day, she started feeling fairly normal. She stated that they were mild flu symptoms. Her temperature was only 100 for about a day. She stated that that was expected. Then, she went into this flare-up about the 10th day after the vaccine. The first 3 or 4 days after the flare up began, the flare up was worsening. Then, she got it under a little bit of control, so she was not coughing all night and having to sit up as she was sleeping. Now, she was concerned about the pain and tightness in her chest and the hacky cough. She wanted to make sure it was not going into like a viral pneumonia or another thing. She did not know. She kept increasing her Advair use and was at the top of that. She was doing the duoneb which she did not usually have to do. She had not had to do that since Jan2020 when she had the 5-week flu, or it could have been COVID (they were calling it a hoax back then). She was using her duoneb 4 times a day and now she was using it to 2-3 times, but she was still getting chest tightness, hacky cough. It was kind of like nausea- it was hard to explain, it was kind of like a chest nausea, which she had also had back in Jan2020 when she had the bad flu. She also would get this laryngitis and had trouble talking. With her flare-up, her chest tightness/nausea feeling in the chest continued. Now, she was getting into laryngitis type of thing, but she could loosen that up with her duoneb but if she got to the point where she could not do that, she would definitely have to see someone right away. She clarified that when her chest got tight, the dry, hacky cough continued/increased. When she did the breathing treatment, it loosened it up for about 3-4 hours and some of the pain would go away in her chest. If she talked too much, she would begin to cough. She had had this flare up 3 times in her life, it was not very common. She was diagnosed with asthma in her 40s, and this was her 3rd time ever having anything like this. This was the first time she had experienced a flare up like this. She had had 3 episodes since she had had asthma in her 40's and all 3 bad episodes were about the same. All the episodes were related to illness, it did not just happen out of the blue. It happened with a viral respiratory thing or the flu. The adverse events did not require a visit to the emergency room or physician office. The patient stated that she would call her physician or the clinic "today or tomorrow". She had not been to a doctor since her asthma flared up. Her respiratory doctor/pulmonologist moved away, there was no respiratory doctor nearby right now. So, her general practitioner was following her because it was a mild case and she had mild asthma. If it was severe, her doctor would make her go to a specialist. Relevant tests were reported as no. The patient used to be followed with pulmonary function tests until her respiratory doctor moved away. The patient stated that she took care of her 94 year old mother several days a week and because of all of the variances coming out, she thought it was her civic duty to prevent it from spreading through the population and creating more variances which was why she received the vaccine. She stated her doses were scheduled a month apart because they expecting to get a shipment of Moderna and they did not. They had to run to Buffalo to get the Pfizer vaccine, but they left her doses scheduled a month apart because the appointments were so hard to get. Normally, it would be 3 weeks. Her card clearly said Pfizer and they told her Pfizer, and they told her the reason for it being scheduled at 4 weeks. The patient called to inquire whether asthma flare-ups had been seen in clinical trials. It was not a reported side effect from the paperwork she received. When she looked online, she could not really find anything. She was thinking of going to a clinic but was wondering if there were any reports of flare-ups with asthma with the vaccine. With regards to causality, the patient stated it was a concern because she usually did not get a flare-up unless she was sick. She stated that there were many variables, and that it was spring, and bugs were out, but she did not usually get a flare-up like this. She stated that maybe it was a challenge to her immune system, the antibodies, but she did not know. She suspected the flare-up was related to the vaccine, but she did not have any idea. She would say yes, but she had no way of knowing. The flare-up usually only appeared if she got ill or something weird happened to her. The clinical outcomes of the events flu-like symptoms, fever, achy and fatigue were recovered/resolved on 27Mar2021; sore arm and headache were recovered/resolved on 28Mar2021; asthma flare up, dry, hacky cough, pain and tightness in her chest and nausea feeling in her chest were not recovered/not resolved; she gets this laryngitis, has trouble talking and she wants to make sure its not going into like a viral pneumonia were unknown. The reporter believed there was a reasonable possibility that the events sore arm, flu-like symptoms, asthma flare-up, dry, hacky cough, pain and tightness in her chest and nausea feeling in her chest were related to BNT162B2. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information the events asthma flare-ups and viral pneumonia are attributed to intercurrent medical conditions, unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2021-04-27 | respiratory tract congestion, sleepiness, chills, fever, headache |
aches and pain in her shoulder and neck; had exceptionally felt like she wanted to go to bed and nap...
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aches and pain in her shoulder and neck; had exceptionally felt like she wanted to go to bed and nap; She was not able to sleep and did not get up until 10 today; painful and hard; She stated to move her hair even to the touch it is painful; definitely something abnormal; Her hands, mainly her right, and ankles are swollen; Her hands, mainly her right, and ankles are swollen; congested in her chest; she is feeling a little confused; horrendous lumps on her head (some the size of a quarter, some a half dollar; fever; Excruciating pain in my head; peculiar neck pain/ aches and pain in her shoulder and neck; swelling of my arms and hands; Felt Achy; Felt off balance; chills; This is a spontaneous report from a contactable consumer reporting for herself. A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation . Medical history included thyroid mass (Diagnosed over 5 years ago. She never got a biopsy of it) , pelvic mass , cardiac disorder (Diagnosed when she was 49 or 50) , cardiac pacemaker insertion. The patient's concomitant medications were not reported. The patient experienced horrendous lumps on her head (some the size of a quarter, some a half dollar on an unspecified date with outcome of unknown , felt off balance on 12Apr2021 with outcome of not recovered , peculiar neck pain/ aches and pain in her shoulder and neck on 13Apr2021 with outcome of unknown , aches and pain in her shoulder and neck on an unspecified date with outcome of unknown , had exceptionally felt like she wanted to go to bed and nap on an unspecified date with outcome of unknown , she was not able to sleep and did not get up until 10 today on an unspecified date with outcome of unknown , painful and hard on an unspecified date with outcome of unknown , she stated to move her hair even to the touch it is painful on an unspecified date with outcome of unknown , definitely something abnormal on an unspecified date with outcome of unknown , her hands, mainly her right, and ankles are swollen on an unspecified date with outcome of unknown , congested in her chest on an unspecified date with outcome of unknown , she is feeling a little confused on an unspecified date with outcome of unknown , chills on 12Apr2021 with outcome of recovered , fever on an unspecified date with outcome of unknown , felt achy on 12Apr2021 with outcome of not recovered , excruciating pain in my head on 13Apr2021 with outcome of not recovered , swelling of my arms and hands on 12Apr2021 with outcome of recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 68 | 2021-04-27 | sleepiness |
4-23-21 Discomfort at injection site, otherwise feeling very good. 4-25-21 At approx. 10 PM exper...
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4-23-21 Discomfort at injection site, otherwise feeling very good. 4-25-21 At approx. 10 PM experienced rapid onset of acute nausea and mild vertigo. 4-26-21 After a sound night's sleep by 7 AM, the above (4-25) symptoms diminished. However, by 10 AM nausea symptoms became acute AND vertigo symptoms markedly increased, making the room look like it was spinning. Patient was able to bed rest until 1 pm and felt much better with symptoms markedly diminishing to low level 'dull nausea'. 4-27-21 After sound sleep, all above symptoms tapered off, leaving patient with very low energy level, yet able to perform ADLs--and feeling more homeostasis by 8 PM.
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| 68 | 2021-04-30 | headache, chills, fatigue |
confused/When talking to her she is talking out of her head/hought her condo was turned completely a...
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confused/When talking to her she is talking out of her head/hought her condo was turned completely around; She is having headaches; muscle pain; chills; double vision; dizziness; her arm, and joint pain; her arm, and joint pain; extremely exhausted; This is a spontaneous report from a contactable consumer. A 68-year-old female patient (consumer's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 08Apr2021 (Batch/Lot number unknown as complainant does not have the product with them at the time of call) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter was calling about her mother. The patient was fine before she got this shot and no one can seem to help her. They had the vaccine on 08Apr2021 and her mom (patient) started having severe reactions to it on 10Apr2021. Patient had the chills, muscle aches, muscle pain, headache, dizziness, her arm, and joint pain. She did not have fever, but had chills. She had double vision now. The symptoms are not going away. They are getting worse. They took her mom to the ER. The patient was confused. When talking to her she was talking out of her head. The severity of confusion is she thought her condo was turned completely around. Patient was not getting better. Went to the doctor and the doctor was at a lost. Patient was extremely exhausted. Caller stated they all took the same shot on the same day and her mom was the only one to have a reaction. Patient was literally out of her mind. Caller's dad had to take patient to the store with him because he didn't want to leave her by herself. They live in a condo on the second floor. Her mom thought the condo was reversed. Her dad was worried to leave her mom by herself because he didn't want her to go out the wrong door and go over the balcony. Her mom was not like that prior to receiving COVID19 Vaccine. Reporter was asked if there was an antidote. They were told patient should see her doctor and that she need treatment but no one could give they something to antidote the vaccine. The outcome of events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 68 | 2021-04-30 | headache |
headache; soreness to the arm; Too late to get the second dose; This is a spontaneous report from a ...
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headache; soreness to the arm; Too late to get the second dose; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not available), via an unspecified route of administration on 11Jan2021 (at the age of 68-years old) at a single dose for COVID-19 immunization. Medical history included respiratory disorder from Dec2020 and ongoing. Concomitant medications were not reported. The patient received the first dose and stated that she only had a headache and soreness to the arm on an unspecified date. The patient was at the ENT being checked for a respiratory infection when she was contacted to make her second dose appointment. She had the respiratory problem since December and had made the appointment for the ENT prior to the first dose of the vaccine. She confirmed that she was not diagnosed with a respiratory infection. She was told to reschedule her second dose appointment which was originally scheduled for 01Feb2021, but she asked the pharmacy and was told that it was too late to get the second dose. She wanted to know if she can get the second dose after six weeks. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 68 | 2021-04-30 | headache |
Headache, on left side of head; This is a spontaneous report from a contactable nurse (patient). A 6...
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Headache, on left side of head; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 15Apr2021 (after 10:00 as reported; at the age of 68 years old) at a single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8732), via an unspecified route of administration at the upper right shoulder on 26Mar2021 (after 17:00 as reported; at the age of 68 years old) at a single dose for COVID-19 immunization. The patient experienced headache, on left side of head on 16Apr2021 10:00. The event was reported as serious (disabling). It was reported that the patient decided to take the vaccine because everyone should take the vaccine, and because of the virus. There were no additional vaccines administered on same date of the Pfizer suspect. The AEs did not require a visit to the emergency room and physician office. There were no prior vaccinations (within 4 weeks). There were no AEs following prior vaccinations. The patient had no medical history (including any illness at time of vaccination), no family medical history relevant to AEs and no relevant test. The outcome of the event was not recovered. Relatedness of drug to reaction(s)/event(s): Causality assessment between BNT162B2 and the event headache, on left side of head as per primary source reporter via global introspection was related. Information on the lot/batch number has been requested. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and the known product profile, the causal relationship between the reported headache , left side head and the BNT162B2 vaccination is possible. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to agencies as appropriate.
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| 68 | 2021-04-30 | fever, fatigue, cough |
today she is off kilter again; feels a heaviness in her eyes; all that coughing like something is ir...
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today she is off kilter again; feels a heaviness in her eyes; all that coughing like something is irritating her lungs and she can't stop; it was making her lungs hypersensitive.; all of a sudden she got really really hot, she runs about 97-97.4 and she got so hot and her face got really red like she had a high fever and she was 99.2; burning in her stomach and a stomach ache; burning in her stomach and a stomach ache; never has that much energy when she was normal/had tons of energy; woke up on day 4 in the middle of the night and her lungs were pinching, pinching, pinching, like and asthma attack and she couldn't stop it and she had to get her old fashioned inhaler to stop it; tired; had weakness with climbing stairs and with exertion/ zapping her energy; 2 inches below the injection site the muscle was hard and swollen and sore; 2 inches below the injection site the muscle was hard and swollen and sore; 2 inches below the injection site the muscle was hard; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER- BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 07Apr2021 14:40 (lot number: EW0150) at age of 68 years as single dose for COVID-19 immunisation. Medical history included low vitamin D, lungs were working at 75% the capacity of an 84 year old and not 68 year old and asthma attacks. Concomitant medications included vitamin D2 and D3 and regular vitamins for low vitamin D, had been taking that for 6-7 weeks, tiotropium bromide (SPIRIVA RESPIMAT) 2.5mcg takes 2 inhales a day in the morning and salbutamol sulfate (PROAIR) 2 puffs and a special medication because her lungs were working at 75% the capacity of an 84 year old and not 68 year old and put her on an asthma medication to open her lungs. Patient got a flu shot every year and got it in Jan2021 and nothing. Patient stated that her symptoms were mild. Patient stated on day 1 after she got the shot she had nothing, that was 07Apr2021. Stated the next day (08Apr2021) she did not have injection site soreness but 2 inches below the injection site the muscle was hard and swollen and sore and remained that way for days 2, 3 and about day 4 it started to recede and day 7 it was tender. Stated it was one muscle and it was below the injection site, not at the injection site. Stated it was a lifting muscle, if she lifted her arm up it could only go so far and she would feel it and drop her arm down. Stated she got the injection in her left arm as she used it the least. Stated on days 2 (09Apr2021), 3 and 4 she had weakness with climbing stairs and with exertion, she could do it but she would notice it was more of a struggle. Stated that today she was off kilter again. Patient relayed that she looked all over online to see if she was sick with something. Stated she was tired on days 3 (10Apr2021) and 4 and that on days 5 (12Apr2021) and 6 she had tons of energy and she worked from dawn to dusk waxing floors and never has that much energy when she was normal. Stated that all of a sudden on day 5 and 6 she was perfect and then toward the evening of day 6 she thought it was her as she had to go to the Secretary of States and stand in line to renew her license and she did well and got home and started feeling tired. States she woke up last night of day 6 (13Apr2021) with a burning in her stomach and a stomach ache and it woke her and made her feel like she had food poisoning or something like that and nothing happened and she took 2 Tums and it kind of settled that down. Stated on day 7 (14Apr2021) she woke up and the stomach part was gone and all of a sudden she got really really hot, she runs about 97-97.4 and she got so hot and her face got really red like she had a high fever and she was 99.2, which is not much for most people but she feels and she took Motrin and after that she still feels a heaviness in her eyes and her temperature is 98.6 and she is normally in the 97's and was running a 2 degree fever and now maybe a 1 degree fever and she felt it in her eyes and didn't feel sick. Stated she felt fatigued like she want to take a nap but didn't feel ill. Stated whatever was going on was zapping her energy. Stated she woke up on day 4 (11Apr2021) in the middle of the night and her lungs were pinching, pinching, pinching, like an asthma attack and she couldn't stop it and she had to get her old fashioned inhaler to stop it. Stated this hadn't happened and she had been taking the special medication for 3 weeks now and it was very rare for her to get those attacks and this was worse than any. Patient relayed that today all day even with the special medication to open her lungs she can feel in her lungs that they were, she can't explain it, like they are gripping and releasing and gripping and releasing a little but. Stated she knew she was having some kind of asthma thing going on, it was not making her cough it was making her lungs hypersensitive. Stated she was expecting everything and she did read and nobody had symptoms that last more than 7 days and she was expecting them to be gone tomorrow, or she hopeed anyways. Stated the last 10 days had been easy-peasy and all of a sudden she was waking with all that coughing like something was irritating her lungs and she can't stop. Patient provided that it woke her husband up with her coughing for half an hour. States this lasted half an hour and was more than normal and something really irritated her lungs, shouldn't have happened as she is on the other thing every day and has not had an attack with that. Patient stated her provider didn't know as it was so relatively minor and was unusual but minor and she did not feel like it was life threatening. Stated her brother had Covid and she did not feel like she was trying to breathe and couldn't, or suffocating and dying. She did not feel that. The air irritated to even breathe and made her cough and couldn't stop and that was the first time she had to use an inhaler on top of on inhaler and something made her lungs respond to nothing there. Stated it may be her immune system thinking something was there, the headless thing in her lungs. Patient stated she thought she was over it and then got the fever not understanding if the fever was Covid related and she stayed at home and didn't go out until yesterday it was the 1st day out since Thursday and how could she have caught anything if she wasn't near anybody. Stated these were just thoughts in her head. Outcome of events was unknown.; Sender's Comments: The reported event of asthma aggravated was assessed as possibly related based on temporal association. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
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| 68 | 2021-05-03 | fatigue, fever |
fever; fatigued; Did not have much energy/having no energy/low energy; Left Arm was painful and it g...
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fever; fatigued; Did not have much energy/having no energy/low energy; Left Arm was painful and it got swollen a bit; Left arm painful; Foggy and not clear; extreme shortness of breath/cannot catch her breath; almost hyperventilating/Hyperventilation; This is a spontaneous report from two contactable consumers (including husband and patient self) and patient self. A 68-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6204) at single dose on 20Mar2021 14:54 injected in left arm in the muscle for Covid-19 immunization. Medical history included shortness of breath, hypothyroidism and COVID-19 back in Dec2020. She had some food allergies that were diagnosed prior to getting the vaccine. Patient was tested positive for COVID on 21Dec2020 and negative on 20Jan2021. The symptoms followed for patient was a little coughing and no smell for 3 days and a little shortness of breath. Family medical history was none. Concomitant drug included levothyroxine 0.75 ug, once daily for hypothyroidism, which was taking for 15 years (as of 19Apr2021). No previous history of all previous immunization with the Pfizer vaccine considered as suspect. No Prior Vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer suspect. Patient experienced left arm painful on 20Mar2021 about an hour or two after she got the injection, did not have much energy on 21Mar2021 08:00, foggy and not clear from 21Mar2021 to 22Mar2021 08:00, shortness of breath started 24Mar2021 or 25Mar2021, and hyperventilation on an unknown date in Mar2021 (reported as a week or 9 days after receiving vaccine). The shortness of breath was what she referred to as hyperventilating. That came a week after the vaccine. The same date they took shot was when the arm pain started and the low energy was the day after. Foggy and not being clear was from 21Mar2021 to 22Mar2021. Shortness of breath started 24Mar2021 or 25Mar2021. In additional to shortness of breath, she had been hyperventilating. That began approximately a week or 9 days after receiving vaccine. Left arm was painful and it got swollen a bit and lasted for 48 hours. The husband experienced arm pain and said he almost had a fever and felt fatigued. The reporter thinks patient (his wife) felt the same. She had arm pain and not much energy. They came out of that ok. About a week after the first injection, she just cannot catch her breath. She started hyperventilating to the point where the husband thought she would expire. She also experienced being foggy and not clear and having no energy. First, she went to a Cardiologist and he said there was nothing wrong. She then saw a lung doctor who send for respiratory chest and did chest CT scans and everything was clear on both test. He did not prescribe any medications. A week after she saw him, she went to the ER on 31Mar2021for hyperventilation and shortness of breath. They prescribed Xanax (AER 2021434900). She said it did not work and they prescribed something else. It was 25 mg twice a day which was in a pharmacy vial. They then prescribed Lorazepam. She was afraid to take it. She took one instead of two. The dose was 0.25 mg twice daily. The ER did CT scan of chest with Contrast. It was negative for thromboembolism (also reported as CAT scan's negative for blood clots). She had shortness of breath before the vaccination and it got worse. She was managing it though. Outcome of left arm painful, foggy and not clear, did not have much energy/having no energy/low energy was resolving. Outcome of shortness of breath and hyperventilation was not resolved. Outcome of the other events was unknown. Information about lot/batch number has been requested.
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| 68 | 2021-05-03 | headache, fatigue |
throbbing headache; exhausted; muscle aches; sick; fatigue; hands had tremors; body aches; This is a...
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throbbing headache; exhausted; muscle aches; sick; fatigue; hands had tremors; body aches; This is a spontaneous report from a contactable consumer. This 68-years-old Female consumer reported herself that: Country: Report about covid vaccine: Yes. Reporting type: AE. Reporter type: Non-healthcare Professional reporting for a patient. Patient name: (name). DOB: ## Age group: Elderly (65+ Years). Current age: 68. Current age unit: Years. Gender: Female. Is pregnant: No. Race: (race). Address street: (address). City: (city). State: (state). Zipcode: ### Phone no.: ## Email: (mail id). Covid vaccine details: Product=COVID 19 Brand=Prizer. Lot number= EN6198. Lot unknown= False Administration date=03Mar2021 Administration time=10:15 AM Vaccine location= Right arm. Dose number=1 Facility type vaccine: (name) Facility name: (name) Facility address street: (address) Facility city: (city) Facility state: (state) Facility zipcode: ### Facility country: If other vaccine in four weeks: No. Other medications in two weeks: Albuterol Inhaler. Adverse event: I had a throbbing headache in the back of my head that has lasted 12 days. It was the worst headache I have ever had and had terrible fatigue. My hands had tremors and I had body aches for 3 days. Headache so bad I had to get a CT scan Adverse event start date: 05Mar2021 Adverse event start time: 12:00 AM Adverse event country: Ae resulted in: Doctor or other healthcare professional office/clinic visit. If patient recovered: Recovering If treatment ae: Yes. Ae treatment: CT scan, Blood work. If covid prior vaccination: No. If Covid tested post vaccination: Yes. Covid test post vaccination: Covid test type post vaccination=Nasal Swab Covid test name post vaccination=Rapid Test Covid test date=12Mar2021 Covid test result=Negative. Known allergies: No. Other medical history: Cancer in remission for 6 years. Follow-up (23Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that included: Patient Details: Initials: (name). Sex: Female. Is the patient also the reporter? Yes Date of birth: ### Country of Incidence: Reporter Details: Reporter type: Consumer or other non health professional. Reporter type details: self. First name: (name). Surname: (name). Address line: (address). Town / City: (city). County / State: (state). Post code / ZIP code: ## Country: Telephone: ## Email address: (mail). Primary / Prescribing Healthcare Professional Info: Country: Event Details: Company aware date: 23Mar2021 Report type: Follow-up Report no new event Products: Suspect products: COVID Vaccine: NDC number: Not Provided. Lot Number: Not Provided. Reason for no lot number: Other: follow up report and she previously provided it. Expiry date: Not Provided. History: Concomitant Products: Other Products Not Provided. Other conditions: Other Conditions Not Provided. Investigations: Investigations Not Provided. Additional Context: Other Reference(s): No Transfer to agency Required. Additional Context: She had her first shot three weeks ago tomorrow. She is scheduled to get second one tomorrow. She was sick for 13 days after the first one. She was so sick. The headache was so bad the doctor sent her for a CT scan of her head. The headache was at the crown of the head and down into the back of the head. She never had a headache in the back of her head like that before. Her doctor wanted to make sure no bleed. It started lightly for two days and got worse and worse. It was 13 days before it went away. On top of that she had muscle aches in the beginning, but those went away. She was exhausted. She has already sent this in to Pfizer. She is questioning if she should get the second dose. She did get a COVID test and that was negative. She has done what she was supposed to do. Reference Number: she doesn't have a reference number. She has been on hold for two hours. She held because she feels this is very important. She really don't want to end up in trouble because she gets the second vaccine. Her doctor said it is a tough call. When she has to go get a shot and walk in with an EpiPen it gives her an ugly feeling. Her doctor is really not thrilled. She is darned if she does and darned if she doesn't. She knows one lady that died two days later and another one that died a couple of days later. They were both in another place. One was the wife of a surgeon. She thinks it has been reported. One was a community leader. They are waiting on the autopsies. Caller declined to proceed with a report for the two women that died after receiving the COVID vaccine. One died in the bathroom on the second day. The other is a doctor's wife and she passed one to two days after the shot. Neither was expected. Caller doesn't have their health records. She doesn't live in the same town. She is sure they are aware at Pfizer that this happened. She can't find anything. She didn't get a reference number from Pfizer. She gave the lot number when she reported it before because she remembered she had to get the card. She also reported it through (name). (name) gave her a confirmation number of ## on 13Mar2021. She think she would have filed them at the same time, so she probably reported it to Pfizer on 13Mar2021. Caller is going to delay the second shot. She knows she has up to 42 days. to get it. Is there a product complaint to report: No. Is there a medical information request: Yes. Please describe the medical information request: She is questioning if she should get the second dose. Is this an Other report: No Site: Call Centre # Contact Centre Ref: ##, ## Follow-up (23Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that included: Primary source(s) of information: Reporter title: (title). Reporter given name: (name). Reporter family name: (name). Reporter's postcode: ### Reporter country code: Qualification: Consumer or other professional. Reporter Phone Number: ### Patient characteristics: Patient: PRIVACY. Sex: male. Patient First Name: (name). Patient Last Name: (name). Drug(s) Information: Characterization of drug role: suspect. Proprietary medicinal product name: Pfizer-Biotech COVID-19 Vaccine. Identification of the country where the drug was obtained: Country of authorization/application: Active Substance Information: Active Drug substance names: Pfizer-Biotech COVID-19 Vaccine. Narrative case summary and further information: Case narrative: Originating AE Request: REQ-# Attachments: 1 Reporter Subtype: Patient. PQC Present: No. AE Present: Yes. PQC Details: Request Name: REQ-# Product: Pfizer-Biotech COVID-19 Vaccine. Question: Potential Duplicate case: Caller stated she reported this online to Pfizer safety on 13Mar. Caller received the first dose of the Pfizer covid vaccine on 03Mar and it made her sick for 13 days. She had a really bad headache for 9 days and had a CT scan done for the headache, she was in the hospital, was exhausted. Caller is scheduled for second dose tomorrow. caller wanted to know if the side effects lasted that long after the first dose with other people. caller is a 68 years old female. Caller stated she is not sure about if the 2 females who received the covid vaccine were Pfizer covid vaccine or not but they died in (place name). Caller refused to provide any other information including age of the patients. Caller stated that one of them was a Doctor's wife. Request Name: REQ-# Product: Pfizer-Biotech COVID-19 Vaccine. Question: Question: Caller wanted to know how many people experienced severe headache and were they given the second dose.
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| 68 | 2021-05-04 | fatigue |
Felt lightheaded/Dizziness; tired; a bit nauseous; felt vertigo when moved my head, doctor believes ...
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Felt lightheaded/Dizziness; tired; a bit nauseous; felt vertigo when moved my head, doctor believes it's cervical vertigo and linked to my neck; This is a spontaneous report from a contactable consumer (patient, self-reported). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in right arm, on 29Jan2021 at 09:30 PM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included lymphoma (finished treatment last year. Currently cancer free with white blood cells recovering and close to normal range), depression, anxiety and vertigo. The patient had known allergies with Penicillin. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks which included Alprazolam (XANAX), Ibuprofen, and Paxil. The patient reported that on 29Jan2021 at 10:00 PM, she felt lightheaded after initially being vaccinated. She felt funny and tired and a bit nauseous yesterday. She woke up this morning and felt vertigo and dizziness if she moved her head at all. She had a history of vertigo, but it didn't usually come on unless she had missed a dose of medication or had done something to hurt her neck as her doctor believes it was cervical vertigo and linked to her neck. The patient did not receive any treatment for the events. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 68 | 2021-05-07 | headache, chills, fever |
she feels like she has Covid; feeling chest pain/her chest is sore; headache/her head just starting ...
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she feels like she has Covid; feeling chest pain/her chest is sore; headache/her head just starting hurting; she is scared; She used to weight 143 pounds 9 months ago, she states she is swelling up.; overall body aches; cramping; eyes had swollen; fever of 101.9°F/temperature like 101.9 degrees, a fever; chills; nausea; wiping would be pink/She also states that she when she went to the bathroom, she wiped pink and it worsened and turned darker.; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1, via an unspecified route of administration, administered in Arm Right on 12Apr2021 11:00 (Lot Number: EP7534; Expiration Date: 31Jul2021) as SINGLE DOSE (at the age of 68 years old) for covid-19 immunisation. Medical history included she is on the borderline of Chronic obstructive pulmonary disease (COPD). She was taking breathing medicine, but has been taken off of it, she is doing so well; osteoporosis; osteoarthritis; osteopenia. Concomitant medication included hydrocodone (HYDROCODONE) taken for osteoporosis, osteoarthritis, osteopenia, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On unspecified date the patient experienced feeling chest pain/her chest is sore, headache/her head just starting hurting, she is scared, she used to weight 143 pounds 9 months ago, she states she is swelling up and overall body aches. On 14 Apr2021, she experienced wiping would be pink/She also states that she when she went to the bathroom, she wiped pink and it worsened and turned darker. She wiped this morning, and she thinks it stopped. She felt cramping. It started light pink, then a couple days ago it was darker. She was a walk in patient at the clinic to be checked out. She lives alone, has no companion for a sex life, she had no new medications. She went to her physician yesterday 22Apr2021, and had a pap smear and blood draws. Her MD told her to take Airborne around the time of the second vaccine. On 16Apr2021 she experienced nausea. On 22Apr2021 the patient experienced eyes had swollen, fever of 101.9°F/temperature like 101.9 degrees, a fever, chills. On 23Apr2021 the patient experienced cramping.The headache has been on and off all weekend. She felt she was dying. The worst yesterday. She read all the Covid symptoms and all her symptoms point toward Covid. She feels like she has Covid from unknown date.She has chest pain and tries to ignore it, but she can't. She has to go get her pain pills because her head just starting hurting.The patient underwent lab tests and procedures which included body temperature: 101.9 degrees fahrenheit on 22Apr2021, blood test: unknown results on 22Apr2021, pap smear: unknown results on 22Apr2021, weight: 143 lbs on 9 months ago. Therapeutic measures were taken as a result of overall body aches. She took gas pain pills, allergy relief pain pills because her whole body hurt. She has been applying warm towels to her eyes to help with swelling. Outcome of fever of 101.9°F/temperature like 101.9 degrees, a fever, chills was recovered on 23Apr2021. Outcome of eyes had swollen, headache/her head just starting hurting, nausea, wiping would be pink/She also states that she when she went to the bathroom, she wiped pink and it worsened and turned darker was recovering. Outcome of feeling chest pain/her chest is sore was not recovered. Outcome of she feels like she has Covid, she is scared, cramping, he used to weight 143 pounds 9 months ago, she states she is swelling up, overall body aches were unknown.
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| 68 | 2021-05-12 | malaise |
passing blood clots from her rectum; blood clots; deathly ill; the lymph nodes underneath the arm sw...
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passing blood clots from her rectum; blood clots; deathly ill; the lymph nodes underneath the arm swell up / She swelled up on her right side; kind of in the breast/chest area, up a little higher than the breast and it was very uncomfortable; This is a spontaneous report received a contactable consumer, the patient. A 68-year-old elderly female received the first dose of intramuscular BNT162b2 (solution for injection; Lot ER8737 and expiry information not provided) as a single dose in the left arm on 08Apr2021 at 11:00 (at 68-years-old) for COVID-19 immunisation. Relevant medical history included ongoing back problems for which she takes medication. Concomitant medications included unspecified medication for back problems. The patient denied any other vaccines within four weeks prior to this vaccine. The patient reported that she generally gets the flu shot every year and has never had any adverse reactions. The patient also mentioned that she previously tramadol (for an unspecified indication) in the past but has not taken it for years. The patient reported that she received her first dose on 08Apr2021 at (Privacy). The patient explained that within six hours she was deathly ill. The patient reported that stayed very ill for quite a few days. The patient stated when she gets up in the morning, she gets up early and she always goes to the bathroom. The patient stated that on 13Apr2021, when she went to the bathroom, she started passing blood clots from her rectum which went on until 16Apr2021. When describing the blood clots, the patient stated 'envision sunny side up eggs, between six to eight of them, and in between that was all this webbing holding the clots together'. The patient stated while she was urinating, the clots were just pouring out of her rectum. The patient clarified that there was not blood in her stool. The patient explained that she took the opportunity to get some plastic gloves and look through her stool for blood and there was not any. The patient stated that her underwear and the toilet paper was stained. The patient also stated that she was reading that whichever arm you get the vaccine, the lymph nodes underneath the arm swell up. The patient explained that her lymph nodes did not swell up underneath her left arm where she got the shot. She swelled up on her right side. She clarifies she was swollen underneath her arm, kind of in the breast area and chest area, up a little higher than the breast. It was very uncomfortable. The patient denied any visits to the emergency room or doctor's office for the events. The outcome of the event passing blood clots from her rectum was recovered on 16Apr2021. The outcome of the events deathly ill, the lymph nodes underneath the arm swell up / She swelled up on her right side, and was very uncomfortable was unknown.
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| 69 | 2021-01-03 | cough, runny nose |
Vaccinated at mass vaccination event for nursing home staff and residents on 12/18/2020. Staff of nu...
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Vaccinated at mass vaccination event for nursing home staff and residents on 12/18/2020. Staff of nursing home. Developed cough and runny nose and tested positive for COVID-19 on 12/20/2020. Ongoing exposure to sister who lives with her and is also COVID+
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| 69 | 2021-01-03 | malaise |
On 12-21-2020, after the injection patient states she did not feet well and her right index finger b...
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On 12-21-2020, after the injection patient states she did not feet well and her right index finger began to hurt right after. She states the right index finger pain started to hurt also on 12-23-2020. She states she will be receiving her second dose on Thursday 01-07-2021.
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| 69 | 2021-01-05 | headache, malaise, fatigue |
Extremely tired, arms and legs felt like lead. Sharp pain top of ankles. Tireness, achiness, joint p...
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Extremely tired, arms and legs felt like lead. Sharp pain top of ankles. Tireness, achiness, joint pain, muscle pain, headache. Feeling unwell.
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| 69 | 2021-01-05 | sweating, headache, fatigue, cough, sleepiness, chills |
Soreness in the arm started later on the same day (late evening on 12-30-20). Woke up at 5:00 am the...
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Soreness in the arm started later on the same day (late evening on 12-30-20). Woke up at 5:00 am the next morning (12-31-20)with severe chills, headache and dizziness. Felt as if I had covid all over again (was diagnosed with covid on October 12, 2020). My whole body ached and I was extremely fatigued. All I wanted to do was sleep and I also started a slight cough. Later on in the afternoon I started to sweat profusely. I had chills/sweats all through the afternoon and into the evening. I did not even get out out bed until the next afternoon (1-1-21). For 2 days afterwards I had chills/sweats and on 1-2-21 I had terrible stomach cramps and diarrhea.
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| 69 | 2021-01-07 | dehydration, chills, fever, headache |
fever; she was dehydrated; unable to sleep until 3:30am; Headache; body aches; Chills; Pain / receiv...
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fever; she was dehydrated; unable to sleep until 3:30am; Headache; body aches; Chills; Pain / received the vaccine on 18Dec2020, at that time she only had symptoms of pain; This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number CJ1685) via an unspecified route of administration on 18Dec2020 at single dose in the right arm for COVID-19 immunization. Medical history included gum surgery on 29Dec2020. Concomitant medication included amoxicillin trihydrate (AMOCILLINE) from 29Dec2020 post gum surgery. The patient received the vaccine on 18Dec2020. At that time she only had symptoms of pain (onset date 19Dec2020). On the night of 04Jan2021, she had chills and needed 3 blankets and 2 robes. Three hours later her chills were gone and she had a temperature of 105 degrees (fever onset date 05Jan2021). She also had a headache (headache onset date 04Jan2021). She took two paracetamol (TYLENOL) and was unable to sleep until 3:30am. She woke at 9am (05Jan2021). She checked her temperature again and it was 99.2. This was after going 12 hours without taking paracetamol. Then she had body aches (body aches onset date 04Jan2021) but no headache. She thought she was dehydrated and she drank some water. Her headache was gone. She was scheduled for the second vaccine on 08Jan2021. She was told that her body would respond stronger and the symptoms be worse since she responded 17 days after getting the vaccine. The event pain (after vaccination, on 19Dec2020) was resolved on 19Dec2020, chills was resolved on 05Jan2021, fever was resolving, headache was resolved on 05Jan2021, body aches was resolved on 05Jan2021. The outcome of "unable to sleep" and "she thought she was dehydrated" was unknown.
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| 69 | 2021-01-07 | fever, malaise, headache |
Injection site is red, swollen, hot. Muscle aches, feverish, headache general malaise. I took Tylen...
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Injection site is red, swollen, hot. Muscle aches, feverish, headache general malaise. I took Tylenol, Advil and used ice for the headache.. The side effects didn?t start until day after the vaccine. This is the third day post vaccine side effects are starting to subside.
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| 69 | 2021-01-08 | fatigue, chills, fever | Nausea Extreme tiredness Body Ache Chills Fever. 100f |
| 69 | 2021-01-10 | fever |
Fever ranging from 100.2 degrees F to 102.2 degrees F for 36 hours, moderate relief with Tylenol. ...
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Fever ranging from 100.2 degrees F to 102.2 degrees F for 36 hours, moderate relief with Tylenol. Joint pain for 72 hours with mild relief with Tylenol. Loss of appetite for 24 hours. Left deep armpit pain for 4 days, just subsiding but still evident. Left deltoid injection site warm and red with redness tripling in size over 3 days (covered entire deltoid region.) Site remains warm and red since initial injection but seems to be improving today (day 4 post vaccine)
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| 69 | 2021-01-11 | fatigue |
Fatigue, Intermittent stabbing pains moving everywhere around my body continuously; skin sensative ...
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Fatigue, Intermittent stabbing pains moving everywhere around my body continuously; skin sensative to touch with burning feeling, swollen glands under armpits, neck.. Lasting now over a week. Some lessening with GabaPenton prescription after telehealth consult. His thinking it was neuropathic pain.
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| 69 | 2021-01-12 | fatigue, chills, fever |
Chills starting about 24 hr after receiving vaccine then a fever of 102 which decreased to 100 by be...
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Chills starting about 24 hr after receiving vaccine then a fever of 102 which decreased to 100 by bed time and then was back to normal the next day. Very tiered after fever was back to normal which lasted for aprox. 24 hours. 3 days after vaccine I was feeling fine again
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| 69 | 2021-01-13 | body temperature increased |
Sore arm; increase in temperature; This is a spontaneous report from a non-contactable other healthc...
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Sore arm; increase in temperature; This is a spontaneous report from a non-contactable other healthcare professional (reported for herself). This 69- year-old female patient (reported for herself) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EK423), via an unspecified route of administration, on 05Jan2021 at 10:30 AM (at the age of 69-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient did not have any allergies to medications, food, or other products. The patient does not have any medical history. The patient was not taking any concomitant medications. The patient did not receive any medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jan2021 at 04:00 AM, she experienced a sore arm and an increase in temperature. The patient did not receive treatment for the events. The clinical outcome of the events sore arm and an increase in temperature was recovered. Patient was not tested for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.
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| 69 | 2021-01-14 | cough, fatigue |
experiencing pain in her back where kidneys; fatigued/extreme fatigue; dry cough; diarrhea; aches/pa...
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experiencing pain in her back where kidneys; fatigued/extreme fatigue; dry cough; diarrhea; aches/pains/aches and pains around her body; severe pain in injection arm; injection site very painful; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. She reported that the evening of her first dose, she experienced severe pain in injection arm on 06Jan2021. She stated that night injection site very painful. She had to take Tylenol Extra Strength overnight. She stated that she woke up and she was fine. On 09Jan2021, she reported feeling fatigued, dry cough, extreme fatigue, diarrhea, aches/pains, and aches and pains around her body, but no fever. She woke up this morning on 11Jan2021, experiencing pain in her back where kidneys, still fatigued but no fever. She has taken the Covid test and does not have the results. She wanted to know if these are side effects of the vaccine or is this potentially the Covid virus. The events were assessed non-serious. The outcome of severe pain in injection arm, injection site very painful was recovered, of fatigued was not recovered, of other events were unknown. Information on the lot/batch number has been requested.
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| 69 | 2021-01-16 | fatigue, fever, headache | Headache Fever 100.3 Muscle ache Fatigue Pain at injection site |
| 69 | 2021-01-17 | influenza like illness, malaise |
I felt quite sick, like I had the flu; became very lightheaded and dizzy; passed out; felt quite sic...
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I felt quite sick, like I had the flu; became very lightheaded and dizzy; passed out; felt quite sick; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at 12:30 at single dose in left arm for covid-19 immunization. Medical history included R.A.D., osteopenia, migraine with aura, the patient had previously suffered episodes of vasal vagal syncopy when she got the flu or other severe illnesses, and the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medication included atenolol, atorvastatin, azelastine, and fluticasone. The patient previously took gramicidin, neomycin sulfate, polymyxin b sulfate (NEOSPORIN) and experienced allergies. The morning after receiving the vaccine, she felt quite sick, like she had the flu. When she got up from bed and went to the bathroom to urinate, she became very lightheaded and dizzy. She attempted to return to bed, but passed out on the bedroom floor before she could get to the bed, and seized while she was unconscious. Once she came to, she was helped to bed and, after about 90 minutes, felt much better, and got up, and ate food and had coffee. All events occurred at 07:30 AM on 09Jan2021. All events were reported as non-serious by reporter. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was resolved in Jan2021. Information on the lot/batch number has been requested.
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| 69 | 2021-01-18 | fatigue, sluggishness |
Both left and right knees extending 6"above and below area, was extremely inflamed, warm to touch, p...
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Both left and right knees extending 6"above and below area, was extremely inflamed, warm to touch, painful making legs feel like 2 cement blocks to walk. Both shoulders were inflamed and muscles locked causing difficulty in mobility. Both hip joints felt irritated, the left more aggravated and painful. Also the body experienced being tired and sluggishness needing more than usual sleep. This lasting about 8 days. Treatment: ActivIce/Biofreeze spray several times daily and elevation to release pressure and blood flow.
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| 69 | 2021-01-19 | fatigue, runny nose, malaise, sweating, headache, chills |
Patient advises that she had developed injection site soreness on the night of her injection. The ne...
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Patient advises that she had developed injection site soreness on the night of her injection. The next day, she started with symptoms of generally feeling unwell and headache. She also reports that several days after the vaccine, she had some shortness of breath, dizziness, and weakness but did not seek medical care. Patient states she had fatigue, muscle pain, chills, sweating, and runny nose on 1/15/2021. On 1/18/2021, patient complains of headache. COVID test was ordered and patient was advised to go to Urgent Care for exam if she felt she needed to see a doctor. COVID test resulted negative.
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| 69 | 2021-01-19 | headache, malaise |
At 1332, she called into the office to let us know that she was not feeling well after her vaccine. ...
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At 1332, she called into the office to let us know that she was not feeling well after her vaccine. 1331 2 RN's got to her vehicle to assess her. She stated she was feeling "not right", complained of her left arm hurting, a headache, and right ear pressure. Vital signs at 1339 showed a BP of 138/76 done by manual cuff, a pulse was taken radially and was 78 bpm, with a regular rate and rhythm by palpation, respirations were 26 breaths per minute, and her O2 saturation was 99%. 1342 she had episodes of emesis out the side of her vehicle multiple times. 1344 EMS was called. 1347 50mg of IM Benadryl was administered into her right deltoid. EMS arrived at 1349 and care was transferred over at that time. Her husband took her car keys and was driving separate to Emergency Department.
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| 69 | 2021-01-19 | throat pain |
Pt reports Choking sensation: sore throat "constricting" onset 1523hrs. VS 128/74, puls 77. No other...
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Pt reports Choking sensation: sore throat "constricting" onset 1523hrs. VS 128/74, puls 77. No other symptoms observed. Administered 20ml Oral Diphenhydramine. Maintained observation and VS assessment through 1553hrs. Pt reported sore throat but no constricting in throat post Benedryl. Directed to PCP to see allergist before next dose.
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| 69 | 2021-01-19 | fever, headache |
Patient describes Soreness at injection site, later experienced body aches, headache, fever that is ...
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Patient describes Soreness at injection site, later experienced body aches, headache, fever that is rising and hoarseness in voice
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| 69 | 2021-01-20 | headache, fatigue |
anterior cervical fusion; Headache; tested positive for COVID-19; tested positive for COVID-19; musc...
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anterior cervical fusion; Headache; tested positive for COVID-19; tested positive for COVID-19; muscle aches; Loss of taste; Loss of smell; Nausea; sore arm; Tiredness; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EJ1686, intramuscular in right deltoid on 03Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included ongoing essential tremor started in her 50's. The patient's concomitant medications were not reported. The patient did not receive other vaccine within four weeks. On 03Jan2021 the patient experienced sore arm and tiredness. On 07Jan2021 the patient experienced anterior cervical fusion and was hospitalized from 07Jan2021 to 09Jan2021. On 08Jan2021 the patient experienced nausea. On 09Jan2021 the patient experienced muscle aches, loss of taste and loss of smell. On unknown date the patient experienced headache. The patient was tested positive to COVID-19 on 11Jan2021. The patient did not visit Physician Office or Emergency Room. Laboratory data included COVID-19 Rapid Test positive on 11Jan2021. The outcome of the events tested positive for COVID-19, and anterior cervical fusion was unknown. The outcome of the events sore arm, tiredness, nausea, muscle aches, headache was resolving. The outcome of the events loss of taste, loss of smell was not resolved.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and COVID-19 test positive on 11Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use. This 69-year-old female had medical history of ongoing essential tremor started in her 50's. The reported anterior cervical fusion was most likely due to concurrent disease, and unlikely causally related to the vaccine of BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 69 | 2021-01-21 | throat irritation, cough |
While half way through eating a Lean Cuisine Butternut Squash Ravioli dinner I suddenly couldn't swa...
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While half way through eating a Lean Cuisine Butternut Squash Ravioli dinner I suddenly couldn't swallow. I coughed and threw up what I had eaten. My throat was extremely itchy and my head became very congested. I have never had a food allergy before but after searching that I found the symptoms to be similar. My face was not particularly swollen but I was unable to eat anymore and my throat continued to be very itchy on the right side. I eat mostly on that side due to a dental problem on the left side. I took an antihistamine, gargled with mouth wash, used a Netti Pot and sucked a cough drop. The itchiness was reduced by the next morning and gone by that afternoon.
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| 69 | 2021-01-22 | headache, fatigue |
Extreme fatigue, headache, dizzy, backache, cold sore. General weakness especially in lower extrem...
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Extreme fatigue, headache, dizzy, backache, cold sore. General weakness especially in lower extremities - started 7-10 days after injection.
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| 69 | 2021-01-24 | chills, headache |
Rapid heart beat in chest, neck and head, Elevated blood pressure Pounding head ache Chills with unc...
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Rapid heart beat in chest, neck and head, Elevated blood pressure Pounding head ache Chills with uncontrollable shaking
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| 69 | 2021-01-24 | cough |
Patient complained of lips and throat swelling, she also started coughing (dry cough), blood pressur...
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Patient complained of lips and throat swelling, she also started coughing (dry cough), blood pressure high at 189/112. She was given 100mg of Benadryl and an Epi Pen was used. She recovered well with reactions subsiding and blood pressure down to 159/96.
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| 69 | 2021-01-24 | headache, chills |
At 6:00 AM, suddenly had severe pain in left side of neck, headache, extreme vertigo, chills and nau...
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At 6:00 AM, suddenly had severe pain in left side of neck, headache, extreme vertigo, chills and nausea. Multiple sessions of vomiting. Saw rings of colored lights and squigly lines. Took Tylenol and Benadryl per PCP by phone. Dizziness and chills went away in about 12 hours. Still saw squigly lines at night. Much better the next day but queasy for another 24 hours.
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| 69 | 2021-01-25 | chills, influenza like illness, sweating, headache, dehydration |
2:00-chills all the way down my right side (2pm-7am Started throwing up...12 hours of nausea and vom...
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2:00-chills all the way down my right side (2pm-7am Started throwing up...12 hours of nausea and vomiting 3:00-extreme headache (took aspirin for pain) -lower back hurt -pain in right shoulder, elbow, wrist -couldn?t lay on right side (bruising at site but no swell -couldn?t move without vomiting -woke up at midnight completely wet with sweat and sweating continuing even today Tuesday -weakness all over (felt like I had had the FLU) ? I knew there was potential for side effects before taking the vaccine...I was totally unprepared for so many symptoms and how intense they were and what little I could do to relieve any of them. Never had fever that I am aware of. Today I?m weak and sweating is unreal. ?? Should I prepare/expect my second dose around Feb. 14 to have the same effect on me.? Not looking forward to that. I was almost ready to go to the ER I was getting so dehydrated and weak.
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| 69 | 2021-01-25 | fatigue, throat pain, headache, chills |
sore throat, stiff neck, chills, body aches, nausea, headache (day 2 still have headache), extreme f...
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sore throat, stiff neck, chills, body aches, nausea, headache (day 2 still have headache), extreme fatigue, swollen lymph nodes, increased blood pressure, night sweats
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| 69 | 2021-01-26 | chills, cough, fatigue, fever |
HPI: 69 y/o woman with minimal PMH of hysterectomy and cystic mass resection in 2016. She presented ...
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HPI: 69 y/o woman with minimal PMH of hysterectomy and cystic mass resection in 2016. She presented with c/o fatigue, fevers, shaking chills, SOB/cough, anorexia, N/V/D for the past 6 days (GI symptoms started 2 days ago). Husband reports she has also had periodic confusion during this time. She received her second COVID vaccine 7 days ago and symptoms started the following day.
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| 69 | 2021-01-26 | headache | Imediately after receive injection left eye is RED and mild headache. |
| 69 | 2021-01-26 | malaise, headache, fever |
first 24hours nothing, second night was woke by pain in arm, swelling, redness, slight fever, headac...
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first 24hours nothing, second night was woke by pain in arm, swelling, redness, slight fever, headache, felt under the weather. Third day more swelling, redness and headache. Today, forth day, swelling going down still red, no headache and feeling better in general. Took tylenol for headache and pain.
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| 69 | 2021-01-26 | fever |
She having bilateral leg pain and weakness to the lower extremities. Low grade fever of 100.1. Was s...
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She having bilateral leg pain and weakness to the lower extremities. Low grade fever of 100.1. Was sent to ER for evaluation of leg weakness.
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| 69 | 2021-01-27 | headache, chills, fever |
blurred vision that lasted nearly two weeks; Headache; bedridden due dizziness; bedridden due dizzin...
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blurred vision that lasted nearly two weeks; Headache; bedridden due dizziness; bedridden due dizziness; extreme debilitating aches and pains; body felt numb; fever; chills; This is a spontaneous report received from a contactable nurse (who is also the patient). A 69-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: RH9899, expiry date: unknown), intramuscular in left arm, on 21Dec2020 09:30, at single dose, for COVID-19 immunization. Medical history included allergies to shellfish and bee stings. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and is not pregnant. On 23Dec2020 at 20:00, the patient experienced headache, blurred vision that lasted nearly two weeks, extreme debilitating aches and pains, body felt numb, bedridden due dizziness, fever and chills. Treatment for the events included ibuprofen (ADVIL). The patient was not tested for COVID-19 since the vaccination. The outcome of the events was recovered on an unspecified date. The reporter assessed this case as non-serious.
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| 69 | 2021-01-27 | headache, influenza like illness, chills, fever |
After about 12 hours I started having muscle aches in both arms which then became full body ache lik...
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After about 12 hours I started having muscle aches in both arms which then became full body ache like flu symptoms. Fever chills during the night. Still had 99.5 fever at 7 this morning and dull headache. Took 2 Tylenol. Still sore but getting better.
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| 69 | 2021-01-27 | fever, sweating, headache, chills |
1st shot...none 2nd shot: 1st night-fever, headache, chills major all over stiffness ...
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1st shot...none 2nd shot: 1st night-fever, headache, chills major all over stiffness 2nd night- fever over 100 degrees, major chills and shivering, joint stiffness, no headache 3rd night- no fever but MAJOR sweating, sweating, sweating. No headache, stiffness much improved. 4th day - all symptoms almost gone, no headache, stiffness improved. Arm still sore
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| 69 | 2021-01-28 | chills, fever, headache | Fever up to 101.6, chills, headache, muscle soreness |
| 69 | 2021-01-28 | chills | Nasuea, Chills, Joint aches |
| 69 | 2021-01-28 | fatigue | Extreme fatigue for 2 days |
| 69 | 2021-01-28 | headache |
body aches increased; headache worse; This is a spontaneous report from a contactable consumer (pati...
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body aches increased; headache worse; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration (reported as injection) in the left arm on 08Jan2021 at a single dose for COVID vaccine due to the patient's age and lives in continued care retirement community. Medical history included ongoing pain and ongoing persistent headaches, both since 2009. Concomitant medication included erenumab aooe (AIMOVIG) from an unspecified date in 2020 (started taking it 3 months ago). The patient reported side effect from the vaccine received on 08Jan2021. She has had body aches and headaches since 2009, so she figured after reading about the side effects, she would probably have worse body and headaches, but the body aches lasted maybe 4-5 days, from the time of vaccination, she has what was called new daily persistent headaches, which was a rare form of headache. They didn't have meds for it, because not many people have it, it was not a money maker to try to find something that works. She figured this would make headache worse and that was what it did, they were normally a level 7 or 8 on an unspecified date, and they increased to a level 9 on Jan2021, and she couldn't find a way to get it back down. The patient called her headache specialist and she thought steroid injections might help but wanted her to talk to someone to let them know the side effect the patient was having, with the headaches. Her body aches never go away, headaches never go away, and the day of the vaccine, she still had them both as normal, but after receiving the vaccine, her body aches increased, they went up a level, they were normally, a level 7 on an unspecified date, and after the vaccine, they went up to an 8.5 on Jan2021. She took Tylenol, regularly, every 4 to 6 hours, and after about 4 days, the body aches were down to the normal ache. But, the headache did not. The headache was starting to get worse. The outcome of the event body aches increased was recovering while the other event was not recovered. Information on the lot/batch number has been requested.
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| 69 | 2021-01-28 | sleepiness, fever, malaise, fatigue, dehydration |
temperature of 105.5 and stated it would fluctuate between 104-105; blurred vision; balance was off;...
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temperature of 105.5 and stated it would fluctuate between 104-105; blurred vision; balance was off; first it was up around 163/71 and then over time it was really low 118/58; HR was high; body was jerking; arm that she got the injection in was dropping; dehydrated; urine is darker; real thirsty; extremely weak; tired and exhausted; feeling horrible; couldn't stay awake, fell asleep; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 14Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included left hip replaced on 16Nov2020 and had her right hip replaced on 29Dec2020. There were no concomitant medications. Patient reported that she got the shot at 1:30 pm and on the way home she started getting tired and exhausted on 14Jan2021. She got home and went right to bed. She felt like she couldn't stay awake, fell asleep and woke up about 6 pm then with a temperature of 105.5 and stated it would fluctuate between 104-105. She was just feeling horrible. At 7:30 pm, patient had a temperature of 103.5 and at 7:45 pm, her temperature was 104. On 14Jan2021, patient stated that she couldn't see straight, had blurred vision, having trouble walking, her balance was off and falling into walls. Her body was jerking and the arm that she got the injection in was dropping. Patient called her cardiology office, and was advised to take Tylenol 3-4 times per day and alternate it with Motrin. She was also taking coated 325 mg aspirin. She can hold her head up and was not jerking as much as she was. She was doing noticeably better. Patient had put ice bags on her groin, stomach and throat to try to cool down through the night. This brought temperature down to 103. She woke up at 12 am she was 102. Her temperature at the time of report was around 101-102. She took her blood pressure it was going crazy, first it was up around 163/71 and then over time it was really low 118/58 and heart rate was 130 for a while and went to 103. The back of her neck still felt so weak and she still feels extremely weak and exhausted. She went on to report that her HR was high and B/P was up but since then it has come down. The night of 14Jan2021, her b/p was low.On 14Jan2021, patient was also real thirsty and her urine was darker and was probably dehydrated and thought that she was real jerky muscle-wise, like she is not in control of anything last night. That she has not taken BP or heart rate on 15Jan2021, but it was not pounding today though. She was doing better today at the time of report. Patient was recovering from the events of fever, blurred vision, and balance was off; not recovered from tired, jerking, and dehydration. Outcome of remaining events was unknown.
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| 69 | 2021-01-29 | chills, fatigue | I felt dizzy, tired and had chills. I rested overnight and feel fine now. |
| 69 | 2021-01-29 | fatigue, headache |
Vaccine arm swollen, woke up with hand tingling, and red palm. Red palm and tingling went away withi...
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Vaccine arm swollen, woke up with hand tingling, and red palm. Red palm and tingling went away within 30 minutes. But 2-3 hours later three fingers had peeling. Also wrinkly fingers. Increased water and added electrolytes. Notified doctor, who instructed to elevate and ice arm, and to start benadryl. Also take benadryl before next vaccine. Left arm may still be slightly swollen, but most swelling gone by 12 hours. Sore arm for a couple days, intermittent headache which took tylenol for. Fatigue, still.
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| 69 | 2021-01-29 | headache | sore arm, headache that night, nausea the following day. |
| 69 | 2021-01-29 | fever, headache, fatigue, chills | Mild pain, headache, chills, and abdominal pain. Mild-moderate fever 102.3. Moderate fatigue. |
| 69 | 2021-01-29 | fever, headache | Moderate headache and fever for 12 hours |
| 69 | 2021-01-30 | chills, fever, headache, fatigue |
Chills for about 3 hours, slight fever, then the fever broke. Also had headache, brain fog, some fa...
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Chills for about 3 hours, slight fever, then the fever broke. Also had headache, brain fog, some fatigue. Slept 9 hours and next day felt tired with low appetite but fever, chills were gone. By 48 hours, all symptoms had passed and I felt normal.
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| 69 | 2021-01-30 | headache, body temperature increased |
Had chills all night - from ~ 5pm until 5am on the 30th. @ 5 am om the 30th - I had intermittent p...
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Had chills all night - from ~ 5pm until 5am on the 30th. @ 5 am om the 30th - I had intermittent periods of chills - but much less severe. Also had a temp of 100,2 w/ slight headache. Started taking tylenol about 3 am on the 30th.; then every 6 hours after. Did stay in bed - slept basically until 9am - this date 1/31/21. Although I think this was a "normal" reaction - just thought I should report it - to add to generally data about the vaccine.
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| 69 | 2021-01-30 | headache, chills | Flu symptoms: chills, diarrhea , headache, sore left arm (injection site) |
| 69 | 2021-01-30 | headache |
Adrenal crisis treated with 30mg prednisone, 50mg hydrocortisone x2 6 hours apart, caffeine, Motrin,...
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Adrenal crisis treated with 30mg prednisone, 50mg hydrocortisone x2 6 hours apart, caffeine, Motrin, Zofran, chicken broth for electolytes> Signs included hypotension, nausea, headache, weakness, I am a retired doctor married to an Endocrinologist and living to take care of my 2yo grandson for my daughter who is a resident in PEDS , I and my family are very familiar with managing my illness, which infrequently presents with crisis and I very rarely must be hospitalized .
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| 69 | 2021-01-31 | cough, headache, fever, malaise, fatigue |
feeling ill; headache; fever; tired; a slight cough; Nausea; Just an overall feeling of being sick n...
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feeling ill; headache; fever; tired; a slight cough; Nausea; Just an overall feeling of being sick not feeling well; Pain in my back that radiated between my shoulder blades and down and to my lower back like crossed my kidneys; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248), via an unspecified route of administration at Right arm on 12Jan2021 10:00 at SINGLE DOSE for COVID-19 vaccination. Medical history included diabetic, high blood pressure and possible Atrial fibrillation (AF). Concomitant medications in two weeks included lisinopril, atorvastatin, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient started feeling ill the day after the shot, she had a headache, fever, tired, a slight cough, Nausea, Pain in her back that radiated between her shoulder blades and down and to her lower back like crossed her kidneys. Just an overall feeling of being sick not feeling well. She was questioning whether she may have been exposed to Covid and she was experiencing Covid symptoms. The events started from 13Jan2021 01:00 AM and not recovered at the time of reporting. No treatment received, no covid prior vaccination, no covid tested post vaccination, no known allergies.
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| 69 | 2021-01-31 | influenza like illness, fever |
Got the flu like body aches; Got 100 temperature; Had a sore arm but it was mild; Started hurting a ...
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Got the flu like body aches; Got 100 temperature; Had a sore arm but it was mild; Started hurting a little bit more; This is a spontaneous report from a contactable nurse, the patient. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248; Expiration Date: Apr2021), intramuscular in the right upper arm on 15Jan2021 at 12:30 (at the age of 69-years-old) as a 0.3 ml single dose for COVID-19 immunization. Medical history included atrial septal defect, palpitations, and COVID-19 from Aug2020 to an unknown date. The patient had COVID antibody titers done in Aug2020 and Dec2020 and they were "270." Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), cyanocobalamin (B12-VITAMIIN), estrogens conjugated (PREMARIN), pravastatin (MANUFACTURER UNKNOWN), and escitalopram oxalate (LEXAPRO). On 15Jan2021 after getting the vaccine, the patient had a sore arm but it was mild. Then as the night went on, it started to hurt a little bit more. On 16Jan2021, the patient had flu like body aches, and had a temperature of 100. The patient did not receive any treatment for the events. The clinical outcome of the sore arm that hurt a little bit more was not recovered; while that of the flu like body aches and a temperature of 100, were unknown. The nurse thought the events were related to the vaccination.
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| 69 | 2021-02-01 | fatigue, body temperature increased, chills |
Left arm injection site tenderness from 01/12/2021 through 01/19/2021. Severity on 1-10 scale = 5. R...
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Left arm injection site tenderness from 01/12/2021 through 01/19/2021. Severity on 1-10 scale = 5. Resolved with no intervention. Fatigue from 01/12/2021 through 01/21/2021. Severity on 1-10 scale = 7. Resolved with rest. No residual. Received 2nd dose on 02/01/2021 in right deltoid at 1:22 pm. Temp on day of dosing was 97 degrees - normal for me. 02/02/2021 AM right arm soreness, achy all over, and chilled. By 1 PM temp was 100.1. Took 500 mg of Acetaminophen, fLuis?s and rest
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| 69 | 2021-02-01 | sweating |
This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration in Jan2021 (on Thursday) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller received the first dose of the vaccine on Thursday in Jan2021 and she's felling bad, she couldn't go to work and would like to know what she could do. Had been down ever since. Couldn't get out of bed. Has a temperature. Felt so bad she couldn't go into work today (18Jan2021). Not sure what's going on. Clarified she's referring to the Pfizer COVID-19 Vaccine. Had she known what she knows now she would not have taken it. The patient was hot, sweating, and dizzy. (Facility name) administered the COVID-19 Vaccine. Didn't know if she needs to go get tested. Felt like crap. Felt bad. Hasn't been out of bed in three days. Requested to be transferred. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.
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| 69 | 2021-02-01 | fever, chills |
2:AM on Feb 18 started chills while sleeping. Had hot tea and blankets and it subsided. fever of ...
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2:AM on Feb 18 started chills while sleeping. Had hot tea and blankets and it subsided. fever of 100-101 throughout the day. Sleeping. Pain at injection site . Symptoms lasted about a day and a half. This was the first dose!
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| 69 | 2021-02-01 | fever, chills | Chills x 24 hours, felt feverish, hives onset 01/21/2021 |
| 69 | 2021-02-01 | throat irritation |
Within 15-minutes of vaccination, the patient reported a "scratchy" sensation in their throat. They ...
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Within 15-minutes of vaccination, the patient reported a "scratchy" sensation in their throat. They were monitored on-site by EMS. No documentation provided suggesting allergic reaction that needed treatment.
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| 69 | 2021-02-02 | headache |
Waited 15 min as required. On drive home around 3:15 p.m. developed tingling in lips and tongue no ...
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Waited 15 min as required. On drive home around 3:15 p.m. developed tingling in lips and tongue no swelling, It eventually subsided. At around 8 p.m. back began to itch no rash nor hives and subsided within 15 min. guess. Soreness in arm next morning with slight headache. Soreness at vaccine site all day and night unable to raise arm over head. Wednesday morning Feb. 3 less soreness at site and able to raise arm above head.
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| 69 | 2021-02-02 | fever |
At injection site in right arm, bruising developed, and redness appeared approximately 3 inches belo...
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At injection site in right arm, bruising developed, and redness appeared approximately 3 inches below injection site. It was a large red area about size of a small apple. The raised area was red and warm. Fever 102.9 Nausea Dizziness Bladder control dysfunction - once Persistent headache.
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| 69 | 2021-02-03 | fatigue, headache, fever, chills |
Temperature of 101.5 -- chills - headaches - shoulder & neck pain - muscle pain - fatigue - vomiting...
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Temperature of 101.5 -- chills - headaches - shoulder & neck pain - muscle pain - fatigue - vomiting Feeling better on day 2
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| 69 | 2021-02-03 | headache |
PT complaining of Headache and Dizziness post vaccination. After Evaluation PT states symptoms have...
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PT complaining of Headache and Dizziness post vaccination. After Evaluation PT states symptoms have resolved and refused treatment or transport.
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| 69 | 2021-02-03 | influenza like illness, fever, headache |
dizziness/dizzy; little headache; felt like she had the flu/flu-like symptoms; body aches; low grade...
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dizziness/dizzy; little headache; felt like she had the flu/flu-like symptoms; body aches; low grade fever that never went over 101.4/low grade fever between 99.6 and 100; red rash on her chest and upper abdomen; it was diffuse not pinpoint, wasn't raised/rash was across her chest, breasts, and above her belly button, but not on her back; pain in her right arm which got stronger at the injection site overnight/sore arm; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248, expiry date: Apr2021), via an unspecified route of administration on 15Jan2021 at 12:30 at a single dose on the right arm for COVID-19 immunization. The patient has a medical history of having covid infection in Aug2020 where her symptoms were low grade fever and headaches only. The patient also stated that when she gets a virus, she always gets this kind of rash. The patient is in an ongoing year -long antibody study where they check for antibodies every 3 months. The results of the 1st titre was 270 after her 10-day quarantine period, and in Dec2020, it was still 270. There were no concomitant medications. The patient reported that she had a sore arm on Friday, the day of the vaccination, 15Jan2021. She experienced pain in her right arm which got stronger at the injection site overnight. Then on Saturday 16Jan2021 at 11:00 AM all her symptoms started. She developed a low grade fever that never went over 101.4, a little headache, dizziness, and body aches. She stated that it was weird because she rarely gets sick, but she felt like she had the flu. She is getting a low grade fever between 99.6 and 100, flu-like symptoms and was dizzy. Then on the night of Saturday 16Jan2021, when she went to bed she had a red rash on her chest and upper abdomen; it was diffuse not pinpoint, wasn't raised. The rash was across her chest, breasts, and above her belly button, but not on her back. The patient reported that she still has the rash, and that it has actually gotten worse; it's spread more across her whole chest which is typical. Since when she gets a virus, she always gets this kind of rash; it doesn't itch; it's just kind of there and it's always in the same place whenever she gets it. The outcome of the event 'red rash on her chest and upper abdomen; it was diffuse not pinpoint, wasn't raised/rash was across her chest, breasts, and above her belly button, but not on her back' was not recovered while the outcome of the other events was unknown.
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| 69 | 2021-02-03 | lethargy, headache |
a background headache all day; lethargy; bit of fogginess; This is a spontaneous report from a cons...
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a background headache all day; lethargy; bit of fogginess; This is a spontaneous report from a consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3302), via an unspecified route of administration, in the right arm on 15Jan2021 at 15:30PM (at the age of 69-year-old) as a single dose for COVID-19 immunization. Medical history included just sensitivities, not allergies, to NSAIDS and some pain meds. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medication taken within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that on the first day nothing. On 16Jan2021, the second day (as reported), the patient experienced lethargy and a bit of fogginess. The third day, 17Jan2021, the patient had a background headache all day. The events were reported as non-serious. The patient finally took (acetaminophen) TYLENOL before bed, for the headache, waking on the fourth day feeling normal. The clinical outcome of the events lethargy, bit of fogginess, a background headache all day was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 69 | 2021-02-03 | malaise, chills, headache, influenza like illness, fever, fatigue |
INJECTION SITE PAIN, TIREDNESS, HEADACHE, MUSCLE PAIN, CHILLS, FEVER, INJECTION SITE SWELLING, INJEC...
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INJECTION SITE PAIN, TIREDNESS, HEADACHE, MUSCLE PAIN, CHILLS, FEVER, INJECTION SITE SWELLING, INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL FLU LIKE SYMPTOMS
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| 69 | 2021-02-03 | malaise, fatigue |
Injection site soreness; tiredness; muscle pain; feeling unwell; This is a spontaneous report from a...
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Injection site soreness; tiredness; muscle pain; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 14Jan2021 at 09:00 at a single dose in the hospital for COVID-19 immunization. Medical history included autoimmunity of unknown origin and seafood allergy. The patient is not pregnant at the time of vaccination. Concomitant medication included folic acid, methotrexate, multivitamins (vitamins nos), and fluoxetine hydrochloride (PROZAC). The patient experienced injection site soreness, tiredness, muscle pain, feeling unwell for 30 hours on 14Jan2021 at 12:00. The patient did not receive treatment for the events. Outcome of the events was recovered on 15Jan2021. Information on batch/lot number was requested.
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| 69 | 2021-02-03 | fever, chills | Constipation began early evening; Chills and fever began around 8 p.m. same day as the inoculation. |
| 69 | 2021-02-03 | throat irritation |
The patient was referred by her primary care provider's office to receive COVID-19 vaccination. She ...
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The patient was referred by her primary care provider's office to receive COVID-19 vaccination. She received her first dose of Pfizer-BioNTech COVID-19 vaccine at approximately 15:07 hrs. Due to her history of allergic reactions to multiple medications (including sulfa antibiotics and ceftriaxone), she was advised to extend her monitoring period to at least 30 minutes post-injection. At around 15:50 hrs I was notified that the patient was feeling a tingling sensation in her throat, itching, and a change in her voice. She was transferred to a stretcher for acute management of suspected anaphylaxis. Airway, breathing, circulation, and mentation were assessed immediately. EMS was called immediately via 911. Her vital signs were obtained, with a BP 168/90 mm/Hg, HR 105/min, RR 24/min. She reported shortness of breath at the time. There was no stridor or wheezing on exam. She appeared in mild respiratory distress. At 15:54 hrs she was given an intramuscular EpiPen injection (0.3 mg autoinjector) in her left thigh. At 15:58 she was given an intramuscular methylprednisolone injection (125 mg) in her right thigh. Immediately after that EMS team arrived and took over her care with plans to administer diphenhydramine intramuscularly, and will transfer to ED for further management. Throughout the event the patient remained awake, alert, and fully oriented.
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| 69 | 2021-02-04 | chills, fever | Fever of 103.7, vomiting, diarrhea, myalgia, shaking chills, called 911 |
| 69 | 2021-02-04 | cough, throat irritation |
Pt C/o coughing, SOB,and throat irritation 25 minutes after the vaccine was administered. Also repo...
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Pt C/o coughing, SOB,and throat irritation 25 minutes after the vaccine was administered. Also reported that her throat and neck felt swollen and tongue began to feel "thick".
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| 69 | 2021-02-04 | headache | Today I have muscle and joint pain, a headache and nausea |
| 69 | 2021-02-04 | headache | slight headache, slight, nausea, chilling |
| 69 | 2021-02-06 | headache |
Started within 2 hours of vaccine (8 pm) an extremely sore arm. Then the pain started to radiate to...
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Started within 2 hours of vaccine (8 pm) an extremely sore arm. Then the pain started to radiate to my shoulder. By the next day, it was really painful in my shoulder and across my back almost to my backbone. It was painful to move my arm up or down or to reach for things. This lasted 3 to 4 days. Then my neck on the same side as the shot (left) began to hurt so badly I couldn't move my neck up or down or sideways. It was strange the way the pain slowly moved across by arm to my shoulder to my back and up my neck. I've never experienced anything like this before. Today my pain in my neck is bearable but I have soreness and a headache. I hope I am at the end of the cycle to this event as I am scheduled for my next shot soon.
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| 69 | 2021-02-07 | fatigue, headache, malaise | Arm is very sore and itchy. Headache, fatigue, restless. Just did not feel well. Lasted one day. |
| 69 | 2021-02-07 | fatigue, nasal congestion |
felt like she was having the onset of pneumonia; muscle and body aches; muscle and body aches; ongoi...
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felt like she was having the onset of pneumonia; muscle and body aches; muscle and body aches; ongoing congestion in one nostril/stuffiness; felt tired and run down; feeling itchy/Her head, neck and back are very itchy; rash/like a fever type rash; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3249, unknown expiration), via an unspecified route of administration in the left shoulder area on 16Jan2021 at 11:15 AM at a single dose for COVID-19 immunization. Medical history included COPD (has it for lots of years) and nickel sensitivity. She does not have any reactions to her previous unspecified vaccines but had a normal reaction like sore arm. Concomitant medication included bimatoprost (LUMIGAN). The patient previously received flu vaccine and pneumonia vaccine, both for immunization in 2020 around the end of Sep or beginning of Oct. The patient reported side effects regarding the COVID vaccine and said she was a little confused and unsure if she was having a problem or if she should see a doctor. On 16Jan2021 at 11:15 AM, she had the first dose of the COVID vaccine and afterward she had a lot of effects which were mostly muscle and body aches in Jan2021. She also experienced some ongoing congestion in one nostril but saw this as just more congestion and that she was having to blow her nose more in Jan2021. She did the (app name) report but didn't report the stuffiness. She did report that in the first few days she felt like she was having the onset of pneumonia and felt tired and run down (Jan2021). Two days ago, she started feeling itchy (Jan2021) and she didn't know what it was, she didn't know if she ate something or what. Now she has developed a rash (Jan2021) which is ongoing until now. Her paperwork said the rash would happen right away if it was caused by the vaccine. The patient wanted to know if this is something she should be concerned about and if the rash could appear or started this long after she had the vaccine. Her second dose is due on 06Feb2021. The patient wanted to know if the vaccine contains nickel or any metal substances in it since she had compared her rash to her nickel sensitivity. The patient wanted to know if rash is a side effect from the vaccine and how long it will last. She didn't put rash down for the safety check either as she didn't know if it was caused by the vaccine. Today her rash, she is so itchy. She does have it on her neck and certain areas but not everywhere. It looks like what would happen after a bad fever. It is not raised but is like a fever type rash. She did note that she had an increase dose of a medication eye drops (Lumigan; Lot: T and a 0 or O followed by 544, and NDC: 0023320503. Expiry: Jan2022) around the time the rash started but after getting the vaccine. Her head, neck and back are very itchy. She mentioned that she waited 2 days and did not put this event in the (app name). She would have reported it yesterday, but she didn't get one yesterday. She also noted that it was very dry there and cold and a person is going to get dry skin. She does have an allergic to metal and wondered if that was in the product. In her neck area, it looks just like when she would wear a cheap necklace. No treatments received. The events did not require emergency room or physician office visit. The patient has no prior vaccination within four weeks. The patient had not yet recovered from events rash/like a fever type rash and congestion in one nostril/stuffiness; while unknown outcome for the remaining events.
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| 69 | 2021-02-07 | fatigue, fever, chills |
Fever; chills; fatigue; nauseous; throwing up; Diarrhea; severe stomach pain; stomach pain with swel...
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Fever; chills; fatigue; nauseous; throwing up; Diarrhea; severe stomach pain; stomach pain with swelling and feeling bloated; no appetite; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 69-year-old female patient received first single dose of BNT162B2 (Solution for injection, lot number: EJ 1686, exp date not reported), via an unspecified route of administration (left arm) on 14Jan2021 13:45 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. Medical history included allergies to seafood, latex, and steroids. The patient had COVID prior to vaccination (date/s unknown). The patient had no other relevant history. The patient was not pregnant at time of vaccination and was not pregnant at the time of reporting. Concomitant medications/other medications the patient received within 2 weeks of vaccination included amoxicillin, calcium, cinnamomum verum (CINNAMON), chromium, and multivitamin (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took ephedrine and codeine and experienced allergy to both. On 15Jan2021 13:30, the patient experienced fever, chills, fatigue, nauseous, throwing up, diarrhea, severe stomach pain with swelling and feeling bloated; and no appetite. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The events were considered as non-serious by the reporter. Treatment for the events included ondansetron (ZOFRAN), dexamethasone 0.5 (unit not reported), and doxycycline 20 mg. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events at the time of reporting.
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| 69 | 2021-02-07 | fatigue |
1/28 vaccinated, 1/29 fatigue, 1/30 pt started experiencing right side pain below breast, 2/5/21 pt ...
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1/28 vaccinated, 1/29 fatigue, 1/30 pt started experiencing right side pain below breast, 2/5/21 pt went to PCP and was diagnosed with Shingles.
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| 69 | 2021-02-07 | headache, chills |
headache body chills body aches eye throbbing All symptoms were a milder version of what I experienc...
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headache body chills body aches eye throbbing All symptoms were a milder version of what I experienced when I had Covid -19 in NOvmeber 2020. I also had slight injection site pain that radiated to the left side of my neck
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| 69 | 2021-02-08 | fatigue, fever, chills | Chills/Shaking, 102 fever, swollen lymph nodes under chin, nausea, tiredness |
| 69 | 2021-02-08 | headache |
Lot # EN6201 exp 2/13/2021 Approximately 30 seconds after pt received vaccination pt c/o her neck g...
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Lot # EN6201 exp 2/13/2021 Approximately 30 seconds after pt received vaccination pt c/o her neck glands "locking up." Described it as feeling a knot in her neck glands with pain. Pt states this has happened to her in the past and is unable to determine what causes it to happen. Also c/o mild headache and dizziness. Pt hasn't eaten yet today. Denies any respiratory issues. Episode lasted approximately 10 min then pt denied "tight neck glands" is now feeling fine. Was monitored for additional time in waiting area before going home in no apparent distress. 1028 BP 154/73, HR 86, 97% O2 sats on room air 1037 BP 156/66, HR 80, 97% o2 sats on room air
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| 69 | 2021-02-09 | chills, fatigue, nasopharyngitis, fever |
cold; Fatigue; Chills; Fever; This is a spontaneous report from a contactable consumer (patient) via...
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cold; Fatigue; Chills; Fever; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 69-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL8982) at left arm, via an unspecified route of administration on 21Jan2021 13:30 at single dose for covid-19 immunisation. Medical history was none. Prior vaccinations (within 4 weeks) were none. Family Medical History Relevant to adverse events was none. There were no concomitant medications. The patient experienced chills on 22Jan2021, fever on 22Jan2021, fatigue on 23Jan2021, cold on an unspecified date. The patient received no treatments. The patient had the Pfizer shot last Thursday (21Jan2021) and afterward had chills and fever. Now she was so tired. The events did not require a visit to Emergency Room or Physician Office. The patient's weight was 145-150 lbs. The outcome of events chills and fever was recovered on 23Jan2021; of fatigue was not recovered; of cold was unknown.
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| 69 | 2021-02-09 | fatigue |
Soreness at shot site; fatigue; migraine; This is a spontaneous report from a contactable consumer (...
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Soreness at shot site; fatigue; migraine; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 12Jan2021 at 14:30 at a single dose, for COVID-19 immunization. Relevant medical history included allergies to sulfa drugs. Concomitant medications included escitalopram, alprazolam, paracetamol (TYLENOL), simethicone (GAS X), and vitamin D. The patient previously took aspirin and experienced allergies. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the Facility. On 12Jan2021, at 14:30, the patient experienced soreness at shot site, fatigue, and migraine. The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events was unknown. The patient has not been tested for COVID-19 since vaccination. Information on the lot/batch number has been requested.
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| 69 | 2021-02-09 | headache, fever, chills |
Pain through back across both arms and neck.; A headache that feels like my heads going to explode.;...
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Pain through back across both arms and neck.; A headache that feels like my heads going to explode.; swell up like a balloon; Nauseated; Chills; fever; Pain on both my legs cannot walk; Pain through back across both arms and neck. Cannot lift my arms; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the right arm on 20Jan2021 16:00 at single dose for covid-19 immunization. Medical history included atrial fibrillation from an unknown date and unknown if ongoing , hypersensitivity (Known allergies: Yes) from an unknown date and unknown if ongoing, covid-19 (if covid prior vaccination: Yes) from an unknown date and unknown if ongoing. Concomitant medications included unspecified medications. The patient experienced pain through back across both arms and neck, the patient cannot lift their arms. The patient also experienced pain on both their legs cannot walk, a headache that feels like their heads going to explode, nauseated all the time, swell up like a balloon, chills and fever. It was reported that the events occurred on 21Jan2021. Therapeutic measures were taken as a result of pain through back across both arms and neck. The patient did not recover from the events. Information on the lot/batch number has been requested.
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| 69 | 2021-02-09 | nasopharyngitis, fever, chills, fatigue |
This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A...
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This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (EL8982) via an unspecified route of administration on 21Jan2021 12:30 at single dose in left arm for COVID-19 immunisation. No additional vaccines administered on same date of Pfizer suspect. Medical history included COVID-19 virus from Jun2020 to an unknown date. There were no concomitant medications. The patient reported fever, joint pain and tiredness, experienced fever, cold and chills after the first dose, all on Jan2021. She was asking how long these symptoms usually persist. The patient received COVID shot last Thursday. Had chills, fever, ugly fever blisters, and fatigue. The patient asked how long does the fatigue stay in the system because she is really tired. She was tired since 22Jan2021. She had chills on the night of 22Jan2021. She is done with fever and chills, she is just tired. Had COVID-19 virus in Jun2020. Feel like she has it again. The temperature was 99 degrees, began on night of 22Jan2021. Fever blisters started on 23Jan2021 reported as are subsiding, but still present. She was still really tired. Woke up Saturday and thought she had COVID-19 virus all over again. The events did not require visit to AES, because she was ok. Event outcome of fever blisters was not recovered, while for others was unknown.
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| 69 | 2021-02-09 | productive cough |
right ear began to hurt; eustachian tube inflammation; slight vertigo; metallic taste in mouth; phle...
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right ear began to hurt; eustachian tube inflammation; slight vertigo; metallic taste in mouth; phlegm drainage in throat; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (left arm) on 20Jan2021 (15:00) at single dose for Covid-19 immunization. Medical history included penicillin allergy (Known allergies: penicillin, ciprofloxin, levofloxacin, hylan G-F, lexapro, bacitracin). Concomitant medication included potassium chloride. The patient previously took Ciprofloxin, Levofloxacin, Hylan G-F, Lexapro, and Bacitracin and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 (10:00), the patient began to experience slight vertigo accompanied by metallic taste in mouth and phlegm drainage in throat (reported as "phlym"). When she laid down in bed at right side mainly her vertigo got worse. Late Saturday afternoon (23Jan2021), her right ear began to hurt. She went to urgent care at 7:30 pm. The doctor prescribed vertigo exercises, Flonase nasal spray for possible eustachian tube inflammation and ibuprophin. On Sunday (24Jan2021: today), the patient was still experiencing pretty severe vertigo; not much improved. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient had vertigo exercises, ibuprophin, and Flonase spray as treatment. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination.
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| 69 | 2021-02-10 | chills, headache, fever |
About 12 hours after I had severe chills and fever up to 102.2, muscle pains & very slight headache ...
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About 12 hours after I had severe chills and fever up to 102.2, muscle pains & very slight headache Symptoms lasted 24hours EXCEPT for a feeling in my head that I have had when getting off my antideprssant--sort of fuzzy/shaken feeling. Wondering if it's making my meds for that ineffective.
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| 69 | 2021-02-10 | fatigue, headache, fever |
Recovered from covid-19 December 2020. Mild case with antibodies but all covid tests were negative ...
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Recovered from covid-19 December 2020. Mild case with antibodies but all covid tests were negative After vaccine Arm soreness Fever above 102 Severe body aches Fatigue Headache
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| 69 | 2021-02-10 | headache, fever, fatigue | Slight fever nausea headache fatigue |
| 69 | 2021-02-10 | headache |
Beginning on January 15 and lasting for 18 days, I experienced confusion, extreme migraine-strength ...
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Beginning on January 15 and lasting for 18 days, I experienced confusion, extreme migraine-strength headaches, ripping pain in chest, ribs, upper back, shoulders, neck, head. I could not sit or lie down comfortably. I saw Dr. on February 1 who ordered a CT scan which was clear. He prescribed Prednisone and Robaxin 500 mg. I saw Dr. again on February 4 at which time most of the pain subsided but my body was very sore. It is now February 11 and I still feel a bit of cloudiness, but am much better. Hopefully, I'll feel like myself within a few days.
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| 69 | 2021-02-10 | malaise, dehydration, fatigue, sleepiness, fever, chills, headache |
deyhydration; sick; sinus tachycardia; diarrhea; Fever over 102 degrees Fahrenheit; chills; headache...
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deyhydration; sick; sinus tachycardia; diarrhea; Fever over 102 degrees Fahrenheit; chills; headache; body aches; fatigue; dizziness; Pfizer COVID-19 Vaccine on 12Jan2021 with immunosuppressant mesalamine; Pfizer COVID-19 Vaccine on 12Jan2021 with immunosuppressant mesalamine; will fall asleep through the day for 3-4 hours at a time and she does not even nap usually; Muscle pain; Neck ache; Backache; Problems with walking; problems with balance; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3246), via an unspecified route of administration on the left arm on 12Jan2021 14:30 at a single dose for covid-19 immunization. Vaccine was not administered in a military facility. Medical history included ongoing ulcerative colitis, ongoing high cholesterol, ongoing high blood pressure, celiac disease from 2005 (this has been tested too many times to count and it has been negative since after initial diagnosis 2005), arthritis (all her life) ongoing, hip replacement surgeries first done in 2005; repair of same hip in 2015; other hip in 2017. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccines include Pneumonia Vaccine, Shingles Vaccine and Flu vaccines; all on an unspecified date for immunization. She never had adverse events with those. Ongoing concomitant medications included rosuvastatin (5 mg tablet) for high cholesterol, mesalamine (400 mg capsule) for ulcerative colitis and lisinopril from 2018 for high blood pressure. According to the patient, she knows that mesalamine is an immunosuppressant and anti-inflammatory to keep inflammation in the colon down. This consumer was administered her first dose of Pfizer COVID-19 Vaccine on 12Jan2021 14:30 with immunosuppressant mesalamine. The night of 14Jan2021 patient had headache, chills, body aches, diarrhea, fatigue, fever and dizziness like Covid 19 symptoms. She went to the ER during the past 11 days for IV fluids due to deyhydration from the diarrhea. Today, 25Jan2021 is the first day she has been out of the house, except to go to the ER, since she received her 1st vaccine dose. On Jan2021 muscle pain, neck ache, backache, problems with balance and problems with walking. Events probably started with intense diarrhea starting 14Jan2021; then Fever over 102 degrees Fahrenheit and chills 14Jan2021; Specific onset dates and onset times unknown otherwise other than between 14Jan2021 and 16Jan2021 onset dates. It was a rolling week of agony after that with one adverse event after another until she ended up in the emergency room on 16Jan2021 because she was so dehydrated and was really sick. She was not admitted to the hospital related to any of these events; but while in the emergency room she was given intravenous fluids; a chest x-ray; blood work; after maybe 5-6 hours she was sent home; she was also given a COVID test which was negative; and then 2 days later took another COVID test which was also negative. Both COVID tests were Rapid Tests: on 16Jan2021 and 18Jan2021. On the Chest xray they suggested she had some sinus tachycardia which is just a rapid heartbeat and not surprising; nothing else showed up on Chest x-ray; as far as anything else testing/results wise there was only some facetious blood work which they just said to follow-up with her PCP regarding but nothing really out of the ordinary. She can finally out of bed on a regular basis for a couple of hours daily; she is still very fatigued; she has no muscle pain, neck aches or body aches at this time; she does not have the strength she should have; is no longer experiencing headaches or fever; but is extremely tired. She will fall asleep through the day for 3-4 hours at a time and she does not even nap usually (Jan2021). She has not driven yet but assumes probably once she is a little stronger she will be able to drive again. She did not have upper respiratory, chest or cough issues. The outcome of the events fever, headache, body ache, muscle pain, neck ache was recovered on Jan2021; fatigue was not recovered. The outcome for the other events was unknown.
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| 69 | 2021-02-10 | nasopharyngitis, runny nose, fever, chills |
Tested positive for COVID; Tested positive for COVID; Lost taste and smell; Lost taste and smell; co...
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Tested positive for COVID; Tested positive for COVID; Lost taste and smell; Lost taste and smell; cold like symptoms; Fever; chills; nausea; vomiting; felt cold; runny nose; This is a spontaneous report from a contactable consumer (patient). This 69-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via intramuscularly at left arm on 07Jan2021 at single dose for prevention. Medical history included allergic to Penicillin, quite a bit of discomfort with two shingles shots, exposed to COVID-19. Concomitant medications were none. The patient experienced cold like symptoms, Fever, chills, nausea, vomiting, felt cold, runny nose, all on 17Jan2021 10:00; lost taste and smell on 21Jan2021; tested positive for COVID on 22Jan2021 10:20. The patient received the first inoculation 07Jan2021, she had symptoms. The patient was tested for COVID on 22Jan2021 and both tested positive. The patient was scheduled to have their second dose on 28Jan2021, and she wanted to know if she should get it or not. She did not feel it was a result of the vaccination. She felt it was because she got exposed to COVID-19. Her symptoms were more severe on that one day. She felt like she was getting a cold that day. She was a compassionate care giver for her mother and wanted to get tested before they went to see her in a facility. She was surprised when she got a positive result. She still had a cough, runny nose and cold like symptoms. Her loss of taste and smell started about 4-5 days ago. Outcome of the event tested positive for COVID was unknown, of the event Lost taste and smell was not recovered, of other events was recovering.
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| 69 | 2021-02-10 | sleepiness |
Within a few seconds I felt very sleepy, my face became numb which began spreading to my mouth. Ment...
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Within a few seconds I felt very sleepy, my face became numb which began spreading to my mouth. Mentally spaced-out, weak and unable to drive my car even a few yards. Requested ambulance and was taken to emergency room. EMT administered Intravenous Benadryl. In hospital Pepcid was administered immediately. The numbness eventually spread throughout my body and I felt twitching/trembling, particularly my mouth and jaw. My feet felt like they were being pulled away from my body. After testing was complete, Solu-Medrol was administered and all symptoms disappeared immediately.
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| 69 | 2021-02-11 | chills, headache, throat irritation |
Patient experienced dizziness and a burning sensation in chest and throat within minutes of this inj...
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Patient experienced dizziness and a burning sensation in chest and throat within minutes of this injection, that initially resolved only to reoccur later that afternoon in conjunction with chills, body aches, headache. Patient was feeling so bad with confusion and dizziness the next morning such that she was unable to get out of bed and had call in sick to work. Patient symptoms continued for the next week and she was unable to return until 19 January (but still symptomatic and short of breath on exertion). Patient was tested for COVID-19 infection on 19 January which was negative. Patient then followed up with her primary care doctor the following and retested for COVID-19 (also negative again). Primary care provider performed basic labs without revealing any abnormalities. Patient does not feel back to normal at this time - she continues to have intermittent chills and the headaches only stopped in the past 7 days.
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| 69 | 2021-02-11 | fatigue |
approx 24 hrs after 2nd dose vaccine-- extreme pain, entire legs (both), felt very heavy and like ha...
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approx 24 hrs after 2nd dose vaccine-- extreme pain, entire legs (both), felt very heavy and like hamstrings were "pulled" and shins and ankles in pain as well. In addition, overall body fatigue, feeling exhausted. All symptoms continued for approx 36 hours, gradually ending after 48 hours
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| 69 | 2021-02-11 | headache |
Patient sitting in chair, alert and oriented x 3, skin color was ashen. Patient felt strange over he...
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Patient sitting in chair, alert and oriented x 3, skin color was ashen. Patient felt strange over her chest, light headed, patient said she feels like she was going to pass out immediately after vaccine administration. VS 100/60 mmHg, pulse 64, RR 22. Patient complaints of headache, nausea and skin clamy and warm. Site manager made aware, o2 @ 2 L via nasal cannula administered. EMS transport to hospital. Daughter was made aware via VM, unable to reach 3x attempts.
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| 69 | 2021-02-14 | body temperature increased |
5:30pm: hands and feet felt very cold. Mild chills began. 6:10pm: temp was 98.3F Bundled up on the c...
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5:30pm: hands and feet felt very cold. Mild chills began. 6:10pm: temp was 98.3F Bundled up on the couch - socks, boots, leggings, sweatshirt, 2 blankets - and napped. 9:00pm; finally felt warm. Back and shoulder muscles were very sore. Temp had risen to 100.3F. Took 400mg ibuprofen and went to bed. Awoke the next morning feeling great. No residual effects.
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| 69 | 2021-02-14 | chills, headache |
Slight fever, chills, headache, body ache, general weakness; no treatment needed; duration of sympt...
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Slight fever, chills, headache, body ache, general weakness; no treatment needed; duration of symptoms was about 36 hours; I had covid19 about 100 days earlier than the date of the administration of this first covid vaccination
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| 69 | 2021-02-14 | fatigue |
The evening of Feb 4th she started feeling tired. Feb 7th still tired, started feeling anxious, hear...
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The evening of Feb 4th she started feeling tired. Feb 7th still tired, started feeling anxious, heart was beating harder and faster, stomach felt upset, she was burping a lot Feb 8th went to primary care doctor. BP was 175/90. She felt dizzy and lightheaded, ringing in ears was louder than usual She gave another BP med to take, but she didn't take it. Instead took an extra of hr own propranolol. Yesterday was the first day the sxs were better. Other than taking the extra propranolol on Feb 8th, she just rested 2/11/21 is the first day the tiredness has let up
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| 69 | 2021-02-14 | fatigue |
Triggered an Auto immune flair up response I get with Sjogrens syndrome..Generalize muscle and joint...
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Triggered an Auto immune flair up response I get with Sjogrens syndrome..Generalize muscle and joint pain, Extremely dry eyes, mouth. Fatigue. Dizziness. Diarrhea. from 1/29/2021 to 1/31/3021
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| 69 | 2021-02-14 | fever, sluggishness | Sluggish quizzing weakness slight temp |
| 69 | 2021-02-15 | chills, fatigue, headache, body temperature increased, fever |
Fatigue, chills, headache, temperature (100.5), loss of appetite, restless sleep, swollen arm at in...
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Fatigue, chills, headache, temperature (100.5), loss of appetite, restless sleep, swollen arm at injection site, red injection site that is about 4? long, itching injection site. Injection site still red, swollen and itching. Taking Tylenol and using topical Benadryl for itching. Appetite returned on 2nd day. Fever, fatigue and chills lasted 1 day.
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| 69 | 2021-02-15 | chills, headache, runny nose |
HEADACHE, NAUSEA, JOINT INFLAMMATION, EXCESSIVE NASAL MUCOUS DRAINAGE, DISORIENTATION, DIZZINESS, HY...
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HEADACHE, NAUSEA, JOINT INFLAMMATION, EXCESSIVE NASAL MUCOUS DRAINAGE, DISORIENTATION, DIZZINESS, HYPERSENSITIVITY TO LIGHT AND NOISE, LACK OF URINATION, BOUTS OF DIARREAH, CHILLS WITH SKIN ICE COLD TO TOUCH, FREEZING FEET, UNABLE TO DRINK LIQUIDS; COULD NOT EAT FOR 3 DAYS; NO FEVER
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| 69 | 2021-02-15 | chills, fever |
2/14/21: 10:30pm - 1:00am chills 2/15/21: 3:00am fever, 102.5 2/15/21: 7:30am and 12:45pm fever, 99....
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2/14/21: 10:30pm - 1:00am chills 2/15/21: 3:00am fever, 102.5 2/15/21: 7:30am and 12:45pm fever, 99.8
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| 69 | 2021-02-15 | fatigue, headache, fever |
Developed fever, fatigue, extreme joint pain, HA, ear ache, tachycardia, SOB. Had Covid 11/4, and t...
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Developed fever, fatigue, extreme joint pain, HA, ear ache, tachycardia, SOB. Had Covid 11/4, and these are all symptoms that she had when she had Covid. Continues with HA, ear ache, joint pain, fatigue and SOB today. MD has not responded yet.
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| 69 | 2021-02-15 | fatigue |
2 days after injection, left side neck, throat area had gland swelling and pain. Extremely tired ...
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2 days after injection, left side neck, throat area had gland swelling and pain. Extremely tired that night. I had an appointment with Dr. that afternoon on an unrelated issue but mentioned these symptoms to him. He suggested taking Zyrtec, along with Tylenol or similar OTC and prescribed an antibiotic. I still have symptoms 4 days later.
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| 69 | 2021-02-15 | throat pain, runny nose |
On 1/24/21, 5 days after vaccine started getting sore throat and runny nose, 3 days after symptoms s...
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On 1/24/21, 5 days after vaccine started getting sore throat and runny nose, 3 days after symptoms started loss of smell and taste.
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| 69 | 2021-02-16 | fatigue |
Took 1st shot and got anxious; a lot of fatigue; felt something in her chest area/chest feeling funn...
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Took 1st shot and got anxious; a lot of fatigue; felt something in her chest area/chest feeling funny; Head spinning; Weakness; nerve pain; stomach nausea; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiry date: unknown), via an unspecified route of administration, in the right arm, on 16Jan2021 14:15 at a single dose for covid-19 immunization. Medical history included left-sided breast cancer from 2005 and lymph nodes removed on her left side. Concomitant medications included pravastatin and a lot of vitamins. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccine administered on same date of the Pfizer suspect. It was reported that the patient took first shot and got anxious on 16Jan2021. The patient also experienced a lot of fatigue on 16Jan2021, went home and got worse then was hospitalized. The patient had a virtual visit with her doctor and wanted some advice, and her doctor didn't give her any prescriptions. The patient also felt something in her chest area on 16Jan2021, after receiving the COVID-19 vaccine. Events anxious and fatigue required emergency room visit. The patient was hospitalized from 25Jan2021 to 27Jan2021 for the events anxious and fatigue. The patient also experienced head spinning, chest feeling funny, weakness and stomach nausea on unspecified date in Jan2021. Reported she was given all kinds of medicine in the hospital. She said as long as she was laying down, she was good. She said once she got up, and moved around, she felt the weakness again. She said she was put on depression medicine (Jan2021) while in the hospital, and was given 4 different prescriptions at discharge. She said the only thing that helps her go to sleep at night is a 1/2 tablet of generic alprazolam for anxiety. She said she knows she can't stay on the generic alprazolam forever, clarifying that is why the doctor put her on the depression medicine. Reported she was given the following medications in the hospital, as well as, prescriptions to continue the medications at home after her hospital discharge: escitalopram 10mg for depression. She said she is to take one escitalopram 10mg every evening for 30 days. She said she was given escitalopram 10mg for the two days she was in the hospital. Generic gabapentin 100mg for nerve pain (Jan2021) and she is to take 1 capsule nightly for 30 days. She said she started the gabapentin 100mg while she was in the hospital. Pantoprazole 40mg, she was given a one-time small IV bag of pantoprazole 40mg for her stomach while she was in the hospital (clarified she was given on 27Jan2021 at 05:26). She said she was having some stomach nausea (Jan2021), and the pantoprazole 40mg was to protect her stomach. She said she told the doctor she didn't want to take the pantoprazole 40mg any longer because she thought she was being given too many different medicines. Reported her fatigue is not the same as it was when she went to the hospital, but the fatigue is still there. Reported her lab work (Jan2021) was good, and her test results were fine when she was in the hospital. She said she was told she was 30% from being on the verge of having heart disease. She said her doctor told her the heart disease was preventable if she eats right, and makes some other changes. She said her cholesterol has gone done. She said she just has the fatigue, and that was why she was put on medicine. Therapeutic measures were taken as a result of the event anxious, fatigue, nerve pain and stomach nausea. Outcome of the event fatigue was recovering while it was unknown for all the other events.
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| 69 | 2021-02-16 | headache, malaise |
69 yo female reports AE after receipt of Covid vaccine #1 (EN 5318 13 FEB 21) via drive thru event. ...
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69 yo female reports AE after receipt of Covid vaccine #1 (EN 5318 13 FEB 21) via drive thru event. She reports within minutes she felt unwell but had difficulty being more specific. She states she felt a warmth in her chest which traveled to her stomach. A few minutes later she felt SOB, and could not catch her breath. She states her respiratory rate increased. She talked to staff and was told if got worse to honk horn or use flashers. She did not request additional assessment. She waited her required 15 minutes and drove home another 20-25 minutes. She states she noted her face swelling. She thinks she may have had some throat swelling, but then wasn't sure. She developed some nausea, but no emesis which continued for 2-3 days. She denied watery or red eyes, runny nose, pruritis, rash, palpitations, heart racing, chest pain, cough wheezing. She states the breathing symptoms resolved in a few hours. She was unsure of the facial swelling resolution time frame. She developed a headache and felt malaise for 2-3 days, then symptoms resolved. She never took any medications other than her prescriptions. She did not seek care during symptom time frame.
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| 69 | 2021-02-17 | headache |
Sore arm; neck pain; radiated to shoulder; radiated to back toward backbone, then up back; headache;...
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Sore arm; neck pain; radiated to shoulder; radiated to back toward backbone, then up back; headache; This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL9263 and expiry date unknown) on 26Jan2021 18:00 at single does via an unspecified route of administration into her left arm for COVID-19 immunization. Medical history included Lupus, Lyme disease, hypothyroid, Meniere's, and sulfa allergies. The patient had not had COVID prior the vaccination, COVID not tested post the vaccination. Concomitant medication included levothyroxine (LEVOTHYROXINE), acyclovir (ACYCLOVIR), ezetimibe (EZETIMIBE), hydroxychloroquine (HYDROXYCHLOROQUINE). No other vaccine received in four weeks. The patient experienced adverse events from 20:00 on 26Jan2021. She experienced sore arm, radiated to shoulder, then to back toward backbone, then up back and side of neck. It's very painful. On 07Feb2021 ("today"), her neck pain was better but she had a headache. These events took place ongoing for several days after and since she had the vaccine. It was reported that the events resulted in Disability or permanent damage. The patient did not receive treatment for the events. The outcome of the events was provided as recovering.
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| 69 | 2021-02-18 | fatigue | heavy fatigue, achy |
| 69 | 2021-02-21 | chills, fever | Chills, body aches, fever, sore arm |
| 69 | 2021-02-21 | fatigue |
After my vaccine, I had problems breathing for about 5-10 minutes. My symptoms were different this ...
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After my vaccine, I had problems breathing for about 5-10 minutes. My symptoms were different this past two weeks. I experienced nausea, dizziness, felt like my brain was on fire. Last week I could not comprehend what people were saying, I did not understand. Extreme irritation, anxiety, depression. Fatigue and tiredness, my legs are weak. My blood pressure went skyrocketed: 169/80.
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| 69 | 2021-02-21 | fatigue |
Patient received first dose of Pfizer Covid vaccine at 13:00 at vaccination clinic on 2/21/2021. Pa...
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Patient received first dose of Pfizer Covid vaccine at 13:00 at vaccination clinic on 2/21/2021. Patient began to complain about feeling tired and wanted to take a nap later in the afternoon. Patient's husband found patient at 16:30 almost unresponsive and checked a BG reading which resulted at 25. Husband gave patient oral forms of sugar and transported to ER where he BG slowly normalized. Husband reports patient has been a well controlled diabetic and has never has an incident like this happen previously.
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| 69 | 2021-02-21 | headache, chills, fever |
chills; fever; body aches; headache; vomiting; This is a spontaneous report from a contactable consu...
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chills; fever; body aches; headache; vomiting; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a sngle dose for covid-19 immunization. Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. She mentioned that she received the vaccine on Sunday (unknown date) and reported that for the last 4 days she had been pretty sick with fever, chills, headache and body aches. She had been alternating acetaminophen (TYLENOL) and ibuprofen (ADVIL). She did have COVID in Nov2020. The patient inquired if the symptoms after dose 2 would be worse if she's had COVID in the past. She also inquired if she will have the same symptoms for the second dose and if how long side effects will last. She add that she did have some vomiting on Sunday later after she got the vaccine. She was wondering because she is to get the second dose on the 21st, the pharmacist did say that sometimes people who have had the Covid virus already can sometimes experience strong side effects from the vaccine. She does not want to feel or get sick. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 69 | 2021-02-21 | headache | During sleep time kept waking up and feeling like I was going to vomit. Headache. |
| 69 | 2021-02-21 | headache |
A few hours after getting the vaccine, my arm became sore. It got worse as the night went on. It was...
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A few hours after getting the vaccine, my arm became sore. It got worse as the night went on. It was extremely achy. It was still happening as of Saturday, I also felt lightheaded. I felt like a was on a merry-go-round, it felt like it kept getting faster and faster. I felt dizzy all day Saturday. I had to rest all day. I lost my appetite. Anytime I got up to go to the bathroom, I had to hold something to walk. I also had a mild headache. I felt better on Sunday. My arm was still a little sore as of yesterday but it is better today.
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| 69 | 2021-02-21 | fever, headache | Fever of 102 degrees, headache lasting for 12 hours. Tylenol taken. |
| 69 | 2021-02-22 | chills, fever, sweating, headache |
sore arm - started about 24 hrs later and lasted about 2 days severe headache - started about 24 hr...
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sore arm - started about 24 hrs later and lasted about 2 days severe headache - started about 24 hrs later and persists still chills and sweating - started about 36 hours later and persists still stomach ache and diarrhea - started the 15th, worsened over days and still persists fever - although I felt like I had a fever i did not record a fever until the 21st-22nd--it was 100.2
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| 69 | 2021-02-22 | fatigue, headache | Fatigue, headache, diarrhea |
| 69 | 2021-02-22 | fever, fatigue | Sore arm, slight fever (100.6), fatigue, slight intestinal distress |
| 69 | 2021-02-23 | chills, fever, fatigue | Over 2 days had severe joint and muscle aches in knees and back. Fatigue. Slight fever and chills. |
| 69 | 2021-02-23 | chills |
Lightheaded or dizzy; Dry heaves; Very warm; Charley horses in both legs; Chills; This is a spontane...
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Lightheaded or dizzy; Dry heaves; Very warm; Charley horses in both legs; Chills; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302), via an unspecified route of administration in right arm, on 26Jan2021 at 13:15 (01:15 PM), at a single dose, for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease (COPD). The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a doctor's office or urgent care facility. On 26Jan2021 (reported as 12:15 AM; pending clarification), the patient woke up lightheaded or dizzy, with dry heaves, very warm, and with Charley (reported as Charlie) horses in both legs, then she got the chills. This morning (27Jan2021), the patient felt fine. No treatment was administered for the adverse events. The patient was not tested for COVID-19 post vaccination. The patient recovered from the events on 27Jan2021.
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| 69 | 2021-02-23 | headache, chills, fever |
Chills; Fever of 100.2; Headache; Muscle ache; This is a spontaneous report from a contactable consu...
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Chills; Fever of 100.2; Headache; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 13:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 26Mar2020, she tested positive for Covid. In the beginning of May2020, she went to get tested for antibodies, she did have them, that she received a report, number was 8.2 and knows that at 1.4 she would be considered to have antibodies so they told her it was good that her number was high, she asked them what it meant and they told her they did not know. Patient had chills, fever of 100.2, bad headache, and muscle aches on 20Jan2021. She took Tylenol to treat her symptoms and they went away, and states they would come back as Tylenol wore off. Her symptoms have completely resolved however she does not have the exact date. Outcome of the events was recovered on Jan2021. Information about lot/batch number has been requested.
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| 69 | 2021-02-23 | headache, lethargy |
Got dizzy and nauseous not long after the shot. The next day had a one sided headache which lasted 1...
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Got dizzy and nauseous not long after the shot. The next day had a one sided headache which lasted 1 1/2 days. Very lethargic which I understand is normal. I was concerned about the one sided headache. Was on the left side of my head. The shot was in left arm. Have not idea if that would make a difference.
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| 69 | 2021-02-23 | headache |
Patient experienced vertigo within 15 minutes of administration of COVID 19 shot. Her blood pressur...
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Patient experienced vertigo within 15 minutes of administration of COVID 19 shot. Her blood pressure was 97/73. Five minutes later it was 123/83 and a third reading approximately 15 minutes after the original was 120/81. The patient slowly felt better and was able to walk to find her companion. She had a headache and decided to go home and forgo grocery shopping. The next day she came in person to report experiencing tinnitus and mild headache still. I sat with patient until she felt good enough to walk and then walked with her per her request to help her find her friend. After about an hour of slowly getting better, but not good enough to follow through with her grocery shopping plans. She decided to go home with her friend and rest and come back tomorrow to grocery shop and report back with any further symptoms. She was feeling better enough to grocery shop and she was reminded to please fill out form for reporting purposes.
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| 69 | 2021-02-23 | headache |
I previously reported a severe headache following the vaccine, similar to but worse than the headach...
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I previously reported a severe headache following the vaccine, similar to but worse than the headache I experienced when I had Covid-19 in March of 2020. I reported that the headache had resolved. However, the headache recurred upon awakening on Tuesday, 02/23/2021 and slowly resolved over several hours and again today, 02/24/2021 I awoke with the headache again. The headache is almost gone but lingers.
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| 69 | 2021-02-23 | sweating, chills, headache | Violent chills Headache Profuse Sweating Nausea Diarrhea Light-headedness Weakness |
| 69 | 2021-02-23 | sweating |
The itching was located just below the injection site at a spot where the skin was a little red; The...
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The itching was located just below the injection site at a spot where the skin was a little red; The itching was located just below the injection site at a spot where the skin was a little red; terrible itching in her left arm; out of balance, her balance was messed up; nervous; Sweaty; Feeling hot; felt like her heart was racing fast; felt dizzy/terrible lightheadedness; Feeling anxious; trouble sleeping; sharp pain in her muscle; This is a spontaneous report from a Pfizer-sponsored program. A contactable other health care professional reported that a 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot EL9263) via an unspecified route of administration at arm left on 24Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included drug allergies, IV contrast reaction. The concomitant medication was not reported. It was reported patient got the Pfizer COVID 19 vaccine Sunday 24Jan2021 at 13: 00PM in the left arm. She was scheduled for the second dose of the vaccine 16Feb2021. she got the vaccine and was perfectly fine; she started the wait time of 45 minutes and about 10 minutes into it she got really hot and felt like her heart was racing fast; felt dizzy on 24Jan2021. A nurse practitioner and a doctor came over and sat with her; she got some water and she was okay. They thought it was anxiety related to coming into a crowd, but for the next 36 hours she continued to feel anxious and on edge; she felt like she had too much caffeine. That night she had trouble sleeping; she had sharp pain in her muscles on 24Jan2021, it would be in one of her thighs then the other one. This was about 12 hours after the vaccine. States she took some tylenol and it did help. Adds she just continued to feel anxious and she was sweaty. States she has never has anything like this before. Today she felt perfectly fine; all of her symptoms had resolved. Then today, when she was driving to a routine GYN exam and she experienced a terrible itching on her left arm on 24Jan2021. It was sudden and startled her. The itching was located just below the injection site at a spot where the skin was a little red, feathery red, just below the injection site. Now the itching has stopped but it is still red. she couldn't hardly feel it being injected, she doesn't usually have reactions to vaccines, she never had anything, but she has a few drug allergies, and she was separated out, she was flagged to wait 45 minutes after, instead of the 15. She does have an IV contrast reaction, and some other things, nothing she knew was in the vaccine, she was fine and wasn't worried that she was aware of. She thinks she got too hot, she had on a coat, she was sitting and panning through stuff, reading on her phone, and all of a sudden she had terrible lightheadedness, she never fainted in her life, she is pretty sturdy, she didn't know what to think, she was lightheaded, and it was not vertigo, not like the room was flying, but she was like out of balance, her balance was messed up, and she sat there a minute, she was too hot, she got out of her coat, and it got worse, she could feel her heart racing, and she was talking to herself, she thinks she nervous, she could feel her heart pounding, and was instructed to raise her hand if she had issues, so she raised her hand, a nurse practitioner came over, she raised her hand, and the doctor making rounds came over and he said take off your mask off, she did, that helped somewhat, it was that blasted mask, she couldn't get enough air, he gave her water, she thinks she got too hot and perhaps got nervous and didn't think she was she said she's not been around people, and was suddenly in a huge crowd, everyone was appropriately distanced, it was an extreme presentation, after 5-6 minutes, she was good, it went away, but for 36 hours she didn't feel right, she could feel sometimes her balance wasn't right, she was just not herself, she could do her usual, she lives on a farm, she did usual farm stuff, but was not herself, and in the night, she woke several times, her heart was beating too fast, too much, but she went back to sleep, and she told her son, she said it felt like she had had 4-5 cups of really strong coffee. So the next day she was ok. Absolutely her normal, and then she didn't think anything about it, and was driving to a routine GYN exam, which was canceled last moment due to an emergency, she was driving and suddenly her arm started itching, this was Tuesday, so 48 hours after, not the site, it was distal, underneath it, maybe 2-3 inches under injection site. The site did nothing, she looked that night, no redness, lump, no raised area, no warmth, nothing, but then she had itching, intense itching like poison ivy, and she scratched and thought wait a minute, at her appointment she looked at her arm, this area was 3-4inches under the site, that was red, feathery looking and flat, macular, not raised, no induration, no warmth, no lump, no pain, it was feathery dusty red and the next day it was gone, she did nothing to it, she thought to put hydrocortisone, and looked at it, but it was so faint and wasn't itching. The seriousness was reported as non-serious. The outcome of the events was Feeling hot was recovered on 24Jan2021; Heart rate increased; felt dizzy; Muscle pain; Sweaty was recovered on 25Jan2021; Feeling anxious was recovered on 26Jan2021; Vaccination site rash; Vaccination site erythema recovered in 2021. Vaccination site pruritus was recovering; Difficulty sleeping; Loss of balance, Nervous was unknown.
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| 69 | 2021-02-23 | throat irritation |
Patient arrived to ED with itchy throat, facial swelling and erythema and tachycardia. Patient was g...
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Patient arrived to ED with itchy throat, facial swelling and erythema and tachycardia. Patient was given Benadryl and Pepcid (dose and route unknown), and sent home with a prescription for Methyprednisolone 4 mg dose pack and Ventolin for home use. Patient reports reactions to other medications in the past, having an extensive allergy list.
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| 69 | 2021-02-24 | headache, fatigue |
Racing heart for about 8 hours Diarrhea for 3 days Fatigue for 5 days Headache for 5 days Nausea for...
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Racing heart for about 8 hours Diarrhea for 3 days Fatigue for 5 days Headache for 5 days Nausea for 3 days Muscle pain for 2 days Joint pain (right knee swollen and painful) for 2 days UTI started 4 days after vaccine
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| 69 | 2021-02-24 | throat pain, pneumonia |
Within 20-minutes of vaccination, the patient reported pain in their throat, SOB, tingling in their ...
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Within 20-minutes of vaccination, the patient reported pain in their throat, SOB, tingling in their arms, and chest pressure. EMS evaluated patient on-site. Patient was hypertensive (184/96). 12-lead EKG was NSR, rate of 79 bpm, no ST elevation. FSBG was 137 mg/dL. ETCO2 was 40mmHg with normal square waveform. EMS initiated transport to Hospital Emergency Department. En route, patient became more hypertensive (200/106). In ED, she remained hypertensive and was admitted to inpatient telemetry unit. Patient had 1-night stay to rule out cardiac-related events. Anaphylaxis was ruled out. Discharged with diagnosis of vaccine reaction and chest tightness.
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| 69 | 2021-02-25 | chills, fatigue, headache |
Started with headache and tired, then chills, then left breast itchy, then arm and armpit became sor...
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Started with headache and tired, then chills, then left breast itchy, then arm and armpit became sore, body aches and backache all night. I took Bismuth 525mg at 9am, acetaminophen 1000mg at 11am, felt better for a few hours, took acetaminophen 500mg at 6pm.
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| 69 | 2021-02-25 | chills, fatigue, fever, headache |
After booster: Chills, Fever, severe headache, severe body aches, foggy thinking, unable to walk, sl...
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After booster: Chills, Fever, severe headache, severe body aches, foggy thinking, unable to walk, slept all day, very weak, couldn?t remember what happen rest of day after booster (2-24) or then next day during sever reaction.(2-25) Day of shot arm hurt for several hours then went away. Day 3 still listless, tired, headache, foggy.
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| 69 | 2021-02-25 | chills, malaise, headache, fatigue |
Beginning @ 8 hours following second dose, full range of side effects began, preventing any sleep th...
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Beginning @ 8 hours following second dose, full range of side effects began, preventing any sleep that night, and continuing throughout the entire next day and night (02/24/2021), finally subsiding over the course of the next day (02/25/2021). Side effects included: Injection Site Pain; Tiredness; (raging) Headache; Muscle pain; Chills; Joint pain; What felt like fever (in between shuddering chills) - not evident in temperature; Nausea (non-productive); Feeling unwell; (tender) Lymph nodes. Debilitating and confusing. Glad to have received the vaccine in any case (small price to pay).
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| 69 | 2021-02-25 | fatigue |
Woke up in middle of night with body aches, especially in my legs. Kept me awake for hours. I was ...
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Woke up in middle of night with body aches, especially in my legs. Kept me awake for hours. I was exhausted the next day. Aches and exhaustion subsided over 48 hours. After 2nd injection I experienced the same but milder reaction on the tenth day after the injection. However, I have been tired for a longer period of time. About 3 days.
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| 69 | 2021-02-25 | sweating, malaise, chills |
Awaken at 7 a.m. feeling sick and had to get to bathroom, sweating profusely, vomited, feeling very...
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Awaken at 7 a.m. feeling sick and had to get to bathroom, sweating profusely, vomited, feeling very faint, extreme diarrhea, lasyed almost 2 hrs before being able to get up and shower off and go to bed, chills for 2 days and extremely weak. Afraid to get the 2nd shot!
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| 69 | 2021-02-25 | fever, fatigue, chills |
Developed fever of 101 degrees, shaking chills, joint and muscle pain, extreme fatigue, lack of appe...
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Developed fever of 101 degrees, shaking chills, joint and muscle pain, extreme fatigue, lack of appetite, which persisted for about 24 hours. Low grade fever present Day 2 after vaccine administered.
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| 69 | 2021-02-25 | throat irritation |
After receipt of the Covid-19 vaccination, patient developed a scratchy throat and some tightness. D...
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After receipt of the Covid-19 vaccination, patient developed a scratchy throat and some tightness. Diphenhydramine 25 mg/mL and methylprednisolone 125 mg/2mL injections were administered and patient was observed for resolution of symptoms
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| 69 | 2021-02-26 | fatigue, fever |
02/25/2021 Pfizer-BioNTech COVID-19 Vaccine EUA 02/26/2021 Mild soreness at site of injection 1 da...
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02/25/2021 Pfizer-BioNTech COVID-19 Vaccine EUA 02/26/2021 Mild soreness at site of injection 1 day after first shot; soreness only on that day - no longer sore 02/27/2021 Fever 100.2 degrees F and fatigue 2 days after first shot; took (2) 325mg of Tylenol gel caps and rested/slept
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| 69 | 2021-02-26 | headache, fatigue | ACHY ARM; JOINT PAIN; HEADACHE; FATIGUE; DIARRHEA |
| 69 | 2021-02-26 | headache | headache next day only one day |
| 69 | 2021-02-26 | fever, fatigue, chills, headache |
Chills, fever, body aches, nausea, headache, mind fogginess, light headed, tired, sleepy ( 36 hours)...
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Chills, fever, body aches, nausea, headache, mind fogginess, light headed, tired, sleepy ( 36 hours) Body aches, nausea, fogginess, light headed, tiredness (2 weeks)
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| 69 | 2021-02-27 | chills, fever, fatigue | Soar arm, fatigue, low grade fever, chills |
| 69 | 2021-02-27 | malaise, fatigue |
On the 14th day post vaccine 2 my right arm was sore near area of injection site. Rest of my arm wa...
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On the 14th day post vaccine 2 my right arm was sore near area of injection site. Rest of my arm was fine. I also felt tired and general malaise. Within 12 hours and after taking 2 Alleve tablets I felt much better
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| 69 | 2021-02-27 | malaise |
MY heart rate increased to 88 when my normal is 55 and my blood pressure went to 246/120 within the ...
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MY heart rate increased to 88 when my normal is 55 and my blood pressure went to 246/120 within the first five minutes. I felt totally incapacitated, nauseous, lightheaded, "wiped out", generally drugged and ill. This lasted for about 45 minutes and then subsided. For the rest of the day I had periods off and on of feeling exhausted and tired.
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| 69 | 2021-02-27 | nasal congestion |
Within 10 seconds I began to feel that something was wrong. A full body response of a swirling con...
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Within 10 seconds I began to feel that something was wrong. A full body response of a swirling congestion, extreme weakness. very blurry vision and couldn't think straight. I had trouble walking to recovery room, felt nauseous and weak and had a very fast heartrate. I had to stay in private recovery room for 45 min. I was still very ill and nervous at this point. I left with a family member and asked to be driven to the nearby hospital emergency room. For a precaution . We parked across from ER entrance for another 1 hour till I slowly regained strength to 50% normalcy. I went home afterwards and had to go to bed. I was unable to drive my own vehicle home. Day 2, still feel weak, shaky and not normal. I consider this a serious adverse reaction that did not receive medical intervention but will prevent me from getting the second Pfizer shot. After 5 hours post injection I felt 60% normal . Day 2, 70 per cent normal. The vaccination facility was not able to do blood pressure monitoring ( which is a problem for anyone experiencing reactions.) They said their protocol was to call 911/ambulance. My blood pressure was checked by a certified PA with professional equipment at the 3 hour post injection time and the diastolic pressure was still below 50. And heart rate above normal. Still weak and nauseous.
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| 69 | 2021-02-27 | throat irritation, cough | Coughing, feels like throat is getting tighter, itchy throat, evaluated by EMS-refused transport |
| 69 | 2021-02-28 | chills, sinus headache, headache |
Day1- headache in nasal sinus area and between eyes, Day 2- muscle aches, joint pain, dizziness, nau...
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Day1- headache in nasal sinus area and between eyes, Day 2- muscle aches, joint pain, dizziness, nausea, lack of appetite. That evening, awoke out of sleep at 3 am with extreme abdominal pain, walked to bathroom and almost passed out, had to lay on the floor for 15 minutes.. After a half our it happened again. No diarrrhea but had 2 soft formed stools (very unusual for me). A lot of nausea, weakness and abdominal pain. Chills for 2 days.
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| 69 | 2021-02-28 | fatigue |
At time of vaccine on , had a fishy/metal taste in her mouth, which lasted till bedtime. First day,...
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At time of vaccine on , had a fishy/metal taste in her mouth, which lasted till bedtime. First day, arm was sore, not red or swollen. Next few days had severe fatigue, muscle pain, swollen lymph nodes in neck. Next day, 2/13after vaccine when woke up, had a white coated tongue which lasted one day. That evening, her tongue swelled up which lasted about a week. Pt saw doctor at medical center on Feb 15. He advised you to take Tylenol and 2 benedryl day of vaccine and he wrote her a script for an EPI pen for after the vaccine and to use as needed.
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| 69 | 2021-02-28 | headache, chills, fever |
Initial onset Nausea, headache progressing to fever, chills, severe pain throughout the body at a...
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Initial onset Nausea, headache progressing to fever, chills, severe pain throughout the body at approximately 3:am, lasting approx 30 hrs. Still experiencing moderate headache
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| 69 | 2021-02-28 | headache, fatigue, sweating, malaise |
muscle spasms; wasn't feeling well; she stumbled again, and fell against her car; too tired; cry; pa...
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muscle spasms; wasn't feeling well; she stumbled again, and fell against her car; too tired; cry; patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine; patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine; headaches/The headache is above her ear and the pain is "past 10"; She recalled experiencing "swelling around her eyes" and "had some swelling" after the 1st dose of the Pfizer-Biontech COVID19 vaccine/left eye swelling; had some swelling; Dizziness/Lightheadedness; Vomiting; Blurry vision; She said the left arm pain started immediately after receiving the COVID-19; Injection site swelling; she is sweating something fierce under her arms; peeing on herself (running to bathroom more); lady asked her to call her when she got home, and she forgot, saying her mind wasn't there; acid reflux taste in mouth/she tasted the COVID-19 Vaccine shot when it was administered; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982; expiration date: unknown) at the age vaccination of 69-year-old via an unspecified route of administration in the upper left arm on 19Jan2021 08:00 (also reported as 11Dec2020) at a single dose for covid-19 immunization. Medical history included was hit by a truck a GM and the truck busted her legs up, ongoing RSD (Reflex Sympathetic Dystrophy) pain since 1991 and was prescribed with oxycodone/acetaminophen (PERCOCET), rheumatoid arthritis from 1991 to an unknown date, spinal cord implant is in her spine, and goes from her spine to her waist, and from her waist to both legs, and down to her ankles from 1991 to an unknown date and migraine when she was 12 or 13 years old. There were no concomitant medications. She received the vaccine in a hospital. The patient previously had a flu shot for immunization but was allergic to the flu shot. It was reported that a patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine on 19Jan2021 08:00. On 19Jan2021, the patient reported that she said she had a slight headache, left eye swelling, dizziness, vomiting, blurry eyes, sweating up under her arms, and peeing on herself (running to bathroom more) after receiving the COVID-19 Vaccine. It was reported that the patient had injection site swelling on 19Jan2021. She said she has never had any side effects like what she is experiencing now after getting the COVID-19 Vaccine. She reported that her mild headache turned severe over the weekend, and she had to wrap a towel around the back of her head, so she could lay down. She said the headache pain was a sharp pain at the bottom of the back of her head and neck. She clarified she had migraines when she was 12 or 13 years old, but the headache pain she had now is nothing like the migraines she had then. She further clarified that her severe headache feels like a knife in the back of her head and neck. She said the pain is more severe on the right side of her head than the left. She said right now she has pressure in the front of her head with a slight headache. She additionally clarified that the swelling in her left eye comes and goes and is persisting. She said her left eye didn't swell close, but her granddaughter told her it looks like something is wrong with her left eye. She added that she had dizziness this morning when she was going to work. She said she stumbled when she was walking this morning but drove to work anyway. She said when she got to work, she wasn't feeling well on an unspecified date, so she decided to go back home. She said when she was walking to her car, she stumbled again, and fell against her car. She reported when she first got the COVID-19 Vaccine (19Jan2021), she was driving in a bad way. She said after she got her COVID-19 Vaccine, she picked up an elderly lady she sits with, and the elderly lady told her she wasn't normal. She said the elderly lady told her she was too relaxed while she was driving, like she was in a daze. She said the elderly lady said she was scared for her and herself when she was driving. She said the elderly lady asked her to call her when she got home, and she forgot, saying her mind wasn't there. She mentioned that she had to wait 15 minutes after receiving her COVID-19 Vaccine (19Jan2021), and when she was driving home, she had to pull over and get out of her car to vomit. She said she had an acid reflux taste in mouth before she threw up. She said she threw up a little bit last night when she had a severe headache. Clarified her eyes are constantly blurry now. She said she has to put her glasses on to see but has to turn her head sideways in order to see anything past her blurriness. She said her burry eyes are worse at night. She stated that she was sweating something fierce under her arms, she said she has to take 3 showers a day now to get rid of the sweating and smell under her arms. She said she has never sweated like that before. She reported her left arm is sore too. She said the left arm pain started immediately after receiving the COVID-19 Vaccine (19Jan2021). She said she has swelling too, and has been rubbing her left arm with alcohol, but the left arm soreness is still there. She reported that she tasted the COVID-19 Vaccine shot when it was administered. She has blown off calling her doctor when she first experienced her side effects, but then her headache got worse. She said she so spoke to doctor 30 minutes before calling Pfizer. She said she told her doctor if her headache comes back, she is going to the emergency room when she gets off work after tonight. She stated that she has been experiencing headaches/muscle spasms that have been getting worse. She says they last 15-20 minutes and then it stops. The headache is above her ear and the pain is "past 10". Yesterday night (unspecified date), the headache was so severe that she wanted to go to the ER but was too tired. The patient reported that she was taking ibuprofen (ADVIL) for her slight headache. She said she took the Advil for a couple days and nights, and her headache eased up some with the Advil. She reported that 2 days ago she bought aspirin, caffeine, acetaminophen (EXCEDRIN MIGRAINE). She also reported that she started taking Ibuprofen when her headaches became severe. She said the Ibuprofen eased the headache, but the headache comes back. Reported she took pain medicine prescribed from a doctor way back, and the prescription pain medication doesn't ease her headache pain. She clarified that the medication was dispensed in a pharmacy was oxycodone, acetaminophen (PERCOCET). She called her doctor when she returned home from work this morning, and her doctor told her to call Pfizer to report her side effects. She reported when she went to work this morning, she got lightheaded. She took Percocet and other medications, but it hasn't relieved it. She says it's not a migraine. She recalled experiencing "swelling around her eyes" and "had some swelling" after the first dose of the Pfizer-Biontech COVID19 vaccine on 19Jan2021. She reported on 02Feb2021 that she was calling back today to report that her headaches were worse. She said her headaches are not a migraine, but more like a muscle spasm in the right side of her head, above her ear. She said the pain is between her neck and ear on the right side of her head. She said the headache pain feels like it is as big as a golf ball. She said her headache pain is so severe, the headache pain wakes her up in a cry. She said the headache pain lasts 15-20 minutes, and then eases up slightly. She said the headaches have been happening twice at night, and twice during the daytime. She said the headache pain doesn't last long. She mentioned that she has been doing self-remedies. She said she ate a spoonful of mustard to ease the headache, and the spoonful of mustard did ease her headache. The patient inquired if she should get the second COVID-19 Vaccine if she is continuing to experience headaches after receiving the first COVID-19 Vaccine. The outcome of the events headache, eye swelling, blurry vision, frequency urinary were not recovered, as for the events dizziness, vomiting, vaccination site pain and vaccination site swelling were recovering, while the outcome of the other events was unknown.
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| 69 | 2021-02-28 | headache |
temp 100.4 HR 105 pulse ox 96 severe upper arm pain (both arms) Hallucinations !! se...
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temp 100.4 HR 105 pulse ox 96 severe upper arm pain (both arms) Hallucinations !! severe Headache neuropathy SEVERE Hands were like frozen
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| 69 | 2021-03-01 | chills |
Injection site pain; tiredness; muscle pain; chills; swollen lymph nodes. Symptoms started three hou...
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Injection site pain; tiredness; muscle pain; chills; swollen lymph nodes. Symptoms started three hours after injection and lasted a day and a half, except swollen lymph nodes and injection site pain that lasted a couple of days longer. Patient took acetaminophen and symptoms resolved without further treatment.
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| 69 | 2021-03-01 | cough, chills, headache, fatigue |
1st shot = only tender at injection site but remains tender. 2nd shot = 1 hr after injection: feelin...
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1st shot = only tender at injection site but remains tender. 2nd shot = 1 hr after injection: feelings of fatigue, soreness at injection site with swelling, slight throbbing in back of head/neck, later in PM ate late lunch Big Mac meal around 3:00 but not hungry though had no breakfast, aching in knee and hips began to become constant with movement. Slept a couple of hours and began to feel chilled to bone rest of evening, headache continued, thirst and frequent urination (1 1l2 hr apart), had stopped all medication to allow shot to work. Friday late evening early Saturday Am chill became violent in shakes used blankets/plastic sheets/socks to get warm. Slept in 2 hrs increments all night. Saturday sipped fluids
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| 69 | 2021-03-01 | dehydration |
she got the shot on 1/31/2021. Over the next 3 days she developed poor oral intake and diarrhea ev...
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she got the shot on 1/31/2021. Over the next 3 days she developed poor oral intake and diarrhea every 15 minutes; required hospitalization on 2/3/2021. Was hospitalized at Hospital. Hospital course was complicated by sepsis, pressors, intubation, GI bleed with ruptured rectum requiring surgery (ostomy). anticipated discharge 3/3/2021.
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| 69 | 2021-03-01 | headache |
Woke up (6a) with head ache, body aches, loss of appetite, fuzzy thinking, raised hard area at injec...
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Woke up (6a) with head ache, body aches, loss of appetite, fuzzy thinking, raised hard area at injection site - 5in long, 3in wide - slept most of day. Symptoms mostly gone by 3/2 7am, with exception of raised area at injection site and mild fuzzy thinking. Took two tylenol for headache 6p
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| 69 | 2021-03-02 | chills, headache |
shaking; chills; headache; diarrhea; overall body aches; This is a spontaneous report from a contact...
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shaking; chills; headache; diarrhea; overall body aches; This is a spontaneous report from a contactable pharmacist. A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 vaccination. Medical history included she was previously positive for Covid in Oct2020 to an unspecified date and she received monoclonal antibody treatment (Remdesivir) 3 months prior to her first dose of the vaccine; patient had COPD, oxygen dependent and diabetes from 2016 to an unknown date; and obesity in 2014 to an unknown date. There were no concomitant medications which was reported as patient had not had any other recent vaccinations or started any new medications. Patient received monoclonal antibody treatment 3 months prior to her first dose of the vaccine. Patient probably tested positive and was treated probably the same day she had the positive test (in Oct2020), reporter was sure all of this happened at the hospital, but he doesn't have that information, and the COVID test type was unknown. Reporter's question was related to information about this specific type of patient, having received the monoclonal antibody treatment on 12Oct2020, to an unknown date, which was Remdesivir and also having had COVID then, then having reactions to the dose, would the second dose be necessary, effective, or safe to give to this patient. The patient had her first dose of the Pfizer Covid vaccine 3 weeks ago (estimated as 27Jan2021 by standing order and not prescribed). The patient had general same symptoms listed for side effects of the vaccine that were more severe than others. The patient experienced effects after the first dose of the vaccine as shaking and chills for two days, and headache, diarrhea, and overall body aches (Jan2021). Reporter wanted to know of any studies or research on patients who have been positive for Covid 19 prior to getting the vaccine and treated with monoclonal antibodies and if they do have similar titers to those who have been vaccinated. The reporting pharmacist that the events were serious, and he thought these were medically significant. The patient's symptoms resolved after 72 hours, and reporter did not believe that they did any treatment other than to sleep. The events recovered on an unspecified date in 2021. Information about Lot/ Batch number requested; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events tremor, chills, headache, diarrhoea and pain cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 69 | 2021-03-02 | chills, nasal congestion, headache |
Stuffy nose; Chills; Strong heartbeat; Severe diarrhea; Headache; This is a spontaneous report from ...
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Stuffy nose; Chills; Strong heartbeat; Severe diarrhea; Headache; This is a spontaneous report from a contactable consumer. The consumer reported for herself that the 69-years-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Lot number: EL9262) via an unspecified route of administration on 17Feb2021 13:00 on Left arm at single dose for covid-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing. Concomitant medication included simvastatin, ropinirol [ropinirole] (ROPINIROL [ROPINIROLE]), vitamin d3 (VITAMIN D3). The patient previously took first dose of bnt162b2 (COVID 19 Pfizer Bio Tech) on 27Jan2021 01:15 PM on Left arm for covid-19 immunisation, montelukast and experienced drug hypersensitivity. The patient experienced stuffy nose, chills, strong heartbeat, severe diarrhea, headache all on 18Feb2021 01:15AM with outcome of recovered. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. The event was assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 69 | 2021-03-02 | fatigue, headache, chills, malaise |
she was sick for about 8 hours; Throwing up; Unable to keep anything down; Headache; Chills; Ringing...
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she was sick for about 8 hours; Throwing up; Unable to keep anything down; Headache; Chills; Ringing in the ears; Hot flashes; Blood pressure went up; Was so dizzy if she moved her eyes she would nearly pass out; Was so dizzy if she moved her eyes she would nearly pass out; Very weak and tired; Very weak and tired; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL3247; expiration date: unknown) at vaccination age of 69-year-old via an unspecified route of administration left arm on 28Jan2021 10:00 at a single dose for To keep from getting COVID (covid-19 immunization). The patient medical history was none. The patient's concomitant medications were not reported. The patient stated that she got the first vaccine the other day and within 12 hours (28Jan2021 22:00), she was not feeling well. At 8:30 the next morning (29Jan2021), she was sick for about 8 hours. She was throwing up, had a headache, chills, ringing in the ears, hot flashes, her blood pressure went up, she was unable to get anything down, not even medication [pending clarification]. She was so dizzy if she moved her eyes, she would nearly pass out. She could not move out of the chair for about 6-8 hours. The dizziness was severe and awful. She added only one ear is ringing really bad, the right ear. It is off and on and persisting. Her very weak and tired which was persistent. One hour it may be bad and the next she will be drained. The patient inquired if it is true since she heard the second dose is worse. She also wants to know if she should get the second dose or not. The received treatment for the adverse events was reported as none [pending clarification]. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement) was reported that her blood pressure went up and recovered on 29Jan2021, and weight was 175-180 pounds on an unspecified date. The outcome of the event feeling unwell was unknown, as for the events weakness, tiredness and ringing in ears were not recovered, while the outcome of the other events was recovered on 29Jan2021. Information about Lot/Batch number has been requested.
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| 69 | 2021-03-02 | fatigue, headache |
Headache on only the left side of the head - treated with Advil 200 mg 4X daily. Lasted 11 days and...
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Headache on only the left side of the head - treated with Advil 200 mg 4X daily. Lasted 11 days and was worse late in the day. Fatigue and weakness for 48 hours.
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| 69 | 2021-03-02 | fatigue |
tired; very sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 69-y...
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tired; very sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809; expiry date: unknown) via an unspecified route of administration in the left arm, on 11Feb2021 at 14:30 at a single dose, for COVID 19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Facility where vaccine was administered was reported as "other". On 12Feb2021, the patient had a very sore arm. The patient was tired the next day (13Feb2021). The patient did not receive treatment for the events. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination. No follow-up attempts are possible. No further information is expected.
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| 69 | 2021-03-02 | fatigue |
became almost non-responsive/nearly totally nonresponsive; her blood sugar went down to 25; she was ...
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became almost non-responsive/nearly totally nonresponsive; her blood sugar went down to 25; she was tired; This is a spontaneous report from a contactable consumer. A 69-year-old female patient (reporter's wife) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EN5318) on 12Feb2021 on right arm at a single dose for COVID-19 immunisation. Medical history included diabetes diagnosed about 30 years prior. Concomitant medications were none. Patient got the 1st dose of bnt162b2 and 4 hours after getting it, her blood sugar went down to 25 (12Feb2021) and she became almost non-responsive. She took a lot of carbohydrates after the shot before she plummeted. Reporter asked if there had been any reports of this and should she take the 2nd shot. Reporter said that he is reporting the side effect of that approximately 4 hours after receiving the shot, which his wife is diabetic, she was tired and then her sugar dropped to 25 before he realized she had an issue. He says she was nearly totally nonresponsive (12Feb2021). He said this was very abnormal and her sugar has never been that low. He said after he realized her sugar dropped to 25, he got some ice cream into her and then some (brand name withheld), then he got her blood sugar which the next reading was 47, then the third reading was mid 90s, so then he took her to the emergency room and they ran tests. He says by then her blood sugar was 250-280, which they thought was good after it had been that low. He says that they did blood tests and did not find anything abnormal, and her blood sugar has been good since then. He said she was not admitted to the hospital, and they went home that night. He said that this had never occurred before, period. Reporter said that everything seems to be normal at this point, though it scared them. He said his wife has not gotten the second dose yet, and they have questioned if she should take the second dose since this happened, and he was wondering if Pfizer may have advice to provide them on getting the second dose for her. The outcome of events was recovered on an unspecified date.
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| 69 | 2021-03-02 | fatigue |
Extreme fatigue for 3 days Itching all over body Soreness in right arm where the vaccine was recei...
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Extreme fatigue for 3 days Itching all over body Soreness in right arm where the vaccine was received Treatment: cortisone cream and tylenol 2 days after vaccine Outcome: Improved and better on 4th day
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| 69 | 2021-03-02 | headache |
At 2:00am, I had severe pain on the right side of my head...very severe headache, face pain, ear pai...
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At 2:00am, I had severe pain on the right side of my head...very severe headache, face pain, ear pain, jaw pain that included my teeth being very sensitive. Tylenol helped ease the pain. It lasted 13 hours. The following night, I had the same exact pains on the left side of my head that lasted 12 hours. For 2 days after, I had a few twinges of pain on the left side of face, mostly below the ear, didn't last more than a couple minutes.
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| 69 | 2021-03-02 | headache |
I had a headache and my eyes hurt. The back of my eyes were very painful/pressure. this occurred for...
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I had a headache and my eyes hurt. The back of my eyes were very painful/pressure. this occurred for several days. It got less severe as time went on. My eyes continue to be tired and I have a slight headache. there is no change in vision that I am aware. I am concerned about receiving the second COVID vaccine.
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| 69 | 2021-03-02 | headache |
sore arm. Cannot raise above my head; Sore arm; numbness and tingling of lips and tongue; numbness a...
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sore arm. Cannot raise above my head; Sore arm; numbness and tingling of lips and tongue; numbness and tingling of lips and tongue; Back began to itch; Slight headache; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN5318) via an unspecified route of administration on the left arm on 01Feb2021 14:30 at a single dose for COVID-19 immunization. Medical history included high blood pressure, high cholesterol, IBS, indigestion, heart burn, colon polys removed, Morton neuroma, torn meniscus left and right, total hyst with bilat oophorectomy and tonsils removed, Shellfish allergy and many medication allergies. Concomitant medication included metoprolol, hydrochlorothiazide, colecalciferol (VIT D3), zinc and pyridoxine hydrochloride (B6). The patient previously took epipen for shellfish allergy. Sat in waiting area 15 minutes as directed. After leaving in car about 10 min. Into ride home she experienced numbness and tingling of lips and tongue on 01Feb2021 15:00. Eventually subsided by 5 pm. Back began to itch, no rash nor hives subsided in about 10 min. Sore arm started about 17:00. Slight headache during night and sore arm continued esp. to lay on left arm impossible. At 8:18 a.m. still sore arm. Cannot raise above my head. No swelling in arm at injection site. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events numbness and tingling of lips and tongue and Back began to itch was recovered on 01Feb2021 while outcome of the other events was not recovered.
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| 69 | 2021-03-02 | headache |
eczema flare up, skin red, her left anterior chest was burning and itchy, skin pain; headache; on ea...
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eczema flare up, skin red, her left anterior chest was burning and itchy, skin pain; headache; on early Friday evening she ended up with joint pain that was so bad, she thought she was going to die. She said her wrist, elbows, fingers, hips, knees, every joint down to her ankles, hurt; This is a spontaneous report from a contactable nurse (patient; retired nurse) via a Pfizer-sponsored program. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6201), via an unspecified route of administration in the right deltoid on 10Feb2021 at 12:35 PM (at age of 69 years old) at a single dose for COVID-19 immunization. The vaccine was administered to the patient at a convention center. The patient's medical history included eczema from 24Dec2018 and ongoing, rosacea (developed Rosacea at 65 years old), and the patient also reported that she used to be 5'4" and she lost 2 inches. She said she had a bone density test recently and was told she is 5'2". She said she objected to the measurement of 5'2", so the nurse told her to stand as tall as she can, and then the nurse noted her height as 5'2-1/2". There were no concomitant medications. There were no additional vaccines administered on same date of BNT162B2. The patient had no prior vaccinations within 4 weeks. On 12Feb2021, the patient experienced eczema flare up, skin red, her left anterior chest was burning and itchy, headache, skin pain, and "joint pain that was so bad, she thought she was going to die. She said her wrist, elbows. fingers, hips, knees, every joint down to her ankles, hurt". The patient said she received her first COVID-19 Vaccine on 10Feb2021. She said everything was fine after she received her COVID-19 Vaccine. She didn't even have a mark on her arm where she received the COVID-19 Vaccine. The patient reported that she got the first dose of the COVID-19 vaccine on 10Feb2021 and is due to the second dose on 03Mar2021. Approximately 2 and half days later she got an eczema flare that was quite severe out of the blue since she was having eczema diagnosed since she was 67 (as reported; she is 69 today). She still has some itching and burning and she wondered if this was something that has been reported also for other psoriasis/eczema patients. She was concerned about taking the second dose since she thinks this may be caused by the vaccine as she stated that nothing has changed in her life aside the vaccination. The patient reported she takes tacrolimus for the treatment of her eczema. Also she said that she had some joint pain for a couple of days. She said 2-1/2 days later (Friday, 12Feb2021), out of the blue, she had an eczema flare up. She said she was diagnosed with eczema at 67 years old. She said Friday night (12Feb2021) into Saturday (13Feb2021) her left anterior chest was burning and itchy. She clarified her skin was really red and angry looking, and painful. She said she has not had any pain with her eczema in a long time. She said she took topical ointments and medication for the eczema flare up. She said she was surprised at the intensity of her eczema flare up. She clarified her initial diagnosis for eczema was on her left anterior chest and bra strap area, and arms. She said she has never had eczema on her face or any other part of her body. She said she was totally asymptomatic prior to getting her first COVID-19 Vaccine. She said on early Friday evening (12Feb2021) she ended up with joint pain that was so bad, she thought she was going to die. She said her wrist, elbows, fingers, hips, knees, every joint down to her ankles, hurt. She said she had a headache. She said by Sunday (14Feb2021) her joint pain and headache were gone. She said her symptoms went away so quickly. The patient asked if people reported a flare up with psoriasis or eczema after getting the COVID-19 Vaccine and if should she have any concerns about getting the second COVID-19 Vaccine shot on 03Mar2021. The patient her eczema treatment included a combination of oral and topical medications. She clarified she used more of the prescription topical lotion than the over-the-counter oral medications. She received Famotidine 10mg (clarified as Pepcid AC; NDC Number: 11673-031-65, Lot Number: OFE2821, Expiration Date: Feb2022). Her doctor told her she could take up to 20mg of Famotidine if her symptoms were bad. She said on Friday (12Feb2021) and Saturday (13Feb2021) she took 20mg of the Famotidine until she felt her symptoms were under control. The patient also received cetirizine 10 mg (reported as generic Zyrtec; NDC Number: 11673-502-87, Lot Number: 8ME2877A, Expiration Date: Sep2022). The patient reported that she took 20mg of the generic Zyrtec for the itching. She said her doctor told her she can take up to 20mg of the generic Zyrtec, if needed for itching. She said otherwise, she would normally take 10mg generic Zyrtec, as needed. The patient also received Tacrolimus Ointment 0.1% (Protopic Ointment; NDC Number: 0168-0416-30, Lot Number: JZ8459, Expiration Date: Apr2021), applied to affected areas twice a day and Triamcinolone Acetonide Cream, 0.1% (she stated she refers to it as "TAC" Cream; NDC Number: 67877-251-80, Lot Number: Y064, Expiration Date: Oct2022). The patient reported that she uses the "TAC" Cream under her breasts where her bra sits because the "TAC" Cream is less expensive than the Tacrolimus Ointment 0.1%. She said she uses the "TAC" Cream as needed, and the "TAC" Cream keeps her skin hydrated. She said she used the Protopic Ointment (Tacrolimus Ointment 0.1%) on Friday (12Feb2021), and then switched to the "TAC" Cream. The patient has had no itching or pain since early Monday (15Feb2021). Her joint pain and headache treatment included Advil Liquid Gel 200mg (UPC Number: 305730169080, Lot Number: 56264, Expiration Date: Jun2023). She said she took a couple Advil Liquid Gels on Friday (12Feb2021). The patient reported that she switched from Tylenol to Motrin because the Motrin worked well. She clarified she meant Ibuprofen when she said Motrin. She said she calls everything Motrin when she is referring to Ibuprofen. She said she took Tylenol occasionally and never felt the Tylenol worked. She said she hasn't taken Tylenol in a long time. She said Tylenol didn't work as well as the NSAIDs. She did not have the Tylenol NDC, Lot, and Expiration Date. The patient reported that she takes Bufferin Brand Aspirin normally for pain. She said she sees someone who treats her holistically, and that person recommended the Bufferin Aspirin because it was not as damaging to the body. She said since the Bufferin Aspirin takes longer to work, she took the Advil Liquid Gel for faster pain relief. No further details provided. The events eczema flare up, skin burning sensation, skin red, skin pain, joint pain, and headache were reported as serious - medically significant. The patient reported that she felt her symptoms were medically significant because her eczema flare up was so different from what she has ever experienced before. She said nothing had changed in her routine, and she has been in control of her eczema. She said she has had only very minor eczema flare ups. The events did not require a visit to emergency room and to physician office. The outcome of the events eczema flare up and skin red was recovering. The outcome of the events headache and joint pain was recovered on 14Feb2021. The outcome of the events skin burning sensation, skin pain, and itchy skin was recovered on 15Feb2021. The events eczema flare up, skin burning sensation, itchy skin, skin red, skin pain, joint pain, and headache were assessed by the (patient) as related to BNT162B2.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 69 | 2021-03-03 | chills, headache, fever |
The morning of 3/2 around 4AM - abdominal cramps with nausea (vomited once), achiness, headache, fe...
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The morning of 3/2 around 4AM - abdominal cramps with nausea (vomited once), achiness, headache, fever (100.4) and chills. Felt better by the end of the day. Much better the next day.
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| 69 | 2021-03-03 | chills, fever, malaise |
Muscle pain, joint pain, chills, fever, and pain at the injection site. overall feeling unwell. a li...
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Muscle pain, joint pain, chills, fever, and pain at the injection site. overall feeling unwell. a little swollen at the injection site.
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| 69 | 2021-03-03 | fatigue |
Patient had arm and leg weakness, fatigue, confusion, nausea, body aches that lasted about 48 hours ...
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Patient had arm and leg weakness, fatigue, confusion, nausea, body aches that lasted about 48 hours and are improving.
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| 69 | 2021-03-03 | headache, chills |
Had my first vaccine shot on Thursday 2 day later on Saturday evening. I started getting a headach...
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Had my first vaccine shot on Thursday 2 day later on Saturday evening. I started getting a headache within an hour very achy body, headache and chills, did not seem to have a fever. continued all day Sunday. Monday body felt better weak and still had a headache. kinda felt a heavy feeling in my lungs.
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| 69 | 2021-03-03 | headache |
She said she has a run of pain that pops up here, and there, and everywhere/pain going down her body...
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She said she has a run of pain that pops up here, and there, and everywhere/pain going down her body; Headache; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264; expiry date: unknown) intramuscular in the left arm, on 01Feb2021 between 16:00-16:30, at a single dose, for COVID-19 immunization. Medical History included Right-sided Breast Cancer over 30 years ago. No lymph nodes were involved, so she didn't need chemotherapy or radiation. She had breast reconstruction and right mastectomy performed. She also had 2 hip replacements. Other medical history included nerve disorder and car accident. She has had bad nerves since she was 18 years old. She said she hasn't worked in over 30-something years because she worked so much to raise her kids by herself and send them to college. She said her psychiatrist and a doctor told her she had to stop working. She walks 5 miles every day and has no underlying conditions. Concomitant medications included an unspecified nighttime medication for her nerves and pain medication because she was in a car accident. The patient previously received first dose of BNT162B2 (Lot Number: EK9231) in the left arm, on 11Jan2021 for COVID-19 immunization. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient did not have previous immunization with a Pfizer vaccine. No additional vaccines administered on same date of the Pfizer suspect. The vaccine was administered in a Field. The patient reported that she got her second Pfizer COVID-19 Vaccine dose on 01Feb2021. After she got the second COVID-19 vaccine shot she was okay for a while, then she had a little injection site pain immediately after receiving the COVID-19 vaccine injection. She said the injection site pain was gone, clarifying if she mashes the injection site, the injection site doesn't hurt. She was only able to have shots on her left arm because she had a right mastectomy, so she can't have anything on her right side. On 02Feb2021, the big boom hit, and it has been all day. She has been breathing well and has no temperature. On the same day (02Feb2021) the patient experienced run of pain that pops up here, and there, and everywhere. She had a headache, as well. She was concerned if should take anything for the pain. She does not want to do what is not right. She wanted to do things the way that Pfizer has suggested. She put heat around face, neck, and arms, but now the pain was going down her body. She has been microwaving rice in a bag and using the heated bagged rice to apply heat to her face, neck and arms. She had a physical recently with unknown results, but she had no recent blood work. The events did not require emergency or physician visit. Outcome of the event injection site pain was recovered on 02Feb2021, while for the other events was not recovered.
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| 69 | 2021-03-03 | fever |
chest pain, subjective fever 9 days after vaccine; 10 days after hospital admit Dx with pericarditis...
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chest pain, subjective fever 9 days after vaccine; 10 days after hospital admit Dx with pericarditis + 8mm pericardial effusion
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| 69 | 2021-03-03 | throat irritation |
Shortly following injection, the patient complained of chest tightness, itchy throat, and mild eryth...
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Shortly following injection, the patient complained of chest tightness, itchy throat, and mild erythema of the skin with pruritus. Serial vital signs were monitored for almost 2 hours and were stable. She was in no acute distress. 8 mg of dexamethasone was administered with improvement of her symptoms.
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| 69 | 2021-03-04 | chills, malaise | Pfizer-BioNTech Covid-19 Vaccine Chills for 6 hours Nausea Feeling unwell |
| 69 | 2021-03-04 | chills, fever, headache | Headache, fever, chills, body aches, sore glands under left arm. |
| 69 | 2021-03-04 | fatigue |
Woke up the following day (1/29/2021) with extreme vertigo. I have a history of vertigo, last episod...
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Woke up the following day (1/29/2021) with extreme vertigo. I have a history of vertigo, last episode 4 or 5 years ago. This episode lasted 5 hours; Exhaustion and slept for 4 hours; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EZ9264), via an unspecified route of administration on right arm on 28Jan2021 at 15:45 at the age of 69 year old at a single dose for COVID-19 immunisation at the hospital. Medical history included coronary artery disease, vertigo (I have a history of vertigo, last episode 4 or 5 years ago). Allergies to medications, food, or other products was dilantin, streptokinase. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Concomitant medications were not reported. The patient previously took dilantin, streptokinase and experienced allergies. It was reported that patient woke up the following day (29Jan2021, 09:00 AM) with extreme vertigo. This episode lasted 5 hours. Following that, about an hour after she arose, she had exhaustion and slept for 4 hours. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the event vertigo aggravated on 29Jan2021 14:00 and recovered from exhaustion on an unspecified date in Jan2021.
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| 69 | 2021-03-04 | headache, fatigue |
Jittery a few minutes after the injection that went away Tiredness that lasted about 3 days Cold for...
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Jittery a few minutes after the injection that went away Tiredness that lasted about 3 days Cold for about 4 days but no fever Headaches that were nagging for about 4 days Diarrhea the first that did not last long Nausea that lasted for about 2 eqyw
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| 69 | 2021-03-04 | lethargy |
Increasingly short of breath, lethargic. O2 sat dropped to 75%. Placed on 10 liter oxygen. BP 150/70...
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Increasingly short of breath, lethargic. O2 sat dropped to 75%. Placed on 10 liter oxygen. BP 150/70 (pulse 74). BP 126/97. BS 292. Sent to the ED.
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| 69 | 2021-03-04 | sinus congestion, cough, throat pain |
Severe sore throat; sinus congestion; non-productive cough; This is a spontaneous report from a cont...
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Severe sore throat; sinus congestion; non-productive cough; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (Lot number: El9267), via an unspecified route of administration on 10Feb2021 14:15 at single dose in the left arm for COVID-19 immunization. Medical history included osteoarthritis from an unknown date. Concomitant medication included spironolactone. On 11Feb2021 08:00, the patient experienced severe sore throat, sinus congestion and non-productive cough. The patient did not receive any treatment for the events. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.
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| 69 | 2021-03-05 | chills, fatigue | Nausea, vomiting, bodyache, chills, fatigue, abdominal pain |
| 69 | 2021-03-05 | chills, fever, headache, fatigue |
It started around 8:00 PM on 3/4/2021 with severe pain in the arm, lots of fever, excruciating heada...
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It started around 8:00 PM on 3/4/2021 with severe pain in the arm, lots of fever, excruciating headache, heavy tiredness, chills along with fever. I tried Advil at first. No relief. I switched to Tylenol with the same results. No appetite. Tolerated some Saltine crackers with sips of Coca Cola, and sips of water. Stayed in bed all of 03/05/2021. I didn't stomach any meals, felt like throwing up, but didn't. Today 03/06/2021, left the bed, showered, still running a fever and not feeling like eating.
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| 69 | 2021-03-05 | fatigue |
One week after Vaccine #1 I began to have swelling & itching of the face-eyes, lips and cheeks, extr...
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One week after Vaccine #1 I began to have swelling & itching of the face-eyes, lips and cheeks, extreme itching of both hands, massive diarrhea and some difficulty swallowing. I took oral benadryl (50 mg) and prednisone (@ 50 mg) and applied cold packs to my face and hands. I also took Allegra 180 mg LA 2x/daily for two weeks after the reaction. Vaccine dose 2 was administered on 2/17/2021 (Pfizer, Lot # EN6201) at Hospital, . One week after that (2/25/2021) I again had facial swelling and itching and massive diarrhea. I took Benadryl 25 mg and Allegra 2x/day and continue to do so. The facial swelling/itching continued. In addition I had, since the first vaccine, extreme fatigue, resulting in a decrease in my ability to walk (down from 3 miles to just over 1 mile) and to swim (shortness of breath, reduction in ability to swim laps). I visited my Rheumatologist on 3/2/2021 and he administered an injection of methylprednisolone to try and tamp down the continuing reaction. That seems to have made a difference.
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| 69 | 2021-03-05 | fatigue |
Within minutes of receiving the first dose of Pfizer vaccine, I began feeling dizzy, lightheaded, ...
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Within minutes of receiving the first dose of Pfizer vaccine, I began feeling dizzy, lightheaded, and off balance. This was followed by nausea, itchiness under my lip, fatigue and pain at the injection site. These were gone the next day except for nausea which lasted a few more hours.
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| 69 | 2021-03-05 | headache, chills, fatigue | Body aches, fatigue, chills,headache, tiredness |
| 69 | 2021-03-05 | sweating |
Itching from head, neck, arms, hands 25 minutes after administration Given patient's own dye-free be...
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Itching from head, neck, arms, hands 25 minutes after administration Given patient's own dye-free benadryl 25 mg po at 1500 at 1507, she was having continued itching and flushed at 1515, itching reduced, flushing improving at 1518, itching to hands, neck improved Face still flushed and sweating
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| 69 | 2021-03-05 | malaise |
2125-patient reports she is not feeling well, while sitting in the waiting room. Patient reports she...
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2125-patient reports she is not feeling well, while sitting in the waiting room. Patient reports she feels a warm sensation all over her body and epigastric discomfort. Vital were assessed. Denies chest pain, shortness of breath, difficulty breathing, dizziness. Patient reports symptoms were not improving, patient sent to ER for evaluation at 2140. Report given to PA. no medication given in clinic. Patients airway is patent, alert and oriented to person, place, time. answering questions appropriately. walking on own. Husband transported patient to hospital.
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| 69 | 2021-03-06 | fatigue, chills, fever |
Around 1 am woke with chills, myalgia, fever to 100.5. Didn't take anti-pyretic. Slept on and off. A...
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Around 1 am woke with chills, myalgia, fever to 100.5. Didn't take anti-pyretic. Slept on and off. At around 3am woke up. Walked to bathroom to urinate. Stood up, started severe nausea and retching. The next thing I remember is finding myself on the ground in the bathroom, retching into the shower area. Called my husband (we are both physicians). My shirt was completely drenched. I was unable to stand up for 5-10 minutes. He noted a 6" hole in the wall (completely through the sheetrock) behind me. I had no memory (and still don't) or falling or hitting my head. He walked me back to bed. My BP was 110/65, pulse was around 70, pulse ox was normal. Continued retching not as severe. Took one Zofran. Eventually fell asleep. In the morning noticed a painful area at the left posterior part of my scalp. There were flakes of sheetrock there. The next day I was tired, felt slightly off balance, otherwise ok. Feeling of vague fuzziness, off-balance continued for a few days, then resolved.
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| 69 | 2021-03-06 | fatigue |
Pain in my lower right side and back. Hives on my upper legs and upper arms. Purple spots on my shin...
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Pain in my lower right side and back. Hives on my upper legs and upper arms. Purple spots on my shins. Extreme fatigue resulting in shortness of breath when I walk a very short distance. Coughing up very small traces of blood. Muscle and joint pain. In particular sore abdomen, back and upper shoulders. Pain is sharp when I cough or move a certain way. Sometimes it is just a persistent aching.
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| 69 | 2021-03-06 | headache, chills, cough |
At midnight following vaccination developed severe chills, body aches, headache, and cough that last...
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At midnight following vaccination developed severe chills, body aches, headache, and cough that lasted until 9:00 AM. General aches and headache continued the next several hours.
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| 69 | 2021-03-06 | headache, fatigue, chills |
I left facility at 3:34 pm where I received the vaccine. At 6:30 pm I became so extremely tired I we...
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I left facility at 3:34 pm where I received the vaccine. At 6:30 pm I became so extremely tired I went to sleep in my clothes. I woke up a few hours later with a pounding headache; the sound of my heartbeat like a snare drum in my ears, nauseated and with a very, very sore arm. Later, throughout the night, I had continuous head pain, nightmares, chills and soreness. I am better today, but still shaky, I took one Naproxen tablet at around 1 am, as well as a melatonin.
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| 69 | 2021-03-06 | headache | severe lower back pain shoulder pain (both) neck discomfort slight headache |
| 69 | 2021-03-06 | headache | patient became flushed, stated hard to breathe, headache, nausea and back ache |
| 69 | 2021-03-06 | malaise, headache, chills, sweating |
Previous HSV1 infection (10 years ago) reactivated - oral cold sore 2 days after injection. Day 1 p...
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Previous HSV1 infection (10 years ago) reactivated - oral cold sore 2 days after injection. Day 1 post injection. Feeling as if ?coming down? with something. Chills headache sweats . Day 5. Cold sore persists and unwellness (not as pronounced or uncomfortable)
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| 69 | 2021-03-06 | sleepiness, fatigue |
I received the 2nd dose of the Pfizer vaccine on 3/2/21. My reactions to the vaccine: 1st dose on ...
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I received the 2nd dose of the Pfizer vaccine on 3/2/21. My reactions to the vaccine: 1st dose on 2/9/21: a little sleepy and a bit sore at the site of the injection. Both symptoms were gone within 24 hrs. 2nd dose on 3/2/21: tired and sleepy the next day and a little itchy rash and sore arm at the site of injection that was about one inch in diameter. The sleepiness and tiredness were gone within 24 hrs. The itchy and sore part of my arm at and around the injection site lasted for about 5 days. I put on Benadryl cream and took Tylenol and that helped. I also put on aspercream to take away some of the pain because I'm a side sleeper and it hurt to sleep on that side. Today is Sunday (3/7/21) and there is no more itchiness or pain but I still feel a little hard bump when I rub around the site of the injection. That doesn't bother me because the sore arm and itchiness at the site of the injection are gone.
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| 69 | 2021-03-07 | chills, headache | Headache, neck ache, nausea, chills, heartburn.. |
| 69 | 2021-03-07 | chills, fever, fatigue | 103 fever Chills Muscle/body aches Extreme tiredness |
| 69 | 2021-03-07 | chills | All over body aches and chills |
| 69 | 2021-03-07 | fatigue |
checked her BG which was 25; minimally responsive; tiredness; This is a spontaneous report from a co...
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checked her BG which was 25; minimally responsive; tiredness; This is a spontaneous report from a contactable pharmacist. A 69-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EN5318), via intramuscular on 12Feb2021 13:00 at single dose in right arm for COVID-19 immunisation. Patient had history of diabetes and had been well controlled for a long time. The patient's concomitant medications were not reported. Shortly after vaccination, patient began complaining of tiredness and told husband she wanted to take a nap. At 16:30 husband found patient minimally responsive and checked her BG (blood glucose) which was 25. Husband gave patient oral forms of sugar and transported to the ER (Emergency Room) where her BG slowly improved to normal range. Outcome of the events was resolved.; Sender's Comments: The patient had history of diabetes. The reported blood glucose decrease and hyporesponsive to stimuli were more likely due to pre-existing diabetes, and less likely causally related to the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 69 | 2021-03-07 | head discomfort |
Approximately 30-40 minutes after vaccine, I experienced blurred vision in my left eye and had left ...
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Approximately 30-40 minutes after vaccine, I experienced blurred vision in my left eye and had left sided tingling and weakness. I have had several episodes of that since, and my vision in that eye continues to be somewhat blurred. I have continued to have swollen lymph nodes in many areas of my body as well as pressure in my head.
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| 69 | 2021-03-07 | headache, fatigue, fever |
25 hrs after vaccination I developed a severe headache, body aches, low fever, weakness, fatigue, le...
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25 hrs after vaccination I developed a severe headache, body aches, low fever, weakness, fatigue, left arm achy and sore to touch. So far, has not improved in another 24 hrs.
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| 69 | 2021-03-07 | headache |
Dermatomyositis rash flare up/ facial skin inflamed, bright red, and swollen; rash on her face; Derm...
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Dermatomyositis rash flare up/ facial skin inflamed, bright red, and swollen; rash on her face; Dermatomyositis rash flare up/ facial skin inflamed, bright red, and swollen; rash on her face; headache; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL9265, expiration date: May2021) via unspecified route of administration in the left arm on 16Feb2021 14:00 at single dose for COVID-19 immunization. Medical history included dermatomyositis since 1993 and sinus problems (sinus disorder). Concomitant medications included immunoglobulin human normal (GAMUNEX) and methotrexate 2.5 mg tablets, both for dermatomyositis; and diphenhydramine hydrochloride (BENADRYL 50 mg) IV as premedication. It was reported that every 2 weeks, a nurse comes to her home and gives her a Gamunex 85gram infusion. She clarified she use 4-Gamunex 20gram vials, and 1 Gamunex 5gram vial to make up her Gamunex 85gram infusion. Product information: Gamunex 5gram Vial (uses 1 vial) (NDC Number: 13533-800-20, Lot Number: B36JE00393, Expiration Date: 20Jul2023) and Gamunex 20gram Vial (uses 4 vials) (NDC Number: 13533-800-24, Lot Number: B8GLE00933, Expiration Date: Aug2023). Reported she takes Methotrexate 2.5mg tablets three times a week. She stated she gets pre-medicated every 2 weeks with IV Benadryl prior to her Gamunex 85gram infusion. She provided the IV Benadryl 50mg product vial information as: (NDC Number: 0641-0376-21, Lot Number: 080010, Expiration Date: Aug2022). The patient previously took budesonide 3 mg capsule (taper dose) from 18Nov2020 to 13Feb2021 for microscopic colitis. On 16Feb2021, on the first day after vaccination, patient had a mild headache. The patient woke up on Saturday morning, 20Feb2021, with her facial skin inflamed, bright red, and swollen. She had a rash on her face as she could feel the unevenness of her facial skin when she placed her hand on her face. Patient reported that she called her neurologist to inform her of the adverse reaction, and her neurologist told her to report the reaction to manufacturer. She said what she experienced on Saturday (20Feb2021) was a Dermatomyositis rash flare up, which for her is very rare. She said she normally doesn't have any skin involvement when she has a Dermatomyositis flare. As a treatment, she said she took generic diphenhydramine 25 mg on 20Feb2021 (lot number: Lot Number: P112026, Expiration Date: Sep2020); and took 2 more since then (She said she takes 1 Diphenhydramine 25mg at a time); and her facial redness is down, but she still has a rash, and her face is a little bit swollen. Her facial skin was still elevated a little bit. Her facial swelling has improved quite a bit from Saturday (20Feb2021), stated she does not have any swelling around her eyes now. She said her facial skin is not as red as it was on Saturday. Outcome of the event headache was recovered on unspecified date in Feb2021; while dermatomyositis rash flare up was recovering.
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| 69 | 2021-03-07 | headache |
A week of extreme weakness, dizziness, aches and pains, headaches. Just couldn?t get out of bed. Aft...
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A week of extreme weakness, dizziness, aches and pains, headaches. Just couldn?t get out of bed. After a week I have weakness and dizziness.
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| 69 | 2021-03-07 | headache |
Heà daçhe réally tired stayed in bed and slept most of dà y. Next dà y nót só tired felt some b...
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Heà daçhe réally tired stayed in bed and slept most of dà y. Next dà y nót só tired felt some better bút still had heà dache linger for another 2 dà ys
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| 69 | 2021-03-07 | throat pain, cough, runny nose, fever |
a little cough; sore throat; runny nose; a bit of pressure in chest; fever; her heart was beating fa...
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a little cough; sore throat; runny nose; a bit of pressure in chest; fever; her heart was beating fast; Granddaughter had covid virus and passed to caller/she tested positive for COVID 19/she was diagnosed with COVID; she was feeling bad; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date: 30Apr2021), via an unspecified route of administration at the right arm on 24Jan2021 07:15 at a single dose for COVID-19 immunization. The patient's medical history included diabetic. The patient's concomitant medications were not reported. It was reported that the patient's granddaughter had COVID virus and passed to the patient. The 2nd dose appointment scheduled for 14Feb2021. Patient stated she had the first dose of the Pfizer COVID 19 vaccine on 24Jan2021 at 0715AM in the right arm. After that, she found out she got infected with COVID 19. On 01Feb2021, she tested positive for COVID 19. On 28Jan2021 (also reported as on 28Jan20201 or 29Jan2021), she was feeling bad. Her little granddaughter had COVID virus (was infected at the school) and passed it on to her. Now she has been going to different places checking it out and she went to urgent care because her heart was beating fast on 02Feb2021. She had an electrocardiogram and her lungs were okay on an unspecified date. They told her was eligible to get an infusion but she doesn't know what it is. The urgent care clinic told her she could get the infusion but then she can't get the second dose of the Pfizer COVID 19 vaccine. She wants to ask if this is true. She was being offered a monoclonal antibody infusion. When ask if this is the first time to call, she stated she called once before right after she found out that she had the COVID 19 infection to ask if she could still get the second shot. She did report at that time that she had gotten the first dose and then tested positive for COVID 19 and she previously provided product information including the lot number from her vaccine card. She added that her heart has been going very fast and has been having fever on 02Feb2021 for two or three days. It is not as high today as it was before. She does want to get the second dose. The first dose helped her so much. On 04Feb2021 (reported as yesterday), she was checked at urgent care because of heart concern and a bit of pressure in chest. Patient stated she only had a little cough, sore throat and runny nose, but she hasn't experienced any other symptoms on an unspecified date. The patient's weight was 54.43 kg on 01Feb2021. The outcome of the events "fever" and "her heart was beating fast" was recovering, while the outcome of the other events was unknown. Patient was scheduled to receive her second dose on 14Feb2021.
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| 69 | 2021-03-07 | fever |
Severe Diarrhea and fever (about 100) started on day of injection (2-2-21) and lasted about 1 week. ...
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Severe Diarrhea and fever (about 100) started on day of injection (2-2-21) and lasted about 1 week. During this time I noticed loss of movement and strength in both legs. This continued to worsen. By about 2-23-21 (day I received 2nd dose) muscles in legs were very constricted making it difficult to walk. Plus I have lost strength in both hands. Contacted my doctor who refereed me to a Neurologist . The Neurologist ran tests on 3-5-21 that indicate that I have nerve damage. Doing physical therapy in an attempt to loosen muscle constriction and regain strength.
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| 69 | 2021-03-07 | sleepiness, fatigue |
I'm not sure this was from the vaccine, but it seems like the only likely cause: I had Pfizer Shot#2...
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I'm not sure this was from the vaccine, but it seems like the only likely cause: I had Pfizer Shot#2 on 2/23/21. I was feeling great for an entire week. Then, a week after the second shot, I got the worst fatigue I can ever remember, except maybe when I was pregnant, starting the evening of March 1. When I awoke on March 2, my body aches were so intense, I felt like I couldn't move out of bed. Then during the day, I tried to take my usual outdoor walk - usually ~ 5 miles/day. I had to turn around part-way because I was so exhausted and my legs felt both like concrete and like they were quaking from tiredness. Later that afternoon, I fell asleep sitting up in my chair SIX times, even though I almost NEVER take a nap! I kept doubting myself because I haven't read about delayed onset of symptoms, but we don't go anywhere indoors at all except for getting the shot at the pharmacy and an MD clinic appointment now and then. (I did have an annual MD appointment on March 2, so was in the clinic that very day, using all precautions. I don't imagine I could have gotten ill instantly from something at the clinic though?) In ensuing days, I continued to feel super-fatigued, but have had more energy each day, to the point where, now, 6 days later, I feel "almost" like myself. I'm still unsure of walking the full 5 miles without getting too tired, and certain body aches are still hanging on (knee, wrists, fingers), but I'm otherwise feeling good. If I had the symptoms right after the shot, I would have been sure it was from the shot, but since it was delayed a week, I was uneasy and it felt a bit scary because I felt so unlike my healthy, spry, active, motivated self. One other odd thing, that may be totally unrelated, but just in case - on the very day of the second shot, I got a huge stye on my left eye - something I haven't had in decades. It has still not gone away after 2 weeks. Just in case you get other reports, I am letting you know about this as well. The fatigue and body aches sound a lot like what is to be expected after the shot, but I do know there have been some eye-related issues as well.
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| 69 | 2021-03-08 | fatigue |
Very sore arm starting about 4 ours post injection. Couldn't raise it above shoulder level. Felt v...
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Very sore arm starting about 4 ours post injection. Couldn't raise it above shoulder level. Felt very thick and heavy. Throbbing. Pulsating, as though I could feel my heartbeat in my arm when I went to bed. Took to Tylenol or sleep would have been impossible. Woke up to a less painful arm and it improved throughout day feeling almost normal by bedtime 24 hours later. Took 2 Tylenol to ensure sleep. Woke up Tuesday morning and arm felt almost 2100% normal. I thought, wow, that wasn't so bad. BUT I WAS WRONG. Tuesday mid morning, I began to feel what I would describe as jittery. Around 11:00 am a wave of nausea washed over me and subsided. I thought maybe I needed to eat as I hadn't yet so I had lunch. After lunch I began to feel nauseous again and like diarrhea was coming. After going to the bathroom, the nausea started building again, and the diarrhea recurred, and the nausea heightened. By mid afternoon I was on the floor hugging the toilet bowl wanting to vomit, waiting to vomit, groaning. It's been years since I've had nausea or vomiting and the whole experience was unexpected from what I read about possible reactions. I wondered if it was food poisoning but my husband and I had eaten the same thing and he was fine. Finally about 3:30-4:00, 48 ours post vaccine, I threw up multiple times, perhaps 5 times. After about 4:30 pm it was over. I was worried that if I ate again I'd be sick so I only drank decaf tea. I felt exhausted from the ordeal but very wired and jittery too. I crawled into bed hoping for sleep. No luck. At 3:00 am I was still watching the clock and shocked that I couldn't sleep. I had to get up at 6:30 in the morning due to some construction at our home. I was legit exhausted Wednesday. I no recurrence of the nausea or diarrhea after the bout on Tuesday afternoon. I ate modestly but normally on Wednesday and slept normally Wednesday night. Nothing more to report, although I read that up to a week later some people experienced a reaction so I wanted to give it a week to see if anything else would happen. Nothing else to report.
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| 69 | 2021-03-08 | influenza like illness |
had second covid shot approx. 3 weeks ago, past two weeks has had rash intermittent, decreased appe...
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had second covid shot approx. 3 weeks ago, past two weeks has had rash intermittent, decreased appetite, ache, last weekend had bodyaches/flu symptom, diarrhea. Today has upper lip swelling (3/3/21)
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| 69 | 2021-03-08 | runny nose |
Strong allergy symptoms. Heavy nose drainage and aching eyes/cheekbones. Lasted one day took Benadry...
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Strong allergy symptoms. Heavy nose drainage and aching eyes/cheekbones. Lasted one day took Benadryl and slept.
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| 69 | 2021-03-08 | throat irritation |
Patient returned approximately 20-30 minutes post 2nd COVID vaccination with complaints of throat it...
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Patient returned approximately 20-30 minutes post 2nd COVID vaccination with complaints of throat itching and feeling like her throat is closing. Patient and husband waited 15 minutes in office as instructed but while driving home noticed above symptoms and returned to clinic. Patient states that when these symptoms began she used her albuterol inhaler in her car and states symptoms resolved immediately following this. Upon arriving back at clinic patient was noticeably anxious though exibits no evidence of respiratory distress or difficulty breathing. Patient denies any difficulty breathing, current throat/lip/tongue itching or swelling. Treatment in clinic included 50mg IM Benadryl. VS and exam were normal. Patient monitored for 45 minutes and discharged in stable condition with her husband.
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| 69 | 2021-03-08 | throat irritation |
Complain of feeling hot, flashed, scratchiness in the back of throat. No swelling, hives, itching, S...
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Complain of feeling hot, flashed, scratchiness in the back of throat. No swelling, hives, itching, SOB. Patient had tingling in hands and face that patient stated is normal with her MS. T98.1, P80, R18, BP139/89, O2 sat 94%. Pt advised to take Benadryl when she gets home because it makes her very drowsy
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| 69 | 2021-03-09 | body temperature increased, chills, malaise, influenza like illness, fatigue |
Temp over 102 first night, over 100 second night, chills third night. Malaise, fatigue, difficulty c...
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Temp over 102 first night, over 100 second night, chills third night. Malaise, fatigue, difficulty concentrating Large muscle aches, pain in both sides of my neck Left arm red, hot, bruised Feels like the flu after 4 days
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| 69 | 2021-03-09 | chills, headache, malaise, fatigue |
About 5 hours after vaccination, unusual ?stingy? headache and tiredness, some malaise after nap. Sy...
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About 5 hours after vaccination, unusual ?stingy? headache and tiredness, some malaise after nap. Symptoms lessened, then disappeared during morning of next day. About 30 hours after vaccination, hot flashes (no fever), chills, tired, but jittery with difficulty sleeping, dizzy, head felt ?weird?, - mostly diminished in morning. About 48 hours after vaccination, headache and tiredness returned -still no fever. Very little soreness in arm over the past two days since injection.
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| 69 | 2021-03-09 | chills, headache, fever |
Wednesday, the morning after the shot: 101.7 fever and in bed all day; chills/cold; can "feel my ...
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Wednesday, the morning after the shot: 101.7 fever and in bed all day; chills/cold; can "feel my skin;" stomach and diet off; bowels off; chest and upper back pressure; deliberate taking of a deep breath; tinny taste in my mouth; slightly headache; low energy; Thursday, the second day after the shot: 99.7 temp; stomach and diet off; chest and upper back pressure; deliberate taking of a deep breath; tinny taste in my mouth; thirsty Friday, day three: stomach and die off; chest and upper back pressure; deliberate taking of a deep breath; tinny taste in my mouth; thirsty Saturday, day four: chest and upper back pressure; deliberate taking of a deep breath; tinny taste in my mouth Sunday, day five: chest and upper back pressure; deliberate taking of a deep breath Monday, day six: chest and upper back pressure; deliberate taking of a deep breath Tuesday, day seven: chest and upper back pressure; deliberate taking of a deep breath Wednesday, day eight: chest and upper back pressure; deliberate taking of a deep breath
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| 69 | 2021-03-09 | fatigue |
Restless sleep, brain fog upon awakening, quite a bit of bone pain and muscular aches, fatigue . Las...
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Restless sleep, brain fog upon awakening, quite a bit of bone pain and muscular aches, fatigue . Lasted most of day after injection.
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| 69 | 2021-03-09 | fatigue |
her lymph node in her breast is killing her; breast pain/ she is not sleeping well due to the pain; ...
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her lymph node in her breast is killing her; breast pain/ she is not sleeping well due to the pain; thought she pulled a muscle at first; tired; not sleeping well due to the pain; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EL9267), via an unspecified route of administration on the left arm, second dose on 17Feb2021 at single dose, for COVID-19 vaccination. The patient's medical history was not reported. There were no concomitant medications. Patient took the first dose of Pfizer-BioNTech COVID-19 mRNA vaccine (Lot: EL9264) on 27Jan2021 for COVID-19 vaccination. Patient got her second dose of the Pfizer Covid vaccine 17Feb2021 and experienced side effects such as painful lymph node and breast pain on 18Feb2021. She said that her lymph node in her breast is killing her on the side that she had the vaccine. She clarified that it is very painful and her breast itself is very painful. She said that she did go to the doctor to be sure that is what it was. She further reported that by Thursday night (18Feb2021), it started bothering and her breast started bothering her. She thought she pulled a muscle at first. She said that it has progressed and got worse and that Sunday night she was in agony. She called the doctor Monday for her left breast that hurts. She said that she is taking ibuprofen (ADVIL, Lot: DJ6716, Expiration: Dec2022), taking 3 of them at a time, but it is not really helping. She had no reaction at the injection site. It is not red and you cannot see anything there. She said that is why she is not even sure. She said that there was no pain at all there. She said that there is nothing wrong with her and she does not feel sick, she just hurts. She said that she was tired because she is not sleeping well due to the pain. Patient wants to know what pain medication she could use that will not counteract the vaccine. The outcome of the events was not recovered.
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| 69 | 2021-03-09 | fatigue |
Received COVID vaccine on 2-22-2021 an hour later started to have right arm pain at the site of the ...
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Received COVID vaccine on 2-22-2021 an hour later started to have right arm pain at the site of the injection. Since has had multiple issues and concerns, such as SOB, dizziness, joint and right arm pain, fatigue and nausea that started about an hour after receiving her vaccine. She said she has SOB at rest but with any type of exertion she is gasping for air. Rates her joint pain off the charts with walking and is bent over.
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| 69 | 2021-03-09 | influenza like illness, headache |
AFTER RECEIVING PFIZER COVID-19 VACCINE #2, I EXPERIENCED "NORMAL" FLU-LIKE SYMPTOMS FIRST DAY AND 1...
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AFTER RECEIVING PFIZER COVID-19 VACCINE #2, I EXPERIENCED "NORMAL" FLU-LIKE SYMPTOMS FIRST DAY AND 1/2. ON SECOND DAY, AWOKE WITH SLIGHT HEADACHE AND SEVERE LEFT NECK PAIN, UNABLE TO MOVE HEAD FROM SIDE TO SIDE. FELT NAUSEAUS ON AND OFF ALL DAY. THE NEXT MORNING BEFORE WAKING, I COULD FEEL THE PAIN MOVING FROM THE LEFT TO THE RIGHT SIDE BEHIND MY NECK, FROM EAR TO EAR. THIS IS CONTINUING ON DAY 4 WITH NO RELIEF. CALLED MY PROVIDERS' OFFICE WHERE NURSE TOLD ME SHE HAD THE VERY SAME THING THAT LASTED 2 WEEKS, NECK PAIN PLUS FATIGUE. I HAVE NOT FOUND ANY INFORMATION RE. THIS SYMPTOM ONLINE.
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| 69 | 2021-03-09 | fever |
Severe inflammation of thyroid only in the evening which radiated out under jaw to ears. Lasted appr...
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Severe inflammation of thyroid only in the evening which radiated out under jaw to ears. Lasted approx.4 weeks. Fever every evening for approx. 4 weeks. Night sweats every night for the past 6 weeks and still continuing. Some of these have been drenching every hour for 4-5 hours. Sometimes less severe but these are ongoing. During the day none of these symptoms existed except a little soreness when touching the thyroid.
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| 69 | 2021-03-10 | cough, headache, runny nose |
march 5 sever throbbing headache relieved with a 1000 mg of tylenol. march 6 headache return but na...
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march 5 sever throbbing headache relieved with a 1000 mg of tylenol. march 6 headache return but nagging just enough let yuo know it tis there and feel of blah and depression runny nose, march 7 systems persist . march 8 mild headache and sniffles march 9 a cough still the feel of blah and headache with sniffles
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| 69 | 2021-03-10 | fatigue, sweating |
diaphoretic, leg tremors, fatigued, short of breath, dizziness, chest pressure and weakness, which ...
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diaphoretic, leg tremors, fatigued, short of breath, dizziness, chest pressure and weakness, which occurred 10 minutes after injection. Patient went to the emergency department within the Medical Center. Patient had an EKG and blood work. Patients symptoms were worse on exertion. She is followed by pulmonology and has been taking prednisone 40mg daily for the past and Bactrim for prophylaxis. Patient had respiration rate in the 30s, and was saturating well on 3L oxygen which is her baseline. EKG was normal. Patient tested negative for COVID-19 on 3/10/21. Patient was admitted to general medicine floor.
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| 69 | 2021-03-10 | throat pain, sweating, headache, fatigue, cough, chills, fever |
02/11/2021 Noon - severe nausea 2200 - nausea resolved 2330 - extreme fatigue which continued throug...
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02/11/2021 Noon - severe nausea 2200 - nausea resolved 2330 - extreme fatigue which continued through 03/06/2021 then became moderate fatigue - continues to present. 02/12/2021 0030 - dry raspy cough - continues to present but lessened in intensity over time. HISTORY 01/2020 01/08/2020 - felt fine at movie theater, while walking to car swallowed & became aware that my throat was suddenly quite sore - difficult to swallow. Within 15min throat so sore could hardly swallow. Had start of dry cough. ON increased dry cough; HA; joint pain; sweats/chills; low grade fever. 01/10/2020 - HA resolved. Sore throat less painful; very uncomfortable dry cough. Extreme fatigue. 01/11-19/2020 - Due to fatigue, unable to be out of bed for more than a few minutes. Hydrating/soup. Couldn't carry on verbal conversation due to dry cough - no SOB if didn't try to talk. 01/20/2020 - Was able to get up & dressed; left house for short time. Felt better, cough less of problem but persisted. Took about 3-4 weeks to feel 100%. AN ASIDE My osteoarthritis pain, in left hip only, began to get much worse after 01/2020 episode. It took a quantum leap forward in pain again after 1st COVID-19 vaccination.
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| 69 | 2021-03-10 | fever, headache | 103+ fever, headache, joint pain, trouble breathing, Had sever case of covid 19 3/9/2020 |
| 69 | 2021-03-10 | fever, influenza like illness, chills |
flu-like symptoms; fever; chills; aches/pains; vomiting; abdominal pain -feels like severe case of t...
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flu-like symptoms; fever; chills; aches/pains; vomiting; abdominal pain -feels like severe case of the flu; This is a spontaneous report from a contactable nurse reported for self. This 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL9267) at single dose on 09Feb2021 14:15 in left arm for COVID-19 immunisation. Medical history included severe respiratory infection from Nov2019. Patient thought she might have had COVID, but she was way early, before anyone knew it was in the country, back in Nov2019, she had a severe respiratory infection. Patient stated that her husband was a respiratory therapist, and he fortunately had enough albuterol to choke a horse with, and if it had not been for that and the nebulizer, the caller would have had to go to the hospital. Patient stated that she would wake up in the night and need three or four treatments. Patient stated that before being sick, she had horses and it would take 15-20 minutes to do her routine with the horses, but while she was sick, it took two hours. Patient stated that she would walk out and back, and it was an ordeal, she was tired and short of breath. Patient stated that the doctors called it severe respiratory inflammation, and that was in Nov and Dec2020. Patient stated that she was put on steroids at that time, and she really didn't want to go back to the doctor, so she took some of her husband's steroids, he had some dexamethasone, and she took that and started to feel better. There was no concomitant medication taken. Patient reported flu-like symptoms on 11Feb2021 after her first dose of Pfizer Covid19 vaccine. Symptoms included fever, chills, aches, pains, vomiting, abdominal pain -felt like severe case of the flu on 11Feb2021. Patient would like to know if these were normal adverse events and if they could be worse for her, because she may have had a Covid infection previously. Patient asked what was the efficacy after one dose of the Pfizer-Biontech Covid19 vaccine if she chose not to get the second dose. Patient took her first dose of the Pfizer COVID vaccine on 09Feb2021. Patient stated that two days later, she had side effects and had had them for the last 6 days. Patient stated that if someone picked it, she had it. Patient stated that she had a fever, chills and pain. Patient's fever was running at 102.5 in Feb2021, and she could get it down with paracetamol (TYLENOL) and alcohol. Patient stated that she heard somewhere that the first dose offers 85% protection against the virus, and she was wondering if that was accurate. Caller was scheduled for her next dose on 09Mar2021. Patient was still having aches and pains, and she had vomiting. Patient stated that she was still not over this part of it yet. Patient stated that her side effects started on 11Feb2021 between 4 and 5PM, so more than 48 hours later and they all of a sudden just hit her. Patient stated that the vomiting had stopped, but she did still get some abdominal pain once in a while, but the vomiting stopped about two days ago, but for a while she could not keep food down, and she was just trying to take paracetamol (TYLENOL). For events fever, chills, aches and pain, patient confirmed that these were all still ongoing, but they were getting better. Patient stated that these side effects were a little better yesterday, the caller got up and took a dexamethasone 5 mg and felt better. Patient stated that when she woke up this morning, she was feeling god awful, so she took another dexamethasone, and she was better this afternoon. Patient planned to go to an urgent care today, but she had not been to a doctor yet. Patient stated that they must not have been that serious because she did not go to a doctor, it was like a bad case of the flu, feeling like she got run over with a truck. Patient stated they were serious, but nothing life threatening, caller confirmed all side effects were medically significant. Patient stated that she read that people who had COVID, would react with more severe side effects to the vaccine than people who did not have COVID, and she was wondering if that was correct. The outcome of event vomiting was resolved in Feb2021, outcome of event abdominal pain was unknown. The outcome of rest events was resolving. The patient assessed drug result was related for all the events, Method of assessment: Global Introspection.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "flu-like symptoms and associated fever, chills, aches, pains, vomiting, abdominal pain " and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. More information such as complete medical history and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 69 | 2021-03-10 | fever |
Within 2 hours of 2nd shot Ibegan to feel weak and began vomiting around 6pm. Also having diarrhea ...
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Within 2 hours of 2nd shot Ibegan to feel weak and began vomiting around 6pm. Also having diarrhea in ileostomy bag. I did not sleep Monday 3-8 night. Vomiting .stopped the next day. Little appetite. Temp 3/11 was 99.3 slightly high. No adverse event after first dose 2/15/21.
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| 69 | 2021-03-11 | fatigue |
Tinnitus. Lightheadedness. One week after shot, both continue. Lightheadedness is subsiding. Tinn...
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Tinnitus. Lightheadedness. One week after shot, both continue. Lightheadedness is subsiding. Tinnitus is worse as the day goes on (have experienced it before but this is a recurrence). Tired for the first three days. These events have continued.
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| 69 | 2021-03-11 | headache, sleepiness, chills, fatigue |
Day of injection arm swollen and sore by 7 pm. Next morning woke up with headache, body ache, chill...
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Day of injection arm swollen and sore by 7 pm. Next morning woke up with headache, body ache, chills and extremely tired. These symptoms last all day and night. Slept most of day and laid around. Next morning still felt tired but aches and chills gone. 5 days later, midday headache and body ache started again with chills and tired feeling. Lasted 4 hours and then stopped. Never ran a fever or had any other symptoms. Never saw a doctor just road it out. Seem to be fine now, 8 days later but still feel tired off and on. Might just be because I'm old.
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| 69 | 2021-03-11 | headache |
69-year-old F with medical history of hypertension, diabetes on insulin, and hyperlipidemia who expe...
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69-year-old F with medical history of hypertension, diabetes on insulin, and hyperlipidemia who experienced headache, burning to the injection side, and chest tightness immediately after her 1st dose of the vaccine. Denies shortness of breath, palpitations, dizziness, or any other symptoms. She did not look in any acute distress, her lungs clear to auscultation bilaterally, cranial nerves 2-12 intact and no pronator drift. Vital signs 98%RA, HR 76 , BP 150/90. She was observed in the medical tent for total of 30 minutes and given water and was reassured. She felt completely asymptomatic prior to discharge and confirmed that her headache, burning side, and chest tired were all completely resolved. She was ambulatory before discharge and was advised to call 911 or go to the nearest emergency room if any she she verbalized understanding and agreed to the treatment plan.
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| 69 | 2021-03-11 | throat pain, chills | Muscle aches, joint pain, swollen lymph nodes in neck, chills, sore throat/tonsils/back of tongue |
| 69 | 2021-03-11 | fever, headache, fatigue, chills | Chills, fever, headache, tiredness, nausea, injection site pain, muscle pain |
| 69 | 2021-03-11 | fever, lethargy, body temperature increased, pneumonia |
Pfizer COVID-19 Vaccine EUA 3/2: Pt received Pfizer vaccine 2/26/2021 and started feeling progressi...
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Pfizer COVID-19 Vaccine EUA 3/2: Pt received Pfizer vaccine 2/26/2021 and started feeling progressively worse - endorsed fever, diarrhea, body aches, trouble breathing, lack of appetite. On 3/2/2021 pt and husband presented to ED. Pt's husband stated that pt had become more and more confused since she received the vaccine and that on 3/2 she could not complete her sentences. Temp 101.6 on arrival, tachycardic in 130s, tachypneic in 120s, but not hypoxic. Patient was given acetaminophen on arrival. IV was inserted and patient was given 1 L intravenous fluid replacement as well as 2 g ceftriaxone for broad-spectrum coverage within 3 hours of arrival. Blood work was drawn that shows no leukocytosis but lactic acidosis to 3.3. There are multiple electrolyte abnormalities, hyponatremia 127, hypokalemia 2.8, creatinine 1.01, ALT 59 AST 53, ALP 136, total bili 1.3, lactic acidosis 3.3, troponin 0.02. Patient was given 40 mEq of oral potassium. Additional L of normal saline was given for total of 2 L normal saline bolus. Chest x-ray shows right basilar pneumonia. Also shows pulmonary nodule of which husband was made aware. LFTs are noted be elevated, so biliary ultrasound was obtained that was negative with limit to body habitus. Husband was updated. Azithromycin was added on. Rapid COVID antigen was negative. 3/3/21: Febrile, SOB overnight. Pt more lethargic, trailing off in the middle of sentences and having difficulties following conversation. Continue sepsis protocol, add vancomycin IV to ceftriaxone and azithromycin. Frequent neuro checks. MRCP. Chest pain-free, serial cardiac enzymes from yesterday to demonstrate nonischemic pattern likely type 2 NSTEMI. 2/2 blood cultures from 3/2 positive for Streptococcus pyogenes (Group A). Vancomycin and azithromycin dc'd. 3/11: Discharged from hospital. Patient admitted for acute hypoxic respiratory failure secondary to right basilar community-acquired pneumonia. Blood culture grew Streptococcus pyogenes, patient was initially treated with ceftriaxone and switched to Ancef . repeat blood culture on 03/04/2021 showed no growth. Patient will complete a total 14 day course of antibiotics with amoxicillin from culture negative date. Patient had right-sided pleural effusion, pulmonary consulted and she underwent thoracentesis x2 culture showed no growth, considered parapneumonic effusion. Patient required 2 L continuous oxygen and deemed stable for discharge. She will follow up with Pulmonary in 3 weeks, outpatient chest CT in 4-6 weeks to be ordered by Pulmonary to assess lung nodule and known thoracic aortic aneurysm. PTOT recommended home discharge with VNA. On discharge patient was a febrile and hemodynamically stable. Remained COVID negative throughout.
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| 69 | 2021-03-12 | dehydration | Altered mental status, moderate dehydration, nausea and vomiting; Addison?s crisis |
| 69 | 2021-03-12 | headache |
I was very dizzy. The room was spinning very fast and I became nauseated with a bad headache. The s...
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I was very dizzy. The room was spinning very fast and I became nauseated with a bad headache. The symptoms were worse the first day and lasted for a week. I took Dramamine for the dizziness and Tylenol for the headache.
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| 69 | 2021-03-12 | sweating |
Sweaty palms and blood pressure went up within 10 minutes of vaccine but then it started to go down ...
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Sweaty palms and blood pressure went up within 10 minutes of vaccine but then it started to go down so I left. I normally have low blood pressure. A few days later I got LOUD tinnitus and some ear popping.
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| 69 | 2021-03-12 | lethargy, influenza like illness, fever, headache |
Flu like symptoms 2 days after injection. Lethargy, headaches, sore arm at the injection site. Fev...
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Flu like symptoms 2 days after injection. Lethargy, headaches, sore arm at the injection site. Fever, but no chills
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| 69 | 2021-03-13 | sleepiness, respiratory tract congestion, fatigue | Fatigue, sleepyness, lack of energy, congestion |
| 69 | 2021-03-13 | throat clearing |
Very sharp pain about one inch below left collarbone, halfway between neck and shoulder. Remained no...
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Very sharp pain about one inch below left collarbone, halfway between neck and shoulder. Remained noticeable, and very sensitive to touch, for 8 hours. Gone the next morning. About 6 hours after injection had frequent need to clear my throat that occurred for about 3 hours.
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| 69 | 2021-03-14 | chills, fatigue, body temperature increased |
Next day after shot: Fatigue first, vomited once, had chills, temperature 101.8, reduced appetite. ...
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Next day after shot: Fatigue first, vomited once, had chills, temperature 101.8, reduced appetite. Following day okay except for sore arm, fatigue, lack of appetite.
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| 69 | 2021-03-14 | chills, fever |
Extreme fever chills and night sweats Began after the second dose of the COVID 19:vaccine and still...
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Extreme fever chills and night sweats Began after the second dose of the COVID 19:vaccine and still continue
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| 69 | 2021-03-14 | cough, fatigue |
Immediately, I had a cough, which is odd. But I do have intermittent cough, and this may have trigg...
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Immediately, I had a cough, which is odd. But I do have intermittent cough, and this may have triggered it. It is not covid but cough of long-standing. The next day I had sore arm, muscle pains, cold body temperature (97.1 F), and wheezing. Wheezing was new and it hurt and worried me. Intense fatigue. Wheezing has resolved but the rest still there and it is 11 days since vaccine
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| 69 | 2021-03-14 | fatigue, body temperature increased, chills, headache |
Injection site red and swollen., Nausea and diarrhea. Headache,. Tiredness. Muscle pain. Temperature...
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Injection site red and swollen., Nausea and diarrhea. Headache,. Tiredness. Muscle pain. Temperature (102). Severe chills.
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| 69 | 2021-03-14 | headache, fatigue |
I had the normal headache, fatigue, and joint pain in my knees with the first and second dosage of P...
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I had the normal headache, fatigue, and joint pain in my knees with the first and second dosage of Pfizer. But something different occurred after the second dosage. I experience knee pain daily from surgery a few years ago. My right knee is always a bit swollen and painful. After the second dose of Pfizer, I experienced shooting pains in my knees, especially the right knee. This pain was unlike anything I had ever experienced before. It was almost like a hot poker was intermittandly being held to my knee, and a sensation radiated down my leg. It sensationn occurred the evening after the shot was administered, and lasted only that evening. After this experience, I can report that the swelling and pain in my knee has drastically reduced. I feel that the inflammation in my right knee has noticeably decreased, and the swelling has almost completely subsided.
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| 69 | 2021-03-14 | headache, fever |
Headache, Neck ache, then Fever 3/13/2021 10:30 evening headache started thru the night, Sunday 03/1...
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Headache, Neck ache, then Fever 3/13/2021 10:30 evening headache started thru the night, Sunday 03/14/2021 fever started thru out the day until Monday morning 03/15/2021 then slight headache again
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| 69 | 2021-03-14 | fever, chills, headache |
My only reaction to Shot #1 was feeling fatigue for about a day It was Shot #2 that I had a reaction...
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My only reaction to Shot #1 was feeling fatigue for about a day It was Shot #2 that I had a reaction. Approximately 20-25 minutes after the shot, while driving home, I felt dizzy and light-headed. By the evening, I had a fever, chills, headache, body aches, pain in my left arm (shoulder, elbow down to my wrist); nausea and vomiting. Condition lasted Tuesday evening and throughout Wednesday. By Wednesday evening I felt a little better and by Thursday afternoon, most of the symptons had dissipated
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| 69 | 2021-03-14 | fever, chills |
First dose 12:30pm metallic taste, slight nausea, brief light headed. Approx 1:20pm moderate arm sor...
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First dose 12:30pm metallic taste, slight nausea, brief light headed. Approx 1:20pm moderate arm soreness lasting 2 days. Second dose administered about 3:00pm about 1hour later injection site soreness. Next day about 4:30pm extreme arm pain, 100.4 fever and chills. Took 2 Tylenol. Approx 11:30pm no fever or arm soreness.
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| 69 | 2021-03-14 | fever, fatigue, chills | Fever Chills Muscle Aches Fatigue Pain, redness and swelling at injection site |
| 69 | 2021-03-14 | fever, fatigue, headache | Fever, chills, body aches, headach, fatigue, slight nausea |
| 69 | 2021-03-14 | fever | Very hard chills, fever, nausea, night sweats & dizziness |
| 69 | 2021-03-15 | chills, headache | Bad Chills, body aches. Headache Sore arm |
| 69 | 2021-03-15 | chills, lethargy, fever, headache |
Chills at onset only; then fever, occassional headache & backache, and lethargy for 48 hours. Temp ...
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Chills at onset only; then fever, occassional headache & backache, and lethargy for 48 hours. Temp averaged 100, hit 101 once, 102 once. Took acetaminophen 3X during the 48 hour period. After 48 hours 100% normal.
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| 69 | 2021-03-15 | fatigue |
Blacked out; fractured nose; fainting; very tired and cold; very tired and cold; light headed; thirs...
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Blacked out; fractured nose; fainting; very tired and cold; very tired and cold; light headed; thirsty; nausea; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9266), via an unspecified administered in the left arm on 13Feb2021 at 08:15 AM at SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Medical history included arthritis (No chronic health conditions besides arthritis). Concomitant medications included venlafaxine hydrochloride (EFFEXOR), simvastatin, and colecalciferol (D3). The patient previously took cipro [ciprofloxacin hydrochloride] and experienced allergies. Historical vaccine includes first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), via an unspecified route of administration in the left arm on 22Jan2021 at 5:00 PM for COVID-19 immunisation. It was reported that for 2 days, patient was very tired and cold. At day 4 while at her trainer, the patient experienced light headed, thirsty, nausea, and had blacked out. All tests were normal at emergency room (ER), but have fractured nose. The patient wanted to understand if this fainting can be related to the second shot. Cardiologist said no problems in the heart. All events started on 17Feb2021. There was no treatment received for all events. The patient had COVID test post vaccination via nasal swab on 17Feb2021 which showed negative result. On an unspecified date in 2021, the patient recovered from all events.
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| 69 | 2021-03-15 | headache |
Being in the Mall, accompanied by her cousin, felt a severe headache and pain in both shoulders foll...
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Being in the Mall, accompanied by her cousin, felt a severe headache and pain in both shoulders followed immediately by fainting, cardio-respiratory arrest that required call 911 for emergency transfer to Hospital. She was intubated in the emergency room treated by the doctors, Cardiologist and Intensive care where she was subjected to hypothermia and other treatments due to the serious neurological damage that she presented. No other organ seemed compromised. Never came out of the coma, passing away on February 26, 2021.
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| 69 | 2021-03-15 | fever, chills, headache |
Chills, shakes, headache, nauseous and full body aches for 6 hrs. Temperature for 3 days started at ...
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Chills, shakes, headache, nauseous and full body aches for 6 hrs. Temperature for 3 days started at 102 for 4 hrs. Then down to 101 - 100 next 24-36 hrs. Next 24 hrs temp. was 99. - 100. Chills, shakes and nauseous came back again 72 hrs later and lasted about 4 hrs. Headache and nauseous lasted a large part of 3 days. Took Tylenol when symptoms first started and stopped after 3 days when symptoms completely stopped.
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| 69 | 2021-03-15 | fever |
After 1st vaccine, 5 days after shot, noticed an itchy, light pink circular area below shot site. No...
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After 1st vaccine, 5 days after shot, noticed an itchy, light pink circular area below shot site. No rash, just itchy, about inch & half in diameter. Lasted 3 days, then went away. After 2nd vaccine which was given in same arm, the next day after shot, noticed the same itchy, light pink patches on upper arm, but several patches and bigger in diameter. Lasted 3 days. also with 2nd vaccine I had a low grade fever (101) the following day but was the fever was gone that evening.
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| 69 | 2021-03-16 | headache |
Severe back ache and groin. Like a kidney infection. Hard to move without experiencing pain. This is...
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Severe back ache and groin. Like a kidney infection. Hard to move without experiencing pain. This is not a small amount of pain either! Also had a headache first!
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| 69 | 2021-03-16 | headache |
Late afternoon on 3/16/2021, I became dizzy. Then I became quite dizzy to where I had to sit down. ...
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Late afternoon on 3/16/2021, I became dizzy. Then I became quite dizzy to where I had to sit down. my head began to hurt as well and I became nauseous. I went to my bedroom to lay down and took a pail with me in case I became sick to my stomach. I did throw up three separate times. The dizziness persisted throughout the night. by this morning, 3/17/2021 I felt better for the most part.
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| 69 | 2021-03-16 | lethargy, headache, fever, chills |
2/25 woke up at 7:30 a.m. with fever, chills, and severe body aches all day 2/26 same as previous da...
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2/25 woke up at 7:30 a.m. with fever, chills, and severe body aches all day 2/26 same as previous day plus lethargy 2/27 woke up at 3:30 a.m. with SEVERE headache and partial loss of vision Went to ER and they diagnosed me with a moderate stroke and mild cognitive issues with right hemisphere vison loss in both eyes.
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| 69 | 2021-03-16 | fever |
Presents to PCP 2 days after 2nd covid vaccine with fevers, chest heaviness, palpitations, syncope (...
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Presents to PCP 2 days after 2nd covid vaccine with fevers, chest heaviness, palpitations, syncope (fell and hit head), swollen lymph node under arm, bilateral ear pain. Sncyope thought to be vasovagal and not related to vaccine. OTC treatment for symptoms.
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| 69 | 2021-03-16 | fever | Fever 101 degrees, joint aches, lasting 8 hours; rash on upper trunk lasting 3 days |
| 69 | 2021-03-17 | fatigue, influenza like illness, fever |
Low grade fever ( 100.3), joint pain, severe fatigue, mild nausea Dizziness ( fogginess) "Flu-like" ...
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Low grade fever ( 100.3), joint pain, severe fatigue, mild nausea Dizziness ( fogginess) "Flu-like" symptoms for 48 hours
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| 69 | 2021-03-17 | headache | Dizziness, Confusion, Headache 2 days |
| 69 | 2021-03-17 | fever |
Fever Aches confusion weakness joint paint UNABLE to walk. ending in a 6 day hospital stay. Hospita...
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Fever Aches confusion weakness joint paint UNABLE to walk. ending in a 6 day hospital stay. Hospital says it could not be caused by the vaccine 2 covid
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| 69 | 2021-03-18 | chills, headache, fatigue |
Sore arm; body aches; fatigue; headache; upper stomach cramp; chills; sensitive skin; symptoms got w...
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Sore arm; body aches; fatigue; headache; upper stomach cramp; chills; sensitive skin; symptoms got worse; This is a spontaneous report received from contactable consumer, the patient. A 69-year-old elderly female received the first dose of BNT162b2 (solution for injection; Lot EN6201 expiry not provided) as a single dose via unspecified route in the right arm on 14Feb2021 at 11:30 AM (at 69-years-old) for COVID-19 immunisation. Relevant medical history included asthma, hypothyroidism, and high blood pressure (BP). The patient has an allergy to penicillin, sulfonamide (sulfa), eggs, shellfish and peanuts and all tree nuts. Concomitant medications sans posology/indications included levothyroxine sodium (SYNTHROID), valsartan (DIOVAN), atenolol (TENORMIN), amlodipine, and diazepam (VALIUM NOVUM). The patient did not receive any other vaccines on the same date. The patient denied being diagnosed with COVID-19 prior to the vaccination. The patient reported that on 16Feb2021 at 05:00pm she experienced a sore arm, body aches, fatigue, headache, upper stomach cramps, chills , sensitive skin (no hives) and these symptoms got worse on the second day and continue (fifth day not including day of vaccine), The patient was tested for COVID via nasal swab PCR on 19Feb2021 and was negative. There was no treatment received. The outcome of the events, sore arm, body aches, fatigue, headache, upper stomach cramps, chills, and sensitive skin (no hives), was not recovered.
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| 69 | 2021-03-18 | fatigue, headache, chills, fever |
Increased blood pressure and heart rate. Chills - fever- headache - body aches - sick to my stomach ...
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Increased blood pressure and heart rate. Chills - fever- headache - body aches - sick to my stomach - tireness - swollen and red arm at injection site along with some itching. Woke up with these symptoms next day after vaccine. Blood pressure, heart rate, and other symptoms were better by day 2 but swollen arm and redness still persists. Still have a slight headache.
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| 69 | 2021-03-18 | fatigue, sweating |
woke up 2:00 am 3/19 with abdominal cramps; stomach discomfort, vague nausea, intestinal cramps. Had...
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woke up 2:00 am 3/19 with abdominal cramps; stomach discomfort, vague nausea, intestinal cramps. Had 2 bowel movements, soft but not diarrhea, slight sweats. Most of the night had difficulty sleeping, very restless. Upon waking, still very tired, fuzzy feeling, but no more abdominal issues.
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| 69 | 2021-03-18 | fatigue |
very fatigued; It has mostly remained above 100 all day today. As I sit and type, it is currently 13...
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very fatigued; It has mostly remained above 100 all day today. As I sit and type, it is currently 135, significantly higher than normal for sitting and typing.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, expiry date not reported), via an unspecified route of administration on the right arm on 03Feb2021 08:30 at single dose for covid-19 immunisation. Medical history included ankylosing spondylitis, osteoarthritis, hypothyroidism, osteoporosis, known allergies: NSAIDs from an unknown date and unknown if ongoing. Concomitant medication included alendronate sodium (ALENDRONATE), arnica montana and thyroid (ARMOUR THYROID). The patient previously took neosporin, dolobid, diflunisal and experienced allergies. The patient was 69 years old when she received the first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899, expiry date not reported) on the right arm on 14Jan2021 08:30 for covid-19 immunisation. The patient reported that they went to bed at 10:30pm last night; very fatigued. At 4:08am on 04Feb2021, tapped them and reported that her heart rate had been above 120 for 10+ minutes while she was lying down. She checked the Heart app and it showed that her heart rate had been in excess of 120 for 2.5 hours while she slept. Her resting heart rate is normally 70 or below. She got up; the heart rate remained elevated for another hour or more, finally dropping below 120 at 5:30am. She was very fatigued (from the high heart rate?; as reported) for several more hours. It has mostly remained above 100 all day today. As she sit and type, it is currently 135, significantly higher than normal for sitting and typing. It was reported that the events occurred on 04Feb2021 at 01:30 am. No treatment was received for the events. The patient did not recover from the events.
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| 69 | 2021-03-18 | headache, chills |
HEADACHE/MIGRAINE, DIZZINESS, CHILLS, BODY PAIN, IMPAIRED COGNITION,EARS RINGING, CHEST PAIN,BREATHI...
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HEADACHE/MIGRAINE, DIZZINESS, CHILLS, BODY PAIN, IMPAIRED COGNITION,EARS RINGING, CHEST PAIN,BREATHING DIFFICULTIES
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| 69 | 2021-03-18 | headache | 03/17: Head ache 03/18: Left-side body ache; overall bad; chilled; no fever |
| 69 | 2021-03-18 | nasopharyngitis |
Cold; Sore left arm; This is a spontaneous report from a contactable consumer, the patient. A 69-ye...
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Cold; Sore left arm; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number LC3302), via an unspecified route of administration in the left arm on 12Feb2021 at 17:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Relevant medical history included diabetes (diagnosed 4-5 years ago). The patient did not have any relevant family medical history. Concomitant medications included echinacea and vitamins, both from an unknown date at an unknown dose for an unknown indication and unspecified medications for diabetes, cholesterol and thyroid, all started prior to the vaccine. The patient previously received a shingles shot (unspecified product) for immunization and experienced injection site soreness. The patient did not receive any other vaccines on same date of the BNT162B2 vaccine and no prior vaccinations within 4 weeks of the vaccine. On 12Feb2021 the patient experienced a cold approximately five hours after the vaccination (reported as 21:30 - 22:00) which was a little worse on Saturday but started to get better and a sore left arm within a few hours of receiving the vaccine (exact time unknown). The events did not require a visit to ER or physician's office and there were no relevant tests performed. The patient stated they have not had a cold in over a year and would like to know if it is a symptom of the vaccine. The patient reported she is taking echinacea liquid and it usually helps within 36 hours and now this is her third day. It has gotten better because she takes echinacea and vitamins as well. The patient stated her left arm was sore, but not bad. She first stated it was 3-4 inches above elbow and later stated it was about 4 inches from shoulder and she did not think it was in the muscle. The patient has an appointment for her second dose in 4 weeks, the patient inquired if there will be an issue with her receiving second dose in 4 weeks instead of 3 weeks. The clinical outcome of the cold and sore left arm was recovering.
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| 69 | 2021-03-18 | fever, fatigue, chills | Four days of fatigue, chills, fever, body aches |
| 69 | 2021-03-18 | fever, headache |
Beside left arm hurt, whole body was aching, headache, sleeping about 36 hours, chill, a little high...
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Beside left arm hurt, whole body was aching, headache, sleeping about 36 hours, chill, a little high fever....
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| 69 | 2021-03-19 | chills, fatigue |
Rash on injection site, swelling on the arm, chills, rash on vaginal and anal area, hives on chest, ...
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Rash on injection site, swelling on the arm, chills, rash on vaginal and anal area, hives on chest, back, and arms, fatigue, and muscle aches
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| 69 | 2021-03-19 | chills, lethargy | Chills, body aches, lethargy, pain and swelling at injection site |
| 69 | 2021-03-19 | chills, fever |
3/18 Chills and slight temperature. Sore arm 3/19 Injection site warm and red 3/20 arm still warm, ...
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3/18 Chills and slight temperature. Sore arm 3/19 Injection site warm and red 3/20 arm still warm, but less than previous day slightly ref
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| 69 | 2021-03-19 | chills, fever | Extreme chills fever101.2 Fainted |
| 69 | 2021-03-19 | fatigue |
After 3 weeks , I came down with severe case of heart palpitations, body weakness ,cold body, shakin...
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After 3 weeks , I came down with severe case of heart palpitations, body weakness ,cold body, shaking body, had to call 911 , in hospital was diagnose with Atrial Fibrillation, did not have this problem before!! Have to take 4 new medications for the rest of my life!!! I may experience stroke in the future. For a early few days had pain in my left arm. For the next few weeks overall tiredness. strange feelings in my head!!!!
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| 69 | 2021-03-19 | headache | 2 consecutive days of headaches in the morning, subsiding in the evening |
| 69 | 2021-03-19 | sweating, fever, headache, fatigue, chills |
Two hours after receiving my second vaccine I became very tired. Roughly 12 hours after that (1 am)...
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Two hours after receiving my second vaccine I became very tired. Roughly 12 hours after that (1 am), I awoke with chills and shakes. When I awoke in the morning, I experienced headache, fever (99.9), body aches, chills and slight nausea. These symptoms lessened towards the end of the day. I awoke during the night (about 24 hours after first experiencing chills) in a pool of sweat. Although I didn't take my temperature, I felt like my fever had broken and most other symptoms were gone. The following morning I felt weak and tired.
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| 69 | 2021-03-19 | fever, fatigue, headache |
Had a fever from 101.4 - 101.9 from onset through late evening on 3/19. Treated with Tylenol that lo...
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Had a fever from 101.4 - 101.9 from onset through late evening on 3/19. Treated with Tylenol that lowered the fever but didn't take it away. Other symptoms included nausea, loss of appetite, muscle aches, pain in both eyes, pain in the lower backside of my head, pain at injection site. Fatigue. Slept all day and through the night. 3/20/2021 8:50 am - as I complete this form I still have side effects even though most symptoms are gone now; Currently, extremely fatigued with a headache that is at the back of my head only. Soreness at injection site. Other symptoms are gone.
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| 69 | 2021-03-19 | sleepiness | Sleepy, felt heavy chest, blood pressure up |
| 69 | 2021-03-20 | chills, fever |
fever between 104 & 105; looses her balance; she ache's all over.; Chills; falling over; This is a s...
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fever between 104 & 105; looses her balance; she ache's all over.; Chills; falling over; This is a spontaneous report from a Pfizer-sponsored program received from a contactable female consumer. A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982, Pfizer COVID-19 vaccine NDC/EXP: Unknown,) in her right arm via an unspecified route of administration on 29Jan2021 10.30 (at the age of 69-years-old ) as single dose for covid-19 immunisation. Medical history included ongoing breast cancer since Feb2020. Caller said that she had breast cancer with radiation last June and July. She asks if this could be affecting her receiving her vaccine now. The patient concomitant medications were not reported. On 31Jan2021 patient experienced a fever between 104 & 105, looses her balance, she aches all over, having chills, and falling over and this has been going on for just under a week. She says she got the shot last Friday and the symptoms started Sunday (On 31Jan2021). The patient body temperature included fever between 104 & 105 fahrenheit , fever 100.4 for 4 days ,104.5 fahrenheit ,103 fahrenheit,101 fahrenheit. Caller said that her fever temperature has been 104.5 degrees Fahrenheit a couple times, and went down to 103 degrees Fahrenheit, was down to 101 degrees Fahrenheit and is back up today. Caller said she just took a couple of Tylenol 650mg UPC, Caller said she took 650mg today, that was the first she took, two 650mg.Therapeutic measures were taken as a result of fever between 104 & 105, chills and pain. The outcome of the events were unknown.
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| 69 | 2021-03-20 | fatigue, chills |
passing out; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my hea...
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passing out; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my head; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my head.; Chills; fatigue; nausea; lightheadedness; vertigo; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EM9810) via an unspecified route of administration, administered on the left arm on 26Feb2021 15:15 at a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included calcium carbonate (OS-CAL) and vitamin. The patient previously took BNT162B2 for COVID-19 immunisation (first dose on the left arm at 01:30 PM, lot number: EL 1283); and SHINGRIX vaccine in 2019, codeine and cipro and experienced allergies. On 27Feb2021 03:30 PM, the patient experienced chills, fatigue & then sudden nausea & lightheadedness that resulted in passing out. Unfortunately, the patient fell on a tile floor & hit her head resulting in a 1.5 inch gash in the back of her head. When she went to the ER, it was determined that she now had vertigo (which she never had before) but obviously hard to tell if it was a side effect of the vaccine or from the fall. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events which included CT scan, ekg, chest X-ray, bloodwk (unknown results) and Epley maneuver. The facility where the vaccine was administered was in a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Patient is not pregnant. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 69 | 2021-03-20 | fatigue, headache | Dizziness, headache and tired. Arm at injection site was sore. Lasted two days. |
| 69 | 2021-03-20 | headache, fatigue, sleepiness |
I was up set; Muclse spams feel like something crawling in my leg; I feel crap. I got to work but fe...
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I was up set; Muclse spams feel like something crawling in my leg; I feel crap. I got to work but feeling like I do I can't work; a slight temp 90.2; had choking episodes; feels like her throat is closing up when she is eating; Food get stuck in my throat; sleeping all day; tired; Headache; Nausea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6201; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in left arm on 05Mar2021 as single dose for COVID-19 immunisation. Medical history included food allergies and meds allergies, anxiety, depression and blood pressure (abnormal). Concomitant medications included clonazepam (KLONOPIN) taken for anxiety from 2001, buspirone (BUSPIRONE) taken for anxiety from 2001, bupropion hydrochloride taken for depression from 2001, bupropion hcl taken for depression from 2001, and amlodipine besilate taken for blood pressure abnormal from 08Mar2021. On 05Mar2021 19:00, the patient experienced headache, and nausea. On 06Mar2021 19:00, the patient experienced sleeping all day, and was tired. On Day 2, she still had more side effects which wake her up. On 10Mar2021 19:00, the patient experienced had choking episodes, feels like her throat is closing up when she was eating, and food got stuck in her throat. On an unspecified date, the patient was upset and muscle spasms felt like something crawling in her leg and felt "crap"; she got to work but feeling like can't work. The patient reported that she had been having side effects and she was scared to have the shot because of her side effects and have when her body don't recognize it. She was asking when they go away. She has had a headache and nausea, was tired and sleeping all day. She felt like her throat was closing up when she eats. She had a choking episode and her grand daughter had to hit her on her back. She had choking episodes last night and this morning and she was now eating soft foods. She saw her doctor Monday for a regular appointment and she told him what happened. He wanted her to take the second dose but she was afraid to take it. She was afraid she will have worse side effects. Right now, she had nausea and drinking ginger ale. Her doctor called her which she was upset because he haven't seen her at all. Last time was 2019; and she just told him how she feel and want person to person. Patient reported she was not going to take 2nd dose because she do not want to go through anymore side effects. Everyone said that there were no side effects. That's wrong and she was having side-effects from day 1 on Friday night. There was an ingredient which she has allergies to. She told the nurse all meds allergies and food allergies which they told her that nothing in it will cause any side effects. They were wrong. She felt crap and she got to work but feeling like she can't work. Patient refused to take 2nd dose. Patient stated that she do not want to go through what she was going through now. The patient reported that she had a slight temp 90.2 on an unspecified date. The events required a visit to the physician office. The patient had no prior vaccinations (within 4 weeks). Outcome of events choking episodes, nausea, tired, feels like her throat is closing up when she was eating, Food get stuck in my throat was not recovered; sleeping all day was recovered on 07Mar2021; headache was recovered on 10Mar2021; and outcome of the rest of events was unknown.
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| 69 | 2021-03-20 | headache, sweating | Nausea, headache, sweating, overall body aches |
| 69 | 2021-03-20 | headache | Headache, diarrhea, nausea, welts on face, general weakness and body pains. |
| 69 | 2021-03-20 | fever, headache |
extreme headache, extreme eye ache, aching joints, queasy stomach, low fever, diarrheas. Lasted 2 da...
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extreme headache, extreme eye ache, aching joints, queasy stomach, low fever, diarrheas. Lasted 2 days
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| 69 | 2021-03-21 | fatigue, headache | headache, nausea, fatigue |
| 69 | 2021-03-21 | head discomfort |
Patient became dizzy and felt "pressure in her head" 10 minutes after vaccine administration. Vitals...
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Patient became dizzy and felt "pressure in her head" 10 minutes after vaccine administration. Vitals signs monitored and patient placed in a supine position. Symptoms resolved within 30 minutes.
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| 69 | 2021-03-21 | headache, fatigue, fever |
Had Covid 19 December 2020 with severe Total Body Aches, Headache, fatigue. Recovered after 4 weeks...
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Had Covid 19 December 2020 with severe Total Body Aches, Headache, fatigue. Recovered after 4 weeks bedrest. I had no pain at injection site till the next morning. I also felt I had Covid 19 all over again with fever 100.3 X 3 days. Tylenol would not take the symptoms away.
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| 69 | 2021-03-21 | malaise |
I felt dizzy, nausea, felt unwell, weak, faint, started to slump over, was collapsing, hands turn re...
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I felt dizzy, nausea, felt unwell, weak, faint, started to slump over, was collapsing, hands turn red, tightness in the upper part of my body, lips tingling, tightness / swelling in my cheeks and mouth, very severe headache. I was rushed over to ER. Next day still had tingling of lips, felt unwell. By third day, felt better. I had an anaphylactic reaction to the vaccine. Three of my systems were adversely effected. Dr. and others are UNDERREPORTING the anaphylactic reactions cases. Just because I didn't die or an Eppie Pen was not given to me. doesn't mean I should not be included in the statistics.
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| 69 | 2021-03-21 | fever, sweating |
Pain at site in arm, March 16th (day after) Diahhrea & low grade fever March 17th, 18th Friday, M...
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Pain at site in arm, March 16th (day after) Diahhrea & low grade fever March 17th, 18th Friday, March 19th, itching at injection site on left arm, no pain just very, very itchy Took Immodium, Wed 17th & 18th and Tylenol for low grade fever, sweating. Took Benadryl Sat. 20th after topical did nothing, Today, March 21st. No pain in arm just continues to itch at injection site
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| 69 | 2021-03-21 | fever, sleepiness, headache, fatigue |
Sunday after Saturday night vaccination I woke up with Headache, fever was 101.8, chills ,muscle ach...
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Sunday after Saturday night vaccination I woke up with Headache, fever was 101.8, chills ,muscle aches, very tired- spent day on couch sleeping-next day Monday I still have slight fever 98.9 but am feeling better. NOTE : Sunday at around 5;00 I had to take Excedrin tension headache 1 tab This got rid of my headache !
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| 69 | 2021-03-22 | chills, fever, fatigue |
Patient had adverse reaction to shot #1 including rash, increased heart rate, nausea so she decided ...
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Patient had adverse reaction to shot #1 including rash, increased heart rate, nausea so she decided that she wanted to get Moderna instead of Pfizer. Appointment was scheduled and she received her 2nd shot Moderna. Side effects included 3 days of severe symptoms of fatigue, nausea, vomiting, chills, fever and over all severe body aches. Aside from the above, no other reactions noted from 2 different vaccines. Patient was called and educated.
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| 69 | 2021-03-22 | headache, fatigue |
Symptoms: Severe headache, nausea, muscle aches, very tired, left arm pain, dizziness, weakness - be...
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Symptoms: Severe headache, nausea, muscle aches, very tired, left arm pain, dizziness, weakness - began some time in early morning of March 21 Called Emergency Room. Spoke to ER doctor who recommended: 2 Tylenol, 1/2 Benadryl, plenty of fluids, eating light, light activity level I followed these except used only 1 extra strength Tylenol which I repeated twice during the day. Spent most of day sleeping. Improvement by morning of March 22. March 22 - tiredness continued so limited activity.
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| 69 | 2021-03-22 | headache |
Day 1 - 10 hours after- tightness in upper chest/throat and soreness in left arm. Day 2 - Woke up wi...
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Day 1 - 10 hours after- tightness in upper chest/throat and soreness in left arm. Day 2 - Woke up with my finger joints stiff, swollen and throbbing with pain (this subsided on day 4) Day 3 - No symptoms Day 4 - Woke up with rash (burning) on right side of my neck, and headache.
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| 69 | 2021-03-22 | fever |
Severe vomiting repeatedly the night/morning after injection; fever; body aches; This is a spontaneo...
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Severe vomiting repeatedly the night/morning after injection; fever; body aches; This is a spontaneous report from a contactable consumer. A 69-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2, lot unknown as unable to locate, via an unspecified route of administration, administered in arm right on 18Feb2021 09:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Historical vaccine information included BNT162B2, brand Pfizer , dose 1, administered 28Jan2021 13:30 in the right arm. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported; acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]) taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. On "19Feb2021 09:00 PM", the patient experienced severe vomiting repeatedly the night/morning after injection. Then 48hrs later (in Feb2021) developed fever and body aches again. No treatment was received. Outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 69 | 2021-03-23 | chills, fatigue |
monday march 22nd shot at 10am , severe chills by 12midnight, took 1 tylenol every 6 hours through ...
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monday march 22nd shot at 10am , severe chills by 12midnight, took 1 tylenol every 6 hours through tuesday and feeling tired, slept by evening, starting to feel better and wednesday ok . did not call a dr.
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| 69 | 2021-03-23 | chills |
Just after midnight of the day I received the shot, I started getting the chills although I wasn't c...
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Just after midnight of the day I received the shot, I started getting the chills although I wasn't cold. The shaking escalated into seizure-like shaking, quivering, jerking. This lasted until approximately 7:00 a.m. My husband had to physically hold me and walk me to the bathroom. He gave me a bottle of water but I wasn't able to unscrew the cap nor hold the bottle and sip from it because my head and hand were shaking uncontrollably
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| 69 | 2021-03-23 | fatigue, body temperature increased, headache | 104.5 temperature Dizzy exhausted Body aches vomiting Severe diarrhea Headache |
| 69 | 2021-03-23 | fatigue, body temperature increased |
sore arm initially after injection on monday mar 22- next day arm was itchy and also felt tired and...
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sore arm initially after injection on monday mar 22- next day arm was itchy and also felt tired and had slight temperature of up to 99.6 the second evening-around the second day by 10PM felt great except arm felt very itchy (removed bandaid as thought maybe latex issue?) and tried not to scratch- wed morning mar 24, had swollen lymph nodes left arm and also red rash at injection site and a bit lower and off to one side and some raised red dots-had no issues with initial vaccine shot- baby book shows that I had delayed rash reaction to child hood vaccines in 1952
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| 69 | 2021-03-23 | fatigue, headache | Headache and extreme fatigue |
| 69 | 2021-03-23 | fatigue, headache |
Deep bone and muscle aches, severe headache, no appetite, dizzy and disoriented when standing, extre...
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Deep bone and muscle aches, severe headache, no appetite, dizzy and disoriented when standing, extremely tired, all began about 12 hours after injection. Adverse reactions started to subside about 12 hours after onset, and were completely gone after about 36 hours.
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| 69 | 2021-03-23 | lethargy, headache, fatigue, malaise, chills, fever |
Took the 1st shot Thurs. Feb 25, no effects, 21 days later took 2nd shot on Thursday 3/18/21. That n...
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Took the 1st shot Thurs. Feb 25, no effects, 21 days later took 2nd shot on Thursday 3/18/21. That night my arm was sore, came down with aches, headache, tiredness, then chills, fever, weakness, dry heaves, light headedness but did not passout. Stayed in bed for two days, Friday n Saturday. Got up Sunday layed around all day. Got up Monday, Tuesday and today, Wednesday the 24th with headache and feelilng blah, no energy. Vaccine site still slightly sore and itches too. still not feeling myself, today is Wed. Mar 24. May not have any bearing on vaccine but too much of a coincidence.
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| 69 | 2021-03-23 | lethargy, headache | Headache, tremendous back pain from neck to hips, legarthy |
| 69 | 2021-03-23 | throat pain |
Severe pain in spine, neck, chest, and arm. Started about 10 days after the vaccine. Sore throat, la...
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Severe pain in spine, neck, chest, and arm. Started about 10 days after the vaccine. Sore throat, lack of sleep, and lack of hunger or thirst.
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| 69 | 2021-03-24 | chills, headache |
Within 30-minutes of vaccination, the patient reported shortness of breath, chills, dizziness, and c...
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Within 30-minutes of vaccination, the patient reported shortness of breath, chills, dizziness, and chest pressure. EMS evaluated the patient on-site. The patient was hypertensive (223/180). EMS administered O2 2lpm via nasal cannula. In the ED, the patient reported they felt flushed with a headache. They remained hypertensive (167/89). ED physician admitted patient to inpatient telemetry unit for 1-day. Discharged with diagnosis of chest tightness with associated SOB and palpitations, reproducible on palpitation, troponin negative and EKG with no acute ST-T wave changes, no arrhythmia noted on telemetry, low likelihood of acute coronary syndrome. Patient was instructed to follow-up outpatient for PET stress test and 2D Echo.
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| 69 | 2021-03-24 | fatigue, headache, chills | Headache,chills, joint pain, fatigue, injection site pain, nausea |
| 69 | 2021-03-24 | headache | Searing headache, upset stomach, mild nausea. |
| 69 | 2021-03-24 | headache |
she started feeling tingling and numbness in her finger tips bilaterally, extended to her hands, sta...
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she started feeling tingling and numbness in her finger tips bilaterally, extended to her hands, started noticing in her bilateral toes; numbness in her finger tips bilaterally, extended to her hands, started noticing in her bilateral toes.; she was getting intermittent headaches; This is a spontaneous report from a contactable Physician reported for a patient. A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 17Feb2021 (Lot Number: EN6201) at age of 69-year-old at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at time of vaccination. Concomitant medication(s) included atorvastatin (LIPITOR). The patient previously took first dose of bnt162b2 on 27Jan2021 (Lot number=EL3262) at single dose for COVID-19 immunization. On 20Feb2021, she started feeling tingling and numbness in her finger tips bilaterally, extended to her hands. She reported after few days he started noticing in her bilateral toes. Patient also reported that she was getting intermittent headaches on 20Feb2021. The events resulted in emergency room/department or urgent care and hospitalization. The patient was hospitalized for 1 day. It was unknown if any treatment was received for the events. The patient underwent lab tests and procedures which included Nasal Swab SARS-CoV-2 Antigen: negative on 08Mar2021. The outcome of the events was not resolved.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events paraesthesia, hypoaesthesia and headache cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 69 | 2021-03-24 | headache |
PCP notified health department his ct reported when receiving her 2nd vaccine on 3/6/21, she did not...
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PCP notified health department his ct reported when receiving her 2nd vaccine on 3/6/21, she did not feel vaccine liquid going into her arm, asked the vaccinator if that was normal, told yes. PCP responded, not normal, called ?Moderna manufacturer (Pfizer was given per ct consent form), was told ct should have received another dose right at that time. 3/18/2021 a third dose of Pfizer vaccine was administered to the client as lead vaccine RN felt possible loss of too much vaccine when 2nd dose given, discussing with client she may have a strong reaction following this dose. 03/21/21- f/u phone call-ct very happy to have had a reaction! Sore, red, itchy arm and a bit of a headache after the third dose.
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| 69 | 2021-03-24 | fever |
Fever, muscle and joint aches, eyeball aches, loss of appetite, extreme fatigue. On the first day af...
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Fever, muscle and joint aches, eyeball aches, loss of appetite, extreme fatigue. On the first day after the second dose (Tuesday, March 16, 2021), I slept 19 hours, sat up for 1 hour, and went back to bed and slept another 16 hours. Upon waking on the second day after the vaccination (Wednesday, March 17, 2021), the fever had broken and the aches were not as severe but still present. No food or drink were consumed as I slept the entire time. On the third day after the vaccination (Thursday, March 18, 2021), aches were gone, but I was so weak with little energy. In addition, I had lost 3.5 pounds since the day of the vaccination. I could not find a thermometer (as well as was too tired to look), so I cannot tell you what my temperature was, but my face/forehead was hot to the touch.
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| 69 | 2021-03-25 | chills | mini chills |
| 69 | 2021-03-25 | headache | headache, vomiting |
| 69 | 2021-03-25 | headache | Headache, body aches, wanted to sleep. Ok the next day |
| 69 | 2021-03-25 | headache | Sore arm (muscle not injection) for 2 days and a headache for a week - and still having. |
| 69 | 2021-03-26 | chills |
About 20 Chicken pox-like papules (no pus or scab) emerging on the knuckles of 7 fingers, palm of le...
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About 20 Chicken pox-like papules (no pus or scab) emerging on the knuckles of 7 fingers, palm of left hand, above and below the knee on left leg, bottom of big toe on right foot. These 3-7mm papules(?) multiplied by day 2, some white heads in middle of red, inflamed and painful to the touch 3-7mm patches. When a few were lanced (to relieve pressure and be able to use my hands), they bled minimally, but no solids, fluid or pus. It wasn't until the afternoon of day two that I determined they were a result of the vaccine. Prior to that, I explored numerous possibilities and nothing fit. It was a Saturday, so I couldn't call my doctor. Throughout the evening of day 1 and all day 2 I had chills and some body aches.
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| 69 | 2021-03-26 | headache, sleepiness, chills, fatigue, fever |
Fever (afternoon and evening), chills (middle of the night until mid-morning), headache (2 days), fa...
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Fever (afternoon and evening), chills (middle of the night until mid-morning), headache (2 days), fatigue/sleepiness (2 days), loss of appetite (2 days).
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| 69 | 2021-03-26 | influenza like illness, fatigue |
Pfizer-BioNTech COVID-19 Vaccine EUA I had no symptoms after the first Pfizer vaccine. On Tuesday, ...
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Pfizer-BioNTech COVID-19 Vaccine EUA I had no symptoms after the first Pfizer vaccine. On Tuesday, March 23, 2021 I had the second vaccine and had flu symptoms the next day with body aches and fatigue. I felt better the day after that-Thursday. This morning, Saturday, as soon as I got out of bed, my face burned and turned bright red. I looked like I had a sunburn. My arms, especially around my elbows turned an angry red. They didn't burn as badly as my face. Around an hour later, the redness subsided, but my face still feels hot. I don't feel like myself and am taking it easy today. I want to report this so you are aware of the reaction. I take no medications and am extremely healthy. My last vaccine was in 1976.
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| 69 | 2021-03-26 | fever, fatigue, nasal congestion, chills, cough |
This is a 70 year old female with paroxysmal atrial fibrillation (anticoagualted on Eliquis), obstru...
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This is a 70 year old female with paroxysmal atrial fibrillation (anticoagualted on Eliquis), obstructive sleep apnea (uses CPAP), mitral valve regurgitation, remote tobacco use, hypertension and dyslipidemia who presents to the ED for worsening dyspnea, cough, subjective fever, chills and body aches that have been ongoing for the past several days. The patient indicates that her dyspnea is exacerbated with exertion but she denies chest pain, pleuritic chest pain, leg swelling or calf pain. She mentions that she has received both of her COVID-19 vaccines (Pfizer); the first immunization was on 02/25 followed by her second immunization which took place eight days ago on 03/18. She is not confident that she has had any contact with a known sick or definitive COVID-positive individual recently. Of note, the last documented incidence of testing for COVID-19 was performed on 10/31/2020 after the patient was seen at a Clinic after a exposure for a COVID-positive individual. Testing at that time had resulted negative. To her knowledge, she states that she had, in fact, tested positive for COVID-19 in late fall of 2020, but she was not hospitalized. Yesterday (3/26/2021), she was evaluated at a Pharmacy where she was testing for COVID-19 which has since resulted positive. The patient denies any other acute symptoms of illness. In the ED, the patient was found to have acute respiratory failure with hypoxemia and pneumonia due to SARS-CoV-2 infection. Review of Systems Constitutional: Positive for chills, fatigue and fever. Negative for activity change. Respiratory: Positive for cough and shortness of breath. Cardiovascular: Negative for chest pain and leg swelling. Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting. Genitourinary: Negative for dysuria. Musculoskeletal: Positive for arthralgias and myalgias. Negative for gait problem. Neurological: Negative for syncope. All other systems reviewed and are negative. Vitals Blood pressure 159/79, pulse 65, temperature 36.4 °C (97.5 °F), temperature source Oral, resp. rate 18, height 1.6 m (5' 3"), weight 107 kg, SpO2 98 %. Physical Exam Vitals reviewed. Constitutional: General: She is awake. She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is morbidly obese. She is ill-appearing. She is not toxic-appearing. Interventions: Nasal cannula in place. HENT: Head: Normocephalic and atraumatic. Nose: Congestion present. Mouth/Throat: Mouth: Mucous membranes are dry. Pharynx: Oropharynx is clear. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Decreased breath sounds present. Comments: Diminished breath sounds in all lung fields. Occasional cough. Abdominal: General: Bowel sounds are normal. There is no distension. Palpations: Abdomen is soft. Tenderness: There is no abdominal tenderness. Musculoskeletal: General: Normal range of motion. Cervical back: Normal range of motion and neck supple. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Behavior: Behavior is cooperative.
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| 69 | 2021-03-27 | body temperature increased, fatigue | Migraine, uncontrolled temp, fatigue, soreness |
| 69 | 2021-03-27 | chills, fatigue | Chills without fever, total body pain not just aches, mental fogginess, extreme fatigue |
| 69 | 2021-03-27 | chills, headache, fatigue, fever |
Chills, aches, headache, fatigue, and fever of 103.9 for 36 hours for the second shot. Fever was 101...
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Chills, aches, headache, fatigue, and fever of 103.9 for 36 hours for the second shot. Fever was 101.9 on first.
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| 69 | 2021-03-27 | fatigue, chills, headache, fever |
I;30 am--chills, fever, severe headache, body / joint aches.... 5:30 am-added nausea to above conti...
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I;30 am--chills, fever, severe headache, body / joint aches.... 5:30 am-added nausea to above continued all of 3/24--fever broke 3/25 @4:00am , then other gone with tiredness for rest of day 3/26--okay-back to normal, just little tired
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| 69 | 2021-03-27 | influenza like illness, chills, headache |
mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; jo...
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mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; joint/muscle pain; joint/muscle pain; injection site pain; headache; labored breathing; dry-heaving after second syncope; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: LOT 6205 (as reported)), via an unspecified route of administration in the right arm, on 08Mar2021, at a single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications included sertraline; docusate sodium, ferrous fumarate (FERRO-SEQUELS); and multivitamin - all taken for unspecified indications, start and stop dates were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6201) on 15Feb2021 17:00 in the right arm for covid-19 immunization at 69-years-old. The patient did not have covid prior vaccination. The patient did not receive any other vaccines in four weeks. The vaccine was given at the public health clinic. The following day on 09Mar2021 15:30 after a short walk, the patient experienced flu-like symptoms, chills, joint/muscle pain, injection site pain, headache, syncope (2x) with mild seizure, labored breathing, and dry-heaving after second syncope. The patient was then taken by ambulance to the ER (resulted in an emergency room visit) and was given saline fluids via IV. The vitals and EKG were "ok" on 09Mar2021. The patient recovered relatively quickly and was released. The only symptoms remaining on 11Mar2021 were mild headache and mild nausea. The patient had not recovered from headache and nausea at the time of the report; while recovered outcomes on Mar2021 for all the other remaining adverse events. The patient was not covid-tested post-vaccination.
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| 69 | 2021-03-27 | malaise |
I initially had 2 days or so of feeling very ill. Then ok for 5 days. Then second round of reaction...
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I initially had 2 days or so of feeling very ill. Then ok for 5 days. Then second round of reaction started. Intense pain and swelling of right side of neck for 3 days. Also left wrist unable to use. Pale, ill. Vital signs ok. Then on 3/8, pain switched to left side of neck and upper back. 3/10, right neck again with swollen lymph nodes bilateral. 3/11 back of neck and upper back hurts. Intense. Could not sleep. 3/12 pain in upper quads and hips, mid pack. Feeling freezing cold. Temp ok. Called my Dr. Right side of neck continued to hurts even now (3/28/2021) but at least I can function now. I no longer feel sick, brain fog, cold. So greatly improved but not normal. Reaction has lasted a month. Vaccine number one resulted in 2 days feeling ill with upper back pain, chills but only a few days. First night vomited, passed out. First vaccine reaction was frightening but was short lived. I am a retired RN.
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| 69 | 2021-03-28 | fatigue |
Patient states that she had numbness in both feet and legs. Several days later these symptoms were ...
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Patient states that she had numbness in both feet and legs. Several days later these symptoms were getting worse and she went into a seizure, lost control of her use of her legs, arms and her bladder. She called 911 and transported to y Hospital ER. She had MRI w/ negative results and was given fluids. She was released to go home. Pt has appt w PCP and will discuss her symptoms w/ them. Pt is still weak, has fatigue but can use her arms and legs. She is not able to do normal activities. She had her 2nd Covid dose on 3/26/21 @ 9:20 am in her right arm.
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| 69 | 2021-03-28 | fatigue |
Received Pfizer-BioNTech vaccine on 1/26/21 and 2/16/21. Presented to ED with fatigue and shortness ...
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Received Pfizer-BioNTech vaccine on 1/26/21 and 2/16/21. Presented to ED with fatigue and shortness of breath. Was found to have a GI bleed and was tested for COVID-19 prior to admission to hospital for treatment. Was admitted from 3/22/21 to 3/27/21 and reported only mild COVID-19 symptoms during stay.
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| 69 | 2021-03-28 | productive cough |
03/23/21: Patient presented and was admitted through the ED forof breath that has been present for a...
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03/23/21: Patient presented and was admitted through the ED forof breath that has been present for a week, getting worse with productive cough of whitish sputum's but in large amounts throughout the day. PMH significant to COPD. Stated she is been doing her neb treatments without improvement. Has had some constipation and left lower quadrant abdominal pain. on day of admission, chest x-ray showed bibasilar atelectasis with possible pneumonia. Rapid Covid 19 came back positive. Her D-dimer was elevated. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
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| 69 | 2021-03-29 | headache |
slight headache; extremely dizzy; joints ached; nauseated; felt really weak; This is a spontaneous r...
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slight headache; extremely dizzy; joints ached; nauseated; felt really weak; This is a spontaneous report from a contactable nurse (patient). This non-pregnant 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6202) via an unspecified route of administration in the left arm on 23Feb2021 at 07:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, COVID-19, tape allergy, and osteoarthritis all from unknown dates and unknown if ongoing. The patient reported taking concomitant medications. The patient previously received nubain for an unknown indication and experienced allergy, codeine for an unknown indication and experienced allergy, oseltamivir phosphate (TAMIFLU) for an unknown indication and experienced allergy, and amoxicillin sodium; clavulanate potassium (AUGMENTIN) for an unknown indication and experienced allergy.The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 23Feb2021 after receiving her injection, she went home and in a little while she had a slight headache. She took a muscle relaxer and went to bed around 11:30. When the patient got up to go to the bathroom, she was extremely dizzy, her joints ached, she was nauseated and felt really weak. The events were reported as non-serious and did not require hospitalization. The clinical outcomes of slight headache, extremely dizzy, joints ached, nauseated and felt really weak were recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.
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| 69 | 2021-03-29 | sweating |
Vertigo, loss of consciousness, vomiting, diarrhea, sweats, inability to control limbs to stand or w...
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Vertigo, loss of consciousness, vomiting, diarrhea, sweats, inability to control limbs to stand or walk, altered vision (white picasso slides),
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| 69 | 2021-03-30 | fatigue, fever |
Low grade fever (37.7); fatigue; achiness; This is a spontaneous report from a contactable consumer....
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Low grade fever (37.7); fatigue; achiness; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 26Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced low grade fever (37.7), fatigue and achiness on 27Jan2021. The symptoms onset day after vaccination; symptoms resolved within 24 hours. The patient underwent lab tests and procedures which included Low grade fever: 37.7 on 27Jan2021. Outcome of the events was recovered on an unknown date in Jan2021. Information on the lot/batch number has been requested.
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| 69 | 2021-03-30 | headache, nasopharyngitis |
Sick, minor cold; sick, minor cold; Watery eyes; headache; This is a spontaneous report from a conta...
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Sick, minor cold; sick, minor cold; Watery eyes; headache; This is a spontaneous report from a contactable consumer received from a Pfizer Sponsored Program Pfizer First Connect. A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL3302), intramuscular, administered in Arm Left on 21Jan2021 13:00 as single dose for covid-19 immunisation at Hospital. The patient medical history and concomitant medications were not reported. On 29Jan2021, The patient experienced sick, minor cold, watery eyes, headache. Patient has already got her first dose of the Covid vaccine on 21Jan2021. She took 600mg Ibuprofen two hours before getting the vaccine. She was reading that taking ibuprofen prior to getting the vaccine could have been a problem as far as the efficacy. on 29Jan2021, she started to get sick, she does not think it is related. She has a little cold. She wondered what she should do. She is scheduled for the second dose. HCP stated She will have the first consult with hcp on Monday. She does not have a hcp right now. no email When querying outcome of her cold, states it is different, on the night of the 29th she had watery eyes and a tiny headache. She sneezed twice maybe the next day. She is slightly nasally and now it has gone to her throat and down to her chest. It is like a typical cold. She does not think she had a fever, but she did not take her temperature. She did not take ibuprofen. She normally would take ibuprofen if she does not feel good. She knows she has a cold, she did not have a sore throat. Normally when she get sick she gets a sore throat and that nose like feeling, but with this cold her symptoms are super slight. Reports she has had some doozy colds in the past. She wanted to mention that Friday night she was in a car with a driver running errands, and she thinks she may have picked up a cold from the driver that was nasally and blew his nose. States when she gets a cold, she really gets a cold and this cold is minor compared to colds she has had prior. When she got the first shingrix shot, she developed a large red, swollen, elliptical circle thing that took up half of her arm from elbow to the top of the arm. She had two doses of the shingrix. When she took Benadryl and ibuprofen before getting the second dose of shingrix, she did not have a reaction. Patient took 1st dose of Covid vaccine and developed a cold about 8 days later. Patient also took 600mg of pain reliever and is now hearing that it can decrease the efficacy of the Covid vaccine. The action taken in response to the event for BNT162B2 was not applicable. The outcome of events was unknown.
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| 69 | 2021-03-30 | influenza like illness, fatigue, fever |
she had terrible stomach cramps; stomach upset; tired; low grade fever; flu like symptoms; This is a...
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she had terrible stomach cramps; stomach upset; tired; low grade fever; flu like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, in the left arm on 23Jan2021 at 09:00 (at the age of 69-years-old) as single dose for COVID-19 immunisation. The patient had no medical history and family history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not underwent any lab investigation. Caller, reporting on the BNT162B2 shot and who got the first shot on 23Jan2021 and want to know if any one else has these side effects. After the first vaccine, by Tuesday she was experiencing a low grade fever and flu like symptoms on 25Jan2021. The next day on 26Jan2021 she was better but tired. On the following day she was better. She explained that she knew that was side effects. A week later on 06Feb2021 she had terrible stomach cramps and stomach upset that have lasted for 3 weeks. She explained she was getting better but then after the second dose the events came back in full force. She explained that she has had loose stools and was going all day long to the bathroom. She has never had this problem, actually always has the opposite problem. She wanted to know if we have had any other reports like this. The stomach cramps are almost like mensural cramps all day long. She also has stomach upset and every time she eats, it goes right through her. The patient did not visit to emergency room and physician office. Caller did not mention testing positive for COVID during the call, only that this only happens when she has a virus. The events were assessed as non-serious by the reporter. Outcome of the events low grade fever, tired and flu like symptoms were recovered on 27Jan2021 and not recovered for other events.
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| 69 | 2021-03-30 | sinus congestion, headache, fatigue, cough |
Annoying headache; sinus congestion; cough; fatigue; This is a spontaneous report from a contactable...
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Annoying headache; sinus congestion; cough; fatigue; This is a spontaneous report from a contactable 69-year-old non pregnant female Other Health Professional reported for herself that:A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN,) via an unspecified route of administration on 03Feb2021 12:30 as SINGLE DOSE for covid-19 immunisation .Medical history included from an unknown date and unknown if ongoing. On 03-FEB-2021 15:00 patient experienced the Annoying headache and sinus congestion and cough and fatigue and outcome of the event was not recovered. No follow-up attempts are possible; information about lot number cannot be obtained.
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| 69 | 2021-03-31 | fever, chills, headache |
paralyzed with no sensation at all in her legs till her waist; headache; fever 101.2; weakness; chil...
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paralyzed with no sensation at all in her legs till her waist; headache; fever 101.2; weakness; chills; fell; This is a spontaneous report from a contactable Physician. A 69-year-old female no pregnant patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Mar2021 10:30 AM at single dose for COVID-19 immunisation. No pregnant at time of vaccination. Medical history included prior spinal cord trauma with rt foot drop. No Known allergies. No COVID prior vaccination. The patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 69-year-old, via an unspecified route of administration at single dose for COVID-19 immunisation. The patient started the next day on 11Mar2021 02:00 PM, after the 2nd shot with headache, fever 101.2 and weakness. Took Tylenol and went to have a nap. She woke up with still fever and chills, when she tried to get up she fell. She was currently in the hospital, paralyzed with no sensation at all in her legs till her waist. AEs resulted in Emergency room/department or urgent care, Hospitalization for 5 days, disability or permanent damage. Lab data included Nasal Swab on 11Mar2021: Negative. No COVID tested post vaccination. Solumedrol 1000mg IV were received. Treatments were received for the events. Outcome of the event was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 69 | 2021-04-01 | fatigue, headache |
Left side of neck, site of injection, elbow, joints and muscles down left side; Left side headache c...
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Left side of neck, site of injection, elbow, joints and muscles down left side; Left side headache continuing to spread; Left jaw, cheek, nasal area swelling; left eye sagging/ occasional eye droop; Tired; general aches mostly on left side; wobbly; hives; skin itching; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534 and expiration date not provided) via an unspecified route of administration, administered in left arm on 15Mar2021 15:45 as a single dose for COVID-19 immunisation. Medical history included hypertension, chronic dry eye, Bells Palsy, arthritis, allergies to penicillin, injected iodine and food sensitivities. The patient is not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan, multivitamin and ciclosporin (CEQUA). On 15Mar2021 15: 45, the patient experienced left side headache continuing to spread. Left jaw, cheek, nasal area swelling and left eye sagging (previous site of Bells Palsy attack)-Left side of neck, site of injection, elbow, joints and muscles down left side. She was tired and progressed to general aches mostly on left side and was somewhat "wobbly" on 15Mar2021 15:45. She later had hives and skin itching on an unspecified date in Mar2021 which lasted a couple of days. Tiredness continues and swelling in face and occasional eye droop at 4 days out. No treatment was given in response to the events. The outcome of the event fatigue was not recovered while the outcome of the rest of the events was recovered on an unspecified date in Mar2021. The patient has not been tested for COVID-19 post vaccination.
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| 69 | 2021-04-01 | fatigue |
Lung disorder; Post procedural complication; Shaking; Feeling down; Tiredness; This is a solicited n...
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Lung disorder; Post procedural complication; Shaking; Feeling down; Tiredness; This is a solicited non-interventional study report from the marketing program received from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (BNT162B2), intramuscular in Jan2021 (Batch/Lot number was not reported) as single dose, second dose intramuscular on 15Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; methotrexate sodium (METHOTREXATE SODIUM), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; adalimumab (HUMIRA, Solution for injection in pre-filled syringe), subcutaneous from 2015 (Batch/Lot number was not reported) to 2020, at 40 mg (40 mg,1 IN 2- 2), subcutaneous from 2020 (Batch/Lot number was not reported) and ongoing, at 40 mg (40 mg,1 IN 2- 2) for Moderate To Severe Rheumatoid Arthritis and lupus. Medical history included hatal hernia, blood clots on legs were not worsened with Humira, non smoker, abstains from alcohol, allergy to latex manifested by rash, allergy to Sulfa drugs manifested by upset stomach. Concomitant medications included lisinopril (LISINOPRIL) taken for blood pressure, start and stop date were not reported; ezetimibe (ZETIA) taken for blood cholesterol, start and stop date were not reported; folic acid (FOLIC ACID) taken for rheumatoid arthritis, start and stop date were not reported; esomeprazole magnesium (NEXIUM) taken for hiatal hernia, start and stop date were not reported; apixaban (ELIQUIS) taken for blood clots on legs, start and stop date were not reported; prednisone (PREDNISONE) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported; proline (PROLIN) taken for an unspecified indication, start and stop date were not reported; tramadol (TRAMADOL) taken for pain, start and stop date were not reported. The patient experienced lung disorder on an unspecified date with outcome of not recovered, post procedural complication on an unspecified date with outcome of unknown, shaking on an unspecified date with outcome of not recovered, tiredness in Jan2021 with outcome of recovered in Jan2021, feeling down on an unspecified date with outcome of unknown. Clinical course: Solicited report by a consumer of a 69 year old female with events of small tumor on thyroid, blood clot on both legs, coughing and shortness of breath and non-serious lungs issue caused by methotrexate, after surgery shaking a bit, tired and cloudy weather caused to feel down a bit with HUMIRA 40MG/0.4ML (ADALIMUMAB). The patient had a relevant medical history of hiatal hernia and blood clots on both legs. On unknown dates, the patient experienced lungs issue caused by methotrexate, after surgery shaking a bit and cloudy weather caused to feel down a bit. In 2016, the patient experienced blood clot on both legs. In Sep2020, the patient experienced small tumor on thyroid. On 01Sep2020, the patient experienced coughing and shortness of breath. In Jan2021, the patient experienced tired. In Jan2021, the tired resolved. Methotrexate and covid-19 vaccine were also considered suspect. In Sep2020, the patient was admitted in hospital for cough, shortness of breath and was treated with unknown oral and intravenous antibiotics. While she was in the hospital, it was discovered that she had a tumor on her thyroid. She had stayed a week in hospital. She also had a lung issue. It was discovered lots of scar tissue on lungs and according to the physician it might be from patient's lupus, rheumatoid arthritis or methotrexate. The physician said that it was caused by the methotrexate not the Humira. Methotrexate was stopped for her. Patient denied to have pulmonary fibrosis and said that according to her doctor she did not have it and she did not know her diagnosis as it was not discussed with her doctors. For problems in lungs, patient was on oxygen. Patient was off of Humira for three weeks. She had surgery on thyroid biopsy. After the surgery she was shaking a bit. She thought it was because of the anesthesia but she was fine shortly after. The biopsy results were inconclusive which looked like it was not cancerous but physician could not really tell patient if it was or it was not. On unknown date in 2020, patient had restarted Humira again. On 04Dec2020, patient had thyroid tumor removed and was on oxygen until 11Jan2021. Sometimes the cloudy weather caused patient to feel down a bit. She did not have any paper work for the blood test. It was unknown if patient was enrolled in a covid-19 vaccine trial. In Jan2021, patient received 1st dose covid-19 vaccine manufactured by Pfizer. On 15Feb2021, patient received 2nd dose covid-19 vaccine manufactured by Pfizer. The reported events except for coughing were serious as medically significant. The patient underwent lab tests and procedures which included biopsy: inconclusive in Oct2020 and in Dec2020, biopsy of tumor: inconclusive in Sep2020, blood test: unknown results in 2020, computerised tomogram of chest: unknown results in Oct2020, COVID-19 TEST: negative in 2020 and in 2020. The action taken in response to the events for bnt162b2 was not applicable, for methotrexate sodium was permanently withdrawn on an unspecified date, for adalimumab was dose not changed. The reporter's assessment of the causal relationship of the events with the suspect products bnt162b2 and methotrexate sodium was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Pfizer is a marketing authorization holder of methotrexate sodium in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of methotrexate sodium has submitted the same report to the regulatory authorities. Information on Lot/Batch number has been requested.; Sender's Comments: Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of events, cannot be completely excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 69 | 2021-04-01 | sweating |
face numbing/numbness on face; fast heart beat; face numbing burning; sweating; This is a spontaneou...
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face numbing/numbness on face; fast heart beat; face numbing burning; sweating; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration, administered in right arm on 05Mar2021 13:45 as a single dose for COVID-19 immunisation. Medical history included high blood pressure and stroke. The patient is not pregnant. It was not sure if there were known allergies. The patient did not receive other vaccine within 4 weeks prior to the COVID vaccine but took other medications in two weeks (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included unspecified medication. On 05Mar2021, within one hour of the vaccine, the patient experienced face numbing burning, sweating, fast heart beat and numbness on face that will not go away all day every day since the vaccine. The events resulted in Emergency room/department or urgent care and eventually hospitalization on an unspecified date for 2 days. It was unknown if treatment for the events were given. The patient underwent COVID test post vaccination via Blood test/ CBC differential on 05Mar2021 and was negative. The outcome of the events was recovered with sequelae on an unspecified date in Mar2021. Information about lot/batch number has been requested.
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| 69 | 2021-04-01 | pneumonia, headache, cough, chills |
3/13/21 Pt presented to an urgent care with generalized aches, chills, HA, diarrhea and cough. Nasal...
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3/13/21 Pt presented to an urgent care with generalized aches, chills, HA, diarrhea and cough. Nasal swab was positive for SARS-CoV-2 and she was diagnosed with COVID-19. 3/17 She presented to ED w/ cough, HA, weakness and decreased appetite. Room air pulse ox was 88%. She was found to have bilateral infiltrates on CRS and was hyponatremic. She was admitted to the hospital on oxygen and decadron.. On 3/18 she was weaned off oxygen. She was discharged to home on 3/19 to complete a 10 day course of decadron.
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| 69 | 2021-04-03 | fatigue |
inner ear disorder; debilitating; extreme dizziness; nausea; vomiting; stomach discomfort; slight we...
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inner ear disorder; debilitating; extreme dizziness; nausea; vomiting; stomach discomfort; slight weakness; This is a spontaneous report from a contactable consumer. A 69-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN5318), via an unspecified route of administration, administered in Arm Left on 25Jan2021 13:30 (at the age of 49-years-old) at a single dose for COVID-19 immunization. Medical history included blood pressure, cholesterol and seasonal allergies. Blood pressure and cholesterol controlled by meds. Other medical history included drug hypersensitivity. The patient was known allergies to Codeine, Erythromycin, Septra, Sulfa drugs, Vicodin, Medrol. The patient's concomitant medications were not reported.. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced inner ear disorder, very debilitating, extreme dizziness, nausea, vomiting on 27Jan2021 at 08:30 AM. The patient had inner ear problems before, 5 or 6 in my lifetime. She was still experiencing some stomach discomfort and a slight weakness. She had no idea if her inner ear problems this week are related to the vaccine or not. The outcome of events were recovering.
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| 69 | 2021-04-05 | fatigue, headache |
On 3/24, I woke up nauseous, extremely fatigued, with sore joints, headache, and abdominal pain. A ...
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On 3/24, I woke up nauseous, extremely fatigued, with sore joints, headache, and abdominal pain. A few days later I noticed I had extreme shortness of breath. I went to see my PCP on or about 3/31. He listened to my heart and discovered a rapid heartbeat. He then took an EKG. He wanted to put me on lifetime meds immediately. I was in shock because I truly believe this is a reaction to the COVID vaccine. I have never had arrhythmia. In fact, I had a wellness visit with the Dr. about 3 months previously and all was good. I have been seeing him for four years since I moved. He does not think my new diagnosis is related to a vaccine reaction, but I find it highly suspect that 4 other women in my large circle of friends also have AFIB after 2nd shot. I spent Easter in the ER and they pumped Metoprolol in my bloodstream. I did not stay in the hospital that night. I went to see the Dr. on Monday morning on 4/4. He prescribed Metroprolol 25 mg and Xarelto 20 mg IMMEDIATELY. I picked up the meds and started this regimen. In speaking with other women, I believe this terrible diagnosis is a direct result as a reaction from the vaccine.
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| 69 | 2021-04-06 | fatigue |
If she laid her arm on it, it was painful on the left side where she got the injection between her l...
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If she laid her arm on it, it was painful on the left side where she got the injection between her left breast and axilla; couldn't go back to sleep; very tired; weak; She had the lump and that was in the lymph node; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; irregular heart beats; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; baseball sized lump. It was hard/where she got the injection; It looked like it was connected to the breast because it was so huge.; Fever blister; heart beating so out of rhythm; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in arm left on 18Mar2021 at 12:20 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing coeliac disease; hypothyroidism, is diabetic and has irregular heartbeat from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine taken for hypothyroidism; hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN/HCTZ MYLAN) taken for blood pressure measurement; metformin, glipizide and pioglitazone hcl taken for diabetes mellitus; acetylsalicylic acid (ASPIRIN 81) taken for thrombosis; metoprolol taken for heart rate irregular, cyanocobalamin (VIT B12) taken for an unspecified indication, all from an unspecified start date and ongoing; famotidine, rosuvastatin, vitamin d2, vitamin d3 and potassium, all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (lot number: EN6198, NDC: 59267-1000-1, expiry: unknown) on 27Feb2021 at 1:40PM for COVID-19 immunisation. The patient got her last shot on 18Mar2021. The first day was fine. She woke up the next morning at three or four with her heart beating so out of rhythm it was crazy. It took almost the whole day. She called her cardiologist and couldn't get into them and she didn't want to go to the ER. She didn't have a way to prove any of that. She also got a baseball sized lump. It was hard. If she laid her arm on it, it was painful on the left side where she got the injection between her left breast and axilla. It extended underneath the axilla. She wasn't able to get in with the cardiologist because she waited to late in the day. She couldn't get off the couch that day because her heart was so out of rhythm. She was very tired and wanted to just lay down. She hates going to the hospital. She doesn't want to go to the hospital. She has a history of irregular heartbeats. She should have gone in and had an EKG. She has pictures of the lump if those are needed. HCP information: Her doctor had said if she had anything like any abnormal heart beats to come in and get an EKG. She also had a fever blister on 22Mar2021 that she hasn't had in years and was asking if this influences her immune system. She had the lump and that was in the lymph node and now a fever blister on the top lip. Heart beating so out of rhythm: it lasted all that day. She took a nap after she talked to the doctor's office and slept for several hours. When she woke up it was kind of back in rhythm, but it was going in and out. It wasn't as frequent as it was prior to nap. Prior to the nap it was almost continuous. It slowed down a lot on the 19Mar2021 and was gone by 20Mar2021. Outcome of event: She has PAC's and PVC's anyway. That is why she follows up with the cardiologist. They haven't been so out of rhythm as they were after the vaccine. She couldn't go back to sleep. She still has them occasionally and that is kind of normal for her. She was weak and tired. Baseball sized lump: it has gone down. She took pictures to show her friends who were all getting the shots. It is gone now. It might have started on 20Mar2021. She woke up with the lump on Saturday. She has recovered completely. Her daughter said she needed to get it checked out. Reporter had heard of a lump on the breast was a side effect. It looked like it was connected to the breast because it was so huge. Seriousness criteria: It was irritating because it was so big. It was painful if she put her arm down. It was like her breast were engorged. Causality: Heart beating so out of rhythm: she hasn't had it that bad, so she thinks it was. She had it a long time ago, maybe once before, but it never lasted that long or took her down like that. She is not the only one that has had the complaint of irregular heartbeats. She put on social media what she experienced and how weak she got. Several friends said that happened to them as well. She doesn't know their history. Reporter declined to do a report on her friends. That was another reason she didn't go to the hospital. She thought it was a normal side effect. She thinks she found on her paperwork about the lump in the lymph nodes. The patient underwent lab tests and procedures which included electrocardiogram: unknown results and heart rate: irregular on an unspecified date. The outcome of the event fever blister was not recovered, while of the rest was unknown. Reporter seriousness for heart beating so out of rhythm was reported as disabling.; Sender's Comments: Based on the information currently available and the plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events 'heart beating so out of rhythm ', 'baseball sized lump (where she got the injection/It looked like it was connected to the breast because it was so huge)' cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 69 | 2021-04-06 | fever |
Mild syncope; Mild syncope; Low grade fever; Arm soreness 1st 24 hours; This is a spontaneous report...
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Mild syncope; Mild syncope; Low grade fever; Arm soreness 1st 24 hours; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN9581), via an unspecified route of administration in left arm on 02Mar2021 13:30 (at the age of 69-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's first dose of bnt162b2 (lot not reported) (at the age of 68-years-old) in left arm on 01Feb2021 at 14:00 for Covid 19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have other vaccines within 4 weeks prior to the COVID vaccine. Medical history included mild syncope episodes and pacemaker. The patient had no allergies to medications, food, or other products. Concomitant medications included alondranate, calcium, metropolol and an unspecified multi vitamin. The patient experienced arm soreness in the first 24 hours on 02Mar2021. Mild syncope and low grade fever 20 days after dose 2 (on 21Mar2021 at 13:00). The treatment received for the adverse events was paracetamol (TYLENOL). The outcome of all events was recovered on 03Mar2021 for pain in extremity and in Mar2021 for the rest of the events.
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| 69 | 2021-04-07 | chills |
vision loss; Severe Migraine over her right eye; blurriness, can't see out of right eye, very blurry...
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vision loss; Severe Migraine over her right eye; blurriness, can't see out of right eye, very blurry was reported as worsened; Body Aches; Nausea; Chills; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), batch lot number unknown, on 22Mar2021 at 09:15 (at the age of 69-year old) at single dose for COVID-19 Immunization. Relevant medical history was not reported. The patient received first dose of the same vaccine on 01Mar2021, on the left arm. Caller states that she has usually gotten sick with the flu shot. Concomitant medications were not reported. On 22Mar2021 the patient experienced chills. On 23Mar2021 the patient experienced nausea, body aches and severe migraine over her right eye and vision loss. She stated that when she covered her good eye she could not see the couch due to blurriness in the right eye. The patient was treated with ibuprofen and acetaminophen (TYLENOL), used hot packs, cold packs and a hot water bottle.The patient recovered from chills on 23Mar2021, she was recovering from nausea and body aches but was not recovered from severe migraine over right eye and can't see out of right eye, very blurry (reported as worsened). Information about lot/batch number has been requested.
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| 69 | 2021-04-07 | fatigue, malaise |
a week after both COVID-19 vaccinations (Pfizer) patient had sudden onset of shortness of breath and...
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a week after both COVID-19 vaccinations (Pfizer) patient had sudden onset of shortness of breath and chest pain with extreme fatigue and malaise. This happened for 3 days after 1st vaccine. Recovered 90%. Same symptoms onset a week after 2nd COVID-19 vaccine but symptoms were a little worse and did not resolve
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| 69 | 2021-04-09 | fatigue, headache |
she got really tired; She started having problems on 12Mar2021 & went to the Emergency Room on 24Mar...
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she got really tired; She started having problems on 12Mar2021 & went to the Emergency Room on 24Mar2021 & was diagnosed with Bells Palsy; he had a severe headache, as well. She said the headache felt like major pressure and pain on the right side of her head, specifically behind her right ear; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (BNT162B2, Formulation: solution for injection, Lot number - EN6206, expiry date- not reported) via an unspecified route of administration in right arm on 10Mar2021 at 12:00 PM as single dose for COVID-19 immunization. Medical history included ongoing type 1 diabetes mellitus Stated she has had Type 1 Diabetes Mellitus for about 50 years, sleep apnoea syndrome for years, thyroid disorder and influenza immunisation. Concomitant medication(s) included trazodone. On 12mar2021, the patient started having problems on 12mar2021 & went to the emergency room on 24mar2021 & was diagnosed with bells palsy and he had a severe headache. She said the headache felt like major pressure and pain on the right side of her head, specifically behind her right ear and she got really tired. The outcome of bells palsy is recovering whereas the outcome of headache and tired is recovered and unknown respectively. The patient underwent lab tests and procedures which included computerised tomogram: normal on 24Mar2021 and computerised tomogram head: normal on 24Mar2021. Therapeutic measures were taken with events. The patient took Prednisone and Venlafaxine for Bell's palsy and myalgia pain and trazodone taken for sleep apnoea syndrome. The other medication used for events were Valtrex, Tylenol and Acetaminophen.
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| 69 | 2021-04-11 | fatigue |
Initial nausea and vomiting two weeks after administration, followed by progressive dementia-like sy...
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Initial nausea and vomiting two weeks after administration, followed by progressive dementia-like symptoms, including fatigue, muscular weakness and tremor, confusion, memory problems, lack of concentration. Abandonment of previously routine household and personal tasks. Inattentiveness to personal hygiene. Inability to perform previously routine tasks. Notable lack of concern about lost physical and mental capabilities.
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| 69 | 2021-04-13 | headache |
Weakness in left leg, blod clots in lungs, severe headaches continuing I went to emergency on Febru...
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Weakness in left leg, blod clots in lungs, severe headaches continuing I went to emergency on February 23, 2021 where I treated for weakness in left leg and was admitted to hospital where I received treatments for a double pulmonary embolism on March 1.
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| 69 | 2021-04-14 | dehydration, fatigue |
patient has become extremely fatigued and is experiencing bodyaches for several days. she had the sa...
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patient has become extremely fatigued and is experiencing bodyaches for several days. she had the same thing happen to her after the first shot, but this only lasted for 2 days and resolved. this time her symptoms are lasting for 4 days and because they are not resolving, she is in the ED. she is also found to be clinically dehydrated
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| 69 | 2021-04-14 | headache, chills | Severe headache, long lasting cramps over entire night in both legs, and chills |
| 69 | 2021-04-16 | chills, sweating, headache |
She was so dizzy; Stool black; Explosive bowel movements; hot and cold chills; hot and cold chills; ...
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She was so dizzy; Stool black; Explosive bowel movements; hot and cold chills; hot and cold chills; drenched in sweat; walker to back up in the bed; Nauseous; Sore arm; Slight headache; This is a spontaneous report from a contactable consumer (the patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; Lot Number: EM9810), on the morning of 16Feb2021 09:58 (at the age of 69-years-old) intramuscularly in the right arm as a single dose for COVID-19 immunization. The patient's medical history included knee replacement surgery years ago, dyslipidemia, depression, insomnia, constipation problems; she was taking clopidogrel (PLAVIX) because she had a hole in her heart last year (2020). This was fixed (on an unspecified date), and she was only taking PLAVIX once a day for one year, which will be until Jul2021; the patient called it a hole in her heart because that was what her heart specialist told her. Concomitant medications included: clopidogrel bisulfate (PLAVIX) taken for hole in heart from Aug2020 and ongoing, venlafaxine hydrochloride (EFEXOR), simvastatin (ZOCOR), and temazepam. The patient had an allergic reaction to sulfamethoxazole/ trimethoprim (BACTRIM), and she was also allergic to hydrocodone bitartrate/ paracetamol (VICODIN). On 17Feb2021, had a slight headache and a sore arm. On Friday, 19Feb2021, she woke up very nauseous to her stomach; no treatment received. The patient had hot and cold chills really bad. Her head was just drenched in sweat and this occurred all day long. When she did go to use the restroom and had a bowel movement, her stool was black. It was like black tar around 10:00 or 11pm, it was bad. Every time she sat down to use the bathroom, the sweating would get more intense and every time she would get up and use the restroom, she had to use a walker. Then, she used the walker to back up in the bed (19Feb2021), and she seemed to be okay. It seemed like the sweats would go away and she would get the cold chills. The patient just put a heating pad on her stomach, and this occurred all day long until Saturday morning. She mentions she does have constipation problems, but this was explosive. She couldn't get to the restroom a few times. She had several explosive bowel movements on 19Feb2021 10:00. Her husband brought the garbage pail in the bedroom and she did use plastic on the bedding. By 11:30-12pm on Saturday (20Feb2021), it completely stopped, but she was still sweating. She was so dizzy. It would hit her so bad and her head as wringing wet. However, when she would get back in the bed and lay down flat, the sweating would go away, and she would start to get the cold chills. The patient explained the sweating/hot and cold chills went away by yesterday afternoon (unspecified date). She was able to walk back and forth to the restroom with no problems. She verified all of her symptoms have improved. On 02Apr2021, the patient reported she received the second dose of the vaccine on 09Mar2021. The patient reported that sore arm and chills were important medical events, for which no treatment was received. Treatment received for diarrhea included "limgen". The outcome of explosive bowel movements and stool black was recovered on 20Feb2021, and the other events recovered on an unspecified date. Follow-up (02Apr2021): New information received from a contactable consumer includes: medical history, product data, concomitant medications, and event details. Case upgraded to serious. Follow-up attempts are completed. No further information is expected.
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| 69 | 2021-04-16 | cough, body temperature increased, chills, fatigue, pneumonia |
Adverse effects chronology: Mar 25 sore arm only Mar 26 cough, diarrhea, dizziness, fatigue, loss of...
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Adverse effects chronology: Mar 25 sore arm only Mar 26 cough, diarrhea, dizziness, fatigue, loss of appetite Mar 27-30 all symptoms intensified daily, intermittent chills started on 29th Mar 31 all symptoms intensified, started using Albuterol inhaler Apr 1 all symptoms intensified, room spinning dizziness resulted in fall, temperature 99.9F Apr 2 Hospital emergency room, covid tests negative, diagnosis: diverticulitis and pneumonia. 3 intravenous antibiotics started metronidazole, clindamycin, rocephin Apr 3 admitted to hospital floor, continued antibiotics Apr 4 electrolyte infusion series started Apr 5 cough lessening, continued antibiotics and electrolyte infusions Apr 6 covid test negative Apr 7 transferred to rehab facility, continued antibiotics, electrolyte drinks Apr 8-14 antibiotic courses allowed to expire, symptoms improving, appetite returning slowly (lost 15 lbs), negative covid test Apr 15 released to home Apr 16 diarrhea stopped, slight dizziness remains, appetite improving
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| 69 | 2021-04-17 | chills, headache |
heart palpitations; Slight headache; Muscle Aches; Left arm hurt; chills; Very high blood pressure; ...
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heart palpitations; Slight headache; Muscle Aches; Left arm hurt; chills; Very high blood pressure; This is a spontaneous report from a . A contactable consumer (reported for herself). The 69-year-old female patient received first dose BNT162B2 (Pfizer Covid-19 Vaccine Lot Number: EP7534 and Expiry date: Unknown) via an unspecified route of administration on left arm at a SINGLE DOSE on 18Mar2021, for COVID-19 immunization. Medical history and concomitant medication were not reported. On 18Mar2021 (the night she received the Pfizer Covid Vaccine, dose one) she woke with her heart pounding (heart palpitations), slight headache, muscle aches, and left arm hurt. When she went to the doctor, on an unspecified date in Mar2021, they took her blood pressure, and it was very high. It was stated that she went to primary care physician and then she was sent to a Cardiologist. On 26Mar2021, she underwent electrocardiogram and echocardiogram, results were normal for both the investigations. On the same day 26Mar2021, she also had Holter monitor test done (electrocardiogram ambulatory) however the results were pending. On 20Mar2021, the patient recovered from the events of slight headache, muscle aches, left arm hurt and high blood pressure, the outcome of the event of pounding heart was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 69 | 2021-04-26 | influenza like illness, headache, chills |
(Pfizer shot #2)? serious flu like symptoms including full body aches requiring pain pills for relie...
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(Pfizer shot #2)? serious flu like symptoms including full body aches requiring pain pills for relief, chills, severe headache, and sudden onset of lightheadedness accompanied by nausea . Felt like I was going to pass out and throw up simultaneously. Symptoms persisted for approximately 36 hours requiring me to miss work for two days.
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| 69 | 2021-04-26 | nasopharyngitis, productive cough |
shortness of breath; productive cough; a lot of throat congestion; she felt like she woke up with a ...
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shortness of breath; productive cough; a lot of throat congestion; she felt like she woke up with a cold; felt hot; she couldn't sleep,; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737, expiration date: 30Jul2021, NDC number: 59267-1000-02), via an unspecified route of administration, administered in the left deltoid on 08Apr2021 10:30 at single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia. Patient stated she has had fibromyalgia for about 20 years. She said she had a fibromyalgia flare up with increased back pain, and had a Toradol 60mg intramuscular injection in her left hip on Tuesday, 06Apr2021. Concomitant medication included ketorolac tromethamine (TORADOL) for fibromyalgia from 06Apr2021. It was reported she had her first COVID-19 vaccine injection on Thursday 08Apr2021 at 10:30AM. She said that night (08Apr2021) she couldn't sleep and woke up at 3:00AM (09Apr2021) with shortness of breath, productive cough, and throat congestion. She said she had so much throat congestion, she could hardly talk. She clarified she felt like she woke up with a cold. She said she still had the productive cough, but her other symptoms went away by 8:30AM-9:00AM on 09Apr2021. She said she hadn't had a cold in 4 years. She said she read something on the internet that suggested her symptoms may be due to having the COVID-19 virus prior to getting the COVID-19 Vaccine. She said if she had the COVID-19 virus prior to getting her first COVID-19 Vaccine, she was totally asymptomatic. She said she wanted to know what she should do. Patient further reported she felt her shortness of breath was medically significant because she was mouth breathing. She clarified she felt hot during that time, and took her temperature, which was 97 degrees. She said she thought the fact she was hot was medically significant because she thought she may have a bad respiratory infection or something. The patient was not brought to the emergency room or physician's office in response to the events. The patient recovered from shortness of breath, felt hot, throat congestion on 09Apr2021; recovering from productive cough, and unknown outcome for the remaining events. The events were assessed as related with bnt162b2.
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| 69 | 2021-04-28 | fatigue |
it'll feel like little flutters; Heart palpitations; Shortness of breath; Didn't feel like normal se...
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it'll feel like little flutters; Heart palpitations; Shortness of breath; Didn't feel like normal self; Site pain; Chest pressure; Difficulty sleeping because of heart rate; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EP7534), via an unspecified route of administration administered in right arm on 29Mar2021 at 09:20 (at the age of 69-year-old) at hospital facility as SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within four weeks. The patient had no relevant medical history. Patient reported that she has people in the family that have had heart problems. Concomitant medication included unspecified vitamins. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EM9990 or EM9890) administered in the right arm on 08Mar2021 (at the age of 69-year-old) for COVID-19 immunisation and had a little fast heart rate but not constant, little fatigue and site pain. The patient previously took steroid injections 2 years ago (2019) and had heart palpitations before. The patient further mentioned that normally after the steroids wear off, the heart palpitations go away. The patient reported that she did not have any problems following the first dose of the COVID-19 vaccine. Caller reported that she had a little fatigue and site pain for just a couple of days but that everything was fine. Patient reported that she felt a little heart palpitations for maybe a day or two and then it was gone following the first dose of the COVID-19 vaccine. After she got the second dose of the COVID-19 vaccine on 29Mar2021, she noticed the heart palpitations again and a little shortness of breath. The heart palpitations and shortness of breath were nothing that she felt that she had to run to the emergency room or anything over. The patient reported that now it was getting difficult for her to sleep sometimes at night because of the heart rate. The patient also reported that she was trying to figure out that from this length of time between her second dose of the COVID-19 vaccine on 29Mar2021 and time of call on 14Apr2021, could the heart palpitations be a side effect from the COVID-19 vaccine. Patient also mentioned that when she experienced heart palpitations before, a whole work up was ordered and she was referred to cardiology and that nothing was found during the work up after previous experience with heart palpitations. The patient also mentioned that she has been fine, that she has been able to work and walk and that she gets her 10,000 steps every day. After getting the COVID-19 vaccine, she was tired and didn't feel like her normal self. The patient also reported that when the time had arrived to get the second dose of the COVID-19 vaccine, about a week before, she may have had a little fast heart rate but not constant. It was also reported that following her second dose of the COVID-19 vaccine on 29Mar2021, the fatigue started about the same time as it did following the first dose, on the second day post-vaccine on 30Mar2021. Patient reported that she was kind of tired and just taking a nap during the day. The fatigue was still ongoing. It was also reported that patient was starting to feel better other than the heart palpitations. The patient reported that yesterday, 13Apr2021, she felt great and could do her normal routine, other than feeling chest pains and palpitations. The heart palpitations are not constant, but are more regular during the day than she was used to. The heart palpitations were really bad last night, 13Apr2021, and that she had difficulty sleeping because of heart rate (couldn't hardly sleep at all). The patient's doctor was scheduling her for an echocardiogram. The patient's doctor did an electrocardiogram (EKG) on her on 08Apr2021 and there was nothing there (normal). The patient's doctor was scheduling her for a stress echocardiogram. The patient also mentioned that after returning from the physician's office, her husband went back and looked at the symptoms from the COVID-19 vaccine information sheet. The patient reported that her husband thought that she needed to call to eliminate everything, that they are trying to figure out why the patient was experiencing the heart palpitations. The patient also mentioned that 2 days ago she got on her treadmill to walk and went for 30 minutes. Patient reported that it normally takes her 5 minutes to recuperate, but that time it took her 20 minutes before she felt comfortable after her walk. The patient also reported that the site pain was nothing serious following both doses of the COVID-19 vaccine. The site pain began shortly after receiving the vaccine and went away after the second day following both vaccines. The shortness of breath probably started about 5 days after she got the second dose of the COVID-19 vaccine. The shortness of breath wasn't enough that she felt that she needed to run to the emergency room. It just felt like when she would breathe, especially at night as she normally breathes with her mouth closed at night, the patient felt like she had to open her mouth to breathe because she can still feel the pressure in chest. The patient was still experiencing the heart palpitations. The heart palpitations are a little worse because they happen so often. Patient reported that initially, she would have a few heart palpitations and then go for hours with none. Patient reported that now, she was feeling the heart palpitations quite a bit. Patient reported that it feels kind of like a little pressure in her chest and then it'll feel like little flutters. The patient further reported that she experiences a little pressure in her chest when she experiences the heart palpitations. At times, the chest pressure would go away, but she always feels the chest pressure there now. The chest pressure has gotten worse over the past couple of weeks and that she was thinking that it would go away like the first one did. Patient reported that she went to the doctor last week and was given an EKG. Patient reported that the EKG was fine and that her physician was scheduling other tests to make sure it's nothing with her heart. The patient didn't think that the heart palpitations and shortness of breath were from the COVID-19 vaccine, but that her husband looked at the vaccine information paper after her doctor's appointment and said she should call Pfizer. The patient had not yet recovered from heart palpitations, shortness of breath, fatigue, and chest pressure while outcome of the rest of the events was unknown.
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| 69 | 2021-04-30 | chills, fever |
body ache; fever 100.6; Chills; Muscle ache; This is a spontaneous report from a contactable consume...
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body ache; fever 100.6; Chills; Muscle ache; This is a spontaneous report from a contactable consumer. A 69-year-old Female consumer reported in response to Non-HCP letter sent in cross-referenced case which included that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration, in arm left on 09Feb2021 12:45 (at the age of 69-year-old) as single dose for COVID-19 immunization. The patient medical history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, in arm left on 19Jan2021 12:30 as single dose for COVID-19 immunization and experienced headache, chills, fever and muscle ache. Patient concomitant medications were not reported. No other product(s) were taken together with the COVID-19 vaccine. illness at time of vaccination was None. On 09Feb2021 at 20:00, patient experienced body ache, fever 100.6, chills, muscle ache lasted about 24 hrs. The patient underwent lab tests and procedures which included body temperature: 100.6 on 09Feb2021. Adverse events did not require visit to Emergency room nor Physician Office. Seriousness of the event was reported as non-serious. The outcome of events was recovered. No follow-up attempts are possible. No further information is expected.
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| 69 | 2021-04-30 | cough, body temperature increased, pneumonia, fatigue, chills |
This is a spontaneous report from a contactable pharmacist (patient). A non-pregnant 69-year-old fem...
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This is a spontaneous report from a contactable pharmacist (patient). A non-pregnant 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 24Mar2021 at 15:30 (at the age of 69 years old) (Lot Number: ER8732, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, asthma, hypertension, penicillin allergy, and sulfonamide allergy. Concomitant medications included etanercept (ENBREL) from an unspecified start date to 21Mar2021; prednisone; and unspecified blood pressure medication. The patient also received first dose of BNT162B2 for COVID-19 immunisation in left arm on 03Mar2021 at 15:00 (at the age of 69 years old) (lot number: EN6199, unknown expiration). On 25Mar2021, the patient experienced sore arm. On 26Mar2021 at 12:00 PM, the patient had cough, diarrhea, dizziness, fatigue, and loss of appetite. From 27 to 30Mar2021, all symptoms intensified daily and had intermittent chills on 29Mar2021. On 31Mar2021, all symptoms intensified, started using Albuterol inhaler. On 01Apr2021, all symptoms intensified, the patient experienced room spinning dizziness resulted in fall and had temperature 99.9F. On 02Apr2021, the patient visited (hospital name withheld) emergency room, COVID tests negative (Nasal Swab), diagnosis: diverticulitis and pneumonia. Three intravenous antibiotics started metronidazole, clindamycin, and Rocephin. On 03Apr2021, the patient was admitted to hospital with continued antibiotics. On 04Apr2021, electrolyte infusion series started. On 05Apr2021, cough lessening, continued antibiotics and electrolyte infusions. On 06Apr2021, the patient had COVID test negative (Nasal Swab). On 07Apr2021, the patient was transferred to rehab facility with continued antibiotics and electrolyte drinks. From 08 to 14Apr2021, antibiotic courses allowed to expire, symptoms improving, appetite returning slowly (lost 15 lbs; started in Apr2021), negative COVID test (Nasal Swab). On 15Apr2021, the patient was released to home. On 16Apr2021, the patient's diarrhea stopped, slight dizziness remains, appetite improving. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination. The patient received metronidazole, clindamycin, rocephin, electrolytes as treatment for the events. The events resulted in emergency room/department or urgent care visit. The patient was recovering from events diverticulitis, pneumonia, sore arm, cough, dizziness/room spinning dizziness, fatigue, loss of appetite, intermittent chills, fall, and temperature 99.9F. Outcome of lost 15 lbs was unknown. The patient recovered from diarrhea on 16Apr2021. The events diverticulitis, pneumonia, sore arm, cough, diarrhea, dizziness/room spinning dizziness, fatigue, loss of appetite, intermittent chills, fall, and temperature 99.9F assessed as serious (hospitalization) for 6 days. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 69 | 2021-04-30 | nasal congestion |
Severe inflammation of tendons in right ankle (esp. primary tendon); Nose bleeds; Stuffy nose with l...
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Severe inflammation of tendons in right ankle (esp. primary tendon); Nose bleeds; Stuffy nose with little mucus present; Burning in nose; Burning top of mouth; This is a spontaneous report from a contactable healthcare professional (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in the right arm on 08Feb2021 (at the age of 69-years-old) as single dose for COVID-19 immunization. Medical history included multiple seasonal allergies, possible Crohn's disease, gluten sensitivity, allergic or sensitive to all antibiotics and prescription pain killers. The patient was not pregnant at the time of vaccination. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), hydrochlorothiazide, montelukast, and cetirizine hydrochloride (ZYRTEC). The patient previously received BNT162B2 (batch/lot number was not reported), dose 1, administered in the right arm on 12Jan2021 (at the age of 69-years-old) 12:00 PM for COVID-19 immunization. The patient did not have other vaccines in four weeks. In Mar2021, the patient experienced severe inflammation of tendons in right ankle (especially primary tendon identified in MRI), nose bleeds, stuffy nose with little mucus present, burning in nose, and burning top of mouth. The events resulted in doctor or other healthcare professional office/clinic visit and disability or permanent damage. Treatment included antibiotic for sinus and boot for foot/tendon. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, A possible contributory role of the suspect product to the development of severe inflammation of tendons, nose bleed, stuffy nose with little mucus, burning in nose and burning top of mouth cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 69 | 2021-05-01 | fatigue |
Sudden fatal heart attack. Patient went from a medically well person of 69 and died suddenly of PES ...
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Sudden fatal heart attack. Patient went from a medically well person of 69 and died suddenly of PES within 2 weeks of dose. Patient reported arm pain, fatigue, and coldness to extremities
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| 69 | 2021-05-04 | cough |
COVID/tested positive for the Covid-19; COVID/tested positive for the Covid-19; slight cough; This i...
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COVID/tested positive for the Covid-19; COVID/tested positive for the Covid-19; slight cough; This is a spontaneous report from a contactable consumer (patient). A 69 year old female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right (in the morning) on 14Jan2021 (at the age of 68 years old) (Batch/Lot Number: EL0142, Expiry date Mar2021) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Right (in the morning) on 03Feb2021 (at the age of 69 years old) (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunization. No other vaccines were given within 4 weeks. Facility in which the vaccine was given was associate with a hospital. 'The caller declines being sick at the time of vaccination.' Medical history included blood pressure abnormal, , gout, blood cholesterol. Concomitant medication(s) included telmisartan (TELMISARTAN) 40 mg once a day 'for maybe a year' for blood pressure from 2020 and ongoing; amlodipine (AMLODIPINE) 5 mg once day, taken for a year for blood pressure from 2020 and ongoing; allopurinol (ALLOPURINOL) 300 mg once a day taking this for 3 years for gout from an unspecified start date and ongoing; eicosapentaenoic acid ethyl ester (VASCEPA) 1gm, two a day taking this for about a year for blood cholesterol from an unspecified start date and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL]) for an unspecified indication from an unspecified start date and ongoing; vitamins nos (MULTIVITAMIN [VITAMINS NOS]) taken for an unspecified indication from an unspecified start date and ongoing. Past vaccine history includes Tetanus Vaccine on an unspecified date and experienced arm pain Also reported Maybe it was the Shingles Vaccine on an unspecified date that gave her a sore arm. The patient called to report that she did get the Pfizer COVID vaccine and she did get COVID after she got the vaccine. Patient called to report she had her 1st and 2nd dose of the Pfizer Covid-19 vaccine on 14Jan2021 and 03Feb, respectively. She mentioned that she was tested positive for the Covid-19 virus on 21Mar2021 and so she is calling to report it. On 19Mar2021 The patient experienced covid/tested positive for the covid-19 and slight cough. The adverse event did not require an emergency room or physician office visit. The patient underwent lab tests and procedures which included Sars-cov-2 test: (covid test) on 21Mar2021 results positive, SARS-CoV-2 test (Rapid COVID test) on 29Mar2021 results negative, SARS-CoV-2 test (PCR COVID test) on 29Mar2021 results positive. The clinical course was reported as follows patient got tested on 21Mar2021, the symptoms started around 19Mar2021, and on 23Mar2021 she got the results of her tests. She says she doesn't think she still has COVID. She says she still has a slight cough and that she has had 2 COVID tests since original positive test. She says one test was negative on 29Mar2021, a rapid test, and one was positive on 29Mar2021, a PCR test. She says the cough has improved, it is not getting worse but it is still there. She says she hasn't had a negative test and that her COVID got worse for 6 days, but that it is now mostly gone except the cough. The clinical outcome of the events was recovering.
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| 69 | 2021-05-04 | fatigue, fever |
Very tired; The rash is red, bumpy, and itchy/ a rash across her shoulders and upper chest area abov...
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Very tired; The rash is red, bumpy, and itchy/ a rash across her shoulders and upper chest area above her breasts/Light bumpy rash all over my face; Itchy/ itchiness; The rash is red, bumpy, and itchy; High fever; This is a spontaneous report from a contactable consumer (patient). A 69-year-old patient received second dose of (COVID-19 VACCINE) , expiration date 30 Jun 2021, on 30 Mar 2021 09:30 at single dose in left arm for COVID-19 immunization. Medical history included ongoing Diabetes mellitus from Feb 2004. Concomitant medication included diabetes medication. The patient previously received first dose of vaccine, Expiry Date: 30 Jun 2021 on 09 Mar 2021. The patient previously received Penicillin and Sulfa for severe tonsil and adenoid inflammation and experienced anaphylactic shock. They told her to remember not to ever take these medications. The patient had completed the second dose of the Covid vaccine on 30 Mar 2021. On 31 Mar 2021 she had a high fever for 24 hours but was not sure how high it was. On 05 Apr 2021, she started to have a rash across her shoulders and upper chest area above her breasts. This had been going on for about ten days. The rash was red, bumpy, and itchy. She asked could she take Benadryl to calm it down a bit. She stated the rash on the shoulders and chest was red and bumpy. In the symptoms that they had listed on the handout, it stated that unless the rash covers the whole body, its just part of your symptoms. The rash only covers her shoulders and back the upper part and went across her chest, not her whole body. It showed up on and off on her face, but it's not itchy. The rash on her chest and shoulders had been going on for 10 days. She also became very tired on 10 Apr 2021, which was unusual. She stated the itchiness started then the rash. She was still itchy, and after she showered last night, she put some really good cream caller First Aide used for all kinds of rashes like Psoriasis and eczema. She put it on her shoulder and top part of her chest. It calmed down the itching and the redness. The longer she was up the itching stared, and she put cream on that area again. It's keeping it at bay. She noticed the rash on her face last night after she washed her face. That was the third or fourth time when she noticed it. She noticed it on 10 Apr 2021, but could have been coming and going before that. Anytime she was washing her face and brushing her teeth she notices it. It's a light bumpy rash all over her face. She felt very tired when she went to bed and took a nap on Saturday and Sunday. The outcome of High fever was resolved on 01 Apr 2021. The outcome of Very tired was unknown. The outcome of The rash is red, bumpy, and itchy/ a rash across her shoulders and upper chest area above her breasts/Light bumpy rash all over my face was resolving. No follow-up attempts are needed. No further information is expected.
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| 69 | 2021-05-04 | headache |
Injection site pain and swelling; Injection site pain and swelling; mild headache and sensitivity to...
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Injection site pain and swelling; Injection site pain and swelling; mild headache and sensitivity to light; mild headache and sensitivity to light; muscle pain around shoulders and neck; muscle pain around shoulders and neck; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6201)), via an unspecified route of administration, administered in arm left on 08Feb2021 14:00 (at the age of 69-years-old) at single dose for COVID-19 immunization, the patient was not pregnant at the time of vaccination. The patient medical history included bronchitis chronic, uterine cancer from an unknown date and unknown if ongoing. The patient previously received codeine and experienced drug hypersensitivity within 2 weeks. The patient concomitant medications were not reported. The patient did not receive any other vaccines and was not tested for covid test prior to the COVID vaccine. On 08Feb2021 18:30 (04 hours and 30 minutes after the vaccination), the patient experienced injection site pain and injection site swelling, mild headache and sensitivity to light (headache), (photophobia), muscle pain around shoulders and neck (arthralgia), (neck pain). The patient did not received treatment for the adverse event. Seriousness of the event was reported as non-serious. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected
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| 69 | 2021-05-10 | respiratory tract congestion | cardiac arrest |
| 70 | 2021-01-04 | headache, sleepiness, head discomfort, fatigue |
Pfizer-BioNTec COVID-19 vaccine Patient received vaccine on 12/22/2020 and on 12/29/20, she emailed ...
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Pfizer-BioNTec COVID-19 vaccine Patient received vaccine on 12/22/2020 and on 12/29/20, she emailed us saying that she was feeling sleepy, tired, was having night sweats, and had headaches. Her head felt like someone had put a heavy stone on it. She can still function.
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| 70 | 2021-01-04 | headache |
Persistent headache/ felt very sick with headache on and off; I had body ache; Nausea; Dizzy; I was ...
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Persistent headache/ felt very sick with headache on and off; I had body ache; Nausea; Dizzy; I was feeling very weird/ felt awful; my arm hurt; This is a spontaneous report from a contactable nurse reporting for herself. A 70-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EH9899 (as reported: "don't know if it E or and F, looks like EH9899") & Expiry Mar2021, via an unspecified route of administration on 22Dec2020 as a single dose (age at vaccination 70 years old), for COVID-19 immunization. Medical history included pulmonary hypertension. The patient's concomitant medications were not reported. The patient had a persistent headache that doesn't go away, and had body ache (onset 23Dec2020). She reported feeling "like I had COVID." She went and got tested because she was a healthcare worker; her first test was negative (Dec2020) and her second test today (29Dec2020) was negative. She thought because it all started the day after vaccine (23Dec2020), that day she felt very sick with headache on and off, nausea, and was dizzy. She was feeling very weird and her arm hurt and she knew that she was going to have some side effect, so she went to work and took some ibuprofen (MOTRIN) for the pain and that was it. She took the vaccine on Tuesday, Wednesday she felt awful, Thursday, the only thing she had was pain in arm that's it but Friday started again with headache and all these symptoms that haven't gone away. The clinical outcome of the event persistent headache, body ache, nausea, dizzy, feeling very weird/ awful was not recovered.
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| 70 | 2021-01-04 | malaise, fever, headache, fatigue, chills, influenza like illness, sweating |
sweats; Feeling of unwellness like she had the virus or bad flu; Feeling of unwellness like she had ...
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sweats; Feeling of unwellness like she had the virus or bad flu; Feeling of unwellness like she had the virus or bad flu; could not hardly open eyes/eyes were very heavy; could not hardly open eyes/eyes were very heavy; chills; tiredness; headache; muscle pain; weakness; Joint pain; Fever; Injection site swelling and redness; Injection site swelling and redness; injection site pain; Nausea; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left upper arm, on 21Dec2020 (at the age of 70-years-old) at a single dose for COVID-19 immunization. Medical history included COVID-19 (lasted 3 weeks), high blood pressure (family history in mother and father), lumpectomy, breast cancer, radiation treatment, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, diabetes, obesity, fibroid tumors, fibroid tumors surgery, thyroid problem, bone density problem, and lower lobe left of lung piece cut out (not cancer). The patient previously received chemotherapy (MANUFACTURER UNKNOWN) for breast cancer, pethidine hydrochloride (DEMEROL) for post fibroid tumors surgery and experienced swollen hands and arms, influenza vaccine (MANUFACTURER UNKNOWN) in 2020 (usually gets swelling/red arm), and oxycodone hydrochloride;paracetamol (PERCOCET) and experienced feeling sick. Concomitant medications included unspecified medications for high blood pressure, thyroid problem, and bone density problem and unspecified nasal spray, water pill, and vitamins. The patient experienced could not hardly open eyes/eyes were very heavy, chills, tiredness, headache, muscle pain, weakness, joint pain, fever, injection site swelling and redness, injection site pain, nausea, sweats, and feeling of unwellness like she had the virus or bad flu on 22Dec2020. The clinical course was reported as follows: The patient felt fine the day when injection was given, but the next day, it was like she had COVID again. She had COVID 3 months ago and it lasted for 3 weeks. It was the same symptoms she had. She could not open her eyes hardly. They were very heavy. The patient had the chills, temperature, sweats, and injection site pain (the next day). There was also swelling and redness that remained for 6 days. The patient reported that if she still puts her hand on it now, there is some sensitivity. She also had tiredness and headache. The patient reported that she only had each of these symptoms for 24 hours (as reported) and the headache was gradually improved. The patient had muscle pain and weakness. She laid down and all she could do was sleep for 24 hours. The patient had nausea for 4 days. She did not have swollen lymph nodes. The patient underwent lab tests and procedures which included blood pressure: 120/80 on an unspecified date and bone density: unknown results on an unspecified date. The clinical outcome of could not hardly open eyes/eyes were very heavy, chills, tiredness, headache, muscle pain, weakness, joint pain, fever, sweats, and feeling of unwellness like she had the virus or bad flu was recovered on an unspecified date, nausea was recovered on 26Dec2020, and injection site swelling and redness and injection site pain was recovered on 28Dec2020. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
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| 70 | 2021-01-05 | headache, throat irritation |
severe headache, dizziness, vomiting, elevated bp, turned pale, legs shaking scratchy throat, rash ...
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severe headache, dizziness, vomiting, elevated bp, turned pale, legs shaking scratchy throat, rash to face and throat,
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| 70 | 2021-01-05 | fever, chills, fatigue |
fatigue; 102 fever; chills; This is a spontaneous report from a contactable consumer. A 70-year-old ...
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fatigue; 102 fever; chills; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration in left arm on 29Dec2020 15:00 at a single dose for covid-19 immunization. Administration was done in a Nursing Home/Senior Living Facility. The patient's medical history was not reported. Concomitant medication included trazodone and methimazole. On 01Jan2021 at 03:00, the patient experienced fatigue, 102 fever and chills. The outcome of the events was not recovered. There was no treatment received for the events. The consumer considered the events as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19.
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| 70 | 2021-01-06 | fever, malaise, headache, fatigue, chills |
Was referred by Dr for evaluation of reaction to first COVID vaccine. First vaccine on 12/21/2020 Pf...
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Was referred by Dr for evaluation of reaction to first COVID vaccine. First vaccine on 12/21/2020 Pfizer-BioNTech. Administered by her place of work. Vaccine was administered in left arm. Had same symptoms as when she had COVID in 10/2020 these symptoms lasted for 12 hours. Started the following day 24 hours after vaccine administration. Symptoms include injection site redness for 6 days, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, and overall feeling of un wellness lasting 12 hours. First symptoms was eyelid heaviness and weakness. No treatment, symptoms resolved on their own. Second vaccine due 1/11/2021. Was covid positive 10/2020- no appetite, aches, chills, sweating, weakness, heavy eyelids, fatigue, ongoing for 3 weeks. Has had difficulty in the past to flu vaccines with local injection site reactions. 09/2020 flu vaccine no symptoms. Has had pneumonia vaccine with no difficulties. Has not received shines vaccine yet.
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| 70 | 2021-01-07 | body temperature increased, headache |
Had my 2nd vaccine on Jan 7, 2021. My arm was sore when I went to bed that night. I woke at 5:15 AM ...
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Had my 2nd vaccine on Jan 7, 2021. My arm was sore when I went to bed that night. I woke at 5:15 AM feeling achy. I took my temp and it was 98.8F which is a temp for me since I run low, around 96.9F I got ready for work at the hospital and went in. around 0830 my temp was 99.5 and I was more achy and sore. I called Employee Health and they said to continue to monitor my temp and call back if it passes 100. Then around 3PM , my temp was 101.5F I remain very achy and have some occasional ear pain and a mild headache,
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| 70 | 2021-01-07 | headache |
She verbalize she develop headache, nausea, dizziness. She was evaluated onsite by Rescue and relea...
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She verbalize she develop headache, nausea, dizziness. She was evaluated onsite by Rescue and released home feeling better at 10:25 am.
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| 70 | 2021-01-08 | headache, fatigue | Headache extreme fatigue, did not work yesterday; Narrative: |
| 70 | 2021-01-08 | fever | Fever Narrative: |
| 70 | 2021-01-11 | fatigue, sweating, headache |
Had a headache/fatigue following vaccine, but improved 24-48 hours afterwards. Pt woke up Sunday and...
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Had a headache/fatigue following vaccine, but improved 24-48 hours afterwards. Pt woke up Sunday and felt jittery, lightheaded, sweating, numbness/tingling in both hands, feeling strange
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| 70 | 2021-01-11 | headache |
very bad headache; feels terrible/feeling bad; she was sick; This is a spontaneous report from a con...
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very bad headache; feels terrible/feeling bad; she was sick; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL4238, Expiration date: 30Apr2021), via an unspecified route of administration at site of right arm at 14:00 on 06Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing high cholesterol for several years. Concomitant medication included rosuvastatin calcium (CRESTOR) for cholesterol (had taken it for several years). The patient had a bad headache and feels terrible at 6 am on 07Jan2021, she wanted to know if she could take something for the headache. She got up at 6 am and feeling bad on 07Jan2021, she left for work and came home, and she was sick. Her feeling terrible started sometime during the night. She was feeling fine on 06Jan2021. These events were identified as non-serious by reporter. Vaccination Facility Type was in public health department. Vaccine was not administered at military facility. No history of all previous immunization with the Pfizer vaccine considered as suspect. Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. No adverse events required a visit to emergency room. No prior vaccinations within 4 weeks. No adverse events following prior vaccinations. The outcome of events 'headache' was not recovered; of rest events was unknown.
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| 70 | 2021-01-11 | sweating | sweating, lightheaded, tingling/numbness in both hands, high blood pressure, swollen arm/redness |
| 70 | 2021-01-11 | fever, headache, chills |
fever of 105F; chills; severe headache; arm pain; This is a spontaneous report from a Pfizer-sponsor...
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fever of 105F; chills; severe headache; arm pain; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable healthcare professional (HCP). A 70 year-old female patient (pregnancy information not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on 18Dec2020 (at the age of 70 years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to receiving the vaccination it was not reported if the patient had been tested for COVID-10. It was also not known if she received any other vaccinations in 4 weeks or other medications in past 2 weeks. On 18Dec2020, the patient received the first dose of the COVID-19 vaccine and had arm pain that lasted for a few hours at that time. Seventeen days post first vaccination (approximately 04Jan2021), she developed a fever of 105F, chills and severe headache which have now resolved. She wanted to know if she should get the second vaccine in series given her side effects. it was not reported if the patient was hospitalized or treated for the events.The clinical outcome of the events of arm pain, fever of 105F, chills and severe headache was recovered on an unspecified date. It was not reported if the patient was tested for COVID-19 after receiving the vaccination. Information about batch/lot number has been requested.
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| 70 | 2021-01-14 | cough, respiratory tract congestion |
At approximately 10:30pm on 1/14/2021, resident was noted to have a rash on her face, hands, arms, a...
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At approximately 10:30pm on 1/14/2021, resident was noted to have a rash on her face, hands, arms, and chest. VS:100.2, 113, 20,108/59, 84% room air. applied nasal cannula at 4-L, telephoned Physician orders 6mg Decadron one time order, a second set of Vitals , reads 99.3, 110, 20, 106/60, 90% on 4-L N/C. On coming shift advised. At approximately 2:00am on 1/15/2021, resident congested and coughing. BP 151/70, pulse 124, temp 98.1 forehead, resp 20 and pulse oc 79% on 3L. At approximately 2:30am PRN cough syrup and breathing tx. Resident's condition began to worsen with breathing tx. This LPN updated at 0248 doctor on resident's condition. Doctor gave permission for resident to go to hospital. At 4:19am the Er called to say resident passed away.
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| 70 | 2021-01-14 | fever | fever, aches. called in sick to work. |
| 70 | 2021-01-16 | headache | Severe headaches, nausea, vomiting, swelling of face and throat |
| 70 | 2021-01-17 | headache, sweating | dizzy, wobbling side to side, severe headache, sweating, vomiting. |
| 70 | 2021-01-18 | fatigue, headache, chills, fever |
Received first COVID vaccine at 4:30 on Monday, 1/11; Morning of 1/12 had expected symptoms of heada...
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Received first COVID vaccine at 4:30 on Monday, 1/11; Morning of 1/12 had expected symptoms of headache, chills, tiredness; Evening of 1/12 at about 6:30 pm diarrhea approximately 5 - 6 times and febrile about 99.3 (normal temp is around 96.8 - 97.4); Night of 1/12 about 11:00 pm got very dizzy, bad nausea, headache worse and this continued until about 3:30 - 4:30 am on 1/13; day of 1/13 chills and headache continued throughout day, lessening by early evening; Evening of 1/13, about 8:00 pm developed rash on head, face, neck and chest and took a Benadryl, which knocked me out and given no sleep the night before, I slept until noon of Thursday and returned to what I consider full health by 4:00 pm, about 72 hours after receiving the shot.
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| 70 | 2021-01-18 | fatigue |
Fatigue, chest pressure. Followed up with PCP EKG showed ST elevation; scheduled stress echo next we...
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Fatigue, chest pressure. Followed up with PCP EKG showed ST elevation; scheduled stress echo next week.
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| 70 | 2021-01-18 | headache | Developed a severe headache followed about 24 hours later by nausea |
| 70 | 2021-01-19 | malaise |
After 45 minutes post vaccine my tongue felt fat. I did not have trouble breathing or swallowing. Af...
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After 45 minutes post vaccine my tongue felt fat. I did not have trouble breathing or swallowing. After approximately 1hour the tongue no longer felt fat but started feeling rough and a red spot about 1/4 inch has developed on the top/side of my tongue. I have not consulted treatment at this time.
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| 70 | 2021-01-20 | body temperature increased, headache |
I had COVID-19 in December for more than 3 weeks. I felt like I felt during that time.. I was weak...
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I had COVID-19 in December for more than 3 weeks. I felt like I felt during that time.. I was weak. I hurt everywhere. I had a temperature. of 101-102 degrees. My normal temperature is 97.6. I had a severe headache. My vision was impaired. I would go from freezing to being very hot.
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| 70 | 2021-01-20 | chills, headache |
Strong chills; Bad headache; Very painful abdominal cramping; Heavy salivating; Nausea/going to vomi...
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Strong chills; Bad headache; Very painful abdominal cramping; Heavy salivating; Nausea/going to vomit; Both hands went numb with pins and needles; Both hands went numb with pins and needles; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1284), via an unspecified route of administration from 08Jan2021 09:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included known allergies: latex, high blood pressure, hypothyroidism, and mitral valve prolapse. There were no concomitant medications. At 11am, 2 hours after receiving the first COVID19 vaccine, my reactions occurred simultaneously. The patient experienced Strong chills, Bad headache, Abdominal Very painful abdominal cramping, Heavy salivating, Nausea, Both hands went numb with pins and needles, the patient felt like she was either going to vomit or have a bowel movement, ultimately it was the latter. This is when both her hands went numb. These reactions lasted 15-20 minutes and then dissipated with the exception of a lingering less painful headache through Friday and Saturday. The patient did not receive treatment for the events. The outcome of the events was recovered.
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| 70 | 2021-01-20 | fatigue |
Trouble sleeping, body aches, stomach upset, extreme fatigue. All symptoms cleared up by 1/21/20...
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Trouble sleeping, body aches, stomach upset, extreme fatigue. All symptoms cleared up by 1/21/2021.
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| 70 | 2021-01-20 | headache, malaise |
Headache with burning lips burning and stinging in right side of face with slight swelling. Pulsati...
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Headache with burning lips burning and stinging in right side of face with slight swelling. Pulsating area below lip on right side of face. Pulsation visable when looking at face. On the first day, Jan 19, 21. Nausea,dizzyness and off balance,headache. Second day 1/22/21 just general unwell feeling all day with headache.
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| 70 | 2021-01-20 | headache |
tightness of shoulders and neck; tightness of shoulders and neck; started having severe nausea in th...
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tightness of shoulders and neck; tightness of shoulders and neck; started having severe nausea in the last hour; Has a slight headache; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 08:00 in left arm at single dose for covid-19 immunization. Medical history included ongoing diabetes (she had it for 20 years), ongoing asthma (she had it for 25 years), ongoing cirrhosis of the liver non alcoholi diagnosed two years ago, ongoing hypertension diagnosed in the last three months, ongoing fatty liver diagnosed two years ago. There were no concomitant medications. Patient had Covid vaccine this morning at 8 am (12Jan2021) that was fine after 15 minutes, but patient started having severe nausea in the last hour and was unresolved by her nausea medicine. Patient had a slight headache. Patient stated that the headache which was mild, tightness of shoulders and neck started at 13:30. Patient stated that she took acetaminophen 1000 units and used a heating pad for the shoulder. Outcome of nausea was not recovered, and outcome of events were recovered on 12Jan2021. Information on the lot/batch number has been requested.
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| 70 | 2021-01-20 | throat irritation | Swelling face, itchy, slightly closed feeling in throat. Benadryl 50 mg given, went to ED. |
| 70 | 2021-01-21 | body temperature increased, headache, chills |
Headache and achy feeling that night. Next day headache progressively got worse, queasy went to ful...
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Headache and achy feeling that night. Next day headache progressively got worse, queasy went to full nausea, trouble eating anything because of the nausea, aches in every joint, temperature reached 100.2 before going to bed (I almost never hit 97.2), chills. Thursday, still have milder headache, still achy all over, arms just feel heavy, temp still at 98.9. Friday, still have headache and loss of appetite, but much better
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| 70 | 2021-01-21 | chills, fever, headache, fatigue |
Headache, Fever, Chills, Nausea, Body Aches. Restless. Worst symptoms lasted 24 hours. The next 24 h...
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Headache, Fever, Chills, Nausea, Body Aches. Restless. Worst symptoms lasted 24 hours. The next 24 hours was lingering headache, fatigue, but improved from day before.
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| 70 | 2021-01-21 | headache |
Patient experienced mild headache, resolved quickly (less than 30 mins) without intervention, evalua...
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Patient experienced mild headache, resolved quickly (less than 30 mins) without intervention, evaluated by Nurse practitioner
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| 70 | 2021-01-21 | headache |
Patient experienced mild headache, improved without intervention No other complaints, vital signs no...
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Patient experienced mild headache, improved without intervention No other complaints, vital signs not taken at the time
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| 70 | 2021-01-23 | fatigue, headache | Bad Headache, Fatigue for a duration of 28 hours |
| 70 | 2021-01-24 | chills |
She feels a little bit of chills and weakness; She feels a little bit of chills and weakness; Cold a...
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She feels a little bit of chills and weakness; She feels a little bit of chills and weakness; Cold and hot feeling on [her] body; This is a spontaneous report from a contactable consumer (patient). This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced delayed symptoms after the first injection of the COVID-19 vaccine, received on 06Jan2021. Patient explained feeling fine the first three days post injection, and later on 09Jan2021 having "chills" and weakness. She then described her experience as "cold and hot feeling on her body". She felt good, her breathing was okay. Her oxygen and everything was okay. Outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 70 | 2021-01-25 | chills, fever, cough |
Cough fever chills then on 1/22/2021 coughs fever chills severe abdominal pain nausea vomiting indi...
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Cough fever chills then on 1/22/2021 coughs fever chills severe abdominal pain nausea vomiting indigestion
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| 70 | 2021-01-25 | chills, fever, malaise, headache |
Patient self-reporting through the hospital's electronic reporting system. In her own words, "Recei...
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Patient self-reporting through the hospital's electronic reporting system. In her own words, "Received 2nd Pfizer COVID-19 Vaccine. Beginning 17 hours later, I had extreme weakness, headache, chills and fever. I had to take off Friday, January 22, 2021, from work because of not feeling well. I still am not feeling well".
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| 70 | 2021-01-26 | fatigue, chills, headache | Headache, chills, fatigue |
| 70 | 2021-01-26 | fatigue, headache | extreme fatigue, headache, loss of appetite lasted 24 hours |
| 70 | 2021-01-28 | body temperature increased, headache |
Body ache; diarrhea; Headache; Elevated temperature; This is a spontaneous report from a contactable...
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Body ache; diarrhea; Headache; Elevated temperature; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3302), via an unspecified route of administration in the left arm, on 14Jan2021 at 09:00 (at the age of 70-years-old) at a single dose for COVID-19 immunization. Medical history included heart disease and high blood pressure (HBP). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included acetylsalicylic acid, clopidogrel (PLAVIX PLUS). Other concomitant medications included unspecified blood pressure medication, unspecified cholesterol medication, and unspecified thyroid medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced body ache, diarrhea, headache, and elevated temperature on 15Jan2021 at 14:00. The events were reported as non-serious. The patient underwent lab tests and procedures which included body temperature: elevated on 15Jan2021. The patient did not receive any treatment for the events. The clinical outcome of body ache, diarrhea, headache, and elevated temperature was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 70 | 2021-01-28 | chills | Chills |
| 70 | 2021-01-28 | fatigue, lethargy |
Dizziness/ Very dizzy; Pain on her arms; very lethargic; Fatigue/ Extremely tired; This is a spontan...
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Dizziness/ Very dizzy; Pain on her arms; very lethargic; Fatigue/ Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient receive first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Batch/lot number: EK9231), via an unspecified route of administration injection once to left upper arm in inner muscle on 10Jan2021 at single dose for covid-19 immunization. The patient had no relevant medical history and concomitant medications. The patient experienced fatigue/ extremely tired in Jan2021, dizziness/ very dizzy on 14Jan2021 18:30, pain on her arms in Jan2021. Consumer said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last Sunday and has been experiencing some side effects. These side effects include Dizziness, Extreme fatigue and Pain on her arms. She wants to know if this was normal. She got her shot, later clarified as COVID shot, at hospital last Sunday, so about a week ago, and had no side effects up until yesterday, she was extremely tired, and last night about 6:30PM, she was very dizzy until 5 this morning. She works at a hospital; they gave the shot. Outcome of extremely tired: stated she was in bed, was just very lethargic, being very dizzy went away at 5 this morning, states she has recovered completely but she is just a little off. When asked for vaccination card, states she shouldn't have gotten up that fast, this was really weird that it would wait 5 days. This was her first shot, thinks the dose was on the paper, it was 0.3mg, she was not sure. The outcome of events for dizziness/ very dizzy was resolved on 15Jan2021, for fatigue/ extremely tired was resolving, for other events was unknown.
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| 70 | 2021-01-28 | fatigue |
feeling tired; This is a spontaneous report from a contactable consumer via a Pfizer sales represent...
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feeling tired; This is a spontaneous report from a contactable consumer via a Pfizer sales representative. An 8-decade-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 for COVID-19 immunization. On an unspecified date, the patient experienced feeling tired after receiving the second vaccination which did not last long, maybe half a day. It was reported that the patient was not tired after the first vaccination. Outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 70 | 2021-01-28 | headache, chills | Headache and chills |
| 70 | 2021-01-29 | malaise, headache |
Acute fainting episode during the night following the day of the vaccine. Hit my head on the stone ...
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Acute fainting episode during the night following the day of the vaccine. Hit my head on the stone floor and was unconscious. Taken to ER in ambulance. All diagnostics were normal and after blood pressure returned to normal and getting 4 staples in my scalp I was released. Since coming home I have been very ill with weakness, vertigo, nausea, and headache.
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| 70 | 2021-01-29 | fever, chills |
Day 1 & 2 irritability and depression Day 3 nausea, fever, chills & diarrhea - really felt bad, bu...
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Day 1 & 2 irritability and depression Day 3 nausea, fever, chills & diarrhea - really felt bad, but no vomiting. Was able to eat. Day 4 (today) fever, chills and diarrhea - feel a little better than yesterday. Still able to eat ok. I have not contacted my healthcare provider about these symptoms because it is the weekend. If I still have symptoms on Monday, I will call him. In the meantime I?m taking Tylenol for the fever and drinking water to stay hydrated.
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| 70 | 2021-01-29 | throat irritation |
Lips started tingling, Lips tingled more and roof of the mouth got tingling, ears itchy, throat itch...
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Lips started tingling, Lips tingled more and roof of the mouth got tingling, ears itchy, throat itchy, throat felt slightly closed up Took a Claritin and sat for an hour til the symptoms cleared up. Took Benydril when I got home because the tingling started coming back in my lips. Symptoms were gone in another couple of hours.
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| 70 | 2021-01-29 | throat irritation |
Patient describes having lips tingling, and feeling hot as well as her upper gums occurring about 7-...
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Patient describes having lips tingling, and feeling hot as well as her upper gums occurring about 7-8 minutes after the vaccine administration. Patient denies any difficulty in breathing. Patient is drinking some juice- describes the feeling of her throat feeling scratchy. 1035 VS- HR-52, 96% RA, 132/76. At 1048 patient reports that she feels better and the symptoms have gone away and she feels the same as she did when she came into have her vaccine. Patient will continue to wait a full 30 minutes after beginning of being checked out. 1100- patient reports again feeling the same as she did when she walked in and feels ok to leave.
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| 70 | 2021-01-30 | headache, chills, fatigue |
1/27/2021 and 1/30/2021chills and headache @ noon on. 1/30/2021 also had gut cramping. 1/27/2021 thr...
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1/27/2021 and 1/30/2021chills and headache @ noon on. 1/30/2021 also had gut cramping. 1/27/2021 through 1/30/2021 I was also very tired and napped for hours. I slept and covered up and the chills and headache abated.
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| 70 | 2021-01-30 | headache, chills | Chills, vomiting, headache after 30 hours of receiving COVID-19 Vaccine |
| 70 | 2021-01-30 | headache, fever, chills | Stomach ache, nausea, dry heaves, headache fever(101.3) chills body aches, headache, brain fog |
| 70 | 2021-01-30 | influenza like illness, fever, chills |
12:25 Slight dizziness with an overall hot feeling for @12min, then 2 hours later chills and slight ...
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12:25 Slight dizziness with an overall hot feeling for @12min, then 2 hours later chills and slight feverish feeling slight nausea,, which lasted ...then just turned into flu like feeling...insomnia with body feeling slightly jittery till 4am ,took nighttime cold tablet. Flu like symptoms till 31st am.
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| 70 | 2021-01-30 | fever, fatigue | At around 09:30 am I was feverish, tired and sick at my stomach and vomited twice. |
| 70 | 2021-01-31 | sweating, chills, fever |
Fever/temperature about 101 degrees; Sweating; chills; This is a spontaneous report from a contactab...
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Fever/temperature about 101 degrees; Sweating; chills; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3247) on 14Jan2021 at single dose in Left Upper Arm for COVID-19 immunisation. Medical history was none. There were no concomitant medications. She had vaccine on Thursday 14Jan2021 and last night or probably Saturday into Sunday she experienced the chills and fever. She was fine now, but all day on 17Jan2021 she experienced a fever of a temperature about 101 degrees, she was now back to normal. She had chills and sweating. She took Tylenol. She had her first dose on 14Jan2021. Then the symptoms started either late Saturday on the 16Jan2021 or going into Sunday on 17Jan2021. All she knows was Sunday was when she woke up with the chills and the fever. She was sweating, which started after taking the Tylenol. She took the Tylenol Sunday morning. She stated that no symptoms are ongoing at the moment. She felt good right now, there are No symptoms at the moment. She has had No positive Test for Covid before the vaccine. She had a negative Antibody Test, but it was About a good 6 months ago in 2020. She has had No issues with vaccines in the past. The outcome was recovering.
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| 70 | 2021-01-31 | malaise, headache |
Pt received her Pfizer vaccine. During post vaccine monitoring she began to complain of not feeling ...
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Pt received her Pfizer vaccine. During post vaccine monitoring she began to complain of not feeling well. Pt complained of lightheaded/dizziness, headache, and weakness and transferred to wheelchair. Vital signs monitored (148/77, spo2 100%). Patient stated this is above her baseline and not usual. Patient began to complain of chest pressure and was transferred to EMS stretcher to continue to monitor and transferred to hospital.
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| 70 | 2021-02-01 | fatigue, headache |
I was at RCSJ-Meg After 15-20 minutes my vision blurred, I had bad headache, felt very hot, somewhat...
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I was at RCSJ-Meg After 15-20 minutes my vision blurred, I had bad headache, felt very hot, somewhat dizzy and tired. I sat for 45 minutes until I felt better. Vision cleared, headache disappeared after 15-20 minutes thereafter .. I iced my arm when I came home, and fell asleep for a few hours.
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| 70 | 2021-02-01 | headache, fatigue |
Muscle aches; joint aches; exhausted feeling; slight headache; This is a spontaneous report from a n...
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Muscle aches; joint aches; exhausted feeling; slight headache; This is a spontaneous report from a non-contactable consumer (patient herself). A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on the right arm on 18Jan2021 at 12:00 PM at a single dose for COVID-19 immunization, given by the retirement home and administered at the nursing home/senior living facility. Relevant medical history included pre-diabetic, obesity, high lipids, and allergies to some psychiatric (psych) medications (meds) only. Concomitant medications included risperidone, calcium levomefolate (DEPLIN), travoprost (TRAVATAN), ibuprofen, and famotidine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Jan2021 at 15:30 (also reported as "beginning around 3 pm"), the patient experienced muscle aches, joint aches, exhausted feeling, and slight headache mainly in the afternoon. The reporter assessed all the events as non-serious. The patient did not receive any treatment for the events. The patient was recovering from all the events. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
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| 70 | 2021-02-01 | headache, head discomfort, malaise |
arm soreness/Arm hurt; headache; swollen glands; head "felt stuffy"; very weak muscles (had to be he...
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arm soreness/Arm hurt; headache; swollen glands; head "felt stuffy"; very weak muscles (had to be helped to the bathroom); very weak; not feeling well; very sick; This is a spontaneous report from a contactable consumer (patient). This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 12Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 70-year-old. Medical history included Sars-Cov-2 infection (Mar2020), sick for 5 or 6 days, who knowingly has antibodies, and has donated plasma on multiple occasions, asthma but does not report respiratory symptoms, mild hypertension, migraines, vascular problems, and chronic portal vein thrombosis (PVT). Concomitant medications included linaclotide (LINZESS), hydrochlorothiazide, rosuvastatin, montelukast, levothyroxine, clopidogrel. On 13Jan2021 at night, she reports arm soreness/arm hurt, and that when she woke up the next day she 'felt like she had Covid all over again' with: headache, swollen glands, head 'felt stuffy', very weak muscles (had to be helped to the bathroom), no fever but caller did state that she took a Tylenol. From Wednesday to Saturday she didn't feeling well, but every day she felt a little better. She has asthma - drug out my peak flow meter (as reported). No asthma sx during this whole thing. She reported adverse events and thinks some might have been stunted by the Tylenol she took after the first dose. She reported she was very sick, she still had like waves of not feeling well. She had most of the symptoms that she had was when she had Covid. She was sick, she was in bed and could not move. The most severe symptoms were on 13th and slowly each day felt better and it was until Saturday was when she really started to feel a 100 percent herself. Events were reported as non-serious. She had recently lab test within the last month or so. She had two or one and blood and everything was negative, everything was normal. Outcome of very sick and not feeling well is not recovered, while the outcome of the other events is recovering. She should receive the second dose on 02Feb2021. Information about lot/batch number has been requested.
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| 70 | 2021-02-01 | headache, fever |
Fever, headache, general achy. Than suddenly six days later intense burning, tingling, painful feeli...
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Fever, headache, general achy. Than suddenly six days later intense burning, tingling, painful feeling in both legs and feet with weakness in both legs
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| 70 | 2021-02-01 | productive cough, chills |
I have been having symptoms for 6 days now. Feeling very parched, especially after eating Feeling as...
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I have been having symptoms for 6 days now. Feeling very parched, especially after eating Feeling as if I were mildly allergic to what I had eaten and having the impression that upper palate was a little swollen, even if it wasn't. Mouth and upper palate always feels funny after eating making me not wanting to eat much Chalky mouth Mucous in the throat and mouth today Chills, muscle soreness, loss of appetite yesterday
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| 70 | 2021-02-02 | fatigue, headache |
Very tired with small headache on Jan 30. Monday, Feb 1 awoke to a fib situation. Went to ER and w...
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Very tired with small headache on Jan 30. Monday, Feb 1 awoke to a fib situation. Went to ER and was cardioverted back to regular rhythm
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| 70 | 2021-02-02 | headache |
PATIENT COMPLAINED OF TIGHTNESS ACROSS CHEEK AND HEADACHE. 11:35 BP 121/81, HR 70, RR 16 11:40 BP 12...
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PATIENT COMPLAINED OF TIGHTNESS ACROSS CHEEK AND HEADACHE. 11:35 BP 121/81, HR 70, RR 16 11:40 BP 122/68, HR 69, RR 16 11:45 BP 121/78, HR 70, RR 16 11:55 PATIENT LEFT SITE IN STABLE CONDITION
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| 70 | 2021-02-02 | respiratory tract congestion, sneezing, headache |
Sneezing, congestion, headache, pain at injection site. Slight upset stomach. Have taken acetaminop...
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Sneezing, congestion, headache, pain at injection site. Slight upset stomach. Have taken acetaminophen and Sudafed.
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| 70 | 2021-02-03 | chills, headache, fever | Fever 100, pain at injection site, body aches, chills, headache |
| 70 | 2021-02-03 | chills |
bad chills/terrible chills; terrible acid reflux for 3 hours; couldn't even walk, she had to crawl a...
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bad chills/terrible chills; terrible acid reflux for 3 hours; couldn't even walk, she had to crawl and her husband had to walk her around, she couldn't do anything; threw up; very dizzy/dizziness; vertigo; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, unknown expiration), via injection in right arm on 13Jan2021 at a single dose for COVID-19 prevention. Medical history included ongoing vertigo (in car accident a little over 5 years ago, that affected a big nerve in left temple, and so every once in a while she will get vertigo so bad that she falls over), ongoing GERD (from a hiatal hernia; diagnosed many years ago), ongoing high blood pressure diagnosed about 15 years ago, ongoing bad cholesterol diagnosed 10 to 15 years ago, ongoing heart burn, ongoing hiatus hernia, and car accident a little over 5 years ago. Concomitant medications included ongoing omeprazole sodium (OMEPRAZOLE) for GERD, heart burn, and hiatal hernia (started this product at least 10 years ago; takes the product as needed if she is having heart burn or is going to eat spicy food); ongoing vitamin D3 for vitamin supplementation (started product about 8 months ago, because her doctor told her too, she guesses her vitamin was low); ongoing metoprolol for high blood pressure and to prevent stroke (started product at least 15 years ago; her BP could be regular but it could shoot up when she is upset, so she takes this to prevent stroke); ongoing hydrochlorothiazide for blood pressure (started product at least 5 years ago); pravastatin for bad cholesterol (started the product at least 4 or 5 or more years ago); and ongoing acetylsalicylic acid (BABY ASPIRIN) to prevent stroke (has been taking this product forever, at least for 10 years). The patient reported that she received the first COVID shot on 13Jan2021. She was okay on the 13th, 14th, and 15th. However, on the 16th (16Jan2021), she woke up and threw up once and was very dizzy for three days. She mentioned that she had like vertigo, she couldn't even walk, she had to crawl and her husband had to walk her around, she couldn't do anything. She had vertigo (16Jan2021). She was that way on Saturday and Sunday. On Monday, the patient's son took her to acupuncturist for her dizziness and was able to get up fine and walked away. After the acupuncture, she felt fine, like she was all better. On 19Jan2021 (reported as yesterday), she was fine. She woke up at midnight and had terrible acid reflux for 3 hours even though she had hardly eaten. She does take omeprazole for heart burn, and she had taken omeprazole earlier in the day, but it was just coming up, that acid and burning. She drank milk to coat the stomach and it went away at 03:00 AM. She had very bad chills/terrible chills (20Jan2021) and her teeth were chattering, she couldn't even talk, and couldn't control the chills. She is fine now. She clarified that she got vertigo from a car crash years ago and haven't had it in almost a year. Chills are not ongoing at this time, she has not had any for about 4 hours now, and she is hoping she is recovered completely, but it may be too soon to tell. She did not receive other vaccines on the same day as the COVID vaccine. The patient is wondering if all this could be from the vaccine. The patient wanted to know if it is safe to take the second shot. She was scheduled to receive the second dose on 03Feb2021. The patient recovered from the events threw up on 16Jan2021; unable to walk and vertigo on 18Jan2021; dizziness on 19Jan2021; and terrible acid reflux on 20Jan2021. While unknown outcome for chills.
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| 70 | 2021-02-03 | throat pain, cough, fatigue, runny nose | Cough-sore throat,runny nose-fatigue |
| 70 | 2021-02-03 | fever, chills |
Intestine discomfort, multiple bowel movements (no diarrhea), chills, feverish (but no fever), muscl...
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Intestine discomfort, multiple bowel movements (no diarrhea), chills, feverish (but no fever), muscle aches. I'm reporting this 24 hours after getting the 2nd Pfizer shot. Reaction started overnight. Don't know at this time how long this will last. Have not called doctor. Taking Tylenol.
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| 70 | 2021-02-03 | fever |
I have daily fever of 99-100,6 especially in the morning, tired. I would like to know if will be saf...
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I have daily fever of 99-100,6 especially in the morning, tired. I would like to know if will be safe to take the second dose.
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| 70 | 2021-02-04 | fatigue, fever, sweating, headache, chills |
Fever 101 for two days. Chills sweats muscle aches and joint pain, headache, fatigue dizziness weakn...
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Fever 101 for two days. Chills sweats muscle aches and joint pain, headache, fatigue dizziness weakness, diarrhea . Had Weakness for two more days.
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| 70 | 2021-02-04 | headache, fever |
The following morning, I experienced a slight fever (99.1), mild headache, and pain to the touch at ...
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The following morning, I experienced a slight fever (99.1), mild headache, and pain to the touch at the injection site. These lasted only one day.
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| 70 | 2021-02-04 | headache | Shingles. Severe pain and blisters on right side shoulder neck and head |
| 70 | 2021-02-04 | malaise, fever, chills |
Initially patient had fever of 100.7, chills, malaise, symptoms have resolved Patient took Advil now...
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Initially patient had fever of 100.7, chills, malaise, symptoms have resolved Patient took Advil now symptoms have resolved
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| 70 | 2021-02-04 | fever, fatigue, cough, chills |
I had shortness of breath, cough, chills and fever, along with body aches. I was coughing a white m...
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I had shortness of breath, cough, chills and fever, along with body aches. I was coughing a white milky sputum. There was no indication of lung infection. Extreme fatigue.
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| 70 | 2021-02-04 | fever, fatigue |
Low grade fever; fatigue for 4-5 days post injection; This is a spontaneous report from a contactabl...
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Low grade fever; fatigue for 4-5 days post injection; This is a spontaneous report from a contactable nurse (patient). A 70-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 16Jan2021 08:00 at single dose for covid-19 immunisation. Medical history included Hashimoto's thyroiditis, celiac and allergy to wheat. Patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine, estradiol (ESTRACE) and colecalciferol (VIT D3). The patient experienced low grade fever and fatigue for 4-5 days post injection on 16Jan2021 at 16:30. Patient recovered from the events on Jan2021 and had not received any treatment. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The events were reported as non-serious. Information on the lot/batch number has been requested.
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| 70 | 2021-02-04 | runny nose, throat irritation, sneezing |
I was sneezing non stop; injection site was sore; can't taste; nose started running/ my nose was lik...
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I was sneezing non stop; injection site was sore; can't taste; nose started running/ my nose was like a faucet, non stop, clear; asked if it can it give her COVID since her symptoms were similar to COVID; asked if it can it give her COVID since her symptoms were similar to COVID; I felt scratchy in my throat; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248 and expiration date not provided), via an unspecified route of administration in the left arm on 13Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took shingles vaccine for immunization and experienced shingles. The patient reported that she got her first dose of the COVID vaccine on 13Jan2021. On 17Jan2021 night and into 18Jan2021, she felt scratchy in her throat. She did not think anything of it because the temperature change was not unusual in the patient's state and so she thought it was that. But, on 19Jan2021, her throat was more scratchy and then her nose started running more. By Wednesday, 20Jan2021, her nose was like a faucet, non stop, clear and her throat was definitely scratchy and she was sneezing non stop. Her injection site was sore too which she totally expected. Now, her physician has given her a steroid pack and did a rapid test, which was negative but the following day they are doing a PCR test, so, she will see. She also stated that she can still smell but can't taste and that started last night, 20Jan2021. She asked if they were seeing these. And if this was listed or being reported and if she should get the second dose. She went on to state that "I would not call my symptoms severe and I'm having my PCR tomorrow, but when they mention to me that they have had other patients with this experience". She also asked if it can it give her COVID since her symptoms were similar to COVID and other people are having symptoms. She also reported that 4 months ago, she got her first shingles vaccination and "it knocked me on my butt, I still haven't got the second injection but I got shingles" and asked should she have gotten the COVID vaccine if she just got over shingles 3-4 weeks ago. She reported that she got her first dose of the COVID vaccine on 13Jan2021 and her second dose is scheduled for 30Jan2021 (17days apart). She did not have a question about the timing of the vaccine, only mentioned when her second dose was due and the it was 17 days after the first. She wanted to know if Pfizer was seeing a lot of this, and it could this her body reacting to the vaccine. She wanted to know what she should do with the second vaccine, if she should get it. She works at a school and has been making sure to wash her hands and everything. The outcome of the events Rhinorrhoea, and Vaccination site pain was unknown. The outcome of the event ageusia was not recovered while the outcome of the rest of the events was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082498 same drug/event, different patients
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| 70 | 2021-02-05 | chills, headache, sweating, fever |
Unable to fall asleep the night of the second dose. Felt progressively worse as night went on. By ...
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Unable to fall asleep the night of the second dose. Felt progressively worse as night went on. By 3am, had fever, chills, couldn't stop shaking or get warm, had headache, skin sensitive almost hurt when touched. Felt too bad to get out of bed but eventually got up, took acetimetophen, drank water, added clothes and blankets and returned to bed. Body kept tensing up very tightly so that all muscles were constricted/tights and impossible to relax. This continued for a few hours. By morning, I thought I was starting to feel better. These symptoms returns for a second round about 2pm that afternoon and continued until about 6pm. On the nights of 2/3, 2/4 and 2/5, I wake up around 3am extremely hot and sometimes damp, despite air temp of 66 to 68 degrees. This resolves after about an hour and body feels normal.
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| 70 | 2021-02-05 | chills, headache |
My reaction began typically enough, with a sore arm and chills. The chills subsided by the evening,...
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My reaction began typically enough, with a sore arm and chills. The chills subsided by the evening, but symptoms continued and migrated from there. The arm remained sore for 3 days and then began to itch. This itchiness continued on and off for the next 2 days. My neck and shoulder were also sore. The shoulder continued to be sore for about 4 days. I had an intermittent headache, also for 4 days. The worst part though, is the nausea, which also comes and goes. But it can last for many hours and now, even after 8 days, I am still experiencing this. I can find nothing in the writings about this vaccine to corroborate this side effect and I am therefore worried about the second shot.
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| 70 | 2021-02-05 | chills, headache | Chills, 6 hours, body aches 24 hours, headache 24 hours, foggy brain 24 hours |
| 70 | 2021-02-05 | chills, headache | Chills aches headache tylonol. Lasted about 24 hours |
| 70 | 2021-02-05 | headache | Severe headache, face flushing, swollen tongue, throat closing off |
| 70 | 2021-02-05 | headache |
2/5/21 2nd Pfizer COVID vaccination ~1050. Began to feel nauseous, headache, increased BP. She had...
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2/5/21 2nd Pfizer COVID vaccination ~1050. Began to feel nauseous, headache, increased BP. She had these symptoms with 1st dose also. Was given acetaminophen 500mg po x 1 at 1100. During observation the headache began to resolve. Tends to get nauseated/car sickness and is currently on Prilosec. Placed on pulse oximeter and vital signs monitored. Symptoms are resolving during observation period and a friend is picking her up so she does not need to drive and friend will observe her the rest of the day.
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| 70 | 2021-02-06 | chills, fever, nasal congestion, influenza like illness, fatigue |
Severe myalgia, chills, fever - flu like symptoms, fatigue, dizziness, joint pain and bilateral met...
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Severe myalgia, chills, fever - flu like symptoms, fatigue, dizziness, joint pain and bilateral meta-tarsal pain on hands (which I used to have as part of my osteopenia. But was symptomless for a while). After about 18 to 20 hours after vaccination experienced severe bilateral metatarsal pain and joint pain on knees and back. Mild to moderate nasal congestion. Took 1 gram APAP /Benadryl alternating with ASA 325mg along with bedrest. Over the course of 2 days the pain (myalgia and arthralgia), flu-like symptoms and congestion resolved.
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| 70 | 2021-02-06 | fatigue, chills, headache |
chills, muscle pain, pounding headache, light-headed, fatigue lasted for approximately 24 hours. Mu...
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chills, muscle pain, pounding headache, light-headed, fatigue lasted for approximately 24 hours. Muscle aches and pounding headache w fatigue for an additional 24 hours. Fatigue for an additional 12 hours. Resolution by 4th day. Took 650 mg aspirin every 3-4 hours for first 48 hours.
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| 70 | 2021-02-06 | fatigue, chills, fever, sinus congestion |
Fever, chills, sinus congestion, extreme fatigue, general body aches. Followed by migraine. Sympto...
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Fever, chills, sinus congestion, extreme fatigue, general body aches. Followed by migraine. Symptoms residing 24 hours later
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| 70 | 2021-02-06 | headache, fatigue | None stated. |
| 70 | 2021-02-06 | fever | Fever 103, shakes, chills, profound weakness, loss of appetite, high blood sugar |
| 70 | 2021-02-06 | fever |
Developed multiple (approximately 15-20) canker sores in my mouth approximately 12-15 hours post inj...
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Developed multiple (approximately 15-20) canker sores in my mouth approximately 12-15 hours post injections; low grade fever
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| 70 | 2021-02-07 | chills, fever |
chills; feverish; shakes; This is a spontaneous report from a contactable consumer (patient). A 70-y...
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chills; feverish; shakes; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EH9899), via an unspecified route of administration on 21Jan2021 11:00 at SINGLE DOSE for covid-19 immunisation. Medical history included Blood pressure, Acid reflux, urinary tract. Concomitant medication included enalapril (ENALAPRIL) for Blood pressure, omeprazole (OMEPRAZOLE) for Acid reflux, and took another pill (Unspecified Medication) for urinary tract (Not clarified), 10 mg a day. The consumer reported she had the COVID vaccine 22Jan2021 11:00, was great all day, had no reaction, felt fine, ate, was active and then about 8:15 at night all of a sudden, she started to get the shakes and the chills and was feverish and she guessed it was an adverse reaction to the vaccine or side effect she did not know. Right now she was normal, slept okay but she was just wondering was this a normal. She took 2 Tylenol every night 4-5 hours, 500 mg took 2. The consumer meaned they don't even say this on the form if you get this reaction what you could take so she took it myself and it did help, the fever reducer. The patient underwent lab tests and procedures which included body height was 5 foot 5 and a quarter on an unknown date; body temperature was 101.2 on 21Jan2021, and 98.6 in Jan2021, Swab test on Tuesday (unknown date) with unknown result, didn't get the result yet. The event outcome was recovered in Jan2021.
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| 70 | 2021-02-07 | fatigue, nasopharyngitis, throat pain, cough, runny nose, sleepiness |
sore throat; discharge/drainage from nose; really tired; couldn't stay awake 4 hours after, she went...
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sore throat; discharge/drainage from nose; really tired; couldn't stay awake 4 hours after, she went to bed and slept for 12 hours; muscle aches; nose was crusty; discharge from her nose, bloody/it was a little bloody; inflammation; cold; Cough; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 15Jan2021 at single dose for covid-19 immunization. There were no concomitant medications and medical history. She had still has a sore throat, it has been a week since her first injection, and she immediately like got a sore throat straightaway, then drainage, and she was really tired and had to go to bed in about 4 hours. She couldn't stay awake 4 hours after, she went to bed and slept for 12 hours after the first shot. There was discharge from her nose, bloody, crusty like a cold, and she seldom ever has a cold and that continued, she didn't feel good until about maybe 4 or 5 days later. Sore throat was immediately after she thinks, it was certainly the next day (16Jan2021), and her date of vaccine was 15Jan2021. Now states and cough developed not until later. On 15Jan2021, she had the shot, she was really tired, muscle aches, the kind of things on the sheet, if not that evening, but the next day (16Jan2021), then drainage, it was white at first, it didn't turn yellow until a few days later, had a yellowish tinge, so she is sure there was inflammation, and her nose was crusty, in the morning it was a little bloody, and she had a sore throat, and probably by the Wednesday or Thursday, so 20 or 21Jan2021, there was a little cough, in the evening, and she is not experiencing that today. The outcome of the event sore throat was not recovered, cough was recovered on 22Jan2021, cold was recovering, other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 70 | 2021-02-07 | headache | Headache the night of injection |
| 70 | 2021-02-07 | malaise, cough |
due to get the 2nd dose, but she tested positive for COVID yesterday; due to get the 2nd dose, but s...
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due to get the 2nd dose, but she tested positive for COVID yesterday; due to get the 2nd dose, but she tested positive for COVID yesterday; Dizzy; starting to get foggy; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899 or EH9897), via an unspecified route of administration at the left arm on 04Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing diabetic, blood pressure high, high cholesterol and sore arms from previous vaccines (unspecified).She had energy for a whole week after getting the vaccine, that she has not had for a long time, she even cleaned out her whole garage; has been waiting to do that for 3 years; had to make herself stop to rest. There were no concomitant medications. The patient got her first dose on 04Jan2021 and was due to get the 2nd dose this coming 25Jan2021, but she tested positive for COVID on 21Jan2021. She has been sick for a week which started with an irritating cough on 14Jan2021. She went to the ER because she was dizzy as could be on Jan2021. She does not remember which day; she was starting to get foggy on Jan2021. She was not admitted. She did a drive through rapid test on 21Jan2021 and it was positive. Lot numbers: Handwriting on her card was bad and she cannot tell if the last digit of the Lot number is a 9 or 7. The vaccine was administered in an open tent clinic outside in a parking lot outside a hospital and not in a military facility. The outcome of the event was unknown. Information on Lot/Batch has been requested.
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| 70 | 2021-02-07 | fever, fatigue | fever of 100.5 for over 16 hours, muscle aches, fatigue |
| 70 | 2021-02-08 | chills | Chills muscle aches |
| 70 | 2021-02-08 | fatigue, chills | Vomiting, diarrhea, chills, fog head, tiredness, slight sore arm |
| 70 | 2021-02-08 | fatigue, headache | fatigue, headache, muscle & joint aches, mental fog |
| 70 | 2021-02-08 | headache, fatigue | Headache, Fatigue, Tingling & Numbness, Tightness in upper chest 11:20am-4pm |
| 70 | 2021-02-08 | headache |
PATIENT COMPLAINED OF TIGHTNESS ACROSS CHEEK AND HEADACHE. 11:35 BP 121/81, HR 70, RR 16 11:40 BP 12...
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PATIENT COMPLAINED OF TIGHTNESS ACROSS CHEEK AND HEADACHE. 11:35 BP 121/81, HR 70, RR 16 11:40 BP 122/68, HR 69, RR 16 11:45 BP 121/78, HR 70, RR 16 11:55 PATIENT LEFT SITE IN STABLE CONDITION
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| 70 | 2021-02-08 | malaise |
Pt reported she received the first dose, two days later, she fell ill, tested positive for COVID-19 ...
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Pt reported she received the first dose, two days later, she fell ill, tested positive for COVID-19 and received the antibody therapy. Pt will wait 3 months before she receives the second dose of the Pfizer vaccine.
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| 70 | 2021-02-08 | fever, chills | Uncontrolled chills without fever for approximately 30 minutes |
| 70 | 2021-02-08 | runny nose, headache, cough, sneezing |
about 5 hrs after injection started to get headaches, during the night i felt really hot but then i ...
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about 5 hrs after injection started to get headaches, during the night i felt really hot but then i had to get extra blankets because i was freezing. Then when i woke up i had Muscle pain. Then i started throughout day i started Sneezing, watering up, coughing, runny nose. muscle pain is getting better but still have the other symptoms
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| 70 | 2021-02-08 | sleepiness |
Patient felt sleepy, blurry vision. BP 131/55 (pulse 62), O2 sat 100%. After rest, patient felt bet...
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Patient felt sleepy, blurry vision. BP 131/55 (pulse 62), O2 sat 100%. After rest, patient felt better.
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| 70 | 2021-02-09 | chills, headache, fever |
Chills; Fever; Aches and pains/throbbing of a headache; Aches and pains/throbbing of a headache; Thi...
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Chills; Fever; Aches and pains/throbbing of a headache; Aches and pains/throbbing of a headache; This is a spontaneous report from a contactable consumer. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL9261, via an unspecified route of administration on 24Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included COVID-19 flu six months ago. There were no concomitant medications. The patient experienced chills on 25Jan2021 01:00 with outcome of recovering, fever on 25Jan2021 01:00 with outcome of recovering, aches and pains/throbbing of a headache on 25Jan2021 01:00 with outcome of recovering. Her symptoms all started about 1AM, she was woken up to them. Chills: they are better, she has an ice pack on her head for the throbbing of a headache. The action taken was not applicable. She wanted to take a Tylenol. It will probably go away tomorrow she was hoping to get some relief in the mean time.
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| 70 | 2021-02-09 | cough, fatigue |
face looks a little bit swollen; super tired; light dry cough /Light coughing; feeling like weaknes...
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face looks a little bit swollen; super tired; light dry cough /Light coughing; feeling like weakness; bone pain; muscle ache; She had some prior ache before but today it was stronger; This is a spontaneous report from a contactable consumer (daughter). A 70-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EJ8982 and Expiration Date unknown) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis, blood pressure high, had Corona virus before in Nov2020, and ongoing ache. The concomitant medication was reported as Lisinopril at 10 mg, one tablet a day for Blood pressure high and Vitamins. Patient woke up this morning (23Jan2021) super tired, light dry cough and face looks a little bit swollen. No just tired, she was feeling like weakness, a lot bone pain or muscle ache like a lot. The patient had some prior ache before but today it was stronger. She still feels some pain. Treatment for bone pain or muscle ache, pain was Ibuprofen. The reporter wanted to know if these symptoms are common reactions to the vaccine; if the COVID-19 vaccine can give a COVID-19 infection; if patient should receive the second dose of the COVID-19 vaccine since she was having these side effects. The outcome of events, bone pain or muscle ache, pain was not recovered. The outcome of other events were unknown. No follow-up attempts are possible. No further information is expected.
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| 70 | 2021-02-09 | malaise, fever |
I had been running a temperature, I am usually 97.6 it was 99.1; I started to not feel good; This is...
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I had been running a temperature, I am usually 97.6 it was 99.1; I started to not feel good; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 18Jan2021 as a single dose, for COVID-19 immunization, lot number: unknown. Medical history included thyroid cancer and they took her thyroid (as reported). Concomitant medication included levothyroxine sodium (LEVOXYL) as she had thyroid cancer and they took her thyroid. Patient stated that she had first of her vaccine on 18Jan2021 (a week before the report was last Monday) and she felt fine, just the injection site (no further clarified). Starting on 23Jan2021 (reported as Saturday) she started to not feel good and on 24Jan2021 (reported as Sunday yesterday) she had been running a temperature, it was only like she was usually 97.6 it was 99.1 and she took paracetamol (TYLENOL) and it took the temperature down but she was wondering, patient called her doctor and she thought that it was too far, too many days have passed since the vaccination to have symptoms. Second dose scheduled for 08Feb2021. Outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 70 | 2021-02-09 | fever, fatigue |
Fever, aching, nausea, loss of appetite, and fatigue. Used 2 Tylenol ES. Nothing really changed. Thi...
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Fever, aching, nausea, loss of appetite, and fatigue. Used 2 Tylenol ES. Nothing really changed. This morning fever was 100.6 F. That has now dropped to normal w/Tylenol. Appetite is coming back.
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| 70 | 2021-02-09 | runny nose, sneezing, influenza like illness, fever | Flu like symptoms, sneezing, runny nose, stomach pain and achy all over. Low grade fever one day. |
| 70 | 2021-02-10 | body temperature increased, headache |
Body aches, Abdominal pain, diarrhea, nausea, headache, chills, low temp 99.8 Thurs 2/4 & continui...
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Body aches, Abdominal pain, diarrhea, nausea, headache, chills, low temp 99.8 Thurs 2/4 & continuing thru Thurs 2/11
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| 70 | 2021-02-11 | chills |
blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumpin...
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blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumping to my head and became very hot; face turned red and was hot to the touch; facial muscles became weak on both; difficult to make facial expressions; my mouth began to tremble; chills; facial muscles became weak on both; difficult to make facial expressions; This is a spontaneous report from contactable consumers. An 70-year-old female non-pregnant patient received her first dose bnt162b2 (BNT162B2; Solution for injection; lot number: EL9283) via an unspecified route of administration at Left arm on 28Jan2021 12:30 at single dose for COVID-19 immunisation at Clinic. Medical history included high blood pressure, high cholesterol. Concomitant medication included rosuvastatin calcium (CRESTOR), amlodipine, calcium carbonate simethicone. There was no other vaccines in four weeks. The patient previously took iodine had contrast, procaine hydrochloride (NOVOCAIN) had drug allergy, omeprazole (PRILOSEC) and had drug allergy, olmesartan medoxomil (BENICAR) had drug allergy. Five minutes after the injection 28Jan2021 12:35, patient felt blood pumping to her head and became very hot. Her face turned red and was hot to the touch. Then, facial muscles became weak on both sides and made it difficult to make facial expressions. Lastly, her mouth began to tremble and had chills. Symptoms subsided about 30 minutes after the injection. she worried about getting the second injection. The patient received treatment with Liquids/electrolytes. The events result in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in 2021.
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| 70 | 2021-02-11 | fatigue |
Arm hurt at site of shot, Very Tired, Very Thirsty (drank 3 full glasses of water in a couple minute...
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Arm hurt at site of shot, Very Tired, Very Thirsty (drank 3 full glasses of water in a couple minutes), Weak leg, (briefly, Aching, Dry eyes even with home humidifier on furnace, ribs hurt for about 5 min. and wheezing upon awakening at 4:45am, most symptoms gone by about 7:30am, Thursday.
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| 70 | 2021-02-11 | throat pain, cough |
Patient tested positive for COVID-19 on 2/4/21, she had symptoms of cough and sore throat on 2/2/21....
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Patient tested positive for COVID-19 on 2/4/21, she had symptoms of cough and sore throat on 2/2/21. She was admitted to hospital on 2/12/21 COVID-19 pneumonia and hypoxic respiratory failure.
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| 70 | 2021-02-11 | fever | low grade fever for 12 hours, body aches, sore arm |
| 70 | 2021-02-14 | chills |
Patient reported nausea, vomiting, weakness, chills, unable to keep food down, face broke out in ras...
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Patient reported nausea, vomiting, weakness, chills, unable to keep food down, face broke out in rash around eyes and rash on hand. Patient reported symptoms lasted over a week. Went to ED, given IV fluids and discharged home.
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| 70 | 2021-02-14 | fatigue, headache |
Sore arm w/in 2 hours. Lasted 24 hrs Fatigue, w/in 2 hours, lasted 24 hrs Muscle aches, began in 1...
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Sore arm w/in 2 hours. Lasted 24 hrs Fatigue, w/in 2 hours, lasted 24 hrs Muscle aches, began in 12 hrs, lasted 12 Headache, began in 12 hrs, lasted 6
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| 70 | 2021-02-14 | fatigue |
Night of Feb 13. Felt tired around 10 pm, headed for bed. Lay down and room started spinning. Starte...
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Night of Feb 13. Felt tired around 10 pm, headed for bed. Lay down and room started spinning. Started feeling nauseous. (Note no alcohol consumed since New Year?s.) sat up, read a while, tried lying down again 3 times with same result. Got up to walk, threw up. After about 15 min was able to lie down and sleep. Process took about 2 hours in all. Mild nausea and dizziness continuing to now, Monday afternoon. Note lifelong history of motion sickness related to boats, planes, swaying motions, sometimes car travel.
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| 70 | 2021-02-14 | headache, chills, fever, fatigue |
Dose 1: mild pain at injection site Dose 2: moderate pain at injection site; fatigue, chills, musc...
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Dose 1: mild pain at injection site Dose 2: moderate pain at injection site; fatigue, chills, muscle aches, low grade fever (100), headache
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| 70 | 2021-02-14 | headache, fatigue, chills, fever |
Explosive Diarrhea, & explosive vomiting lasting over 10 hours. Rapid heart rate which began prior t...
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Explosive Diarrhea, & explosive vomiting lasting over 10 hours. Rapid heart rate which began prior to above diarrhea & vomiting. Muscle cramping & muscle twitching much like electrical shock especially in lower extremities along with severe headache. Low grade fever & mild chills. Extreme tiredness/low energy which still remains. There was also a degree of dizziness which remains as well.
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| 70 | 2021-02-14 | sweating |
Patient feeling sweaty and weak.. History of DM and HTN. Did not take meds this morning. BP- 195/92...
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Patient feeling sweaty and weak.. History of DM and HTN. Did not take meds this morning. BP- 195/92, after 2 minutes 199/101, after 5 minutes- 179/101 Monitored and released to home after 30 minutes. Will take BP meds when gets home and follow up with primary MD
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| 70 | 2021-02-15 | chills, fever, fatigue |
2/10 I had pain at injection site, mild fever and some chills, and extreme fatigue. The fatigue ...
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2/10 I had pain at injection site, mild fever and some chills, and extreme fatigue. The fatigue continued through mid-day, 2/15
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| 70 | 2021-02-15 | fatigue |
pt stated that right after the vax she got really bad back pain. Later that day she had muscle pain...
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pt stated that right after the vax she got really bad back pain. Later that day she had muscle pain, joint pain and fatigue. Next day she still had muscle and joint pain. On 2/15/21 she had developed a itchy rash on both elbows and later spread almost over her entire body. Pt contacted her PCP which instructed to go to the ER. She was given prednisone and Benadryl at the ER. They wrote her a rx for prednisone and she is to FU w/ PCP on 2/19/2021.
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| 70 | 2021-02-15 | fatigue |
Date and time of vaccination: (list both if they received both shots): 1/12/21 0830; 2/12/21 1500 Br...
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Date and time of vaccination: (list both if they received both shots): 1/12/21 0830; 2/12/21 1500 Brand and lot of vaccine: 1st EL9262 , 2nd EN9581 extreme fatigue, itching underarm of injection site, lightheadedness, poor appetite
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| 70 | 2021-02-16 | sweating, headache |
woke up morning after shot with headache, slight nausea, severe muscle and joint pain and muscle wea...
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woke up morning after shot with headache, slight nausea, severe muscle and joint pain and muscle weakness, could hardly sit up by myself, this was 2/11/21. I continued to feel these symptoms with lessening severity over the next 3 days until Sunday 2/14/21 at which time, late in the afternoon, I fell asleep and woke up drenched in sweat but feeling pretty much back to normal self and have felt normal self since then.
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| 70 | 2021-02-17 | malaise |
shingles/I've had shingles before, this was the 4th time; shingles/I've had shingles before, this wa...
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shingles/I've had shingles before, this was the 4th time; shingles/I've had shingles before, this was the 4th time; kidney infection; hurting on my waist around the back; diverticulitis; Her blood pressure went up to 211/92; does not feel well; afraid of taking it if it will be any worse; sick; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot: EL3248, expiry 30Apr2021), intramuscular on 23Jan2021 08:15 at a single dose in the left arm for COVID-19 immunization (prevention because she has autoimmune). Medical history included Behcet's syndrome and Sjogren's syndrome, both are overactive immune system problem/autoimmune diseases, which were diagnosed 20 years ago; diagnosed allergies; compromised immune status; respiratory illness; genetic chromosomal abnormalities; endocrine abnormalities (including diabetes) and obesity; and patient have had shingles before. Family history was reported as none. Concomitantly, she was just taking daily medications that were not relevant. There was no prescriber for the vaccine. It was through a hospital. It was reported that vaccination was given at 08:15 to 08:30. Patient had no history of previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered the same date of the Pfizer suspect. Patient had not had prior vaccinations (within 4 weeks). Patient received her first dose of the Pfizer vaccine on Saturday 23Jan2021. She stated, on Tuesday 26Jan2021, patient was hurting on the waist around the back. On Wednesday, 27Jan2021, that next morning, she went to see her internal doctor and they thought a kidney infection or not; he was not sure if she had a kidney infection or what was going on. Patient went home and it got worse and patient went to the ER (Jan2021), also reported as ended up going to the ER. They did a CT scan gave her medicine. They did a CT scan and said it was not her bladder or anything (Jan2021). They thought it was diverticulitis; nothing helped. They gave her medication and she kept getting sick (2021). No further details provided on medication given. On Friday, 29Jan2021, early morning, patient went back to the ER, they did another CT with contrast it wasn't diverticulitis, but it was shingles, and patient have had shingles before, this was the 4th time. It was reported that when the doctor came in, he thought this was shingles and she has had shingles previously. She has had it about 3 other times and the pain was just off the scale (Jan2021). Her blood pressure went up to 211/92 and they were giving her morphine for the pain (Jan2021). She was questioning if she should get the second dose. She has two autoimmune diseases and it was an overactive immune disease. She took the one vaccine and her doctor said to contact Pfizer being as it is kind of new and especially since she has the autoimmune issues. She would like to know if it is safe for her to have the second vaccine. She does not know if she will be over this. She does not feel well (Jan2021). She was afraid of taking it if it will be any worse (Jan2021). Patient felt all right until she had the vaccine, on Tuesday the problem started (26Jan2021). They were giving her medication for the shingles and for the pain. Patient stated that "it set something off". Patient was still sick (2021), still taking pain pills. Patient didn't know how many days she has. Her second vaccine is on 13Feb2021. As sick as she has been, and her overactive immune system and if she still has the shingles those can last a long time, she doesn't want to go through what she went through. This was a lot of pain and with shingles they can last, 6 months or a year. The nurse called her back and told her to report to Pfizer. Patient was taking the medicine for the shingles right now. She doesn't know what will happen. She doesn't want to be sick. Patient asked for the efficacy after 1 dose and how much protection it has. She did fill out something because she talked with someone else. She confirmed it was through VAERS and not with Pfizer. She said the pain around her waist was a little better because they gave her the medicine for shingles and she has pain pills. She said one was Valacyclovir and she could not remember the name of the other. Patient had required two trips to ER. First one was on 27Jan2021 and went to internal medicine doctor and that night went to the ER. They did CT scan and it was not bladder or anything. Second visit on 29Jan2021 and did CT with contrast and the doctor thought it was shingles since she had shingles three times before. She has had them internally. The doctor said it would not necessarily need to be externally break outs. The next two times she did not break out. She did not have anything around her waist. Therapeutic measures were taken as a result of the events hurting on my waist around the back, kidney infection, diverticulitis, shingles, and sick. The outcome of the event hurting on my waist around the back was recovering. The outcome of the event kidney infection, diverticulitis, shingles, sick, blood pressure went up to 211/92, does not feel well, and "afraid of taking it if it will be any worse" was unknown.
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| 70 | 2021-02-18 | chills, malaise, headache | Chills, joint pain, body aches, syncopal episode, diarrhea, headache, malaise |
| 70 | 2021-02-18 | chills | Chills, muscle and bone pains |
| 70 | 2021-02-18 | chills | muscle and bone pain, chills, irregular glucose levels, extreme confusion and disorientation |
| 70 | 2021-02-18 | cough, throat irritation |
10 minutes after receiving her first dose of Covid vaccine, patient felt dry, itchy throat and had a...
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10 minutes after receiving her first dose of Covid vaccine, patient felt dry, itchy throat and had a dry cough. She was brought to us by EMS staff for medical evaluation. BP was elevated. Denies any other symptoms. Face slightly flushed, chest CTA, RRR, able to communicate well, A&O. BP 184/115 left arm, repeat after 10 minutes: 164/102. has hypertension and took her med today. Symptoms resolving and after approx 20 minutes, completely resolved. Patient declines to be transferred to local healthcare facility and agreed to call her PCP once she returned home to notify of BP and possible reaction to vaccine. Feeling much better, she stated her husband was here and she was going home.
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| 70 | 2021-02-18 | fatigue, throat pain, headache | She has some symptoms, not severe, but minor; fatigue, headache, sore throat. |
| 70 | 2021-02-18 | fatigue | Nausea, fatigue, soreness |
| 70 | 2021-02-18 | headache, sweating |
Sore arm, headache, nausea, sweats Time: from 7PM (Feb. 17th) until morning of the second day (Feb. ...
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Sore arm, headache, nausea, sweats Time: from 7PM (Feb. 17th) until morning of the second day (Feb. 19th).
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| 70 | 2021-02-18 | headache |
Feeling very hot; lips numb and tingly; lips numb and tingly; headache; dizzy; heart beating hard in...
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Feeling very hot; lips numb and tingly; lips numb and tingly; headache; dizzy; heart beating hard in chest; anxiety; nausea with dry heaves; nausea with dry heaves; elevated blood pressure; This is a spontaneous report from a contactable nurse (self-reported). A 70-year-old female patient (who was not pregnant at the time of vaccine) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; el3249) via an unspecified route of administration, at right arm on 14Jan2021 14:00, at hospital for COVID-19 Immunization. Medical history included HTN (hypertension), GERD (Gastrooesophageal reflux disease), oral cancer 2020 with surgery only, arthritis, hypothryroid and allergies to nickel. Concomitant medications included, irbesartan (AVAPRO), levothyroxine, liothyronine (NP THYROID), lansoprazole (PREVACID), ibuprofen (MOTRIN) and paracetamol (TYLENOL). The patient previously took metoclopramide (REGLAN) and prochlorperazine edisylate (COMPAZINE); patient had allergies to both drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of medications the patient received within 2 weeks of vaccination, included: avapro, np thyroid, prevacid, motrin, Tylenol. On 14Jan2021 at 14:15 (after 15 minutes of dose), the patient experienced feeling very hot, lips numb and tingly, headache, dizzy, heart beating hard in chest, anxiety, waited another 15 minutes, taken to ER (Emergency Room) on site; elevated blood pressure, nausea with dry heaves. Patient was taken into Emergency room/department for urgent care and received treatment IV solumedrol, ativan and zofran, oral Benadryl. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unknown date in 2021; Sender's Comments: There is a reasonable possibility that the events headache and nausea were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported serious events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 70 | 2021-02-19 | headache, fatigue, fever | 1) Extreme fatigue; 2) Muscle ache; 3) Fever (101.1); 4) Nausea; 5) Headache. |
| 70 | 2021-02-21 | chills, fatigue, body temperature increased |
27 hours after injection I began to feel a migraine, chills, incredibly tired and my temperature wen...
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27 hours after injection I began to feel a migraine, chills, incredibly tired and my temperature went up to 100.8. My chest was tight and achy and my oxygen levels stayed at about 88. I slept about 10 hours and woke up feeling fine. My chest is sore and achy but better than yesterday.
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| 70 | 2021-02-21 | chills, fever, headache | Fever,chills,upset stomach, body aches,headache |
| 70 | 2021-02-21 | chills, fever |
Woke up in middle of night with fever, chills, teeth rattling, nausea, dizziness, weakness. Took ace...
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Woke up in middle of night with fever, chills, teeth rattling, nausea, dizziness, weakness. Took acetaminophen and some anti -nausea drugs I had on hand. Fever left, but returned next night. Weakness, no appetite stayed for two days. Thought it was the flu, but no upper respiratory symptoms. Thought it might be Covid-19 but tested negative. Finally decided it was a reaction to the vaccine.
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| 70 | 2021-02-21 | fatigue, influenza like illness |
Felt fine at first, but then suffered flu-like symptoms including extreme fatigue, stomach discomfor...
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Felt fine at first, but then suffered flu-like symptoms including extreme fatigue, stomach discomfort, gas, nausea, loss of appetite, acid reflux. Some symptoms have ceased or lessened, but extreme fatigue, lack of appetite and some stomach discomfort and acid reflux discomfort continues.
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| 70 | 2021-02-21 | fatigue, fever, headache, chills |
7 hours after injection, experienced extreme tiredness. Overnight, awoke with body aches, joint pai...
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7 hours after injection, experienced extreme tiredness. Overnight, awoke with body aches, joint pain, and injection site pain. Early morning awoke to body aches, headache, and extreme fatigue. While not chilled, needed three layers on top and two layers on bottom and on feet. Temperature at 8AM was 97.0. Voracious appetite and ate normally and with vigor. Slept for 3.5 hours and awoke to fever of 100.3 and voracious appetite. Ate normally. Body aches and joint pain were gone. About an hour later, temperature returned to normal but headache persisted. No longer fatigued, but still tired. Headache persisted that evening and still present at this writing, 8AM Monday.
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| 70 | 2021-02-21 | fatigue |
Aside from expected soreness at injection site, no adverse reactions through rest of Feb 10 and a...
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Aside from expected soreness at injection site, no adverse reactions through rest of Feb 10 and all of Feb 11 and 12 Starting February 13 and continuing through today (Feb 22), I have had the following symptoms: Vestibular migraine - very severe at the beginning, receding with time, but still concerning Nausea - on and off for full period, no relation to food intake Fatigue - tired most all of the time, could fall asleep at any time Balance - variable for this period, no falls, but do not feel safe to drive
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| 70 | 2021-02-21 | fatigue |
it felt like the reaction i generally have had with steroid injections for my spine. I was wide awa...
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it felt like the reaction i generally have had with steroid injections for my spine. I was wide awake all night. By the following afternoon I was exhausted and no longer feeling that effect. Nothing was done since it did not last. It was suggested that I report it since it is not mentioned as a side effect in the list of information.
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| 70 | 2021-02-21 | fatigue | Dizziness that is continuing, fatigue, arm soreness, swelling of lymph nodes |
| 70 | 2021-02-21 | fatigue |
Hypercalcemia AKI encephalopathy acute vomiting fatigue acute ER 2/15 ICU 2/15 Hospitalized till 2...
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Hypercalcemia AKI encephalopathy acute vomiting fatigue acute ER 2/15 ICU 2/15 Hospitalized till 2/2021 IVs extensive electrolyte medications
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| 70 | 2021-02-21 | sweating, fatigue |
Approx. 1 hr. & 20 min. post injection, severe reaction: Severe upper abdominal pains, multiple, unc...
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Approx. 1 hr. & 20 min. post injection, severe reaction: Severe upper abdominal pains, multiple, uncontrollable formed to diarrheal bm's triggered vagal response, passed out, severe diaphoresis, violent chilling loss of control of bowel movements. Lasted approx. 30-35 minutes. crawled with head hanging to floor to keep from passing out, to locate a phone for help. after several of agonizing attempts to try and climb up to couch to elevate legs high above head and laying there for approx. 20 or more min. blood pressure came up some. (Did not call emergency services) afraid of hospitalization due to all chronic health problems, (forgot to report earlier that I am Hypothyroid as well) previously hospitalized for a Thyroid Storm. This is day 10 from injection and still have nausea, dizziness & fatigue, (also have couple episodes of abdominal pain). (I want to add that I felt completely fine prior to receiving 2nd Pfizer Covid dose). I am contacting my doctor today to receive some IV fluids.
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| 70 | 2021-02-21 | throat irritation |
5min after vaccine as per daughter, her mother began complaining of "burning " in her chest , itchi...
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5min after vaccine as per daughter, her mother began complaining of "burning " in her chest , itching in her throat, lump in her throat, hives/redness noted on throat and chest. RRT responded and accompanied patient to ED
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| 70 | 2021-02-22 | body temperature increased, lethargy, sweating |
2/7/21 Increased difficulty chewing, swallowing, evaluated by SLP and dietician. Diet texture down-g...
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2/7/21 Increased difficulty chewing, swallowing, evaluated by SLP and dietician. Diet texture down-graded x 2 with poor appetite and recent 6lb weight loss. 2/8/21-APRN updated regarding poor appetite and difficulty chewing as well as downgraded texture of diet. Also informed of increased s/s of discomfort and increased use of PRN Oxycodone for pain. 2/9/21- elevated temp 100.7. 2/9/21 Covid pcr test negative. 2/9/21-N.O.?s APRN BMP, Albumin and Pre-albumin Level in am. 2/11/21-elevated temp 100.4. Covid rapid test negative. 2/12/21- CBG recorded at 517 at 5:20 am. Resident also has an elevated temp of 100.9. Tylenol administered per order. Vital signs include resp 24, radial pulse 134, O2 sat 83%. Supplemental oxygen administered via nasal cannula. Head of bed elevated. DR. notified at time via telephone. Order given for sliding scale for CBG. Guardian updated regarding changes in residents condition, poor prognosis. Guardian requests Hospice eval and admit. Guardian requests comfort care no hospitalization, no IV's, no G-tubes, no labs etc, D/C of Palliative services. ARNP informed. 2/12/21 Acute Telehealth visit with APRN due to increased lethargy, elevated CBG?s despite poor appetite and insulin administration. Resident unresponsive to verbal and noxious stimuli at time of visit. N.O. Morphine sulfate 20mg/ml, give 2.5mg PO/SL Q4hr PRN pain/shortness of breath. 2/12/2021-Admitted to Hospice, Lethargic, diaphoretic, T 98.1 P 130's R 18 O2 high 80's to low 90's via O2 mask at 3L. 2/12/2021- Resident legs and arms noted to feel cool this afternoon, 02 sat was 97% with 02 on @ 3L with mask Noted resident with sob and increased pulse. Prn morphine 0.25ml sl. given with good effect. Resident was less restless and quiet in her bed. Checked on resident several times this shift for needs. Resident noted to not move in her bed @ 8:15pm and noted she was not breathing. Supervisor called and pronounced resident deceased.
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| 70 | 2021-02-22 | fatigue, headache |
Sharp stabbing pains in left hip socket, approx. 3 - 5 times/hour, with buckling of left hip if walk...
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Sharp stabbing pains in left hip socket, approx. 3 - 5 times/hour, with buckling of left hip if walking. Lesser joint pains in left ankle. Gradually resolving by Day 4. Tylenol 500 mg tablet taken on Day 3 was not effective. Minor symptoms: fatigue, mild headache.
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| 70 | 2021-02-22 | headache, fatigue, chills |
2 hrs. After injection mild chills & fatigue. 14 hrs. After injection mild chills, mild headache, ve...
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2 hrs. After injection mild chills & fatigue. 14 hrs. After injection mild chills, mild headache, very tired/fatigue, moderate to severe upper body muscle aches, mild migratory chest pains for about 30 minutes. 24 hrs after injection just overwhelming fatigue& mild headache continued for another 12 hrs. 48 hrs. After injection symptoms gone.
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| 70 | 2021-02-22 | headache, fever | Body aches, fever (102 F), headache beginning night of 2nd inoculation, continuing through next day |
| 70 | 2021-02-22 | headache, fever |
pt stated that went to bed w/ a sore are the night after receiving the covid vax. She woke up the ...
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pt stated that went to bed w/ a sore are the night after receiving the covid vax. She woke up the next day w/ unbearable pain all over her body, body aches, joint pain, head ache, back ache. She felt like she had fever but she said it was only 99. Her left arm was swollen, red and hot around the injection site. Pt states she still has shaky, achy legs and swelling in left arm. Pt called her PCP and left message for them to give her a CB.
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| 70 | 2021-02-22 | headache |
When I left facility I had a mild headache. After getting on the highway face turned beet red with ...
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When I left facility I had a mild headache. After getting on the highway face turned beet red with mild swelling. Throat felt tight but not closed. An hour later the headache was worse. Took a Tylenol and slept for an hour. Woke up itchy. Glands on right side of neck very sore with pain radiating to base of skull. Swelling in face subsided after a few hours. Later at night I was still itchy with some small red hives on my arms, legs, and stomach. Arm very sore. Woke several times during the night with nausea. Woke up morning of the 20th with mild dizziness, upset stomach and severe diarrhea, Serious headache all day. Hives subsided but was still itchy. On the 21st felt much better but still with diarrhea. Today is the 23rd and no diarrhea since this morning.
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| 70 | 2021-02-22 | headache |
The patient began to have hot flashes and some dizziness. She felt "disoriented in her eyes," while ...
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The patient began to have hot flashes and some dizziness. She felt "disoriented in her eyes," while also having a slight headache. The feeling went away after 10 minutes and began 15 minutes after receiving her second Pfizer vaccine dose.
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| 70 | 2021-02-22 | headache |
approx. 5 minutes after receiving the vaccine client started c/o nausea. She was given an antacid an...
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approx. 5 minutes after receiving the vaccine client started c/o nausea. She was given an antacid and it helped. She says by the time she got home she had a Headache that lasted off and on for 3 days. She took Excedrin and it helped.
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| 70 | 2021-02-22 | malaise, chills, influenza like illness, headache |
I began getting chills and felt feverish. I also had body aches and pains as when ill with the flu. ...
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I began getting chills and felt feverish. I also had body aches and pains as when ill with the flu. There was a sense of nausea initially but it went away. There was pronounced feeling of heat located subcutaneously on my right outer thigh. It came and went about every minute or so. (I counted the seconds in between each incident). I am still experiencing flu like symptoms (bodily aches, slight headache, mild chest pain, and general ill-feeling.) I will contact my primary care physician today about my concerns but felt it necessary to document these mild but disturbing side effects.
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| 70 | 2021-02-23 | chills, sweating |
nauseous; severe stomach cramps; shortness of breath; chest tightness; diaphoretic; chilled; cold to...
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nauseous; severe stomach cramps; shortness of breath; chest tightness; diaphoretic; chilled; cold to the touch, ashen; cold to the touch, ashen; patient was treated as if a heart attack; This is a spontaneous report from a contactable healthcare professional (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 29Jan2021 15:30 at a single dose for Covid-19 immunization. Medical history included high BP, and cholesterol. Patient had no known allergies. Concomitant medications included amlodipine and simvastatin. The patient experienced nauseous, severe stomach cramps, shortness of breath, chest tightness, diaphoretic, chilled, cold to the touch, ashen on 01Feb2021 at 15:30. Ambulance was called, patient was brought to the ER and was hospitalized on an unknown date for 2 days. Treatment of events: patient was treated as if a heart attack, nitro, baby aspirin. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not tested positive for Covid-19 after vaccination. Outcome of the events was recovered. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on a compatible temporal relation. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 70 | 2021-02-23 | headache, cough, fatigue, malaise, nasopharyngitis, fever |
arm pain in shot arm suddenly began to get worse at 10:00 pm. , severe underarm pain began then al...
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arm pain in shot arm suddenly began to get worse at 10:00 pm. , severe underarm pain began then also and found swelling like an orange, swelling lasted 8 days but was decreasing in size. became very cold and went into violent shaking tremors - 4-6 of those as i lost count. these violent tremors were from 10:30 pm on monday through 1:45 am tuesday. i had one other tremor on day 4. fever for 4 days and spiked on 5th day ranging from 101.8 - 100.3, severe all over body aching especially right armpit, lower back especially right side and across shoulders, aching lasted 8/9 days and lessened after 5 days. pressure on chest which ranged from very heavy to mild and in some form lasted 10 days, hurt to breath but i could breath. woke up on night 7 with heavy, painful chest pressure on left side but it subsided in 6-8 hours. nasty headache began day 2 and lasted several days; nothing relieved it. headache for 4/5 days and then off and on for a few days. i am not prone to headaches. coughing which lasted several days. on third day post vaccine had violent nausea one time. became weak and lightheaded. no energy and stayed in bed 5 days. on day six i started getting out of bed for several hours multiple times/day. weak and very low energy. exhausted easily. i had some of these symptoms for 10 days. the first 5 days were terrible and i was very ill.
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| 70 | 2021-02-23 | headache, fatigue, throat pain, chills, malaise |
Fatigue; Body Aches/Soreness; Chills; Swollen and Sore Tongue; Swollen and Sore Tongue; Diarrhea; Lo...
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Fatigue; Body Aches/Soreness; Chills; Swollen and Sore Tongue; Swollen and Sore Tongue; Diarrhea; Loss of Appetite; Throat swelling; Headache; Malaise; Shortness of Breath; Thick Mucus in Nose & Throat; Thick Mucus in Nose and Throat; Horseness and Sore Throat; Horseness and Sore Throat; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on right arm on31Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included autoimmune, tachycardia, acid reflux, penicillin allergy, walnuts allergy. Concomitant medication included estradiol and levothyroxine. The patient previously took lanolin and erythromycin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021 patient experienced fatigue, body aches/ soreness, chills, swollen and sore tongue, diarrhea, loss of appetite, throat swelling requiring 2 visits to the ER (emergency room). Culminating in Steroid injection and oral Prednisone. Headache, malaise, shortness of breath, thick mucus in nose and throat, hoarseness and sore throat. The adverse events result in Doctor or other healthcare professional office/ clinic visit and Emergency room/department or urgent care. The seriousness of the events was assessed as non-serious by the reporter. Therapeutic measurements were received for the events with steroid injection at the ER and oral Prednisone. The outcome of the events was reported as not recovered. Information on the lot/batch number has been requested.
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| 70 | 2021-02-23 | headache, fatigue |
3rd day after vaccine: fatigued, headache, unable to concentrate 4th day: disoriented, strange visio...
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3rd day after vaccine: fatigued, headache, unable to concentrate 4th day: disoriented, strange visions when eyes were closed, fatigue, VERY loud ringing in ears, tight chest, puffy eyes, heart racing & pounding 5th day:Diarrhea, fatigue
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| 70 | 2021-02-23 | headache |
30 minutes after the shot my center of my nose and spreading to high upper lip and roof of my mouth ...
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30 minutes after the shot my center of my nose and spreading to high upper lip and roof of my mouth got numb. In addition I had a ?tickle? down the left side of my throat. Three days later I was itchy on my lower arms and upper legs. I also had a headache off and on for several days.
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| 70 | 2021-02-23 | headache |
My mother complained of a severe headache within 1 hour of receiving the injection. 18 hours later s...
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My mother complained of a severe headache within 1 hour of receiving the injection. 18 hours later she was rushed to the the ER with a Hemorrhagic stroke. Hospitalized for 3.5 days, cognitive impairment remains, resulting in the need for rehabilitation therapy.
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| 70 | 2021-02-23 | sweating |
Pt. in tent 6 at observation lane felt throat tightness, sweaty palms. Paramedics assessed her once...
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Pt. in tent 6 at observation lane felt throat tightness, sweaty palms. Paramedics assessed her once the symptoms subsided paramedics released pt. to leave.
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| 70 | 2021-02-23 | lethargy, headache, body temperature increased |
extreme cold internally, head ache and tremors within 10 or 15 mins. Sat for 20 more minutes, then ...
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extreme cold internally, head ache and tremors within 10 or 15 mins. Sat for 20 more minutes, then walked to parking garage. Breathing became labored as I walked the block to car - no one was around. Pulled off mask and sat in car - it subsided in 15 minutes. Body temp was 94.5 remainder of the day. 96.5 today. Awoke nauseated, headache, left foot and hand pain and very sore left arm. Nausea stopped about 3:00 pm, when body tremors started again. Cold all day with no energy
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| 70 | 2021-02-23 | malaise, headache, fatigue, fever | Body aches, felt feverish, weakness, headache, fatigue, overall malaise |
| 70 | 2021-02-23 | malaise, headache |
A little after midnight, I woke up shaking because I was so very cold. It felt almost like a seizur...
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A little after midnight, I woke up shaking because I was so very cold. It felt almost like a seizure because my lack of control was evident in my movements. With my heaviest PJs on, it took 8 blankets to finally warm me up. I am on a CPAP machine but I was having a hard time getting my breath. I was also nauseous but never threw up. I finally got back asleep a little after 3 am but woke several times after that. This morning, I had a terrible headache and can't get rid of it. Although I feel better than last night, I feel lousy. It is now 2 pm and I just want this to be over. On the first shot, I didn't have any reaction at all.
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| 70 | 2021-02-24 | chills |
After the vaccine my right arm was sore at the injection site. Later that night, after I went to bed...
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After the vaccine my right arm was sore at the injection site. Later that night, after I went to bed around 10:30 pm I started feeling nausea, followed by vomiting twice. Throughout the night I had body aches from head to toe. Also experienced body chills which continued the next morning.
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| 70 | 2021-02-24 | headache, fatigue |
Five hours after receiving the vaccine my husband I and were both extremely tired and fell asleep fo...
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Five hours after receiving the vaccine my husband I and were both extremely tired and fell asleep for about an hour - we were not able to complete simple tasks and went to bed early. My husband was up every half hour urinating from 6pm until about 3am. We both felt fine this morning but about 11am I got super dizzy and had to sit down, the dizziness caused vomiting and a sever headache. I laid down for about an hour and feel a bit better but the headache has remained!! Hopefully this too will pass in a few more hours! Just thought you might want to know. If it gets worse I will contact my doctor. My husband has not had any other adverse reactions.
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| 70 | 2021-02-24 | headache |
Within 30-minutes of vaccination, the patient returned to the vaccine clinic to report her face beco...
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Within 30-minutes of vaccination, the patient returned to the vaccine clinic to report her face becoming hot, her cheeks being red, and a headache. EMS evaluated patient on-site. Patient was hypertensive (206/96). EMS transported patient to Emergency Department for further evaluation. In ED, patient was still hypertensive, but in no acute distress. Per patient, she was taken off losartan by PCP in September secondary to hyperkalemia. ED physician administered losartan and Tylenol. Patient was discharged with HTN, HA, and vaccine reaction.
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| 70 | 2021-02-24 | sweating |
Patient was alert and conversational throughout first COVID-19 Pfizer vaccination. During post vacci...
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Patient was alert and conversational throughout first COVID-19 Pfizer vaccination. During post vaccination waiting period, patient became unresponsive and exhibited convulsion like movements in her waiting chair. Pharmacist quickly evaluated patient and patient was only minimally responsive to painful stimuli only. Breathing was rapid, shallow, and irregular with an expiratory wheeze heard upon auscultation. Patient was slouched in chair but supporting self and had a strong grip with her left hand. Skin condition was warm but diaphoretic. Ambulance 911 service was called. No swelling of the throat, mouth, face, nor lips was seen. Patient continued to be non-responsive, with non-comprehensible sounds, and was not opening eyes or following commands. Due to worsening ability to breath and wheezing on expiration, epinephrine 0.3 mg was administered intramuscularly into the left thigh at 1230 on 2/25/2021. Approximately 5 minutes after epinephrine administration, the patient?s work of breathing improved, wheezing was diminished upon expiration, and respiratory rate had slowed to 16 breaths per minutes. BP was 160s/80s and HR 98 (after epinephrine administration). Patient began opening eyes spontaneously but was still not following commands. Ambulance service then arrived, report was given, and patient was transported to Hospital Emergency Department. Patient was under the care of Doctor at the emergency department and received albuterol/ipratropium nebulization, dexamethasone 10 mg Iv, famotidine 20 mg IV, and magnesium sulfate 2 g IV. After the physician evaluated the patient and talked with family, the patient?s family stated that the patient has a history of anxiety related reactions such as this with convulsion like activity. Doctor then determined that the patient did not have an anaphylactic/allergic reaction and instead had a anxiety related vasovagal type reaction. Doctor stated that the patient could receive the second COVID-19 vaccine dose in 3 weeks without issue. Patient then discharged from Emergency Department (unsure if AMA). Patient then presented to the pharmacy with her daughter after discharge to fill in staff on the outcome of the reaction. Patient appeared to be at baseline mentally and physically. Pharmacist contacted Emergency Department to discuss case with patient?s nurse to obtain information about medications received in the emergency department. Patient daughter stated that she would like to be present for second dose of vaccine to help avoid a similar anxiety related reaction from occurring.
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| 70 | 2021-02-24 | sweating | Rapid heartbeat, lightheaded, sweating, about 5 min duration. Then again 23 hours after vaccination. |
| 70 | 2021-02-24 | lethargy |
did I have a heart attack. No doctor will see me to give me an EKG; Collapsed; Crushing chest pain; ...
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did I have a heart attack. No doctor will see me to give me an EKG; Collapsed; Crushing chest pain; chest was killing me and hurting and I was sobbing and it lasted about an hour and 15 minutes; Side of my neck hurt; My back hurt; It was just awful; Lethargic; I ended up vomiting for 2 days after the chest pain receded; slept for 16 hours; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 2 patients (husband and wife). This case refers to the wife with serious adverse events. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982, expiration was not reported), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. Medical history included acid reflux. Concomitant medication included dexlansoprazole (DEXILANT) for acid reflux. Patient reported that she had terrible severe reaction on the 22Jan2021. They were vaccinated on the 18Jan2021 and on the night of the 22Jan2021, she had such crushing chest pain that she just collapsed. Her chest was killing her and hurting and she was sobbing and it lasted about an hour and 15 minutes. The side of her neck hurt and her back hurt. It was just awful. Patient reported that she have called everybody. She have called her doctor's assistant and she confused her. Patient reported that they just went in because they were 70 and 71 and got the vaccine but then she ended up vomiting for 2 days after the chest pain receded and they took baby aspirin and then she just vomited and vomited and slept for 16 hours. They were both very lethargic. She asked her what should she do. She does not know if this was a reaction to the vaccine or did she have a heart attack. No doctor will see her to give me an EKG. They say they are not seeing patients. The patient recovered from chest pain on an unspecified date; while outcome of the remaining events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021115775 same reporter/drug, similar event, different patient.
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| 70 | 2021-02-25 | chills, headache, fever |
chills starting 7 hours after shot muscle aches, headache fever 100.5 starting 16 hours after ...
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chills starting 7 hours after shot muscle aches, headache fever 100.5 starting 16 hours after shot fever of 101.4 one day following shot fever lasting 3 days along with severe headache and muscle aches
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| 70 | 2021-02-25 | chills, headache |
Rapid heartbeat Numbness in my neck and face Numbness in my lips, swelling in lips Numbness tip of ...
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Rapid heartbeat Numbness in my neck and face Numbness in my lips, swelling in lips Numbness tip of tongue Chills, weakness, headache, blurred vision for a short time Took Benadryl on my own, continued taking non drowsy Claritin 5 days after shot feeling better. Still have slight numbness in my lips and feeling weak
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| 70 | 2021-02-25 | chills |
I received my first Pfizer Covid injection Feb. 18, 2021. I experienced chills, nausea, some flu s...
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I received my first Pfizer Covid injection Feb. 18, 2021. I experienced chills, nausea, some flu symptoms starting Feb. 22 Monday evening - Feb 25th. I threw up Wed. Feb. 24 morn. I started feeling better on Friday, Feb. 26th and resumed normal activities. My temp from Feb. 22 - 25th was 96.1. I also experienced flu symptoms and felt as if "a truck ran over me".
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| 70 | 2021-02-25 | fatigue, chills, influenza like illness |
Pt received dose #1 Pfizer COVID vaccine 2/4/21 @ vaccine clinic. 2/8/21 @ 1155 presented to ED for ...
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Pt received dose #1 Pfizer COVID vaccine 2/4/21 @ vaccine clinic. 2/8/21 @ 1155 presented to ED for workup of myalgias, nausea, fatigue. Per ED note "chills, onset 4 days ago. Pt recently had the COVID19 vaccine and since, has been experiencing "flu like sx's" and "she feels horrible". She tried imodium, with minimal relief. Endorses abd pain, nausea, diarrhea, GERD, feeling gassy, trying to stay hydrated, decreased appetite. Denies fever, sore throat, congestion, cough, urinary sx's, SOB, CP. Patient is otherwise healthy and has no other complaints." Workup negative, prescribed zofran and discharged home without escalation of care.
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| 70 | 2021-02-25 | headache |
slight soreness on head; Knees extremely sore; passed out; fuzzy feeling; This is a spontaneous repo...
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slight soreness on head; Knees extremely sore; passed out; fuzzy feeling; This is a spontaneous report from a contactable consumer(patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809) on 10Feb2021 at 16:30 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included type 2 diabetes mellitus, hypertension and allergy to Victoza. Concomitant medications included metformin, dulaglutide (TRULICITY), atorvastatin and fluoxetine. On 10Feb2021 at 21:00 about the patient five hours after vaccine in kitchen washing dishes, passed out. No symptoms or light headedness leading up to this event. Patient woke up on floor hit head minor and knees. On 11Feb2021 the patient complained slight soreness on head, fuzzy feeling. Knees extremely sore, small cut on ankle. Her doctor adviced to report this due to the time event happened in relation to vaccine (as reported). No treatment reported for events. At the time of the reporting the patient was recovering from the events. .
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| 70 | 2021-02-25 | nasopharyngitis, nasal congestion |
stuffy nose; like a cold but it doesn't feel the same as a cold; This is a spontaneous report from a...
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stuffy nose; like a cold but it doesn't feel the same as a cold; This is a spontaneous report from a contactable consumer(patient). A 70-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3246), intramuscular at Arm Left on 17Jan2021 07:30 at the 70 years old at single dose for COVID-19 vaccination. The medical history included asthmatic. The concomitant medications were none. The patient had the first dose of the vaccine on the morning of 17Jan2021 and that afternoon on 17Jan2021 she started having a stuffy nose like a cold but it doesn't feel the same as a cold. This has been occurring for 9 days now. She called to ask if this was one of the more obscure side effects of the vaccine. The patient received the vaccination on the 17Jan2021, and in the afternoon of that day, she got a stuffy nose. She said that she did not see it as a side effect, but 9 days later she still has a stuffy nose. She said that she does not have a temperature, headache, or anything else going on. She said that she knows a stuffy nose is a side effect of Covid-19 though. The caller said that she has been reporting this on the (App Name) everyday. The patient said that the stuffy nose was the same as it had been. The patient said that she was not feeling sick, sick, just stuffed up. She did not have shortness of breath or anything like that. There was no History of all previous immunization with the Pfizer vaccine considered as suspect. The events did not require a visit to Emergency Room and Physician Office. There was no family Medical History Relevant to events. There was none Prior Vaccinations within 4 weeks. There were none relevant tests. The outcome of the events was not recovered.
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| 70 | 2021-02-25 | throat irritation | Problem swallowing , scratchy throat. Duration <60 minutes. |
| 70 | 2021-02-26 | chills, fatigue, sweating, fever |
Severe fever chills, fever, sore arm - slightly swollen and red, which then got itchy, extreme sweat...
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Severe fever chills, fever, sore arm - slightly swollen and red, which then got itchy, extreme sweating, tiredness, slight nausea, intermittent headaches, strong muscle and joint pains, slight swollen glands in neck
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| 70 | 2021-02-27 | chills, fatigue, headache, nasopharyngitis |
Freezing cold to the point of shivering and teeth chattering - chills, headache, body ache, foggines...
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Freezing cold to the point of shivering and teeth chattering - chills, headache, body ache, fogginess, extreme fatigue. Tylenol every 6 hours. Cold packs on head and neck. All except headache went away by Friday, 2/26/2021.
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| 70 | 2021-02-27 | sinus headache |
RECEIVED BOTH PFIZER COVID VACCINES ON 01/29/21 & 02/19/21. WENT TO clinic ON 02/28/21 REPORT HEADAC...
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RECEIVED BOTH PFIZER COVID VACCINES ON 01/29/21 & 02/19/21. WENT TO clinic ON 02/28/21 REPORT HEADACHE AND SINUS PRESSURE. DIAGNOSED WITH SINUS HEADACHE .
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| 70 | 2021-02-28 | chills, sweating |
hour 28 after shot:sweating, chills, flushing hour 48 after shot: severe stomach cramps, diarrhea, v...
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hour 28 after shot:sweating, chills, flushing hour 48 after shot: severe stomach cramps, diarrhea, vomiting, chills--resolved after 9 hours
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| 70 | 2021-02-28 | headache |
Pfizer-BioNTech COVID-19 Vaccine EUA: During observation period, vaccine recipient complain of throa...
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Pfizer-BioNTech COVID-19 Vaccine EUA: During observation period, vaccine recipient complain of throat tightness and headache. They were monitoring by EMS. No further intervention needed.
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| 70 | 2021-02-28 | sweating | "Sweaty" which lasted for 10 minutes and then resolved |
| 70 | 2021-02-28 | fever, headache, chills |
eyelids became puffy; eyes became glassy; fever; body aches; chills; bad headaches; implanted breast...
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eyelids became puffy; eyes became glassy; fever; body aches; chills; bad headaches; implanted breast skin became blotchy; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E63247) , via an unspecified route of administration in the right arm on 01Feb2021 at 15:00 (at the age of 70-years-old) as a single dose for COVID-19 immunization. Medical history included Raynaud's syndrome, chronic lymphocytic leukaemia, irradiated thyroid gland, high cholesterol, previous breast cancer, allergy to latex and adhesives, and breast implants. Concomitant medications included levothyroxine sodium (SYNTHROID); rosuvastatin (MANUFACTURER UNKNOWN), and unspecified multivitamins. The patient previously took povidone/iodine (BETADINE) on unknown dates for an unknown indication and experienced drug allergy. On 05Feb2021 at 21:00, the patient experienced fever, body aches, chills, bad headaches, and implanted breast skin became blotchy. On 07Feb2021, the patient's eyelids became puffy and eyes became glassy,. All the events were reported as serious for disability. The peak temperature was 101 degrees Fahrenheit on an unknown date in Feb2021. The patient contacted the doctor, eye care professional and hematologist/oncologist for the events. On 08Feb2021, the patient had a COVID-19 nasal swab PCR which was negative. The patient was not treated for the events. The clinical outcome of the fever was recovered on 12Feb2021; while that of the body aches, chills, bad headaches, implanted breast skin became blotchy, eyelids became puffy, and eyes became glassy were recovering.
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| 70 | 2021-02-28 | throat irritation |
About 20 - 25 minutes patient developed scratchy throat in the parking lot after initial 15 minute o...
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About 20 - 25 minutes patient developed scratchy throat in the parking lot after initial 15 minute observation period. Was brought back to Observation for assessment. Denies other sx (no SOB, palpitations, sensations of lip or throat swelling, itchiness, etc.) Patient observed for additional 20 minutes . Symptoms improved and no development of additional or denied symptoms. Patient requested to leave after repeat observation. Discharged with strict ED precautions. All questions answered.
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| 70 | 2021-03-01 | chills, sweating |
Severe chills followed by sweats during part of the night. No treatment. Felt totally fine the nex...
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Severe chills followed by sweats during part of the night. No treatment. Felt totally fine the next morning.
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| 70 | 2021-03-01 | fatigue, headache |
Headache, vomiting, extreme exhaustion. Vomiting and headache lasted about 2 hours. Slept afterwar...
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Headache, vomiting, extreme exhaustion. Vomiting and headache lasted about 2 hours. Slept afterwards for almost 12 hrs. Thereafter, symptoms gone other than fatigue and sore arm.
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| 70 | 2021-03-01 | malaise, headache, fatigue, chills |
Dizziness & slight weakness about 10-15 mins after leaving site (had to wait 15 mins before they let...
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Dizziness & slight weakness about 10-15 mins after leaving site (had to wait 15 mins before they let us drive off the site) I stopped by a convenience store to pick up a bottle of water. Severe Headache -started about 30 mins later along with tiredness and chills. Headache subsided after a few hours and then experienced extreme muscle pain in my neck and shoulders along with a feeling of malaise. Did not take any OTC drugs. Layed down in bed and tried to sleep.
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| 70 | 2021-03-01 | malaise |
Lost consciousness for brief period; bleeding from small gash in head; broke my finger; feeling out ...
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Lost consciousness for brief period; bleeding from small gash in head; broke my finger; feeling out of sorts; feeling light headed; This is a spontaneous report from a contactable consumer (patient) who reported that a 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number:EL3246), via an unspecified route of administration into the right arm on 10Feb2021 07:45 at a single dose for COVID-19 immunisation. Medical history included known allergies to CT dye, COVID-19 from an unknown date prior to vaccination and known allergies to sulfa drugs. Patient was not pregnant. Patient had unspecified concomitant medications. On 11Feb2021 08:00, patient woke up feeling out of sorts and feeling light headed, patient sat down and the next thing she knew she was on the floor bleeding from a small gash in her head, she lost consciousness for a brief period and also broke her finger. The events required emergency room and physician office visit. The patient had 3 staples in her head and a finger splint for the events "bleeding from a small gash in her head" and "broke her finger". Outcome of events was recovering.
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| 70 | 2021-03-01 | fever | fever 100.9, nausea, no appetite |
| 70 | 2021-03-02 | chills, fever, headache |
rash on legs, arms, chest and stomach; headache; fever; chills; body ache; 3 days with out sleeping;...
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rash on legs, arms, chest and stomach; headache; fever; chills; body ache; 3 days with out sleeping; This is a spontaneous report from a non-contactable consumer (patient herself) via Medical Information team. A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Relevant medical history included anaphylaxis with insect bites from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took codeine and diazepam (VALIUM) and experienced hyperkinetic reaction. The patient stated that she received the vaccine on 14Jan2021, and that day 6 hours later, she had headache, fever, chills and body ache; and the next day on 15Jan2021, when she woke up, she had rash on legs, arms, chest and stomach, and she still had the rash. On an unspecified date, the patient had 3 days with out sleeping. The patient assessed the events as non-serious. The patient further reported that she was hyperkinetic and she has had that reaction many years prior reporting, before when taking codeine or VALIUM, one of the ingredients in VALIUM. She went to the doctor the first day, who saw her rash and told her to report that. It was not itching. The patient had the appointment for the second dose of the Pfizer vaccine, this coming Thursday and wanted to know if there would be a problem to get the second dose. She was afraid to get the vaccine the first time, because she had a history of anaphylaxis with insect bites. She carried an epi pen, and the vaccine provider had one too and the paramedics was there, and everything was okay; they were nice with her. The patient didn't have any problem until later. The patient spoke to her health care professional and he thought it was okay for her to get the second dose and the health care professional just told her to put a cream on her rash. Therapeutic measures were taken as a result of rash on legs, arms, chest and stomach, which included putting a cream on her rash. The patient was not recovered from the rash on legs, arms, chest and stomach, while the outcome of the events "headache, fever, chills, body ache, and 3 days with out sleeping" was unknown. No follow-up attempts are possible. No further information is expected.
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| 70 | 2021-03-02 | fatigue, malaise, nasopharyngitis |
all-over body rash that was "very red, like a tomato"; itchiness; skin was red, both sides same size...
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all-over body rash that was "very red, like a tomato"; itchiness; skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen; skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen; redness of the skin; whole body was in pain; severe allergic reaction; felt unwell; Joint muscle pain; flushed red; Tiredness; Injection site pain; joint and muscle pain; joint and muscle pain; white blood cell count on the lower side; possible damage to the kidneys; could have been possible that she had COVID and was asymptomatic, or she had it; cold; not feeling normal; This is a spontaneous report from a contactable consumer (patient) Medical information team. A 70-years-old female patient started to received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 13Feb2021 at single dose for COVID-19 immunization. Medical history included dystonia and migraines from an unknown date and unknown if ongoing, COVID-19 antibody test positive from Nov2020 to an unknown date. The patient was taking unspecified concomitant medication for dystonia and migraines. The patient experienced a "severe allergic reaction" to her first dose of BNT162B2 in Feb2021. She had all-over body rash that was "very red, like a tomato" and showed up 35-40hours after her dose. She states her doctor does not recommend she get the second dose. The patient meant by allergic reaction, she had a number of things, she experienced tiredness, injection site pain, joint muscle pain, she felt unwell, this all happened on the Saturday, the same day she got the vaccine on 13Feb2021. Then on Sunday 14Feb2021, all the symptoms she spoke about were still there and so she rested all day. On 15Feb2021, she looked at her elbows, clarifying the inside of elbow, her elbow creases, and on both elbow creases the skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen down to her thigh, it was working it's way down to the knee, the color was like a beet red, tomato color, it was under the arms, started with elbow, was at her neck. The more down the redness spread, the more it red in color it also got. When she noticed this she called the doctor. When she called the doctor, the doctor said get over to the Emergency Room right away. Her husband and her were both on the phone and were telling the doctor that she doesn't want to go to hospital, she asked if she can just come into the doctors office. The doctor said No. He told her that needs to get special lab work done, and he needs to send her information over to the ER. He said this could do possible damage to the kidneys. The doctor said lets not forget the last time she did a blood test, which was in Nov2020, at that time she came up positive with COVID antibodies. It could have been possible that she had COVID and was asymptomatic, or she had it. The doctor said that they need to do another COVID test or it could be she had a COVID cold or a cold with antibodies, her doctor doesn't know. The fact that she had that test that came back with COVID antibodies test but not have COVID in Nov2020 was something to consider. He was concerned may be there is more to this, or just a rash. The doctor said that he is not equipped say what it should be. The doctor said he will speak with them at the hospital. Tiredness subsided yesterday afternoon on 15Feb2021, it subsided before she went to the ER visit. Right now, it's kind of like a lasting effect because she is not feeling normal. The injection site pain was still there but not as bad. The joint muscle pain subsided this afternoon around 1 o clock. It first began a half hour after leaving the stadium and she was experiencing it while driving back home, the pain continued and got worse. When she got up on Sunday morning her whole body was in pain, she was not getting better on Sunday and that's when she sat on couch rest of the day. For red skin, with the temperature of the skin, she didn't feel it to see if it was hot or anything, it was more this feeling that its just not going away getting worse, it didn't feel hot, there was no texture on the skin either. She just noticed she was flushed red. She called the doctor first, and he said that he was sending information to the emergency room. Then she went to (name of place withheld) ER. They took her temperature, there was no fever. She was then relieved from the ER in 2.5 hours and went home. She still has redness on the skin. In the hospital, they gave her 40 mg of prednisone and an injection or Benadryl, and prescription for prednisone to take for the next 4 days while tapering down. She did take Benadryl about 2 hours ago, she did notice all the sudden she was getting itchy. She is less itchy now. With the itchiness, she just observed this about 2 hours ago. She took Benadryl, she has somewhat improved, she is still itchy but not to the point that she will scratch heavily. She does not have her COVID CDC Card at the moment, her husband has that information but he is on a conference call with a client and she cant disturb him. The patient was scheduled for a second dose on 06Mar2021. That's where she has a question, the doctor is saying that he is not sure about getting second shot. They took lab work at the hospital and said everything was fine except for white blood cell count, it was on the lower side in Feb2021. She has had no vaccines on the same day or in the 4 weeks prior. She hasn't had any vaccines. She did have to visit the emergency room. She only called the doctors office, the doctor said not to come in and go tot he ER. She has No relevant family medical history that she would like to share. The severe allergic reaction, "skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen", injection site pain, redness of the skin, itchiness, joint muscle pain and whole body was in pain was recovering. The event tiredness recovered with sequelae on 15Feb2021 and the event joint and muscle pain was recovered on 16Feb2021. The outcome of the remaining events was unknown. Information on the lot/batch number has been requested.
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| 70 | 2021-03-02 | fatigue, malaise, fever, headache, chills |
fever, chills, itching at injection site followed by severe pain in upper and lower left arm, no uri...
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fever, chills, itching at injection site followed by severe pain in upper and lower left arm, no urine output for 24 hrs, vertigo, fatigue, severe stabbing pains in face and head, stiff neck, no appetite, difficulty swallowing, pain in joints, chest pain, pain across upper back, stomach pain,. Symptoms lasted for 3 to 4 days. Severe head pain lasted 4 days. Could not raise left arm for 24 hrs after injection. After 6 days fatigue and general malaise still present. Stomach pain still comes and goes.
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| 70 | 2021-03-02 | fatigue, fever, malaise |
the day after my first vaccination I woke with bilateral wrist stiffness and pain, bilateral ankle k...
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the day after my first vaccination I woke with bilateral wrist stiffness and pain, bilateral ankle knee and swelling in my ankles. This subsided in a few days. I was holding off on taking my Orencia infusions because I wasn't sure when I would be able to get the vaccine. Orencia dosing is every 4 weeks and I am supposed to take any vaccinations two weeks post infusion. After my second vaccination, I had a full flare. Swollen joints, IBS symptoms, fatigue,fevers, decreased appetite. I went to my rheumatologist and scheduled an infusion as soon as possible. I had to stop taking NSAIDs because my creatinine became abnormal. I had my Orencia 750mg on Februray 1, 2021, but continued to feel ill and started a prednisone
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| 70 | 2021-03-02 | headache, head discomfort |
Patient complained of heaviness in head, pain in back of head. BP 161/64 (pulse 75). Given 2 small b...
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Patient complained of heaviness in head, pain in back of head. BP 161/64 (pulse 75). Given 2 small bottles of water, and was encouraged to engage in deep breathing.
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| 70 | 2021-03-02 | headache |
wrist pain; wrist pain and it locked up.; little bumps on the back of her hand; Headache; This is a ...
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wrist pain; wrist pain and it locked up.; little bumps on the back of her hand; Headache; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EJ1686) on 03Jan2021 in the morning before 12:00 pm (at 70 years) at single dose in right arm for COVID-19 immunization.Medical history included hypertension from 2002. Concomitant medication included enalapril for hypertension from 2002 (she tried several things- unspecified-before enalapril, took a number of months before she found something to tolerate). The patient on 24Aug2015 (at 65 years) took varicella zoster vaccine live (oka/merck) (ZOSTAVAX) for immunization and experienced shingles (it started a couple months after the shot, she had skin discoloration, black spots over the skin, caused by her bathing suit and the pool water, and it stayed for about 1.5 years, she was using a cream. It was maybe 2 years before it disappeared). Patient received first dose of the vaccine on 03Jan2021, after in Jan2021, she had a headache, a week and half later pain in wrist and wrists locked up, pain floated up to the back of her hand, continued since, locking of wrist stopped, pain continued, little bumps came on the back of hand.Patient added she may have had headache the second day (as reported), it came and went, she didn't pay attention, she had a headache morning and it gone as of 15Feb2021, but still came and went. Wrists locking up recovered before 24Jan2021. Bumps on back of hand started the same time, it came and went, stayed most of last week, still had it this week, about the same.No blood tests done since this happened.Final outcome of headache was unknown. Wrists locking up recovered in Jan2021. Bumps on back not recovered. wrist pain was recovering.Patient took the second dose of the vaccine (lot EN5318) on 24Jan2021 in the afternoon (maybe 2 or 3:00PM) at single dose in left arm for COVID-19 immunization. On 12Feb2021 patient lost part of mobility in the small finger of the right hand, can't lift it all the way above. Patient was scheduled to go to the doctor on 15Feb2021 in the afternoon. Patient saw joint pain listed on contraindications, would like to know the nature of the joint pain described from side effects of the covid vaccine. She was concerned of a blood clot, unsure what happened or what can cause it, was unsure if it was muscular or something. Patient would like to know whether blood clots and muscle pain have been reported as a side effect of the covid vaccine.
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| 70 | 2021-03-02 | headache |
For 1 day I had a severe headache , but it resolved . Then I had nausea for 5 days ....still continu...
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For 1 day I had a severe headache , but it resolved . Then I had nausea for 5 days ....still continuing but getting less . Now I have all of sudden tinnitus which I have had only once before when I had a bad reaction to hair dye . The Tinnitus began at 2 PM today , March 3rd ,,,,,and is continuing at this moment . I hope this will resolve . I called all my MD's and they said to call an ENT MD tomorrow if it continues .
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| 70 | 2021-03-02 | headache | Headache with waviness in right eye peripheral vision. Resolved in an hour. |
| 70 | 2021-03-02 | malaise |
dizzy, feeling funny, and shallow breathing. vital signs stable, x 3 02 sat 98% . Physician disch...
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dizzy, feeling funny, and shallow breathing. vital signs stable, x 3 02 sat 98% . Physician discharged to home
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| 70 | 2021-03-03 | chills | Foul smelling urine Feeling of fogginess Intermittent chills |
| 70 | 2021-03-03 | fatigue, fever, headache |
I received the 1st Pfizer dose on 1/30/21 and 2nd Pfizer dose on 2/20/21. After the 2nd dose, I de...
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I received the 1st Pfizer dose on 1/30/21 and 2nd Pfizer dose on 2/20/21. After the 2nd dose, I developed mild fever (under 100)*F, a bad headache, blurred vision, nausea, joint pain and fatigue. I took Tylenol for the fever and headache and recovered after 2 days. However, on 2/28/21 I developed a SECOND SERIES OF SIDE EFFECTS starting 8 days after the 2nd dose. I developed a fever of 100.7*F , a bad headache, nausea, palpitations, and severe joint pains and strong fatigue. I consulted my PCP, who recommended I fill out this report. I took Advil on 2/28, improved after 2 days, and now have a slight headache and some fatigue but otherwise recovered.
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| 70 | 2021-03-03 | fatigue, fever, malaise, chills |
severe asthma; trouble breathing; might have the coronavirus; My face is blood red; I am worried; Wh...
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severe asthma; trouble breathing; might have the coronavirus; My face is blood red; I am worried; Wheeze; she is also shaky; general malaise; heart attack; and last night she drank some water and choked on it then couldn't get her breath and; chest was hurting radiating to my arm down; fever; chills; exhausted/just felt very tired; her arm that was sore was the one where she had her injection; This is a spontaneous report from a contactable consumer (patient). A 70 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EM9810), via an unspecified route of administration (on left arm) on 15Feb2021 (at the age of 70 -years-old), single dose for COVID-19 immunization. Medical history included asthma, sleep apnea, thyroid problem, prediabetes, cpap use, all from an unknown date. There were no concomitant medications. Patient reported her face is blood red. Last night her chest was hurting radiating to my arm down. It felt like someone was strangling her with water. She noticed my symptoms were what people experience after receiving the second dose. She had fever, chills, exhausted and just felt very tired after receiving the first dose. She still have trouble breathing. She had severe asthma. She was not breathing normally. When she put the mask on it's even harder to breath. She was worried. She thinks, she might have the coronavirus. Consumer says that she is still not feeling well after receiving her first dose of the Pfizer COVID-19 vaccine on February 15th. She says that the first day after getting it, she had pain in her arm, it was achy, it was not really painful enough to where she had to take Tylenol for it. She says yesterday on the second day she had fever, chills, tiredness, general malaise, and today she is not feeling well. Caller says she was having trouble breathing, and did a treatment with her nebulizer which she has because she has real bad asthma. She says her breathing is labored and she wheezes every once in a while. She says she would like to see if there is anything that she needs to do, because she works with children, and if she is coming down with the corona virus she doesn't want to be around them with it. She says that her breathing is problematic today. She says she doesn't think that she is having a severe reaction, she has no rash or those kind of symptoms. She says it seems to be just the asthma, and last night she drank some water and choked on it then couldn't get her breath and her chest hurt and she had pain down her arm and thought oh gosh she was having a heart attack.Caller says she has done no treatments other than the nebulizer treatment. No further details provided about the nebulizer treatment. Caller says the provider said no Tylenol right away, so she didn't take any yesterday with her fever, and she didn't have a thermometer to take her temperature, but her face was really hot and she was having chills, which usually means she has a fever. She says that her arm that was sore was the one where she had her injection. She says that never really was that bad, everyone said their arm had ached, and she has a high pain threshold so it never bothered her. Her wheezing and little trouble breathing was better, after she did some breathing treatments with the nebulizer, she is not breathing well but she is breathing better. She says she is also shaky and doesn't know if that is just nerves, or if this is also something going on. Caller says that it has been a while since she had blood work, which was the last time she went to see physician, but she doesn't know the results for what they found out. The outcome of the events Breathing difficult,wheeze was recovering, other events was unknown.
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| 70 | 2021-03-03 | fatigue |
Severe fatigue and body aches and day 4 a severe rash on my back that lasted two weeks. Treated wit...
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Severe fatigue and body aches and day 4 a severe rash on my back that lasted two weeks. Treated with OTC steroid lotions.
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| 70 | 2021-03-03 | headache | Headache not mediated by over the counter pain meds |
| 70 | 2021-03-03 | lethargy, fatigue, chills |
Pain in left arm within 30 minutes of administration. General tiredness/lethargy within10 hours (upo...
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Pain in left arm within 30 minutes of administration. General tiredness/lethargy within10 hours (upon waking next morning). Sore/stiff neck within 14 hours. Body aches, chills within 16 hours. Stomach/abdominal discomfort within 20 hours. Diarrhea at 36 hours. At 36+ hours - arm pain considerably less. Body aches and chills gone by 36 hours. Continued stomach/abdominal discomfort seems to be improving after 40 hours.
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| 70 | 2021-03-03 | malaise, fatigue, chills |
right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen ...
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right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen and throbbed; Right leg ankle still hurt; flu symptoms appeared; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; tired; chills; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 11Feb2021 10:00 at single dose in arm left for COVID-19 immunisation. There was no medical history and no known allergies. Concomitant medication included colecalciferol (D3) and multi vitamin. The patient did not have COVID prior vaccination. There was no other vaccine in four weeks. After about 4 hours after first Pfizer shot on a Thurs (11Feb2021), the patient experienced flu symptoms appeared, Left arm, muscles, joints hurt, chills, tired, not feeling well, on 11Feb2021 16:00. Right leg ankle still hurt after 24 hours Friday and Saturday by Sunday. Right leg calf was red swollen and throbbed on 14Feb2021 16:00. Monday (on 15Feb2021) the patient called physician and had sonogram on right leg which showed blood clot in lower back of leg from ankle to knee. Doctor put immediately on rivaroxaban (XARELTO) blood thinner for blood clot. Blood work has been done on 15Feb2021. The patient would follow up on 02Mar2021. She was concerned about taking second COVID vaccine dose on 04Mar2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid was not tested post vaccination. The event outcome was unknown.
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| 70 | 2021-03-03 | runny nose, nasal congestion |
suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; congestion; running nose; This i...
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suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; congestion; running nose; This is a spontaneous report from a contactable consumer reporting for his/her mother. A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Jan2021 (when 70 years old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, congestion, running nose, chills, cough, covid 19 symptoms on 02Feb2021 with outcome of unknown. The reporter wanted to know what kind of the covid test should she get done and if the patient could take the second dose on 08Feb2021 or should she wait. Information on the lot/batch number has been requested.
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| 70 | 2021-03-04 | chills | Swelling to lips (angioedema), soreness, chills |
| 70 | 2021-03-04 | fatigue, headache, respiratory tract congestion, cough |
Significant COVID symptoms short of hospitalization including aches severe headaches congestion ling...
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Significant COVID symptoms short of hospitalization including aches severe headaches congestion lingering cough fatigue diarrhea
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| 70 | 2021-03-04 | headache, fever |
2nd dose at 1615 on March 4, HA started morning of the 5th, pt called and spoke with triage RN at 14...
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2nd dose at 1615 on March 4, HA started morning of the 5th, pt called and spoke with triage RN at 1400, triaged per protocol and pt directed to ED for "worst HA of life". Pt also endorsing fever, nausea, "sparkles" in vision of 1 eye. Pt took tylenol and advil w/o relief (doses unknown).
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| 70 | 2021-03-04 | headache |
My last injection was on 1/28/21. That day and few days after I had no site pain. I did have aches...
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My last injection was on 1/28/21. That day and few days after I had no site pain. I did have aches and pains and bad headache and chest pressure for hours during the night which I reported and which disappeared next day. However, the site pain in my right arm continues and is pretty bad temporarily and also periodically. Not a big deal but decided to report it. Seems very odd since it's been so long.
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| 70 | 2021-03-04 | sweating, headache, chills, fatigue |
Dizziness, Hot flash starting at the base of my neck & spreading up through my head followed by swea...
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Dizziness, Hot flash starting at the base of my neck & spreading up through my head followed by sweating hands/palms followed by feeling very cold and then cycling back to hot flash, more sweaty palms, & back to chills. Minor nausea. Lasted from 8:15am til 11:30am. I called my care team at clinic they suggested that I call "911", but I did not call "911". My daughter who is a nurse came over to my house & stayed with me until 11:30am. On 03/05/2021 I woke up at 8:00am with a mild headache, minor muscle aches, tired, a little brain fog, & minor nausea which is continuing as of 10:35am as I am completing this form.
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| 70 | 2021-03-04 | fever, chills, malaise |
From about 8:30pm-1:30 am I experienced chills, fever(99.6), leg aches, outer ear aches, neck aches....
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From about 8:30pm-1:30 am I experienced chills, fever(99.6), leg aches, outer ear aches, neck aches. General ill feeling. Couldn?t go to sleep. Began to feel horrible. Cold feet. Took an Advil and within 15 minutes all symptoms went away.
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| 70 | 2021-03-04 | fever, fatigue, sweating, chills | chills, fever, sweats, tiredness |
| 70 | 2021-03-05 | body temperature increased | Aching muscles, temp of 100.0, chills, fatigue |
| 70 | 2021-03-05 | chills, malaise, fatigue, headache |
Chills, excessive tiredness, excessive thirst, headache, general overall achy and not feeling well a...
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Chills, excessive tiredness, excessive thirst, headache, general overall achy and not feeling well at all! I took tylenol, which seemed to help some with headache. My symptoms started by noon of the day of vaccine, lasted over the weekend. On the following Monday I started to feel better.
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| 70 | 2021-03-05 | sweating | Patient was diaphoretic and fainted |
| 70 | 2021-03-06 | body temperature increased |
Generalized aching , 102 degree fever, nausea and generalized weakness. Symptoms began 10 hours afte...
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Generalized aching , 102 degree fever, nausea and generalized weakness. Symptoms began 10 hours after vaccination and lasted about 30 hours. Treatment was bed rest and naproxen sodium.
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| 70 | 2021-03-06 | headache, fatigue |
headache , and nausea for the first two days and fatigue . These were fine . But , the nausea has ...
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headache , and nausea for the first two days and fatigue . These were fine . But , the nausea has continued. It's severe . I went to Hospital emergency room because I was feeling very ill and had developed Tinnitus . The nausea has continued for 10 days . The tinnitus is severe . I have never had Tinnitus , except at brief moments as far as I can remember . I recognized it but have never had it for any length of time . This is ongoing for 3 days now + nausea continues . Scary . I am now on a course of prednisone .
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| 70 | 2021-03-06 | malaise |
Same onset of symptoms as first dose, but different symptoms this time ( 7-8 days after shot develop...
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Same onset of symptoms as first dose, but different symptoms this time ( 7-8 days after shot developed symptoms). Trunk itches and belly fat feels like someone is squeezing it, swollen hands and feet. This time had puffy eyes and lips,with neck and genitals itching. Over my body an erythema that turns white when stroked. On my right arm, where I received the shot, very large splotch approximately 3 inches by two inches (red and swollen.) Feeling of malaise and dizzy. Stiff neck and swollen joints in fingers. Visited outpatient clinic for check up. Given Hydroxysine HCL 25mg x 3 per day. When I was in my early 30s had an anaphylactic reaction to something I ate??? Went to ER for shot of epinephrine. We never discovered what it was I was allergic to.
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| 70 | 2021-03-06 | fever, headache | fever, body aches, severe headache, nausea, GI UPSET, |
| 70 | 2021-03-06 | fever | Diarrhea and fever for a couple of hours |
| 70 | 2021-03-07 | chills, headache, fever, fatigue |
Fever, chills, headache, nausea, body aches, redness and sore left arm, lack of appetite, couldn't s...
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Fever, chills, headache, nausea, body aches, redness and sore left arm, lack of appetite, couldn't sleep, fatigue, rash at injection site and down the arm and then several days post injection rash on thigh
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| 70 | 2021-03-07 | cough, fatigue, chills |
Pfizer-BioNTech COVID 19 Vaccine EUA Fatigue the day after my vaccine. Felt like I was "in a fog"....
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Pfizer-BioNTech COVID 19 Vaccine EUA Fatigue the day after my vaccine. Felt like I was "in a fog". Went to bed at 8pm, coughed for an hour (not my asthma cough), chills, woke up at 8am Felt fine the 2nd day after my vaccine.
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| 70 | 2021-03-07 | cough |
Pt. was having difficulty breathing. Paramedics assessed. She kept coughing. Unable to catch brea...
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Pt. was having difficulty breathing. Paramedics assessed. She kept coughing. Unable to catch breath. Davie Fire Rescue was called to transport pt. Received Albuterol treatment. Pt. transported to hospital.
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| 70 | 2021-03-07 | fatigue, headache | Aches, stiff joints, headache, very tired & very, very sore arm |
| 70 | 2021-03-07 | fatigue, sweating, chills |
began to pass out; because every time I tried to lift my head, I would start blacking out again; diz...
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began to pass out; because every time I tried to lift my head, I would start blacking out again; dizzy; diaphoresis; fell against the wall; violent high abdominal pain; n having multiple, large formed bowel movements; shaking; chills; nausea; fatigue; This is a spontaneous report from a contactable consumer. This 70-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EM9809) , via an unspecified route of administration on 12Feb2021 at 09:45 (at the age of 70years old) at single dose for covid-19 immunisation. Medical history included hypersensitive to latex, allergies to levaquin, ddavp, CT scan dye, codeine, fentanyl, primary immune deficiency, myasthenia gravis, Sjogren's, autonomic neuropathy, myelodysplastic syndrome, von Willebrand's, Barrett's esophagus on unknown date and unknown if ongoing and received Pfizer Covid vaccine (dose 1, Lot: EL9261) on 22Jan2021 at 2:45am on left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Relevant concomitant medication was not provided. At approximately 9:50 AM on 12Feb2021, the patient received second Pfizer Covid-19 vaccine in left arm at Administration facility. The patient waited the 15 minutes post injection. At approximately 10:19AM, the patient left site & drove to her home without issues. At home approximately at 11:20am, she had violent high abdominal pain like she never had before. she proceeded to the commode and began having multiple, large formed bowel movements then began to pass out. She began to have diaphoresis and violent shaking and chills. She had passed out on commode and fell against the wall. She later managed to pull pants up and crawl with head hanging down stated that because every time she tried to lift her head, she would start blacking out again. This continued until after approximately 20 minutes. She managed to pull herself up to the couch and raise legs high above heart and head and let head hang off couch to restore blood pressure. The patient mentioned that shot triggered something with her autonomic nervous system. On 22Feb2021, she was still with nausea, fatigue and dizziness. The outcome of events was not recovered. No treatment was received for events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19.
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| 70 | 2021-03-07 | fatigue |
The following day she had gout in the middle toe of the left foot, which was in the same area that s...
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The following day she had gout in the middle toe of the left foot, which was in the same area that she had had a reaction about 4 years prior. She continues to have the pain. He did blood work and her uric acid is high, put her on Colchicine and it lowered her uric acid 1/2 point and followed the diet. He then put her on Allopurinol and will do more blood work in about 40 days. Also had arm soreness and tiredness, but they were no big deal.
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| 70 | 2021-03-07 | headache, chills, dehydration |
Patient received first Pfizer COVID-19 vaccine on 1/20/2021 and second dose on 2/12/2021. Patient ha...
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Patient received first Pfizer COVID-19 vaccine on 1/20/2021 and second dose on 2/12/2021. Patient had minor symptoms such as body aches with both vaccine doses which resolved. Patient then stated she started to experience headache, nausea, and body aches, decreased oral intake, and chill starting on 2/18/2021. On 2/20/2021 patient had several loss of consciousness episodes. Patient presented to the Emergency Department on 2/21/2021 with a chief complaint of syncope, nausea, and vomiting and subsequently admitted to the hospital for potential sepsis, syncope, hyponatremia, dehydration, lactic acidosis. (Continued on second page)
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| 70 | 2021-03-07 | headache, fatigue | Extreme Fatigue Headaches Mild Nausea |
| 70 | 2021-03-07 | fever, throat pain |
The only treatment I sought was self prescribed...Ibuprofen as needed for fever and fluids As the da...
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The only treatment I sought was self prescribed...Ibuprofen as needed for fever and fluids As the days progressed, I feel tightness and heaviness in my chest.. Almost as if there is an upper respiratory infection Thursday evening, I started running a fever and had a sore throat that would not quit Fever was in range of 101 degrees As the day progressed on Friday, the fever returned and spiked to 101 in the evening Saturday more fever in the evening to 102 degrees. Sore throat sort of subsided Constipation set in and has still not resolved itself Today, Monday; I was hoping for relief but none Looking at this report...I am frightened of consequences I am generally in good health
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| 70 | 2021-03-08 | chills, fatigue |
At 6am I was awakened with chills, muscle aches. I took a Tylenol and went back to bed sleeping ano...
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At 6am I was awakened with chills, muscle aches. I took a Tylenol and went back to bed sleeping another 4 hours after already sleeping for 8 hours. I spent the remainder of the day with fatigue and sometimes muscle aches. I took one more Tylenol and the symptoms subsided by 6 pm that day.
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| 70 | 2021-03-08 | cough, throat irritation |
Felt hot, face was flushed, began coughing, throat itched, blood pressure was elevated 184 / 118. H...
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Felt hot, face was flushed, began coughing, throat itched, blood pressure was elevated 184 / 118. Heart rate was " fast" but was not told rate, but even. No treatment given ...just monitored for approximately 45 min and sent home when coughing stopped and blood pressure was down to 164 / 106. They did check bp repeatedly, checked o2 levels, blood sugar, heart rate repeatedly. Told cannot return for 2nd vaccine. Primary doctor today verifies cannot have 2nd vaccine due to reaction to first vaccine.
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| 70 | 2021-03-08 | fatigue, headache, nasopharyngitis |
Exactly 8 hours after the vaccine was given, I felt very fatigued, felt cold, had a mild headache, a...
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Exactly 8 hours after the vaccine was given, I felt very fatigued, felt cold, had a mild headache, and had sharp, but not debilitating, pain in both the right and left side of my lower abdomen whenever I moved. The symptoms lasted 24 hours except for the mild headache which is still continuing one week after the vaccine was given.
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| 70 | 2021-03-08 | fatigue, sweating |
profuse sweating with extreme light headedness Same symptom occured on 3/3, and 3/5 with feeling of ...
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profuse sweating with extreme light headedness Same symptom occured on 3/3, and 3/5 with feeling of tiredness afterwards. No symptoms since.
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| 70 | 2021-03-08 | fatigue |
3/5/21 Restlessness, fatigue & arm soreness. 3/6/21 Arm fevered, inflamed and bruising at and aroun...
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3/5/21 Restlessness, fatigue & arm soreness. 3/6/21 Arm fevered, inflamed and bruising at and around injection area 3/7/21 Arm worsen with the bruising and redness 3/8/21 & 3/9/21 No improvement in arm Took Benadryl- no change
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| 70 | 2021-03-08 | headache, fever, chills |
AT 9:30 PATIENT WAS UNABLE TO SWALLOW, MUSCLES IN NECK, THROAT AND JAW WERE VERY TIGHT; COULDNT SWAL...
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AT 9:30 PATIENT WAS UNABLE TO SWALLOW, MUSCLES IN NECK, THROAT AND JAW WERE VERY TIGHT; COULDNT SWALLOW OR SPIT. TIGHTNESS MOVED DOWN TO SHOULDERS AND CHEST. PT WENT TO ER ; STARTED SHAKING UNCONTROLLABLY, THIS STARTED AND STOPPED 3 TIMES; ALSO HAD HEADACHE, FEVER AND CHILLS, ER GAVE HER IV BENADRYL AND PT IS STILL TAKING BENADRYL.
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| 70 | 2021-03-08 | sneezing, runny nose |
Pfizer vaccine sudden onset dramatic sneezing and runny nose March 6-8 very painful lower back star...
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Pfizer vaccine sudden onset dramatic sneezing and runny nose March 6-8 very painful lower back started March 7 and continues as of today
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| 70 | 2021-03-09 | chills, fatigue, headache | Fatigue, body aches, headache, chills |
| 70 | 2021-03-09 | chills, malaise |
She received the vaccine, and went to bed at midnight and felt great all day long. She believes abo...
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She received the vaccine, and went to bed at midnight and felt great all day long. She believes about 5 minutes later started having chills. She has a weighted blanket and had that with 2 other blankets on her, and started shaking, and then her teeth started chattering and could not prevent them from banging together. She was afraid she was going to break a tooth. This lasted for almost an hour. She finally fell asleep and normally does not move when sleeping, and tossed and turned all night. She usually gets up a couple of times a night to use the bathroom, and did not get up until 6:00 Am, and when she tried to get up she was woozy, and was not able to walk due to feeling like she was going to fall over and almost fell in the bathroom but has grab bars that she was able to grab. She normally gets up at 4:00 Am, and got up at 8 after getting up at 6. She was not able to sit up and when she got up for the day was listing like a drunken sailor and not able to eat and managed to get some water down. She did take a Tylenol, and took her VS which were normal. She had tried to call her doctor but due to weakness was not able to. She was still uneasy from a deep sleep last night, but today she is feeling better but afraid of losing her balance. Her arm is still a little sore, but pretty good right now.
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| 70 | 2021-03-09 | fatigue, headache, lethargy |
Day after 2nd vaccine, very tired, lethargic, slight headache. Day 2 Woke up with painful swollen ...
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Day after 2nd vaccine, very tired, lethargic, slight headache. Day 2 Woke up with painful swollen armpit on left side, by the evening...additional swollen and sore spot under collarbone, with a noticeable lump. (Left side also.)
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| 70 | 2021-03-09 | fatigue, malaise, headache, chills |
injection site pain, tiredness, headache, joint pain in knees, chills, nausea , feeling unwell week ...
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injection site pain, tiredness, headache, joint pain in knees, chills, nausea , feeling unwell week and dizzy
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| 70 | 2021-03-09 | fatigue | Tiredness, mind fog, diarrhea |
| 70 | 2021-03-09 | fatigue | exhausted, nauseated, achy, chilled |
| 70 | 2021-03-09 | headache, lethargy | PRETTY BAD HEADACHE SUCCESSFULLY TREATED WITH TYLENOL; LETHARGY; MINOR SORENESS AT INJECTION SITE |
| 70 | 2021-03-09 | headache, fever | Fever, headache, body aches, slight nausea |
| 70 | 2021-03-09 | headache |
Bad headache for 36 hours until I gave in and took 1 Tylenol. Felt exhausted for 48 hours and slept...
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Bad headache for 36 hours until I gave in and took 1 Tylenol. Felt exhausted for 48 hours and slept much more than usual.
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| 70 | 2021-03-09 | fever, headache |
Seven or so hours after injection on Saturday, I developed a rash that quickly became hives on my lo...
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Seven or so hours after injection on Saturday, I developed a rash that quickly became hives on my lower back, which spread to my inner thighs. Took Benadryl OTC tablets, and used Benadryl topical gel on affected areas. Overnight, the rash spread to my outer thighs. By about 9am the next day, (Sunday) developed a headache which became more severe as the day wore on, a fever (102), and, body aches. Talked with my primary care manager on Sunday afternoon who advised me to continued with my benadryl treatment, but to go to the ER if I developed any breathing problems. This all persisted in varying stages of severity through Tuesday, when I started having breathing issues, and went to the ER, where I was given steroids and a breathing treatment, chest xray, blood tests, etc. Was also given a prescription for five days of prednizone, and, released.
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| 70 | 2021-03-10 | chills, fatigue |
Fluctuating temp, 100.3-97.5 for 5 days, muscle weakness, body aches, unsteady on my feet, nausea, n...
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Fluctuating temp, 100.3-97.5 for 5 days, muscle weakness, body aches, unsteady on my feet, nausea, no appetite, brain fog, extreme fatigue, for 8 days or more. COPD so much worse that I had to use albuterol twice a day which I didn't use before lasting 2 weeks. No daily walk for 2 weeks because I couldn't balance properly. Sweats and chills not corresponding to temp fluctuation 2 weeks. Night sweats which I have never had before EVER. My scleritis kicked in really bad, worse than ever before. I still don't feel well 19 days later
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| 70 | 2021-03-10 | chills |
Two days after the vaccine I began having chills and nausea, after that day I?ve felt queezy all the...
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Two days after the vaccine I began having chills and nausea, after that day I?ve felt queezy all the time,, however waves of extreme nausea pass over me with chills. I have been hoping each wave is the end. Reading ?side effects? it should be gone in 3 days. However today, 10 days later, was worse than ever . I spent the whole day in bed nauseated and vomiting, chilled with 4 blankets over me. My temperature was not high (97). I keep hoping the side effects are finished, but this has gone on longer than your information predicts. This is too long to feel this way.
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| 70 | 2021-03-10 | chills |
Hoarseness, joint and muscle aches, chills, dizziness, diarrhea. Symptoms present upon waking next d...
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Hoarseness, joint and muscle aches, chills, dizziness, diarrhea. Symptoms present upon waking next day after vaccine and have continued for 36 hours. They are unresolved at this time.
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| 70 | 2021-03-10 | fatigue, fever |
began with fatigue; segued into body and joint aches, followed by high fever that eased down to 101....
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began with fatigue; segued into body and joint aches, followed by high fever that eased down to 101.1 by 7am. Fever totally gone by 9pm on Tuesday.
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| 70 | 2021-03-10 | headache |
Muscle pain; Headache; Having issues breathing; could not swallow; Muscle tightness in right jaw, mo...
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Muscle pain; Headache; Having issues breathing; could not swallow; Muscle tightness in right jaw, mouth, neck, shoulder; Muscle type convulsions in neck, shoulder, arms and upper chest; This is a spontaneous report from a contactable consumer reported for self. This 70-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via intramuscular on 24Feb2021 at 10:00 AM at single dose in left arm in a pharmacy or drug store for COVID-19 immunization. The patient's medical history included high blood pressure. The patient had known allergies: anabolic steroids, many antibiotics. The patient did not have COVID prior vaccination. The patient's concomitant medications included hydrochlorothiazide, triamterene (MAXZIDE) and vitamins. At 24Feb2021 at 10:00 PM, the patient experienced muscles in neck, jaws and throat started clinching up and she could not swallow. The patient began having issues breathing. The patient was advised to go to emergency room (ER). At ER, patient started with muscle type convulsions in neck, shoulder, arms and upper chest. The patient had several episodes. Doctor administered diphenhydramine hydrochloride (BENADRYL) intravenously, did blood and urine workup. After 4 hours the shaking stopped, and the muscle contractions lessened. The patient was sent home. Next day 25Feb2021, she still had some residual muscle tightness in right jaw, mouth, neck, shoulder. On third day 26Feb2021, she had light shaking of hands and arms. The patient was still taking 25 mg diphenhydramine hydrochloride every 8 hours. She added ibuprofen (ADVIL) because she also had muscle pain and headache. The patient was recovering from the events. The patient did not test COVID post vaccination. Information on lot/batch number has been requested.
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| 70 | 2021-03-10 | lethargy, fever, cough, chills, fatigue |
Inflammation in areas with arthritis, chills, fever, coughing and congestion in lungs, fatigue, dep...
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Inflammation in areas with arthritis, chills, fever, coughing and congestion in lungs, fatigue, depression, lethargy, brain fog, nausea, diarrhea, pinched nerve between should blades, swelling in both hips
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| 70 | 2021-03-11 | headache, influenza like illness, fever, chills, fatigue |
Flu-like like symptoms. Headache, chills, low grade fever, extreme fatigue, some queasiness. Symptom...
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Flu-like like symptoms. Headache, chills, low grade fever, extreme fatigue, some queasiness. Symptoms have persisted for 10 days at this point and are no better. Chills seem to be getting worse. Advil helps Headache and chills, but I can't take it every day without upsetting my stomach.
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| 70 | 2021-03-11 | headache, fever, chills |
Injection site pain Headache with ?brain zaps? for a period of 2+ hours Joint pain over entire body ...
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Injection site pain Headache with ?brain zaps? for a period of 2+ hours Joint pain over entire body Chills with severe trembling Fever Vomiting for a period of hours Severe itching on my back, shoulders and upper arms for two days
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| 70 | 2021-03-11 | pneumonia |
reveled mild pneumonia; I tested positive for Covid19 19Feb (3 weeks +2days) after 2nd dose of vacci...
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reveled mild pneumonia; I tested positive for Covid19 19Feb (3 weeks +2days) after 2nd dose of vaccine; I tested positive for Covid19 19Feb (3 weeks +2days) after 2nd dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262; expiry date: unknown) via an unspecified route of administration in the left arm, on 28Jan2021 at 15:00, at a single dose, for COVID-19 immunisation. Medical history included known allergies to penicillins. Concomitant medication included acyclovir (ACICLOVIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284) in the left arm, on 06Jan2021 at 13:00, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID-19 vaccination. The patient had dry cough and difficulty getting deep satisfying breath about 12Feb2021 (2 weeks + 2 days) after 2nd dose of Pfizer vaccine. The patient tested positive for COVID-19 nasal swab on 19Feb2021 (3 weeks +2days) after 2nd dose of vaccine. On 24Feb2021, patient was seen in a physician office for symptoms of cough and shortness of breath (SOB). On the same day (24Feb2021), chest X-ray revealed mild pneumonia. Patient was now on prednisone, azithromycin and albuterol inhaler. Patient was a little better and was now on 3rd day of taking 3 medications. Outcome of the events was recovering.
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| 70 | 2021-03-11 | fever, chills |
Fevers 101.8, body aches, chills. Fevers respond to acetaminophen but recur within hours. This is ...
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Fevers 101.8, body aches, chills. Fevers respond to acetaminophen but recur within hours. This is the 3rd day of symptoms
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| 70 | 2021-03-11 | fever, headache, chills |
Pancreatitis, mild. In addition had fever/chills, nausea, headache, joint pain all in first 24 hour...
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Pancreatitis, mild. In addition had fever/chills, nausea, headache, joint pain all in first 24 hours.
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| 70 | 2021-03-12 | chills, malaise, headache, fatigue |
Headache, left ear -deep pain, right pain up my neck to my jaw. Chills-couldn?t get warm . Achy all ...
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Headache, left ear -deep pain, right pain up my neck to my jaw. Chills-couldn?t get warm . Achy all over . Extremely tired. Don?t know if I had a fever-no thermometer. Started feeling sick around 4 am Thursday morning, chills & rest of symptoms about 8. Chills stopped around 4:30pm. Headache lasted through Friday. Friday night feeling pretty well. Just tired
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| 70 | 2021-03-12 | influenza like illness, headache, fever |
Mild flu like symptoms re fever up to 100.5, chills, and headache beginning about 12 hours after sec...
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Mild flu like symptoms re fever up to 100.5, chills, and headache beginning about 12 hours after second dose and then lasting 24 hours
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| 70 | 2021-03-12 | fever, chills | Fever chills weakness extreme body aches for 2 days |
| 70 | 2021-03-13 | fatigue, chills, headache | Headache, nausea, heartburn, chills, pain in arm pit on same side as shot was given and tiredness. |
| 70 | 2021-03-13 | headache, chills, fatigue, fever, throat pain |
12:15 a.m. Horrific headache, horrible body shakes and chills High fever, extreme fatigue, sore th...
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12:15 a.m. Horrific headache, horrible body shakes and chills High fever, extreme fatigue, sore throat, extreme pain in armpit Fluids, advil, lots of sleep. Still fatigued
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| 70 | 2021-03-13 | headache, chills, fatigue | Headache, rigors, body aches, fatigue |
| 70 | 2021-03-13 | headache, influenza like illness, chills, fatigue |
Flu like symptoms. Chills and hard body shakes that I could not control until I finally got warm, b...
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Flu like symptoms. Chills and hard body shakes that I could not control until I finally got warm, body aches, especially back of head and neck, extreme tiredness, I already have post covid tiredness, but this tiredness is worse than the post covid tiredness. I have been in bed since it started at 4 am Saturday, March 14, 2021
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| 70 | 2021-03-14 | fatigue, headache |
Pain and swelling at injection site - unable to raise arm above head Treated with Tylenol. Resolve...
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Pain and swelling at injection site - unable to raise arm above head Treated with Tylenol. Resolved in 36 hours. Severe generalized headache, myalgia, arthralgia, extreme fatigue, loss of appetite, but no fever. No analgesic helped symptoms. Required bedrest for three full days. Symptoms resolved after four days.
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| 70 | 2021-03-14 | fatigue, fever, headache, chills |
Chills; fever; extreme fatigue; muscle achiness; headache; swollen arm; rash on arm; This is a spont...
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Chills; fever; extreme fatigue; muscle achiness; headache; swollen arm; rash on arm; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot#: EN6202, expiration date unknown) on 23Feb2021 at 12:15 AM at the age of 70-year-old at single dose via an unspecified route of administration at left arm for COVID-19 immunization. Patient was not pregnant at time of event and at the time of vaccination. Medical history included allergy to sulfa. Patient previously received 1st dose of BNT162B2 (Lot#: EL9264) on 02Feb2021 at 02:00 PM at the age of 70-year-old at left arm for COVID-19 immunization. Concomitant medications included raloxifene, fish oil, ergocalciferol (VIT D) and calcium. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced chills, fever, extreme fatigue, muscle achiness, headache, swollen arm, rash on arm; all on 23Feb2021 at 15:00. Outcome of the events was recovering. No treatment was received for the events. Events were reported as non-serious. Events didn't result in emergency room visit or physician office visit. No seriousness criteria was reported: no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.
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| 70 | 2021-03-14 | headache |
syncope; afib; afib; soreness, redness, and pain at injection site/left arm pain/under arm pain; sor...
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syncope; afib; afib; soreness, redness, and pain at injection site/left arm pain/under arm pain; soreness, redness, and pain at injection site; her blood pressure was really high and kept going up and down like a roller coaster; She was taken to the ER and began feeling sick to stomach in ambulance; headache; felt her ears vibrating; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; She is anxious about getting the second vaccine; Enlargement of lymph nodes; increased heart rate; This is a spontaneous report from a contactable Nurse reported for self. This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 on Arm left at single dose (Lot # EL9262, Expiration: May2021) for covid-19 immunisation. Medical history included Atrial fibrillation from Jan2020. Had 2nd dose appointment scheduled but canceled appointment. Concomitant medications included apixaban (ELIQUIS) from 07Feb2021 at 5mg twice a day by mouth (provided SN100089537925, LOT 1771228, EXP: May2023, NDC: 0003-0894-21) for Atrial fibrillation. History vaccine included a Tetanus shot 40 years ago (1981) for immunisation and reacted terrible to it. She reports having and experienced soreness, redness, and pain at injection site. She reports getting a mammogram sometime after receiving the vaccine. They saw a spot they are going to recheck and saw swollen lymph nodes on the left side/ Enlargement of lymph nodes, which is the same side she received her vaccine. She was told it was most likely due to the vaccine. Six days later she suddenly felt sick, near syncope, couldn't catch her breath. It got so bad she thought she was dying and called EMS. Leads confirmed afib, her blood pressure was really high and kept going up and down like a roller coaster. She was taken to the ER and began feeling sick to stomach in ambulance. IN the ER she received 1000 ml of fluids and additional metoprolol in addition to dose she took that evening at home. She was sent home to follow up with her Cardiologist the following Monday. He wasn't sure if it was due to vaccine and started her on twice daily eliquis and increased her toprolol immediate release to twice daily. The following Friday night she got a headache and felt her ears vibrating. Her home EKG was fine, but blood pressure was high again and stayed up for hours. Took additional toprolol. Came down after 5 hours. Breast, arm and clavicle starting hurting two weeks and one day after the injection. She is anxious about getting the second vaccine. Asked PCP if she needed an antigen test to see if she needed a second dose of the vaccine. She says she got her first dose 01Feb, then on Wednesday, 03Feb she went and got a mammogram which had already been planned. She says that they saw enlarged lymph nodes to her left breast, under arm, and clavicle which they said are due to vaccine, but they also said they saw something else so they wanted to do a repeat mammogram three months later. She says it took two weeks, but suddenly her left breast and under arm were killing her, caller did not clarify this statement. She says she talked to her doctor who said don't worry it might take a while to go down. She says that the other thing is she has known atrial fibrillation that was diagnosed a year ago, and most of the time it is quick and doesn't last long, sometimes she doesn't know she is having it. She says 6 days after the first dose she started to feel ill, she had been in bed reading so she got up to get some water and suddenly felt like something was wrong and like she was going to pass out, she couldn't breathe, so she called EMS. She says her atrial fibrillation is not unusual, but she has never had it to where she couldn't breath. She says that the rate they estimated was 350, and her only other documented that was high like that was 150. She says that they treated her and she went home, and when she saw her cardiologist they said they don't know if the vaccine had to do with this, and to report it. She says a week later, on Friday a week ago, she started feeling funny standing while she was working on the computer in the middle of the afternoon, she felt like her ears were vibrating, which was very unusual, and she didn't know what was wrong so she looked at her Cardia app, and her heart was in normal sinus, and she checked her blood pressure which for her was sky high, up to 190/100 which her blood pressure is usually very low. She provided a second blood pressure that call handler was unable to capture and caller did not clarify as she no longer had her log with her. She says for hours her blood pressure (BP) went up and down, which was a similar or same thing as what happened that night she went to the ER with her atrial fibrillation, her BP would go up and down like riding a wave. She says needless to say, she has two questions: she says she doesn't know if there have been reports of that vaccine making A-fib worse, she is scared to get her second dose which she was supposed to get Monday a week ago, but put off primarily before the second thing with BP, she thought she would wait because she could hardly move her left arm so she put it off until the next Wednesday, She says that her second dose is now scheduled for 03Mar, so 4 weeks between doses, and she is a little afraid to get it because she doesn't know if her response was over the top or caused the other things, going to the ER with A-fib was terrifying, and she doesn't want that to happen again. She says people say that she has got to get her second dose because she won't be protected, so she would also like to know if it is possible for her to get antigens early on. She says that she had a tetanus shot 40 years ago, and had a horrible reaction after it, then years later they did a titer for tetanus and they said she would likely never need a tetanus shot again since she had built up such a high level and would never need it again. She says is it possible that she had enough immunity that she wouldn't need the second dose, or would there be an antigen test that could tell her if she would need a second dose, if so what is that test? She says she is afraid the next dose will kill her. AE treatment included says that when she went to the ER it was about 12:30AM when she arrived, they did not admit her. She says on the way to the ER in the EMS truck they gave her Cardiozyme to get her blood pressure going down and gave her 1000 cc fluids, and Metoprolol, another dose. She says that the Cardiozyme was IV push in the ambulance, she doesn't have the information to provide for all of the heart stuff they gave her, NDC/LOT/EXP: Unknown for Metoprolol or Cardiozyme. She clarifies that she takes Metoprolol normally every day that they have had her on that is extended release and she takes it at night. She says she had taken that at 09:30PM, and by the time she got there to the ER after midnight a little, they after gave her another to see if it would bring her heart rate down. She says that they kept her there a couple of hours, until her heart rate was normal, though her BP was up a bit. She says that they told her they could admit her but she said she would rather go home if they thought it was safe, and she went home. She says that her sister came home and stayed with her, whose husband is a cardiothoracic surgeon. Metoprolol: Caller says that the Metoprolol she is taking is in a pharmacy bottle that says use by 08Feb2022, it does not have an official label, the NDC or LOT are not on there. She says that they gave her 60 to take of regular Metoprolol, not extended release, which is 25mg to take twice a day by mouth, so 60 tabs and she would need to get refills as it is a months worth. Metoprolol extended release NDC/LOT/EXP not provided when queried. She clarifies that the not extended release is called Toprol/Metoprolol Tartrate 25mg. Caller says that her swelling lymph node limited the use of her arm, she can't pick up anything or lift her self up while moving in the bed, she is miserable, it hurts to put pressure on her arm and she can hold her arm up and move it around she can do anything with not holding anything, she feels a tightness there, even when she breathes or coughs. She says her left arm was sore initially for 3-4 days after getting the shot but the soreness left. She says she was told on 03Feb that she had swollen lymph nodes, which was two days after the shot, but she couldn't feel them then, she couldn't tell, and had no pain. She says it was two weeks later that happened, it was so odd that it was two weeks before it was hurting then got progressively worse. Caller says that Tuesday a week ago she thought she must have done weights with her arms since her muscles were sore, but it was only on one side and she hadn't done any exercise since after she went to the ER she was being careful what she did, and she thought she strained her arm and realized what it was, it has gotten progressively worse over the last week. She says last night she started looking up remedies, she has been putting ice on it, and the clinic said use warm, and she rubbed castor oil on it last night in the shower then this morning she massaged her arm with castor oil and put a warm wash cloth over it. She says that castor oil has anti inflammatory properties. She says she has not noticed a difference yet, but she has only done it two times. She says it also said she can take Aleve or Ibuprofen, they told her at the ER, they also started her on Eliquis the night she was there, which she had never been on, they didn't consider her A-f fib bad enough. She says that is what has her concerned, she got the shot then 6 days later A-fib made her feel like she couldn't breathe. She says also her BP and heart rate going back up made her sick to her stomach that subsided when her BP was coming down but then it started going back up again, when she went to the ER that Saturday night on the 6th but by the time she got there it was the 7th. Outcome of the events was unknown.; Sender's Comments: The possibility that suspect drug may have contributed to the reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 70 | 2021-03-14 | influenza like illness, fever | Fever of 99-100 degrees and flu like symptoms |
| 70 | 2021-03-14 | nasal congestion |
After receiving her vaccine, client stated that she has a stuffy nose. Vital signs obtained by EMS ...
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After receiving her vaccine, client stated that she has a stuffy nose. Vital signs obtained by EMS BP 173/83, HR 69, O2 sat 98%. Client stated she is feeling better. Discharged home by EMS.
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| 70 | 2021-03-14 | fever |
Fever to 101.3 F approximately 24 hours after vaccination. This resolved with over-the-counter feve...
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Fever to 101.3 F approximately 24 hours after vaccination. This resolved with over-the-counter fever reducing medication (not specified by patient). Brief neck pain and arthralgias in the arms and legs also on the day following vaccination. These resolved spontaneously. She was asymptomatic 48 hours after vaccination.
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| 70 | 2021-03-15 | chills, fatigue, headache, fever, sleepiness |
she was freezing cold but no temperature registered; nausea; no energy; she was sleepy; head hurt; c...
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she was freezing cold but no temperature registered; nausea; no energy; she was sleepy; head hurt; chills but no temperature; fever; fatigue/exhausted; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EN9810, expiry: unknown), intramuscular in the muscle of her right shoulder on 05Feb2021 11:00 at a single dose for covid-19 immunization at a public health department. The patient has no medical history and concomitant medications. The patient is experiencing chills but no temperature on Feb2021, fever on Feb2021, fatigue on Feb2021, nausea, and no energy. She had her first shot last Friday (05Feb2021) and was fine. She stated that yesterday afternoon (11Feb2021), she felt really bad. She called the clinic to see if it was symptoms of Covid. She stated that she was freezing cold, but no temperature registered on 12Feb2021 at 13:00. Her head hurt on 11Feb2021 13:00 and she took Ibuprofen but it never let up, so she took Tylenol. She was sleepy on 11Feb2021 14:00 and was napping so she laid on the couch. The patient was also nauseous on 11Feb2021 14:00 but never threw up. She called the clinic to see if she should get tested for Covid. She stated that since she got up that she is exhausted, felt like she had no energy on 11Feb2021 14:00. The patient wanted to know if she needed to be concerned or if this is something that will run its course. She had to go get blood work at the hospital on Wednesday and that everyone had on masks and she did not think that she was exposed. The patient has no prior vaccinations (within 4 weeks). The outcome of the events feeling cold and feeling of total lack of energy was recovering, head pain and nausea recovered on 11Feb2021 while event sleepy was not recovered. The outcome of the other events was unknown.
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| 70 | 2021-03-15 | chills, nasopharyngitis, malaise |
2nd injection was was March 13, 9:30 am. Slept that night (Saturday) for 10 hours. Sunday stayed a...
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2nd injection was was March 13, 9:30 am. Slept that night (Saturday) for 10 hours. Sunday stayed at home. Monday (3-15-21) did a few errands and had constant diarrhia By 7:00 pm did not feel well and went to bed. Had nothing to eat all day, and by 8:00pm was vomiting fluids only and more diarrhia. slept fitfully with muscle cramps, shivers, then seats-cold and hot throughout the night. Finally awake and out of bed my 11:00 am
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| 70 | 2021-03-15 | chills |
received vaccine on 3-11 and 2 hours later total body aches. on 3-13 she woke up with blisters and r...
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received vaccine on 3-11 and 2 hours later total body aches. on 3-13 she woke up with blisters and rash to both lips and sores in mouth, rash to right anterior chest and chills
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| 70 | 2021-03-15 | headache, fatigue, chills, fever |
Headache, 102 Fever, nausea, chills, body aches, extreme fatigue Started 3-13-2021 at 7 pm until 03/...
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Headache, 102 Fever, nausea, chills, body aches, extreme fatigue Started 3-13-2021 at 7 pm until 03/14/2021 @ noon Nausea/upset stomach and extreme fatigue until 3/15/2021 Continue to have mild upset stomach and body fatigue with irritated airway
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| 70 | 2021-03-15 | headache, fatigue | Joint and muscle pain (Hips, Knees, Feet, toes, Hands, fingers, ankles), tired, and headache |
| 70 | 2021-03-15 | malaise, fatigue |
few heart quivers/heart is trembling/occasionally feeling her heart jumping around a bit/occasionall...
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few heart quivers/heart is trembling/occasionally feeling her heart jumping around a bit/occasionally her heart is still quivering for no rhyme or reason; Vomiting; exhausted all day from being sick; exhausted all day from being sick; feeling slightly queasy/queasiness; diarrhea actually started before 1 AM/but was mild and escalated and by 1 AM it was extremely bad; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL9264; Expiration Date: May2021), intramuscular, administered in Arm Left (left upper arm) on 25Feb2021 11:00 (at 70-year-old) at 0.3 mL, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Vaccination Facility Type was clinic. The patient previously took flu shot (she took the flu shot every fall and she has never had a reaction like this). It was reported that the patient started feeling queasy within 1 hour of the dose the same day. She confirmed by 1 AM 26Feb2021 she had diarrhea and vomiting which was about 14 hours after shot. She says the diarrhea actually started before 1 AM, so could have been 25Feb2021, but was mild and escalated and by 1 AM it was extremely bad. She confirmed the diarrhea was mild the same day as the vaccine and then got worse. She has also had a few heart quivers since this happened nothing constant but occasionally she feels like her heart is trembling. She thinks it was Saturday which would have 27Feb2021 because Friday, the day after the vaccine she was exhausted all day from being sick and maybe from the vaccine also but she thinks it was the next day, Saturday when she started occasionally feeling her heart jumping around a bit. She says occasionally her heart is still quivering for no rhyme or reason, just every once in a while she notices it. She says hopefully if she does take the second shot she will do better. The outcome of the event " few heart quivers/heart is trembling/occasionally feeling her heart jumping around a bit/occasionally her heart is still quivering for no rhyme or reason" was not recovered, "exhausted all day from being sick" was unknown, while for other events was recovered.
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| 70 | 2021-03-15 | fever, influenza like illness, headache, fatigue, chills |
4:45pm nausea, acute fatigue, headache 5:55pm vomiting x2, low fever, chills x 3.5 hours 9:25pm fat...
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4:45pm nausea, acute fatigue, headache 5:55pm vomiting x2, low fever, chills x 3.5 hours 9:25pm fatigue and flu-like aches only, acute symptoms lessening
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| 70 | 2021-03-15 | fever |
Took 1 hour to drive to pharmacy. Noticeable effects started on way home. Started to feel nauseous, ...
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Took 1 hour to drive to pharmacy. Noticeable effects started on way home. Started to feel nauseous, and from my neck to entire head, I felt swollen. Got home, collapsed in chair, had a faint sign of difficulty breathing, but not bad. Still felt swollen. Disappeared about 2 hours at home. Nausea getting worse. Feeling chilled, feverish, and dizzy. Unable to sleep that night, so nauseated I couldn?t even swallow water without wanting to puke. Shot on Tuesday, didn?t feel much better till Friday. Ok now.
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| 70 | 2021-03-16 | body temperature increased | 103 temperature, loss of consciousness, low BP. Dizziness. |
| 70 | 2021-03-16 | chills |
Chills, muscle aches, joint pain starting about an hour and a half after getting the vaccine, and la...
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Chills, muscle aches, joint pain starting about an hour and a half after getting the vaccine, and lasting for 3 days.
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| 70 | 2021-03-16 | fatigue |
Since my second shot on February 19, I have started sleeping more and more. I am sleeping from 14 t...
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Since my second shot on February 19, I have started sleeping more and more. I am sleeping from 14 to 18 hours a day and could sleep more if I didn't force myself to get up. No other symptoms just extreme fatigue
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| 70 | 2021-03-16 | fatigue |
Patient was to receive PFIZER manufacturer for second dose of vaccine series but received MODERNA in...
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Patient was to receive PFIZER manufacturer for second dose of vaccine series but received MODERNA in error. Followed up with patient the next day and on 3/17 - patient reported symptoms (ache, some fatigue) after second dose that resolved within 3-4 days. She was advised to report this event to her private MD, which she did.
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| 70 | 2021-03-16 | headache, chills, cough |
She is legally blind in her good eye; Felt like crap; proverbial headache was reported as worsened/p...
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She is legally blind in her good eye; Felt like crap; proverbial headache was reported as worsened/pain and tightness in both jaw lines was reported as worsened; I do have migraine; Hives; this is just a nightmare if this is not a normal problem; Can't think; pain and tightness in both jaw lines; pain and tightness in both jaw lines; thrush; proverbial headache/When I bend over I have a blinding headache; no coordination; Vomiting projectile/Throwing up right away; arm was hurting; swelling in arm; Chills; uncontrollable bladder gushing leaking; shaky arms; unable to eat anything; has been as sick as a dog; non stop coughing; Rib pain; This is a spontaneous report from a contactable consume. A 70-years-old female patient received bnt162b2 (BNT162B2) , via an unspecified route of administration on 2Feb2021 as a single dose, for covid-19 immunisation . Medical history included arthritis from 1992 and ongoing Verbatim: Arthritis , fibromyalgia from 1994 and ongoing Verbatim: Fibromyalgia , gastrooesophageal reflux disease from 1992 and ongoing Verbatim: GERD , lactose intolerance from 1992 and ongoing Verbatim: Lactose intolerance , depression from 1994 to an unknown date Verbatim: Anxiety depression , hypertension from 1992 to an unknown date Verbatim: Blood pressure high , MRSA , water pollution from an unknown date and unknown if ongoing She was unable to drink anything except sips of cold water and eat a few ice chips. She is unable to drink lukewarm water. This was prior to getting the vaccine , surgery from an unknown date and unknown if ongoing She had 22 surgeries in 4 years on her left eye. It started with pressure testing then infections. The patient reported she is legally blind in her good eye, has been as sick as a dog, non stop coughing, , non stop coughing , thrush on 23Feb2021, proverbial headache/when i bend over i have a blinding headache, , no coordination, vomiting projectile/throwing up right away arm was hurting, swelling in arm chills, uncontrollable bladder gushing leaking pain and tightness in both jaw lines unable to eat anything can't think felt like crap. The outcome of the events: Unknown: blindness, thrush, shaky arms, unable to eat anything, Can't think, Felt like crap, I do have migraine; Recovered, vomiting, swelling in arm; Recovoring illness, cough, rib pain, Not recovered headache, no coordination, uncontrollable bladder gushing leaking, pain and tightness in both jaw lines, pain and tightness in both jaw lines; Chills recovered with sequelae.
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| 70 | 2021-03-16 | headache |
a few minutes after receiving her vaccine the patient complained of feeling flushed, lightheaded, mi...
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a few minutes after receiving her vaccine the patient complained of feeling flushed, lightheaded, mild headache. she had no rashes or shortness of breath. It was a few minutes before the patient reported to the observation nurse that she was having these symptoms. By the time I was called over, the patient stated she was already feeling better. Her vital signs were recorded and her case was discussed with the doctor on duty. The patient was kept for an additional 10 minutes of observation. Her symptoms completely resolved and she was discharged to home after the doctor saw her per the doctor's instructions. The patient left the clinic ambulatory with out any further complaints.
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| 70 | 2021-03-16 | headache |
Headache, stomach ache dizzy nausea pain in shoulder very sore , blood sugar dropped to 60, blood...
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Headache, stomach ache dizzy nausea pain in shoulder very sore , blood sugar dropped to 60, blood pressure 185 systolic; has not been to doctor yet
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| 70 | 2021-03-16 | nasopharyngitis |
12 hours after shot, shaking and cold. Leg cramps. Little sleep. However, I went throughout my day ...
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12 hours after shot, shaking and cold. Leg cramps. Little sleep. However, I went throughout my day with no issues and symptoms ended around 6pm the next day.
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| 70 | 2021-03-16 | throat pain, throat irritation |
throat tightness , throat itching f/u call made; caller reports throat still sore and feels swollen...
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throat tightness , throat itching f/u call made; caller reports throat still sore and feels swollen, but able to swallow soft foods and liquids; continues to take allergy med and tylenol; unable to take Ibprofren d/t intolerance
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| 70 | 2021-03-16 | fever, chills |
I thought I was going to die; Sick; over a 103 temperature/the fever was so high; I had such bad chi...
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I thought I was going to die; Sick; over a 103 temperature/the fever was so high; I had such bad chills; nausea; I would throw it up; arm was so bad, it had it's own pulse, a pulse of it's own, I couldn't lift it at all plus the pain was like a tooth ache pain; checks your oxygen level and normally its 98-99, it went down to 91/her oxygen level was down to 90; my chest was shortness of breath; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored program. A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 24Feb2021 (at the age of 70-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included viruses, flus (I have had viruses, flus my whole life), five surgeries, gallbladder removed, and asthma, all from unspecified dates and unspecified if ongoing. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) on an unspecified date, at the age of 70-years-old and experienced a very sore arm. On an unspecified date in Feb2021 the patient experienced, "I thought I was going to die", "sick", "over a 103 temperature/the fever was so high", "I had such bad chills", "nausea", "I would throw it up", "arm was so bad, it had its own pulse, a pulse of its own, I could not lift it at all plus the pain was like a tooth ache pain", "checks your oxygen level and normally its 98-99, it went down to 91/her oxygen level was down to 90" and "my chest was shortness of breath". The clinical course was reported as follows: "I wanted to call today because I got the Pfizer COVID Vaccine 3 weeks ago, 03Feb2021 it was. After the first dose I had a very sore arm and that was it. It was more sore than normal vaccine, but it was that was all I had. After the second dose I was not aware that I would get sick to the extreme that I did. I found out afterwards that other people have said this, I did not know at the time. I thought I was going to die. I am a 70-year-old woman, I am not young, and I have had viruses, flus my whole life and I got so sick. First, I had over a 103 temperature, it came on suddenly, 12 hours to the minute after I got the vaccine. On top of that I had such bad chills I never saw anything like that in my life, 5 blankets on top of me, sweaters, sweatshirts and the fever was so high. I could not keep the Tylenol down because I had nausea and I would throw it up. So, I could not even get rid of it. Then on top of that my arm was so bad, it had its own pulse, a pulse of its own, I could not lift it at all, plus the pain was like a tooth ache pain, it was excruciating. I have had 5 surgeries, my arm hurt worse than all 5 surgeries put together. And I had my gall bladder removed and everything, nothing hurt to this extent. Now also I have asthma, nothing severe but I do have asthma, so I have one of those little oximeters and you put it on your finger and it checks your oxygen level and normally its 98-99, it went down to 91, all night it was 91, my chest was shortness of breath. I was ready to go to the hospital. And I did not know it was going to be that bad." When clarified about the treatment the patient stated that "yes, the Tylenol helped once I could hold it down. The doctor gave me something to stop the vomiting and the nausea. And then I could take the Tylenol and then the Tylenol worked great. But at first, I was so sick I could not hold the Tylenol down in my stomach I would throw it up, that was the problem." When asked about lab work the patient stated that she had not had lab work done since the first vaccine. She stated that she had stayed in the house because she had other health issues and was afraid to come out for 11 months. So she had not gone out to get anything done. The patient stated that she called because if a third dose was needed, she suggested that a smaller dose be given to small people. She stated that she took childrens medicine most of the time because she was tiny. She wanted to know if Pfizer in the future would be making doses for small people and doses for bigger people. Her suggestion was to have a separate booster to go by weight or by gender, men usually did not experience the same. The clinical outcomes of the events "I thought I was going to die", "sick", "over a 103 temperature/the fever was so high", "I had such bad chills", "nausea", "I would throw it up", "arm was so bad, it had its own pulse, a pulse of its own, I could not lift it at all plus the pain was like a tooth ache pain", "checks your oxygen level and normally its 98-99, it went down to 91/her oxygen level was down to 90" and "my chest was shortness of breath" were all recovered/resolved on unspecified dates. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 70 | 2021-03-16 | fever, headache |
Symptoms: Headache, nausea, body and joint ache, fever. Treatment: Tylenol and bed rest Time c...
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Symptoms: Headache, nausea, body and joint ache, fever. Treatment: Tylenol and bed rest Time course: 18 hours and continuing.
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| 70 | 2021-03-16 | fever, sweating |
Very high fever (I think), sweating (lost 4 lbs of 123), nausea, passed out. Husband found me on t...
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Very high fever (I think), sweating (lost 4 lbs of 123), nausea, passed out. Husband found me on the ground (just a short time), shook me, and I responded. Went to bed, stayed in bed the next day.
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| 70 | 2021-03-16 | fever |
Symptoms of maculopapular rash, mild fever (oral 100 degreed F), burning and itching sensation relat...
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Symptoms of maculopapular rash, mild fever (oral 100 degreed F), burning and itching sensation relative to rash. Rash location on arms, legs, chest, back, feet, hands, head. Rash was raised and red. Developed within 24h of COVID vaccine dose. Treated at home with scheduled diphenhydramine, Tylenol, hydrocortisone topical cream, and Pepcid. After two visits to PCP office, eventually treated with intramuscular steroid injection.
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| 70 | 2021-03-17 | chills, headache, fatigue | chills, fatigue, body aches, nausea, headache |
| 70 | 2021-03-17 | fatigue, headache |
Two weeks of excruciating headaches and overwhelming fatigue. Slept most of the day. Decided to fore...
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Two weeks of excruciating headaches and overwhelming fatigue. Slept most of the day. Decided to forego second shot, since it was my understanding that the reaction would be even worse.
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| 70 | 2021-03-17 | headache, fever, chills | fever, chills, headache, pain everywhere |
| 70 | 2021-03-17 | headache |
Headaches everyday since vacine received. Take pain releiver but after several hours, headache tart...
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Headaches everyday since vacine received. Take pain releiver but after several hours, headache tarts again.
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| 70 | 2021-03-17 | fever, headache, chills, malaise, fatigue |
Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swe...
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Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, feeling unwell, swollen lymph nodes Had these side effects for 24 hours, but the injection site swelling has lasted for a week. Took tylenol for the side effects and it helped.
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| 70 | 2021-03-17 | fever, headache | Body aches, headache, fever of 101.5 |
| 70 | 2021-03-18 | chills | Back ache, chills, vomiting and diarreau |
| 70 | 2021-03-18 | fatigue |
have some trouble sleeping; feelings of anxiousness, anxiety; Eyes dry; Ribs hurting; Wheezing; Arm ...
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have some trouble sleeping; feelings of anxiousness, anxiety; Eyes dry; Ribs hurting; Wheezing; Arm started hurting; Very tired; Very thirsty; One of legs got weak; achy; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9261), via an unspecified route of administration, in the right arm on 10Feb2021, 12:15 at a single dose for covid-19 immunization. The patient's medical history included ongoing Hashimoto's Hypothyroidism from 2000 (had it at least five years before a diagnosis), allergies year-round, depression, pneumonia, wheezing, calcium deficiency from an unknown date and unknown if ongoing. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for Hashimoto's Hypothyroidism from an unspecified start date and ongoing; bupropion hcl (BUPROPION HCL) taken for depression from an unspecified start date and ongoing; loratadine (LORATADINE) taken for allergies year round from an unspecified start date and ongoing; aspartate calcium, aspartate zinc, calcium ascorbate, glucosamine sulfate, magnesium aspartate, manganese aspartate (BONE STRENGTH) taken for calcium from an unspecified start date and ongoing; carbinoxamine maleate (OMEGA 100), colecalciferol (VITAMIN D3), chondroitin sulfate, collagen, glucosamine (COLAGEN) taken for an unspecified indications from an unspecified start dates and ongoing. When she was older the patient was given the high dose Flu Vaccine and had this reaction where her arm was red from shoulder down to elbow. After that she told them not to give her the high dose Flu Vaccine. She gets the regular Flu Vaccine. She assumes it occurred year turned 65, but was not sure. She does not have a lot/exp/NDC to provide. The patient experienced arm started hurting and very tired (around 7:00-7:30), very thirsty (had to drink three tall glasses of water back to back, reported she was never that thirsty), one of legs got weak (for a brief moment one of her legs was very weak and noticed while walking from the living room to the bed room) and achy on 10Feb2021. It was reported that the patient took a bath with Epsom Salt and it id not help. She got in bed by 8PM. Normally she goes to bed around 9:30-10 PM, but she was very tired. She then followed up and stated she went to sleep after the news about 10:20. Then at 4:45 AM she woke up because her eyes were very dry. Stated she has a humidifier in the apartment and usually has no trouble with her eyes, but they were very dry. She also noticed her ribs were hurting and it was noticeable on 11Feb2021. She was also more achy, but it the ribs hurting did not last real long. Then she noticed she was wheezing (11Feb2021). She knows she was wheezing because she has had pneumonia in the past and had wheezing then. The wheezing she had after the vaccine was not real bad. It stopped after about 10-15 minutes or so. She had laid down in bed for a while then got up around 5:30 AM. She felt better around then, but it took until like around 8AM before she felt fully okay as her arm was still aching. The outcome of the event arm started hurting and achy was recovered on 12Feb2021; eyes dry, ribs hurting and wheezing recovered on 11Feb2021; thirst and muscular weakness recovered on 10Feb2021, and unknown outcome for the remaining events.
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| 70 | 2021-03-18 | headache, nasopharyngitis | Short of breath headache chest pain nausea cold symptoms |
| 70 | 2021-03-18 | headache |
I immediately stated that the injection made me feel hot. Then my hands and face turned red. The c...
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I immediately stated that the injection made me feel hot. Then my hands and face turned red. The clinicians took my BP and it was over 170. They called the ER and took me directly there. The ER doctor administered Benadryl in IV. The redness started to go away and BP returned to normal. There was also a headache. Release from ER 2 hours after event. Subsequent fluctuations in BP and redness over the next 3 days. Saw PCP and he requested that I see allergist to determine cause of reaction in vaccine formula.
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| 70 | 2021-03-18 | headache |
Progress Notes (Nurse Practitioner) ? ? Cosigned by: MD at 3/18/2021 2:57 PM Expand AllCollapse Al...
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Progress Notes (Nurse Practitioner) ? ? Cosigned by: MD at 3/18/2021 2:57 PM Expand AllCollapse All COVID VACCINE CLINIC 3/16/2021 Date: 3/16/2021 Subjective Patient is a 70 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle in the medical bay by staff given prior allergic rxn to unspecified eye gtt. During her 30 minute waiting period after the injection, the patient began to experience headache. She denied rash or SOA This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to red flag findings. PMH anaphylaxis to unspecified eye gtss, prompting vaccine to be given under observation in medical bay. During 30" observation period, pt developed mild headache. Pt treated with Tylenol 500 mg tab x 2. ALLERGY REVIEW OF SYSTEMS: Patient complains of headaches Mild headache during 30" observation period: CONT negative HENT negative Eyes negative Respiratory negative Skin negative GI negative Musculo negative Previous Reactions: anaphylaxis to an unspecified eye gtt as a teenager Objective Vitals Vitals: 03/16/21 1522 BP: 110/68 Pulse: 55 Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: No oropharyngeal exudate. Eyes: Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Behavior: Behavior normal. Clinically, pt developed a mild headache during 30" observation. She was administered her vaccine Dose #1 of 2 in the medical bay after reporting having anaphylaxis to an unspecified eye gtt as a teenager. Assessment/Plan Treatment included: observation, Tylenol, snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Electronically Signed 3/16/2021 3:23 PM
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| 70 | 2021-03-18 | malaise |
Patient received second dose of Pfizer at 10:16 AM and was waiting in the waiting area. Reports no ...
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Patient received second dose of Pfizer at 10:16 AM and was waiting in the waiting area. Reports no issues with the first does. At 10:39, observer alerted writer that patient stated she wasn't feeling well. Pt was brought back to close observation room. Initial BP was elevated, other VSS. She c/o chest pressure and that she can feel "every vein in my body". Denies any shortness of breath. Reports h/o CAD. Carries nitro with her. At 10:49 AM, reports that chest pressure is increased and now is feeling "tingling all over". States that the pressure doesn't feel as though she need Nitro. Advised that, due to symptoms, would recommend f/u in ED if symptoms continue. At 10:55 AM, Patient requests to be taken to the ED. Husband is accompanying her today. Patient was taken via wheelchair by HCP.
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| 70 | 2021-03-18 | nasal congestion |
About five hours after receiving the shot I got really congested and started feeling dizzy. Still c...
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About five hours after receiving the shot I got really congested and started feeling dizzy. Still congested and feeling dizzy the following day
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| 70 | 2021-03-19 | sneezing, cough |
Nausea,weakness, lack of appetite,wheezing,coughing ,sneezing, diarrhea. I can not stay out of bed ....
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Nausea,weakness, lack of appetite,wheezing,coughing ,sneezing, diarrhea. I can not stay out of bed . Please help me . I have taken Tylenol
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| 70 | 2021-03-19 | throat irritation, headache |
This was 2nd dose. Starting before I sat down in the observation area: Pressure and pain at back of ...
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This was 2nd dose. Starting before I sat down in the observation area: Pressure and pain at back of neck, dizziness, difficulty swallowing. This persisted until 3/17. I had a similar reaction to the first dose. 3/15: Rash on face and neck. 3/16 Rash spread to chest and upper arms. 3/17 face swollen; headache, scratchy throat. 3/18: Symptoms subside by end of day, although skin still a little blotchy. I did tell the person who gave me the injection about my reaction to the first dose and she looked for the rapid response team to watch me, but she didn't find them. I suggest a sign in the waiting area indicating which symptoms are of concern (hard to distinguish immune response from allergy and/or anxiety attack.
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| 70 | 2021-03-20 | chills, headache, fever, lethargy |
lethargy; Chills; fever; muscle soreness; Major headache; nausea; Bad reaction at injection site; Th...
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lethargy; Chills; fever; muscle soreness; Major headache; nausea; Bad reaction at injection site; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810), via an unspecified route of administration, administered on the Left arm on 04Feb2021 14:30 as SINGLE DOSE for covid-19 immunisation. The patient medical history was none. If other vaccine in four weeks: No. Other medications in two weeks: no. Other vaccine same date details: other vaccine same date dose number was 2. Facility type vaccine was Hospital. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: No. The patient experienced lethargy, chills, fever (pyrexia), muscle soreness (myalgia), major headache (headache), nausea and bad reaction at injection site (injection site reaction); all (non-serious) on 04Feb2021 17:30. Adverse event: Chills, fever, muscle soreness, major headache, nausea, lethargy, bad reaction at injection site. There was no treatment for AE. The outcome of events was recovered on an unspecified date in Feb2021..
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| 70 | 2021-03-20 | headache, fatigue |
fatigue; headache; muscle & joint aches; muscle & joint aches; This is a spontaneous report from a c...
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fatigue; headache; muscle & joint aches; muscle & joint aches; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of BNT162B2 (BNT162B2, product: COVID 19, Pfizer- BIONTECH, Solution for injection, Lot number: 9269) via an unspecified route of administration, administered in Arm Left on 06Feb2021 10:30 as single dose for covid-19 immunisation. Medical history included hypertension (controlled) and irritable bowel syndrome. Known allergies was none. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), verapamil, spironolactone (ALDACTONE) and losartan all are via unspecified route from unspecified date at unspecified dose and frequency for unspecified indication. Facility type vaccine: Other, if other vaccine in four weeks, COVID prior vaccination and COVID tested post vaccination reported as no. historical vaccine included first dose of BNT162B2 product: COVID 19, Pfizer- BIONTECH, Lot number: 8982 on 16Jan2021: 02:00 PM unspecified route Left arm for COVID-19 immunization. The patient experienced fatigue, headache, muscle and joint aches on 06Feb2021 14:30. Patient received treatment for AE reported as no. The outcome of the events was resolved on an unspecified date in Feb2021.
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| 70 | 2021-03-20 | headache | Severe headache Stiff neck |
| 70 | 2021-03-20 | lethargy, malaise |
8 days after receiving 1st vaccination Lightheaded, dizzy , weakness in legs Feels like Cotton i...
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8 days after receiving 1st vaccination Lightheaded, dizzy , weakness in legs Feels like Cotton in my brain Fog brain Lethargic, malaise
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| 70 | 2021-03-20 | fever, chills, fatigue |
Left arm swollen at site of injection. Arm and finger swollen next morning. Tingling in toes. Ton...
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Left arm swollen at site of injection. Arm and finger swollen next morning. Tingling in toes. Tongue raw and sore and loss of taste. Very tired and achy. Low grade fever and chills. Unable to put two sentences together. Fill like my head is full of fog.
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| 70 | 2021-03-20 | fever, chills |
nausea; low grade fever; chills; 4hrs after shot: redness at injection site; red rash about 3" in di...
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nausea; low grade fever; chills; 4hrs after shot: redness at injection site; red rash about 3" in diameter on non vaccinated arm. Rash is not itchy or raised; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264), via an unknown route of administration on 11Feb2021 at 16:00 (04:00 PM) in Left arm at single dose for COVID-19 immunisation at Pharmacy or Drug Store. Age at vaccination was 70 years. The patient wasn't pregnant at the time of vaccination. Patient had allergies to medications, food, or other products. Other medical history included asthma. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included fluticasone propionate, salmeterol xinafoate (ADVAIR) at 250/50; lisinopril (LISINOPRIL) at 40 mg dose; salbutamol sulfate (VENTOLIN) Inhaler. The patient experienced redness at injection site 4hrs (at 20:00) after shot on 11Feb2021. On 12Feb2021 at 18:00 (06:00 PM), she experienced nausea, low grade fever, chills 24hrs after shot; on Feb2021 experienced red rash about 3" in diameter on non vaccinated arm 40hrs after shot. Rash was not itchy or raised. Patient didn't received treatment for the adverse event. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Serious was reported as no. Outcome of all events was unknown. No follow-up attempts are possible. No further information is expected.
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| 70 | 2021-03-20 | fever, sluggishness |
Started chilling about 24 hrs. after vaccination.........then low grade fever for about 6 hrs. Felt...
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Started chilling about 24 hrs. after vaccination.........then low grade fever for about 6 hrs. Felt very sluggish, no energy, went to bed about 830 pm and slept thru to morning and symptoms were gone. I took Tylenol 2 times the the afternoon.
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| 70 | 2021-03-21 | body temperature increased, headache |
Left arm extremely tender, arm and leg muscles sore, low grade 99.2 temp and massive headache fro...
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Left arm extremely tender, arm and leg muscles sore, low grade 99.2 temp and massive headache from nose to back iofhead
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| 70 | 2021-03-21 | chills, headache, fatigue | Fatigue, headache, chills, all minor |
| 70 | 2021-03-21 | fatigue, chills |
Morning after 2nd dose: Tiredness/ fatigue, chills, muscle soreness, joint pain and stiffness. Last...
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Morning after 2nd dose: Tiredness/ fatigue, chills, muscle soreness, joint pain and stiffness. Lasted about 36 hours. Took naproxen 375 mg which seemed to help
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| 70 | 2021-03-21 | fatigue |
The day following the vaccine, I experienced a sore left arm. Ten days following the vaccine, I bega...
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The day following the vaccine, I experienced a sore left arm. Ten days following the vaccine, I began having extreme fatigue and muscle aches throughout my entire body. I felt inflamed. The fatigue impaired my ability to walk and do normal activities. I mostly wanted to sleep. At first I did not associate the symptoms with the vaccine, but then realized it was probably associated. The fatigue and muscle aches lasted about 7 or 10 days.
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| 70 | 2021-03-21 | headache |
Began with a headache, then progressed to sore neck-back and sides, progressed into swollen glands a...
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Began with a headache, then progressed to sore neck-back and sides, progressed into swollen glands and soreness in neck, jaw and around ear area. Jaw became very sore. Opening mouth to eat became difficult. Headache had subsided 24 hours after neck episode began. From beginning of episode to current (3/22/2021), which is slightly over a week the adverse effects have gradually lessened. However, slight soreness in the front of neck, glands and jaw. Seems to lessen each day.
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| 70 | 2021-03-21 | fever, fatigue, malaise |
Over a period of 4.5 days, fever, fatigue, joint pain, muscle pain, loose stools, general malaise ...
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Over a period of 4.5 days, fever, fatigue, joint pain, muscle pain, loose stools, general malaise My concern is that now post 23 days after 2nd vaccine, I?m still having fatigue, no endurance, mild/moderate body aches, worse at night, still some episodes of loose stools.
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| 70 | 2021-03-22 | headache, chills, fever | Slight headache, chills, fever of up to 101.6 for 3-4 days & very painful underarm ! |
| 70 | 2021-03-22 | sweating, dehydration |
13 hours after injection while sleeping had strong urge to go to the bathroom, bowel movement, resul...
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13 hours after injection while sleeping had strong urge to go to the bathroom, bowel movement, resulting in massive diarrhea. During process, became very dizzy and felt nauseous and faint. Attempting to get up from toilet, and getting assistance from husband in an adjoining bedroom, made it to a second bathroom, passing out, again, complete empty of bowels severe diarrhea again while passed out on floor. Unconscious for about one minute, until revived by husband. Sweating, faint, very low BP. Taken to hospital by husband after getting composure admitted for observation due to apparent dehydration from massive diarrhea event. Results possible cardiac instability, dehydration from diarrhea, vegas nerve activity with Discharge the next day 03/22/2021 with follow up with cardiac Dr and primary, ongoing
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| 70 | 2021-03-22 | fever, chills |
nauseous, swollen lymph nodes under right armpit, chills, fever of 102, joint pain. 5 days later sa...
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nauseous, swollen lymph nodes under right armpit, chills, fever of 102, joint pain. 5 days later same symptoms
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| 70 | 2021-03-23 | chills, headache |
12pm felt achy and lightheaded. Developed chills and headache. Pain and headache became severe with ...
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12pm felt achy and lightheaded. Developed chills and headache. Pain and headache became severe with no relief from Tylenol. Continued throughout day into evening. Sleep of and on. Unable to walk to bedroom. Dizzy and feeling faint. Husband pushed me, by walker, into bedroom and helped me get ready for bed. Could hardly stand or roll over in bed. This was 11pm. Woke up at 10:30am. No further aching. Headache remaining, but mild. Tight feeling around head. Still dizzy. All symptoms resolved by 10pm. Upper left arm warm to touch with no lump.
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| 70 | 2021-03-23 | chills, fever, sweating, headache, cough | Fever/Chills, Cough, Headache, Diahrrea, Dizziness, Nausea, Perspiration, Overall Weakness |
| 70 | 2021-03-23 | cough |
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All ...
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Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 3/24/2021 Date: 3/24/2021 Subjective is a 70 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience a change in her cough and felt nauseated. She felt better shortly after 5 minutes but then her husband noted some redness in skin color in her legs and on her abdomen. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, collapse, hypotension, rapid progression of symptoms, respiratory distress, skin changes and increased in HR. Upon arrival to bay, HR 180-190. Pt's husband states pt with hx of svt. Usually in high 200's or low 300's if it comes on. Hx of having HR in the 150s at times. Usually resolves on its own with elevation of feet above pt's head per pt's husband. He is not worried about it but wanted to know what her pressures were doing. PT with alz. Pt's husband is main caregiver. ALLERGY REVIEW OF SYSTEMS: Redness went away after sitting down.: CONT negative HENT negative Eyes negative Respiratory negative Skin negative GI negative Neuro negative Previous Reactions: none Objective Vitals Vitals: 03/24/21 1045 03/24/21 1101 03/24/21 1115 BP: (!) 141/86 124/80 124/82 Pulse: (!) 180 (!) 158 (!) 150 SpO2: 100% 100% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: She is well-developed. Comments: Flushed appearance upon arrival to bay. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Regular rhythm. Tachycardia present. Heart sounds: Normal heart sounds. Comments: HR came down to 150-160's after Trendelenburg position. Ice pack placed on chest. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert. Mental status is at baseline. She is disoriented. Gait: Gait normal. Comments: Disoriented at baseline per pt's husband. Pt able to tell me who her husband is and their plans for cruise this summer. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Assessment/Plan Treatment included: water and Trendelenburg position Follow up response to treatment: fair. Patient discharge: AMA. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Discussed pt's HR despite of pt being stable here that they ought to seek further medical care in the ED. Pt husband declines as "she's done this before and I'm not worried. We will go to the hospital if she is not getting better. I think when we get home, in her normal environment, she will be fine." He voices appreciation for our evaluation and concerns. She was able to demonstrate assistance to standing position without reports of feeling dizzy or lightheaded. Pt color does look better. Redness is gone and she continues to report to feel well. Pt wheeled out in wheelchair. Husband is aware of our recommendations. APRN Electronically Signed 3/24/2021 10:59 AM Division of Health
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| 70 | 2021-03-23 | fatigue, headache |
Woke up the next morning with intense body aching from head, neck, shoulders, arm, spine; lightheade...
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Woke up the next morning with intense body aching from head, neck, shoulders, arm, spine; lightheaded, fatigued, and weak all day, no fever, took ibuprofen that evening (day after vaccine), and symptoms resolved by the next morning.
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| 70 | 2021-03-23 | headache |
1015 Received vaccination 1045 Developed left sided headache, right sided facial droop and perioral ...
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1015 Received vaccination 1045 Developed left sided headache, right sided facial droop and perioral paresthesias 1046 Evaluated by medical control; vital signs include BP 160/90, pulse 55, respirs 14/minute, O2 sat 98% RA. With smile right side of mouth lower and asymmetric compared with left, confirmed by husband. Nonfocal neuro exam otherwise with normal neurosensory and eyebrow/forehead motor 1055 Reevaluated with similar findings 1100 Ambulance called 1115 Ambulance arrived for transport
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| 70 | 2021-03-23 | headache |
Shortness of breath, severe chest tightness started 5 to 8 minutes after the injection lasted for 5...
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Shortness of breath, severe chest tightness started 5 to 8 minutes after the injection lasted for 5 minutes and were followed by an overwhelming weakness, confusion, later also by abdominal cramps, some urinary urgency- all gradually improved over 30-40 minutes. I felt later agitated, had dry mouth, headache- improved after drinking 8-10 cups of water. I did not seek help. I stayed in the shot area in a large tent.
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| 70 | 2021-03-23 | nasal congestion, headache, paranasal sinus discomfort |
Systemic: Headache-Severe, Additional Details: had swelling in sinuses and pressure behind her nose....
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Systemic: Headache-Severe, Additional Details: had swelling in sinuses and pressure behind her nose. she also has ringing in her ears
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| 70 | 2021-03-23 | fever, chills |
8 pm - hyper, frequent urination,chills,fever,nausea,weakness , feeling ?faint?. Symptoms lasted 4 ...
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8 pm - hyper, frequent urination,chills,fever,nausea,weakness , feeling ?faint?. Symptoms lasted 4 days . Then intermittent fever & chills . After 4 days red & swollen @ site of FIRST injection (NOT the 2nd injection !) . Extreme fatigue for a week .
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| 70 | 2021-03-23 | fever |
The vaccine was administered to this patient while in Skilled Nursing Care at this facility for Lumb...
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The vaccine was administered to this patient while in Skilled Nursing Care at this facility for Lumbar Spinal Stenosis. Following the injection the patient has experienced intermittent fever of unknown origin, severe skin pain to extremities, and paralysis to both upper and lower extremities. The symptoms are being investigated and the patient remains hospitalized.
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| 70 | 2021-03-24 | chills, fatigue, malaise, fever |
I had a horrible reaction to the second shot of Covid 19; I really thought I was going to die; It wa...
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I had a horrible reaction to the second shot of Covid 19; I really thought I was going to die; It was so bad; that's how bad that was; I woke up with the migraine headache, I never had a migraine; I had complete chills; I had a bad fever; I had complete exhaustion; my whole body hurt; I had complete exhaustion; my whole body hurt; I started vomiting, I had repeated vomiting; I just could not feel any worse; No, I just don't feel great yet, I lost 5 pounds truthfully; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 16Mar2021 (at the age of 70-years-old) as single dose for covid-19 immunization. Medical history included thyroid disorder (thyroid). Concomitant medication included thyroid (NATURE THROID) for thyroid. On 17Mar2021, the patient experienced that she had a horrible reaction to the second shot of COVID 19; she really thought she was going to die; It was so bad; that's how bad that was; the patient woke up with the migraine headache, she never had a migraine; the patient had complete chills; the patient had a bad fever; the patient had complete exhaustion; her whole body hurt; the patient started vomiting, she had repeated vomiting; she just could not feel any worse. The patient stated, "No, I just don't feel great yet, I lost 5 pounds truthfully" and with treatment, the patient stated, "No, just drink water." The patient thought maybe other people were having this, were other people calling that they got that sick and the patient was not obese or anything. The patient know they make it like if they were overweight, terribly overweight, have a worse reaction, the patient was a little overweight but hardly any. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 70 | 2021-03-24 | cough, chills, nasopharyngitis, throat pain |
Full blown cold with sour throat, chills, cough and off the chart blood pressure and heart rate!! T...
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Full blown cold with sour throat, chills, cough and off the chart blood pressure and heart rate!! Took 3 days to be some what better, but cough is still with me.
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| 70 | 2021-03-24 | fatigue, headache |
Exacerbation of fibromyalgia symptoms. Severe muscle and joint pain. Headache. Increased fatigue t...
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Exacerbation of fibromyalgia symptoms. Severe muscle and joint pain. Headache. Increased fatigue times four days.
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| 70 | 2021-03-24 | fatigue |
Extreme fatigue, afternoon of 2/27 -- had to lie down; fatigue for the next two weeks -- often took ...
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Extreme fatigue, afternoon of 2/27 -- had to lie down; fatigue for the next two weeks -- often took an afternoon nap (which otherwise never do). Fatigue is better now. Right breast -- vague discomfort (also reported breast symptoms that started 3 days after first shot, VAERS report #380584). The breast discomfort (slight nipple tenderness; feeling of breast fullness, and sometimes warmth; slight fullness under arm) is off and on and continues even now, 03/24/2021.
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| 70 | 2021-03-24 | fatigue |
Patient presented 2 days after injection with bilateral lateral chest pain radiating to back, interm...
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Patient presented 2 days after injection with bilateral lateral chest pain radiating to back, intermittent, sometimes at rest and sometimes with walking. Had previously been walking 2 miles twice daily, found extreme fatigue stopped her from walking more than 4 blocks with onset at same time. Evaluation included normal CBC w/ diff, ESR, CRP, CMP, LFTs. With pain no better, further eval 3/12 included RUQ U/S ddimer, NT-ProBNP. US showed dilated IVC and hepatic veins, EKG showed only bradycardia at HR 47. Patient eventually agreed to admission, workup for ACS negative with normal echo, clear coronary angiogram. Continuous monitoring showed severe bradycardia with episodes in 20s, pain improved with nitroglycerine. Pa
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| 70 | 2021-03-24 | fatigue |
Bruising of foot; foot was all messed up/it was all bruised and swollen, but it was not broken. She ...
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Bruising of foot; foot was all messed up/it was all bruised and swollen, but it was not broken. She says this was her right foot; Fatigue; had a low blood sugar episode she supposed; passed out/Unconsciousness; had muscle spasms almost to seizure amount of shaking/full body muscle spasms; had muscle spasms almost to seizure amount of shaking/full body muscle spasms; crashed unconscious to the floor/fell/fell backwards/caught her foot under the vanity; This is a spontaneous report from a contactable consumer (patient) reporting for herself A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 20Feb2021 11:00 (Lot Number: EN6201) as a SINGLE DOSE (at the age of 70 years old) for covid-19 immunisation. Medical history included breast cancer from 1988 to an unknown date , ovarian cancer from 2015 to an unknown date , she has had lymph nodes removed from her right arm "30 years ago" from 1988 to an unknown date, pass out from unknown date to unknown date. Concomitant medication included olaparib (LYNPARZA) taken for ovarian cancer from Feb2020 at 150mg, 2 tablets in the morning and 1-2 tablets at night by mouth.She says she is a little person and couldn't tolerate the side effects of that, so she varies how many she takes based on her side effects. She says she is supposed to take 300mg in the morning and 300mg at night. She says how she takes it is, she takes 150mg or one pill in the morning, then one or two at night depending on how she is doing. Historical vaccine information included BNT162B2 dose 1, lot no: EL9264, route left arm for Covid-19 immunisation. Past drug history included on days of intravenous (IV) chemo when she was being highly treated in the past sometimes she would pass out. The patient reported approximately 15 hours after the shot, on 21Feb2021 she had muscle spasms almost to seizure amount of shaking, full body muscle spasms. She clarifies that her side effects didn't kick in until 02:30AM on 21Feb2021. She says at 07:00AM on 21Feb2021 she got up and went into the bathroom and passed out, and had a low blood sugar episode she supposed. She crashed unconscious to the floor. She said that could be from the shot, but she is also a high risk patient, a cancer patient, and is on a maintenance chemo drug. She says on days of intravenous (IV) chemo when she was being highly treated in the past sometimes she would pass out, so she doesn't know if that was related to the COVID shot or not. No testing had been done on high risk patients, so she thought maybe this could be a good heads up for something someone else may experience. Her side effects were on and off for several hours, the shaking and spasms would subside and then start again. She says that they went away, and then she got up and passed out, and her foot was all messed up, she doesn't know what she did when she fell, but she had it checked and it was not broken, it was all bruised and swollen, but it was not broken. She says this was her right foot. She says she thinks she fell backwards, and she thinks she caught her foot under the vanity. On unknown date, she experienced bruising of foot, fatigue, foot was all messed up/it was all bruised and swollen, but it was not broken. She says this was her right foot. Outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 70 | 2021-03-24 | malaise, sweating |
After patient received vaccine and waited 15 minutes she asked if she could wait longer because she ...
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After patient received vaccine and waited 15 minutes she asked if she could wait longer because she didn't feel well. Paramedic was called and took patient to the EMS tent - per EMS pt was diaphoretic with hypotension and near syncope -after laying down BP normalized and pt resumed normal status. Pt requested to go to the ED. Pt is currently being treated with chemotherapy and had her last dose 5 days prior. She was brought in by EMS after appearing cool, diaphoretic, nauseous, and unwell after vaccine administration. Patient states that she was feeling nauseous, dizzy, and weak 1 hour after administration. She likely had a vasovagal-like response to vaccine administration. Did not lose consciousness.
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| 70 | 2021-03-25 | chills, fever, headache | body aches, chills, headache, 101 fever, for 24 hours |
| 70 | 2021-03-25 | fatigue, headache, sweating, throat pain, fever, runny nose, sleepiness |
About 5 hours after the second dose I could not stay awake. I had horrible sweats all night. The fol...
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About 5 hours after the second dose I could not stay awake. I had horrible sweats all night. The following morning my joints were stiff, and I hurt all over. I could not straighten my legs, and my fingers were curled. I could not straighten them. I had 102.2 fever, sore throat, headache, runny nose. Slept most of day 1. Day 2 I had sweats, fatigue, loss of appetite, but thought I was getting better. I was able to straighten my legs and fingers. Day 3 I still had sweats, runny nose, sore throat, headache. Ok by day 4. I did not see my dr.
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| 70 | 2021-03-25 | fatigue, headache |
70 y/o female of Asian descent developed a mild, pruritic, hive-like rash on her left arm and leg ab...
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70 y/o female of Asian descent developed a mild, pruritic, hive-like rash on her left arm and leg about 2 days (21 Jan 2021) after receipt of her 2nd BioNTech vaccine (injected in her left arm; no other vaccines given on that day). Patient did not self-treat. Rash continued on 26 Jan when patient was evaluated in Medical Center ER – described as "3 small wheals located on left upper and lower extremity with excoriations"; she was treated with Benadryl 25 mg orally and the itching decreased and the rash significantly diminished. No other signs or symptoms concerning for allergic reaction. Patient also reports onset of muscle aches, starting within 48 hours of vaccine receipt; also reports onset of fatigue, headache, and feeling hot. The headache and feeling hot resolved within 72 hours, but fatigue and muscle aches continued. Reports muscles hurt in her arms legs, and chest. Around 22 Jan, patient began having diffuse joint pain in her extremities. The pain became significantly worse on Sun, 24 Jan. Patient self-treated with Ibuprofen with some relief. By 26 Jan, when patient sought evaluation at ER, she described the joint pain as "unbearable" and rated pain intensity as 9/10. In the ER, patient was afebrile and her exam noted: bilateral hand and wrist swelling (left>right), but no redness or warmth at joints; full ROM, but pain increased with movements. Diagnosed as reactive arthritis and prescribed Tiger Balm and Lidocaine patches, with continued Ibuprofen recommended. At follow-up appointment with patient's PCM on 29 Jan, she reported continued muscle and joint pains. She reported some relief with topical analgesics and Ibuprofen, but Ibuprofen upset her stomach, so was changed to Celecoxib 200 mg twice daily as needed. Topicals and Benadryl were renewed. (Benadryl helped rash, but patient ran out and had recurrence of pruritic rash.) Muscle pain continued in her extremities. Reported fair control of muscle pain with topical analgesics and Celecoxib. Reported having "muscle spasms" in her hands. Patient reported increased sensitivity – painful sensation when she touched something cold. Reported using a pot holder to hold a cold can of soda to reduce pain. Joint pain primarily in hands, wrists, shoulders, feet, ankles, and knees. Reported swelling of hands and wrists resolved after about 2 weeks. She also had swelling of her left foot, which resolved. Reported some relief of joint pain with topical analgesics and Celecoxib, but joint pain interfering with sleep. Patient's fatigue continued. Spouse describes as decreased stamina. An example: they used to go out to do errands over a 2-hour period and it would not impact patient's energy level; now, after 2 hours of minimal-to-moderate activity, patient is exhausted. Follow-up with PCM on 8 and 18 Mar 2021 – rash resolved, but generalized muscle aches and joint pains continue. No localized joint swelling. Full ROM. Labs ordered (see below) – patient's Rheumatoid Factor was elevated; she is pending a Rheumatology evaluation (appointment on 17 April). No history of recent trauma or injury. No previous history of similar joint pain. No history of arthritis or Rheumatic disease. Not previously diagnosed with COVID and never tested positive for COVID; was quarantined in 2020 after returning from being on a cruise ship. After 1st COVID vaccine in Dec, she experienced a headache and local redness and tenderness at vaccination site, lasting less than 3 days.
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| 70 | 2021-03-25 | fatigue, malaise, headache |
70 y/o client experienced H/A, bad taste in mouth, maliaise, fatigue, and wheezing 24 hours after 2n...
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70 y/o client experienced H/A, bad taste in mouth, maliaise, fatigue, and wheezing 24 hours after 2nd Pfizer COVID Vaccination dose. Client stated it seemed as if she had "glaze" over eyes. Client stated she had no adverse reactoins from first dose but dos have hx of COPD. Client described it as "feeling like she had COVID" AND IS GETTING TESTED FOR covid-19 WITH pcp ON 2/24/2021
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| 70 | 2021-03-25 | headache, fever, malaise |
Started to not feel well 10 hours after injection. About 12 hours after the injection I had nausea,...
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Started to not feel well 10 hours after injection. About 12 hours after the injection I had nausea, vomiting, fever, headache. Symptoms ended about 24 hours after injection.
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| 70 | 2021-03-25 | headache |
3/26/2021 Ms. Rudd was observed post Covid-19 immunization for 30 minutes based on pre-vaccination...
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3/26/2021 Ms. Rudd was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness.chest pain and head ache Assessment : Time of assessment 1707 .Actions taken: increased observation time, VS taken with BP- 125/78. P - 75, O2- 98%, JUICE OFFERED AND DRINKING, TOOK TO STRETCHER VIS WHEELCHAIR TO CONTINUE TO MONITOR. Vs RECHECKED AT520P, 141/75, P- 77. DENIES FURTHER CHEST PAIN OR DIZZINESS. GIVEN WATER, OFFERED TO CALL DAUGHTER BUT PATIENT REFUSED. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 40 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/26/2021 4:25 PM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc
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| 70 | 2021-03-25 | fever, headache, chills |
I had my 2nd Pfizer Covid shot on 3/23/21 at 10:20 am. By 11:55 pm on that same day I began to feel ...
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I had my 2nd Pfizer Covid shot on 3/23/21 at 10:20 am. By 11:55 pm on that same day I began to feel chilled. By 2:30 am on 3/24/21 I had a temperature of 101.2 f. and took 1 Tylenol 500 mg.. I slept very poorly. By 11 am on 3/24/21, I still had a 100 degree fever and chills with a slight headache. No left arm muscle ache however. I took another Tylenol 500 mg at that time. By 5 pm on 3/24/21, my fever went up to 100.2 and I took another 500 mg Tylenol. I went to bed at 9 am, slept poorly but woke up at 7 am with a normal temperature of 98.
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| 70 | 2021-03-26 | fatigue |
About 24 hours after receiving my second dose, I became extremely fatigued. I had trouble finishing...
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About 24 hours after receiving my second dose, I became extremely fatigued. I had trouble finishing my work day. When I went home I went straight to the Lazy Boy. Was too tired to fix any supper for a couple hours. Then I ate and rested another 2 hours before I felt OK.
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| 70 | 2021-03-26 | sweating, headache |
I took the vaccine at 11:20 a.m. on Thursday 3/25/21. About 3:00 a.m. I awoke with a splitting head...
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I took the vaccine at 11:20 a.m. on Thursday 3/25/21. About 3:00 a.m. I awoke with a splitting headache, my night gown was soaked with sweat, I ached all over and I was nauseated. Walking to the bathroom was painful. I took two Tylenols These symptoms continued throughout the day on Friday. I awoke Saturday free of symptoms.
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| 70 | 2021-03-26 | fever, chills | Flushed face, rapid heartbeat, minor fever and chilla |
| 70 | 2021-03-27 | body temperature increased, fatigue, headache |
Temperature high=104 decreasing each hour over 8 hours Extreme coldness for an hour subsiding over ...
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Temperature high=104 decreasing each hour over 8 hours Extreme coldness for an hour subsiding over 8 hours Muscle & joint ache Headache...at times like migraine with light sensitivity VERY TIRED Loss of appetite Disorientation Off balance
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| 70 | 2021-03-27 | chills, cough, headache, sweating, runny nose, sneezing | Chills, cough, sweats, runny nose, vomiting, loss of appetite, sneezing, headaches |
| 70 | 2021-03-27 | chills, cough |
Mild coughing about a half hour after vaccination administered Mid-afternoon, achiness and chills Ab...
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Mild coughing about a half hour after vaccination administered Mid-afternoon, achiness and chills About 7 pm, intense itching and tenderness at vaccination site Took aspirin, slept all night, some symptoms in the morning, but they were gone by about 10 am
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| 70 | 2021-03-27 | headache, chills, fatigue |
Swollen lymph node on right side of neck, swollen spot on back of right side of head, fatigue and h...
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Swollen lymph node on right side of neck, swollen spot on back of right side of head, fatigue and headache, chills n
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| 70 | 2021-03-28 | sweating |
RN notified of patient having reaction and being taken by ambulance. Per EMT report, pt. began havin...
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RN notified of patient having reaction and being taken by ambulance. Per EMT report, pt. began having chest pain radiating down her arm, chest heaviness, right arm numbness, and some shortness of breath. Vitals BP:146/78, O2 94% on room air. Patient also pale and diaphoretic. Taken by ambulance to emergency room. Patient has extensive cardia history per EMT report: has pacemaker, had stress test and scheduled for a cardiac procedure. 3/29/21 Phoned patients daughter to follow up with patient's status. Patient does not have cell phone and speaks Bosnian. During hospital stay, she reports her O2 sats were low, had a heart cath. procedure,
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| 70 | 2021-03-30 | chills, fever, malaise, fatigue, headache |
Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; This is a spontaneous r...
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Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; This is a spontaneous report from a contactable other HCP (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Unknown), via an unspecified route of administration, administered left arm on 19Jan2021 09:30 AM (at the age of 70-years-old) at single dose for covid-19 immunization. The patient was not pregnant. Other vaccine details were First dose Pfizer biotech Covid-19 vaccine EUA with vaccination date 26Jan2021 (Other vaccine same date vaccine date) at left arm. Patient's medical history included 6 months post chemo for lymphoma. No known allergies reported. The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks. On 27Jan2021 01:00 AM the patient experienced tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell. No covid prior vaccination. No covid tested post vaccination. No treatment received for events. The outcome of event was recovering. Information about lot/batch number has been requested.
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| 70 | 2021-03-30 | fatigue, chills, headache, fever |
Tired; headache; chills; fever; nausea; dizziness; weakness; body shook; This is a spontaneous repor...
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Tired; headache; chills; fever; nausea; dizziness; weakness; body shook; This is a spontaneous report from a contactable 70-year-old female consumer (patient, non-pregnant) received second dose BNT162B2 (Solution for injection, brand: Pfizer, lot number: EL3246) via an unspecified route of administration in Arm Left on 23Jan2021 at 08:15 AM for COVID-19 immunization. Patient medical history included High BP, Hyatal hernia. Concomitant medications included fish oil, atenolol, omeprazole, ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER). Patient previously took rosa canina (ROSE HIPS, need to take over time) and had allergy. Historical vaccine included first dose BNT162B2 (COVID19, brand: Pfizer, lot number: EK9231) on 02Jan2021 at 08:45 AM on Left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Jan2021 20:45, patient had tired, headache, chills, fever, nausea, dizziness, weakness body shook for about a hour and half. No Seriousness criteria was reported. Outcome of events was recovering.
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| 70 | 2021-03-30 | fatigue, fever, headache, influenza like illness |
sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sud...
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sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; Fever; headache; flu like aches; tiredness; This is a spontaneous report from a contactable female consumer (patient) A 70-year-old female patient (non -pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EJ1686; Expiration Date: unknown), via unspecified route of administration, anatomical location: - Left arm On 20Jan2021 at single dose for COVID-19 immunisation. The patient Medical history included Slight asthma, fibromyalgia. concomitant medications include Shingrix on 04Jan2021. Patient experienced Fever, headache, flu like aches, tiredness Not concerned about this, had same reaction to shingles vaccine. But six days later sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs. Had a negative reading for covid three days after vaccine. The intensity of the feeling began to decrease after 48 hours but the feeling and weakness is still present..patient was not diagnosed with COVID-19 vaccination. The patient was tested for COVID-19 since the vaccination, (covid test type Nasal swab, covid test date-23Jan2021, covid test result-Negative) The outcome of event was not recovered.
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| 70 | 2021-03-30 | sleepiness, fatigue |
Moderate to severe fatigue; I have trouble staying awake during the day, especially early evening. ...
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Moderate to severe fatigue; I have trouble staying awake during the day, especially early evening. I need more and longer naps than usual. Because I have leukemia, I do have fatigue normally.; Moderate to severe fatigue; I have trouble staying awake during the day, especially early evening. I need more and longer naps than usual. Because I have leukemia, I do have fatigue normally.; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 19Jan2021 09:00 (Batch/Lot Number: EL3249) as single dose for Covid-19 immunization. Medical history included ongoing leukaemia, chronic pain, gastritis, colitis, supraventricular tachycardia, depression, xerostomia, afibrillation, migraines, fatigue, and others. Concomitant medication included ibrutinib (IBRUTINIB) taken for leukaemia. The patient previously had Known allergies for drugs Bactrim, Belladonna, Diclofenac, DMannose, IV contrast media, Mobic, Metoclopramide, Metoprolol, Protonix, and Pyridium. Patient not had other vaccine in four weeks, Other medications in two weeks includes Ibrutinib (for leukemia). On 19Jan2021 on 13:00, patient had Moderate to severe fatigue; "I have trouble staying awake during the day, especially early evening. I need more and longer naps than usual. Because I have leukemia, I do have fatigue normally, but it has gotten Much worse". Patient not had COVID prior vaccination; patient not tested COVID post vaccination. There was no treatment received for the adverse events. Th outcome of the events was not recovered.
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| 70 | 2021-04-02 | headache |
light headache; site pain morning after; This is a spontaneous report from a contactable other healt...
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light headache; site pain morning after; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 70-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318), at 70 years of age, via an unspecified route of administration on 07Feb2021 03:45 at single dose, in left arm for COVID-19 immunization. The patient medical history included Multiple sclerosis and unknown if ongoing. Patient had an statins allergy. Concomitant medication included gabapentin, Prozac, gemfibrozil, losartan and coq10. On 07Feb2021: 07:00 PM, the patient experienced light headache and site pain. The events were considered as non-serious. No treatment was given for the events. Patient did not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on an unknown date.
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| 70 | 2021-04-06 | headache, chills |
4:30pm slight nausea; arm pain; mild headache 5:00 pm headache more severe; up the back of head, des...
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4:30pm slight nausea; arm pain; mild headache 5:00 pm headache more severe; up the back of head, described as unusual pain; thought a migraine was coming on. 5-7:00pm headache continues to worsen; chills; research on line side effects of Pfizer vaccine and they coincide with symptoms; 7:05 gets up to urinate (no assistance needed); screams out in pain 3 times while on toilet; starts to vomit; right side of face (eye and cheek and mouth droop like a stroke; left hand starts to curl. Loses consciousness immediately thereafter. 911 call; paramedics on the way; airway was swept and clear; gurgled breathing. Rushed to Hospital and assessed as having massive brain bleed. Pronounced dead at 10:22pm. Acute Hemorrhagic Stroke on Death Certificate.
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| 70 | 2021-04-06 | malaise, chills, dehydration, fever, headache, fatigue |
Tiredness; Headaches; Chills; Fever; Nauseated; Dizziness; Weakness; felt sick; can't see as good, h...
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Tiredness; Headaches; Chills; Fever; Nauseated; Dizziness; Weakness; felt sick; can't see as good, her eyes are weak; Difficulty breathing; thought she was having a heart attack; dehydrated; fast heart beat that felt like her chest was full; fast heart beat that felt like her chest was full; Injection Site Pain; blood pressure fluctuated; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 27Feb2021 12:00 (lot number: EN6202; expiration date: 30Jun2021) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure and stroke from 2012 to an unknown date. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN) taken for stroke from 2012 and ongoing; clopidogrel bisulfate (CLOPIDA) and simvastatin both taken for high blood pressure from 2012 and ongoing; ongoing amlodipine, lisinopril, and metoprolol all taken for high blood pressure. On 27Feb2021, she took the first vaccine. From that day, for 2 days, she had injection site pain. On 07Mar2021, she started having tiredness, headaches, chills, fever, felt nauseated, had a fast heart beat that felt like her chest was full and thought she was having a heart attack, dizziness, weakness, felt sick, and difficulty breathing. The patient added that she can't see as good, her eyes are weak. She was going to make an appointment to get her eyes checked. For dizziness event, she has to sit on the side of her bed for 10 minutes and she was still dizzy. She has to hold on to something because she feels like she is going to fall. She was given meclizine three times a day for this event. For tiredness event, she stated that it fluctuates during day. After she takes a paracetamol (EXTRA STRENGTH TYLENOL) and lays down for a while, she feels ok and then she feels tired again. For fast heart beat that felt like her chest was full and thought she was having a heart attack event, it comes and goes, she had it yesterday (21Mar2021) but hasn't had it today (22Mar2021) but she doesn't know if it is gone. Her symptoms were usually in the morning when she first gets up. She has been to the emergency room (ER) on 07Mar2021 and on 13Mar2021 and they say that nothing is wrong. On 07Mar2021, they gave her an IV because they thought she was dehydrated. On 13Mar2021, she went back to another hospital ER. She felt worse and her son came and got her and took her to the ER. They did a whole workup MRI of her head, x rays, blood work and everything. They didn't know what was causing it because it had it been over a week since her vaccine and they sent her home. She has been laying down and staying hydrated. She couldn't hardly get up and they asked her what has she done different and the only thing different was the vaccine. Everything listed on the risk factors [side effects] is how she is feeling. She was not hospitalized, they gave her medicine and told her to stay hydrated and sent her home and was told to follow up with her physician. She finally got an appointment for tomorrow (23Mar2021) with her physician. She can't drive because of the dizziness. All of her tests came back normal. They said her blood pressure fluctuated on 2021 but that is normal. Outcome of the injection site pain was recovered on 01Mar2021, of the difficulty breathing was recovering, of the headache, chills, fever, dizziness, weakness, and felt sick was not recovered, while of the remaining events was unknown.
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| 70 | 2021-04-06 | fever |
excess vomiting about 10 times in 5 hours; Very high fever; This is a spontaneous report from a cont...
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excess vomiting about 10 times in 5 hours; Very high fever; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19Mar2021 10:30 (Batch/Lot Number: Unknown) as single dose for covid-19 immunization at a clinic. Medical history included asthma, high blood pressure and allergy with Sulfa. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), fluticasone propionate, salmeterol xinafoate (ADVAIR HFA) and apple cider vinegar. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 at 10:00 in the left arm for covid-19 immunisation. The patient experienced very high fever and excess vomiting about 10 times in 5 hours on 19Mar2021 at 22:00. No treatment was given for the events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 70 | 2021-04-06 | sneezing, runny nose, fatigue, chills |
fatigue; mild diarrhea; abdominal pain; gas; runny nose; diarrhea with blood; Sneezing; watery eyes;...
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fatigue; mild diarrhea; abdominal pain; gas; runny nose; diarrhea with blood; Sneezing; watery eyes; orange bowel movement; near syncope; lightheaded/lightheadness; chills; body aches; decreased appetite/poor appetite; This is a spontaneous report from a contactable Other-HCP (healthcare professional) in response to HCP letter sent in cross reference case. A 70-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot Number: EN6201) intramuscularly on 05Mar2021 (at the age of 70-years-old) as a single dose in the deltoid left for COVID-19 immunisation. Medical history included ongoing HTN (hypertension; onset date: years ago; pertinent details: well controlled) from an unspecified date and menopause from an unspecified date and unspecified if ongoing. Concomitant medications included ongoing hydrochlorothiazide orally taken for HTN from an unspecified date, ongoing estradiol benzoate (ESTRADIOL) vaginal taken for menopause from an unspecified date and ongoing multivitamin orally taken for health maintenance from an unspecified date. The patient previously received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot Number: EL9261) intramuscularly on 12Feb2021 as a single dose in the deltoid left for COVID-19 immunisation and experienced sore arms and should injury. Prior vaccinations were reported as none. On 07Mar2021 the patient experienced diarrhea with blood (medically significant), sneezing, watery eyes, orange bowel movement, on 06Mar2021 the patient experienced near syncope, lightheaded/lightheadness, chills, body aches and decreased appetite/poor appetite, on 08Mar2021 the patient experienced fatigue, mild diarrhea, abdominal pain, gas and runny nose. It was reported that the event near syncope was non-serious, did not require treatment. It was also reported that the events near syncope and diarrhea with blood required a visit to the emergency room. The clinical course was reported as follows: "05Mar2021 Vax. 06Mar2021- Lightheadedness onset day after COVID vax #2. Lightheaded, chills, body aches, decreased appetite. 07Mar2021- Sneezing, watery eyes, orange bowel movement, poor appetite, diarrhea with blood. To ER. 08Mar2021- Fatigue, poor appetite, mild diarrhea, abdominal pain and gas, sneezing, runny nose. 09Mar2021- Improved." The patient underwent lab tests and procedures on 07Mar2021 that included: EKG, CBC and comprehensive metabolic panel which were all normal. The clinical outcome of the event near syncope was recovered/resolved on an unspecified date while the clinical outcomes of the events diarrhea with blood, lightheaded/lightheadness, chills, body aches, decreased appetite/poor appetite, sneezing, watery eyes, orange bowel movement, fatigue, mild diarrhea, abdominal pain, gas and runny nose were all unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Diarrhea bloody cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 70 | 2021-04-07 | fever | fever following vaccination requiring admit to hospital for fever, discharged |
| 70 | 2021-04-09 | headache, sleepiness |
loss of appetite; pretty bad headache; body aches; tightness in her chest; Ringing in ears; stomach ...
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loss of appetite; pretty bad headache; body aches; tightness in her chest; Ringing in ears; stomach cramps; slept 15 hours; lump; pimple; infection on the abdomen; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, in Arm Left on 24Feb2021 (Lot Number: EN6202) as SINGLE DOSE for COVID-19 immunization. Medical history included a lot of allergies from an unknown date and unknown if ongoing. Concomitant medications included losartan taken for high blood pressure, start and stop date were not reported; formoterol fumarate, mometasone furoate (DULERA) taken for bronchial hyperreactivity, start and stop date were not reported; fluticasone to help her breathe, start and stop date were not reported; fexofenadine a decongestant for allergies, start and stop date were not reported; tolnaftate antifungal solution for toenail, start and stop date were not reported; and fluorometholone taken for plugged up tear duct, start and stop date were not reported. The patient previously had flu shot once about 15 years ago and it was terrible. With the first dose, the patient started to have loss of appetite, pretty bad headache, body aches, tightness in her chest, ringing in her ears, and stomach cramps. She slept 15 hours the first night. She got up to go the bathroom and then went right back to bed. That happened after first dose and she wasn't too anxious to get the second dose. These were pretty strong. For 24 hours after onset they were pretty severe. Then she experienced variation of these and lessening of severity over seven days. By the next Wednesday she felt her normal self. She got both shots on Wednesday. She didn't have fever or any other problems that COVID people get. The patient had an infection on the abdomen. She took Cephalexin for 10 days. The infection on the abdomen started in early Mar2021. It was like a lump in Mar2021. She went to the dermatologist because there is cancer in her family. The dermatologist told her not to worry. Then it erupted like a big pimple in Mar2021. The outcome of the events was unknown. Follow-up attempts are needed. Information on lot/batch number is available.
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| 70 | 2021-04-09 | fever, chills, fatigue, headache |
Very difficult to fall asleep that evening; Passed out in bed; nausea/queasy; simultaneously had dia...
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Very difficult to fall asleep that evening; Passed out in bed; nausea/queasy; simultaneously had diarrhea and vomiting (several times in a row).; simultaneously had diarrhea and vomiting (several times in a row).; headache; Slept all day; sore arm; chills; very tired; Fever about 100.5/temp now almost 101; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613) via unspecified route of administration in left arm on 23Mar2021 09:30 AM at single dose for COVID-19 immunization. Medical history included prone to bronchitis with bad cold. Known allergies included strong reactions to oxycodone hydrochloride;paracetamol (PERCOCET), zolpidem tartrate (AMBIEN) and some anesthesias. Patient did not have COVID prior vaccination, did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. Concomitant medications included rosuvastatin, loratadine, ergocalciferol (VIT D) and multi-vitamin. The patient previously received first dose of BNT162B2 (lot number: EN6205) in left arm on 01Mar2021 09:30 AM for COVID-19 immunization. Evening of the shot on 23Mar2021 07:30 PM, patient experienced sore arm, chills, later and very tired. Fever about 100.5. Middle of night, about 16-17 hrs after shot (24Mar2021) awoke with nausea. Rose to go to bathroom and simultaneously had diarrhea and vomiting (several times in a row). Extreme tiredness and nausea. About 4:30 took 2 paracetamol (TYLENOL) and anti-nausea med. Passed out in bed on 24Mar2021. Woke about 11:30 AM. temp now almost 101, headache, paracetamol and more anti-nausea med. Slept all day until 10:45 PM 24Mar2021 fever normal, nausea gone, quite tired still. On 25Mar2021, patient was able to get up, still tired but so much better, stomach still queasy. Ate bit of toast, later, rice and applesauce. Bit of headache took paracetamol. Very difficult to fall asleep that evening (25Mar2021), awoke 26Mar2021 and fell so much better although stomach still a bit queasy. Treatment was received for all events. Patient had not tested COVID post vaccination. The outcome of events was recovering.
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| 70 | 2021-04-12 | nasal congestion |
distance vision loss began happening four days after being vaccinated; salivatory glands in mouth dr...
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distance vision loss began happening four days after being vaccinated; salivatory glands in mouth dried up, felt like sucking on lemons, nostrils became stuffed up. This was with in about ten minutes after vaccination was given.; salivatory glands in mouth dried up, felt like sucking on lemons, nostrils became stuffed up. This was with in about ten minutes after vaccination was given.; The initial spontaneous report information received from a contactable consumer (patient) on 23Mar2021 safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 28Mar2021, this case now contains serious adverse reactions. A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EP7534) via an unspecified route of administration to right arm on 22Mar2021 15:00 at single dose for COVID-19 immunization. Patient medical history included high blood pressure, lymes disease, dengue fever, artheritis, known allergies: bees, known allergies: mold, botox and known allergies: some meds. Concomitant medications included lisinopril, vitamins nos and ascorbic acid, thiamine hydrochloride (VITAMIN B AND C COMPLEX). On 22Mar2021 patient reported with salivatory glands in mouth dried up, felt like sucking on lemons, nostrils became stuffed up. This was within about ten minutes after vaccination was given. Patient took benadryl and was observed for 30 min for the events. On 26Mar2021 20:00 patient experienced with distance vision loss began happening four days after being vaccinated patient did not received any treatment for this event. Outcome of event Vision loss was not recovered and Recovered with sequel for other events. No further information is expected.
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| 70 | 2021-04-15 | fatigue |
Date and time of vaccination: (list both if they received both shots): 02/02/21 1100, 02/23/21 1200...
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Date and time of vaccination: (list both if they received both shots): 02/02/21 1100, 02/23/21 1200 Date and time adverse event started: 02/05/21 1100 SOB AFTER FIRST SHOT ,FATIGUE , WAS ADMITTED TO HOSPITAL FOR 7 DAYS , RELEASED AND THEN RETURNED TO THE HOSPITAL , SENT BACK TO , SAW THE DOCTOR 24TH OF MARCH , DOCTOR ADVISED WATER REDUCTION AND THE PATIENT HAD DEVELOPED CHF , PATIENT PAST ON THE 29TH
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| 70 | 2021-04-15 | fatigue |
Day of shot #2 (3/31/21) I experienced nausea in the first 15 minutes and felt confused while drivin...
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Day of shot #2 (3/31/21) I experienced nausea in the first 15 minutes and felt confused while driving. Nausea passed in 2-3 hours and I felt fine. The next day I felt tired, foggy brain, and dizzy. Assumed it was from the shot. Side effects continued/worsened. 4/6/21 I saw my Dr. She checked me over, labs. found nothing wrong with me. Likely side effects from Pfizer. Unlikely that they would last two weeks. Rx Meclizine for dizziness, which didn't really help. Now it's Day 15. Tired and brain fog are gone. I don't feel as dizzy. BUT, when I try to drive, I feel QUITE dizzy with blurred vision. This side effect persists and clearly effects my quality of life.
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| 70 | 2021-04-15 | headache |
Immediate headache, heart racing, weakness, chest sensations, palpitations, nausea, After two weeks...
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Immediate headache, heart racing, weakness, chest sensations, palpitations, nausea, After two weeks of continued symptoms suddenly had Afib with RVR event and went to Er
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| 70 | 2021-04-17 | headache, sweating, fatigue |
Lower chest partial atelectasis or scarring in the lung bases bilateral; Partial lung collapse (both...
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Lower chest partial atelectasis or scarring in the lung bases bilateral; Partial lung collapse (both upper and lower parts collapsed); Lower chest partial atelectasis or scarring in the lung bases bilateral; Beneath this area was a red circle where blood clotted or something; Wheezing; Shortness of breath; Swelling of the face; underneath the arm where the injection site was, a big red circle was noted and it was swollen/under her nose and left elbow were red; underneath the arm where the injection site was, a big red circle was noted and it was swollen; I would get hot and cold; I was sweating; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Fatigue; Pain in left elbow; goes to bathroom and bowel was not emptying the way it should; rib cage is going on the side of body noticed this thumping; Her lips were red; Throat was red; Been sick and just laying around; Her eyes were red; Cramp in left arm where site of injection; Sharp pains were hitting her in her eye, thigh, chest, head, and the arm; Sharp pains were hitting her in her eye, thigh, chest, head, and the arm; This is a spontaneous report received from contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 15Mar2021 (at the age of 70 years) at a single dose in the left arm for COVID-19 immunization. Medical history included lung issues and allergic asthma. Family history included brothers and sisters who died of lung issues and third sibling sister died many years ago due to allergic asthma. The patient previously took flu vaccine for immunization and experienced severe pain throughout her whole body. On 15Mar2021, patient received the first dose of Pfizer COVID-19 vaccine. Later on, that day when she got home after receiving the vaccine, underneath the arm where the injection site was, a big red circle was noted and it was swollen, beneath this area was a red circle where blood clotted or something, she would get hot and cold and take her clothes off because she was sweating but did not have fever, there was pain in her chest, stomach, back and head, wheezing, shortness of breath, fatigue, swelling of the face, pain in left elbow. She goes to bathroom and bowel was not emptying the way it should. She also noted that her rib cage is going on the side of body noticed this thumping, lips and throat were red. She's been sick and just laying around, her eyes, under her nose and left elbow were red, had cramp in left arm where site of injection, and sharp pains were hitting her in her eye, thigh, chest, head, and the arm. Patient clarified that these symptoms began on 15Mar2021, the same day she received the Pfizer COVID-19 vaccine. On 23Mar2021, patient went to the ER and the findings were lower chest partial atelectasis or scarring in the lung bases bilateral and partial lung collapse (both upper and lower parts collapsed). At the hospital her temperature was 98.9 F on 23Mar2021, but 97.1F - 97.7F is her normal temperature. She went to the Pulmonary doctor also, but was getting a second opinion because she knew it could be life threatening. The pulmonary doctor made light of it saying they were just creases, like creases in pants. Patient said crease was a far cry from partial lung collapse on both bases and the Pulmonary doctor also said that it is in the upper part of the lung also. This scared her and made her think nobody cared. She did not know if she should provide the information because the doctor did not seem to believe that that her symptoms were coming from receiving the Pfizer COVID-19 vaccine. She guessed she should provide the information because Pfizer does research. She wanted to know how long do the side effects last and if she should take the second dose. The outcome of the events underneath the arm where the injection site was, a big red circle was noted and it was swollen/under her nose and left elbow were red, pain in her chest, stomach, back and head, wheezing, shortness of breath, fatigue, swelling of the face, pain in left elbow, goes to bathroom and bowel was not emptying the way it should, rib cage is going on the side of body noticed this thumping, lips were red, throat was red, been sick and just laying around, eyes were red was not recovered; while unknown for the other events. Information on the lot/batch number has been requested.
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| 70 | 2021-04-17 | malaise |
she ended up in the hospital her blood pressure was way up, it was at 188; pain in chest; feeling si...
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she ended up in the hospital her blood pressure was way up, it was at 188; pain in chest; feeling sick and stuff; on her right arm she has a hidden rash between her hand and her elbow; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EP6955), via an unspecified route of administration, administered in the left arm on 22Mar2021 at 16:00 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot number: EN6198) on 25Feb2021 at 15:00 on the left arm for COVID-19 immunization and reported that her blood pressure went sky high and it continued to be high and her heart rate was up and caused her to go to urgent care. The patient also previously received a flu vaccine on an unspecified date and her arm was sore for 3 weeks and she felt like she had the flu for 3 days. The patient reported that after she got her second vaccine she had the normal, what people call normal reaction, of feeling sick and stuff on 27Mar2021 then she ended up in the hospital her blood pressure was way up, it was at 188 and she forgets what the bottom number was. She went in because she felt like she was having a heart attack there was a pain in chest like right where the middle of a bra would be. It lasted about 15 or 20 minutes. That is her experience with the vaccine, it is raised blood pressure and she is still dealing with it her blood pressure is still high. She tries not to be scared but the doctors at the hospital made her a little nervous that is why she spent the night but that is a definite side effect. The patient was admitted to the hospital on 27Mar2021 and was discharged on 28Mar2021. They wanted to keep her for 2 nights and do a stress test and she said no way she is not staying for 3 nights in that hospital, the nurses were outstanding they were the most efficient nurses but the hospital food sucked and she got no sleep. Also, on her right arm she has a hidden rash between her hand and her elbow under the skin there is a rash that popped up with the vaccine on an unspecified date in Mar2021. The patient also stated that her blood type is O negative and she does not know she heard that O neg people weren't going to get COVID and she has never got COVID before. The patient also reported that they drew blood 6 times in the hospital to see if she had a heart attack and everything came back negative. it just so happens she had a echocardiogram the day after the first dose was given and her blood pressure was elevated that day but everything was fine. She says it is not relevant but she tested for that out of precaution, her doctor asked her to do that every 2 years and just so happened to fall on the day after the first dose. The patient received treatment for the events she ended up in the hospital her blood pressure was way up, it was at 188, felt like she was having a heart attack and pain in chest. The outcome of the event she ended up in the hospital her blood pressure was way up, it was at 188 was not recovered while the outcome of the other events was unknown.
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| 70 | 2021-04-20 | chills, fever |
lungs feel congested; Chest tightness; chills; fever; inflammation; This is a spontaneous report fro...
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lungs feel congested; Chest tightness; chills; fever; inflammation; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in Right arm on 03Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Asthma, hypertension, covid prior vaccination. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); montelukast sodium (SINGULAIR); losartan; HCTZ; unspecified product "D". The patient previously took erythromycin and experienced allergy. The patient received the first dose of bnt162b2, at the age of 70-year-old, via an unspecified route of administration, administered in right arm on 13Mar2021 11:00 as single dose for covid-19 immunization and experienced fatigue and sore arm. The patient experienced lungs feel congested, chest tightness on 04Apr2021 03:00; chills, fever and inflammation on 03Apr2021. Chills and fever Sat. night into Sunday, fever lasted until Monday 05Apr. Chest tightness, lungs feel congested. Went to doctor, he thought inflammation from vaccine. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received. The patient was not pregnant. The outcome of the events Fever was recovered on 05Apr2021, other events was recovering. Information on lot/batch number has been requested.
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| 70 | 2021-04-24 | fatigue |
My entire body experienced extremely severe body pain; I couldn't walk; rash; Very weak and tired; V...
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My entire body experienced extremely severe body pain; I couldn't walk; rash; Very weak and tired; Very weak and tired; This is a spontaneous report from a contactable consumer (reporting for herself). This 70-year-old female patient received first doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318) via an unspecified route of administration on left arm at a single dose on 04Feb2021 09:45 AM, for Covid-19 immunization. She Received second dose BNT162B2 (Pfizer Covid 19 vaccination, lot number EN6200) via an unspecified route of administration, on left arm at an single dose on 25Mar2021 for Covid-19 immunization. She was not pregnant at the time of vaccination. She had not received any other vaccine in four weeks. Medical history included type II diabetes, high blood pressure and pneumoconiosis. She was allergic to Chlorol Hydrate and Thimerasol. Concomitant medications included Metformin, Losartan HCTZ, Amlodipine, Zyrtec. On 09Mar2021 07:00 AM, the patient experienced a rash above her right knee, up my thigh, and knee pit, felt very weak and tired, her entire body experienced extremely severe body pain from upper neck down to feet. It got so bad that she could not walk, only took baby steps. It was stated that she would cry with hand on the wall with each baby step. On 12Mar2021, the patient went to the hospital emergency room and the patient was tested for Covid-19, blood test came out to be negative, results of SARS CoV-2, diagnostic radiologic EC EKG were unknown. She was treated with intravenous and pain medication. The outcome of the events of rash, felt very weak and tired, extremely severe body pain and could not walk was recovering. No follow-up attempts are needed. No further information is expected.
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| 70 | 2021-04-27 | headache, malaise |
feel strange; rash; throat is not closing; and it was itchy on her arm at the injection site; hard a...
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feel strange; rash; throat is not closing; and it was itchy on her arm at the injection site; hard and hot beside the site of injection; woke up this morning with a patch that was 1.5 wide by about 2 inches wide that was raised, red, hot to the touch, and it was itchy on her arm at the injection site; General malaise; Nausea; Headache; This is a spontaneous report from a contactable consumer (Patient). This 70-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZERBIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9262; Expiry date: unknown) via intramuscular route, administered in right arm as a single dose (at the age of 70-year-old) for COVID-19 immunization. The patients past medical history included Cesarean section (Had 3 of them. Caller said that did well with anesthesia and had no reactions), cataract removal (First was on 24Nov2020 and the second 01Dec2020. Caller said that did well with anesthesia and had no reactions), Hysterectomy (Caller said that did well with anesthesia and had no reactions), Foot surgery (Caller said that did well with anesthesia and had no reactions), cataract removal on 01Dec2020. The patient was allergic to Penicillin and tetracycline. The patient allergic to Keflex and had a rash. Tetracycline she had in her 30's got a shooting pain in her left arm and got another shooting pain in her left arm when she took tetracycline again. She had no other allergies aside from ragweed. She said that she had the Penicillin when she was a kid and Keflex as a young adult. Caller does not have the NDC, Lot, or expiration dates for the Penicillin, tetracycline, or Keflex. Lot: SBF021, exp:Aug2021. The only other time that this happened was 2 years ago when she got her flu shot and the year before that. The first year it was mild reaction and 2 years ago it was the size of a golf ball. This year she had nothing from the flu shot. She took Benadryl last night and was surprised when she saw that this morning. It usually wards off any allergy attack. She did not take a whole one and stated that it knocks her out so she only took a half. The patient said that she took a Advil every 4-6 hours and attributed the well being to that. The patients concomitant medications was not reported. The patient was calling about the COVID-19 Vaccine and said that she received the first shot on 20Jan2021. She said that everything had been fine until this morning and it had been 2 weeks. She had no sore arm. On 20Jan2021, patient experienced a headache for a minute for like 2 days. On 21Jan2021, she had nausea lasted a few minutes then it was gone. Caller said that her headache and nausea symptoms were so fleeting that she did not even report it. She said that it was so mild that it was almost insignificant it was so mild. She said that she did report it at the safety reporting system and at the (Website name) for the vaccination check in. One day on an unspecified date, she did feel strange and on 22Jan2021 she had general malaise, she just felt something was wrong and it lasted about 30 minutes. She said that it was a general feeling that she was not well. She said she took a Advil and ignored it. The patient clarified that last night she started scratching underneath her ear, thought she was going to have a break out, but on 04Feb2021, she woke up this morning with a patch that was 1.5 wide by about 2 inches wide that was raised, red, hot to the touch, and it was itchy on her arm at the injection site. She said that it is no where else, no else on her body. On an unknown date, she felt fine and her throat was not closing and she was not having any trouble breathing or anything. She stated that the spot under her ear was gone. She put Neosporin on it. It was gone this morning. She said that this place on her arm was more of a hard place and a rash now on an unspecified date. She knows the body remembers and years down the road you could get a pain from a injury or surgery. Last night she felt a sharp pain in her right arm. She ignored it and this morning she woke up with this. It is not as hot or red, but it is still raised. The clinical outcome for the events headache recovered on 21Jan2021, nausea recovered on 22Jan2021, general malaise was recovered on 23Jan2021. The outcome for woke up this morning with a patch that was 1.5 wide by about 2 inches wide that was raised, red, hot to the touch, and it was itchy on her arm at the injection site was recovering. The clinical outcome for the other events was unknown.
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| 70 | 2021-04-28 | fatigue, chills |
chills; feeling tired; This is a spontaneous report received by Pfizer from Company via product qual...
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chills; feeling tired; This is a spontaneous report received by Pfizer from Company via product quality complaint from a contactable other HCP reported for her mother-in-law (patient). A 70-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Mar2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chills, feeling tired on an unspecified date. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 70 | 2021-04-28 | headache |
Having headaches every day since this has happened; Had TIA (memory loss); Have no memory of 24 hour...
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Having headaches every day since this has happened; Had TIA (memory loss); Have no memory of 24 hours, could not answer any questions had lost memory; This is a spontaneous report from a contactable consumer (patent). A 70-years-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 04Mar2021 09:45; at the age of 70-years-old, (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient received the first dose of bnt162b2 on 02Feb2021. Medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medication included estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported. No Covid tested post vaccination performed. The patient experienced Transient ischaemic attack (TIA) on 13Mar2021 and was admitted to hospital, she could not answer to any questions and had lost memory. The patient had no memory of 24 hours, could not answer any questions had lost memory. She also complained headaches every day since this has happened (as reported). The reported events were headache (hospitalization, life threatening) on 13Mar2021 09:00 with outcome of recovered with sequelae, Transient ischaemic attack (hospitalization, life threatening) on 13Mar2021 09:00 with outcome of recovered with sequelae, Amnesia (have no memory of 24 hours), (hospitalization, life threatening) on 13Mar2021 09:00 with outcome of recovered with sequelae. Information on the lot/batch number has been requested.
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| 70 | 2021-05-04 | fatigue |
first dose, her blood pressure went sky high and it continued to be high; first dose, her heart rate...
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first dose, her blood pressure went sky high and it continued to be high; first dose, her heart rate was up; tired; Blood pressure continues to fluctuate daily; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient (age at vaccination: 70-year-old) received the first dose of bnt162b2 (BNT162B2, lot EN6198), via an unspecified route of administration in left arm, on 25Feb2021 16:00 as SINGLE DOSE for Covid-19 immunisation. Medical history was none. There were no concomitant medications. On 27Feb2021, her blood pressure went sky high and it continued to be high (reported as medically significant, disability) ending up in urgent care. She doubled her blood pressure medication which she did, she took Carvedilol and she could only take 2 of the double dose at night because she took 2 in the morning. On 27Feb2021, her heart rate was up (135) and felt tired. Her blood pressure continued to fluctuate daily (Feb2021). The patient underwent laboratory tests and procedures which included blood pressure measurement: high, 178/109, 168/98 on 25Feb2021, blood pressure measurement: went down to 60 on unknown date, blood test: negative on heart attack and everything came back negative, blood test: ok on 26Feb2021, blood test: ok on 27Feb2021, echocardiogram: ok, electrocardiogram: ok on 26Feb2021, electrocardiogram: ok on 27Feb2021 (all urgent care to check for blood enzyme for heart attack), heart rate: was up (135) on 25Feb2021. The outcome of the events was unknown. Information on the lot number was already obtained.
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| 70 | 2021-05-04 | headache |
I awoke at 3:15 am, with my face swollen, including eyes, cheeks, below jaw line and lips.; Minor he...
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I awoke at 3:15 am, with my face swollen, including eyes, cheeks, below jaw line and lips.; Minor headache; slight nausea; This is a spontaneous report received from a contactable consumer. A 70-year old-female patient received first dose of bnt162B2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EM9809) via an unspecified route of administration on left arm on 22Feb2021 at 21:00 as single dose for covid-19 immunization. Concomitant medications included: Calamine lotion, benefiber, calcium600/vitamin D. Medical history included allergies to Penicillin, statins, metals. The patient underwent lab tests and procedures, which included elbow replacement on an unspecified date in 2016. It was reported that 18 hours after injection, on 23Feb2021 at 3:15 am, patient woke up with face swollen, including eyes, cheeks, below jaw line and lips. There was no indication of swollen tongue, no difficulty breathing or swallowing. Minor headache and slight nausea. The adverse events required emergency room visit. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. Therapeutic measures were taken as a result of events and included treatment with: Benadryl, Famotidine. Outcome of the events was recovering
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| 70 | 2021-05-05 | dehydration |
Extreme dehydration; Nausea; Vomiting; Severe ataxia; mad global cortical atrophy; This is a spontan...
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Extreme dehydration; Nausea; Vomiting; Severe ataxia; mad global cortical atrophy; This is a spontaneous report from a contactable nurse (patient). A 70-year-old female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6207) at single dose, in the right arm, on 11Mar2021, for COVID-19 immunisation. Relevant medical history included Sjogren's disease form an unspecified date. The patient previously, on 18Feb2021, at 11:45 AM, at the age of 70 years, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6200) at single dose, in the left arm, for COVID-19 immunisation. On 24Feb2021, at 11:00 PM, the patient experienced an unspecified adverse event. Concomitant medications included levothyroxine 112 ug, from an unspecified date, for an unknown indication. On 16Mar2021, mad global cortical atrophy was reported. On 27Mar2021, the patient experienced extreme dehydration, nausea, vomiting and severe ataxia. Physician Office Visit and Emergency Room Visit were required. The patient received on 27Mar2021 normal saline (NS) 2L in ER over 2hr for extreme dehydration, nausea, vomiting and severe ataxia. Relevant laboratory tests included computerised tomogram (CT scan w/o contrast) on 12Mar2021: multifocal to confluent areas of decreased attenuation in the deep white matter ascending into the basal ganglia consistent with mod severe small vessel ischemic/degenerative finalizing; Magnetic resonance imaging head (MRI Brain w/o contrast) on 16Mar2021: no acute findings. Mad global cerebral atrophy and severe renascent small vessel ischemic white matter disease; MRI Neck on 16Mar2021: unremarkable and MRI Head w/o contrast on 18Mar2021: unremarkable. Clinical outcome of the events was unknown at time of this report.; Sender's Comments: Based on the information currently available causality between reported events and suspet product BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 70 | 2021-05-06 | cough |
Coughing; feeling dizzy and Lightheadedness; Weakness; Trouble Walking; This is a spontaneous report...
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Coughing; feeling dizzy and Lightheadedness; Weakness; Trouble Walking; This is a spontaneous report from a contactable consumer reporting for herself. A 70-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 11:40 (Batch/Lot Number: ER8733) as single dose for covid-19 immunisation (age at vaccination 70 years) . The patient medical history and concomitant medications were not reported. The patient experienced coughing on 27Mar2021 with outcome of recovered on the same day , feeling dizzy and lightheadedness on 27Mar2021 with outcome of recovered on the same day , weakness on 27Mar2021 with outcome of recovered on the same day, trouble walking on 27Mar2021 with outcome of recovered on the same day. Course of the event: The patient stated that five to seven minutes after the shot, she started coughing. She started talking to the nurse in the waiting room and she said lets have you sit down. The patient stated she then started feeling dizzy and lightheaded, and needed to lie down. They had no cots in the clinic, so she had to lie on the floor. The patient stated she had weakness and trouble walking. The patient stated this was all over in 3 hours and her family took her back to her care and she drove herself home. The patient stated she had a severe reaction to the first shot and the clinic refused to give her the second dose. No follow-up attempts are needed. No further information is expected.
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| 70 | 2021-05-07 | fever |
slight temperature of 99; kidney function sky rocketed/kidney function: 1.21/kidney function increas...
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slight temperature of 99; kidney function sky rocketed/kidney function: 1.21/kidney function increase; This is a spontaneous report received from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161), via an unspecified route of administration, on 12Apr2021, as single dose, for COVID-19 immunisation. Medical history included lymphoma (large b cell), chronic obstructive pulmonary disease (COPD), blood pressure high, chronic back pain, and allergy. Concomitant medications included loratadine taken for hypersensitivity; and paracetamol (TYLENOL) taken for an unspecified indication, both start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at age 70 years, via an unspecified route of administration, on 18Mar2021, for COVID-19 immunisation. It was reported that the patient received the second dose of 12Apr2021 and had very minimal reactions (unspecified), she felt fine. On 21Apr2021, the patient underwent blood work and showed that her kidney function sky rocketed or increased. Prior to the vaccine, her kidney function was great. She reported that her kidney function prior to the vaccine was 0.69 and it was 1.21 on 21Apr2021 (a week after the second vaccine). She also reported she had a slight temperature of 99 (unspecified date) and this was nothing bad. The outcome of the event "kidney function sky rocketed/kidney function: 1.21/kidney function increase" was not recovered, while slight temperature was unknown.
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| 70 | 2021-05-13 | sleepiness, headache, fatigue |
bumps on arms; Atypical Pneumonia; elevated heart rate; Headache; Sleepy; tired; This is a spontaneo...
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bumps on arms; Atypical Pneumonia; elevated heart rate; Headache; Sleepy; tired; This is a spontaneous report from a contactable consumer (reported on herself). A 70-year-old female patient received first dose of BNT162B2 (solution for injection, Lot number: EN6202 expiry date: unknown) via an unspecified route of administration in left arm on 02Mar2021, as a single dose of COVID-19 immunization. Medical history included COPD, Asthma: She had a cough for two years and had acid reflux which was when they diagnosed her with asthma, Coughing started 1-2 hours after that flu vaccine which she received in 2019, she did not have the NDC number, lot number, or expiration. The caller had not received a flu vaccine since. She was diagnosed with Lichen sclerosus 3 months prior to this report, pneumonia diagnosed 4 years prior to this report, and she believed it was autoimmune. Concomitant medication included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (Trelegy) inhaler dosage text: 1 inhalation a day, 200mcg been taking it a couple of months for asthma and COPD. On 02Mar2021, she had her vaccine in the morning and by the afternoon her heart rate was high at the appointment with her asthma doctor and her heart rate had been elevated ever since. She then noticed bumps on both of her arms when she was getting out of the bath. Her heart rate was still elevated so she went to the Emergency Room a day prior to this report and was diagnosed with atypical pneumonia. She had a headache, she took a Tylenol, and little bumps on both of her arms. The bumps did not itch, but they were still there. Her doctor put her on antibiotics (unspecified). The patient was she was tired and sleepy from the vaccine but did not feel quite so groggy. She did not feel good a week prior to this report, she thought it was something she ate, she was going to reschedule vaccine because of it. She had blood tests (unspecified) done a day prior to this report, in the Emergency Room and they all came out okay, she guessed. She did not have history of previous immunization with the Pfizer vaccine and was not administered additional vaccines on same date of the Pfizer Suspect. She did not have a family medical History relevant to events. The outcome of the events of atypical pneumonia, elevated heart rate, bumps on arms, and headache was not recovered, however the outcome of the events tired and sleepy was unknown. No further information was available.
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| 71 | 2021-01-05 | chills |
Abdominal pain, chills, n/v, dark urine, elevated LFT's, Bilirubin in urine. Patient currently admit...
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Abdominal pain, chills, n/v, dark urine, elevated LFT's, Bilirubin in urine. Patient currently admitted to hospital
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| 71 | 2021-01-06 | headache |
Headache began morning after vaccine was received. Improves with tylenol. Still having intermitten...
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Headache began morning after vaccine was received. Improves with tylenol. Still having intermittent headaches. Has followed up with her PCP.
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| 71 | 2021-01-07 | headache | Mild headache Mild body aches |
| 71 | 2021-01-09 | headache |
Three itchy vesicular lesions on upper left three days after vaccine lasting three days thus far. H...
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Three itchy vesicular lesions on upper left three days after vaccine lasting three days thus far. Headache first twenty four hours. Tylenol, Neosporin ointment, Cortisone cream, Anti-itch cream
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| 71 | 2021-01-10 | fatigue | Chest tightness, body aches, fatigue |
| 71 | 2021-01-12 | cough | Bad cough and explosive diahrea |
| 71 | 2021-01-13 | fatigue |
Patient presented to the COVID clinic today January 14, 2020 for her first COVID-19 vaccine. She wa...
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Patient presented to the COVID clinic today January 14, 2020 for her first COVID-19 vaccine. She was given 0.3 mls of the vaccine IM in the left deltoid.at 2:40 pm. She pulled around to the observation area and at 2:45 she reported that she was experiencing her lips tingling along with chest pressure and SOB. Spo2 was 96% on RA. Oxygen applied via face mask at 4 L.. Sp02 then went up to 99%. At 2:50 BP was 122/80. At this time she reports that the chest pressure has subsided but that she was still experiencing some fuzziness in her eyes. She denies any itching. At 2:53 she reports that her lips are not as numb but that she still has some fizziness. At 2:58 she reports that she feels "real tired" and that she is not as "fuzzy headed". Patient continued to improve. At 3:09 oxygen was removed. Sp02 stayed at 98%. After observing patient for several minutes she was found to be in stable condition to leave the observation unit. She was agreeable to this plan. She will notify her PCP with any further symptoms.
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| 71 | 2021-01-13 | fever, sweating, chills |
I woke in the middle of the night feeling achy and took a Tylenol. Felt feverish all day and took t...
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I woke in the middle of the night feeling achy and took a Tylenol. Felt feverish all day and took two more doses of Tylenol. Feverish enough that I stayed in bed all day. No headache next day still a feverish with chills but seem to sweat little and t goes away. Much better the third day.
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| 71 | 2021-01-14 | chills, headache |
Headache, vomiting, chills, dizziness 24 hour bed rest and Tylenol 1/15/2021, still light headed and...
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Headache, vomiting, chills, dizziness 24 hour bed rest and Tylenol 1/15/2021, still light headed and slightly dizzy
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| 71 | 2021-01-14 | chills |
chills; stomach cramps; watery diarrhea all day and through the evening; This is a spontaneous repor...
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chills; stomach cramps; watery diarrhea all day and through the evening; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EK9231 and expiry date unknown) via an unspecified route of administration in the left arm on 07Jan2021, 12:15PM at a single dose for COVID-19 immunization. The patient's medical history included allergy to scallops. Concomitant medications included metoprolol, omeprazole, simvastatin, magnesium chloride (SLOW MAG), and colecalciferol (VITAMIN D); patient also receive these medications within 2 weeks of vaccination. The patient had previous allergies with Erythromycin. The patient was not pregnant; did not receive any other vaccines within 4 weeks prior to BNT162B2; and was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On Sunday, 10Jan2021, 1200AM, reported as three days after vaccine, the patient developed chills, stomach cramps, and watery diarrhea all day and through the evening. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovering. The report was considered as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.
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| 71 | 2021-01-14 | fatigue | Sore arm, fatigue |
| 71 | 2021-01-14 | throat pain | Sore throat swollen lymph nodes on neck |
| 71 | 2021-01-15 | malaise |
1/15/2021, 8:15 AM Approx. 10 minutes after arising, experienced dizziness, nausea, unwell feeling,...
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1/15/2021, 8:15 AM Approx. 10 minutes after arising, experienced dizziness, nausea, unwell feeling, cold sweat. Lasted approx. 20 minutes. Resolved after lying down..
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| 71 | 2021-01-16 | chills, headache |
injection site redness and soreness, severe migraine headache, severe myalgia (even the tendons in m...
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injection site redness and soreness, severe migraine headache, severe myalgia (even the tendons in my hands and feet hurt), arthralgia, chills, rigors, swollen lymph nodes lasted two and a half days, mostly spent in bed
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| 71 | 2021-01-17 | fatigue, influenza like illness, sleepiness, malaise |
Qualifier: I don't know if this qualifies as an adverse event or not. I got the vaccine at 4:00 pm ...
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Qualifier: I don't know if this qualifies as an adverse event or not. I got the vaccine at 4:00 pm on 1/12/21. When I woke up on 1/13/21, I was very sick. I felt like I had a severe, very bad, horrible flu. I didn't get out of bed until 5pm that evening. No fever. No body or joint aches. Just extreme, overwhelming fatigue and feeling flu-y. This phase lasted about 24 hours. (my right am also hurt, but that was minor) I have a severe case of Sjogrens, a systemic autoimmune disorder. My most debilitating Sjogrens symptom is overwhelming fatigue. If I weren't retired, I would be qualified as disabled. Handicapped tag, etc. Since the vaccination, my Sjogrens has "flared." I feel terrible, exhausted, can't do anything. I have cancelled everything. All I can do is sleep, and feed the cat. I am directly connecting this Sjogrens flare to the vaccine. When I'm in a flare this bad, I usually take a course of prednisone. I have not done this because I don't want to modulate my immune system while it is building covid antibodies. I can't wait for the 2nd vaccine on 2/2/21!
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| 71 | 2021-01-17 | fever |
Patient received vaccination at 6:30PM and honked horn from parking lot at 6:45 PM. Patient appeared...
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Patient received vaccination at 6:30PM and honked horn from parking lot at 6:45 PM. Patient appeared to be short of breath, 911 called at 6:46 PM and EMS on scene at 6:48 PM. At this time, patient was short of breath and "lightheaded." Respirations, oxygen saturation, and heart rate were WNL. BP was elevated (200/110). After evaluation by EMS, patient was encouraged to go to hospital (though patient was not in acute distress per EMS team). Patient declined but said she would wait in parking lot for longer. At 7:15PM, patient honked horn again and said she still felt lightheaded and like she "had a fever." Patient agreed to be transferred to hospital for further evaluation, though she did not seem to be in respiratory distress at this time. Pt transferred to hospital by EMS team at 7:25 PM.
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| 71 | 2021-01-19 | fatigue |
Vomiting , diareeah, nauaea. lots of sinus drainage. overall tiredness. lasted a day . feeling bet...
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Vomiting , diareeah, nauaea. lots of sinus drainage. overall tiredness. lasted a day . feeling better but not 100%.
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| 71 | 2021-01-19 | fever | NECK AND BACK ACHE IN THE MORNING (1/19). FEVER 98.9. TOOK TYLENOL |
| 71 | 2021-01-20 | body temperature increased, fever, fatigue, chills, headache |
REC'D VACCINE ON 1-19-20. ON 1-20-21, STARTED WITH FEVER AND CHILLS. TEMP 101.1. TOOK TYLENOL. HAD S...
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REC'D VACCINE ON 1-19-20. ON 1-20-21, STARTED WITH FEVER AND CHILLS. TEMP 101.1. TOOK TYLENOL. HAD SORENESS AT IJECTION SIT, ALL OVER BODY ACHES AND JOINT DISCOMFORT. HEADACHE, SHIVERING, FATIGUE. ON 1-21-21, PATIENT STATES SHE HAS BEGUN TO FEEL BETTER. TEMP 98.8. STILL ACHY
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| 71 | 2021-01-20 | chills, headache |
couldn't remember passcode for the phone or her address; feeling heavy; chills; headache; This is a ...
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couldn't remember passcode for the phone or her address; feeling heavy; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration first dose on 10Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that after receiving her Covid19 vaccine on Sunday 10Jan2021, reports feeling "heavy", chills, and a headache on Sunday 10Jan2021. On 11Jan2021 Monday afternoon she reports that she "couldn't remember the 4-digit passcode to my phone" or her address, but that her memory came back "in a second". The event couldn't remember passcode for the phone or her address was reported as recovered and unknown for the other events. Information on the Lot/Batch number has been requested
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| 71 | 2021-01-20 | fatigue |
Arm, shoulder and lower back pain, bodyaches, diarrhea, nausea, vomiting, fatigue, weakness on day a...
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Arm, shoulder and lower back pain, bodyaches, diarrhea, nausea, vomiting, fatigue, weakness on day after vaccine; fatigue and weakness on day 2 after.
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| 71 | 2021-01-20 | fever, headache, fever, fatigue, fatigue, chills, chills, headache | 1/20/21 HA, fever, chills, fatigue, pain and swelling at site, nausea and diarrhea |
| 71 | 2021-01-21 | headache, fatigue | Headache Shortness of breath achiness tired |
| 71 | 2021-01-21 | lethargy, headache, fatigue |
Very tired after vaccination. Went to sleep about 8 PM Sat 1/16 and slept most of the next 4 days. ...
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Very tired after vaccination. Went to sleep about 8 PM Sat 1/16 and slept most of the next 4 days. Stomach was queasy. Unable to drink coffee. Tried to push fluids and tried to just eat bland foods. Would wake up sporadically but was unable to awaken enough to watch an entire TV show. Pretty lethargic and brain fog. Was able to wake up a little more on Wed 1/20 but still had the queasy stomach. Started getting Headache and Eye pain and severe upper leg and lower back burning & cramping, I tried taking tylenol which helped a little. By Thursday the pain was worse. I was still tired only walking helped the pain. It got worse if I sat down and extremely bad if I laid down to try to sleep. It's Friday morning & I am planning to go to med check this AM. Symptoms still ongoing
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| 71 | 2021-01-23 | fever, headache | Headache, Body aches, low grade temp. |
| 71 | 2021-01-24 | body temperature increased, chills, fatigue, headache |
Muscle in lower area of throat started to feel slightly tight. Could still breath and swallow. Sever...
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Muscle in lower area of throat started to feel slightly tight. Could still breath and swallow. Several staff members checked on me. Blood pressure top number was 175, ten minutes later it dropped to 155. Staff member stated my pulse was elevated. Although, I only felt the slight tightness in my throat. My oxygen level stayed at 98. They had me stay for an hour and then I went home. By then the tightness started to lessen. After an hour or two the feeling was total gone. My blood pressure had gone back to normal when I checked it at home. The next day at 2 pm [13 hours later] I had a temperature of 99.1, had the chills yet felt warm, started a slight headache and became very tired. At 2 am in the morning everything was over. I woke at my normal time and felt great. Have been doing well ever since.
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| 71 | 2021-01-24 | chills, fatigue, malaise |
Chills, aches, high blood pressure, heart racing, tired, flu sick feel, asthma Jan 14th, 2nd day: fa...
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Chills, aches, high blood pressure, heart racing, tired, flu sick feel, asthma Jan 14th, 2nd day: face swollen, blotchy, numb eyes swollen, sore sockets, upper lip puffed out, burning face feel, asthma
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| 71 | 2021-01-24 | headache, fatigue, fever |
Extremely unusual pain at injection site, (compared to any other past injections) generally achey, ...
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Extremely unusual pain at injection site, (compared to any other past injections) generally achey, headache, occasional waves of nausea, fever 100.4, fatigue (stayed in bed most of the day). There was one occasion where my left hand had a strange involuntary "twitch". I only mention that because on Saturday (1/23/21) i had a few episodes of speech difficulty (words "not coming out right")
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| 71 | 2021-01-24 | headache |
After receiving the first shot on Monday, I developed a headache and double vision on Tuesday night...
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After receiving the first shot on Monday, I developed a headache and double vision on Tuesday night. I consulted an ophthalmologist and I am awaiting the scheduling of an MRI. He could find no physical problem with either eye. The double vision persists. I realize this may be purely coincidental and unrelated to the vaccine, but I felt I should report it.
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| 71 | 2021-01-25 | fatigue, headache, sinus pain |
I am experiencing symptoms similar to that when I had Covid in October,2020. My head is aching, sin...
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I am experiencing symptoms similar to that when I had Covid in October,2020. My head is aching, sinuses aching and ears aching. I?m extremely tired but the pain keeps me from sleeping much.
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| 71 | 2021-01-25 | headache |
persistent headache; even touching her head hurts/hurts to the touch; with this shot her arm really ...
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persistent headache; even touching her head hurts/hurts to the touch; with this shot her arm really hurt when getting it/pain in the arm the shot was given/uncomfortable pain/in their arm after receiving the injection; insist on giving the next dose in 4 weeks; insist on giving the next dose in 4 weeks; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL1283) via an unspecified route of administration in the left upper arm on 06Jan2021 09:40 at a single dose as COVID vaccine. The patient had no medical history. Concomitant medications noted as on other medications but nothing new. She previously got the shingle shot for immunization then her arm hurt a few days. She had no other reaction to vaccines in the past. She received no vaccine on the day of or in the prior 4 weeks. Last Wednesday on 06Jan2021, the patient took the vaccine and has had a headache since; even touching her head hurts. She had a persistent headache that started the day after the vaccine and has continued since. The next day on 07Jan2021 was when the headache started. She took regular Motrin (lot OFE3249A, expiry: May2022) and Tylenol extra strength (lot: LMA051, expiry: Jul2019, perhaps not working anymore) sometimes but they didn't really seem to help. She felt the best when she was standing up or laying down, and she would rather be laying down. She asked "Is this a normal side effect, am I dying? I am not a headache kind of person, I take a Motrin, it goes away and I do not have one for months. It actually hurts to the touch." Should she be worried? She did call the clinic about the headache and was told if it got serious to go to the emergency room, she didn't think it was that serious. It was just persistent. She could leave with the pain if it kept her from getting COVID but the fact it was persistent worried her. It was also reported that on 06Jan2021 with this shot her arm really hurt when getting it and that day but that was all (pain in the arm the shot was given), the next night there was no pain. Her and her husband both oooo'd and ahhhh'd with the pain in the arm but that was it (a very uncomfortable pain they experienced in their arm after receiving the injection). She asked how long a side effect lasts after the vaccine? She also stated that on Jan2021, they insist on giving the next dose in 4 weeks. Asked if the vaccine was given a week later would the efficacy be lower? The outcome of persistent headache was not recovered; of vaccination site pain was recovered on 07Jan2021; and of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021036651 same reporter and drug, different patient and AE
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| 71 | 2021-01-25 | fever |
Nausea, low grade fever, oxygen fluctuating- dropping in 60s. She normally takes oxygen only at ni...
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Nausea, low grade fever, oxygen fluctuating- dropping in 60s. She normally takes oxygen only at night at 1L/hour. She went home from work today and placed her oxygen on at 1 L/hour, increased her prednisone to 20 mg daily from 10 mg daily and performed ipatroprium nebs three times daily.
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| 71 | 2021-01-26 | fatigue, fever, throat pain, nasal congestion | Mild fever, nausea headache, extreme fatigue, muscle ache, stuffy nose, sore throat, sore arm |
| 71 | 2021-01-26 | sweating, chills, malaise |
Nausea; Chills; Sweating; General unwell feeling; This is a spontaneous report from a contactable co...
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Nausea; Chills; Sweating; General unwell feeling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration at the right arm on 11Jan2021 13:45 at a single dose for covid-19 immunization. Medical history included allergic to shellfish and allergic reaction to bee sting 50 years ago. Concomitant medication included losartan potassium (strength: 100 mg) and atorvastatin calcium (ATORVA). The patient experienced nausea, chills, sweating and general unwell feeling on 13Jan2021 12:15. The patient took two paracetamol (TYLENOL) as treatment for the events. The patient was not pregnant at the time of administration. Outcome of events was recovering.
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| 71 | 2021-01-27 | chills, body temperature increased, malaise |
Chills began at 11:15p, by morning 1/27/2021 I had a fever of 101.1. Stiffness in joints, couldn't w...
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Chills began at 11:15p, by morning 1/27/2021 I had a fever of 101.1. Stiffness in joints, couldn't walk without losing balance in early a.m. No appetite. Vomited in early afternoon. Just a very sick feeling. Began feeling better during evening. Was just able to tolerate drinking water. Today (1/28)temp is 98.1. Feeling better, just a little weak.
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| 71 | 2021-01-27 | headache, fever |
Headache - still continuing; Felt fever - like - for 3 days; This is a spontaneous report from a con...
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Headache - still continuing; Felt fever - like - for 3 days; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received BNT162B2 (lot number: EL3246) via an unspecified route of administration on 11Jan2021 10:00 at single dose for COVID-19 immunisation. Medical history included controlled diabetes. The patient was allergic to Penicillin. Concomitant medication included metformin, atorvastatin (LIPITOR), lisinopril, and Multivitamin. On 11Jan2021, the patient experienced headache - still continuing, this is the 5th day after the vaccination. On 11Jan2021, the patient also had felt fever - like - for 3 days. The patient received Advil as treatment. The patient is not pregnant. Events outcome was not recovered.
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| 71 | 2021-01-27 | headache |
Right arm killing her through the night; Little Achy; Headache; This is a spontaneous report from a ...
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Right arm killing her through the night; Little Achy; Headache; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received bnt162b2 (BNT162B2 also reported as Pfizer COVID Vaccine, lot EL3247), intramuscular in the right arm on 13Jan2021 18:00 at SINGLE DOSE for Covid-19 immunisation (reported as prevention for age group). She received the vaccine in a hospital. Medical history included a Covid-19 patient on Mar2020, hypothyroidism and normally had headaches. No other vaccines taken prior to vaccination. There were no concomitant medications. On 13Jan2021 03:00, she had arm pain that was killing her through the night. She was a little achy, had a headache, but no fever. The outcome of events was recovering.
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| 71 | 2021-01-27 | headache |
tenderness on the left arm where she received the vaccine dose.; severe pain in right shoulder joint...
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tenderness on the left arm where she received the vaccine dose.; severe pain in right shoulder joint and right hip joint/It was so severe she could hardly get out of bed; Headache; This is a spontaneous report from a contactable nurse (patient). A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EJ1686, expiration date unspecified), via an unspecified route of administration on 31Dec2020 11:00 at single dose (left arm) for COVID-19 immunization. Medical history included arm soreness from flu shot 2-3 months ago. There were no concomitant medications. It was reported that she received her 1st dose of the vaccine on her left arm on 31Dec2020 as she works with elderly at nursing home and she was of age. Two days after her shot, on 02Jan2021, she experienced little headache which lasted all day but was gone by the following day. On 12Jan2021, 2 days ago, when she woke up and got of bed with severe pain in right shoulder joint and right hip joint which lasted for maybe 10 minutes. It was so severe she could hardly get out of bed. Currently, she had no joint pain. The right shoulder and right hip pain were so odd she thought, but it has also improved since. It's been 2 weeks and she never had this happen before. This lasted a little while, but thought it was from the cold weather since it's been 2 weeks since having the vaccine. She still has a bit of tenderness on the left arm where she received the vaccine dose on an unspecified date. She mentioned this to her supervisor and was encouraged to call and she wants to know if this could be a side effect. The patient had no vaccines the same day or 4 weeks prior. She had the flu shot before in past and the area would be sore for a few days, but now with this Covid vaccine this arm was still tender. Also, she had gotten the shingles shot the same day as the flu shot but that was about 2-3 months ago, at least 2 months ago. The patient had no additional vaccines administered on same date of the Covid vaccine. The patient had no prior vaccinations within 4 weeks prior to the first administration. Outcome of event headache was recovered on 03Jan2021; severe pain in right shoulder joint and right hip joint/it was so severe she could hardly get out of bed was recovered in Jan2021; and outcome of tenderness on the left arm where she received the vaccine dose was not recovered.
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| 71 | 2021-01-27 | influenza like illness |
Flu like symptoms; feeling achy; Left arm sore after second dose injection administered initially de...
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Flu like symptoms; feeling achy; Left arm sore after second dose injection administered initially described as at the injection site; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received second single dose of BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection, lot number: EK9231, exp date: Apr2021), via an unspecified route of administration (Injection to left upper arm ) on 13Jan2021 09:00 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first single dose of BNT162B2 (lot number: EK5730) on 23Dec2020 for COVID-19 immunization wherein she reported left arm sore after first dose injection administered which she recovered completely from after about 4 days (from 23Dec2020 to 27Dec2020). The patient called to ask if it was ok to take something like Ibuprofen or paracetamol (TYLENOL) after having been administered Pfizer COVID-19 Vaccine. She reported left arm sore after second dose injection administered on 13Jan2021 and flu like symptoms on an unspecified date. The left arm sore after first dose injection administered was same reaction she had following the second dose: Left arm sore after second dose injection administered initially described as at the injection site; very sore; her arm being much better since she slept all last night with ice pack on her left arm; but then specified that outcome of that event and flu like symptoms have remained persistent with on and off pattern; The flu like symptoms include feeling achy which started on 14Jan2021 (day of reporting). The outcome of events was not recovered.
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| 71 | 2021-01-27 | fever | FEVER AND BODY ACHES = 1 DAY |
| 71 | 2021-01-28 | headache, fever, chills, fatigue |
fever, chills, headache, muscle spasms, difficulty walking across the room, dizziness, fatigue, bra...
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fever, chills, headache, muscle spasms, difficulty walking across the room, dizziness, fatigue, brain fog
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| 71 | 2021-01-28 | headache | severe headache, rash on arms, face,neckline, throat, and hands |
| 71 | 2021-01-28 | throat pain | sore throat ear ache |
| 71 | 2021-01-29 | chills, fatigue, fever |
11 hours after injection SHAKING CHILLS, teeth chattering to the extreme. 101.5 fever throughout the...
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11 hours after injection SHAKING CHILLS, teeth chattering to the extreme. 101.5 fever throughout the night. Fatigue
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| 71 | 2021-01-29 | fatigue, fever |
FEVER, FATIGUE AND DIARHEA I TOOK TYLENOL AND RESTED FOR 36 HOURS FEVER AND FATIGUE BOTH WENT AWAY ...
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FEVER, FATIGUE AND DIARHEA I TOOK TYLENOL AND RESTED FOR 36 HOURS FEVER AND FATIGUE BOTH WENT AWAY STILL HAVE MINOR DIARHEA OCCASIONALLY
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| 71 | 2021-01-29 | fever, fatigue |
The day after vaccination, I was extremely tired and had a low-grade fever (99.1 F). My muscles ach...
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The day after vaccination, I was extremely tired and had a low-grade fever (99.1 F). My muscles ached all over. I could not get out of bed until 5:00 pm. After that, I was able to do my chores (laundry and washing dishes). I was fine the following day.
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| 71 | 2021-01-29 | throat irritation |
Pt received Covid-19 vaccine at 4:50 pm. patient's daughter, informed observer that her mother has...
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Pt received Covid-19 vaccine at 4:50 pm. patient's daughter, informed observer that her mother has complaints of her face feeling warm and itchy and a scratchy throat. Assessment completed by Dr., daughter to translate due to patient speaking limited English . 50 mg of Benadryl administered orally at 5:05pm. Reassessment completed at , 5:18 PM, face appears to be more reddened and facial swelling noted. Daughter also stated that her mother's voice is becoming hoarse. 125 mg of solumedrol given IM by, RN. at 5:20pm. Patient reassessed at 5:40PM, facial swelling and redness improving. Daughter states that mother 's voice is returning back to normal. and stated that the patient has informed her that she is feeling better. Patient discharged by Dr. at 5:43 PM at daughters request, stating that she will be monitoring her all night and will take her to the ER if symptoms return or worsen.
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| 71 | 2021-01-30 | fatigue, lethargy, chills |
This was my second dose. After the first dose, I only had a sore arm. This time, about 12 hours afte...
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This was my second dose. After the first dose, I only had a sore arm. This time, about 12 hours after receiving the shot, I began to feel aches and pains (like a cold was coming on). During the night I had some chills and the next day I was very achy and very tired. I napped about 4 hours during the day and was asleep by 8p.m. and slept for 12 hours. The next day (second day after the shot), the aches receded but I was still very lethargic for about another 8 hours. I began to feel 'normal' by evening and am felling OK today (third day after the shot). I did drink a lot of water during the whole time as I felt very thirsty (and I am normally a big water drinker!) I also had no appetite until this morning.
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| 71 | 2021-01-30 | fatigue |
several unusual symptoms started 6 days after immunization: sudden, painful outbreak of cold sores, ...
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several unusual symptoms started 6 days after immunization: sudden, painful outbreak of cold sores, stiff, not painful joints, tiredness, and (the most unusual) is an elevation of my blood glucose to at and above 180 for about 24 hours (I have used a continuous glucose monitor for the past 7 months and have learned food/body responses and usually drop into the 120 range over night. i have daily graphs for the time represented here). No treatment except caution on food and continued regular medications, outcome. All these symptoms stopped about 48 hours later on Saturday, Jan 30, 2021. I am reporting for information only regarding this new vaccine. I intend to take my second, booster dose in the regular 3 week interval. Did not consult physician nor clinic.
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| 71 | 2021-01-30 | headache, fatigue |
Very fluish- aches, pains, very bad headache, couldn't get out of bed for 36 hours. After 48 hours ...
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Very fluish- aches, pains, very bad headache, couldn't get out of bed for 36 hours. After 48 hours I am just very tired and having sporadic shooting pains in my head.
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| 71 | 2021-01-30 | headache |
Severe head pain, not a headache, severe throbbing searing pain in the head, causing nausea still pr...
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Severe head pain, not a headache, severe throbbing searing pain in the head, causing nausea still present 14 hours after the head pain started
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| 71 | 2021-01-31 | headache, fever | Fever, headache, upset stomach |
| 71 | 2021-01-31 | sinus pain, malaise, headache, fever |
nauseous; threw up all day; heart races a little bit in the middle of the night/her heart also went ...
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nauseous; threw up all day; heart races a little bit in the middle of the night/her heart also went racing a few times in the night; sinus pain; dizziness/like she was not dizzy today like she was yesterday, but today she was just more like lightheaded; Low grade fever; feeling sick/doesn't feel good; head hurts really bad/terrible headache; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EH9899, expiration date Mar2021) via an unspecified route of administration on 09Jan2021 at a 0.3mL via injection into the left arm for covid-19 immunization. The patient stated that she had Type 2 diabetes which diagnosed about 10 years ago and high blood pressure diagnosed about 20 years ago, so her providers office sent her a text saying the doctor wanted her to have the vaccine. She confirmed that she had no other vaccines on the same day as the COVID vaccine. The patient stated that she had high cholesterol about 5 years ago and her doctor initially put her on Lipitor, but she got to a point where she could not walk, so her doctor put her on something else, but she could not tolerate that either, so then she was switched to the Pitavastatin Calcium. The patient stated that she also had a very sensitive stomach, but she cannot think of the name of what she was diagnosed with because since she had her a couple of seizures started about two years ago this upcoming Aug, she can't think straight. The patient also had GERD about 5 years ago, macular degenerative disease a couple of months ago. All medical condition was still ongoing. Current concomitant medications included levetiracetam (KEPPRA, Tablet) 500mg, once daily, by mouth started from about two years ago, this upcoming Aug for seizures; metformin 1000mg, two tablets daily, by mouth started from about 10 years ago for Type 2 diabetes; allopurinol Tablet 300mg, once daily, by mouth started from probably 2 or 3 years ago for her kidney; metoprolol tartrate (LOPRESSOR, Tablet) 50mg, once daily, by mouth started from 2 years ago for high blood pressure; empagliflozin (Jardiance, Tablet) 25mg, once daily, by mouth has been on this product about 6 months for Type 2 diabetes; lisinopril Tablet 40mg, once daily, by mouth started from probably about 10 years ago for high blood pressure; diltiazem hydrochloride (CARDIZEM CD, 24 hour Capsule) 180mg, once daily, by mouth started from a couple years ago; omeprazole magnesium (Prilosec, Capsule) 20mg, once daily, by mouth started from probably about 4 years ago for GERD; hydrochlorothiazide Tablet 25mg, once daily, by mouth started probably about 10 years ago for high blood pressure; Vitamin D 125mcg or 5000unit Tablet, once daily, by mouth as Vitamin supplementation started taking this about a year ago. The patient had a blood test where her Vitamin D was a little low. Vitamin C was got it over the counter; PreserVision OTC medication, with Vitamin A, E, C, zinc and copper Two capsules by mouth daily started from about two months ago for macular degenerative disease; pitavastatin calcium Tablet 2mg, once nightly, by mouth for High cholesterol; it was on it before, but started back on it a couple months ago. The patient reported she doesn't feel good and got headache on 11Jan2021, had dizziness and low grade fever on 15Jan2021, had nausea and threw up, sinus pain and heart races a little bit on 17Jan2021. She did not want to go through this again. The patient stated that she had the first shot of the Pfizer COVID Vaccine on 09Jan2021. She felt for a day and a half by Monday, 11Jan2021, she has been sick ever since, she did not feel good at all. She had a terrible headache, and for probably one or two days, she ran a low-grade fever. Her headache was still ongoing, but it had eased up because she was taking Tylenol. The patient stated that the dizziness she had, caused her to be nauseous and she threw up all day yesterday. She tried to eat something today and she was just having bad problems with feeling sick all the time. She asked if there are recommendations for getting the second shot after having symptoms like this. Today is the third day that she had been feeling the dizziness and it had improved a little, like she was not dizzy today like she was yesterday, but today she was just more like lightheaded. The patient reported that the nausea was ongoing, she felt like she was going to get like today like she did yesterday. She did not think she still has a low grade fever, she probably had the low grade fever on 15 and 16Jan2021. She just can't seem to shake not feeling good. At first that it was her sinuses because that was where her head was hurting, but then the sinus pain went away but she still had a headache. The patient stated that her heart also went racing a few times in the night. Yesterday was a bad day, but today she was a little bit lightheaded. She tried to eat some toast today, so she will see if she can keep that down. The outcome of the events headache, dizziness, heart rate increased and sinus pain was recovering and the low grade fever was recovered on 17Jan2021 and other events was not recovered.
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| 71 | 2021-01-31 | sneezing, fatigue, malaise |
dizzyish or light headed; didn't feel good/she felt crappy; Sneezing; a little tired/she felt more t...
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dizzyish or light headed; didn't feel good/she felt crappy; Sneezing; a little tired/she felt more tired/very, very tired; This is a spontaneous report from a contactable Nurse (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EL0142) via an unspecified route of administration on to left deltoid on 12Jan2021 at a single dose for covid-19 immunization. The patient said her asthma was very mild, she rarely got sick, she did not know if it would flare if she had COVID, it was diagnosed in childhood. She said she hardly ever had to use her inhaler. Besides, she took a blood pressure medication, but her blood pressure was not high, it was very well controlled, it was not horribly high, she took the medication to keep it down. She said this was diagnosed 5-7 years ago. She did not have diabetes or any ongoing issues. She said she had no other recent vaccinations and has started no new medications. The patient said her side effects that started Thursday and she didn't feel good, she was sneezing, she didn't feel herself, and felt off. She said that there was nothing bad, she was a little tired. She said Friday was worse, she felt more tired, and dizzyish or light headed. She said she was very, very tired, but she never had arm soreness, never horribly sore, not much, she never had any other aches or pains, no fever. She said Friday she didn't feel good at all, she felt crappy, and she took care of her father who is 104, so she can't take a day off. She said that on Saturday she felt ok, she didn't feel great, but nothing ever got to the point she was incapacitated. She said on Sunday she felt better, not 100%, her nose was not as stuffy. She said today she felt pretty good or close to normal, she was still dizzy, but not like the room spins. She said she felt mostly better, and had a lot more energy today, she was not as exhausted. She said that she felt so much better than she was feeling, she was getting better, she was worried when she took second shot. She initially said she did not do treatment for her side effects, then said she took some things since she knew about herself, and when she felt run down, and she didn't think she has had a cold in 2-3 years, she didn't get sick often. She said for her body she knows when she felt run down with aches and pains to certain parts of her body that she didn't feel well, then she might be getting sick/rundown. The patient took Tylenol or Advil for it when she felt more uncomfortable. For Advil (LOT: R77223, EXP: Sep2022), she said she took 200mg, two by mouth as needed, she only took 4 in a 24-hour period. She said if she took it or anytime she took anything, if she took Advil it would be 8-10 hours later, and if she took Tylenol the same day, she never took anything every four hours. For Tylenol (LOT SEA054, EXP Mar2024), she said the Tylenol are 325mg each tablet, so she 650mg when she took this because she took two of them. She said she let 8 hours go between doses, if she felt she needed something again, like if she was not comfortable. She said she didn't feel this where the achy places she aches, she also took when she went to bed at night if she needed to, but she was completely functional and not laying around in bed. She said she got her first dose on 12Jan, and she was supposed to get her second dose on the 02Feb. The patient said she felt it was not serious, but she was concerned about getting the second dose. The patient said her labs are normal, she was scheduled for some the same day as the next time she got the shot, when she was supposed to get labs. The patient said that she called because the side effects usually are supposed to be closer to injection date, it was 72 hours post, and the first couple of days there was nothing. She said she would like an opinion of whether someone thought it was ok to get a second shot. The outcome of the events recovering.
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| 71 | 2021-01-31 | sleepiness |
Client stated, "I feel very sleepy." Spouse reported hat client was lightheaded and dizzy. Fire Re...
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Client stated, "I feel very sleepy." Spouse reported hat client was lightheaded and dizzy. Fire Rescue attended to client on site. Released home with her spouse awake, alert and verbally responsive.
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| 71 | 2021-02-01 | headache |
Moderate to severe headache for 5 days. Consulted PCP on 6th day. Ibuprofen in beginning, then PC...
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Moderate to severe headache for 5 days. Consulted PCP on 6th day. Ibuprofen in beginning, then PCP indicated to switch to Tylenol (which I did)
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| 71 | 2021-02-01 | fever | Fever 100.4 |
| 71 | 2021-02-02 | headache, fever, chills, cough, fatigue |
about 30 minutes after shot was having extreme fatigued to the point i had to go home and lay down....
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about 30 minutes after shot was having extreme fatigued to the point i had to go home and lay down. Bad head ache, chills, upset stomach, Fever of 100.0, extreme soreness at the shot site. A little bit of a cough and stuffy nose. lasted about 3 days. the headache is still lingering.
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| 71 | 2021-02-02 | headache | Left swollen shoulder and arm much above the elbow, continuing to hand and fingers Headache, nausea |
| 71 | 2021-02-02 | fever, headache |
The next day I woke up with severe muscular pain and joint pain, fever of 100 degrees, dizziness, he...
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The next day I woke up with severe muscular pain and joint pain, fever of 100 degrees, dizziness, headache, appetite loss. Took 2 Tylenol and it improved. 6 hours later I took another 2 Tylenol because the headache came back strong. I sleep a couple of times during the day, and also slept well during the night. The next day felt a little bit better but still in bed, but was able to eat better. The next day went to the Dr. and he prescribed me Meloxicam and 6 hour later Tylenol, after that is getting better.
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| 71 | 2021-02-02 | sleepiness, headache |
Pt noted after approx 15 minutes a tingling/burning sensation of tongue At 4:45 pm. No associated ...
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Pt noted after approx 15 minutes a tingling/burning sensation of tongue At 4:45 pm. No associated SOB, facial swelling. She does have prior anaphylaxis reaction to pineapples for which she carries and epi Pen but has never needed to use. Cardiac exam RRR Lungs CTA bilat HEENT, no visible erythema of face or tongue and no noteable facial swelling She was agreeable to 25 mg dose of diphenhydramine and another 15 minute observation. During this time, she began to feel anxious and a mild headache. Vitals at that time were notable for bp 178/81, HR 101 and o2 sat 98%. Still no SOB, facial swelling or other new complaint. She felt improvement in anxiety within 5 minutes, and repeat vitals in 10 min with BP 152/83, HR 89 and O2 sats 96% She still continued with mild sensation change of tongue, but no facial swelling. She does have benedryl at home but I also sent her home with additional 25 mg dose in case she noted recurrent symptoms on the way home . She understands to seek emergency care with any worsening symptoms, or new SOB or facial swelling. She can also use her EPI pen if needed. She felt comfortable returning home- husband picked her up. I will call her to check in this evening and in the morning and will provide updated recommendations regarding second dose of vaccination. I spoke with patient at 8:09 pm - she was at home- feeling much better, however, she did take the second diphenhydramine on the way home, as she began to feel she was having some swelling between her eyes. No SOB Or trouble swallowing. This improved with the second benedryl and has not recurred. She will take an additional 50 mg benedryl before bed, and then she awakes before 6 am- if she has any residual symptoms she will take another dose. Again, she understands to seek emergency care with any worsening symptoms, or new SOB or facial swelling. She can also use her EPI pen if needed. She felt comfortable with this plan. We also reviewed current CDC guidelines and she understands at this time we would not recommend she receive the second Vaccination. She will continue to follow CDC in the event that this recommendation changes. I will submit a VAERS report after following up with her in the morning. ADDENDUM 2/3/21: I spoke with patient again on 2/3/21 at 07:45 am. She is feeling almost completely back to baseline this morning, but planning to take 25 mg diphenhydramine this morning as well. She does note mild headache, which is not abnormal for her. No residual tongue sensitivity or facial swelling. She noted that when she got home last night, she felt very sleepy and sedated from the diphenhydramine and went to bed, and did not take an additional dose of diphenhydramine last night. No SOB, trouble swallowing or any new complaint. No urticaria or itching. We reviewed current CDC recommendations to decline second vaccination given her moderate severe allergic symptoms within first 4 hours of first vaccination. She will follow up with PCP or kidney specialist if she has any continued concern with ongoing symptoms or new issues. She was very appreciative of the followup and care provided.
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| 71 | 2021-02-03 | chills, fever |
Fever 103.6F with chills; Fever 103.6F with chills; Vomiting; This is a spontaneous report from a co...
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Fever 103.6F with chills; Fever 103.6F with chills; Vomiting; This is a spontaneous report from a contactable other healthcare professional reporting for a patient. A 71-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, via an unspecified route of administration on 19Jan2021 at 11:15 (at the age of 71 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included hypertension, seizures, hypothyroid, and attention deficit disorder all from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication names were not reported, but it was reported that she used other medications in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination, The vaccine was given at a Nursing Home/Senior Living Facility. On 20Jan2021 at 12:00AM, the patient experienced fever 103.6F with chills, and vomiting. The patient received treatment of Tylenol 1gm once only for fever and chills. The clinical outcome of fever 103.6F with chills, and vomiting was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 71 | 2021-02-03 | cough, headache, fever, respiratory tract congestion, fatigue |
Fever from 99 to 101.2 the 2nd 24 hrs. Headache neck ache severe fatigue and increased coughing and ...
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Fever from 99 to 101.2 the 2nd 24 hrs. Headache neck ache severe fatigue and increased coughing and congestion
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| 71 | 2021-02-03 | fatigue, chills, headache |
My first dose I woke up in the morning really tired, chills, muscle aches and a headache, that laste...
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My first dose I woke up in the morning really tired, chills, muscle aches and a headache, that lasted all day and next day was a fine. No medication needed. I also noticed knee pain in both knees mainly when I am moving around. I was not having that problem before the vaccine.
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| 71 | 2021-02-03 | fatigue |
I am kind of tired; Redness and little bit of swelling, a patch that is getting bigger just below th...
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I am kind of tired; Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was; Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was; Pain; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: GL1283, on 15Jan2021 at 10 AM at single dose for COVID-19 immunization. The patient had some medical history, but not reported. Concomitant medications were not reported. Patient stated, she received her second dose of the COVID Pfizer vaccine (COVID 19 Vaccine) on Friday at 10 AM and usual it pained next day (16Jan2021) but they went away by the end of the day. However, she noticed that yesterday (17Jan2021) and today (18Jan2021) there was redness and little bit of swelling, a patch that was getting bigger just below the site where the injection was made. Yesterday it was smaller. Today the part was larger and little bit swollen So she thought she better see what's going on. Patient stated she was kind of tired. She was old. For treatment, the patient went to the drug store today and got some Benadryl. So, she took two Benadryl tablets at about three hours prior to the report and it hadn't effected it one way or the other. The patient didn't have any lab test. Patient's height was 5'5 and three quarters. The outcome of the events "Pain" and "Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was" was not recovered at the time of report. The outcome of tired was unknown.
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| 71 | 2021-02-03 | headache |
Within 15-minutes of vaccination, the patient reported a headache and feeling nauseous. EMS managed ...
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Within 15-minutes of vaccination, the patient reported a headache and feeling nauseous. EMS managed the patient's condition on-site.
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| 71 | 2021-02-03 | fever, chills |
Shortness of breath requiring 911 call. Also fever, chills/cold feet, new onset diarrhea and cramps,...
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Shortness of breath requiring 911 call. Also fever, chills/cold feet, new onset diarrhea and cramps, severe weakness.
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| 71 | 2021-02-03 | fever, headache, chills |
In the middle of the night about 2AM in the morning I started feeling nauseated and vomited and then...
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In the middle of the night about 2AM in the morning I started feeling nauseated and vomited and then noticed I had chills. Probably after 8AM I took my temp and I had a fever (102F) for about 10 hours. Started aching all over, joint and muscle aches, I also had headache (took Motrin and headache went away), no pain at the injection site. Almost like I had flu symptoms. I felt miserable all day but next day when I woke up I was fine. Went to work as normal the next day. I forgot to state I had COVID in March 2020 and the symptoms I had felt very much like it.
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| 71 | 2021-02-03 | fever, malaise, influenza like illness, chills |
Where the injection was given is real sore; Chills; Muscle pain; Joint pain; Fever; Nauseated; shaki...
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Where the injection was given is real sore; Chills; Muscle pain; Joint pain; Fever; Nauseated; shaking really hard; feeling unwell; still cold; Just like when one catches the flu, all the symptoms came at one time; It was so stiff one time; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EK01231), via intramuscular route on the left arm on 19Jan2021 12:11 as a single dose for COVID-19 immunization. Medical history included stomach issues, two stents, pacemaker, asthma that turned into bronchitis. Historical vaccine data included the pneumococcal 13-valent conjugate vaccine (PREVNAR 13) first dose in "September" and the second Pneumonia shot on 11Jan2021, second dose, on the right arm within 4 weeks prior to the COVID vaccine. Concomitant medication included ongoing prasugrel for blood thinner. On 20Jan2021 03:00, the patient experienced really heavy chills, she was shaking really hard, she had muscle pain like the flu, joint pain, fever that started at 100.6 degrees Fahrenheit and worsened to 101.6 degrees Fahrenheit, nauseated, feeling unwell. The caller clarifies that all of the symptoms came on at once, around 3am. Just like when one catches the flu, all the symptoms came at one time. The patient reported that it felt like she had the virus (not specified) all over again. The chills had calmed down, but she was still cold. Where the injection was given it was real sore. She had been doing arm circles and such to keep her muscles loosened up. It was so stiff at one time last night (20Jan2021) that she thought, she could not move it. The clinical outcome of events chills was recovering; muscle pain, fever, nauseated, still cold was not recovered; joint pain, shaking really hard, feeling unwell, vaccination site pain, stiff, flu like symptoms was unknown.
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| 71 | 2021-02-04 | chills, headache, fatigue |
about 14 hrs after receiving the second vaccine I had extreme chills, severe body aches and headach...
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about 14 hrs after receiving the second vaccine I had extreme chills, severe body aches and headache, pain in my eyes, moderate arm pain and fatigue. I began feeling better about 10 hrs later but continued to feel fatigued the rest of the day and had body and head ache a couple more days. I had had covid in Sept 2020 and felt worse those 10 hrs than when I had covid.
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| 71 | 2021-02-04 | chills, fever, nasopharyngitis, headache, cough |
cough; injection site pain; headache; muscle pains; joint pain; fever, but not a high fever; nausea;...
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cough; injection site pain; headache; muscle pains; joint pain; fever, but not a high fever; nausea; feeling freezing cold; chills; ache; cold; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), via an unspecified route of administration at left arm on 19Jan2021 08:15 at a single dose for COVID-19 immunization. She was sick (COVID symptoms) all Dec2020 when she was with her sister who had COVID-19. She does not know for sure that she had COVID 19 because she was never tested. She recovered from that illness about two weeks before getting the Pfizer COVID 19 vaccine first dose. The cough was all gone before she had the Pfizer COVID 19 vaccine. No prior vaccinations (within 4 weeks). There were no concomitant medications. The patient had the vaccine on 19Jan2021, two days ago and had not had a problem. She left there and went to the gym for 1 hour afterwards. Then yesterday morning she woke up and has been sick ever since with a cough and chills. She never tested positive for COVID but she was with her sister who had it during Dec2020. She had a cough similar to the one she had in Dec2020 when she was quarantined for COVID symptoms. She was not expecting anything, but it says you can have side effects if you have had COVID-19 so she was calling in about that. On 20Jan2021 she woke up at 02:00 in the morning with a cough; injection site pain which was not sore before; headache; muscle pains, chills; joint pain; fever, but not a high fever; feeling freezing cold; and nausea. She reported 'cold, chills, fever, ache'. She felt a little bit better today on 21Jan2021. She was scheduled to receive the second dose on 15Feb2021 at 08:15. The patient would like to know whether her history of COVID symptoms from Dec2020 may have aggravated her post-vaccination symptoms. The patient would like to know whether there have been other reports of similar post-vaccination as hers. The outcome of the events cough, injection site pain, headache, fever and feeling freezing cold was recovering; event muscle pain, joint pain and nausea was not recovered; event chills was recovered on 21Jan2021; and unknown for the other events.
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| 71 | 2021-02-04 | fatigue, chills |
Chills, muscle and joint pain, and fatigue from 11:00am. Till 5:00pm the day following the injectio...
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Chills, muscle and joint pain, and fatigue from 11:00am. Till 5:00pm the day following the injection
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| 71 | 2021-02-04 | fatigue |
Fatigue swelling of Right Ear internally, painful to the touch Sores in front of mouth, starting on ...
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Fatigue swelling of Right Ear internally, painful to the touch Sores in front of mouth, starting on right side (like a canker sore)
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| 71 | 2021-02-04 | headache, chills, fatigue |
Headache, tiredness, muscle pain, chills, joint pain, soreness at injection site and nausea caused ...
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Headache, tiredness, muscle pain, chills, joint pain, soreness at injection site and nausea caused from the really bad headache.
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| 71 | 2021-02-04 | headache, fever | Fever 99.8-100.8, headache. |
| 71 | 2021-02-04 | fever, fatigue, chills | Nausea, vomiting, fever, chills, fatigue, body ache, stomache upset |
| 71 | 2021-02-05 | fatigue |
Muscle aches and sore left arm in the evening, trouble sleeping that night. Next morning, light head...
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Muscle aches and sore left arm in the evening, trouble sleeping that night. Next morning, light headed, extremely tired, sore arm, joint aches Spent the morning in bed and the afternoon on the couch. Temp 99.8 Took tylenol several times during the day and that night. By the following morning most of the symptoms had disappeared with a moderately sore left arm still present.
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| 71 | 2021-02-05 | malaise |
Within 6 minutes of infection had lightheadedness & difficulty breathing. This was followed by red ...
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Within 6 minutes of infection had lightheadedness & difficulty breathing. This was followed by red flushing to the skin on the face and left neck, shoulder & hip pain. BP initially was 182/98 which is elevated for me. Felt disoriented & very unwell. Over the next few days, low BP was noted @90/62, pulse 58. This occurred intermittently.
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| 71 | 2021-02-06 | headache, fever | Mild site pain, headache, joint pain and fever |
| 71 | 2021-02-07 | chills, fatigue, fever, headache |
Swelling at site of shot, tiredness, headache, muscle pain, chills, joint pain, fever, swollen lym...
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Swelling at site of shot, tiredness, headache, muscle pain, chills, joint pain, fever, swollen lymph nodes. Gout flare up. Began 29 hours after injection with chills and fatigue followed by fever, etc. Lasted until next morning (47 hours after shot) with just a remaining headache.
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| 71 | 2021-02-07 | chills, fever, malaise, headache, fatigue |
The morning following the vaccine, she had a fever, chills, felt really sick. Also had a headache, ...
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The morning following the vaccine, she had a fever, chills, felt really sick. Also had a headache, a lot of muscle and joint pain. She was nauseous, no appetite, and abdominal pain. Very tired as well. She did not take anything for it, just slept and by the morning of 2/6/21 was still tired, but not sick anymore and able to eat some, was not able to prior to this.
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| 71 | 2021-02-07 | fatigue, headache, fever |
10:45 a.m. Fatigue 12::00 pm headache 2:00 pm achy joints 5:00 p.m. took one Tylenol Rapid Release 5...
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10:45 a.m. Fatigue 12::00 pm headache 2:00 pm achy joints 5:00 p.m. took one Tylenol Rapid Release 500mg 9:00 p.m. low grade fever 99.8 10:00 p.m. took two Tylenol Rapid Release 500mg 3:00 a.m. awoke, joint pain all joints, low grade fever and headache took two Tylenol Rapid Release 500mg 9:00 a.m. awoke, fever gone temperature normal, headache, achy joints continued throughout the day 7:00 p.m. headache subsided 10:00 p.m. less fatigue but still achy joints Took two Tylenol Rapid Release 500mg 1/18/2021 9:00 a.m. awoke feeling normal
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| 71 | 2021-02-07 | headache | 2 |
| 71 | 2021-02-07 | headache |
APRN was notified of possible reaction to COVID-19 vaccine (lot # EN9581, exp. 5/31/21) at 2:18 pm. ...
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APRN was notified of possible reaction to COVID-19 vaccine (lot # EN9581, exp. 5/31/21) at 2:18 pm. Patient initially complained of tongue pain and a headache; she then began to develop throat tightness and her voice began to change and she began to clear her throat and developed a "tingling" sensation. EMS was called at 2:25pm. First dose of epinephrine 0.5mg was administered IM right anterolateral thigh at 2:25pm, the sensation of her throat closing persisted at 2:30pm and another dose was administered of epinephrine 0.5mg was administered IM left anterolateral thigh at 2:30pm. EMS arrived and patient left in ambulance at 2:35pm. Vitals: 2:20 pm BP 110/64 HR 85 O2 sat 97% 2:25 pm BP 102/64 HR 93 O2 sat 95% 2:30 pm BP 112/60 HR 87 O2 sat 95% 2:32 pm BP 120/82 HR 90 O2 sat 98%
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| 71 | 2021-02-07 | fever, headache, chills |
Slight swelling , tenderness and redness at site. Fever of 102.9, severe chills, severe aching from ...
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Slight swelling , tenderness and redness at site. Fever of 102.9, severe chills, severe aching from top of legs down, headache but not quite as severe as when hospitalized last year. All symptoms resolved within approx. 20 hours except for the arm site.
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| 71 | 2021-02-08 | chills, headache |
She confirms the rash started after receiving the covid vaccine/terrible rash is up and down both ar...
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She confirms the rash started after receiving the covid vaccine/terrible rash is up and down both arms, the crown of her head, and on her scalp; Pfizer covid vaccine: nausea; Pfizer covid vaccine: chills; Pfizer covid vaccine: hurting at the injection site; Pfizer covid vaccine: headaches/on and off headaches; She cannot speak this morning; Pfizer covid vaccine: vomiting; This is a spontaneous report from a contactable Nurse (patient). A 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL8982, expiry date: 31May2021) intramuscular injection in right upper arm on 19Jan2021 10:00 at single dose for COVID-19 immunisation. Her second dose is scheduled on 10Feb2021. Medical history included stage 4 metastatic breast cancer. There were no concomitant medications. The patient previously took Ibrance for stage 4 metastatic breast cancer and experienced broken out in terrible rash. She is taking Ibrance for cancer, she has been taking it for a while. The past few weeks she has broken out in terrible rash. She went to a dermatologist that stated the rash was from Ibrance. She cannot speak this morning (Jan2021). Her doctors are speaking to each other and she is being told not take Ibrance by the dermatologist and to continue taking from her oncologist. Reports she had a pathology report and it showed her skin eruptions she is having is from Ibrance. She clarifies that her terrible rash is up and down both arms, the crown of her head, and on her scalp. She took the first dose of the COVID-19 vaccine a couple of weeks ago. She is having quite a bunch of side effects from the injection. The side effects she is experiencing after the COVID vaccine are nausea, vomiting, chills, hurting at the injection site which is not terrible, and on and off headaches. Events did not require a visit to emergency room or physician office. Nausea started 3 days after the receiving the vaccine on 22Jan2021. Vomiting is still ongoing on and off and started about a week and half after receiving the vaccine (Jan2021). Chills started right away and she still has the chills. It has not changed. The chills started maybe a day after receiving the vaccine (20Jan2021). Hurting at the injection site started the day after (20Jan2021) and lasted for two or three days and is still ongoing, reports it goes on and off. Reports the hurting at the injection site is not terrible. Headaches started a day or so after receiving the vaccine (20Jan2021) and is still ongoing, on and off. Reporter seriousness for events nausea, vomiting, chills, hurting at the injection site, headaches were reported as medically significant. She is currently taking Ibrance since her oncologist told her not to stop taking Ibrance. The dermatologist said her rash is related to Ibrance. When querying causality she reported that she is not sure because she has been taking Ibrance for a while. She confirms the rash started after receiving the COVID vaccine. Events outcome of nausea, vomiting, chills, hurting at the injection site, headaches was not recovered (nausea and vomiting was reported as worsened), while for others was unknown. Relatedness of drug Pfizer COVID vaccine to events for nausea, vomiting, chills, hurting at the injection site, headaches were reported as related.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 71 | 2021-02-08 | chills, nasopharyngitis |
Patient received vaccine on 1/19/2021. 5 days later had cold symptoms, chills, loss of taste and ...
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Patient received vaccine on 1/19/2021. 5 days later had cold symptoms, chills, loss of taste and smell. positive COVID test.
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| 71 | 2021-02-08 | fatigue, cough, nasal congestion |
Weakness/fatigue - onset 1/31/2021. Persisting thru 2/4/ Nausea - 2/4. Mild cough & nasal congestio...
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Weakness/fatigue - onset 1/31/2021. Persisting thru 2/4/ Nausea - 2/4. Mild cough & nasal congestion since 1/31.
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| 71 | 2021-02-08 | headache |
Had bad headaches, muscle pain, SOB, feels hot inside the body and then it goes away, had chest and ...
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Had bad headaches, muscle pain, SOB, feels hot inside the body and then it goes away, had chest and arm pain
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| 71 | 2021-02-08 | malaise, headache, fatigue, chills |
tiredness, injection site pain, headache, itchey, chills, nausea, feeling unwell, swelling of throat...
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tiredness, injection site pain, headache, itchey, chills, nausea, feeling unwell, swelling of throat, slight rash
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| 71 | 2021-02-09 | chills, fever, headache |
soreness and redness where given the injection; soreness and redness where given the injection; Feve...
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soreness and redness where given the injection; soreness and redness where given the injection; Fever; Headache; Chills; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date not reported), via an unspecified route of administration at the left arm on 20Jan2021 17:30 at single dose for COVID-19 immunization. Medical history included high blood pressure, high cholesterol, thyroid disorder and COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications (unspecified) in two weeks were given. On 21Jan2021 15:00, the patient experienced soreness and redness where given the injection, fever, headache, and chills. No treatment was received for the adverse events. Clinical outcome of the events was recovering.
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| 71 | 2021-02-09 | headache, fatigue |
I had a mild headache for 2 days; sore arm.; Had some fatigue for 2 days.; This is a spontaneous rep...
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I had a mild headache for 2 days; sore arm.; Had some fatigue for 2 days.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number: EL3248, Expiry date: unknown) via an unspecified route of administration on right arm on 23Jan2021 at 08:45 AM at single dose for covid-19 immunisation. Medical history included rheumatoid arthritis, Sjogren's syndrome, fibromyalgia and hypothyroidism. The patient has no Allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included methotrexate, atorvastatin and levothyroxine. The patient stated she had a mild headache for 2 days, sore arm and had some fatigue for 2 days on 23Jan2021 at 18:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and also since the vaccination, the patient was not been tested for COVID-19. Therapeutic measures were taken as a result of the events had a mild headache for 2 days, sore arm and had some fatigue for 2 days which was Tylenol and rest. The outcome of the events headache and fatigue was resolved on 25Jan2021 while outcome for sore arm was resolved on an unspecified date in Jan2021.
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| 71 | 2021-02-09 | headache |
following the vaccination shot on same day 2/6/21 complaints of injection site pain and headache she...
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following the vaccination shot on same day 2/6/21 complaints of injection site pain and headache she was found deceased in her residence 2/8/21 8:00 am
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| 71 | 2021-02-09 | headache |
wave of neurological effects app 5-6 inches wide in a swath starting at back of neck and proceeding ...
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wave of neurological effects app 5-6 inches wide in a swath starting at back of neck and proceeding up over top of head & down my face to my chin; tingling lips; minor headache; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982, expiry date: unknown), via an unspecified route of administration, in the right arm, on 24Jan2021 10:45 at a single dose for covid-19 immunization. Medical history included occipital neuralgia, migraines, and known allergies: chlorine, latex. The patient's concomitant medications were not reported. The patient previously took erythromycin and experienced allergy. The patient is not pregnant. The patient has not had any vaccine in four weeks and no other medications in two weeks. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 24Jan2021 15:00, the patient experienced "a wave of neurological effects app 5-6 inches wide in a swath starting at back of neck and proceeding up over top of head and down my face to my chin. It included tingling lips and minor headache." The patient had no change in blood pressure (BP), heart rate or respirations. No flush or sensation of heat-almost a sensation of numbness. The patient did not receive any treatment for all the events. Outcome of all the events was recovering.
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| 71 | 2021-02-10 | chills |
Feb 10. 8:30 pm started bowel cramping, 10:00 pm to 1:30 am moderate diarrhea with bowel pain. Feb ...
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Feb 10. 8:30 pm started bowel cramping, 10:00 pm to 1:30 am moderate diarrhea with bowel pain. Feb 11 1:30 am moderate vomiting. Felt chills and shaking . No fever.
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| 71 | 2021-02-10 | fatigue | Stomach pain , diarrhea and weakness/fatigue |
| 71 | 2021-02-10 | fatigue |
On second day experienced muscle aches over body and extreme fatigue. Slept most of the day and was ...
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On second day experienced muscle aches over body and extreme fatigue. Slept most of the day and was fine the next day. Also muscle soreness in arm for approximately three days.
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| 71 | 2021-02-10 | head discomfort |
Her head felt funny dizzy, like full headed like she was going to pass out/like she could pass out; ...
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Her head felt funny dizzy, like full headed like she was going to pass out/like she could pass out; Dizzy; Her head felt funny dizzy, like full headed like she was going to pass out; Head became funny, and her body felt funny; Her blood pressure was 160/("something, I don't remember, but it was high"); Her heart was going to pound out of her chest "blow right out of my chest."/her pulse was in the 90s at that point; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at left arm on 27Jan2021 10:30 at single dose for covid-19 immunization. Medical history included she had Grave's disease in the past and her thyroid was irradiated, hypotension, arthritis, stress, macular degeneration, glaucoma, hypertension, Blood cholesterol abnormal, Dry eyes, other medication allergies. Concomitant medications included vitamin b complex (B COMPLEX) for Stress, liothyronine sodium (CYTOMEL) for Hypotension, ezetimibe for cholesterol, fish oil for Macular degeneration and Glaucoma, hydrocodone bitartrate/paracetamol (LORCET) for Arthritis, xantofyl/zeaxanthin (LUTEIN ZEAXANTHIN) for Macular degeneration and Glaucoma, levothyroxine sodium (SYNTHROID) for Hypotension, carmellose sodium (THERATEARS) for Dry eyes, triamterene for high blood pressure, tocopherol (VITAMIN E) as something good to take, latanoprostene bunod (VYZULTA) for Glaucoma, and Multivitamins took once daily by mouth took for 15 or 20 years as feel she should take, all of them were ongoing. The past drug history included before starting latanoprostene bunod (VYZULTA) for Glaucoma, she was on other products that she reacted to including 'Timerol'; 'Represso'; and Bimatoprost (LUMIGAN). During the 15 minute waiting period after administration, patient stated at around 11 minutes she felt as if her heart was going to pound out of her chest "blow right out of my chest", she became dizzy, head became funny, and her body felt funny. Patient stated that they called for the paramedics in which they ran an electrocardiogram (EKG), her pulse was in the 90s at that point, and her blood pressure was 160/("something, but it was high"). Patient stated that they had her wait an additional 20 minutes or so and then she left, but it was about an hour and a half before these effects went away. Patient asked if she should receive the second dose of the vaccine. Heart rate was back down to 90 bpm and her EKG was okay. They told her to wait for 15 minutes in her car; she was sitting talking and she had a couple of minutes left on her wait time when suddenly and she grabbed her chest and her heart, her head felt funny dizzy, like full headed like she was going to pass out/like she could pass out. She put her head on the steering wheel and her friend signaled the paramedics to the car. The paramedics examined her, took her blood pressure and it was a little high 160 over something. The feeling went away and she sat there for about 20 minutes until she was able to drive. One hour to one and one-half later she felt normal. The outcome of the events was recovered on 27Jan2021.
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| 71 | 2021-02-10 | headache, chills |
Headache Heart palpitations Nausea Dry Heaving Chills Diarrhea Lack of appetite Sleep interrupti...
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Headache Heart palpitations Nausea Dry Heaving Chills Diarrhea Lack of appetite Sleep interruption
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| 71 | 2021-02-10 | headache, fatigue |
dental pain; fatigue; headache; loss of taste; loss of smell; body aches; This is a spontaneous repo...
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dental pain; fatigue; headache; loss of taste; loss of smell; body aches; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (BNT162B2), via intramuscularly on 13Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing ankylosing spondylitis and potentially being exposed to COVID. The patient's concomitant medications was not reported. Patient began to have symptoms of COVID on 16Jan2021. The symptoms include Body aches, headache, loss of taste, loss of smell, dental pain, and fatigue. Hence on 22Jan2021 the patient hospitalized and same day had discharge, the patient had, blood sampling, X-ray, oxygen, and intravenous fluid. The patient underwent lab tests and procedures which included blood test: unknown result on 22Jan2021, x-ray: unknown result on 22Jan2021. The outcome of the events was recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
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| 71 | 2021-02-11 | fatigue, chills, fever | nausea, temperature 101 controlled by Tylenol, body aches, chills, fatigue |
| 71 | 2021-02-14 | chills, headache |
The rash now is getting little bumps; itching and a rash on his right arm up to her shoulder and bet...
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The rash now is getting little bumps; itching and a rash on his right arm up to her shoulder and between her legs and small bumps; itching and a rash on his right arm up to her shoulder and between her legs and small bumps; itching and a rash on his right arm up to her shoulder and between her legs and small bumps; next day she felt fine, cold but it's cold; chills; headache; First dose was on 05Jan2021/ Received the second dose on 22Jan2021; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration in left arm (by injection) on 22Jan2021 17:00 (also reported as 16:30) at a single dose for COVID-19 immunization. Medical history included allergic to yellowjacket (anaphylaxis) and bee venom. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient experienced chills and headache on 23Jan2021, next day she felt fine, cold but it's cold on 24Jan2021, itching and a rash on his right arm up to her shoulder and between her legs and small bumps on 25Jan2021, the rash now is getting little bumps on an unspecified date. Patient received Pfizer-BioNtech Covid-19 vaccine on Friday 22Jan2021 around 4:30PM (as reported). On Saturday she experienced chills and headache, next day she felt fine, cold but it's cold in the city, she didn't take anything (Tylenol). Last night she started to get itching and a rash on his right arm up to her shoulder and between her legs and small bumps. She would like to know if this side effects have been reported for the vaccine. The patient reported she is getting a little concerned. She had her 2nd dose of the Pfizer COVID vaccine on Friday, 22Jan2021. She had the side effects that Pfizer submitted in the brochure. She had them starting on Saturday. She had chills and a headache. The headache left her by Sunday morning. She now she has a rash that started last night in her thighs between her legs. Then this morning it is on her arms in the folds. She does not know if that is normal. She is wondering if this is a normal side effect and what to do about it. She has had anaphylaxis from yellow jackets before. She hopes she does not go that direction. Received the second dose on 22Jan2021 at 5 pm. The chills is hard to tell if she still has it as it is cold in the city. She took Tylenol for her headache. She used anti itch cream after she showered. The rash now is getting little bumps. First dose was on 05Jan2021 (LOT: EL0142). No expiration date or NDC for first or second dose is written on her vaccination card. She thought maybe it was her detergent, or bleach, but that is not it. Therapeutic measures were taken as a result of headache which included Tylenol and itching which included anti itch cream. The outcome of the event headache was recovered on 24Jan2021, of event itching and a rash on his right arm up to her shoulder and between her legs and small bumps was not recovered, while for the other events was unknown.
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| 71 | 2021-02-14 | headache |
Patient verbalized history of dizziness with fainting/falling to floor after receiving flu vaccine. ...
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Patient verbalized history of dizziness with fainting/falling to floor after receiving flu vaccine. At 1056, Pt complained of dizziness. Placed into wheeled chair, and brought to private holding room. transferred to gurnee. At 1057, B/P 146/71, heart rate 68bpm, Pulse ox 98%. Pt stated Dizziness 8 out of 10, with mild pain to forehead. Seated with head of bed up at 30 degrees. Offered both juice and water to drink At 11: 02, BP 148/76. Heart rate 71 bpm, 95% pulse ox. Pt states dizziness now 6 out of 10. At 11:18, B/P 135/74, Heart rate 65 bpm, 96% pulse ox. Dizziness 4 out of 10 At 11:29 BP 129/76. Heart rate 64 bpm, 95% Pulse ox. Dizziness one out of 10. Patient states minimal pain to forehead. Sat to edge of bed, without incident. Patient brought to standing position, shifted weight from side to side multiple times, and ambulated around holding room without incident. Stated feeling able to return home, and dizziness gone. Left to home with husband at 11:31
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| 71 | 2021-02-14 | headache | Severe headache, nausea, vomiting, diarrhea. |
| 71 | 2021-02-15 | fatigue, nasopharyngitis |
I felt fine after the injection. 3-4 days later I feel like I got a cold. Very achy and tired. Proba...
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I felt fine after the injection. 3-4 days later I feel like I got a cold. Very achy and tired. Probably has nothing to do with the vaccination but I wear 2 masks and go out very infrequently. I?m very careful. If it?s a cold I must have gotten it at the hospital.
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| 71 | 2021-02-15 | headache |
Headache and neck pain sporadic and occurs predominantly in late afternoon/evening. This is continu...
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Headache and neck pain sporadic and occurs predominantly in late afternoon/evening. This is continuing on 2/16/2021.
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| 71 | 2021-02-15 | sweating |
Systemic: Flushed / Sweating-Mild, Systemic: O2 levels dropped. No flushing/sweating but system woul...
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Systemic: Flushed / Sweating-Mild, Systemic: O2 levels dropped. No flushing/sweating but system would not let me uncheck section-Medium, Additional Details: her oxygen saturations were 93-96% on room air all of January, she received her first vaccine January 20, 2021. She received her second vaccine February 3, 2021. Her sats for February were 92-94% up until the sixth of February when she noticeably dropped to 91% on room air, she started being supplemented occasionally with oxygen on the 8th. She continues to be supplemented with oxygen. Not sure if related to vaccine or not
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| 71 | 2021-02-16 | cough |
Started coughing heavily and very weak - Unable to stand up on her own and could barely walk 5 ft wi...
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Started coughing heavily and very weak - Unable to stand up on her own and could barely walk 5 ft without stopping to catch breath. Administered her inhaler (only taken when having asthma issue due to allergy or exercise) and measured Sp)2 which was at 87 Took my mother to the ED and she was diagnosed with Bacterial Pneumonia - Was tested for Covid-19 which was negative Antibotic Azithromycin was prescribed at ED
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| 71 | 2021-02-16 | sweating | Patient described blurry vision, diaphoretic, low heart rate of 60, hypotensive 90/60. |
| 71 | 2021-02-17 | chills, sweating, headache, dehydration |
passed out; passed out when went into bathroom at 5 am, cut chin when fell; dehydrated; sweats; chil...
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passed out; passed out when went into bathroom at 5 am, cut chin when fell; dehydrated; sweats; chills-shivers; Bad headache; Dizziness; Couldn't sleep; Neuropathy pain in hip/groin; This is a spontaneous report from a contactable consumer reporting for herself. A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EM9809 and expiry date unknown) on 05Feb2021 08:30 at single does via an unspecified route of administration into her left arm for COVID-19 immunization. Medical history included known allergies to statins. The patient had received first dose of BNT162B2 (lot number EL3248) on 15Jan2021 16:00 for COVID-19 immunization (vaccine location=Left arm). The patient had not had COVID prior the vaccination, COVID not tested post the vaccination. Concomitant medication included gabapentin (GABAPENTIN), fish oil (FISH OIL), zinc (ZINC), cyanocobalamin (VITAMIN B 12), iron (IRON). No other vaccine received in four weeks. The patient experienced adverse events from 05Feb2021 at 20:30. She experienced chills-shivers, had bad head ache, dizziness, couldn't sleep, intense neuropathy pain in hip/groin when got out of bed and then passed out when went into bathroom at 5 am (06Feb2021), cut chin when fell. She felt dehydrated. Cold marble floor felt good as she had sweats, so she just layed there awhile. Her husband came to her rescue with water and cold compress for her head. She received lots of liquids and rest. She had good night's sleep on 06Feb2021. The outcome of the events was reported on 07Feb2021 as recovered.
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| 71 | 2021-02-17 | cough, runny nose, throat pain, nasal congestion, headache, fatigue, chills, body temperature increased |
Extreme fatigue; Stuffy nose; Runny nose; Coughing; Sore throat at night; Slight headache; Temperatu...
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Extreme fatigue; Stuffy nose; Runny nose; Coughing; Sore throat at night; Slight headache; Temperature up only one degree; Chills; Unable to sleep; Body ache; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9263), via an unspecified route of administration in left arm, on 22Jan2021 at 12:30 PM, at a single dose, for COVID-19 immunization. The patient's medical history included slightly high blood pressure and depression. The patient was taking unspecified concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 at 12:15 PM, the patient experienced extreme fatigue, stuffy nose followed by runny nose, coughing and sore throat at night, slight headache, temperature up only one degree but chills, and unable to sleep due to body ache. These events ended quite abruptly on 29Jan2021. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 29Jan2021.
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| 71 | 2021-02-17 | fever, chills |
This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient (no...
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This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient (not pregnant) received first dose bnt162b2 (BNT162B2 also reported as product COVID 19 brand Pfizer, lot/batch number expiry date not reported), via an unspecified route of administration in left arm on 05Feb2021 00:45 at SINGLE DOSE for Covid-19 immunisation. Medical history included blood pressure abnormal and chronic kidney disease. She did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included citalopram, diltiazem, amlodipine, calcitriol and iron. The patient experienced cold sweat, slight fever and chills (all non-serious) on 06Feb2021 03:00, no treatment. The outcome of events was unknown. Information on the lot/batch number has been requested.
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| 71 | 2021-02-18 | chills, cough |
I received my first Pfizer vaccination on 12/31/2020 at Vaccination Site. following this vaccine, I ...
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I received my first Pfizer vaccination on 12/31/2020 at Vaccination Site. following this vaccine, I had only a brief episode of chills, nausea and cough for several days. My arm was sore. My second shot 21 days later was a different story. I had it in right arm because my left arm was still aching. ( 01/21/2021 ) date of my second vaccination. Since then I have continually had pain "all over my body" My bones and muscles literally ache so badly I cannot sleep. I have called for appointment with my Dr because it isn't going away. I had a cough ( I never cough) until this past week. My concern is the ongoing aching and soreness in different spots on my skin bones and muscles. My shoulders, neck and pelvic region.
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| 71 | 2021-02-18 | fatigue, headache, runny nose, sleepiness, chills |
Day of Vaccine Tuesday - just tired and right are ached Day after Wednesday started in a.m. nausea ...
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Day of Vaccine Tuesday - just tired and right are ached Day after Wednesday started in a.m. nausea and then vomiting repeatedly throughout the day, body aches and terrible headache, no fever but chilled where teeth were actually chattering, running nose all day, acid reflux, no appetite but even water made me vomit, I became very weak. Slept a lot on and off all afternoon. Next day thursdayI had no symptoms but was weak from all the trauma of the day before. Friday I felt fine
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| 71 | 2021-02-18 | fatigue | Extremely cold, migraines, nausea, tightness in chest, face rash, joint pains, extremely tired |
| 71 | 2021-02-18 | malaise, fatigue |
Over the next week, BP low 90/62; Pulse 58 intermittently; lightheadedness; difficulty breathing; re...
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Over the next week, BP low 90/62; Pulse 58 intermittently; lightheadedness; difficulty breathing; red flush to skin on the face; left neck & shoulder pain; left neck & shoulder pain/ hip pain; fatigue; Very disoriented; BP 182/98, elevated for me; Felt extremely unwell; This is a spontaneous report from a contactable other HCP reported for self. This 71-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 14:00 on Arm left at single dose (Lot # EK4176) for covid-19 immunisation. Medical history included Codeine experienced upset stomach only, Osteoporosis, nothing else ongoing. No covid prior vaccination. No other medications in two weeks. No other vaccine in four weeks. Within 6 minutes of injection had lightheadedness & difficulty breathing. This was followed by red flush to skin on the face. Within the next hour, left neck & shoulder pain, hip pain and fatigue. Very disoriented and BP 182/98, elevated for the patient, felt extremely unwell all on 28Jan2021. Over the next week, BP low 90/62 Pulse 58 intermittently in Feb2021. Doctor or other healthcare professional office/clinic visit, Prolongation of existing hospitalization. No covid tested post vaccination. No treatments received. Outcome of the events was not recovered.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 (COMIRNATY) to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 71 | 2021-02-18 | fever, chills | Fever 102.5 with shaking chills and abdominal cramps |
| 71 | 2021-02-19 | headache, fever, malaise |
1. Migraine headache for 5 days non stop since 2/15/21. There is no relief with OTC meds. 2. Excru...
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1. Migraine headache for 5 days non stop since 2/15/21. There is no relief with OTC meds. 2. Excruciating stabbing electrical pain on the right side of brain since 2/15/21 3. Joints ache, back hurts started 4 days after injection 2/15/21 4. Feverish, malaise, started 4 days after Pfizer 2 on 2/15/21 5. Pfizer vaccine shot 2 has impacted my life negatively since date of injection 2/15/21. I am not well enough to get out of bed and participate in my daily routine. I need ice on my head for non stop headache and stabbing head pain. Side effects suck.
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| 71 | 2021-02-21 | body temperature increased, chills | Temp 101, Aches, Shivering and Chills |
| 71 | 2021-02-21 | chills, headache | Chills, shivering, nausea, headache |
| 71 | 2021-02-21 | cough |
Patient began coughing immediately after sitting down for her observation. Patient had a dry cough. ...
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Patient began coughing immediately after sitting down for her observation. Patient had a dry cough. Vitals every 5 minutes. No acute distress, lungs were clear.
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| 71 | 2021-02-21 | fatigue, chills, headache, fever | Fever, chills, shaking,body aches, headache, dizziness, fatigue |
| 71 | 2021-02-21 | fever, headache |
severe muscle and joint pain; severe muscle and joint pain; fever 100°F; dizziness; severe headache...
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severe muscle and joint pain; severe muscle and joint pain; fever 100°F; dizziness; severe headache; no Appetite; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EI9262), via an unspecified route of administration on 24Jan2021 at 14:00 on the left arm at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination and had no known allergies. The patient previously received the first dose of BNT162B2 (lot number: EH9899) on 03Jan2021 on the left arm for COVID-19 immunization. It was reported that on 25Jan2021, the next day after the vaccination, the patient woke up with severe muscle and joint pain, fever 100°F, dizziness, severe headache and no appetite. The patient took 2 Tylenol and it got better. Six hours later she took another 2 Tylenol because the headache came back; slept a couple of times a day and had a good night's sleep. Next day, she was a little better but still in bed, she fed myself better. The next day she went to the doctor (prior appointment) and was prescribed Meloxicam and Tylenol 6 hours after and was getting better. The outcome of the events was recovered. Post vaccination, the patient has not been tested for COVID.
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| 71 | 2021-02-22 | chills | Chills |
| 71 | 2021-02-22 | headache, chills, cough, fatigue, throat pain, fever, runny nose, sneezing |
4"band around both arms with strong pain & pressure, finger joints "lit up " pain, chills, fever, he...
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4"band around both arms with strong pain & pressure, finger joints "lit up " pain, chills, fever, headache, cold feet/hands & back, light headness -feeling might pass out, sneezing, coughing, extreme fatigue,nasal discharge, loss of taste, nausea, stomach ache, knots in throat (very painful) & swelling.
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| 71 | 2021-02-22 | headache |
Per patient: " I received my 2nd vaccine on Friday, February 12, 2021 and started breaking out on S...
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Per patient: " I received my 2nd vaccine on Friday, February 12, 2021 and started breaking out on Saturday, February 13, 2021 around my forehead and into my eyebrow. I developed body aches as well as a headache and arm soreness. I went to the dermatologist on Wednesday, February 17, 2021 and they cultured the lesions and results came back positive for shingles on February 22, 2021. I called the health department to let you know. "
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| 71 | 2021-02-22 | lethargy, headache, fever, runny nose |
Starting 16 hrs. Post vaccine; sniffles, fever 102 F. , mild bloody nose, arm pain, excruciating h...
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Starting 16 hrs. Post vaccine; sniffles, fever 102 F. , mild bloody nose, arm pain, excruciating head ache and facial pain not relieved by #2 50mg Ultram every 4 to 5 hrs, lethargy, chapped lips and cold sore. February 23rd most symptoms gone except lethargy and cold sore.
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| 71 | 2021-02-22 | fever, chills |
Patient reports experiencing fever and chills that began about 7-8 hours after receiving the 2nd dos...
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Patient reports experiencing fever and chills that began about 7-8 hours after receiving the 2nd dose. This lasted for about 36 hours. Patient also reports having nausea and vomiting that began about 12 hours after receiving the vaccine. This also lasted for about 36 hours total after receiving the vaccine. Patient also reports increased local pain, redness, erythema 36 hours after receiving the vaccine and states that this lasted for about 96 hours. The skin redness started locally to the injection site and then spread to covering the entire upper arm.
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| 71 | 2021-02-22 | runny nose, sneezing |
This is odd and probably not vaccine related, but I thought I would report on off chance someone els...
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This is odd and probably not vaccine related, but I thought I would report on off chance someone else experiences this. After receiving the second vaccine, I sneezed and had a constantly runny/blocked nasal passages for almost 24 hours. It was a long night. I must have sneezed more than 100 times. Never had anything like this before in my life. about 10 AM the following day it simply stopped as fast as it started and has not reoccurred. I received the Pfizer vaccine. Had muscle/joint aches but nothing that happened was a big deal
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| 71 | 2021-02-23 | chills | Very severe chills, flushing, hives, nausea |
| 71 | 2021-02-23 | headache, sweating, chills |
Chills with violent shivering starting second night after vaccine and continued for 3 nights. Dren...
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Chills with violent shivering starting second night after vaccine and continued for 3 nights. Drenching night sweats overnight began the 3rd night and is continuing now but lessening slightly in degree. Headaches. Muscles ache and stiffness particularly in legs. Slight loss of balance from time to time. Loss of appetite. Rash on chest possibly caused by sweating at night. Increased severity when bruised.
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| 71 | 2021-02-23 | headache, fever, chills, fatigue, cough |
Initially on Friday onset of diarrhea, followed by fever to 101 if I remember correctly maybe slight...
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Initially on Friday onset of diarrhea, followed by fever to 101 if I remember correctly maybe slightly above that, cough, debilitating fatique and bone aches and chills and headaches lasting until almost 5 January. Second shot administered 01-18/2021 Pfizer Lot #EL3249 - again, significant fever, terrible chills and bone aches lasting approx 4-5 days.
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| 71 | 2021-02-23 | influenza like illness, headache, cough, fatigue, throat pain |
Dry cough; Sore throat; Diarrhea; Nausea; muscle aches; joint aches; extreme fatigue; Headache; have...
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Dry cough; Sore throat; Diarrhea; Nausea; muscle aches; joint aches; extreme fatigue; Headache; have been sick ever since; flu like symptoms; hoarse; This is a spontaneous report received from a contactable consumer (patient). This consumer reported similar events for herself and her husband. This is the first of 2 reports. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 20Jan2021 at 10:15-10:30 (as reported), at single dose, for COVID-19 immunization, at the hospital. There were no medical history, family history and concomitant medications. The patient had no vaccinations within four weeks prior to the first administration of BNT162B2 vaccine. The patient reported that she and her husband had the Pfizer Covid 19 shot on 20Jan2021 (last Wednesday). She stated that they have been sick ever since. On 20Jan2021, the patient had flu-like symptoms and at 11:00, she experienced headache. On 21Jan2021, the patient experienced nausea, muscle aches, joint aches and extreme fatigue. On 22Jan2021, the patient had sore throat during the night and diarrhea. On 23Jan2021, the patient had dry cough. On an unspecified date in Jan2021, the patient was hoarse. The events did not require emergency room visit of physician office visit. The patient wanted to know if they should get the second shot. The outcome of the events "have been sick ever since", "flu like symptoms", headache, nausea, extreme fatigue and "hoarse" was not recovered; the patient was recovering from muscle aches and joint aches; the patient recovered with sequel from dry cough on 23Jan2021 and sore throat on 24Jan2021; the patient recovered from diarrhea on 24Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093716 Same reporter, suspect drug and events; different patients
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| 71 | 2021-02-24 | body temperature increased |
Emergency Room HPI: The patient is a 71 y.o. female with a PMH notable for COPD, hypertension and an...
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Emergency Room HPI: The patient is a 71 y.o. female with a PMH notable for COPD, hypertension and anxiety and depression who presented on 2/6/2021 for evaluation of shortness of breath. Patient presented to our emergency room yesterday morning from local nursing facility rehab nursing staff reported that she had had a increased shortness of breath for the last 3 days she has been diagnosed with COVID-19 on 2-2-2021. Patient has also received both COVID-19 vaccines. Patient presented to the emergency room with labored respirations conscious awake and was on a non-rebreather at 15 L. upon arrival to our emergency room patient's temperature 101.6°, pulse 169, respirations 40 to blood pressure 142/91 and oxygen saturation 100% on 15 L non-rebreather. Patient received a chest x-ray that showed chronic emphysema and fibrotic changes in the lung no acute processes identified. Patient's white count 12.8, glucose 197, creatinine 1.2, lactic acid 4.6, cardiac enzymes negative, D-dimer 1180, patient has urine culture pending. Patient has received about 3 L normal saline boluses patient was having hypotension 86/52. Patient also received IV acetaminophen a 1000 mg IV in the emergency room along with Decadron 10 mg IV piggyback. Patient was admitted acute care for the need of IV fluids and IV antibiotics for COVID-19 and sepsis 2/12 admit Brief history and initial physical exam: Patient is a 71 year old long-term resident of Rehab and Healthcare. Unfortunately, she contracted coronavirus (COVID-19) at the nursing home. Her respiratory status started to decompensate and so she was brought into the hospital. Initial workup showed significant bilateral pleural effusions and ground-glass opacity of both lungs. She had a significant supplemental oxygen requirement. She was admitted for further evaluation and treatment. Hospital course: The patient was admitted and started on IV Remdesivir. She was given IV Decadron. She was given immune support vitamins. Despite this, her sepsis worsened. When it became apparent that the patient was not going to recover, her daughter did make her comfort care only and hospice was consulted. The patient was found to be appropriate for general inpatient hospice and was made comfort care. Her requirement for morphine and Ativan did slowly rise. Eventually, the patient did succumb to her respiratory failure. Time of death was called at 10:00 p.m. on February 15, 2021 Discharge Condition: expired. Presume cause of death with cardiopulmonary arrest secondary to acute respiratory failure secondary to coronavirus (COVID-19) pneumonia Disposition: Deceased
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| 71 | 2021-02-24 | chills, fever, headache |
Side effects, not anaphylactic adverse reaction. Chills, fever, muscle aches, bad headache, joint pa...
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Side effects, not anaphylactic adverse reaction. Chills, fever, muscle aches, bad headache, joint pain, injection site pain.
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| 71 | 2021-02-24 | fatigue |
Woke up extremely hot, nauseaus. At 0410 I felt like I had to have a bowel movement, sat on toilet f...
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Woke up extremely hot, nauseaus. At 0410 I felt like I had to have a bowel movement, sat on toilet for awhile, projectile diarrhea began. Then vomiting. Same symptoms I had with Covid in June. extremely tired for about a week. Called my son who works for Pfizer the next day (the 4th of February). I want to reschedule my second vaccine for later in March because my Endocrinologist has put in a referral to have my antibodies tested. Unfortunately I just had a tooth extracted and am on antibiotics, not sure if that will affect the antibody test or the second vaccine.
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| 71 | 2021-02-24 | headache, fatigue |
It is probably just a coincidence, since this would be a DELAYED reaction. On the 8th day after fir...
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It is probably just a coincidence, since this would be a DELAYED reaction. On the 8th day after first vaccine, I woke up with moderate muscle soreness all over, but especially in back and trunk area. Also had a moderate headache. No fever. Very uncomfortable all day, movements slow. Much fatigue. I took two naps, which is very unusual. Next day, today, still with symptoms, but improved.
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| 71 | 2021-02-24 | headache |
1st dose - sore arm, foggy first couple days, moderate vertigo day 3. 2nd dose - sore arm, mild head...
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1st dose - sore arm, foggy first couple days, moderate vertigo day 3. 2nd dose - sore arm, mild headache first couple days, severe vertigo day 5.
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| 71 | 2021-02-24 | headache | - erythema diffuse body, hot flashes, headache and ecchymotic areas |
| 71 | 2021-02-24 | lethargy, fever |
1/14/21 - Resident complained of SOB. SPO2 66% on RA, vs 105/66-96-20 T98.2 O2 administered Pox 97% ...
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1/14/21 - Resident complained of SOB. SPO2 66% on RA, vs 105/66-96-20 T98.2 O2 administered Pox 97% Binax test revealed (+) COVID results. Resident transferred to COVID wing. Family (HCP) updated and declined transfer to hospital Resident continued with fever, hypoxia and lethargy. Family elected CMO and Hospice notified. Resident died on 1/16/2021 @ 930AM.
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| 71 | 2021-02-24 | fever, chills |
8:00 p.m. day of injection - Fever & Severe Chills. Chills eased about 3:00 a.m. 02/10/21 7:00 a.m....
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8:00 p.m. day of injection - Fever & Severe Chills. Chills eased about 3:00 a.m. 02/10/21 7:00 a.m. 02/10/21 - abdominal muscles and unable to function extremities very weak loss of bladder control improved very, very slowly until 02/11/21 - 3:00p.m. 02/11/21 return to normal 02/11/21. No lasting consequences
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| 71 | 2021-02-24 | fever, chills | Chills, fever, body aches, pain at injection site |
| 71 | 2021-02-24 | runny nose, chills |
Blood pressure roller coaster over 3 days: highest 148/84 down to lowest 105/85; chills, pain in upp...
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Blood pressure roller coaster over 3 days: highest 148/84 down to lowest 105/85; chills, pain in upper left quadrant chest on 3rd day, vision issue and pressure behind left eye after 5 minutes--pressure lasted for 3 days with different levels of pressure; chills, dripping nose on day 1, and itchiness on both arms especially around elbows--has continued
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| 71 | 2021-02-25 | fatigue, chills | Severe vomiting, chills, fatigue, body aches and shakes lasting 7 days |
| 71 | 2021-02-25 | fatigue |
My arm hurt; I started to get little tired; I couldn't watch TV; My stomach suddenly did not feel we...
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My arm hurt; I started to get little tired; I couldn't watch TV; My stomach suddenly did not feel well; Nauseous; I got cold; Sick; was very hot and so hot; was round up/she was feeling she would faint; waves of feeling like i would pass out; it was just being very hot, then being cold; Blood drained from my head, I just knew I was going to pass out; I took 0.2 rather than the 0.3ml of the first dose; very fast heart rate intermediately for many day; squeezing of chest; muscle hurting/Pain in my body in every muscles, my fingers, my hands, my calves, my feet, my back, neck, everything; digestive disorders; feeling gassy, uneasy; stomach abdomen was just tight; abdominal issue; feeling gassy, uneasy; stomach abdomen was just tight; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: E18982), on 21Jan2021 (at the age of 71-year-old) at single dose for COVID-19 immunisation. The patient reported that based on her history of reactions to medications, the nurses giving injections "decided 0.2ml instead of 0.3ml", which is what they gave, so she got 0.2 that is two-third of the shot. The 2nd shot was for 8'oclock on 11Feb2021. She is very sensitive to shots, vaccines, and to all medications and injections and things like that. She has sensitives thanks to two concussions she had in her life. She never was before that she had two concussions. Second one had a crazy man hit her after that just noticed that just have reactions not adverse or dying but definitely take rest of everything. So she take less of a shot, like a dental shot or cortisone shot, which she had taken in the past. If she has dental shot she cannot take Novocain, had to take Carbocaine or Marcaine and they give her half. Also she had been taking cortisone shot for shoulder for rotator cuff injury. They also have to give her less. Or flu shot: she takes half one week and come back for the other half the next week. Just have reactions. She told to when arrive for medication and did have one anaphylactic reaction but that was to cat skin dye, was told to this two nurses who was administering the vaccine and said to them she was really afraid to take. It is just too much for her. She knows her body. She is sure have reaction but is really afraid and don't know what is the first one will do to her. They just did two nurses and she decided that she will be taking 0.2 instead of 0.3ml which is what they gave. She got 0.2 so that two third of the shot and waited the half an hour, a nurse watched her card and 7 other cards. She did not have the anaphylactic reaction. She went home. Her arm hurt and started to get little tired. The events started the day that she got the shot. Like about 3 or 4 hours later. It is just few hours later she couldn't watch TV so went to laid down and an hour later she woke-up. She walked to her kitchen and blood drained from her head, she just knew she was going to pass out. Her stomach suddenly did not feel well. She tried to get back her bed but she was round up and as far as the bathroom. She got very nauseous, she laid down on bathroom floor. She thought she was sick but didn't round up having to use toilet of few times. Although while she was feeling she would faint. She was very hot and so hot. While lie down, she couldn't even pulling off her pajamas. So when she got cold so she was pulling a towel down and stop and she laid to for two hours, she finally got to her bed. It was a terrible experience. Next day she drank water and had potatoes prepared and went up eating back to later baked potatoes. Next day luckily she did not have repeat of the nausea. She didn't have that anymore of. She did have abdominal issue just not diarrhea or anything but just not feeling well, feeling gassy, so uneasy. This all lasted, that part lasted for 7 days. What concerned her was especially beside first day it was few days she got off again. She was just feel blood drain but not this first time she laid on floor. She couldn't sit on chair to watch TV for about 3 days. She mostly laid on bed but she would get very hot and then very cold during the day. She would get very fast heart beat not continue but really fast like heart was pounding her chest. She felt like someone has their hand inside her body squeezing her chest. She got afraid but didn't want to go hospital. She didn't think she was sick enough. She was concerned. So that was happened and this last was for about 7 days. Then the squeezing of chest part went away. She doesn't want to wind-up on the floor feeling that sick again, she felt so sick it felt like food poisoning. After that, it was just being very hot, then being cold, the fast heart rate, every muscle hurting. Those were the main things that continued for a week. And digestive disorders. It all lasted for about 13 days. She was concerned she had a very fast heart rate intermediately for many days, for about a week. And that's considered an adverse reaction and also she was getting waves of feeling like she would pass out, everything would drain from her head. She experienced stomach ache, feeling hot then cold. She wants to do precautions before taking the second dose on 11Feb2021. She did take may be 3 days later two Tylenol but didn't take anything (clarification requested). She didn't even take vitamins during that time. She was afraid to take anything so she did not. At the same time also there was pain in her body in every muscles, fingers, hands, calves, feet, back, neck, everything. Her stomach abdomen was just tight. She was concerned that last for few days. In last few days she started feel herself and now she is going again tomorrow. So that how she reacted. She doesn't know how much of this shot she told them she could tolerate because everybody is saying second shot will give you more reactions. All she can take this more than that because that was lot. She wants to be herself, don't want laying on floor, don't want to have 105 temperature or anything. The patient was asking if she should take another 0.2ml another two-third of the shot. She just asked them for half that is 0.15 would that be a big difference. She needed to know by 8 o'clock tomorrow. I might be in a queue to get it. She stated: 'So, that's my concern. I'm all alone, I'm a senior, I have no family. I lost my mother to covid. I know I need this vaccine, but I just, I cant get that sick and I'm so afraid I'll wind up with a 105 something, fainting away and no one knowing'. She was asking if reactions after the 2nd dose are worse than the 1st dose, if she didn't have anaphylaxis after 1st one, she shouldn't have it a 2nd time, right. She said, "1st half of flu shot, I get sick, then the 2nd half nothing". She also asked if she can take medications after the vaccine, like Tylenol, or irritable bowel syndrome (IBS) medication she takes as needed. The events resolved, but the patient reported it took her like 13 days before she felt better.
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| 71 | 2021-02-25 | headache | Shortly after receiving the vaccine the patient complained of a headache and nausea |
| 71 | 2021-02-25 | headache |
Within 24 hrs, experienced severe dizziness, resulting in 2 falls while attempting to stand up. Al...
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Within 24 hrs, experienced severe dizziness, resulting in 2 falls while attempting to stand up. Also had headache, loss of appetite, and nausea, but the alarming side effect was the dizziness. Dizziness also subsided after less than 12 hrs.
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| 71 | 2021-02-25 | paranasal sinus discomfort |
the sinus pressure started the 1st two days then this week about 10 days after vaccine the symptoms ...
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the sinus pressure started the 1st two days then this week about 10 days after vaccine the symptoms were getting worst saw my GP and was told i had an ear infection and given 2 antibiotics. ear drops which i have started to take and Zithromax but have not used it yet.
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| 71 | 2021-02-26 | chills, headache, fatigue |
I received the first Pfizer vaccine t 2:45 PM on Thursday, 2/25/21. That night when I went to bed I ...
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I received the first Pfizer vaccine t 2:45 PM on Thursday, 2/25/21. That night when I went to bed I felt chilled and woke up several times feeling chilled. In the morning I felt sick with similar symptoms as when I had COVID-19 in March2020. I had head pains, inner ear pains, naseau, sore muscles, and extreme fatigue. I slept the whole day, waking up and going back to sleep. I dranka little, but just didn't feel like it. I ate a piece of toast with butter that evening and then felt naseauated. I slept through the night and woke up feeling a little better the next day, but still feel tired and have some pains in my head.
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| 71 | 2021-02-26 | fatigue, malaise, headache |
Left and right arms sore and achy for 3 days; felt tired and ill the night of the shot and all the n...
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Left and right arms sore and achy for 3 days; felt tired and ill the night of the shot and all the next day; general malaise feeling; loss of appetite; headache; slight swelling of sinuses and rash on face. Took Benadryl the first and second nights, used hydrocortisone cream on rash, took Tylenol. End of day three feeling better, almost normal.
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| 71 | 2021-02-26 | sweating |
Systemic: Flushed / Sweating-Mild, Additional Details: pt felt flused after 10 minutes. Refused bena...
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Systemic: Flushed / Sweating-Mild, Additional Details: pt felt flused after 10 minutes. Refused benadryl due to previous reaction. Took asa 81 mg and zyrtec 10 mg. Symptoms resolved.
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| 71 | 2021-02-27 | lethargy, fever, headache, fatigue, chills |
12.45 hours after 2nd dose: fever, chills, shaking, joint pain, HA, lethargy, tired; Symptoms lasted...
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12.45 hours after 2nd dose: fever, chills, shaking, joint pain, HA, lethargy, tired; Symptoms lasted 2-3 days, but the following symptoms are still present (10 Days post 2nd dose): HA, lethargy, fogginess and tiredness
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| 71 | 2021-02-27 | fever | extreme nausea for 24 hrs., low grade fever for 48 hrs. |
| 71 | 2021-02-28 | fatigue, malaise, headache |
She started experiencing burning; Rash; Shingles; itching; Headache; Malaise; very tired; This is a ...
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She started experiencing burning; Rash; Shingles; itching; Headache; Malaise; very tired; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: E13247) via an unspecified route of administration on 19Jan2021 11:30 at a single dose for COVID-19 immunization. Medical history included A-fib. Concomitant medication included apixaban (ELIQUIS). Had COVID-19 Vaccine on 19Jan2021 and everything was fine. Had a headache and a little bit of malaise on 20Jan2021. After two days was ok. On 21Jan2021, broke out in what she thinks was shingles. Not 100% sure if it was a major rash or shingles. Wanted to know if that was a possible side effect. Patient was taking Valaciclovir (VALTREX) for Shingles. Doctor suspected it was shingles, but it was possible she had shingles brewing before the COVID-19 Vaccine or the COVID-19 Vaccine brought the shingles out. Second COVID-19 Vaccine is scheduled for 09Feb2021, patient was scared and afraid of it. Doesn't know what to do. On 20Jan2021 she was very tired and had a headache. Next day was ok. On 21Jan2021 thought she had bug bites. Started itching. Then it began traveling and she realized it was not bug bites. She started experiencing burning. Went to two Urgent Care and her Internist. Was told it was basically shingles. Her internist was on the fence because she just had the COVID-19 Vaccine and wasn't certain. Caller stated it was ironic that she broke out after the vaccine. Caller's internist stated for any rash it would be treated the same with Valtrex. Internist stated chances were the rash was viral so if it's not shingles, would be treated with Valtrex. Rash and Itching: Wasn't very bad on Saturday, 23Jan2021, which was the first time she had someone look at it. On Sunday, 24Jan2021 it was full blown and really blossomed. Was initially treating rash as if it was bug bites. Was applying Benadryl tropical. On Sunday, 24Jan2021, started taking Valtrex. Outcome of the events headache, malaise, fatigue was recovered on n unspecified date, while unknown for the other events.
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| 71 | 2021-02-28 | fatigue, fever |
Within first 30hrs of receiving vaccine: chills (twice), body aches, diarrhea (twice); fatigue, fev...
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Within first 30hrs of receiving vaccine: chills (twice), body aches, diarrhea (twice); fatigue, fever (did not exceed 100 degrees). Underarm pain, enlarged lymph node began within 2 days post 2nd vaccine. ( Friday-Sat. Feb. 26-27) Within four days (Sunday Feb. 28) redness, swelling, pain and itching began in upper arm. ....neck pain reduced. By Monday, March 1, I contacted my family practice clinic and received a video consult with Dr.
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| 71 | 2021-02-28 | fatigue | strength difficulty, tiredness, leg weakness, |
| 71 | 2021-02-28 | fatigue | Overly tired Thursday night, Friday and Saturday after injection |
| 71 | 2021-02-28 | headache, fatigue |
headache; nauseous; soreness at the site; extreme fatigue; This is a spontaneous report from a conta...
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headache; nauseous; soreness at the site; extreme fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN5318, expiration date was unknown), via an unspecified route of administration in the left arm on 24Jan2021 at 12:15 at a single dose for COVID-19 immunization. The vaccine facility type was reported as "other." Relevant medical history included hyperactive thyroid; known allergies to penicillin, eggs, and cashews; and severe allergy to all dairy products; all from an unknown date and unknown if ongoing. Concomitant medications included fluvastatin, ezetimibe (ZETIA), acetylsalicylic acid (BABY ASPIRIN), and unspecified multivitamins. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. She had not tested for COVID post vaccination. On 24Jan2021, after 2-3 hours of receiving the vaccine, the patient became very nauseous, which lasted for three days. It had eased at the time of the report. On 24Jan2021, the patient also had soreness at the site, extreme fatigue, and headache. The patient had headache for about one day; however, she managed to deal with it without pain killer. The patient drank a lot of warm water with fresh ginger and lemon (with peel) to control the nausea. The patient was very fatigued for three days following the vaccine. Therapeutic measures were taken as a result of nauseous. The patient did not receive treatment for the events "soreness at the site, extreme fatigue, and headache." The patient was recovering from the events "nauseous, soreness at the site, extreme fatigue, and headache."
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| 71 | 2021-02-28 | malaise, headache, chills |
I got a big side effect dizzy and I was almost falling; dizziness; Headache; Nauseous; Feel pinch in...
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I got a big side effect dizzy and I was almost falling; dizziness; Headache; Nauseous; Feel pinch in my stomach; Lot of pain in my whole body; Chills especially at night; Tinnitus; I can't hear you very well because it's so bad. I have a lot of noise in my ear and I can't listen you very well. I couldn't hear; Little side effect of the vaccine, but it continued till now and I feel so sick now; scared because she was falling; scared because she was falling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: unknown), via an unspecified route of administration on 21Jan2021 (also reported as on Wednesday) at SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure high and diabetes. Concomitant medication included glimepiride (GLIMEPIRIDE) for diabetes and olmesartan (OLMESARTAN) for blood pressure high. It was reported that the patient was experiencing for over a week a lot of side effect of the vaccines. She was scared because she got dizzy which she was almost falling (also reported as scared because she was falling) in Jan2021. The patient also had headaches (a lot of headaches) and every day she had to take pills. She also felt like nauseous and pinch in her stomach. She had a lot of pain in her whole body and have chills especially at night after she had the COVID-19 Vaccine. The patient also had got a lot of tinnitus (lot of noise in her ear and can't listen very well) she can't hear very well because it's so bad. She also felt so sick now that she doesn't feel like doing nothing just to be in bed. The patient events were not recovered (continued till now). Information on the Lot/Batch number has been requested.
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| 71 | 2021-02-28 | malaise |
Severe abdominal pain. Started as diffuse cramps, surged to the most severe pain I have ever experie...
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Severe abdominal pain. Started as diffuse cramps, surged to the most severe pain I have ever experienced. The pain extended below my left rib through the area above my hip to my navel and then to my entire abdominal area. As noted, it ranged from severe cramps (maybe only a 4 on a NPRS) to searing pain that I would mark as a 10 on a NPRS. This subsided and then surged about 5 times in the space of 30 minutes. At one point, I got very hot, but I didn't have a fever. The pain was so bad and I felt so horribly sick that I was about to ask my husband to take me to the ER. I had a Cesarean section in 1978 followed by two natural, unmedicated VBAC births in 1981 and 1985, and, although I know we "can't remember pain," the pain I experienced last night was far, far worse than the pain of childbirth. After it went away, everything immediately went back to normal, as if it hadn't happened.
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| 71 | 2021-02-28 | malaise |
I felt achy and sick as if i were getting the flu. It was difficult to walk up the stairs to go to ...
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I felt achy and sick as if i were getting the flu. It was difficult to walk up the stairs to go to bed, but i went to bed immediately. I was asleep by 9 pm and didn't wake up until 7 a.m. After being up for 30 minutes, i felt like myself ago and no additional effects.
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| 71 | 2021-02-28 | fever, chills, sweating, headache |
Extreme Diarrhea for 5 days ( soiled pj?s, underwear, and clothes because it came on so fast and was...
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Extreme Diarrhea for 5 days ( soiled pj?s, underwear, and clothes because it came on so fast and was so painful that I couldn?t run to the bathroom quickly enough) Fever and chills for 5 days ( would wake up 1-2 times each night drenched in sweat) Severe headache for 4 days
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| 71 | 2021-03-01 | headache, fever | Fever for two days, body aches, massive headaches. It was almost like having Covid all over again! |
| 71 | 2021-03-01 | throat pain |
48 hours after shot in left arm I started to have a earache on left side, traveled down the left sid...
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48 hours after shot in left arm I started to have a earache on left side, traveled down the left side of face, into jaw area and down left side of my throat like tonsils and into neck area. Into 72 hours after shot my face, neck and throat area started swelling. At that time I went to ER for assistance due to the swelling and pain. The ER after taking review thought it a infected saliva gland and treated me for that. As told by ER if no large progress contact my local Dr. and see ENT. On Tues. (one week from Covid injection) I was in touch with my local Dr. they had me come to their office for some care and scheduled me with a ENT. They have been able to get the profuse swelling down out of the left side of my face, neck and throat. I'm scheduled for a CT scan on March 5, 2021 to see where the original problem started. I'm contacting you for two reason's 1. I have a March 10th. appointment scheduled I need to cancel and am having issues doing this. Even in light of all this I want to reschedule for late April for my second shot and am not able to do that as well. 2. Can you assist with any information if this has happened to other folks and if I should be clear to take my second dose. This has been quite a nightmare and hard to bring under control. I believe in the vaccine and this maybe just a quirk in how it happened but any information you can give me would be welcome. I have looked on the website and it does say that there have been people who have also had symptoms like this from the shots where the side they get the shot on reacts. Thanking you in advance for your time and assistance.
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| 71 | 2021-03-02 | fatigue, headache, malaise |
Nauseous; Weak; Really unwell; Tired; Muscle aches; Headache; This is a spontaneous report from a co...
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Nauseous; Weak; Really unwell; Tired; Muscle aches; Headache; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: CN5318, via an unspecified route of administration at right arm on 29Jan2021 09:00 at a single dose for COVID-19 immunisation. Medical history was not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date. There were no concomitant medications. On 29Jan2021, at 7 pm, the patient was nauseous and weak. At 9 pm, the patient was really unwell, tired, headache, muscle aches and nausea. She slept all Friday night, all day Saturday. Late around Sunday was finally able to get out of bed. Asked if she should see a doctor. The patient was still nauseous and weak. The outcome of the events nausea and weak was not recovered. The outcome of other events was unknown.
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| 71 | 2021-03-02 | fatigue, headache |
Headache, cold, hot, nausea, swelling at vaccination site, red and itchy at vaccination site too, fa...
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Headache, cold, hot, nausea, swelling at vaccination site, red and itchy at vaccination site too, fatigue Was sick for 17 days. Dr. prescribed steroids and nausea medication.
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| 71 | 2021-03-02 | headache, chills | Chills, body aches, headaches, slight nausea, sore arm |
| 71 | 2021-03-02 | headache |
Patient received first dose of Pfizer COVID Vaccine and reported headache and lip tingling per obser...
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Patient received first dose of Pfizer COVID Vaccine and reported headache and lip tingling per observation. Given benadryl 25mg x 1.
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| 71 | 2021-03-02 | headache | Headache, upset stomach, light headed |
| 71 | 2021-03-02 | fever, nasopharyngitis, headache | Freezing , headache , nauseous, fever , dizzy |
| 71 | 2021-03-03 | chills, headache | Very bad headache that started around 2 am on 3/2, lasting about 6 hours, with nausea and chills |
| 71 | 2021-03-03 | fatigue, malaise, chills |
states that she received her second Covid vaccine on Monday 03/01/21, and that yesterday she had sid...
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states that she received her second Covid vaccine on Monday 03/01/21, and that yesterday she had side effects of body aches, and just feeling yucky. 3/3/21, she woke up with Hives covering her body. No difficulty breathing, or swelling of Face at this time, per NP, pt to take Benadryl OTC and if Sxs worsen or do not improve she will need to come into to be seen, and if any difficulty breathing, swelling of face/tongue/throat patient is to call 911. 3/4/2021 11:52 AM 71 yo female seen today with c/o hive like rash,, first onset noted on both forearms yesterday 3/3/21 associated with severe itching, she took some benadryl last night, this may have helped for a while, however notes spreading of hive like rash to the entire body including the face starting this morning, bodyaches and chills with extreme fatigue Pt had her 2nd pfizer covid shot 48 hours ago, she denies any other new medications or products.
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| 71 | 2021-03-03 | headache, chills, fever |
Received shot on 2/27 2/28 & 2/29 fever , chills, joint aches, headaches, took Tylenol for fever 2/3...
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Received shot on 2/27 2/28 & 2/29 fever , chills, joint aches, headaches, took Tylenol for fever 2/30 rash started at injection site. I took Benadryl but rash spread and got worse 3/4 went Emergency center for worsening rash, sever itching, and unable to sleep. I was given a Benadryl 25mg injection and a steroid shot. I was to continue taking Benadryl and set up an appointment with my PCP.
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| 71 | 2021-03-03 | headache, fatigue | Severe Headaches Severe joint aches Severe back pain Fatigue Symptoms lasted 7 days |
| 71 | 2021-03-03 | throat pain |
Left side of throat feels swollen, dry, then later notes right tonsil and right side of throat sore....
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Left side of throat feels swollen, dry, then later notes right tonsil and right side of throat sore. did get oral Benedryl 50 mg. Medical Emergency called - patient transported to ED
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| 71 | 2021-03-03 | fever, chills |
2 hrs after shot Roof of mouth and tongue became rough the next morning fever up to 102 Chills down...
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2 hrs after shot Roof of mouth and tongue became rough the next morning fever up to 102 Chills down for the count day 3 I woke up thought I had a swollen gland on left neck and developed blisters or sensitive bumps along left side of tongue. Today 3/4 gland back to normal bumps or blisters still there moving towards tip of tongue on left side
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| 71 | 2021-03-03 | fever, headache |
Fever; nausea; headache; achy. Fever lasted several hours starting around 11:00 pm. Nausea lasted 36...
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Fever; nausea; headache; achy. Fever lasted several hours starting around 11:00 pm. Nausea lasted 36 hours (about), aches and pain lasted about 48 hours. Tylenol for fever.
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| 71 | 2021-03-04 | headache, body temperature increased | Temp 101.4, body aches, headache |
| 71 | 2021-03-04 | headache, chills, fever | Fever, headaches, chills, sore arm. Loss of taste that started on day 3 and lasted 24 hours. |
| 71 | 2021-03-04 | headache, chills |
Patient was experience nausea, dizziness, vomiting, weakness, headache, and chills. It started aroun...
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Patient was experience nausea, dizziness, vomiting, weakness, headache, and chills. It started around 7am on March 3rd, when she woke up. The symptoms lasted almost all day, and he started to feel better around 6:30pm on the same day, March 3rd. He was able to eat and drink at this time without feeling nauseous. On March 4th, he experienced mild headache and was feeling a little dizzy, but much better. She is able to eat and drink, and move around the house now.
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| 71 | 2021-03-04 | headache, chills |
Blood pressure at 4 pm on 3 March was 150. By 8 pm that evening it was 197. Had slight head ache and...
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Blood pressure at 4 pm on 3 March was 150. By 8 pm that evening it was 197. Had slight head ache and face was red. Went to the ER. That night I experienced moderate chills.
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| 71 | 2021-03-04 | sweating, chills, headache |
had chills, sweat, body aches, joint pain, headache. by Sunday I was fine and then Tuesday I develop...
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had chills, sweat, body aches, joint pain, headache. by Sunday I was fine and then Tuesday I developed the worst headache of my life and my face swelled up and my eyes got puffy and I was really sick. I had joint pain and sweats and chills again.
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| 71 | 2021-03-05 | chills, sweating, headache, fatigue, sleepiness |
14 hrs after dose I had intense chills. 2 hrs later woke up drenched in sweat. Bad headache for 24...
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14 hrs after dose I had intense chills. 2 hrs later woke up drenched in sweat. Bad headache for 24 hours, nausea for 24 hours. Very tired, could not get out of bed the next day, slept almost 36 hours.
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| 71 | 2021-03-05 | chills |
Within 5 minutes, I became hot and flushed face, red arms below the vaccination site, red legs. Tre...
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Within 5 minutes, I became hot and flushed face, red arms below the vaccination site, red legs. Treated immediately with benadyl and extra water, followed by benadryl and tylenol 6 hours later and again 6 hours later. After approx 18 hours, my skin looked and acted like a sunburn reaction. After 24 hours I had chills. After 36 hours all symptoms were gone.
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| 71 | 2021-03-05 | fatigue, fever | Extreme fatigue, 101.7 temperature, no appetite, lasted from 8 am to 7 pm |
| 71 | 2021-03-05 | headache, fever, chills | Moderate arm pain Shooting pain in armpit sharp headache, body aches , chills Low fever 99-100 |
| 71 | 2021-03-05 | headache |
This was the second shot in series of 2. First shot only gave me a sore arm at site & was administer...
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This was the second shot in series of 2. First shot only gave me a sore arm at site & was administered on February 6, 2021. Second shot was administered on March 3, 2021. Started feeling these adverse effects about 9 or 10 am the following morning, 3/4/2021. Symptoms were soreness at site, in muscle that goes to the neck, headache, soreness across upper back/shoulder to shoulder. By 4 pm on 3/4, my entire body was reacting with extreme joint pain in all joints, extreme joint stiffness, skin was tender to the touch, temperature of 100.1, sore/stiff neck, and continuing headache. Temperature ceased around 11:30 pm but all other symptoms remained upon going to bed at 1 a.m., 3/5/2021. Upon waking at about 7:30 am 3/5/2021, all symptoms had diminished enough for me to go to an appointment at 10:45 am. However, by the time I headed back home at about 1:30 pm, I was so sleepy I could hardly keep my eyes open. More stiffness and achiness had returned too, especially a sore left underarm. Not the extent of night before, but enough to be uncomfortable. Today, 3/6/2021, I have noticed a sore muscle traveling from my left underarm down to my waist.
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| 71 | 2021-03-05 | fever | achiness, low grade temperature, nausea, started on day of shot and continued for two more days |
| 71 | 2021-03-05 | sleepiness, fatigue, headache |
Friday: Before I left facility I started tingling around my mouth but ignored. When I got home my ar...
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Friday: Before I left facility I started tingling around my mouth but ignored. When I got home my arthritic places that always hurt started intensifying more than usual but not my injection arm. Started itching on my head and went down in different spots on my body. Never had hives except from scratching. Took 1 otc Benadryl when continued itching then again at bedtime. They helped but not 100%. Saturday: Woke up in the morning with more itching, headache, fatigue.Eyes burning for three days, Continued Benadryl and Tylenol for headache and joint aches. No fevers. Monday: went to urgent care. They first gave me a Zyrtec, then 30 minutes later gave me a steroid IM. Did urine test. Prescribed: dexamethazone 4mg. 1 in the morn for 5 days, singular 10 mg. Daily, Zyrtec 10 mg. Daily. Drink lots of water. Each morning after I went to urgent care I?d wake up itching until Friday morning. Itching has improved. Took my last script this morn on Saturday. First day not fatigued and very sleep was Thursday. The other days before I slept a lot. I?m just concerned if it will be okay to take the second dose. I have it on March 19.
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| 71 | 2021-03-06 | chills, fatigue |
Site pain, swelling, chills, body aches 6hrs and by next day. 4 days later- bellyache, cramps, burn...
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Site pain, swelling, chills, body aches 6hrs and by next day. 4 days later- bellyache, cramps, burning diarrhea, nausea, lack of appetite, more fatigue. Last symptoms hard to shake. Better and then back.
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| 71 | 2021-03-06 | chills, headache, fever |
Woke up approximately 12 hours after vaccination, with severe chills causing my teeth to chatter and...
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Woke up approximately 12 hours after vaccination, with severe chills causing my teeth to chatter and shaking all over. Chills dissipated within about 4 hours. Had a very bad headache which also began about same time as chills and lasted for approximately another 12 hours, even though I took tylenol and advil alternating every 4 hours. Had a slight fever, approximately 1 degree over what I normally register for about 8 hours. I showered about 36 hours after vaccination and immediately broke out in a rash (not hives)...more like prickly heat all over my stomach, neck, chest, stomach, inside arms. This lasted until the next day; did not itch or cause any discomfort.
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| 71 | 2021-03-06 | fatigue | soreness in upper arm, tiredness |
| 71 | 2021-03-07 | chills, fever | Covid arm, Chills and slight fever. Day 2 rash on torso |
| 71 | 2021-03-07 | chills |
Hives on both arms, wrists to shoulder. Hives on chest and upper back. Treatment...benadryl and OTC ...
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Hives on both arms, wrists to shoulder. Hives on chest and upper back. Treatment...benadryl and OTC hydrocortizone. Hives started on arms and spread to chest and upper back, under arms. Skin very warm to the touch and chills. I am still dealing with hives and chills...little, if any improvement 03/08/2021.
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| 71 | 2021-03-07 | fatigue, fever, influenza like illness, chills |
Low grade fever, chills, flu-type aching, loss of appetite, extreme fatigue, pain at injection site,...
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Low grade fever, chills, flu-type aching, loss of appetite, extreme fatigue, pain at injection site, joint and muscle pain. The worst of it was the Wednesday after late Monday afternoon vaccination; ie on day two post-vax. Felt like a case of bad flu. Lasted about 2 to 3 days, with tapering severity. A week later, energy level is still down; sleeping more than usual.
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| 71 | 2021-03-07 | fatigue |
For 2 days after vaccine occasionally felt dizzy with fluttering heart. On and off. Then subsided A ...
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For 2 days after vaccine occasionally felt dizzy with fluttering heart. On and off. Then subsided A week after got hot flashes. Then sucsided During the second week I had an episode when I felt like fainting, Throughout the week I am increasingly tired to a level of total exhaustion and bewilderment. I have extreme reservations about taking the second shot as I never felt so extremely exhausted
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| 71 | 2021-03-07 | sweating |
diaphoresis, vertigo, and dry mouth. patient was hydrated and chair was reclined with additional res...
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diaphoresis, vertigo, and dry mouth. patient was hydrated and chair was reclined with additional rest
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| 71 | 2021-03-07 | fever, chills, fatigue | Fever, chills, fatigue, nauseated, dizziness, loss of balance, thristy, no appetite. 2 1/2 days |
| 71 | 2021-03-08 | chills, headache | headache, severe Vertigo, vomiting, chills. bouts of dizziness has continued. |
| 71 | 2021-03-08 | chills, runny nose, headache, fatigue, fever |
fever of 101.9 for 2 full days- lessened on 3rd day-, headache, nausea, chills, muscle aches includ...
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fever of 101.9 for 2 full days- lessened on 3rd day-, headache, nausea, chills, muscle aches including my fingers, runny nose, sore skin to the touch on left lower arm. Sore skin did not occur until 4th day. very fatigued throughout. All symptoms gone by end of 4th day.
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| 71 | 2021-03-08 | chills, runny nose, fever | Fever and Chills body aches joint pain Runny nose diarhea |
| 71 | 2021-03-08 | fatigue, headache, chills | Chills, Headache, Myalgia, Arthralgia, Fatigue, Rash on forearms |
| 71 | 2021-03-08 | fatigue |
The shot was given to me (Sat) in the upper (L) arm about 2 -1/2 inches down from top of shoulder. ...
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The shot was given to me (Sat) in the upper (L) arm about 2 -1/2 inches down from top of shoulder. It was a simple prick however I thought it seemed an odd location. About 24 hours later (Sun) I felt first signs of tenderness at the site but didn't think much of it as that is what I had heard from others about the vaccine. Later in the day it became achy. On Monday morning I noticed my whole arm was achy in addition to the top of my shoulder and the left side of my neck and upper shoulder blade. At 9:30 am I felt very tired and laid down and awoke 4 hours later! My aches were still all there as though I had slept wrong. Again I was not too concerned except that my friends all said their discomfort was gone within 24 hrs. Today is Tuesday and evening and as I sit here I have a very tender, sore, achy upper left arm and a small black and blue spot at the site. It's strange because it doesn't hurt when I touch it, instead it is just an ache/pain that I feel and especially when I move the arm. The tightness and ache in my neck and back and shoulder has lessened. I am reporting as I was not expecting this type of reaction especially to last 3-1/2 days so far. I feel this adverse reaction probably has more to do with the location that the technician chose to give me the vaccine. I am thinking the muscles are reacting to injection.
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| 71 | 2021-03-08 | headache, chills, lethargy |
Very sensitive now to regular meds; lower back felt really heavy; pounding sensation up and down my ...
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Very sensitive now to regular meds; lower back felt really heavy; pounding sensation up and down my torso; feeling of muscle heaviness that I almost felt paralyzed; extreme body ache; chills; I had a bad headache; stinging on both sides of my head and on hands and feet; was very lethargic; arm became real sore and was painful; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249, expiry date not reported), via an unspecified route of administration on the left arm on 27Jan2021 10:30 at single dose for covid-19 immunisation. Medical history included mild lupus, post concussion syndrome (PPCs) and allergies: sulfur (very sensitive to large doses) from an unknown date and unknown if ongoing. Concomitant medication included esomeprazole magnesium (NEXIUM), tramadol, alprazolam and acetylsalicylic acid (ALKA SELTZER). The patient reported that after just a few hours on 27Jan2021, their arm became real sore and was painful to use until next morning, was sore for 2 days. Hurt after much normal use. Woke up on the morning of 28Jan2021 (3 am) with chills, extreme body ache and feeling of muscle heaviness that they almost felt paralyzed. They could still move. They had a bad headache and stinging on both sides of their head and on hands and feet. They took aspirin and went back to sleep. When they got up they felt some better, but did not feel well and was very lethargic. That night they took another aspirin before bed. On the morning of 29Jan2021 (second day ) they again woke up at 3 AM to extreme body ache, the same heavy paralyzing feeling, but this time their lower back felt really heavy and there was a pounding sensation up and down their torso. They repeated the aspirin dose and went back to bed but did not sleep anymore that day. They did feel some better but still very lethargic. Next day better, but took 5 days to feel some normal w/o fatigue. The patient is very sensitive now to regular meds. Therapeutic measures were taken which included aspirin. The patient was recovering from feeling of muscle heaviness that I almost felt paralyzed, extreme body ache, chills, headache, stinging on both sides of my head and on hands and feet, lethargy recovered from arm became real sore and was painful on an unspecified date, while the outcome of the other events was unknown. The patient was not diagnosed with COVID prior to vaccination and has not been tested for COVID since vaccination.
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| 71 | 2021-03-08 | headache, malaise | achy, "just don't feel good", facial swelling, shortness of breath, slight headache |
| 71 | 2021-03-08 | sweating |
felt nauseated and sweaty. resolved with observation and orange juice. no resp symptoms, no rash, no...
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felt nauseated and sweaty. resolved with observation and orange juice. no resp symptoms, no rash, no hives
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| 71 | 2021-03-08 | malaise | Anxious, Shaking, Jittery ,fast heart beat. ill at ease. |
| 71 | 2021-03-09 | body temperature increased |
I have severe MGD on my left side. For 6 months, I had daily elevated temperatures. After starting C...
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I have severe MGD on my left side. For 6 months, I had daily elevated temperatures. After starting Cequa, these subsided. But returned after the COVID shot. Symptoms have not subsided, seem to be getting worse.
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| 71 | 2021-03-09 | fatigue, headache, chills |
After COVID vaccine #2- headache started same evening around 5 pm, tiredness, painful charlie horses...
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After COVID vaccine #2- headache started same evening around 5 pm, tiredness, painful charlie horses. 2nd night- chills, tiredness, sore legs, difficulty walking. 3/7/21- woke up with painful legs, heaviness, unable to walk, continued mild headache. treatment include: Tylenol, Gabapentin and lidocaine cream, avoiding narcotics rehab therapies
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| 71 | 2021-03-09 | fatigue | Sore shoulder same day. Fatique on second day. No other symptoms. |
| 71 | 2021-03-09 | headache | Headache itchy upper lip. BPs 208/87 (pulse 78), 174/66. 98% O2 sat. |
| 71 | 2021-03-09 | headache |
Pfizer-BioNTech COVID 19 Vaccine The day after receiving the vaccine, I had a slight headache and ...
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Pfizer-BioNTech COVID 19 Vaccine The day after receiving the vaccine, I had a slight headache and later that morning I had a site on my rump that was itchy. Later I took a shower and I broke out with shingles rash, now two days later feeling achy. It has been 2 yrs since I had an outbreak of shingles. I tried to call Pfizer to see if I could safely take the Valtrex dosage for the outbreak and after an hour and a half the call dropped and I was not able to call them. I did send them a report via the computer to their web address.
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| 71 | 2021-03-09 | sleepiness |
About 6 hours after the vaccine she felt really, really sleepy. Then she laid down and then her lef...
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About 6 hours after the vaccine she felt really, really sleepy. Then she laid down and then her left hand started stinging all over. Both legs started getting a strange warm sensation, the size of a pea that kept getting warmer. She was not able to get up or open her eyes, doesn't know if she passed out but apparently went to sleep and slept for 3 hours and woke up and went to bed. She then had toe cramps on her left foot, then got up and walked around the bed and laid down again and fell asleep until the morning. She did not feel normal until 3/5/21. On Sunday, 3/7/21 had nausea, took something for that and the next day she was fine.
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| 71 | 2021-03-10 | cough |
red tongue, red lips, bumps on tongue, reactive airways . Cough and asthma symptoms, airways fillin...
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red tongue, red lips, bumps on tongue, reactive airways . Cough and asthma symptoms, airways filling with mucus. Zyrtec, albuterol sulfate
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| 71 | 2021-03-10 | fatigue, chills |
Started with extreme chills in the evening and progressed to chills with tiredness and overall achi...
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Started with extreme chills in the evening and progressed to chills with tiredness and overall aching body lasting about 36 hours from onset.
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| 71 | 2021-03-10 | headache, chills, fatigue, fever | chills, fever, body aches, headache, loss of appetite and no energy/tired |
| 71 | 2021-03-10 | headache, fatigue, sleepiness |
beeps, noise in her ears; muscle and joint pain; muscle and joint pain; tongue was a little numb; fa...
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beeps, noise in her ears; muscle and joint pain; muscle and joint pain; tongue was a little numb; face lips; felt paralyzed/Felt like I couldn't move it like paralyzed a little bit; whole left side of body started going numb/Left side was numb around 7 or 8 that night/all left side was numb; pains in all of her face; pain and soreness in arm/arm was painful; tachycard, high heart rate; very tired, sleepy; very tired, sleepy; headache, heavy in her head; pain in both ears; This is a spontaneous report from a contactable consumer (patient). This 71-years-Old female patient received the first dose of (Pfizer Biontech Covid 19 Vaccine, Lot No. EN6198) intramuscularly at single dose on 23Feb2021 for COVID-19 immunisation. Relevant history and concomitant drugs were unknown. Past dug included flu vaccine in Sep2020. The patient received her first dose of Covid 19 vaccine on 23Feb2021 at 3:30 in the afternoon. She came home and felt, not bad at any time but more or less towards 6:00 or 7:00 at night she started feeling bad. Her whole left side of body started going numb around 7 or 8 that night. Her arm was painful, face lips and all left side was numb. Felt like she couldn't move it like paralyzed a little bit. Clarified as whole left side, even her leg, her feet everything on that left side. She started feeling pains in bones of head, especially her face, clarified all of her face and her left side was numb even her lips on the left side were numb. Her tongue was a little numb. She had muscle and joint pain. The pain, of course, in the arm, but that was normal. Clarified pain in the arm as the injection site. She didn't feel any swell there. She did not take medication for anything. She used a lotion. The lotion was trividol aloe vera arnica caleudula and helped to relive the pain. The arm was still a little painful but it's not bad but that feeling made her tachycard, clarified as high heart rate, feeling like boom boom boom, but she did not have any shortness of breath. The high heart rate was gone the same day. She had no fever or chills. She felt very tired and slept for about 10 hours but during the sleepy she started feeling a headache she couldn't get up because she was so tired and she felt pain in both ears. She had not been to the doctor in a while. She was still old fashioned so she carries everything in a little telephone book. While trying to read information caller states she had to change her eyes. She still felt numbness in left side of left leg but she thought it might be because she had not been exercising. When she was waking up around 9am in the morning, it was yesterday that she felt better in regards to the paralyzed feeling. When pains in her face came she felt and she thought what is this? It only lasted for a little while. It was during the night. The pain and soreness in arm at injection site is still there, she did not feel any swelling, or hot at that site. She confirmed she still felt a little tired, sleepy. It's getting better. She may feel a little heavy in her head and would like to go to sleep, but she was not sleeping. She had many things to do and knew she had to be up. The headache went away and was gone on 24Feb2021. It was persisting for a while, not too hard or heavy, but it resolved by 2 or 3 in the afternoon on the 24th. In regarding to pain in ears she mentioned she no longer had. She had beeps, noise in her ears even at the time she went to bed it was better. The outcome of events paralyzed, pain in arm, tired, sleepy, was recovering, the outcome of events tachycard, pains in all of her face, pain in both ears was resovled, the outcome of other events was unknown.
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| 71 | 2021-03-10 | headache, fever, fatigue | Headache, fatigue,fever, muscle ache at injection site, naysea |
| 71 | 2021-03-10 | sweating, head discomfort |
20 minutes after injection, I began feeling progressively warmer as if I had beads of sweat on my fo...
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20 minutes after injection, I began feeling progressively warmer as if I had beads of sweat on my forehead. I began to feel light as if my body was light. The Lead Monitor came over and had my blood pressure and oxygen levels checked over the next 40 minutes before I felt actually fine and able to walk out. At no point did I have trouble breathing although that question was repeatedly put to me. Then at home I took it easy but noted anything out of the ordinary. 1.5 hrs after the injection and lasting only 2 minutes, I felt like a band was being tightened around my head to the point of discomfort but not pain. 24 hrs after the injection, for less than one minute, my left temple felt pressure as if I had a head cold. I haven't had a headache in a decade so this was unusual for me. 10 hrs after the injection, I was awakened to by cramping from lower Achilles to foot in my right leg only. This lasted painfully for 12 minutes. My right foot itself felt numb. I would stand to stretch the muscle/ tendon but then immediately felt nauseous. I hate feeling nauseous so I would lay back down only to have to stand again due to the pain of the persistent cramping. This was 12 minutes of excruciating leg cramps. When usually I might have only one or two very brief leg cramps per year. 14.5 hours after injection, I awoke very thirsty adn my skin felt very dry. I drank water and applied hand lotion. Thereafter the vaccine site felt sore but the injection site would have been invisible but for the bandaid outline that narrowed down where the injection had to have been located. The vaccine site was never red or pink or raised at all. Just a pin prick if you really looked for it. As a follow-up, the second Pfizer dose was Lot EM9809 on Feb. 26, 2021, and I had no reaction at all. No visible injection site in right arm, no warmness, no light-headedness, no cramps, nothing at all happened.
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| 71 | 2021-03-10 | malaise |
patient experienced tingling in her lips and scratchy throat at ~ 10 minutes after vaccination. Pati...
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patient experienced tingling in her lips and scratchy throat at ~ 10 minutes after vaccination. Patient took diphenhydramine 25mg PO on her own at 10:50. 11:00 not feeling well, team responded, BP 157/89, RH 75, pulse Ox 100%. We remained with patient for 15 more minutes. Patient's symptoms resolved. She was escorted to her car and feeling back to normal.
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| 71 | 2021-03-11 | chills, fatigue, headache |
12/10, 5:00 p.m. Loss of appetite, nausea (continued for next 18 hours), very sore right arm; 12/...
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12/10, 5:00 p.m. Loss of appetite, nausea (continued for next 18 hours), very sore right arm; 12/11, 3:00 a.m. Chills, all over body ache, headache, extreme fatigue, very sore arm; (continued for next 12 hours); 12/11, 12 noon, diarrhea, vomiting (one episode each); 12/12, 6 a.m. - 3 p.m. mild body ache, mild fatigue, mildly sore arm
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| 71 | 2021-03-11 | chills, headache | Joint pain over entire body, chills, nausea, bad headaches, site redness and tenderness,. |
| 71 | 2021-03-11 | dehydration, chills, fever |
led to a fall (possible faint) that caused a head injury (bone chip above her eye).; led to a fall (...
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led to a fall (possible faint) that caused a head injury (bone chip above her eye).; led to a fall (possible faint) that caused a head injury (bone chip above her eye); led to a fall (possible faint) that caused a head injury (bone chip above her eye); led to a fall (possible faint) that caused a head injury (bone chip above her eye); Nausea; shivers; fever; dehydration; This is a spontaneous report from a non-contactable consumer (patient) 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), (batch/lot number and expiry date not reported) via an unspecified route of administration, on 22Feb2021 (in the age of 71-years-old) at single dose for covid-19 immunization. Medical history included chronic headaches, high cholesterol, high blood pressure and minor heart condition. Patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included candesartan, rosuvastatin, gabapentin, topiramate, amitriptyline and erenumab aooe (AIMOVIG), all from an unspecified date for an unspecified indication. It was reported that 2 days after second dose (reported as 24Feb2021), the patient experienced nausea, shivers, fever and dehydration which led to a fall (possible faint) that caused a head injury (bone chip above her eye). As a result, the patient had an ER visit and they provided her with fluids and stitches. The outcome of events was reported as 'recovering'. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 71 | 2021-03-11 | headache, fatigue, fever |
Swollen lymph nodes, fever for three days, body aches covering entire body and joints, fatigue, head...
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Swollen lymph nodes, fever for three days, body aches covering entire body and joints, fatigue, headache. All events lasted for three days
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| 71 | 2021-03-11 | headache |
Afib episode; rapid heart beat; pain in jaw; diarrhea; headache; nausea; dizziness; This is a sponta...
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Afib episode; rapid heart beat; pain in jaw; diarrhea; headache; nausea; dizziness; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number El266) via an unspecified route of administration in the left arm on 05Mar2021 at 09:00 (at the age of 71-year-old) at single dose for COVID-19 immunisation. Relevant medical history included atrial fibrillation, asthma, chronic obstructive pulmonary disease, high cholesterol, acid reflux disease, depression and anxiety. Concomitant medications included clonazepam, apixaban (ELIQUIS), fluoxetine, metoprolol and simvastatin. On 07Mar2021 at 14:00, the patient experienced Afib episode, rapid heart beat, pain in jaw, diarrhea, headache, nausea and dizziness; the events Afib episode and rapid heart beat were considered serious as life-threatening. The patient received corrective treatment for the reported events, which included 2 tablets of metoprolol. The patient did not have COVID-19 prior to vaccination, and she was not tested for COVID-19 post vaccination. The patient recovered from the events on an unspecified date. No follow-up attempts are possible. No further information is expected.
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| 71 | 2021-03-11 | headache |
3/9/21 ER HPI Patient is a 71 y.o. female who presents with complaint of elevated blood pressure sys...
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3/9/21 ER HPI Patient is a 71 y.o. female who presents with complaint of elevated blood pressure systolic of over 200 since last night. Patient said that she has taken her blood pressure medications without much improvement. The elevated blood pressure is associated with frontal headache. No nausea vomiting, no dizziness, no chest pain, no cough or shortness of breath. No fever or chills
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| 71 | 2021-03-11 | sweating |
After first dose of vaccine, c/o chest pain, SOB, diaphoresis, BL arm pain, jaw pain. EMS was called...
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After first dose of vaccine, c/o chest pain, SOB, diaphoresis, BL arm pain, jaw pain. EMS was called and assumed care for transfer to hospital. Contacted patient 2 days after event and patient reports that she was feeling well. She notes that she was not actually transported to the hospital by EMS. She notes that she was evaluated in the ambulance. Since her EKG was normal, she states that she elected to be discharged home. She notes that she believes that she had an anxiety attack as she has events like this previously. She notes that she has discussed the event with her PCP. She is scheduled for 2nd vaccine on 3/20/21.
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| 71 | 2021-03-12 | chills, headache | Chills, headache and all joints aching |
| 71 | 2021-03-12 | headache |
Dull headache for one week and advil would not help. After the headache was gone I have a severe sti...
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Dull headache for one week and advil would not help. After the headache was gone I have a severe stiff and extremely painful left side of my neck. Have used heating pad and no I have on pain patches.
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| 71 | 2021-03-12 | fever, chills |
woke at1 am with pain, that made sleep impossible, diarrheas', nausea, chills , fever; still experi...
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woke at1 am with pain, that made sleep impossible, diarrheas', nausea, chills , fever; still experiencing at 2"15 pm
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| 71 | 2021-03-13 | chills, fatigue | Chills, shaking, dizziness, fatigue, loss of appetite |
| 71 | 2021-03-13 | headache, lethargy |
intense headache, muscle pain, chest pain, chills, nausea, vomiting, lightheadedness, lethargy I to...
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intense headache, muscle pain, chest pain, chills, nausea, vomiting, lightheadedness, lethargy I took Tylenol Extra Strength tablets for the headache & muscle pain. The headaches lasted for 3 days. The muscle pain for 3 days. The vomiting occurred on the day after the shot - 1 time. I remained nauseous for the next 3 days. The chest pain has been on and off for the past 2 days. It has been mild. The lightheadedness lasted for 4 days. The lack of energy is still ongoing, but is getting better.
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| 71 | 2021-03-13 | headache |
Developed slight headache about an hour after shot. Then 7:00 PM was hit with bad case of nausea. ...
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Developed slight headache about an hour after shot. Then 7:00 PM was hit with bad case of nausea. Had nausea meds and took one which calmed things down. Then at 3:00 AM on 3/13 2021 was hit with nausea again.. Took more meds for nausea and have been fine ever since. Developed overall Muscle Aches (not joint aches!) all day Saturday 3/13/2021. Still have some muscle aches today 3/14/2021. Left arm became sore on Saturday 3/13/2021 and whole left shoulder is sore today (3/14). Otherwise feel great!
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| 71 | 2021-03-14 | chills, fatigue |
Besides sore arm, chills, and fatigue, heart flutters were felt within 2- 3 hours of injection. Hea...
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Besides sore arm, chills, and fatigue, heart flutters were felt within 2- 3 hours of injection. Heart felt like it was skipping a beat and was continuous the rest of the day and night. Subsided gradually over the next 2 days after injection.
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| 71 | 2021-03-14 | chills |
Sore Arm for 6 days, migraine the next day only in the morning, chills not fever off and on, stomach...
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Sore Arm for 6 days, migraine the next day only in the morning, chills not fever off and on, stomach ache,
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| 71 | 2021-03-14 | dehydration |
moderate anaphylaxis - body shaking, rapid heart beat, high and fluctuating blood pressure, immedia...
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moderate anaphylaxis - body shaking, rapid heart beat, high and fluctuating blood pressure, immediate dry throat and feeling of dehydration, stomach cramps followed by diarrhea about half hour after onset. Symptoms eased after 30-40 minutes so that I could get home and then diarrhea and weakness and shakiness for 3-4 hours. No epi pen administered because breathing was ok
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| 71 | 2021-03-14 | fatigue |
Pt had her 1st covid-19 vaccine on March 8th -increased fatigue and muscle pain -increased Rhochi ...
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Pt had her 1st covid-19 vaccine on March 8th -increased fatigue and muscle pain -increased Rhochi Affects Pt to continue breathing treatments and immune boosting regimen - pt is going to have chest xray
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| 71 | 2021-03-14 | sweating, headache, fatigue, chills, fever |
Did not begin symptoms until 10 days after injection. Began with body aches on 10th day. On 11th d...
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Did not begin symptoms until 10 days after injection. Began with body aches on 10th day. On 11th day most severe: Extreme chills, all over body aches, fever, stomach pain, fatigue, nausea, severe headache. Days 12 - 14: Body aches, fever, stomach pain, fatigue, nausea, headache, sweats. Day 15 and day 16: (today) Tired, mild headache, fatigue, diarrhea.
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| 71 | 2021-03-14 | fever, chills | Fever and chills for 24 hours and swollen lymph node under left arm for 3/4 days |
| 71 | 2021-03-15 | headache, fatigue, cough |
Circulatory burning within 10 minutes, blurry vision, chest pressure, confusion & inability to conce...
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Circulatory burning within 10 minutes, blurry vision, chest pressure, confusion & inability to concentrate , extreme weakness & fatigue, extreme focused joint pain, headache, coughing and difficulty breathing requiring multiple nebulizer uses every 2 hours over 2 weeks, headache. Face & body rash, . Persistent exhaustion continues requiring 2-3 hour daily naps & non Fibro brain fog continues at 3 weeks.
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| 71 | 2021-03-15 | headache |
71 Year old female C/O Headache immediately after receiving the vaccine. States that "Headache is go...
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71 Year old female C/O Headache immediately after receiving the vaccine. States that "Headache is gone, I just wanted to make sure I'm Ok" Vital signs accessed. WNL. Patient didn't want to go to the hospital or receive further treatment.
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| 71 | 2021-03-16 | chills, headache, throat pain |
Numbing and tingling around mouth area, lightheadedness, dizziness, slight chills sore throat, tired...
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Numbing and tingling around mouth area, lightheadedness, dizziness, slight chills sore throat, tiredness, slight headache, injection site swelling and redness slight fast heartbeat,Light weakness
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| 71 | 2021-03-16 | chills, headache, fever, fatigue |
8 hrs after shot got sore joints, bones, and muscles, head ache, chills, fever up to 101. Fever brok...
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8 hrs after shot got sore joints, bones, and muscles, head ache, chills, fever up to 101. Fever broke 8 am the next morning. Soreness for the next 2 days. tired for 4 days.
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| 71 | 2021-03-16 | fatigue, body temperature increased |
Temperature started on March 4th (day 5 after the vaccination) and peaked at 101.7 on the 5th. Body...
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Temperature started on March 4th (day 5 after the vaccination) and peaked at 101.7 on the 5th. Body aches started on the 4th and got severe on the 5th. Took about 3 days for aches to finally subside. Slight fatigue for 5 days after the highest temperature. Only slightly cool. Heating pad was sufficient for that.
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| 71 | 2021-03-16 | fatigue, malaise, fever, headache |
3/10/2021-Shot given at 9:30 AM. in the afternoon was very tired and achy. Had a headache and gland...
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3/10/2021-Shot given at 9:30 AM. in the afternoon was very tired and achy. Had a headache and glands felt swollen.Took a 2 1/2 hour nap. 3/11/2021- Flu like feeling. Pounding headache, tired, sore muscles, injection site was sore, low grade temperature.( 99.9, 99.5, 100) 3/12/2021- Headache,feeling tried and unwell. Injection site very itchy and staring to swell 3/13/2021-two areas on the left arm are swollen and very itchy. Top swelling in arm near the injection site. Lower swelling is 2 inches by2 inches large 3/14/2021-Swelling in arm increased to 3 inches x 3 inches at the widest spots. Arm was red, hot to the touch and very itchy. 3/15/2021-Swelling in arm was the same. Call Dr. Was told I had " COVID arm"
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| 71 | 2021-03-16 | throat irritation |
After waiting 30 minutes after my injection, I left the hospital and was driving home when I began t...
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After waiting 30 minutes after my injection, I left the hospital and was driving home when I began to feel my face tingling and swelling. This was close to 45 minutes after the injection. I was not sure what I was feeling, but had a similar reaction to the first Shingles shot so I was monitoring what I felt. I went to a walk in clinic about 2 hours after this feeling began. The swelling was on the right side of my face from a midline of my top lip to my right cheek. The doctor I saw told me to take Benadryl and gave me scripts for a Medrol Dosepak and epi pens. I took the Benadryl and got through the evening. I took Benadryl on Saturday and stopped it on Sunday. My face was still puffy, but no worse. Sunday night, my face felt worse and I took the Benadryl again. Monday morning, my face was slightly more swollen. I decided to start the Medrol Dosepak. My face was not feeling good and my throat felt like I was swallowing a boulder when I ate making me think that my throat might be closing up a bit. I decided to use the epi pen, gave myself the shot, got the shakes from the shot, and went to the emergency room as instructed on the pen. My blood pressure was very high arriving at the hospital which was from the epi pen. I was watched at the hospital, the epi pen had done it's work, and I went home 4 1/2 hours later. I have had continued puffiness in my face. I have been given Famotidine to add to the Benadryl as I had with the shingles vaccine reaction. This Wednesday after getting the shot on the previous Friday.
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| 71 | 2021-03-17 | nasal congestion | Left ear, hearing diminished, tinnitus, feeling of congestion |
| 71 | 2021-03-18 | chills, cough | 1/11/2021 patient developed chills, cough. positive covid test. |
| 71 | 2021-03-18 | chills, fatigue, lethargy |
Chills; weak; couldn't get warm; fatigue; vomited; tired and lethargic; muscle pain; Low back pain; ...
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Chills; weak; couldn't get warm; fatigue; vomited; tired and lethargic; muscle pain; Low back pain; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unspecified if 'EL9264' or '3L9264'), via an unspecified route of administration, on 09Feb2021 01:30PM at a single dose on the right arm for COVID-19 immunization. Medical history included thyroid disease (was diagnosed in her 40s, 30 years ago) from 1991, blood pressure high (was diagnosed in her 40s, 30 years ago) from 1991, mitral valve prolapse from 2001 (was diagnosed about 20 years ago), little heart disease (which she was told was nothing to worry about), her heart running away from her (They did extensive heart tests and pictures, all that stuff, put her on a medicine called Atenolol which makes her heart beat regularly and not have spells while she is walking of her heart running away), and double knee surgery three years ago (2018) when they put in false knees. Concomitant medications included levothyroxine sodium (SYNTHROID) for thyroid disease, atenolol (ATENOLOL) from 1991 for 'her heart running away from her' (She has been on atenolol 30 years, since she was 40 something. It is good medicine, and she doesn't have her heart running away.), tramadol (TRAMADOL) for double knee surgery three years ago (2018) when they put in false knees, and she also takes two high blood pressure medications. The patient added that all of the medications she takes she has been on about 30 years. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), on 18Jan2021 01:30PM on the right arm for COVID-19 immunization. The patient reported that she had received both doses of the Pfizer COVID-19 vaccine. She has been told that the AEs (adverse events) associated with the vaccine would happen within 12 hours. However, her AEs had been occurring in stages. On 10Feb2021, she had muscle pain. On 11Feb2021, she woke up and threw up and was in bed all day having fatigue. At the date of report, 12Feb2021, she was still on her bed, tired, and having chills. She wanted to know if it is normal to have these reactions 3 days after the shot. She further reported that she got the second dose. And after feeling wonderful after the first dose, she got the second dose on 09Feb2021 and later that night her lower back was killing her. She later clarified that she had low back pain. She stated that she knows that part of side effects that she read for when someone got the shot was that they can have a headache and she was told side effects should only last 12 hours. She stated that on the 11Feb2021, she woke up that morning and couldn't make it out of bed and vomited, then had to get up and clean her bed and put on new sheets. She only vomited once. She stated she has been so tired and lethargic that she stayed in bed all day on the 11Feb2021. At the time of report, on February 12Feb2021, she was having chills, she couldn't get warm, and she didn't have a fever, but she is still weak. Since she was told side effects would go away within 12 hours and this has been three days, she asked if what she was experiencing was normal. As for corrective treatment the patient reported that she also takes tramadol since she had double knee surgery three years ago (2018) when they put in false knees; that's when she started taking Tramadol for that. She said she also took it for the back pain which it kept it at bay until it wore off. Her lower back pain is already gone at the time of report; she was just having chills still and was tired. She stated she has had so many symptoms on different days that she was just questioning. She stated that everyone else who was sick with the second dose it lasted 12 hours, and her friends who really got sick with it, hers is minor, but she would like to know if it is normal that it is still lasting. Outcome of the event low back pain was recovered on an unspecified date in Feb2021. Outcome of the events weak, couldn't get warm, chills and tired was not recovered. Outcome of the other events was unknown. Information on batch number has been requested.
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| 71 | 2021-03-18 | headache |
Extreme muscle pain and slight headache which was gone by 3/18/2021. Hurt to even turn head. Spike...
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Extreme muscle pain and slight headache which was gone by 3/18/2021. Hurt to even turn head. Spike in blood pressure on 3/18/2021 to 191/91. Returned to 152/71 on 3/19/2021.
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| 71 | 2021-03-18 | lethargy |
With the first vaccine I had a strong hypoglycemic episode 30 hours after the injection. The next d...
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With the first vaccine I had a strong hypoglycemic episode 30 hours after the injection. The next day, about 24 hrs. later I became very dizzy but didn't develop shaking, diaphoresis, or black spots in my vision. (I've had hypoglycemic episodes rarely, maybe every several years, but I know well what they feel like. No further episodes since then. I wasn't prepared for the episode and didn't have candy or orange juice handy. It required I lay down for 10 minutes while I was very shaky and cold, clammy diaphoresis. Pita Chips helped---I presume. Yesterday I received the second dose and 29 hours later I started getting hypoglycemic again but quickly drank some concentrated sugary lime juice. I remained slightly shaken but never developed black spots or diaphoresis. I still felt too light and shaky so I had another half glass of juice and feel normal after about 10 minutes. When I reported this, my daughter, who is an ER doctor, was doubtful the first time it was vaccine related because of the 30 hour gap. Before receiving the second dose, the doctor there also didn't believe it was related for the same reason. But I find it very odd now that after both vaccines, at around the 30 hour mark, I had the same effects. Except for a slight migraine- like headache, no other real symptoms----maybe some lethargy. I'm not diabetic, so I'm not on insulin or diabetic pills. I take a lower dose of blood pressure meds and have well-controlled hypertension. I can't even remember the last time (in years) I had hypoglycemia, but I've never had it as bad as I did the first time. Since I caught it this time with the juice and stopped the symptoms, I don't know if it would have reached the level of the first dose of vaccine.
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| 71 | 2021-03-19 | fatigue, fever |
A few days after injection low grade fever - 99-100 degrees F, fatigue, severe aching neck and back...
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A few days after injection low grade fever - 99-100 degrees F, fatigue, severe aching neck and back After about 7-8 days intense itching arm, raised red area, swelling at injection site. Still with me today
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| 71 | 2021-03-20 | body temperature increased |
Swollen, bright pink cheeks, swollen tongue and interior of mouth, swollen neck, very weak voice and...
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Swollen, bright pink cheeks, swollen tongue and interior of mouth, swollen neck, very weak voice and very weak overall. Per order of a MD steroid dose pack taken as well as Benedryl 50 mg three times daily. Symptoms worsened, nauseated and temperature elevated 1.2-4 degrees above normal. Went to emergency room. Given intravenous solumedrol, Pepcid and Benedryl, then sent home on prednisone 40 mg a day for four days. Symptoms continued. MD took another steroid dose pack. Still worse after first four doses. Then took doctor's orders, prednisone 60 mg for three days, 40 mg for three days, 20 mg for three days then 10 mg for three days while continuing to take Benedryl 50 mg three times daily. I continue to take Benedryl for pink swollen cheeks. I am still weak and have swollen cheeks and neck as well as reduced voice.
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| 71 | 2021-03-20 | headache, fever, fatigue |
fever; crushing body aches; diarrhea; headache; stomach pain; light sensitivity; not able to sleep f...
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fever; crushing body aches; diarrhea; headache; stomach pain; light sensitivity; not able to sleep from pain and disturbing thoughts, exhaustion; not able to sleep from pain and disturbing thoughts, exhaustion; Disturbing thoughts; This is spontaneous report from a contactable consumer (Patient). A 71-year-old female patient received first dose of BNT162B2 (COVID 19, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264), via an unspecified route of administration on 06Feb2021 at 11:00 AM in Left arm at single dose for covid-19 immunisation. Patient was not pregnant. Other medical history was reported as none. No known allergies. Other concomitant medications in two weeks included 500 VitC &100 Vit D per day. No other vaccine in four weeks was reported. On 06Feb2021 at 23:00 (11:00 PM) the patient experienced fever, crushing body aches, diarrhea, headache, stomach pain, light sensitivity, not able to sleep from pain and disturbing thoughts, exhaustion. No covid prior vaccination. No covid tested post vaccination. No treatment for event. Outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.
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| 71 | 2021-03-20 | fever, fatigue, headache, chills |
Moderate pain at injection site in right arm. Pain also began in non-injection left arm (site of the...
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Moderate pain at injection site in right arm. Pain also began in non-injection left arm (site of the first injection) about the same time and worsened over about 8 hours. The pain subsided in the left arm, the first injection site, but continued for about 24 hours in current injection site - right arm. Severe body aches, mild headache, chills, fever (101 F), fatigue, no appetite: began about 6 hours after injection and continued for about 30 hours. Temperature normal and symptoms subsided about 48 hours after injection.
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| 71 | 2021-03-21 | chills | Chills, have had them for several weeks now. Have not gone to drs. |
| 71 | 2021-03-21 | fatigue, headache, chills |
Woke up with my right eye partially closed. Mid afternoon, I had light pain behind right eye which ...
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Woke up with my right eye partially closed. Mid afternoon, I had light pain behind right eye which then radiated up into my head. Suddenly, I also felt very tired and achy with chills but no fever. That continued until I went to sleep that night. The next morning my eye was partially closed but much better then the former afternoon and evening. Also, there was no more headache, aches or chills. My right eye seemed to close a little more as the day went on. Better every day and completely open in about a week.
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| 71 | 2021-03-21 | fatigue, fever, headache |
extreme fatigue; faintness; severe headache; fever(100 degrees); nausea; shortness of breath; rapid ...
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extreme fatigue; faintness; severe headache; fever(100 degrees); nausea; shortness of breath; rapid heart beat; This is a spontaneous report from a non-contactable consumer. A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6205, via an unspecified route of administration, administered in left arm on 04Mar2021 as single dose for COVID-19 immunisation. Medical history included high blood pressure, pre-diabetic, penicillin allergies, allergies to sulfa drugs and bee stings. Concomitant medication included calcium. Historical vaccine included BNT162B2 on 11Feb2021 (lot number: EM9810) for COVID-19 immunization. On 04Mar2021, after 1 hour, the patient experienced shortness of breath and rapid heartbeat. At 12 hours, severe headache, fever (100 degrees) nausea, faintness, extreme fatigue 24 hours later, started to feel normal again 6 hours later. No treatment information was reported. The outcome of the events shortness of breath and rapid heartbeat was recovered on 04Mar2021, For events faintness, severe headache, fever (100 degrees), nausea and extreme fatigue was recovered on 05Mar2021. No follow-up attempts are possible. No further information is expected.
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| 71 | 2021-03-21 | headache |
Within 10 minutes I became nauseous. I left the vaccination center and drove home becoming increasin...
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Within 10 minutes I became nauseous. I left the vaccination center and drove home becoming increasing ill. When I got home I went to bed and slept for two days, nauseous, weak, body aches, a rash under the vaccinated arm and on my back left side, headaches, fever, sleep interruption, vivid dreams. The left arm which had been vaccinated was extremely sore and remained so, just recently lessening. I believe I had Covid 19 in February of 2020 and while I got ill, did not experience the severity of illness that I experienced after vaccination. Now, 17 days later I continue to experience weakness, headaches and recently have had difficulty breathing after exercise. Although the rash has gone away, the left side is still itchy, but less so. I have discussed this with my Doctor and he informed me that my response to second shot may be stronger, although he did not tell me to avoid the second dose.
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| 71 | 2021-03-21 | headache |
Patient presented with frequent falls and left sided weakness with severe headaches for greater then...
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Patient presented with frequent falls and left sided weakness with severe headaches for greater then 24 hours.
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| 71 | 2021-03-21 | malaise, fever, chills, head discomfort |
Shaking chills, Fever (102.2), nausea, vomiting, mlalaise, head pressure, hard red rash at injection...
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Shaking chills, Fever (102.2), nausea, vomiting, mlalaise, head pressure, hard red rash at injection site, swollen nodes at injection site arm axilla
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| 71 | 2021-03-21 | fever, headache | Low grade fever, severe headache, chills, body aches, nausea, for 4 days |
| 71 | 2021-03-21 | throat irritation | Tongue irritated, Throat irritated Rash appearing on stomach back upper legs very itchy |
| 71 | 2021-03-22 | fatigue | First Itching and later rash and then hives and extreme tireness |
| 71 | 2021-03-22 | headache, fever, chills, fatigue | Headache, chills, fever 100.7, fatigue, itchy redness below injection site. |
| 71 | 2021-03-22 | headache |
Headache, muscle aches, hypertension beginning 3 days after shot lasting for 1 week after first shot...
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Headache, muscle aches, hypertension beginning 3 days after shot lasting for 1 week after first shot, lasted 12 dats after 2nd shot
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| 71 | 2021-03-22 | headache |
First dose was uneventful. After the second dose of vaccine I experienced neck and back of head pai...
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First dose was uneventful. After the second dose of vaccine I experienced neck and back of head pain. It's always there. Ibuprofen does not take the entire ache away. Hoping that this will subside. Trying massage, yoga, and home heat massage. It's like a tooth ache.
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| 71 | 2021-03-22 | influenza like illness | FLU LIKE SYMTOMS, EXTREME PAIN IN NECK, EAR AND FACE |
| 71 | 2021-03-23 | chills, fever, sweating | Fever sweats chills vomiting disorientation |
| 71 | 2021-03-23 | headache, malaise, fatigue, throat irritation, sleepiness |
15 minutes after shot, numbness in lips, itchy mouth and throat, within about 5 more minutes throat ...
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15 minutes after shot, numbness in lips, itchy mouth and throat, within about 5 more minutes throat tightness, sensation of difficulty swallowing. Then abdominal pain, nausea, then feeling of something really wrong, I didn?t feel well, then got weaker and weaker, couldn?t lift arms, and felt extremely fatigued, trouble staying awake. Taken by ambulance to medical center. On route, ambulance stopped and another team came in. I was given epinephrine, zofran, Benadryl, and maybe a steroid? Not sure. When I arrived at hospital, t think I was given dexamethasone and famotidine. I was barely awake but could speak. Could not hold anything. After several hours, they woke me up, I felt myself again, and I was discharged. Following days I felt exhausted and dizzy, and had a headache. Took prednisone for five days.
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| 71 | 2021-03-23 | fever, dehydration, headache, malaise |
The patient initially presented (3/3/21) with headache, fevers, nausea, vomiting, diarrhea, myalgias...
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The patient initially presented (3/3/21) with headache, fevers, nausea, vomiting, diarrhea, myalgias, malaise. Patient related she was in her normal state of health and only started to feel poorly after she received her second COVID-19 vaccination three days earlier. She interestingly related that after her first Pfizer COVID-19 vaccination she had significant burning in her stomach that she noted but no other major symptoms and notably did not experience this severe burning in her stomach after the second dose. She denied any chest pain, current dyspnea, productive cough, sore throat, urinary symptoms, sick contacts. She has no history of C. difficile, no recent antibiotics, no recent spoiled foods, no recent travel, no history of radiation. She does have a history of GERD and has had gastritis with mild gastrointestinal bleeding in the past and undergone EGD negative for H. pylori infection. She also has undergone colonoscopies with polyps that have been removed and reported as tubular adenomas. As her hospitalization progressed, she was diagnosed with Severe Sepsis due to E. Coli bacteremia in setting of liver abscess, Cholelithiasis without acute cholecystitis, Atrial Fibrillation with rapid ventricular response, Transaminitis (which resolved). Patient was appropriately treated for these conditions. Also, her known uncontrolled diabetes was treated. Per an Infection Disease note on 3/9/21: The patient has had hx of biliary colic (self diagnosis) now with discovery of non-obstructive cholelithiasis on RUQ US it is plausible that the abscess originated from self limiting cholecystitis/cholangitis which would be consistent with recent abdominal pain exacerbated with oral intake. Difficult to state definitively any relation to COVID-19 vaccination, though may have resulted from associated dehydration. Additional COVID vaccine info (both Pfizer): first dose: 2/7/21 lot# EN 5318 second dose: 2/28/21 lot# EN6202
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| 71 | 2021-03-23 | fever, fatigue |
First shot didn't feel it. Second shot I have a huge welt, red arm and swollen. Had migraine next d...
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First shot didn't feel it. Second shot I have a huge welt, red arm and swollen. Had migraine next day, low fever, nauseous. Today, March 24, 2021, I have a bump under my left arm - swollen lymph node. Arm is still very red. , I was very fatigue d next day.
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| 71 | 2021-03-23 | fever, headache | Headache, nausea and fever |
| 71 | 2021-03-23 | fever |
DAY 1 - HIGH FEVER ( UNDER CONTROL WITH THE USAGE OF TYLENOL) DAY 2 - PALPITATIONS (MILD) DAY 3-DA...
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DAY 1 - HIGH FEVER ( UNDER CONTROL WITH THE USAGE OF TYLENOL) DAY 2 - PALPITATIONS (MILD) DAY 3-DAY 5 - PALPITATIONS DAY 6 - WOKE UP AT 3:30 AM DUE TO PALPITATIONS (AND ABNORMAL SINUS RHYTHM) WENT TO THE ER. RELEASED OH HER OWN INSISTENCE
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| 71 | 2021-03-24 | chills, headache, fatigue | Body aches and pain Severe headache Chills Exhaustion All lasted approximately 24-36 hours |
| 71 | 2021-03-24 | fatigue |
Excessive tiredness. Slept 16 hours straight for a couple of days. I talked to 2 different on peop...
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Excessive tiredness. Slept 16 hours straight for a couple of days. I talked to 2 different on people 3/20/21 on the phone and don't remember talking to them. After sleeping 16 hours I got up and fixed me dinner (which took about 1 hr). I sat down and ate my dinner and the next thing I knew I woke up with my empty plate in front of me. I had fallen asleep again and had slept sitting at the table for another 3 hrs. I was extremely sleepy for about 2 days and them I was fine. Other than being out of it for a couple of days I had no other adverse reactions.
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| 71 | 2021-03-24 | headache, fatigue |
severe pain in joints, wrists, elbows, ankles, hips/ ongoing headache behind eyes/nausea-joint pain ...
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severe pain in joints, wrists, elbows, ankles, hips/ ongoing headache behind eyes/nausea-joint pain wakes me from sound sleep, ongoing exhaustion, lack of appetite
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| 71 | 2021-03-24 | headache |
Delirium/had taken over her body and was the cause of her illness; Severe weakness (could not walk o...
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Delirium/had taken over her body and was the cause of her illness; Severe weakness (could not walk or get out of a chair); Severe weakness (could not walk or get out of a chair); Nausea; Diarrhea; Mild headache; Blurred vision; Significant swelling at injection site which spread to full upper arm; Significant swelling at injection site which spread to full upper arm; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 05Mar2021 08:00 (lot number: EN6199) as single dose for COVID-19 immunisation. Medical history included osteoporosis (not bothersome), known allergies to some antibiotics, and felt dehydrated. The patient was not pregnant at the time of vaccination. The patient was taking other medications like grapefruit juice. The patient previously received first dose of bnt162b2 on 12Feb2021 (dose number 1, lot number: EL9267, administration time: 08:00 AM, vaccine location: left arm). No other vaccines received four weeks prior to COVID vaccination. On 05Mar2021 12:30, the patient experienced severe weakness (could not walk or get out of a chair), delirium (was convinced that (name) had taken over her body and was the cause of her illness), nausea, diarrhea, mild headache, blurred vision, significant swelling at injection site which spread to full upper arm over next three days and remains troublesome. Other symptoms (unspecified) lessened within two to three days and are no longer of concern. The AEs resulted in doctor or other healthcare professional office/clinic visit. Event 'significant swelling at injection site which spread to full upper arm' were treated with application of steroid cream (for arm only). Outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination.
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| 71 | 2021-03-24 | malaise, headache, fever |
Day of vaccination arm was slightly tender. Day 6 my sleep was disturbed about 2 AM by a sick feelin...
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Day of vaccination arm was slightly tender. Day 6 my sleep was disturbed about 2 AM by a sick feeling (slight nausea and headache). Got out of bed at 5 AM with headache still present. Fever of 99.4 about 7AM. Headache continued on and off all day with 2 Tylenol. Fever went down but rose to 99.4 approx. 8PM no headache. Woke today, Thursday, at 5 with no headache but a fever of 100.4; went back to bed until 6. After a shower, my temp was down to 99. After exercise, it was 98. Feeling okay right now.
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| 71 | 2021-03-24 | sleepiness, headache, fatigue, chills |
chills; hives; headache; extreme fatigue/became very tired/exhausted; Couldn't stay awake; cannot fu...
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chills; hives; headache; extreme fatigue/became very tired/exhausted; Couldn't stay awake; cannot function; This is a spontaneous report from contactable nurse (patient) via medical information team. A 71-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: Unknown) via an unknown route of administration on 12Mar2021 at 11:30 at single dose for COVID-19 immunization in airfield where they build airplanes. Medical history included spleen removed many years ago due to enlargement from the blood disorder. Also had ongoing spherocytosis (States takes B12 and Folic Acid for this condition), ongoing sleep disorder, ongoing narcolepsy, chronic fatigue syndrome. She got pneumonia and respiratory failure after pneumonia vaccine and was hospitalized for 6 weeks. This happened years ago. She was almost died. So she avoids vaccines. Concomitant medications included ongoing methylphenidate hydrochloride (RITALIN) for sleep disorder and narcolepsy (20 years), folic acid for spherocytosis, cyanocobalamin (B12-VITAMIIN) for spherocytosis. No prior vaccinations (within 4 weeks). Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 12Mar2021 at 11:30 (Friday as reported). In the evening she started experiencing some reactions (caller states she got the paper with the side effects and it mentions that they are usually worse after the second dose of the vaccine); chills, hives, headache and extreme fatigue on 12Mar2021. She is still very tired (crippling fatigue) and her headache is not so bad. She felt fine until around 1700 of the same day, when she experienced chills, hives, headache, became very tired, couldn't stay awake and went to bed. The next day she still had a headache, was still tired, hives were gone. At this time, just the extreme fatigue is continuing. States that today she is so tired she cannot function. Also mentions that she did not get a vaccine card from the facility that administered the vaccination. States that she is sorry that she got the product because she has a history of chronic fatigue syndrome and wondered if this would trigger it; but that her doctor said it would not. Caller feels that it has, because she can't function and this is terrible. She was afraid to get the second dose if she felt this crappy after the first one. She had no soreness or anything from the injection. With this amount of fatigue, she is just exhausted. States she has not been seen by her doctor, did not expect her doctor to do anything. A visit to emergency room or physician office was not required for events. Events were reported as medically significant. Specific causality was not provided for each event by the reporter. The outcome of event hives recovered on 13Mar2021; for events headache and fatigue was not recovered; for other events was unknown. Information on lot/batch number has been requested.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the events,chills, hives, headache, extreme fatigue ,somnolence and cannot function cannot be completely ruled out.
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| 71 | 2021-03-24 | throat irritation |
Client began complaining of feeling dizzy and was flushed and hot. 3 RNs were on scene assessing cli...
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Client began complaining of feeling dizzy and was flushed and hot. 3 RNs were on scene assessing client. Vitals were taken (180/90; 97% RA; hr 97. Client was given water and a fan was placed near pt. Client then began to complain of chest discomfort and burning in her throat like heartburn. She also began to feel nauseous. The dizziness began to get better. The client initially began to say she was feeling better, a couple minutes later she began to complain of chest pain/pressure. She described it as an elephant sitting on her chest. She also stated that her left shoulder began to hurt. She was also pale. Her vitals at this time were bp of 170/85; 02 of 97%; hr of 78. 911 was called at 4:10pm and arrived at 4:15pm. Chest pain was down to a 4 and nothing of significance was noted by EMS on the heart monitor. Client was given the option to be taken to the ER and she consented to transportation.
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| 71 | 2021-03-25 | chills, fatigue, fever |
Sore arm, 3:00 pm date of vaccine, mild soreness remains 2 days later; chills and fever began approx...
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Sore arm, 3:00 pm date of vaccine, mild soreness remains 2 days later; chills and fever began approx. 11:00 pm date of vaccine (T 99.8), fever 101.2 and 101.3, down to 99.5 with 2 Tylenol day after vaccine; chills lasted an hour; fever broke about 1:30 am 2nd day after vaccine. Temp normal 2nd day after vaccine. Mild fatigue 2nd day after vaccine.
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| 71 | 2021-03-25 | chills, headache |
Chills and 100 fever 7pm Fever persisted through 3-12-2021 Chills for 2 days Diarrhea and vomiting ...
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Chills and 100 fever 7pm Fever persisted through 3-12-2021 Chills for 2 days Diarrhea and vomiting started 10pm continued for 3 days. Terrible headache for two days
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| 71 | 2021-03-25 | fatigue |
heart fluttering and dizziness 2nd day after the vaccination; heart fluttering and dizziness 2nd day...
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heart fluttering and dizziness 2nd day after the vaccination; heart fluttering and dizziness 2nd day after the vaccination; 6th day after the shot she had hot flashes and swelling; 6th day after the shot she had hot flashes and swelling; 2 weeks later had tiredness and dizziness; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in Feb2021 as SINGLE DOSE for COVID-19 immunisation. It was unknown if patient was pregnant at the time of vaccination. Medical history included allergies to penicillin and some other things. There were no concomitant medications. The patient experienced heart fluttering and dizziness 2nd day after the vaccination; repeated 3rd day after the shot; 6th day after the shot she had hot flashes and swelling; 2 weeks later had tiredness and dizziness. All events started in Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment was given for the events. The outcome of all events was unknown. Information on the lot/ batch number has been requested.
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| 71 | 2021-03-25 | headache | Headache Numbness in jaw and lips |
| 71 | 2021-03-25 | lethargy |
The first injection was uneventful. 30 hours after the second injection, respectively, patient sudde...
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The first injection was uneventful. 30 hours after the second injection, respectively, patient suddenly became dizzy. VS assessed. BP 90s/40s, which is abnormal for her, HR 30's which is abnormal, and temperature 95.1 orally. She became lethargic. EMS called and confirmed the same VS. Atropine give three times according to protocol without change in HR. Epinephrine dose given with some improvement in HR, but unable to sustain. Pt transported via EMS to Hospital where she was warmed mechanically, started on an IV epinephrine drip and transported to the cardiac ICU where she was monitored for 2 days. Clinically the patient improved after her body temperature normalized.
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| 71 | 2021-03-26 | fatigue, fever |
On Saturday Mar. 20th, I had my 2nd dose of the Pfizer vaccine. Approximately 3:00 AM, March 21, I ...
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On Saturday Mar. 20th, I had my 2nd dose of the Pfizer vaccine. Approximately 3:00 AM, March 21, I had a very severe reaction to the vaccine causing extreme pain in my belly and lower back. (Mainly my lower right back) The pain was exactly like my kidney stone pain...so painfully intense. Although trying to manage the pain with 2X 500 mg of acetaminophen every 6 hours, I was throwing up, pacing, rocking and becoming so weary of how was I going to get through this. A fever of 101.5 started sometime on Sunday and fluctuated but was no higher than 101.7. A heating pad helped to ease the pain and I was able to get some sleep until the flare up would start all over again. This continued throughout the day for 17 hours. By Monday , March 22, morning the intense pain was gone and my body was recouping. My stomach was achey from either the intense pain or the vomiting. I continured to run a fever of 101. until Tuesday afternoon, March 23.
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| 71 | 2021-03-26 | headache, fatigue, fever | Slight nausea, pain at injection site, fever, fatigue, headache |
| 71 | 2021-03-26 | headache, fatigue |
tired, headache in back of head, dizzy, warm chest, hypertension, evaluated by EMS, transported to E...
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tired, headache in back of head, dizzy, warm chest, hypertension, evaluated by EMS, transported to ER
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| 71 | 2021-03-26 | fever, fatigue |
Please note that I have had Covid-19 2 months prior and have since tested negative. Event: Low gr...
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Please note that I have had Covid-19 2 months prior and have since tested negative. Event: Low grade fever 100.5, extreme fatigue, body aches, sore arm at injection site.
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| 71 | 2021-03-27 | influenza like illness |
At 4 am one week after having received my second dose of Covid-19, I awoke very nauseated and procee...
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At 4 am one week after having received my second dose of Covid-19, I awoke very nauseated and proceeded to start vomiting. Around 7 am I began having uncontrollable diarrhea with weakness and dizziness following. No fever, just flu-like symptoms. With rest and liquids by mid-day I was starting to feel a little better.
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| 71 | 2021-03-27 | malaise, fatigue, chills |
Recd. 1st vaccine at 9:15 am, by 4:00 pm was not feeling well, went to bed. for the following 3 day...
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Recd. 1st vaccine at 9:15 am, by 4:00 pm was not feeling well, went to bed. for the following 3 days I had body aches, extreme chills, night sweats and nightmares, explosive diarrhia, extreme fatigue (slept 23 hours a day). Each following day I slept a little less, but the night sweats and fatigue lasted for 17 days. My temperature remained around 95.7. This is the sickest I have ever felt, even sicker than the Flu I had approximately 30 years ago! No reaction to 2nd vaccine!
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| 71 | 2021-03-27 | malaise |
On March 10th: - Patient woke up with swelling on the lower right side of her lip. - Usual foods eat...
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On March 10th: - Patient woke up with swelling on the lower right side of her lip. - Usual foods eaten that morning: mashed potatoes, milk, cream of wheat - Throughout the day, patient notes she was not feeling well. At 6 PM, she developed rashes on her hip, groin, and abdomen. At 7 PM, she took diphenhydramine 25 mg. By then, her mouth was swollen. Her tongue also started to swell. At 9:30 PM, she had increase itching, burning sensation, and hives worsened. Developed a large rash on her butt. At 10 pm, took a second diphenhydramine; notes she had tongue swelling voice changes (gravel-like quality), and bilateral facial swelling. She was also breathing rapidly. Went into the ER, was checked in after ~3 minutes. She was administered epinephrine IM, IV diphenhydramine, solumedrol 125 mg, and IV famotidine. Patient was also intubated for respiratory distress and airway swelling, and admitted to the ICU. Was intubated until the afternoon of the following day.
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| 71 | 2021-03-27 | fever, headache, fatigue | Headache, fever (101 degree) , violent shaking, and exhaustion; lasted about 36 hours. |
| 71 | 2021-03-28 | sweating, malaise |
Anaphylaxis; Respiratory distress; Sensation of throat closure; trouble breathing; Upper airway swel...
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Anaphylaxis; Respiratory distress; Sensation of throat closure; trouble breathing; Upper airway swelling; Tachycardia; Her tongue started symptomatic; sweating; Generalized erythema; general feeling of unwellness; energy is still very low; Generalized prickle sensation; Nausea; This is a spontaneous report from a contactable consumer (Patient) via telephone. A 71-year-old female patient (non-pregnant) received second dose BNT162B2 (Pfizer, Formulation: Solution for injection, Lot Number: EN9808) administered in Left Arm via an unspecified route of administration on 12Mar2021 at 13:30 at a single dose for COVID-19 immunization. Medical history included Cancer survivor, High BP, Allergies: Shell fish, Allergies: Latex, Allergies: Iodine, urticaria and insect bite/sting allergy, GI sensitivity to all antibiotic, Allergy: surgical scrubs, intestinal reaction to Pneumonia In 2017, (patient had intestinal reaction to Pneumonia Vaccine by (Name) for which she was administered antihistamine, IV Benadryl and Oral Benadryl). On 19Feb2021, patient took historical vaccine BNT162B2 (COVID 19, brand=Pfizer, Lot Number: EN6201) as 1st dose at 12:30 PM on left arm for Covid-19 Immunization and not received any vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. Patient did not receive any recent vaccines for any other conditions prior to the event being reported. Concomitant medication included hydrochlorothiazide taken for BP medication. The patient was not received any vaccine in four weeks. On 12Mar2021, patient experienced anaphylaxis 5 minutes after the vaccine 2nd dose which resulted to visit emergency room and was treated with EPI, Benadryl, Zophyin, DEX and Pepcid. Started with general feeling of unwellness. Her tongue started symptomatic, sweating, trouble breathing, they took BP they injected 1st dose of Epipen which had no improvement, however after 5 minutes given the 2nd dose and body reacted to Epinephrine. Then given Benadryl injection and transported to a different hospital. Corticosteriod DEX was administered. Patient was under ER observation for 5-6 Hours. On an unknown date in Mar2021, patient also experienced upper airway swelling, respiratory distress, difficulty breathing (without wheeze or stridor), energy was still very low, general feeling of unwellness, sensation of throat closure, her tongue started symptomatic, sweating, trouble breathing, tachycardia, generalized erythema, generalized prickle sensation and nausea. Therapeutic measures were taken as a result of anaphylaxis, respiratory distress, general feeling of unwellness, her tongue started symptomatic, sweating, trouble breathing. The outcome of all the events reported as recovering.
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| 71 | 2021-03-30 | chills, headache, fever |
Headache; Fever/fever reaching 99.7F; Chills; pain in the arms; I am a bit nervous in getting the se...
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Headache; Fever/fever reaching 99.7F; Chills; pain in the arms; I am a bit nervous in getting the second dose that I am getting palpitations; This is a spontaneous report from a contactable consumer or other non hcp. A 71-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 13Jan2021 (Batch/Lot Number: EH9231) as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from Mar2020 to Mar2020. The patient had the covid virus in Mar2020. The patient's concomitant medications were not reported. It was reported that she has a question, if a person had the covid virus earlier last year is it still okay to get the Covid vaccine. The first dose was given 13Jan2021. The patient had the covid virus in Mar2020. Caller clarifies that she is actually the patient in this case, and she is speaking about herself. Caller had the covid virus on Mar last year, relatively mild infection. She received the Pfizer vaccine last 13Jan2021. She spoke to a nurse last week since she started experiencing side effects, and was wondering if it was safe that she got vaccinated in the first place considering she had the covid disease prior. Caller mentioned experiencing side effects after the first dose of the vaccine, including severe headache, fever reaching 99.7F, chills, and pain in the arms (akin to getting the flu vaccine but worse). These symptoms have calmed down in a couple of days. She talked to her HCP about this who gave her tylenol but apparently did not do much in managing it. She wants to know if these side effects were expected from the vaccine. Patient was a bit nervous in getting the second dose that I am getting palpitations. Outcome of the events was unknown.
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| 71 | 2021-03-30 | fatigue, headache |
Headache; fatigue; sore arm; This is a spontaneous report from a contactable consumer (patient herse...
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Headache; fatigue; sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot Number: EL3302), via intramuscular in right arm on 05Feb2021 16:00 at a single dose for COVID-19 immunization. Medical history included Migraines and aortic valve insufficiency. Concomitant medications included acetyl carnitine hydrochloride (NEUROTIN), candesartan cilexetil (ATACAND), rosuvastatin calcium (CRESTOR), allopurinol (ELAVIL), topiramate (TOPAMAX) and calcium on unknown date. On 06Feb2021, the patient experienced headache, fatigue and sore arm. Treatment information was reported no. The outcome of the events was recovered on Mar2021. No follow up attempts are possible. No further information is expected.
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| 71 | 2021-03-30 | fatigue |
Right lower extremity DVT; Bilateral PE; Severe fatigue; This is a spontaneous report from a contact...
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Right lower extremity DVT; Bilateral PE; Severe fatigue; This is a spontaneous report from a contactable physician. A 71-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9269) via an unspecified route of administration on 25Feb2021 at a single dose for COVID-19 immunization. Medical history included Allergies: adhesive, CT scan dye & flu shot. Concomitant medication included rosuvastatin. The patient previously received first dose of BNT162B2 on an unknown date for COVID-19 immunization. The patient also previously took Demerol, guaifenesin;phenylephrine hydrochloride (ENTEX), epinephrine, amoxicillin;clavulanic acid (AUGMENTIN) and experienced allergies. On 03Mar2021 17:15 the patient experienced severe fatigue, right lower extremity DVT, Bilateral PE. Events were considered serious, due to hospitalization for 1 day and life threatening. Treatment was received for the adverse event which included apixaban (ELIQUIS). The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19 with unknown result on an unknown date. Patient was not pregnant. The facility where the vaccine was administered was in a hospital. Outcome of the events was recovering. Follow up attempts needed. Further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 71 | 2021-03-30 | fatigue |
1st dose Vaccine on Monday, super tired on Thursday; This is a spontaneous report from a contactable...
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1st dose Vaccine on Monday, super tired on Thursday; This is a spontaneous report from a contactable consumer (Patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot unknown reason=Not available/provided to reporter at the time of report completion), via an unspecified route of administration, administered in Left Arm on 25Jan2021 17:00 as SINGLE DOSE for covid-19 immunisation. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: N/A. The patient medical history and concomitant medications was not reported. If other vaccine in four weeks: No, Other medications in two weeks: No. Facility type vaccine: School or Student Health Clinic. The patient experienced 1st dose vaccine on Monday, super tired on Thursday (fatigue) (non-serious) on 28Jan2021 13:00. If treatment AE: No. It was also provided as product=COVID 19, brand=Pfizer, lot unknown=False, administration date=25Jan2021, administration time=05:00 PM, dose number=2. The outcome of event was recovered on an unspecified date in 2021. Information on batch/lot number was requested.
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| 71 | 2021-03-30 | fatigue |
I have been feeling a little dizzy and very tired.; I have been feeling a little dizzy and very tire...
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I have been feeling a little dizzy and very tired.; I have been feeling a little dizzy and very tired.; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation. Medical history included ongoing ovarian cancer. There were no concomitant medications. "For the last two days I have been feeling a little dizzy and very tired. I am dealing with active ovarian cancer at this time and am concerned about my ability to tolerate this vaccine. I am scheduled for chemo therapy treatment a week before my second shot. I am wondering if I should get the second shot. Could the second shot be delayed for a week?" The outcome of the events was not recovered.
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| 71 | 2021-03-30 | pneumonia, sweating, cough, nasal congestion, headache, chills, fatigue |
lung infection; horrible cough; headache; chills; nasal congestion; Exhaustion; sweats; This is a sp...
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lung infection; horrible cough; headache; chills; nasal congestion; Exhaustion; sweats; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on Feb2021 (reported as 27Jan2021; pending clarification) (lot number: EN62co) as single dose at the age of 71 years old for COVID-19 immunisation. Medical history included known allergies (unspecified). The patient was not pregnant at the time of vaccination. Concomitant medication included omeprazole (OMEPRAZEN), taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 on 27Jan2021 05:30 PM (lot number: ELX47) for COVID-19 immunization. The patient developed a severe lung infection two weeks and two days after her second vaccine (06Mar2021 05:00). She had a horrible cough, headache, chills, sweats, nasal congestion and exhaustion. She has been in bed for 13 days. The AEs resulted in doctor or other healthcare professional office/clinic visit. The patient was given steroid shot and brea (unspecified) as treatment for the adverse events. The patient was not diagnosed with COVID prior to vaccination. The patient underwent lab tests and procedures which included two chest x-rays with unknown results, both on unspecified dates; and COVID-19 nasal swab: negative on 06Mar2021 and also negative on 08Mar2021. The patient has not recovered from all the events at the time of this report.
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| 71 | 2021-04-01 | fever, headache |
Fever; Headache; Redness; Stiffness; Bruising; Neck pain; pain Swelling/Throbbing; pain Swelling; Th...
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Fever; Headache; Redness; Stiffness; Bruising; Neck pain; pain Swelling/Throbbing; pain Swelling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER; Solution for injection; Lot number: EL3302, COVID 19) administered in left arm via an unspecified route of administration on 25Feb2021 at 11:30 AM at single dose for COVID-19 immunization. Medical history included Sarcoma cancer (amputated hand), heart failure, patient was allergic to Morphine, nitroglycerin, pertussis, walnuts, corn and bees. Concomitant medications were not reported. On 04Feb2021 at 12:30 PM, patient received first dose of BNT162B2 (PFIZER; Solution for injection; Lot number: EL0142) administered in left arm for covid-19 immunization. No other vaccine was given in four weeks. It was reported that patient was given other medications in two weeks: 15 meds too many to list. On 25Feb2021 at 22:00, patient experienced fever, headache, redness, stiffness, bruising, neck pain, pain swelling and throbbing which resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The patient received treatment with Meloxicam for 10 days for the events. The patient not had covid prior to vaccination. The patient not tested for covid post vaccination. The outcome of all events was reported as not recovered.
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| 71 | 2021-04-02 | fatigue, respiratory tract congestion, cough |
Palms of hands itched tremendously and turned bright red; Palms of hands itched tremendously and tur...
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Palms of hands itched tremendously and turned bright red; Palms of hands itched tremendously and turned bright red; chest congestion with coughing; chest congestion with coughing; Brain fog; fatigue; muscle weakness; nausea; slight diarrhea; Extremely sore arm up into neck; Extremely sore arm up into neck; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6200), via an unspecified route of administration in the left arm on 15Feb2021 11:00 at a single dose for COVID-19 immunization. Medical history included arthritis and patient was 17 years post endometrial, ovarian cancer, stage 1; she had no known allergies. Concomitant medication included ibuprofen (ADVIL) taken for arthritis. The patient did not have COVID prior vaccination, had no other vaccines in four weeks and was not pregnant. She received the vaccine at a Public Health Clinic. On 15Feb2021 11:45, the patient experienced chest congestion with coughing lasting 45 minutes, brain fog, fatigue, muscle weakness, nausea, slight diarrhea and extremely sore arm up into neck. Twice after the first dose; first onset was 45 minutes after first injection. She also experienced palms of hands itched tremendously and turned bright red, lasting 20-25 minutes. Three days after first dose (18Feb2021). The day of the first injection plus three days after, something happened every day. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6205), via an unspecified dose in left arm on 11Mar2021 11:00 at a single dose for COVID-19 immunization. The patient has not been tested for COVID post-vaccination. Outcome of the events chest congestion with coughing was recovered on 15Feb2021 12:30, palms of hands itched tremendously and turned bright red was recovered on 18Feb2021 and of the remaining events was recovering.
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| 71 | 2021-04-03 | fatigue |
Six days after receiving the vaccine I woke up on Friday, March 12, with a complete feeling of exhau...
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Six days after receiving the vaccine I woke up on Friday, March 12, with a complete feeling of exhaustion. Weakness was extreme in my whole left side and could barely put weight on the left side. I thought this would pass so tried to get along. The next day, Saturday, March 13, the complete exhaustion was even worse. Trying to get out of bed was very hard. I called a friend and went to hospital here . I was admitted, tested, and kept for several days. The report came back that I had a series of "mini" strokes on the right side of my brain, affecting the left side of my body. I could no longer walk at all without aide of person or a walker, After that I was taken to rebab, . I was given pt, OT, etc, and discharged several days later. No doctor or staff could tell me whether this was caused by the vaccine but the close days of administering the vaccine and the sudden onset of symptoms make me very concerned. How can I take a 2nd vaccine without knowing if that will have a worse effect or kill me? Can I take a different vaccine for the 2nd round, without a risk of something worse happening? Can you report to me if there is any correlation at all between this vaccine and my mini strokes?
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| 71 | 2021-04-09 | fatigue |
Slurring speech and then exhaustion. So on March 22nd ER visit. Tests taken: Blood test and CAT Scan...
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Slurring speech and then exhaustion. So on March 22nd ER visit. Tests taken: Blood test and CAT Scan. All came back normal. March 26, MRI done. That showed a stroke. Then on March 31st, saw Drs. (neurologist). Confirmed the stroke and suggested Speech Therapy. Starting on April 19, Sppech Therapy begins. Since Stroke, I have to sleep 12-15 hours a day.
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| 71 | 2021-04-09 | fever, headache, influenza like illness |
Headache; Low grade temperature; Flu like symptoms achy; Flu like symptoms achy; This is a spontaneo...
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Headache; Low grade temperature; Flu like symptoms achy; Flu like symptoms achy; This is a spontaneous report from a contactable Nurse (Patient herself). A 71-year-old-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6207, Expiration Date: Unknown) via intramuscular route of administration in the left arm (Left deltoid) on 18Mar2021 at 15:00 as SINGLE DOSE for COVID-19 Immunization. The patients medical history included ongoing Psoriasis and Psoriatic arthritis from 2008. She had an MI and told her she needed to be on it for a year because of the stent. She has environmental allergies diagnosed 1998. Concomitant medication included Brilinta from 19Oct2021 at 90 mg twice daily as blood thinner. The patient had no family history. The patient had not tested for COVID-19 prior to vaccination and not tested after receiving vaccination. The patient experienced Low grade temperature, Flu like symptoms achy on 24Mar2021 01:00 and Headache on 25Mar2021:07:00 week after receiving the injection. The patient was on a blood thinner because she had a heart attack in Oct 2020. She had first dose a week ago today. She felt fine and had no flu like symptoms. She just had a little soreness. Last night, she had a low grade temperature and feels flu like today and is achy. She checked her temperature this morning. She is normally 97.8 degrees and it was 98.9 degrees. She has psoriatic arthritis and is achy anyway because of that. She has a slight headache when she woke up this morning. She did fine for a week, and through the night, developed these symptoms. No ER or physician's office required. The reporter assessed the events as serious. The outcome of the event headache was not recovered and outcome of all other events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 71 | 2021-04-11 | headache |
About 30 minutes after 2nd vaccine, I felt abrupt pain, shocks and tightening in 3 fingers on my rig...
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About 30 minutes after 2nd vaccine, I felt abrupt pain, shocks and tightening in 3 fingers on my right hand, starting at the knuckles down to finger tips. Pain occurred with or without movement. Knuckles are swollen on that On day 4, pain moved from knuckle to the joint between knuckle and finger tip. Pain occurs mostly with movement but not always, and is from mild to moderate pain. It is day 16 post vaccine, and I still have intermittent pain in the 3 fingers where I hadn?t previously had any prior to vaccine. 30 hrs after 2nd vaccine, I also had a severe headache lasting about 1 1/2 hrs.
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| 71 | 2021-04-14 | cough |
Death R05 - Cough J96.90 - Respiratory failure R55 - Syncope R41.82 - Altered mental status I95.9 -...
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Death R05 - Cough J96.90 - Respiratory failure R55 - Syncope R41.82 - Altered mental status I95.9 - Hypotension M25.551 - Right hip pain Z79.01 - On apixaban therapy
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| 71 | 2021-04-15 | fatigue, malaise |
71- year old woman with past medical significant for hypertension on 10 mg of Lisinopril daily for m...
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71- year old woman with past medical significant for hypertension on 10 mg of Lisinopril daily for many years. She had her first dose of Pfizer vaccine two weeks prior to admission (3/11/21). After her vaccination, patient felt unwell and dizzy in the mornings. She felt persistent fatigue and had a decreased appetite. The week prior to admission she noticed a decrease in her urine output. She denied NSAID use. Her primary care physician ordered blood week and her Cr was found to be 16.54 and BUN of 163, phosphate of 17.5. Her last known Cr prior to her admission was 18 months prior and was 1.17. She was asked to present to the emergency room. Renal ultrasound showed no hydronephrosis or stones. Urinalysis showed 1+ protein, spec grav of 1.023 with a urine protein/creatinine ratio of 0.09. Urine sediment was unremarkable. Her temperature was 95.6 and her BP was as low as 75/46 and she was put on a low dose of levo. CRP was 202.3. COVID was negative. CK wnl. ANA + to 1:160 (dsDNA, Smith, RNP, SS-A, SS-B all negative). Blood smear was negative. Cultures were all negative. Echo showed an EF of 68% with trivial pericardial effusion. Patient was oliguric, and then initiated on hemodialysis. Renal biopsy was performed. The biopsy consists of one fragment which is stained with H&E, PAS, Trichrome, Jones Silver, and HPS stains. Review of all stains reveals 12 glomeruli, one of which is globally sclerotic. The architecture of the kidney is well-preserved. There is interstitial fibrosis with proportional atrophy involving 10% of the biopsy tissue. There is a focal interstitial infiltrate consisting of lymphocytes involving <5% of the interstitium. The tubules show diffuse acute tubular injury. Calcium oxalate crystals are present in seven tubular profiles. The glomeruli show expansion of Bowman's capsule. The mesangium shows normal cellularity. The vessels show no abnormalities. IMMUNOFLUORESCENCE MICROSCOPY: Frozen sections are stained for IgA, IgG, IgM, C3, C1q, kappa, lambda, and fibrinogen. All immunofluorescence stains are negative. ELECTRON MICROSCOPY: Specimens are prepared for electron microscopy and semi-thin sections stained with toluidine blue are reviewed prior to thin sectioning for ultrastructural examination. Electron microscopy demonstrates patent capillary loops. The glomerular architecture demonstrates segmental corrugation of basement membranes with increase in lamina rara interna. No subepithelial deposits and no intramembranous deposits are identified. The tubules show dilated mitochondria and injury. There is segmental effacement of foot processes. There are no subendothelial deposits. Mesangial electron dense deposits are not identified. Patient received three dialysis treatments and Creatinine began to improved down to 1.46 within 8 days.
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| 71 | 2021-04-20 | malaise, fatigue, headache |
4/14-Resident c/o not feeling well and declined scheduled dialysis. c/o bilateral shoulder pain and...
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4/14-Resident c/o not feeling well and declined scheduled dialysis. c/o bilateral shoulder pain and fatigue. AP- 44, BP- 80/45, c/o headache, no chest pain and no SOB. Sent to CMC ER- patient deceased on 4/14/2021.
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| 71 | 2021-04-23 | fever, chills, fatigue, headache, sleepiness |
chills; slight temperature; body aches; headache; dizziness; extreme fatigue; no appetite; very slee...
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chills; slight temperature; body aches; headache; dizziness; extreme fatigue; no appetite; very sleepy; This is a spontaneous report from a contactable consumer. This consumer reported for herself that a 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: UNKNOWN) via an unspecified route of administration, administered in Arm Left on 08Feb2021 13:30 (at the age of 71-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. No chronic health conditions were reported for patient. Concomitant medications included daily calcium and vitamin pill. The patient previously took ciprofloxacin and experienced drug hypersensitivity, historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: UNKNOWN) via an unspecified route of administration, administered in Arm Left on on 18Jan2021 at 02:00 pm (at the age of 71-year-old) as single dose for COVID-19 immunization. On 08Feb2021 at 11:45Pm, the patient reported that he had these symptoms for the 2 days following vaccine included chills, slight temperature, body aches, headache, dizziness, extreme fatigue, no appetite and was very sleepy. It was reported that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior or post to the vaccination. Patient did not receive any treatment for the events. Events were considered non-serious as reported. Patient was recovered with sequelae form all the events. Information regarding Batch/ Lot number have been requested
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| 71 | 2021-04-24 | fatigue |
She says her tooth was bright red; her whole cheek and still; anxious aggravated; upset; she said th...
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She says her tooth was bright red; her whole cheek and still; anxious aggravated; upset; she said this what she has, almost like a fibromyalgia; Shingles became aggravated; she had had broken toe on the other foot that was killing her; total fatigue, no energy at all; total fatigue, no energy at all; abscess on tooth that will be pulled tomorrow; She doesn't have the strength that she had before; This is a spontaneous report received from a contactable consumer (patient) reported that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7534, Expiration date: UNKNOWN), dose 2 via an unspecified route of administration on 11Mar2021 12:00 as SINGLE DOSE, dose 1 via an unspecified route of administration on 18Feb2021 (Batch/Lot Number: EN620) as SINGLE DOSE for covid-19 immunisation. The patients medical history included ongoing asthma since she was 4 years old, ongoing herpes zoster (Shingles) since Nov2019, Raynaud's phenomenon for 20 years, High anxiety, gastroesophageal reflux disease from 4 years. Concomitant medications included amoxicillin at an unspecified dose taken for an unspecified indication for 7.5 days from 29Mar2021 to 05Apr2021; Advair Disc at an unspecified dose taken for an unspecified indication for maybe 30 years she is prescribed twice a day but takes it only once day, fluticasone propionate, salmeterol xinafoate (PROAIR BRONQUIAL) taken for an unspecified indication from an unspecified start date and ongoing; she had been on this for maybe 30 years, as needed, montelukast sodium (SINGULAIR) taken for asthma from an unspecified start date and ongoing for 30 years, multivitamin, sambucus nigra, sodium, zinc (MULTIVITAMIN, SAMBUCUS NIGRA, SODIUM, ZINC) taken for an unspecified indication from an unspecified start date and ongoing, she says she has been taking this forever because she never ate vegetables, magnesium sulfate (MAGNESIUM SULFATE) taken for bowels from an unspecified start date and ongoing from around 4-5 years as it helps with her bowels, felodipine (FELODIPINE ACTAVIS) taken for an unspecified indication from an unspecified start date and ongoing, for 30-40 years; rosuvastatin calcium (ROSUVASTATIN CALCIUM) taken for an unspecified indication from an unspecified start date and ongoing; calcium, colecalciferol (CALCIUM PLUS D3) taken for bones from an unspecified start date and ongoing for 30 years once menopause started, for bones, famotidine (FAMOTIDINE) taken for an unspecified indication from an unspecified start date and ongoing, says she has been on this for maybe 4 years because she was eating a lot of Rolaids. The patient was also taking for concomitant Products Hair, nail, skin vitamin for hair, nail, and skin health and says her nails are nice and strong, she still has wrinkles, but she says that was part of being old. The patient also said flu shot in Sep2020, pneumonia shot, shingles shot on an unspecified date and had nothing. patient says the first shot was nothing, everything was fine, the second shot she was thinking this is good, everything is good, it was on 11MAR2021 but by 14Mar2021 she was in total fatigue, started to get an abscess on tooth, she doesn't think this was because of shot, she has a prostheses, fake hip, her hip was killing her where the actual bone joint was, she had had broken toe on the other foot, that was killing her, she had no energy at all. She says normally, she is 71 years old, she was very active. She says her doctor takes care of everything, in her case she is asthmatic, everything, he does all of her bloodwork. she has to get this tooth pulled, she had some cadaver teeth put in, she went to the gym, everything was great, all the sudden she has an abscess, she went to her periodontist who says it is bad, it needs to be pulled. She says she was going to get her tooth pulled tomorrow. She reports her shingles seemed to get aggravated, her doctor said she will always have this, when she gets upset, aggravated or anxious it flares up, she is now back on the gabapentin, it is like pins and needles under rib cage where the actual shingles were. She says she was asthmatic but it did not bother her lungs one bit, she did not have any lung issues. She says everything happened on 14MAR2021. She reports that she does find she gets tired, she cooked all day Saturday, she stood over the stove all day, she did nothing but that all day. She says her tooth was bright red, her whole cheek and still, she took the last antibiotics, a heavy dose, last dose this morning too. She reports her foot is not bothering her anymore, her hip is still a little sore. She says she can do 2 miles in the gym, it was hard to exercise with mask on, it is always cold, she can't walk, she's limited to what she can do right now. she said this what she has, almost like a fibromyalgia, she diagnosed herself as having this condition, she Googles it and it says its muscle pain, she doesn't have the strength that she had before, she doesn't have hand strength, stamina, to walk a mile killed her, now she can do 2 miles, she is not 100% of what she was, she's coming along though. prior Vaccinations (within 4 weeks); she got her flu shot in SEP2020; AE(s) following prior vaccinations: She says flu shot, pneumonia shot, shingles shot, and had nothing. The patient was recovering from fatigue and asthenia, not recovered from tooth abscess and shingles and rets of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 71 | 2021-04-24 | headache |
severe pain across the front of her stomach/ rash/ shingles; severe pain in her head/it hurt to touc...
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severe pain across the front of her stomach/ rash/ shingles; severe pain in her head/it hurt to touch; severe pain in her head, it hurt to touch and had shocks and her whole body would cramp up; her whole body would cramp up; Tourette's; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198, expiration date: 30Jun2021) at the age of 71-years-old, via an unspecified route of administration in right shoulder on 05Mar2021 at 10:30 at single dose for COVID-19 immunization. Medical history included neuropathy in feet caused Tamoxifen (chemotherapy), anal cancer stage IV, breast cancer, double mastectomy, chemotherapy, and lymph node in left arm. Concomitant medications included gabapentin, meloxicam, and vitamins. There were no additional vaccines administered on the same date with the COVID-19 vaccine as well as within 4 weeks. The patient previously took tamoxifen as chemotherapy and experienced neuropathy in feet. The patient received her first COVID-19 vaccine on 05Mar2021 and on 13Mar2021, she experienced severe pain across the front of her stomach. On 19Mar2021, she said she has something, and it was a rash. She went to care facility on 20Mar2021 and was told she has shingles. The patient stated that the doctor just looked at her and said she has shingles, no testing was done. They told her it was ok for her to get the second shot, but she was worried about that. She experienced shingles since 13Mar2021, she still has it. She was supposed to have the shingles vaccine 4 years ago, but it was expensive. Her son heard on the radio that the shot may cause shingles, it may or may not be related but she wanted to let Pfizer know. The rash was starting to go away, and the pain was not, but the pain was far better. She ended up going to the doctor on 24Mar2021 with severe pain in her head since Mar2021, and she didn't know why. It hurt to touch and had shocks and her whole body would cramp up. Her daughter told her she looked like she had Tourette's, it was happening every 2-5 minutes. The doctor couldn't do anything and told her what she could take. It was an additional thing and the doctor said it was probably from shingles but she did not have a rash there. It was completely gone now. She received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727, expiration date: 31Jul2021), via an unspecified route of administration in right shoulder on 26Mar2021 at noon and stated that it was getting better then, and by 27Mar2021 it was gone completely. She was petrified this was going to happen while she was there to get the second vaccine and they would say she couldn't do it. The outcome of the event shingles was recovering and recovered on 27Mar2021 for all other events.
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| 71 | 2021-04-27 | headache, fatigue |
Dizzy; Blood pressure systolic high; headache; extremely tired; sore arm; This is a spontaneous repo...
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Dizzy; Blood pressure systolic high; headache; extremely tired; sore arm; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL1284 Expiry date: 01Apr2021), via an unspecified route of administration, administered in right arm on 28Jan2021 around 03:30 PM (at the age of 71-years), as a single dose for COVID-19 immunisation. The patient got her COVID-19 Vaccine in her right arm because she had her lymph nodes removed on her left side due to left-sided breast cancer. Medical history included Seizure (She had a seizure at age 6, again at 12, both times she was told that seizures were because of a high fever. She said she was given phenobarbital at the time. She said her tests always showed something was abnormal. She said her next seizure was in her 40s and she had an MRI, and nothing was there. Patient was started on medicine and sent to a neurologist. Patient said she went through lots of medicines and either had a reaction, or the medicine did not control her seizures. In 1998 seizure at her doctor office, and the doctor had to do CPR on her, and then had an ambulance taken her to the emergency room. Patient had a vagal nerve stimulator implanted for seizure control in 1998 and she has a lead that goes to her head and neck, and a battery in her right shoulder). Stroke (In 12Feb2002 that was caused by hormone medicine & seizure medicine that interacted with each other at 52 years old and was hospitalized for 4 months, needing physical therapy, speech therapy, and a couple other types of therapy), Total hysterectomy (in Dec2001, she was started on a hormone pill after her total hysterectomy and hormone pill interacted with a seizure medicine she was taking at the same time, and caused her to have a major stroke on 12Feb2002), Diabetes (2009), TIA (2009), Left-sided breast cancer (From Dec2015 and will make a decision to continue with cancer medicine, anastrozole 1mg takes at supper. Mfg. Zydus Pharmacy NDC: 68382-209-06, GTIN: 00368382209061, SN: 30100085636501, Lot: M009071, Exp: 30Jun2022), Lymphadenectomy, patient had unspecified allergies in the past from medicines and ongoing triglycerides that are out of the ballpark. Patient got her regular flu shot in either Oct2020 or Nov2020. The patient concomitant medications included Anastrozole, Jaediance, Vascepa and Prolia. Patient was taking Jardiance 10mg pill once in the morning at breakfast, for about 2 years, dispensed in a (Pharmacy Name Withheld) pharmacy bottle with no NDC, Lot, and Expiration Date, and the manufacturer is listed as Boehringer Ing on the prescription label. Patient was taking Vascepa 1gm capsule at dinner time daily, and after 3 months of taking Vascepa, her triglycerides are down to 190. She said she started Vascepa 1gram capsules about 1 to 1-1/2 years ago that was dispensed in a (Pharmacy Name Withheld) pharmacy bottle with no NDC, Lot and Expiration Date. She said the manufacturer is Amarin Pharma 1 as listed on the Vascepa 1gram prescription label. Patient couldn't take 2 Vascepa 1gram capsules because she was in too much pain. Patient was taking Prolia injection done twice a year from three years at her doctor office for osteoporosis. On 28Jan2021 (same day of vaccination), patient was immediately dizzy, sat down and the room was spinning, they checked BP and it was up to 180, unknown what was bottom number. They moved me to a separate room and continued to check my BP. Patient walked with a nurse to another chair, and the nurse checked back with her after 5 minutes, and she got even worse. The nurse checked her blood pressure on her right arm, and her top blood pressure number had jumped to 180. Later moved to a private room with a recliner where nurse continued to monitor her every few minutes. Nurse called an emergency room doctor around 3:30PM to see if she needed to be transferred to the hospital emergency room. The emergency room doctor told the nurse to continue monitoring her where she was, and as long as her blood pressure did not go any higher, or nothing else happened, she could go home. Patient blood pressure went down to 130 and she was released from the COVID-19 Vaccine waiting area at 5:30PM. Patient experienced a headache and was extremely tired and had a sore arm. Patient spoke to one of her doctors and they mentioned having the Moderna vaccine for her second dose and one of her doctors told her to take the second COVID-19 Vaccine dose, while another doctor told her not to get the second COVID-19 Vaccine dose. Patient asked if she should get her second vaccine dose if she experienced a reaction to the first also if her BP will go up again with the second vaccine dose because she was afraid it will do it again and asks whether she should take the Moderna instead. Patient asked if she still need to stay away from my new grandson, should wait 21 days after first dose, and should still wear a mask or she was protected. Patient stated that according to nurse, she was only the second person to have that kind of reaction. Patient informed nurse that she was diabetic, but she does not take insulin. She said her last Hemoglobin A1C was 6.4. Patient wanted to visit a cardiologist because she has a big family history of heart problems and though never had a heart attack, but she is always concerned because her triglycerides are out of the ballpark. She clarified that a normal triglyceride level is 150 and her triglycerides were staying over 300. Patient lab tests included blood pressure (180, later came down to 130), triglycerides (over 300) on 28Jan2021, cholesterol and Haemoglobin (6.4) on an unspecified date. The patient did not take any other vaccine on that same day, as well as four weeks prior vaccination. The patient had hoped to get the Moderna COVID-19 Vaccine. She said her primary care doctor told her to take the Moderna COVID-19 Vaccine, but she couldn't find anyone who she could register with. The outcome of the events dizziness and systolic blood pressure increased was recovered for and unknown for all other events.
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| 71 | 2021-04-27 | fever, headache |
lost partial vision in my right eye which has been determined to be a AION; blood pressure elevated;...
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lost partial vision in my right eye which has been determined to be a AION; blood pressure elevated; weak; dizzy; nauseated; fever; headache; This is a spontaneous report from a contactable consumer (patient). This 71- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EN6208), via an unspecified route of administration, on 11Mar2021 at 16:00 (at the age of 71-years-old) as a single dose for COVID-19 vaccination, in left arm. The facility where COVID-19 vaccine was administered was Public Health Clinic facility. Historical vaccine included: bnt162b2 (COMIRNATY, Solution for injection, Lot number EN6200) dose 1 on 18Feb2021 04:00 PM, for covid-19 immunization, left arm. No known allergies. The medical history included: Blood pressure abnormal. Concomitant medications included: Prozac, Inderal, Atorvastatin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 09:00 am, Day after 2nd injection, she felt weak, dizzy, nauseated, fever, blood pressure elevated and had an extremely severe headache. That evening I lost partial vision in my right eye, which has been determined to be AION. Vision has not returned at one month out. Event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment included: Blood pressure monitoring and return 13Apr2021. The clinical outcome of the events was not recovered. The patient was not tested for COVID-19 after the vaccination. No follow-up attempts are possible. No further information is expected.
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| 71 | 2021-04-28 | headache, malaise, fatigue, runny nose, fever |
muscle pain; back pain; fever; felt panicky; neck pain; runny nose; Stinging pain in left leg / pain...
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muscle pain; back pain; fever; felt panicky; neck pain; runny nose; Stinging pain in left leg / pain in left arm; pain in the joints; Red circle around injection site; Weak feeling in arms and legs; body feels heavy; dizziness; Very exhausted; Nausea; Diarrhea; Some cramping in stomach; Brain Fog; Body aches; headache; itchiness; Left arm sore at injection site; anxiety; not feeling well; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 28Feb2021 at 15:00 (at the age of 71-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes diagnosed 15 years ago, obesity, asthma with bronchitis as a child, allergy to other medications, anaphylactic reaction to sulfas twenty years ago (also reported as 50 years ago), muscle hurt/sore arm usually when she got a flu vaccine (unspecified) once a year, allergies to makeup and clothes (diagnosed at least 50 years ago), heart beats fast, low thyroid and borderline high cholesterol. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for 30 years for low thyroid, nebivolol hydrochloride (BYSTOLIC) taken for 25 years, rosuvastatin calcium, (CRESTOR OD) taken for 2 years for borderline high cholesterol and insulin (unspecified). The patient did not receive any other vaccinations on the same day or within 4 weeks of the vaccine. The patient previously took paracetamol (TYLENOL) and diphenhydramine (BENADRYL) as pre-medication since she had allergic reactions to some things and would get this before the flu shot; as well as salbutamol sulfate (PROAIR HFA) for runny nose and coughing. The patient had the first dose of the vaccine on 28Feb2021, and "they" wanted to give her diphenhydramine (BENADRYL) after the vaccine but could not since she was driving. After the vaccination, the patient was not feeling well for 2 days (as of an unspecified date) and thought she was getting better. On 28Feb2021, the patient experienced anxiety. She was more anxious when "that stuff" appeared on the news on day 4 and 5 after the vaccine. She took a small dose of clonazepam 0.5 mg, dividing the pill in 4 pieces as she never took the whole thing. She took it when she got extremely anxious and tried not to take it because it can be habit forming. She may take it 3 times a week or in the middle of the night. It helped a little bit, but she still felt panicky and upset. She woke up feeling anxious. She did not normally take these medications. The patient reported that she experienced headache (constantly several times a week) and left arm sore at injection site, itchiness/ itching all over body (not constant but still happening) from 28Feb2021. On Mar2021 (day 4), the patient experienced dizziness (comes and goes and was not constant like it was), was very exhausted, nausea (tapered off after 2 weeks), diarrhea, some cramping in stomach, brain fog (still struggling and forgets to take her insulin, not as bad as when she first noticed), body aches. At first, the body aches were a pain in the left knee and left elbow and then moved to various joints and muscles. The left knee and elbow pain persisted without ever going away, but also moved to different areas. The calf muscle in left leg pain is also constant. The patient experienced pain in the joints and stinging pain in left leg (below knee down to ankle) from 04Mar2021, runny nose (tapered off) from 07Mar2021, and on an unspecified date muscle pain, back pain, fever, neck pain, pain in left arm. On Mar2021 (two weeks after vaccination), the patient had a red circle around injection site not all the way filled in, but rim around where she got shot. On Mar2021 (3 weeks after vaccination), the patient experienced a weak feeling in arms and legs and other times when she stood up her body felt heavy (persistent but not every day). The patient spoke with her physician who did not believe the patient about the symptoms and recommended she seek psychiatric help. The patient had not received the second dose of the vaccine because her physician did not recommend it. She was upset because her physician told her she could not get the second shot. She was having worsening anxiety because she had not been feeling well for so long, going on 7 weeks. She visited her physician's office 6,7, or 8 times. The patient underwent lab tests and procedures on unspecified dates which included an ultrasound of the leg (did not have a blood clot), an X-Ray of the back (unknown results) and an MRI of the back (did not find anything) to determine the pain. The physician thought it might be a compression fracture, but the MRI did not show anything. The patient was tested for antibodies on 05Apr2021 and had zero antibodies. The clinical outcome of anxiety, felt panicky, neck pain was unknown; dizziness, headache, runny nose, itchiness, pain in the joints, muscle pain, back pain, fever, very exhausted, nausea, diarrhea, some cramping in stomach, brain fog, body aches, stinging pain in left leg / pain in left arm, weak feelings in arms and legs, body feels heavy, left arm sore at injection site, red circle around injection site, not feeling well, was resolving. No follow-up attempts are needed. Information on lot/batch cannot be obtained.; Sender's Comments: Linked Report(s): same patient, different vaccine dose/event
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| 71 | 2021-05-04 | fatigue |
Extremely tired; Sore arm; 2nd shot-muscle pain; This is a spontaneous report from a contactable con...
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Extremely tired; Sore arm; 2nd shot-muscle pain; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration in the right deltoid on 18Feb2021 (Batch/Lot Number: ENb298) as a single dose for COVID-19 immunization. Medical history included diabetes-onset date: years, stroke on 12Feb2002, breast cancer in Dec2015 and cholesterol, headaches, restless legs. Concomitant medications included rosuvastatin calcium (ROSUVASTATIN CALCIUM GENERIC) taken for cholesterol from an unspecified start date and ongoing; tocopherol, ubidecarenone (COQ-10 ST) taken for cholesterol from an unspecified start date and ongoing; gabapentin enacarbil (HORIZANT) taken for headaches, restless legs from an unspecified start date and ongoing; anastrozole (ANASTROZOLE) taken for an unspecified indication from an unspecified start date and ongoing; empagliflozin (EMPAGLIFLOZIN) taken for an unspecified indication from an unspecified start date and ongoing; eicosapentaenoic acid ethyl ester (VASCEPA) taken for an unspecified indication from an unspecified start date and ongoing; denosumab (PROLIA) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, first dose, lot number: EL1298) on 28Jan2021 for COVID-19 immunization and experienced blood pressure systolic high and dizziness. The patient felt extremely tired on an unspecified date and was hospitalized for about a week (7 days), had a sore arm on an unspecified date and was hospitalized for 2 days and experienced muscle pain on an unspecified date. No treatment was administered for the event extremely tired, for the muscular pain Tylenol was taken starting 24 hours after shot - stayed in shot area. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 71 | 2021-05-04 | pneumonia |
I also have COPD; It felt like I had Pneumonia; having trouble breathing; This is a spontaneous repo...
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I also have COPD; It felt like I had Pneumonia; having trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 02Apr2021 as single dose for COVID-19 immunization in an hospital. Medical history included pneumonia (had pneumonia many times before) from an unknown date. The patient's concomitant medications were not reported. On 09Apr2021, it was reported that the patient was having trouble breathing. On 12Apr2021, 10 days after, the patient reported "felt like I had pneumonia" and on an unspecified date, reported that "I also have COPD (chronic obstructive pulmonary disease)." The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 71 | 2021-05-13 | chills, malaise |
I also woke up in the evening drenched with sweat and chills, completely sweat; I also woke up in th...
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I also woke up in the evening drenched with sweat and chills, completely sweat; I also woke up in the evening drenched with sweat and chills, completely sweat; shaking so badly; I was that sick; First shot was February 25, the second shot was April 22nd; First shot was February 25, the second shot was April 22nd; have anaphylaxis at 30 minutes/probably something in the medication that she was allergic to; This is a spontaneous report from a contactable (patient) reported for herself that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number reported as EDOL71/ENOL71, unsure) via an unspecified route of administration on 22Apr2021 12:15 pm as 2nd dose, single for covid-19 immunisation. Medical history included shortness of breath, asthma. Concomitant medications included albuterol (SALBUTAMOL) and budesonide/formoterol fumarate (inhalation aerosol). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Feb2021 at the age of 71 years for covid-19 immunisation and she did fine. Patient stated that lot number for shot 2 looked like EDOL71. It could be ENOL71. The lady didn't write it very well. It could be EN or ED. She was calling to report she had a terrible side effect and she want to document it in the data. She couldn't give that to computer right now, she didn't feel well, she had the Pfizer shot 1 and Pfizer shot 2. She had anaphylaxis at 30 minutes and almost she had crashed her car just after the highway. First shot was February 25, she did fine, the second shot was April 22nd and she had a horrible reaction at 30 min. Patient stated that the problem is they didn't asked her if she was short of breath or if she had any pulmonary complication and so on the second shot she didn't say anything and she forgot to say she has asthma and no one asked her. she forgot to say and so they had her sit in 15min observation and she was fine and she had gone out after she got her vaccination record card sign, she got in her car and 15min. Later while she was driving she went into anaphylaxis. She had to pull over, thank god she didn't hit anybody, she pulled over and parked and she had her inhaler with her so she used the inhaler and she got in the back seat for half an hour to make sure that she drove home, she did not call 911. Patient further stated that she wanted to put it in documentation, if someone is taking something for asthma that probably should not have the second shot one medication is not good enough, the second dose and she also woke up in the evening drenched with sweat and chills, completely sweat and that happened about 8 to 10 hours after the shot on 22Apr2021. After the shot at 12:15 pm and she had the sweat about 11 O'clock at night when she had to lay down and she was shaking so badly she thought she was going to call 911, she was that sick. That's scary, patient stated "I must, I did have crashed in 3 or 4 people during that." So, it was very dangerous to someone who has asthma. That was probably something in the medication that she was allergic to. Outcome of the events was unknown.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the anaphylaxis.
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| 72 | 2021-01-04 | chills |
arms hurting; Lymph nodes hurting on the left side; chills in which she is hot and cold and she coul...
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arms hurting; Lymph nodes hurting on the left side; chills in which she is hot and cold and she couldn't get warm at first and then she is cold; high blood pressure/blood pressure was high 190/116; big toes hurting; nausea; dizziness; feeling weakness legs/Leg feeling weak; This is a spontaneous report from a contactable other HCP reporting for herself. A 72-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: CJ1686), via an unspecified route of administration in the right arm on 28Dec2020 15:00 at single dose for COVID-19 immunisation. Medical history included breast cancer on the left side, hypertension, hiatal hernia, glaucoma, heart disease, hypertension, lymphadenectomy (lymph nodes being taken out was about 20 years before) and headache from 27Dec2020. She was working Sunday into Monday morning and she went to the Director of Nursing, and said she has a Headache on the left side of the temple, and so she went to eye doctor, and he had a test order ESR and so she has a hemorrhage in the left eye, and show she doesn't know if this could be bringing on some of the side effects she was speaking about, like the nausea and the migraine. She has had No positive test for COVID prior to the vaccine, she must have had about 20 tests and all were negative. She has not had any Antibody tests. She had pneumonia vaccine maybe in the last 5-3 years and flu vaccine in Oct2020 and she experienced achy arm. On 28Dec2020 the patient experienced leg feeling weak (about 15 minutes after injection), nauseous at 21:00, dizziness. On 29Dec2020 the patient experienced arm hurting (in the morning), lymph nodes hurting on the left side, chills, blood pressure was high 190/116, big toes hurting. The patient was calling to ask if these side effects she was experiencing were normal. On 29Dec2020 the patient underwent ESR with unknown results. The patient reported that her arm hurting began on 29Dec2020 in the morning. The breast cancer diagnosis was prior to the vaccine as well as her lymph nodes being taken out was about 20 years ago. Her Lymph nodes hurting on the left side started on 29Dec2020 in the morning. Her Leg feeling weak started right after the injection, about 15 minutes after on 28Dec2020. The chills started on 29Dec2020 in the morning in which she couldn't get warm. Her feeling nauseous started on 28Dec2020 in the evening like 9 PM. The Temperature 98.1 was her current temperature taken right before the call, as well as her blood pressure. Her feeling dizzy started after getting vaccine on 28Dec2020, she was fine to drive home, but then again on 29Dec2020 in the morning she felt it also. Her legs felt funny like rubbery. The big toes hurting started an hour before, on 29Dec2020 it woke her up since it was jabbing. The outcome of the events was unknown.
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| 72 | 2021-01-05 | chills, fever, headache | fever (101 highest) headache, chills |
| 72 | 2021-01-07 | chills, fever, headache, cough |
Blood vessels across forehead were very enlarged like a big varicose vein; very sore to the touch; E...
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Blood vessels across forehead were very enlarged like a big varicose vein; very sore to the touch; Every place I touched my head where a blood vessel ran is where the pain was; Terrible chills; Ran the temperature about a 100; Really bad headache; Slight soreness in my arm; Cough; Temporal arteritis; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730, Expiry Date: Mar2021), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. Medical history included sinus issues, allergy, hormone replacement therapy. Concomitant medication included estradiol as hormone replacement, metronidazole (METROGEL), vitamins and supplements. Patient stated, "I had the COVID injection 19Dec, the first one, afterwards there was a slight soreness in my arm to take couple of days, that was it, until this past Monday (28Dec2020) which was the 9th day afterwards, I started having chills, terrible chills, ran the temperature about a 100 and had a really bad headache. Woke up the next day (29Dec2020), I had noticed the blood vessels across my forehead were very enlarged like a big varicose vein and were very sore to the touch. I realized that my headache, every place I touched my head where a blood vessel ran is where the pain was. I've googled all my symptoms and the word that comes up when I read about is - Temporal arteritis. I didn't know if there was any possibility that was connected with that injection. Along with the chills and the fever, I had also had a cough and a headache." Patient stated, "I have been taking Ibuprofen two 200 mg tablets, once today and once last night" as treatment. The outcome of everts was not recovered.
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| 72 | 2021-01-07 | cough, fever, fatigue |
she experienced signs and symptoms of allergic reactions which was progressing; fever; body ache; ti...
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she experienced signs and symptoms of allergic reactions which was progressing; fever; body ache; tired; feels like she doesn't have enough energy; dry cough; This is a spontaneous report from a contactable nurse. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 30Dec2020, the patient experienced signs and symptoms of allergic reactions which was progressing. Mentioned that she had fever, fever with temperature ranging from 98.7°F-102.2°F, body ache, tired and feels like she doesn't have enough energy, dry cough. Wants to know how long does the symptoms last. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 72 | 2021-01-07 | headache |
Day of injection - sore injection site Day 1 post injection - headache, nausea Day 2 post injection ...
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Day of injection - sore injection site Day 1 post injection - headache, nausea Day 2 post injection - nausea Day 3 post injection - increasing nausea, gas Day 4 post injection - Loose stool x 7, gas, nausea
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| 72 | 2021-01-08 | chills | Vomiting, Chills |
| 72 | 2021-01-11 | fever, chills |
Fever 101.9, chills, nausea, body aches, for a day (Thursday), felt better on Friday and ok on Satu...
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Fever 101.9, chills, nausea, body aches, for a day (Thursday), felt better on Friday and ok on Saturday.
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| 72 | 2021-01-13 | headache |
Injection site pain; the arm felt heavy; Aches and pains/the pain extended from her shoulder down to...
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Injection site pain; the arm felt heavy; Aches and pains/the pain extended from her shoulder down to her elbow; aches and pains/pain went from the injection shoulder and spread to the middle of her spine; aches and pains/pain went from the injection shoulder and spread to the middle of her spine; Nausea; total loss of appetite; stated that she gained 10lbs, but she is very physically active.; either not making blood or there was an interference; she was freezing/she woke up cold and could not get warm/ felt cold; she had a little headache; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, Expiry Date: Mar2021), intramuscular at left arm on 31Dec2020 at single dose for covid-19 prophylaxis. Medical history included low sodium, Covid-19 in Nov2020 (She had felt sick for a week and on 13Nov2020 she went to the ER and they did blood tests and she could not eat or drink for 3 days. She stated that she had 4 different IV fluids going and one of them was sodium and the other was for nausea), blood did not clot properly, broke her back. There were no concomitant medications.The patient had a unique reaction after receiving the Covid-19mRNA Vaccine. She clarified that she never had a reaction to a shot before. She received the vaccine on 31Dec2020 and was fine for the first 20 hours. She said that the next morning on 01Jan2021 at 0600 she woke up cold and could not get warm. She said that she spent the next 24 hours to where she kept adding clothes and blankets to keep warm. She stated that she was freezing and the she felt like the interior of her body was freezing even down to her toes felt cold. She also had injection site pain and the arm felt heavy and stated that the pain extended from her shoulder down to her elbow. She stated that the injection site pain was kind of delayed. She had aches and pains. She said that some of the pain went from the injection shoulder and spread to the middle of her spine. She had nausea and total loss of appetite and could not even eat. Her aches and pains after the vaccine were similar aches like she had with the Covid. She said that she had a terrible headache when she had Covid though. She stated that after the 24 hours of receiving the vaccine she had a little headache, but she took a migraine pill for it. She said that she was able to shed clothes, but she could not take a shower, but within 24-36 hours she was back to normal like it all never happened. She said that was when she figured out it was like her hemorrhaging with one of her childbirths. She explained that she had 3 children and hemorrhaged with each of her child births and was going into shock with one of them and felt this freezing sensation due to blood loss. She thought that her reaction to the vaccine was so bad that she was either not making blood or there was an interference. There was some kind of weird interruption. She said that her blood clots break down from minutes to hours after her child birth or with dental procedures. She had a PAI-1 deficiency or Plasminogen Activator Inhibitor-1 deficiency. She said that there was also something deeper that her doctors had not figured out yet too. She said that her blood did not clot properly. She said that she did not bruise or anything, but she was not allowed to have internal surgery without a transfusion. She said that her doctor's started to figure this all out after she broke her back before. She went to a hematologist and had her counts checked regularly. She said that she was being studied by 127 different clinics. She gained 10lbs, but she was very physically active. This was her first dose of teh vaccine. She said that her doctors told her that she needs to be under 48 hours of observation if she gets the second vaccine. Her primary care physician recommended that she did not take another mRNA vaccine. She said that she was taking their advice and canceled her second dose appointment. She said that when she had Covid-19 they did a Chest x-ray on 13Nov2020 and she had low sodium. She said that they gave her tramadol at the hospital for her headache, but she had already taken 3 migraine pills that day. She had already had her flu shot and read somewhere on a website, that mRNA vaccines might cause unstable anticoagulation. She wondered if it could be possible that Covid-19 antibodies interfered with her injection? The outcome of events was unknown.
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| 72 | 2021-01-14 | fatigue, headache |
At facility - tingling & numbness on lips and tongue - predominantly on the left side - this has con...
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At facility - tingling & numbness on lips and tongue - predominantly on the left side - this has continued with occasional spreading to nose & eyes & sometimes on other side of face - it waxes & wanes Same day - headache, dizzy, exhausted - lasted 2 days Next day - nausea, intestinal discomfort - continuing mildly Mild headache continuing
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| 72 | 2021-01-14 | fatigue |
The text phone contacts to me have not worked for past two days. My symptoms now are fatigue, genera...
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The text phone contacts to me have not worked for past two days. My symptoms now are fatigue, general achy joints and muscles, slight swelling and pain at the injection site. I am fine but need help with the survey sent via text does not work. Unable to "Do your weekly post-vaccination check in".
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| 72 | 2021-01-14 | headache, sluggishness |
Abdominal cramping, belly ache, nausea, diarrhea, headache in the night. Queasy in the morning. Sl...
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Abdominal cramping, belly ache, nausea, diarrhea, headache in the night. Queasy in the morning. Sluggish. Bland diet - rest. It seems to be resolving.
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| 72 | 2021-01-14 | headache |
2:15PM headache 10:30PM. Rash and itch on face trunk and under arms ...
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2:15PM headache 10:30PM. Rash and itch on face trunk and under arms Dry scratchy eyes , hazy vision Took Benadryl 25 mg at 10:45PM 1/15/2021. 9AM Rash subsided itch persists and eyes remain dry, scratchy and hazy vision gone 10 AM went to Dr
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| 72 | 2021-01-17 | fatigue |
After waking in the AM of the following morning after vaccination, felt total exhaustion and weakne...
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After waking in the AM of the following morning after vaccination, felt total exhaustion and weakness, unable to function with morning duties, left arm sore with a notable lump approximately 2 inches wide. Able to lie down and sleep for about an hour; awoke and felt better. Took two 200mg ibuprofen and laid down again. Within an hour of rest, felt awake with no weakness or exhaustion. Arm was less sore; however placed a warm heating pad on arm throughout the day which improved the lump and soreness.
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| 72 | 2021-01-18 | fever, chills | Low grade fever, chills, joint and muscle pain. |
| 72 | 2021-01-18 | fever, lethargy, chills |
joint pain persisted; confusion; anorexia; chills began 19 hours after injection; low-grade fever (1...
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joint pain persisted; confusion; anorexia; chills began 19 hours after injection; low-grade fever (100.6); hypotension; hypoglycemia; lethargy; the 2nd dose on 08Jan2021 /1st dose on 20Dec2020; This is a spontaneous report from a contactable Physician (patient). This 72-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 08Jan2021 05:00 PM at single dose (lot number: EK9231) for covid-19 immunisation. Medical history included diabetes, idiopathic encapsulating peritonitis and known allergies to Latex. Concomitant medications included insulin glargine (LANTUS), insulin lispro (HUMALOG), tamoxifen, apixaban (ELIQUIS), simvastatin. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) at left arm on 20Dec2020 01:00 PM for covid-19 immunisation. The patient experienced chills began 19 hours after injection, followed by low-grade fever (100.6), hypotension, hypoglycemia, lethargy, confusion and anorexia on 09Jan2021 12: 00 PM. Illness lasted 17 hours, treated with fluids, anti- inflammatories and sleep. Some new joint pain persisted. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event joint pain persisted was unknown. Outcome of other events was recovered/resolved with sequel.
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| 72 | 2021-01-19 | sweating, fatigue |
Patient seated in observation area after vaccination at 1412. At 1422 patient reported feeling heavi...
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Patient seated in observation area after vaccination at 1412. At 1422 patient reported feeling heaviness in chest rated at 7/10 pain scale, mandibular pain, appeared diaphoretic and fatigued, skin grey/pale, though remained alert and responsive to questions appropriately. Patient also communicates she was having some chest pain prior to the immunization today, though she indicated on her forms that she was feeling well today. Vital signs assessed, P72 R16 O2 99, patient denied difficulty breathing. Rapid response protocol initiated, applied 2L O2 via NC, transferred patient to wheelchair and taken to ED for evaluation by response team. ED assessment reveals calf tenderness and patient reporting TKA x 2 weeks ago, elevated D-Dimer, CT results pending at this time.
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| 72 | 2021-01-19 | sneezing, malaise, fatigue, runny nose | Sneezing,, stuffy, runny nose, and fatigue and malaise. |
| 72 | 2021-01-20 | malaise |
Community member receiving covid vaccine c/o abd discomfort and urge to defecate with left arm itchi...
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Community member receiving covid vaccine c/o abd discomfort and urge to defecate with left arm itching (vaccine receive in right arm). Escorted to bathroom without incident, no rash noted to either arm. Escorted back to monitoring area where approx 15 min later she continued to c/o abd discomfort and "crumminess." ED Charge RN contacted, ED staff transported patient via wheelchair to ED.
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| 72 | 2021-01-21 | chills | 3PM BURNING SENSATION IN THE EYES; DRY MOUTH; CHILLS/NO FEVER |
| 72 | 2021-01-21 | headache |
Patient had an increase in chronic headache frequency and had a near-syncopal episode on 1/21/21. Sh...
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Patient had an increase in chronic headache frequency and had a near-syncopal episode on 1/21/21. She stated that the near-syncopal episode lasted for about 10 minutes. She has had one prior episode that was caused by hypotension and dehydration.
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| 72 | 2021-01-23 | fever, fatigue | sore arm, slight fever, extreme fatigue. lasted most of the day and they are gone now. |
| 72 | 2021-01-24 | chills, fatigue, fever | Injection site pain, tiredness, muscle ache, chills, fever 100.1 |
| 72 | 2021-01-24 | chills | Chills Body Aches Soreness at Injection Site |
| 72 | 2021-01-24 | cough, headache, chills |
1st covid shot on 1/16/21. Then on 1/19/21 I had ortho inject a steroid in my thumb. Right after t...
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1st covid shot on 1/16/21. Then on 1/19/21 I had ortho inject a steroid in my thumb. Right after the steroid shot, I started reactions---Severe headache, chills, nausea, cough, upper chest pain, severe weakness, blood pressure up and down. Went to family doctor 1/22 and covid shot in office showed negative. Worse on 1/24/21 and went to ED. They did a chest x-ray, CTA chest, lots of bloodwork and covid test that took 2 hours to receive results. All was negative except the D-dimer test. Thye thought it might be a result of the 2 injections within days of each other.
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| 72 | 2021-01-24 | malaise, chills, headache |
leg aches, chills, joint pain, malaise started on 3rd day after injection. Today is day 8 after inj...
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leg aches, chills, joint pain, malaise started on 3rd day after injection. Today is day 8 after injection & still have malaise and nausea. Had headache yesterday and day before. Also woke up at 3AM yesterday and day before in a cold sweat. Some leg ache today as well. Have been taking 2 extra strength Tylenol every 6 hrs which sometimes gives relief but not always.
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| 72 | 2021-01-24 | fever, headache, chills |
chills, low grade fever, aches, pain in arm, slight nausea, headache started about 12 hours after re...
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chills, low grade fever, aches, pain in arm, slight nausea, headache started about 12 hours after receiving shot lessening after about 48 hours
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| 72 | 2021-01-25 | headache, fatigue |
At vaccine site, had numbness; tingling on lips and tongue on left side of face; tingling on left si...
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At vaccine site, had numbness; tingling on lips and tongue on left side of face; tingling on left side of face; headache/Mild headache; dizzy; exhausted; GI - mild naseau; intestinal discomfort; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL32216), via an unspecified route of administration on 09Jan2021 10:00 at SINGLE DOSE at arm left for covid-19 immunisation. Medical history included known allergies: yes. Concomitant medications included levothyroxine sodium (SYNTHYROID), lisinopril, fexofenadine hydrochloride (ALLEGRA), progesterone (PROMETRIUM [PROGESTERONE]), and "PULMICO". On 09Jan2021, it was reported that At vaccine site, had numbness, tingling on lips and tongue on left side of face. This has not subsided, sometimes spreading, waxing & waning. Same day - headache, dizzy, exhausted - two days. GI - mild naseau (nausea), intestinal discomfort - on going. Mild headache continuing. The patient did not receive treatment for the events. The outcome of the events was reported as recovering.
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| 72 | 2021-01-25 | sneezing, sneezing |
Experiencing vision blurriness, dry eyes, - utilizes eye drops and resolves. Feels "heavy" some sne...
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Experiencing vision blurriness, dry eyes, - utilizes eye drops and resolves. Feels "heavy" some sneezing too.
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| 72 | 2021-01-26 | chills |
extreme chills; neck is aching; right arm pain; the pain prevented her from sleeping; Itching; This ...
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extreme chills; neck is aching; right arm pain; the pain prevented her from sleeping; Itching; This is a spontaneous report from a contactable consumer report self. This 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at right arm on 12Jan2021 15:30 at single dose for covid-19 immunisation. Medical history included had COVID back in Nov2020, blood cholesterol abnormal. Concomitant medication included Pravastatin for blood cholesterol and unspecified water pill. No prior vaccinations within 4 weeks. No additional vaccines administered on same date. Patient received Pfizer covid vaccine on 12Jan2021 around 15:30. Her right arms started getting in pain about 11pm and the pain prevented her from sleeping most of the night till she took an Aleve around 6am. She took another Aleve on 13Jan2021. She can barely raise her right arm and it is ok if she does not try to use it but if she tried to use her right arm then it is inoperable. At 12Jan2021 night after she got the vaccine she experienced itching, she never got a rash, the itching never got bad and it went away. She has not taken her temperature. She was having extreme chills that started around 13Jan2021 3:00 pm and she cannot get warm, she has blankets piled on her. Her neck is aching (started 13Jan2021 afternoon) and she thought this may be from tensing up since she is cold. No emergency room or physician office visit. The outcome of "Itching" was recovered, of else events was unknown. Information on the lot/batch number has been requested.
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| 72 | 2021-01-26 | headache |
Severe Headache - for 2 days and took Tylenol, Face Swelling - for 1 day and took Benadryl, ...
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Severe Headache - for 2 days and took Tylenol, Face Swelling - for 1 day and took Benadryl, Diarrhea - for 1 day, Arm swollen and hot, - for 1 day, Body muscle pain - for 3 days
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| 72 | 2021-01-26 | sleepiness, headache |
Drowsiness and headache. I slept three hours after I arrived home from 2:30-5:30 and took tylenol...
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Drowsiness and headache. I slept three hours after I arrived home from 2:30-5:30 and took tylenol.
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| 72 | 2021-01-27 | body temperature increased |
Woke up at 6 am to the trunk of my body, mostly left side and spinal area very itchy. It was complet...
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Woke up at 6 am to the trunk of my body, mostly left side and spinal area very itchy. It was completely RED, burning & itchy. All Red. I waited 2 hours and it was not diminishing, took 2 Benadryl tablets. After 7 hours, the redness was disapating but I could see blotches of red hives (again mostly left side) which are mostly still there at 7:45 tonight. Still itchy but not AS itchy. Through all of this my temperature remained between 97.4 and 97.7 which is my normal body temperature. The highest my temperature reached after the 2nd vaccine was 99.3 on 1/26/21.
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| 72 | 2021-01-27 | fatigue, headache |
1st day after Vaccine, soreness on injection sight. 3rd day Fatigue and light headiness, 4th day he...
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1st day after Vaccine, soreness on injection sight. 3rd day Fatigue and light headiness, 4th day headache, nausea, mind fog and imbalance, 6th day ulcers on my tongue, very painful for 3 days, severe crippling muscle cramps in my toes on my right foot during the night while sleeping. hives and red blotches. I didn't feel like myself for at least 12 days after the vaccine. I'm a little nervous about today, 01/28/2021, I took my 2nd dose this morning. Hope I don't have to report anything on the 2nd.
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| 72 | 2021-01-27 | fatigue |
Started with stomach twinges, went away ,5minutes later another hit. Went to eat and when finished m...
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Started with stomach twinges, went away ,5minutes later another hit. Went to eat and when finished meal I started to get double over pain we went home and that took 15 min. The pain was sharp and continues for a total of 30 min. I payed down with heat pad then it went away .since then I feel very tired, no energy,and my arm still feels weak and sore after the first shot .today I go for the second one.
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| 72 | 2021-01-27 | headache |
DROOPING ON RIGHT SIDE OF FACE, EYE LID, RIGHT CHECK, RIGHT SIDE OF MOUTH, HEADACHE N SOME RIGHT EAR...
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DROOPING ON RIGHT SIDE OF FACE, EYE LID, RIGHT CHECK, RIGHT SIDE OF MOUTH, HEADACHE N SOME RIGHT EAR DISCOMFORT, EYE IRRITATION. CAT SCAN DONE AND ALL SHOWED OK AND THE FINAL OUTCOME ITS BELLS PALSY
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| 72 | 2021-01-28 | chills | Sever shakes and chilled to the bone. Fingers went numb with being so cold. |
| 72 | 2021-01-28 | sweating, fatigue |
12 minutes after receiving shot began to feel sweaty and light headed and like I was going to faint ...
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12 minutes after receiving shot began to feel sweaty and light headed and like I was going to faint - felt like something was going on with my heart.
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| 72 | 2021-01-28 | malaise, headache |
pain all around her neck; feeling dizzy; feels kind of weak; she can't think straight; feels like he...
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pain all around her neck; feeling dizzy; feels kind of weak; she can't think straight; feels like her head is big; she didn't feel good; headache; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), intramuscular on 14Jan2021 12:00 at a single dose on left arm for COVID-19 immunization. Age at vaccination: 72 years old. Medical history included hypertension, infection (term highlighted by the reporter: Yes; patient was admitted to a hospital from 29Dec2020 to 30Dec2020 due to infection), dyspepsia (reported as stomach, digestion), psoriatic inflammatory arthritis (she receives infusions for her arthritis once a month), sinus infection/sinus problems a month or two months ago, had cancer back in 1996 (had lumpectomy), stomach problems, and gastric endoscopy. Ongoing concomitant medications included losartan potassium, hydrochlorothiazide, omeprazole, and methotrexate. Other concomitant medications included folic acid, and plantago ovata (METAMUCIL). The patient had a regular flu shot a month ago (Dec2020). She can't remember when. The patient experienced headache on 14Jan2021. At the beginning, she had one, but then she got home, and the headache was like in the back of her head, like in her neck. She had pain all around her neck. She was feeling dizzy. She was able to sleep, however, the pain in her head is still there. She took aspirin along with her regular medication. When providing details, the patient made the comment that she can't think straight. She also has sinus problems, so she doesn't know if she has a headache from the sinus problems or because of the shot. She doesn't have a fever. She just feels like her head is big. She sees the date of when she is supposed to return for her second vaccine, 04Feb2021. She sees the lot number and then it has (name of center). The actual dose is unknown, she knows this is her first dose. She also receives infusions for her arthritis. She receives an infusion at a facility once a month, she used to receive it less than that, but her arthritis has been really bad, so she now does it once a month. She was supposed to go today but she didn't go because she didn't feel good. She had three COVID tests done because she had the sinus situation going on. A COVID test was done yesterday (14Jan2021) and it was negative. Another one was done when she had a gastric endoscopy on 09Dec2020. This test was also negative. She doesn't remember if she had another one in Dec2020 when she was at the emergency center, but all of her COVID tests have been negative. The patient has not recovered from headache. Outcome of the rest of the events was unknown.
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| 72 | 2021-01-29 | fever, chills | Body aches, low grade fever (99.4), chills. Lasted about 5 hours. |
| 72 | 2021-01-30 | head discomfort | Swollen lower lip, "head feels funny" |
| 72 | 2021-01-31 | headache |
Itching/itchy/back was itching like crazy; her shoulder and it was red and it looked like a hive/lik...
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Itching/itchy/back was itching like crazy; her shoulder and it was red and it looked like a hive/like pinpoint little dots/this happened in the same shoulder where she received the vaccine; her shoulder and it was red and it looked like a hive/like pinpoint little dots/this happened in the same shoulder where she received the vaccine; Slight, dull headache; son sprayed her back with a fragranced alcohol and and it started burning; she thought it was a mosquito bite; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL1284), intramuscularly on 06Jan2021 at about 13:00 at single dose in Left arm for COVID-19. There were no medical history and no concomitant medications. She was not allergic to anything. The patient previously took shingles vaccine for immunization before. The patient reported that in the middle of the week (in Jan2021) she started feeling itchy. She said that she did not take anything and never took the flu shot. She was itching so bad last night (on 17Jan2021) she was going nuts. Her doctor told her get BENADRYL. She looked at her shoulder and it was red and it looked like a hive. She said that 5 minutes later and it went away without her taking her BENADRYL. She took the BENADRYL dose that she picked up from and that put her out. She stated that she took 10ml. She was a little itchy. She stated that if you look at the area on her shoulder, it was like pinpoint little dots now and you can barely see it. She said that this happened in the same shoulder where she received the vaccine. She said that she w supposed to get the next one next Wednesday. The patient asked if this was a side effect or just a coincidence. She stated that her symptoms started about a week after the shot sometime, but she did not know the exact day. It was around 13Jan2021 or 14Jan2021. It happened in a matter of seconds and she thought she was seeing things, then it went away. It was red and raised and was gone within 5 minutes at the most. It was weird. She said that she thought it was a mosquito bite. The patient stated that her back was itching like crazy. She stated that she put alcohol on it and it went away. Her son sprayed her back with a fragranced alcohol and it started burning. She also had a slight dull headache in Jan2021 and she had never had that in her life. The outcome of events her shoulder and it was red and it looked like a hive/like pinpoint little dots/this happened in the same shoulder where she received the vaccine was recovered in Jan2021. The outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 72 | 2021-01-31 | headache |
Headache, upset stomach, nausea and diarrhea, and her face was sunburn red and started Friday the 29...
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Headache, upset stomach, nausea and diarrhea, and her face was sunburn red and started Friday the 29th and still sick. throwing up every 15 to 20 mins. Called Dr. on Sunday and was told to take aspirin and Tylenol
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| 72 | 2021-01-31 | fever, chills, fatigue | chills, fever, nausea, fatigue, body aches for six days so far |
| 72 | 2021-01-31 | fever, headache |
On day following shot, I became achy all over, had a headache and slight fever. I went home from my ...
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On day following shot, I became achy all over, had a headache and slight fever. I went home from my shopping trip, took a 3 hour nap. I felt worse so I went to bed and slept 14 hours. I felt better Saturday morning. That evening I noticed a rash on both legs, from ankles to my knees. It is still there, though it doesn't itch or make me feel sick.
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| 72 | 2021-01-31 | fever | severe muscle cramps , muscle fatigue , low grade temp |
| 72 | 2021-02-01 | fatigue, chills, body temperature increased |
Evening after receiving the 2nd COVID vaccine developed chills, body aches, fatigue temp 100.2 took ...
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Evening after receiving the 2nd COVID vaccine developed chills, body aches, fatigue temp 100.2 took Tylenol lasted for about 4-5 hours; fell 200 % better the next day.
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| 72 | 2021-02-01 | headache, chills, fatigue |
Heartbeat irregularities & "thumps" and intense headache -- both starting 6-8 hrs after injection an...
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Heartbeat irregularities & "thumps" and intense headache -- both starting 6-8 hrs after injection and lasting 36 hours. Also chills but no fever. Fatigue. I stayed in bed the entire next day.
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| 72 | 2021-02-01 | malaise, lethargy, influenza like illness, fatigue, sleepiness |
Felt like had the flu; Lethargic; Nauseated/ Nausea; overall unwell feeling, she did not feel well a...
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Felt like had the flu; Lethargic; Nauseated/ Nausea; overall unwell feeling, she did not feel well at all; she slept constantly/sleeping; Tiredness; did not eat; felt like throwing up; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ELI283) via an unspecified route of administration on the left arm on 15Jan2021 10:15 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. She mentioned she felt nauseated on 15Jan2021. She woke on 16Jan2021 and felt like she had the flu. From Friday until Sunday like until 12:45 she slept constantly. She experienced tiredness. She did not eat. She was just sleeping and felt like throwing up (Jan2021). She started the feel the nausea the same day she got the vaccine. She blew it off thinking it was nothing. However, the next morning she felt like she had the flu. She was feeling lethargic. The nausea went away yesterday afternoon. On 19Jan2021 was the first day she felt like herself. She felt like she had the flu soon as she woke up. She had this overall unwell feeling, she did not feel well at all in Jan2021. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require a visit to the emergency room and physician's office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No relevant tests done. The patient recovered from the events nauseated/ nausea and felt like had the flu on 18Jan2021; lethargic on 19Jan2021. Outcome of the other events was unknown.
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| 72 | 2021-02-01 | fever, runny nose |
dizziness; aches; fever; sniffles; pain at injection site; This is a spontaneous report from a conta...
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dizziness; aches; fever; sniffles; pain at injection site; This is a spontaneous report from a contactable health care professional (patient). A 72-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested) via an unspecified route of administration on 13Jan2021 at 07:00 PM on the left arm at a single dose for COVID-19 immunization. Medical history included hypothyroidism and allergies to eggs both from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient did not have COVID-19 prior to vaccination. It was reported that on 14Jan2021 at 07:00 AM, 12 hours after the vaccine, the patient experienced dizziness, aches, fever, sniffles and pain at injection site. The outcome of the events was recovered on an unspecified date in Jan2021. The patient did not receive any treatment for the events. The patient has not been tested for COVID-19 post vaccination. Information on the lot/batch number has been requested.
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| 72 | 2021-02-02 | headache, fever |
1st shot no issue 2nd shot - initial arm soreness, increasing in intensity in evening Morning after ...
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1st shot no issue 2nd shot - initial arm soreness, increasing in intensity in evening Morning after nausea, body aches, headache, fever peak at 101.5 -treated with anti-nausea Ondansetron ODT 8mg, Tylenol 500mg -
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| 72 | 2021-02-02 | fever, cough, headache, throat pain |
Headache, vomiting ,diarrhea, aching joints all over, low grade fever, slight cough ,sore throat, no...
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Headache, vomiting ,diarrhea, aching joints all over, low grade fever, slight cough ,sore throat, no taste or smell.
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| 72 | 2021-02-02 | runny nose | Runny nose & headache |
| 72 | 2021-02-03 | chills, fatigue, headache | Fatigue, headache, chills, aches in extremities. |
| 72 | 2021-02-03 | fatigue |
tends to have low blood pressure; Dizziness; she lies down and then gets up she is dizzy; tired; she...
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tends to have low blood pressure; Dizziness; she lies down and then gets up she is dizzy; tired; she might have almost fainted as the room was spinning; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1284, expiration date 0Apr2021), via an unspecified route of administration in the left arm on 18Jan2021 at 09:30 (at the age of 72-years-old) as a single dose for COVID-19 vaccination. Medical history included Reflux esophagitis, COPD and a root canal on 14Jan2021. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 28Dec2020. Past drug history includes sore arm after COVID-19 vaccination on 28Dec2020. It was unknown if the patient has any allergies to medications, food, or other products. The patient's concomitant medications included oral famotidine (FAMOTIDINE) 20mg twice daily for reflux, (tiotropium bromide) SPIRIVA 2.5mcg, two puffs once daily by mouth for COPD, latanaprost (LATANAPROST)125mcg; one drop each eye at night for Glaucoma, (TIMOLOL) 5% one drop twice daily to each eye and (LORATADINE) 10mg; take once daily by mouth as needed for allergy. The patient did not receive any other vaccine within four (4) weeks prior to the vaccine. The vaccine was administered to the patient at the hospital. On 19Jan2021 the patient experienced dizziness and feeling tired. The patient further described that she had the vaccine on Monday and since yesterday, when she woke up, she has a lot of dizziness; and again this morning when she woke up. Also, when she lies down and then gets up she is dizzy. Mentions she didn't see dizziness on the list of side effects. She knows that is a side effect of COVID. She is asking is dizziness is a side effect of the vaccine wants to know if she should call her doctor. She continued and mentioned that she noticed when she was waking up on 19Jan2021 she was so dizzy that she couldn't get out of bed. Adds she thinks she might have almost fainted as the room was spinning. Mentions she tends to have low blood pressure but this is not typical. As far as side effects from the vaccine she mentions she is tired. The tiredness started after the second dose and has continued through today but not as bad. The clinical outcome of dizziness was reported as not recovered, the outcome of fatigue was recovering and the outcome of almost fainted and low blood pressure was unknown.
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| 72 | 2021-02-03 | sweating |
go to the bathroom, remember wiping and them my husband standing over me on the floor; Sweating prof...
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go to the bathroom, remember wiping and them my husband standing over me on the floor; Sweating profusel; Product use for unapproved combination; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249) via an unspecified route of administration in the right arm on 19Jan2021 at 09:15 at single dose for COVID-19 immunisation. The patient was not pregnant. She received another vaccine (unspecified) in the left forearm on the same date of BNT162B2. Relevant medical history included allergies to tape and potential basal cell cancer. Concomitant medications included melatonin and multi vitamins. The patient previously received varicella zoster vaccine rge (cho) (SHINGRIX) on 21Dec2020, second dose in the left arm. The patient reported that she felt great after the shot at 9:30 am on 19Jan2021 and, at 13:30, she had a potential basil cell cancer removed, and she felt great. On 20Jan2021, at 1:55 am, she got up to go to the bathroom, she remembered wiping and then her husband standing over her on the floor. On 20Jan2021 at 01:45 am, she was sweating profusely; after a minute, she got herself off the floor, back in bed, and she had no feelings of any illness. The patient did not receive corrective treatments for the reported events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The patient recovered from the events on an unspecified date.
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| 72 | 2021-02-03 | lethargy, upper-airway cough syndrome, cough, headache |
positive for COVID; positive for COVID; cough; She felt lethargic and had a dull headache; She felt ...
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positive for COVID; positive for COVID; cough; She felt lethargic and had a dull headache; She felt lethargic and had a dull headache; Her arm hurt the night of the vaccine and the following day; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. This consumer (patient) reported similar events for two patients (patient's husband and patient). This is the first of two reports. A 72-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot EH9899), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunisation. Medical history included cholesterol. Concomitant medication included pravastatin sodium (PRAVACOR) for cholesterol, levothyroxine sodium (SYNTHROID), she had been taking both at least 10 years and were ongoing. The patient experienced her arm hurt the night of the vaccine and the following day since 04Jan2021. She had been tested a few times. Tested in (state) and then came to (state). Quarantined for two weeks and test were negative. She had COVID testing on 11Jan2021 and got results were 13Jan2021. She experienced positive for covid on 11Jan2021, cough and she felt lethargic and had a dull headache on 06Jan2021, she had a mild case, did not have a fever, she went to the walk in clinic, had lungs checked, her oxygen level was normal, she had been testing normal, she did not have any severe symptoms of the COVID, she got post nasal drip and She started Azithromycin on 11Jan2021. The patient was such a careful person. When she went to the supermarket, she wore a shield, mask, and gloves. She did not socialize, was home body. She had no idea how she got it. She did call her internist when she found out she had it. The patient underwent lab tests and procedures which included oxygen level: normal in Jan2021, oxygen level: good on an unknown date, COVID test: negative on an unknown date, COVID test: positive on 11Jan2021, lung checked: clear in Jan2021, testing: normal in Jan2021. The even outcome was unknown.
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| 72 | 2021-02-04 | chills, fatigue |
body aches/ body and legs aches; body and legs aches; joint pain; fatigues; chills; This is a sponta...
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body aches/ body and legs aches; body and legs aches; joint pain; fatigues; chills; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information team. A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on the right arm on 16Jan2021 at 18:15 at a single dose for COVID-19 immunization. The vaccination facility was a public health department. The vaccine was not administered at the Military facility. The patient had no additional vaccines administered on the same date of the Pfizer vaccine. Relevant medical history included gastroesophageal reflux disease (GERD) from an unknown date and unknown if ongoing. The patient had no family medical history. Concomitant medication included cimetidine for GERD, which she had been taking for years and years. The patient had no other vaccinations within four weeks prior to the first vaccination. The patient woke up on Tuesday, 19Jan2021, feeling off; she experienced body aches, joint pain, and fatigues. The symptoms (Sxs) were still ongoing. The patient had question regarding the side effects and duration: if these had been reported and was it normal to still feel the side effects and how long would it last for. The patient was also asking if these were indicative of something more serious. The patient added that her healthcare provider (hcp) told her to take 2 paracetamol (TYLENOL) every 6 hours; however, the Tylenol only lasted for 5 hours. The patient further asked that if she continued to have side effects, at what point should she be do something and wanting recommendations on management. The patient was also asking if the side effects would happen with the second shot. The patient further reported that she felt pretty good on Sunday and Monday (17Jan2021 and 18Jan2021), maybe just a little off, and stated that on Tuesday (19Jan2021), she woke up and started with the classic side effects body aches, joint pain, fatigue, and chills that had continued. She stated she was taking Tylenol 2 extra strength; it worked for about 5 hours and then the effects came back. The patient wanted to know if this was normal to last this long and had this been reported by others. She stated she had contacted her doctor and her doctor did not know. The adverse events did not require any visit to an emergency room or a physician office. Therapeutic measures were taken as a result of body aches/ body and legs aches, joint pain, fatigues, and chills. There were no relevant tests. The patient was not recovered from the events "body aches/ body and legs aches, joint pain, fatigues, and chills."
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| 72 | 2021-02-04 | chills | Chills, severe muscle aches, injection site irritation. |
| 72 | 2021-02-04 | headache |
Headache, fuzziness, and overall weakness that kept me in bed for 1 1/2 days. No fever. Took Tylenol...
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Headache, fuzziness, and overall weakness that kept me in bed for 1 1/2 days. No fever. Took Tylenol and Metamizole..
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| 72 | 2021-02-04 | influenza like illness | muscle aches, flu-like symptoms lost taste and smell 2/1/21 |
| 72 | 2021-02-05 | chills, sweating | Awakened by terrible chills, nausea, and sweats. |
| 72 | 2021-02-05 | headache |
Pfizer-BioNTech COVID-19 Vaccine EUA Laughing uncontrollably, slurring of words, headache, foggines...
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Pfizer-BioNTech COVID-19 Vaccine EUA Laughing uncontrollably, slurring of words, headache, fogginess. Event lasted about one hour.
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| 72 | 2021-02-05 | fever, fatigue, headache | Extreme fatigue, headache, fever 100.2, joint pain at injection site |
| 72 | 2021-02-06 | fever |
Fever the evening of the shot and the next night, sore are at the site of injection for two day Lymp...
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Fever the evening of the shot and the next night, sore are at the site of injection for two day Lymph node swelling the next night after the shot in the left arm pit and has subsided as of today but still tender
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| 72 | 2021-02-07 | chills |
14 hours after the injection I woke up and my teeth were hitting each other. I was not cold or hot. ...
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14 hours after the injection I woke up and my teeth were hitting each other. I was not cold or hot. Within a few minutes my body muscles began twitching uncontrolably. My arm,, legs,, jaw were all fluttering.. This lasted for one hour.
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| 72 | 2021-02-07 | fatigue | Fatigue day after injection |
| 72 | 2021-02-07 | headache, fever, chills |
received shot at 9:26am on 2/5 and felt arm tender and took 2 tylenol later in afternoon - woke up a...
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received shot at 9:26am on 2/5 and felt arm tender and took 2 tylenol later in afternoon - woke up around 2am Saturday 2/6 with body aches - headache -chills - took 2 more tylenol . Got up at 7am - still with same issues but with fever instead of chills and took 2 excedrin had symptoms on and off all day. On Sunday 2/7 - symptoms very mild only real discomfort was left arm still sore but ARM Pit really is sore. Took 2 excedrin and it made it mild discomfort. Only to wake up today Monday 2/8- with again really tender left arm pit & top of arm still moderately tender..
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| 72 | 2021-02-07 | headache |
About 5 hours after getting the vaccine, I developed a headache on 1/26/21. Somehow the vaccine see...
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About 5 hours after getting the vaccine, I developed a headache on 1/26/21. Somehow the vaccine seemed to inflame by nose and sinuses. I went from a headache to a pressure headache from below my eyes to the top of my forehead. Today, is 2/8/21 and I still have a headache. I have contacted my doctor, on 2/1/21 and she prescribed Celecoxib 200 MG for a week. On 2/4/21 I developed a lot of drainage at the back of my throat. I would like to know if I show take the second vaccine? Dr. has recommended that I hold off at this time.
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| 72 | 2021-02-07 | sweating, chills, malaise, headache |
pt stated that her left arm was very sore and then she woke up in a hot sweat, had chills, headache,...
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pt stated that her left arm was very sore and then she woke up in a hot sweat, had chills, headache, and was nauseated. She took medicine for nausea but then she felt even more sick and then vomited. Pt stated she is still nauseated and will contact her PCP if she doesnt get to feeling any better.
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| 72 | 2021-02-07 | malaise, fatigue, headache | site pain, tiredness headache, chills, feeling unwell |
| 72 | 2021-02-07 | fever, headache, fatigue | Tiredness, headache,chills, fever |
| 72 | 2021-02-08 | chills, headache, fatigue |
02/04 - chills and headache all day; 02/05 - headache, fatigue, nausea; 02/06 - headache (partial da...
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02/04 - chills and headache all day; 02/05 - headache, fatigue, nausea; 02/06 - headache (partial day), nausea (am); fatigue all day; 02/07 - minor fatigue most of day
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| 72 | 2021-02-08 | fatigue, headache, chills |
10 hours post vaccination, chills, joint and muscle pain, intense thirst, severe fatigue, headache, ...
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10 hours post vaccination, chills, joint and muscle pain, intense thirst, severe fatigue, headache, and slept 8 hours following morning still muscle and joint pain, fatigue improved, and remained tired throughout the day.
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| 72 | 2021-02-08 | headache |
Extreme headache in eye evening after, next day, and still happening. Drooping eyelid and eyeball on...
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Extreme headache in eye evening after, next day, and still happening. Drooping eyelid and eyeball on left side.
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| 72 | 2021-02-08 | headache |
Dizziness, loss of voice, swollen tongue & back of throat, difficulty swallowing, extreme headache, ...
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Dizziness, loss of voice, swollen tongue & back of throat, difficulty swallowing, extreme headache, & extreme neck ache. EMT's on site gave me a shot of 50 mg of Benadryl in my right arm. Halted the symptoms from getting worse, but symptoms did not clear until 24-48 hrs later.
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| 72 | 2021-02-09 | chills |
Burning sensation when vaccine was injected & the shot hurt. During the rest of evening my left arm...
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Burning sensation when vaccine was injected & the shot hurt. During the rest of evening my left arm was sore. During the night, I couldn't get comfortable because my left arm pit started to hurt and could tell it was somewhat swollen. Woke up next morning and I had a low grade fever and my lymph nodes were tender and hurt to touch. Fever lasted all day & into the late night day after vaccine, but the arm pit lymph nodes lasted three and a half days. They are still a bit tender but not swollen today (02/10/2021). I had NO body aches but a little chills.
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| 72 | 2021-02-09 | headache |
Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after vaccination patient reported dizziness, diplopia...
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Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after vaccination patient reported dizziness, diplopia, headache, and difficulty with answering questions. Denies chest and abdominal pain and shortness of breath. Patient transported to the emergency department where initial vital signs within normal ranges except blood pressure 170/119 mmHg. Physical and neurlogical exam noted above symptoms with cranial nerves, sensation, and extremty strength intact/normal. Patient's symptoms rapidly resolved without intervention. Repeat vital signs within normal ranges except blood pressure 134/91 mmHg. Determined patient experienced a vasovagal episode. Patient discharged to home stable.
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| 72 | 2021-02-09 | malaise, body temperature increased, chills, fatigue, headache |
Pfizer-BioNTech COVID-19 Vaccine EUA tiredness, headache, chills, nausea, vomit, feeling unwell, di...
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Pfizer-BioNTech COVID-19 Vaccine EUA tiredness, headache, chills, nausea, vomit, feeling unwell, dizziness and weakness
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| 72 | 2021-02-09 | malaise, pneumonia, fever, chills, sweating |
Started feeling unwell several days after shot. Chills fever soaked bed sheets and had to call in s...
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Started feeling unwell several days after shot. Chills fever soaked bed sheets and had to call in sick from work. Did telehealth visit with primary who recommended Covid test which came back negative. Primary advised going to Hospital emergency room for tests-she has been in hospital with pnemonia for 14 days and is now in ICU. Drs treating with high dose steroids, antibiotics and high dose oxygen. She is not recovering.
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| 72 | 2021-02-09 | nasopharyngitis |
allergy; cold; heart rate went up to 127, then stayed in the mid 80's; This is a spontaneous report ...
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allergy; cold; heart rate went up to 127, then stayed in the mid 80's; This is a spontaneous report from a contactable consumer (patient). This a 72-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date: not reported), via an unspecified route of administration, on 22Jan2021 03:45 PM at a single dose on the right arm for COVID-19 immunization. The patient was not pregnant. The patient had not received other vaccines in four weeks prior to receiving bnt162b2. Medical history included Hashimoto's, and allergy to statins and fluoroquinolones. The patient had no covid prior to vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) and liothyronine sodium (CYTOMEL). The patient also received another vaccine (unspecified), first dose on 22Jan2021 on the right arm. At about 12:30 or 1:00 pm on Saturday, 23Jan2021, the patient's heart rate went up to 127, then stayed in the mid 80's. She felt like she had an allergy or a cold all of a sudden. She had to rest for a few hours. By 4 pm she felt better. The patient was not tested for covid post vaccination. The patient did not receive any treatment. Outcome of the events was recovered on an unspecified date in Jan2021. Information on the Batch/Lot number has been requested.
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| 72 | 2021-02-09 | fever, headache |
Fever; Headache; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient...
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Fever; Headache; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. This 72-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: Unknown), via an unspecified route of administration on 15Jan2021 (at the age of 72-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was not reported. There were no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 20Jan2021, the patient experienced fever, headache and vomiting 5 days after vaccination. No therapeutic measures were taken as a result of the events. The clinical outcomes of the fever, headache and vomiting were resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 72 | 2021-02-09 | fever |
On my drive home, my face started burning. When I arrived at home the burning increased with redness...
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On my drive home, my face started burning. When I arrived at home the burning increased with redness I reported this information on Tuesday 1/26/21 to the provider of the vaccine. I was told to take Benadryl which I did immediately. On Wednesday, I continued to take Benadryl every 4 hours. On Thursday, my face continued to burn with redness and a rash. I then started to get a low grade fever and it appeared my face was swelling and then we decided to go to Urgent Care. The Doctor said my face was swollen and gave me a 1/2 dose of a steroid shot and a prescription for steroid pills. I saw my Primary Care Doctor 2/8/21 and he said I should not get the second dose of the vaccine.
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| 72 | 2021-02-10 | chills, fever |
got real sick; fever; Nauseous; chills and was freezing to death; chills and was freezing to death; ...
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got real sick; fever; Nauseous; chills and was freezing to death; chills and was freezing to death; her hands and feet were cold; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 25Jan2021 12:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that while on the way home, the patient got real sick, she had a 102 fever, had chills and was freezing to death, and was nauseous. She is feeling a lot better than she did earlier. The husband put a heating pad on her feet, her hands were cold, she had chills, she was cold all over, when you touched her, her hands and feet were cold. The first time he checked, her temperature when she was first home was 101.7, then went up to 102, and stayed there for a while, but she feels like it came down. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 72 | 2021-02-10 | fatigue, headache, chills, fever |
Nausea, Vomiting, fever, chills, body aches, severe headache. (49) hours Fatigue, headache , lighth...
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Nausea, Vomiting, fever, chills, body aches, severe headache. (49) hours Fatigue, headache , lightheaded continue
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| 72 | 2021-02-10 | fatigue, headache, throat irritation |
Blood pressure 170/84; lost ability to speak intelligibly; foggy; headache; scratchy throat; fatigue...
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Blood pressure 170/84; lost ability to speak intelligibly; foggy; headache; scratchy throat; fatigue; Body aches; This is a spontaneous report from a non-contactable consumer. A 72-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 28Jan2021, 11:00 AM (lot number:EL3249), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in Doctor's office/urgent care. The patient medical condition included right Bundle Branch Block, cardiac from an unknown date and unknown if ongoing. The patient had no known allergies. The patient concomitant medication included paracetamol (TYLENOL) and Upgraid. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 06Jan2021, 02:00PM (lot number: EL3249) at the age of 72 years for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for covid-19. Twenty-four hours after vaccine received, on 29Jan2021 at 03:00 PM, the patient suddenly lost ability to speak intelligibly. The patient stated "I was completely aware though a little "foggy". Blood pressure 170/84. Friend present thought I was having a TIA and called 911. Ambulance came. Within 25 minutes, my ability to speak returned slowly. By the time I got to the ER, (45 minutes after onset), my ability to speak had mostly returned." Many blood labs were drawn, CT of head done, MRI of head done. EKG done. No cause of incident or evidence of TIA seen. After 5 hours, the patient was discharged with orders to come back if symptoms reoccurred. The patient had a headache, scratchy throat, fatigue and body aches in 2021. Since then the patient had a variety of tests, labs and Dr. visits. Blood pressure has been higher than her normal of 120/80, at intervals during the day in 2021. Since no evidence of TIA has been found, the patient was wondering if there have been any other reports of this loss of speaking ability (aphasia) occurring with any other vaccine recipients. The patient received treatment for the events. The consumer considered the events as non-serious. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 72 | 2021-02-10 | fatigue, malaise, headache |
Injection site pain, tiredness, headache, joint pain, swelling, redness, feeling unwell, fast heart ...
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Injection site pain, tiredness, headache, joint pain, swelling, redness, feeling unwell, fast heart beat, dizziness and weakness. nausea.
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| 72 | 2021-02-10 | fatigue, fever, chills |
Date and time of vaccination: (list both if they received both shots): 1st: 1/18/2021, 2/8/2021 at 0...
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Date and time of vaccination: (list both if they received both shots): 1st: 1/18/2021, 2/8/2021 at 0900 Brand and lot of vaccine: Pfizer 1st#: el1283, 2nd#: el9263 Starting feeling chills in the afternoon, become worse in the evening. Fever of 101.5. C/o muscle weakness, fatigue. Feels like "covid symptoms". Taking Acetaminophen as needed. Site injection pain as well. Denies dizziness/neuro changes, SOB, chest pain or DIB.
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| 72 | 2021-02-10 | fatigue | Achy, muscle soreness, fatigue, lack of appetite, diarreha |
| 72 | 2021-02-10 | headache |
2:00 am seizure, dizzy, weak, diarrhea, nausea, head pain, rapid heart beat. This got better. 3:30 a...
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2:00 am seizure, dizzy, weak, diarrhea, nausea, head pain, rapid heart beat. This got better. 3:30 am bad seizure with foaming at nose and mouth, convulsions, dizzy, unable to move, terrible head pain, nausea, rapid heart beat, extreme hot and cold spells; freezing from bones out. The seizure got bettter after about an hour, but the tremors did not stop until around 6:00 am.The morning of the shot, I ate a banana for breakfast. Only thing I ate after the shot was late lunch was rice with tomatos in it, green beans, fried squash (all out of my garden).
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| 72 | 2021-02-10 | headache |
This was scary like waking up with Bells palsy/her neck froze up/when she woke up she could not look...
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This was scary like waking up with Bells palsy/her neck froze up/when she woke up she could not look up, down, left or right/It was like her neck was frozen or paralyzed, the muscles would not move; the muscles would not move/She was doing anything to loosen the muscles; shooting pain in her head; She was in a lot of pain in her head and neck.; her neurologist confirmed it was a muscle issue; This is a spontaneous report from a contactable consumer who reported for herself, a 72-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration in the left arm, on 21Jan2021 at the age of 72 years, at around 16:00 at a single dose for COVID-19 immunization. Medical history included her left eye had a virus that was finally taken care of back in Mar2020 but took a year and a half to heal. She had 5 surgery on that eye from an unspecified date. Also, her left lymph node got filled with fluid and was swollen but the doctors were not concerned about it. She would see an ENT for this. The patient has been seeing a neurologist who has done brain scans and MRI's due to the loss of peripheral vision do to eye problems. The patient has no allergies and is basically healthy. Concomitant medications include unspecified "natural stuff". The reporter stated she had a pretty bad reaction with the vaccine and it took 3 days to get over, her neck froze up. She woke on 22Jan2021 with the frozen neck. She got the first shot on Thursday, 21Jan2021, and on Friday morning, 22Jan2021, when she woke up she could not look up, down, left or right. It was like her neck was frozen or paralyzed, the muscles would not move. Any effort to move her neck would send shooting pain in her head. She applied a heating pad, took Aleve, she took a couple of them, a massager, biofreeze, and stayed in bed. She was doing anything to loosen the muscles. The next morning she was able to look up and down but still not left or right. She did the same thing for treatment that day. On Sunday, 24Jan2021, she was better, was able to move her head 3 of 4 directions. She continued with the treatment she had been using and by Monday, 25Jan2021, her muscles loosed up and her neck worked again. She was sure it is muscles and when she called her neurologist confirmed it was a muscle issue. She was in a lot of pain in her head and neck. The patient was under care for her neck and head and wondered if this happened because this was a weak area, she did not know if related. The patient remarked she was scared to get the second dose due to the problems she had with the first. She heard that the second dose was the one with worse side effects. She was in bed 3 days with this first one. It was reported that the events did not require a visit to Emergency Room, and required visit to physician office. Patient called the neurologist due to the pain and was told to go to acute care to evaluate but she didn't go. The patient stated that this was scary like waking up with Bells palsy and was wondering if she would ever get better. She has never had anything like this happen to her before. She has to be attributed it to the shot. The patient needed guidance on getting the second dose, and had questions about side effects. The outcome of the events was recovering. Information on the Batch/Lot number has been requested.
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| 72 | 2021-02-10 | nasal congestion, headache, throat pain | sore throat, headache, nasal congestion |
| 72 | 2021-02-10 | fever, chills, headache, nasal congestion, nasopharyngitis |
colds/flu/headache sxs started about Feb 5, 2021 called number listed and spoke to pt herself. pt s...
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colds/flu/headache sxs started about Feb 5, 2021 called number listed and spoke to pt herself. pt states she had fever and chills this past saturday and sunday. pt was tested for covid monday and was just contacted she was covid positive (unsure test performed). pt today only has nasal congestion. she has not contacted pcp about her positivity. she inquiring about her son who has downs syndrome and has a heart condition. rec: contact pcp for further treatment and or therapies, quarantine herself, wear masks, wash hands, and have son stay with family and limit exposure to her. contact his md for possible vaccination.
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| 72 | 2021-02-11 | chills, influenza like illness |
flu likesymptoms, body aches, chills , patient is no longer feeling those symptoms but last week sta...
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flu likesymptoms, body aches, chills , patient is no longer feeling those symptoms but last week started experiencing"insides shaking". Patient voiced still feeling like "insides shaking" Date and time of vaccination: (list both if they received both shots):1/12/21 11:00, 2/2/21, 11:00 Brand and lot of vaccine:1 vaccine Pfizer lot# EL1283, 2nd vaccine: Pfizer lot #EN5318
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| 72 | 2021-02-11 | headache, chills | Side effects - Headache, Muscle pain, Chills, Joint pain, Fast Heartbeat |
| 72 | 2021-02-14 | influenza like illness | Flu like symptoms |
| 72 | 2021-02-14 | malaise |
20 minutes after administration, left bottom lip started to tingle and then tip of tongue began to t...
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20 minutes after administration, left bottom lip started to tingle and then tip of tongue began to tingle. Also feeling of "unwellness". These symptoms resolved in 3 1/2 hours. The next morning, felt as though I was coming down with illness. this resolved by afternoon.
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| 72 | 2021-02-14 | throat pain, headache |
headaches; Sore throat; This is a spontaneous report from a contactable consumer (reporting for a pa...
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headaches; Sore throat; This is a spontaneous report from a contactable consumer (reporting for a patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),lot number unknown, via an unspecified route of administration on 21Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient's concomitant medications were not reported. The patient experienced headaches and sore throat on 24Jan2021 (also reported as "headaches days 3-6 post-vaccination, Sore throat starting day 6"). The outcome of events was not recovered. Patient did not receive any treatment due to the events. Follow-up attempts are completed. The following information on the batch number has been requested.
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| 72 | 2021-02-14 | fever |
Low grade fever; heart palpitations; This is a spontaneous report from a contactable consumer (patie...
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Low grade fever; heart palpitations; This is a spontaneous report from a contactable consumer (patient) A 72-years-old no pregnant female patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from lot# El9262 on 27Jan2021 (at age of 72 years old ) in the right arm 08:30 at SINGLE DOSE for covid-19 immunisation . First dose received on 06jan2021 (lot#EI3246) 10:30 in the right arm .The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered:Other. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient experienced low grade fever and heart palpitationson 28Jan2021 07:00 .Events were reported as non serious.No treatment received .Outcome of the events was recovered.No Prior to vaccination, was the patient diagnosed with COVID-19.Since the vaccination, the patient had been tested for COVID-19.
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| 72 | 2021-02-15 | chills, body temperature increased | T 102 on yesterday+chills this morning with red (right and neck) and swelling |
| 72 | 2021-02-15 | chills, fever, fatigue | Fatigue, chills, fever 102-104.2, nausea |
| 72 | 2021-02-15 | fever |
Expected the slight fever, 100.2 but also noticed a pulse rate of over 100? 100-110 Is that norma...
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Expected the slight fever, 100.2 but also noticed a pulse rate of over 100? 100-110 Is that normal? Comes down to ~95
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| 72 | 2021-02-16 | chills, fever, throat pain, headache |
Developed Covid 19 7 days after receiving 1st vaccine. Sore throat, chills, fever, body aches, head...
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Developed Covid 19 7 days after receiving 1st vaccine. Sore throat, chills, fever, body aches, headaches.
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| 72 | 2021-02-16 | fatigue, headache, chills |
Pfizer-BioNTech Covid-19 Vaccine EUA Headache all night, achy, chills, fatigue, injection site pain,...
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Pfizer-BioNTech Covid-19 Vaccine EUA Headache all night, achy, chills, fatigue, injection site pain, Feeling a little better by 8am next morning. Taking Tylenol and it helps
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| 72 | 2021-02-16 | fatigue, fever, malaise, chills |
I woke up feeling ill with chills and slight fever. Overall tired and a bit nauseous. Body feels hea...
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I woke up feeling ill with chills and slight fever. Overall tired and a bit nauseous. Body feels heavy.
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| 72 | 2021-02-16 | sweating |
SOB, sweating, dizziness, itching. After the 2nd dose of vaccine I had itching in arms and neck . Th...
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SOB, sweating, dizziness, itching. After the 2nd dose of vaccine I had itching in arms and neck . This was followed by dizziness, high BP, SOB, and nausea. The 2nd shot triggered post itching my neurocardiogenic syncope.
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| 72 | 2021-02-16 | influenza like illness |
Severe flu-like aches. Swollen vertebrae top of neck. Difficulty sitting up for extended periods of ...
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Severe flu-like aches. Swollen vertebrae top of neck. Difficulty sitting up for extended periods of time. Movement of left shoulder, arm, and neck very limited and extremely painful. (Literally crying for 3 days due to pain).
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| 72 | 2021-02-16 | throat pain, fatigue |
Dizziness, spreading numbness from arm to top of head, weakness, all only on left side. Docs said th...
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Dizziness, spreading numbness from arm to top of head, weakness, all only on left side. Docs said they have seen this same reaction once before. After 45 minutes, felt able to drive but on the drive home left side of face and mouth went totally numb and swelled up., strange chemical taste in mouth. Very cold and tired. Went to bed early, slight sore throat. Numbness gradually disappeared over the following morning. Still have a sore throat.
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| 72 | 2021-02-18 | chills, sweating, malaise |
Symptoms began within approximately 12 hours of vaccination with body aches and soreness, weakness a...
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Symptoms began within approximately 12 hours of vaccination with body aches and soreness, weakness and malaise, mental fogginess, chills and sweats, loss of appetite, slight nausea, needed assistance to walk. Symptoms subsided after two days, therefore did not seek medical attention.
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| 72 | 2021-02-18 | chills, fever | Chills, fever, body aches lasting approx 36 hours |
| 72 | 2021-02-20 | malaise |
On 2/2/21 I developed chest pressure and irregular heart beat at 4:00 pm. Went to ER and it spontan...
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On 2/2/21 I developed chest pressure and irregular heart beat at 4:00 pm. Went to ER and it spontaneously resolved while staff was telling me how they would treat it. Gave me Metoprolol 5 mg IV with 500 IV fluids and discharged. Then on 2/6/21 I slept poorly and felt very jittery and had more chest pressure but pulse was regular. then on 2/8/21 at 6:00 am I awoke and felt terrible with chest pressure. Took my blood pressure at home and it was 193/103, and I was very shaky. Went to ER where they did blood work, X-ray, and monitored my heart and blood pressure for 4 hrs. Gradually my blood pressure came down, and my blood work and X-ray probed to be WNL. I was discharged without medication change but had echocardiogram scheduled and follow-up appt. with Cardiologist, on zoom. He started me on Flecainide 100 mg bid, and stress test on 2/24/21 and follow-up appt. with him on 3/3/21. I also had a follow-up appt. with my GP the day after the first ER visit and she ordered more labs, and the echocardiogram. I have continued to have feelings of fluttering and pressure in my chest off and on and they continued after my second vaccine. But my heart has remained regular since starting the Flecainide. But my blood pressure went up to 150/85 on 2/9/21 and again to 142/81 on 2/10/21 both times with feelings of jitteriness and pressure in my chest.
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| 72 | 2021-02-21 | fatigue, headache, malaise, chills |
the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredne...
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the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredness; headache; Muscle pain; joint pain/joint pain in her knees; hot flashes to where she would nearly pass out a couple of times; hot flashes to where she would nearly pass out a couple of times; nausea; face and everything was red; Dizzy; weak; chills; Feeling unwell; I had difficulty breathing; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) on her right arm, via an unspecified route of administration on 26Jan2021 15:30 at SINGLE DOSE for covid-19 immunization. Medical history included multiple myeloma, Kidney failure, dialysis; all on Aug2020 and ongoing and cancer. The patient's concomitant medications were not reported. The patient previously took an unspecified flu shot for swine flu but had a terrible reaction (allergies). It was reported by the patient had injection site pain in her right arm the next day after vaccination. Stated that she had tiredness, headache, muscle pain, joint pain in knees, hot flashes to where she would nearly pass out a couple of times, nausea that was very bad for two days. Stated that her face and everything was red, dizzy and weak and had chills. Stated that it has been eight days since she can do that. Stated that she took Extra Strength Tylenol for headache. The patient also stated that she was feeling unwell, that started on the 27th until today. She also had difficulty breathing that has lasted 8 days, the swelling of her face and throat on the 31Jan2021 for one day. The outcome of the event tiredness was recovering, unknown for events chills, feeling unwell, difficulty breathing and swelling face, while recovered for the other events.
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| 72 | 2021-02-21 | fatigue, headache | very achy muscles, headache lasted over a week, tired |
| 72 | 2021-02-21 | headache |
tingling on top of her ears, headaches, possible rash on top of her hands that resembled prior histo...
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tingling on top of her ears, headaches, possible rash on top of her hands that resembled prior history of contact dermatits
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| 72 | 2021-02-21 | sweating |
Pfizer-BioNTech COVID-19 Vaccine EUA: immediately after receiving vaccination patient reported dizzi...
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Pfizer-BioNTech COVID-19 Vaccine EUA: immediately after receiving vaccination patient reported dizziness, tremors, diaphoresis, and numbness and tingling of legs. Medical emergency team called to evaluate patient. Vital signs checked four times throughout observation period and all were within normal ranges. Patient's symptoms improved with food and juice and able to leave vaccine clinic for home asymptomatic and stable.
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| 72 | 2021-02-22 | headache, chills, fever, cough, throat pain, runny nose |
angina; angina; Fever; Chills; Cough; Sore throat; runny nose; Nausea; Diarrhea; Headache; arm heavy...
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angina; angina; Fever; Chills; Cough; Sore throat; runny nose; Nausea; Diarrhea; Headache; arm heavy; muscle aches and heaviness; muscle aches and heaviness; she just woke up feeling sick; fevers may come like a hot flash; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown), via an unspecified route of administration on 23Jan2021 at a single dose, in left arm for COVID-19 immunization. Medical history included fibromyalgia diagnosed years ago, angina (some stents). There were no concomitant medications. On Jan2021, the patient experienced angina, fever, chills, cough, sore throat, runny nose, nausea, diarrhea, headache, arm heavy, muscle aches and heaviness, and she just woke up feeling sick. The patient experienced multiple AEs after 1st dose of vaccine (received on 23Jan2021). The patient experienced angina later last week. Clinical course: The patient has misplaced card, states her second appointment for the second dose is this Saturday. Caller stated she started having these experiences the day after she was vaccinated with her first dose, received first dose of 23Jan2021. She had fevers, chills, cough- not an aggressive cough, a funny kind of sore throat- like something wrapped around her throat like the muscles of her throat, no congestion but does have a runny nose, states she has some nausea, no vomiting but feeling like she needed to vomit and diarrhea, and headache. The symptoms started about the third day after the vaccine, started with the fevers, stated the fevers may come like a hot flash, lasts seconds even, states you know it is a fever because your bones get hot. These symptom's did not attack her body at one time. Her whole arm stayed heavy, the whole arm not just the injection site, for almost 10 whole days. She previously had fibromyalgia and thought maybe that made the symptoms worse. She had muscle aches and feeling heavy. Her symptoms were spread out over time, no two were at the same time, sore throat was one of the last things. Diarrhea was ongoing, not a runny diarrhea but it was enough to empty stomach and was soft. She was a medic in the military, worked as a Nurse, clarifies she was an LPN and took all the underlying courses to be a PA. One of the issues she found, she thought it may be deadly, as a prior healthcare person and in tune to her body, the people who are in the nursing homes may not be mobile, states so one of the things she felt was just feeling really really sick, that she couldn't put a pin point on it, states she just woke up feeling sick, states she had the urge to get out of bed and got up and after she got up the feeling left her, states a person in the nursing home may just feel really bad and cannot get up, thinks a protocol should be that the people that are immobile should be required to move or if they can't get up they need to move their muscles, people with these symptoms need to get up and get moving. She also has history of angina and a stent, has not had angina in a while and had 3 days where she thought she may need to go talk to her doctor. It was on Wednesday, Thursday and Friday this week. States one of her friends, 92 years old, said she got high after the vaccine and didn't want to talk to anybody, states it was her first dose, she was kind of leery about the 2nd shot, feels like this was kind of aggressive. She had both doses and had no symptoms, but 92-year-old female had no symptoms right away, other than normal body aches and pains, but the next day was high as a kite. Her son has heart disease and she advised him not to take it right now. They were losing a lot of people to the vaccine in nursing homes, no further information provided. This could be affecting good hearts more than damaged hearts, read that this virus likes to work in parts of the body that are already damaged. The outcome of event diarrhea was not recovered, outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, a causal association between the reported angina and BNT162B2 cannot be completely excluded. Note however, that the patient has underlying angina with some stents that may also have contributed to the event. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 72 | 2021-02-22 | fever |
Emergency room 1/11/21 Patient is a 72 year old female who presents with decreased level of consci...
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Emergency room 1/11/21 Patient is a 72 year old female who presents with decreased level of consciousness. The patient is a nursing home patient and had an episode of choking yesterday that was treated with a Heimlich maneuver. Nursing staff at the nursing home reports that she seems to be a bit less responsive today. However, the patient has been for the most part unresponsive for 3-4 months time following a COVID-19 infection. Of note, her oxygen saturation on room air is 72%. The patient is also febrile to 100.8°. She was unable to provide any information and the aforementioned information is gathered from nursing home staff report.
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| 72 | 2021-02-23 | chills, fatigue |
pt states that the next day after her vax she had weakness, chills, fatigue and she still has these ...
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pt states that the next day after her vax she had weakness, chills, fatigue and she still has these symptoms. Pt states that the injection site hurt for just a few days. Pt contacted her PCP regarding her symptoms and was told not worry about them at this time but has an appt next week for an annual check up and will FU w/ her about this at that time.
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| 72 | 2021-02-23 | chills, fever, fatigue |
My arm was sore that night and it's still very sore today. Because of my leukemia I have enlarged ly...
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My arm was sore that night and it's still very sore today. Because of my leukemia I have enlarged lymph nodes and the lymph nodes under my arm has been very, very sore. I've had fevers, chills and fatigue. My stomach has been upset since the vaccine and my appetite has been decreased.
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| 72 | 2021-02-23 | chills |
Chills 24 hrs after vaccine. Sporadic during day for up to 48 hrs. Total body rash noticed 36 hrs ...
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Chills 24 hrs after vaccine. Sporadic during day for up to 48 hrs. Total body rash noticed 36 hrs after vaccine, no raised areas or itching.. No difficulty breathing. Cetirizine HCL 10mg no change in rash after 1 hr.
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| 72 | 2021-02-23 | fatigue |
Extremely sore arm. Pulsing pain Breathing more labored. Brain fog Nausea Extreme Fatigue. F...
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Extremely sore arm. Pulsing pain Breathing more labored. Brain fog Nausea Extreme Fatigue. For two days
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| 72 | 2021-02-23 | headache | Elevated high pressure, nauseas, dizziness and strong headaches. Couldn't sleep well. |
| 72 | 2021-02-23 | lethargy, headache, fever, chills |
About 9:30 arm began to get sore(expected) about 11:00 started with a headache, then chills, fever, ...
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About 9:30 arm began to get sore(expected) about 11:00 started with a headache, then chills, fever, achy from head to toe but mostly back and sides, nauseous, lethargic and couldn't sleep
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| 72 | 2021-02-23 | nasopharyngitis, malaise |
she just does not feel good; Feeling like she is getting a cold; This is a spontaneous report from a...
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she just does not feel good; Feeling like she is getting a cold; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female received the first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283 and expiry date: 30Apr2021), via an unspecified route of administration on the right arm, on 22Jan2021 at 0.3 mL, single for COVID-19 immunization. There were no medical history and concomitant medications. Patient stated she was feeling like she was getting a cold. She clarified that she started feeling this way starting last night on 25Jan2021, and today on 26Jan2021, she just does not feel good. Outcome of the events was not recovered. The reporter considered the events non-serious.
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| 72 | 2021-02-23 | fever |
feeling weak; shaky; fever, 100.4; her eyes start feeling funny and burning when she has a fever; he...
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feeling weak; shaky; fever, 100.4; her eyes start feeling funny and burning when she has a fever; her eyes start feeling funny and burning when she has a fever; arm was a little sore; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for two patients. This is the first of 2 reports. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration at the right upper arm close to the shoulder on 02Feb2021 07:30 at single dose as she doesn't want to get COVID again or give COVID to anyone else. Medical history included metabolic syndrome from 1994 and ongoing, it all started when she was 46 and it runs in her family and it was a genetic thing; ongoing diabetes mellitus, was diagnosed when she was 65, so 7 years ago; she had COVID in Nov2020 but it was just a very mild case and she just had a cough; and cardio artery problems. She takes a lot of medications and she has metabolic syndrome which includes cardio artery problems and diabetes, but she has taken all of those medications for a long time. The patient says she was calling to report a couple little concerns she has. She received her shot on Tuesday, 02Feb2021 at about 7:30 in morning and her arm started at about 2 to 3 in the afternoon and she noticed it was getting sore, but it was no big deal, she did not think anything of it, and on the second day she thought that was it and she was over it on 03Feb2021. She states her husband also mentioned that he had soreness in his arm after his vaccination. She says at three in the afternoon on 03Feb2021, she started feeling weak and shaky, but she didn't think much of that. She says this began around 3 to 4 when yesterday afternoon, 03Feb2021, she had a fever. She says she took her temperature and it was 100.4 and that all kind of was gone by the evening but when she woke up this morning, she was weak and shaky again. Today she got up and was weak and shaky and it never left, she was still weak and shaky. The patient mentions that she was diabetic so she can get weak and shaky when she needs to eat something, but she had just eaten, and she ate yesterday so she doesn't think it was caused by that. The patient says she thinks we should know that she was diabetic. She says then she could tell that she had a fever, so she took her temperature and it was 100.4 which for her was high. She states she didn't even have a fever when she had COVID. The fever began yesterday afternoon (03Feb2021). She says her eyes start feeling funny and burning when she has a fever and they felt that way so that's why she took her temperature. This was the highest it has been in years. She says last night she took her temperature again and the fever had gone away in 30 to 40 minutes, so she thought it was over. She took her temperature again before she called this morning, 04Feb2021 and it was 99.2, which was still a little hot for her. She says for her that's a fever. She was 96 and 97 usually. The patient says she still feels like she has a little fever. She was not someone who usually has a fever and it can be just a little bit of a fever for instance like this morning when she was 99.2. Her eyes were still feeling funny and burning this morning and that was why she took her temperature this morning. The outcome of the event arm was a little sore was recovered on 03Feb2021; feeling weak and shaky was not recovered; fever and her eyes start feeling funny and burning when she has a fever was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162089 Same reporter/drug, similar event, different patient
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| 72 | 2021-02-23 | sluggishness |
Patient complained initially of being sluggish, weak, lightheaded and felt like she was "about to pa...
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Patient complained initially of being sluggish, weak, lightheaded and felt like she was "about to pass out." Patient had not eaten since yesterday. Given orange juice. Patient began experiencing slight altered mental status (appeared to be losing consciousness in-and-out). EMS treating patient and transported patient to ED.
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| 72 | 2021-02-23 | throat irritation, cough |
She arrives with medics after receiving Benadryl and an albuterol breathing treatment. This improve...
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She arrives with medics after receiving Benadryl and an albuterol breathing treatment. This improved her wheeze. Upon my evaluation she is stable but begins to cough. She has moderate posterior pharyngeal irritation as well. She has been monitored. Chest x-ray is reassuring. The present do not think labs are necessary. She is been advised to monitor her symptoms at home and return for any concerns. I recommended Benadryl as well as short course of prednisone. She has received prednisone here and advised her to take prednisone tomorrow and then discuss additional doses with her primary doctor control
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| 72 | 2021-02-24 | chills, fatigue, malaise, headache | Fatigue, headache, Muscle/Joint Pain, Chills, Feeling unwell, dizziness |
| 72 | 2021-02-24 | chills, headache |
Mid afternoon on Wednesday, February 24, 2021, I developed a headache, severe chills, body aches, qu...
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Mid afternoon on Wednesday, February 24, 2021, I developed a headache, severe chills, body aches, queasiness, and I felt very tired. I am currently running a 101 temperature and feel Ike terrible
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| 72 | 2021-02-24 | cough, chills |
Received 2nd vaccine on 2/20/21. Started having some tightness in her throat and tingling on her ton...
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Received 2nd vaccine on 2/20/21. Started having some tightness in her throat and tingling on her tongue the next day. Two days later started having dizziness, and itchy rash and SOB, chills, and nonproductive cough. Went to ER on 2/24/21
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| 72 | 2021-02-24 | headache |
Light headed and dizziness, left side headache tingling sensation down entire left arm to finger t...
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Light headed and dizziness, left side headache tingling sensation down entire left arm to finger tips, and up to chin neck and chest area for about 20 minutes
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| 72 | 2021-02-24 | fever, body temperature increased |
I was feeling chilly and I went to bed early and got under the covers. At 3 in the morning, I had a ...
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I was feeling chilly and I went to bed early and got under the covers. At 3 in the morning, I had a fever - 99. something and aches and pains. I took ibuprofen. I got up at 7:00 am and my temperature had gone up to 100 something. My body ached really bad. It ached all day long ( and fever continued) and it felt like I had a really bad flu. I called my doctor (telemed appt) and she thought it would be over by 24 hours. It did go away after 24 hours.
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| 72 | 2021-02-25 | fatigue, fever, headache | Fever 5am through midnight Headache Nausea am Tired |
| 72 | 2021-02-25 | head discomfort, fever, headache |
pt stated that the same day after getting the vax she developed neck pain, fever, joint pain in arms...
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pt stated that the same day after getting the vax she developed neck pain, fever, joint pain in arms, hands and knees, a splitting headache, also had pain in her ears, face, and upper back. Next day the pain was worse. Pt contacted her PCP and was told to report to VAERS. She still has pressure in her head, eye, ear ache and cant do regular every day activities.
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| 72 | 2021-02-25 | headache, chills, fatigue |
None for first injection. Second injection started with extreme chills, moved to headache, muscle ac...
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None for first injection. Second injection started with extreme chills, moved to headache, muscle ache, weakness. Lasted 24 hours, mitigated with Tylenol. 10 days later, still suffering intermittent fatigue, weakness, inflamed lymph node near left breast, diarrhea and muscle ache.
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| 72 | 2021-02-26 | chills, headache |
On Feb 26th - approximately 45 minutes after vaccination and departing site, symptoms began. Swelli...
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On Feb 26th - approximately 45 minutes after vaccination and departing site, symptoms began. Swelling tongue and throat. Wheezing and difficulty swallowing. Proceeded to ER and taken in at 2pm. Treated at ER with IV of Benadryl, Famotidine, MethlyPredeniSolone, Medrol with little effect. Then did Epipen at 2:40pm. Observed and discharged from ER at 4:50pm . On Feb 27th - skin hives, headache, nausea, chills and overall body pain. Taking Benadryl. Have Rx with 2 EPIPEN kit.
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| 72 | 2021-02-26 | chills |
Developed nausea and vomiting after her COVID vaccine earlier today. Associated with chills and trem...
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Developed nausea and vomiting after her COVID vaccine earlier today. Associated with chills and tremors. These improved 45 minutes ago. Poor PO intake. No abdominal pain. COVID, flu negative. Mild systemic vaccine reaction. Zofran given and rx. Advised patient to speak with her PCP before considering second COVID vaccine.
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| 72 | 2021-02-26 | fatigue, headache | Tiredness, headache, nausea |
| 72 | 2021-02-26 | fever, fatigue |
Had low grade fever of 99 degrees. Extreme fatigue. Shot site is bright red, swollen. Area around...
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Had low grade fever of 99 degrees. Extreme fatigue. Shot site is bright red, swollen. Area around site is swollen, red, and hard to the touch. Swelling, redness, and hard to the touch continues. Hurts to touch or bump entire area.
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| 72 | 2021-02-28 | chills, fever, sweating |
I ache all over, have no energy my chest hurts, bloody nose, sweating, fever and chills.... in gener...
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I ache all over, have no energy my chest hurts, bloody nose, sweating, fever and chills.... in general I feel like I have been poisoned.
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| 72 | 2021-02-28 | headache, fatigue, cough, fever, chills |
fever, chills, muscle ache, headache, cough, nausea (mild), fatigue, sore arm, injection site pain o...
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fever, chills, muscle ache, headache, cough, nausea (mild), fatigue, sore arm, injection site pain onset 12 hours after receiving the vaccine ongoing at this point
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| 72 | 2021-02-28 | malaise, chills, fatigue, headache |
One week after shot, on 2-27 21, I awoke with splitting headache, muscle pain in my neck, nausea, a ...
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One week after shot, on 2-27 21, I awoke with splitting headache, muscle pain in my neck, nausea, a few chills (they did not last long), felt horrible for about 5 hours. I threw up midway, and then just slept. Felt a little better around 2:00 pm, took Tylenol at 4:00pm and that helped a lot. Got out of bed at 5:00 pm. Was able to eat a little dinner at 6:00 pm. Went back to bed around 9:00. Felt better in Am -Sunday, Feb 28; not 100% though. Tired. Long nap. Better today, Mar. 1. -- just a little off - woozy.
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| 72 | 2021-02-28 | malaise, headache |
Trouble breathing; nausea; severe headache/excruciating headache; Feeling generally unwell to the po...
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Trouble breathing; nausea; severe headache/excruciating headache; Feeling generally unwell to the point I almost went to the emergency room/terribly unwell feeling; This is a spontaneous report from a contactable consumer (patient). A 72-years-old non-preganant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EN5318, via an unspecified route of administration on 02Feb2021 15:45 (at the age of 72 years old) for COVID-19 vaccination, Unspecified other vaccine (Pfizer) on 02Feb2021, dose number in the left arm for an unspecified indication.Medical history included asthma from an unknown date and unknown if ongoing (asthma under control), pancreatitis chronic from an unknown date and unknown if ongoing (Occasional chronic pancreatitis), Blood pressure from an unknown date and unknown if ongoing, drug allergies from an unknown date and unknown if ongoing. Concomitant medication included Blood pressure medication. The patient previously took morphine and experienced allergies morphine and sulfa and experienced allergies sulfa. The patient received the vaccination at the hospital. On 02Feb2021, the patient felt as if she was having a heart attack. On 02Feb2021, the patient had trouble breathing, nausea, and severe headache. On 02Feb2021, the patient was felling generally unwell to the point she almost went to the emergency room. The excruciating headache and terribly unwell feeling has lasted well over 10 days. No treatment was received for the events. Outcome of the events was recovering. The patient did not have covid prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19.
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| 72 | 2021-02-28 | runny nose, throat pain, cough |
Passed out; Constant running nose; Cough; bad cough; Sore throat; Diarrhea; This is a spontaneous re...
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Passed out; Constant running nose; Cough; bad cough; Sore throat; Diarrhea; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received the second of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL9267, Expiration Date May2021, via an unspecified route of administration on 08Feb2021 (at the age of 72 years old) as SINGLE DOSE in the left arm for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. Historical information included BNT162B2 dose 1 for COVID-19 vaccination.The patient developed the sore throat on 09Feb2021, Cough; bad cough on 10Feb2021, constant running nose on 11Feb2021. On 11Feb2021, the patient passed out in the bathroom floor, had an ambulance here. Patient still coughing a little, not as badly. The patient experienced diarrhea in Feb2021. Treatment for all events included cetirizine (ZYRTEC), Triamcinolone (NASACORT), pseudoephedrine (SUDAFED), dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL). Outcome of the events Passed out, Sore throat, Constant running nose, Diarrhea was unknown. Outcome of the events Cough; bad cough was not recovered
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| 72 | 2021-02-28 | sleepiness, fatigue | Sleepy and weakness. Drunk like sx at 1900 hr. Currently very tired. Steady gait. |
| 72 | 2021-03-01 | fever, chills, headache, malaise |
Not feeling very energetic; I did not feel good; Chills; Fever; Headache; Did not feel like eating m...
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Not feeling very energetic; I did not feel good; Chills; Fever; Headache; Did not feel like eating much; Achy; This 72- year-old female patient contactable consumer (reported for herself) received the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot EL9265; expiration not provided), via an unspecified route of administration, on 28Jan2021 at 09:15 AM (at the age of 72-years-old) as a single dose for COVID-19 immunization. The facility where COVID-19 vaccine was administered was at a hospital. Medical history included: COVID in Mar2020 and was hospitalized for 10 days, hypertension, thyroid disorder, and flu shot. Concomitant medication included: Hydrochlorothiazide 12.5 mg, once a day for blood pressure and medication for thyroid reported as: "NP" 0.5gms. On 28Jan2021 later on after vaccine, she reported 9:15 pm that she did not feel good. She had chills, fever, headache, did not feel like eating much, was achy, and not feeling very energetic. During the night temperature was 101.4. At 8 in the morning, I started taking 2 Tylenol, 500 mg and it went lower but then it would come back up, so I take more. So, it never went over 101.8. now here we are on the Saturday morning and I am not feeling very energetic and I still have just a 99 temperature. Treatment included: Tylenol. The clinical outcome of the events I did not feel good, chills, fever, headache, did not feel like eating much, Not feeling very energetic, and Achy were unknown. No follow-up attempts are possible. No further information is expected.
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| 72 | 2021-03-01 | sinus congestion |
The patient had 2 doses of Pfizer COVID-19 vaccine as part of staffing vaccination. About 2 weeks a...
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The patient had 2 doses of Pfizer COVID-19 vaccine as part of staffing vaccination. About 2 weeks ago her adult son, who lives with her, tested positive for COVID-19. Patient had some vague sinus congestion symptoms but has environmental allergies and frequently has such symptoms. She was reassured that since she had been fully vaccinated, this was likely the case, but decided she needed to be tested to be sure (facility has worked to keep COVID out). On 2/26/21 she tested positive for COVID by antigen test. On same day she had PCR test, but no results yet. Except for some voice loss and sinus congestion, no other symptoms.
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| 72 | 2021-03-01 | sleepiness, body temperature increased | 102° fever, unable to stay awake, hallucinations, drowsy, 1 night, 1 day, another night and day |
| 72 | 2021-03-01 | sleepiness | SOB, weakness, bilateral trembling, feeling sleepy, evaluated by EMS-cleared |
| 72 | 2021-03-01 | sleepiness | Sleepy, drowsy, evaluated by EMS-cleared |
| 72 | 2021-03-02 | chills, headache |
hands, feet, toes and entire body, felt almost paralyzed; not being able to turn over in bed; could ...
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hands, feet, toes and entire body, felt almost paralyzed; not being able to turn over in bed; could not bend her fingers or toes; muscles throughout her body remained stiff and tight; could not bend her fingers or toes; muscles throughout her body remained stiff and tight; tense muscle aches; Chills; headache; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) at the age of 72-years, via an unspecified route of administration in left arm at 11:00 AM on 16Feb2021 at single dose for COVID-19 immunisation, in hospital. Medical history included pituitary microadenoma from 1969 (52 years) and in good health other than the fibromyalgia; allergies to latex. Patient was not pregnant, was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included desipramine; duloxetine hydrochloride (CYMBALTA); ergocalciferol (VIT D); zinc. The patient previously received first single dose of BNT162B2 (lot number: EK9231) at the age of 72-years via an unspecified route of administration in left arm at 04:00 PM on 25Jan2021 for COVID-19 immunisation. Patient reported that she had been diagnosed with fibromyalgia and saw a rheumatologist that specializes in treating fibromyalgia. At 01:00 AM on 17Feb2021, fourteen hours later, she awoke to not being able to turn over in bed. Her hands, feet, toes and entire body, felt almost paralyzed. She could not bend her fingers or toes. Her muscles throughout her body remained stiff and tight for the next 16 hours. Chills, headache but no fever. Patient took paracetamol (TYLENOL) every four hours, during this time. It did not help with the tense muscle aches. Later on 17Feb2021 (that same day), approximately 19:00 (7:00 PM), her muscles started to relax. Patient was writing this the day after and she felt fine. She could hardly wait for the booster shot. Outcome of the events was recovered/resolved in Feb2021. Since the vaccination, the patient has not been tested for COVID-19.
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| 72 | 2021-03-02 | chills |
Pfizer Covid-19 Vaccine second dose on 02/28/2021 at 1:00 P.M. Very chilly all day next day on 03/...
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Pfizer Covid-19 Vaccine second dose on 02/28/2021 at 1:00 P.M. Very chilly all day next day on 03/01/2021. Redness and pain on the arm at the vaccine site on 03/03/2021 at 9:00 A.M.
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| 72 | 2021-03-02 | chills | Chills beginning the night of the injection and continuing to today. |
| 72 | 2021-03-02 | cough |
15-16 minutes after receiving vaccine, patient states her mouth felt dry and she started coughing. S...
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15-16 minutes after receiving vaccine, patient states her mouth felt dry and she started coughing. She denied shortness of breath, chest pain, throat swelling, voice changes, hoarseness, nausea, abdominal pain, rash, itching. No tachypnea or hypoxia on exam but mild expiratory wheezes noted at bilateral bases. She was treated with a duo-neb by medics (2.5 mg albuterol - 0.5 mg ipratropium). After nebulizer, she felt better with complete symptom resolution. She desired to go home to the care of her daughter. Patient and daughter were advised to present to an ER if symptoms recurred or if patient developed any symptoms.
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| 72 | 2021-03-02 | headache, fatigue, chills | Headache, chills, fatigue |
| 72 | 2021-03-02 | headache, fever |
Headache, fever, swollen arm at injection site burning, rash, muscle ache, overall discomfort. Rash ...
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Headache, fever, swollen arm at injection site burning, rash, muscle ache, overall discomfort. Rash appeared day after injection as well as burning. Day of injection tired, arm very sore, didn't sleep well followed by feeling really sick nausea, just a little, then fever started terrible headache continued until next evening. Now arm sore also realized I have neck pain yesterday and now, still have rash the burning has subsided
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| 72 | 2021-03-02 | headache |
Headaches began later in the afternoon after getting vaccine. Loss of sleep that is abnormal and wor...
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Headaches began later in the afternoon after getting vaccine. Loss of sleep that is abnormal and worrisome due to seizure condition. Sore arm at injection site and general body aches present.
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| 72 | 2021-03-03 | chills | severe vertigo, chills, nausea, vomiting |
| 72 | 2021-03-03 | fatigue |
aches; itching; kind of tired; This is a spontaneous report from a contactable consumer (patient). ...
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aches; itching; kind of tired; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9262, expiry date unknown) in the doctor's office, via an unspecified route of administration on 27Jan2021 at a single dose on the right arm as she was over 65, for COVID-19 immunization. Medical history included ongoing diabetes mellitus a long time ago since she was in her 60's, ongoing blood pressure, ongoing high cholesterol and cyst. Concomitant medication included ongoing losartan (manufacturer unknown) for blood pressure, ongoing pravastatin (manufacturer unknown) for high cholesterol, metformin (manufacturer unknown) for diabetes mellitus from an unspecified date to an unspecified date and ongoing sitagliptin (JANUVIA) for diabetes mellitus. The patient was also prescribed an unspecified antibiotic for a cyst which was taken 2 weeks before the vaccination. The patient did not have prior vaccinations within 4 weeks of the COVID vaccine. The patient experienced itching on 27Jan2021, the same day as the Covid 19 shot later in the day, after she got home. She didn't pay attention to it. The next evening she called her doctor and told him about it and he said it was one of the side effects of the Covid 19 shot and prescribed Benadryl. She started the Benadryl that same night, 28Jan2021. She should not have waited, she should have called the doctor the same day. She called the pharmacy and got the prescription, it's not that far for her. The patient stated that the the itching lasted a couple of days, it is gone, as of an unspecified date. She took Benadryl for the itching, it is the best thing for her. In all, she thinks she went through 2 to 3 days of the whole situation. The patient also stated that she took Tylenol for the aches and that got better. She had aches but the aches from the Covid 19 shot started on 28Jan2021. On the day of the report, she was a lot better. The aches went away but does not recall what day they went away. She feels much better that day. The aches were not severe. She added that the aches and itching lasted for 2-3 days and are totally improved, that they stopped on an unspecified date. State she was able to go outside that day. She added that she was kind of tired. She had to lay down one day because the itching and aches were bad. The outcome of the event kind of tired was recovering while the outcome of the other events was recovered on an unspecified date in 2021.
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| 72 | 2021-03-03 | headache, chills, fever, fatigue |
2nd day I had extreme tiredness, chills, upset stomach, sore shoulder, bad headache. 3rd day same, ...
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2nd day I had extreme tiredness, chills, upset stomach, sore shoulder, bad headache. 3rd day same, with fever & brain fog, & felt very weak, & I had a swollen & sore lymph node under my arm. On day 6 my upper are (& underneath) turned red & swollen. I also had been suffering random itching. On day 8 I went ER, & was given steroid cream. That night most of my back turned red. I put the cream on & it was gone next day, but my arm stayed red & itching. All this has made me weaker, & My stomach hasn?t felt good.
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| 72 | 2021-03-03 | headache |
Numbness and slight swelling on entire left side of face within half hour following shot, accompanie...
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Numbness and slight swelling on entire left side of face within half hour following shot, accompanied by severe stiff neck (left side). Headache and slight transient facial rash with skin discoloration under eyes about two hours later. Mostly subsided by 10:30 PM- about eight hours later, although some numbness remained l through the night. Symptoms were mostly gone the next morning, replaced by arm soreness and bruising at the injection site. Black and blue remains (3 days later).
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| 72 | 2021-03-03 | headache |
stomach cramps; massive diarrhea; nausea; headache; This is a spontaneous report from a contactable ...
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stomach cramps; massive diarrhea; nausea; headache; This is a spontaneous report from a contactable consumer (patient). This 72-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot EK9231) via an unspecified route of administration in the left arm on 22Jan2021 at 17:15 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Medical history included anal cancer from 2009 and unknown if ongoing; and cancer Non-Hodgkin's lymph from 1993 and unknown if ongoing. The patient had no allergies to medications, foods or other products. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included sertraline 100 mg from an unknown date for an unknown indication; rosuvastatin 5 mg from an unknown date for an unknown indication and cetirizine hydrochloride (ZYRTEK) from an unknown date for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported on the fifth day (27Jan2021) she had stomach cramps, massive diarrhea, nausea and headache and had to lay down; lasting from about 09:00 to 18:00. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The clinical outcomes of stomach cramps, massive diarrhea, nausea and headache were recovered on 27Jan2021 at 18:00. It was also reported the patient was not tested for COVID-19 since vaccination.
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| 72 | 2021-03-03 | sweating |
Pt received her first dose Pfizer Covid 19 vaccine and was currently being monitored in the observat...
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Pt received her first dose Pfizer Covid 19 vaccine and was currently being monitored in the observation area for 30 minutes when she developed vasovagal symptoms- diaphoresis, near syncopal episode and hypotension. EMS and nurses responded with the event. initial BP = 90/40. Pt was transferred immediately to the treatment room, was placed on supine position and was further monitored. Pt relates she has these symptoms every time she has her blood drawn. Repeat BP=106/56 after 5 mins. Pt became better after 15 mins, BP=127/68, pulse ox=98 RA, pulse=70.
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| 72 | 2021-03-03 | fever, chills, headache | Chills,fever,almost passed out,headache,sore arm |
| 72 | 2021-03-03 | fever, chills |
Chills; Stomach issues; Fever of 100.4; Sort of feeling achy; Sore arm; This is a spontaneous report...
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Chills; Stomach issues; Fever of 100.4; Sort of feeling achy; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported), intramuscularly on the left arm on 25Jan2021 (13:45) at a single dose for COVID-19 immunization at the university clinic (not a military facility). Medical history allergy to penicillin; allergy to bees; allergy to environmental grass and ragweed; and was in muscle relaxant therapy. Concomitant medications included cannabidiol (CBD OIL) as muscle relaxer; and estrogens conjugated, medroxyprogesterone acetate (PREMPRO). The patient previously took SHINGRIX on 18Oct2019 (when the patient was 71 years old) for shingles vaccine, and had subacute thyroiditis, enlarged thyroid and glands, rash from wrist to arm and shoulder, swollen and sore arm, and swollen neck glands and thyroid around left side. The patient previously took codeine, and had allergy. On 25Jan2021 (20:00), the patient had sore arm. The sore arm improved the next day. On 30Jan2021 (between 18:00 and 19:00), the patient was "sort of" feeling achy. On 30Jan2021 (23:00), the patient had fever of 100.4 (unit was not provided). The patient took paracetamol (TYLENOL) as treatment for the fever, and started getting better. The patient got tested as a precaution, and was negative for COVID-19 test on 31Jan2021. On 31Jan2021 (between 08:00 and 09:00), the patient had stomach issues. On 31Jan2021 (13:00), the patient had chills. The outcome of the events, 'sore arm', 'achy', 'fever', 'stomach issues' and 'chills', was recovering. The patient was due to the second dose of vaccination on 15Feb2021, and wanted to know if it would be okay for her to get it.
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| 72 | 2021-03-03 | throat irritation |
left eye felt tight and felt itchy/severe tightness in her left eye; intense itching in inner ear wh...
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left eye felt tight and felt itchy/severe tightness in her left eye; intense itching in inner ear where you cannot scratch; severe tightness in her left eye that felt like it was going to swell up; hot skin for several hours; hot flashes; She has itching in ears and throat; Onset of burning and itching; Skin had feeling of about to break out in hives/full blown body hives all over; This is a spontaneous report from a contactable nurse. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3249), intramuscular on the right arm, at the age of 72 years, on 13Jan2021 09:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient would like to know if the vaccine was derived from or does it have any products from Acacia. One of the reason's she was asking was because she knows it has Polyethylene Glycol in it. Her resources are limited. She was a retired healthcare provider and she taught graduate level nursing and has background in epidemiology and public health. The Polyethylene Glycol was in the vaccine, according to the prescribing information. Some forms of Polyethylene Glycol in some type of way are derived from gum acacia and she does not know if this is the case for the COVID vaccine. She did have 1st dose and waited 15 minutes. When her left eye felt tight and felt itchy, she took 2 Benadryl and then waited in car a little longer. She felt like she was going to go into what she has had in past 3-4 times relating to fish. She has had full blown facial swelling, intense itching in inner ear where you cannot scratch. Those times, if she had chopsticks, she would want to scratch inside her ear. She never had that with the COVID vaccine. They told her when she got the vaccine that if this develops further, she should go to her doctor or ER, but should not come back there. She did not want to go to the ER and sit there for 12 hours waiting to see if she was going to have a worse reaction, so she went home, took 2 more Benadryl, and went to bed. Eight hours later, she was fine and did not have hives. She then stated she completed report with Pfizer online and did not have a reference number for previous report. For those time when she had these episodes with the fish, she had extreme itching and hives. The worst allergy she had, her fingers looked like they were webbed. She was treated with Adrenaline, Cortisone and Benadryl by injection and that would usually stop the reaction, but it usually takes 3-4 days for the swelling to go down. In later years, if there is a piece of fish mixed in with fried shrimp and she inadvertently eats it, she knows it immediately. She will take Benadryl immediately. She will have facial swelling and swelling around her eyes. The Benadryl will contain it. She will be disfigured for 2 weeks, with bags of fluid in her cheeks. She is going for her second shot tomorrow. She can self treat with Benadryl. In 1994, she had a very positive wheels from an intradermal scratch testing for Acacia and codfish. The patient had an onset of burning and itching, periorbital. She took 2 25 mg Benadryl tablets. She has itching in ears and throat. After my 15 minutes waiting, she left. She had various hot spots of burning skin, legs and arms. Left eye felt like past episodes of itching, about to swell. Her skin had feeling of about to break out in hives. Facility said to go to provider or ER if got worse. She chose not to go to ER, and wait and be miserable for hours on end, while waiting for full blown body hives all over. She took two more 25 mg Benadryl and went to bed. She had intermittent burning skin, various areas, for several hours. About 8 hours later, was resolved. The patient was about to receive 2nd dose of the Covid vaccine. After the 1st dose she experienced an itchy feeling in throat, rotating heat in arms and legs, slight bag fluid under left eye and it felt to her like she was going to have an allergic reaction but did not. She took some Benadryl and after 8 hours she was fine. The patient stated after the first dose of the vaccine she had itching, severe tightness in her left eye that felt like it was going to swell up, and hot skin for several hours. She took two Benadryl while she was still in the waiting period and perhaps that blunted the reaction. She had hot flashes on the drive home. She took two more Benadryl at her daughter house (100mg total after taking 4 that day). She didn't feel good and felt she was on the verge of getting hives. She had episodes of hot skin and itching and after 8 hours it was over and done with and she was fine. She stated she is nervous about the second dose but stated they have what they need if she has an immediate reaction and it is worth the risk of getting vaccinated. Therapeutic measures were taken as a result of left eye felt tight and felt itchy/severe tightness in her left eye (eye pruritus), intense itching in inner ear where you cannot scratch (ear pruritus), onset of burning and itching (skin burning sensation), skin had feeling of about to break out in hives/full blown body hives all over (urticaria). The outcome of the event onset of burning and itching and skin had feeling of about to break out in hives/full blown body hives all over was recovered on an unspecified date while other events were unknown.
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| 72 | 2021-03-04 | fatigue, headache, malaise |
Headache; profound fatigue/tired; not feeling well; sick; This is a spontaneous report from a contac...
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Headache; profound fatigue/tired; not feeling well; sick; This is a spontaneous report from a contactable consumer. A 72-Year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID VACCINE, lot number unknown, expiration date unknown), via intramuscular on the left upper arm, on 21Jan2021 at 16:30 at the age of 72 years old at a single dose for COVID-19 immunisation at senior residence. The patient medical history was none. Concomitant medications were not reported. The patient previously took Shingrix for shingles vaccine (immunisation) and both times she took it she was in bed for 3 days and then she was fine. Patient was calling about the Pfizer BioNtech covid vaccine. Since she had the vaccine and this is the 8th day since she had it. On 21Jan2021, patient had a headache and profound fatigue, she was not feeling well since she got the vaccine. She was still sick on an unspecified date in 2021. Her headache started about 30 minute s after getting the vaccine. That same night she felt really tired and when she woke up she was really fatigued. The patient occasionally takes Advil as treatment. The patient did not visit emergency room and physician office. No additional vaccines administered on same date of the Pfizer suspect. The patient was not recovered from the event sick, while patient was recovering from all other events. Information on lot/batch number has been requested.
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| 72 | 2021-03-04 | fatigue, headache |
Headache; tired; This is a spontaneous report from a contactable consumer. A non-pregnant 72-year-o...
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Headache; tired; This is a spontaneous report from a contactable consumer. A non-pregnant 72-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:EL9261), via an unspecified route of administration in the left arm on 01Feb2021 at 14:00 at 72-years-old at a single dose for covid-19 immunization; administered in a hospital. . The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's medical history was reported as none. Concomitant medications included elderberry [sambucus nigra] (MANUFACTURER UNKNOWN), krill oil (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D); all taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of vaccination. On 02Feb2021 (also reported as 01Feb2021 at 16:00), the patient experienced headache (non-serious) and tired (non-serious). There was no treatment received for the adverse events. The clinical outcome of the events was recovered on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19.
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| 72 | 2021-03-04 | fatigue, fever, chills |
STARTED AT 4PM ON 3/1/2021 WITH CHILLS, GENERALIZED BODY PAIN, FATIGUE, FEVER, LEFT ARM AND AXILLARY...
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STARTED AT 4PM ON 3/1/2021 WITH CHILLS, GENERALIZED BODY PAIN, FATIGUE, FEVER, LEFT ARM AND AXILLARY PAIN WITH DECREASED RANGE OF MOTION, RIB CAGE PAIN . TOOK TYLENOL
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| 72 | 2021-03-04 | headache, chills, fever |
Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until ...
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Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until 6 am. Following day unable to get out of bed, still aching, fatigue and headache. Third day still tired feeling a little better.
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| 72 | 2021-03-04 | headache, fatigue, fever, chills |
Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until ...
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Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until 6 am. Following day unable to get out of bed, still aching, fatigue and headache. Third day still tired feeling a bit feverish but getting better. A more severe reaction than from first shot on 2/8/2021 with similar side effects that lasted about 3 days. Fatigue did not go away.
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| 72 | 2021-03-04 | headache, fever |
Body aches, Headache, Fever of 100.4. Took 2 Tylenol. Still Fever of 99.8 6 hours later. Took 2 m...
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Body aches, Headache, Fever of 100.4. Took 2 Tylenol. Still Fever of 99.8 6 hours later. Took 2 more Tylenol.
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| 72 | 2021-03-04 | malaise, fatigue, headache, chills |
Patient states woke up at 4 AM 2/23/21, felt ill and weak, went to wake up husband, "went black" and...
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Patient states woke up at 4 AM 2/23/21, felt ill and weak, went to wake up husband, "went black" and then blacked out woke up laying on floor, couldn't move arms or legs, not sure if hit head, laid on floor close to 1 hour, difficulty getting back into bed, extreme nausea, dry heaves, weak, headache, dizzy, chills, dizzy x 1 week, dizzy 3/3/21, got into bed 6:30 PM, face flushed and reddened, called daughter who is nurse, daughter checked temperature and blood pressure, no fever, B/P 156/102 (normally 120/82), B/P came down to when retaken to 140/90), was "upset" at time of first B/P reading, causing elevation. Continues to have weakness and fatigue, headache comes and goes.
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| 72 | 2021-03-04 | fever, headache |
Vomiting, diarrhea, headache and mild fever about 12 hours after vaccine and lasting for about 4 hou...
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Vomiting, diarrhea, headache and mild fever about 12 hours after vaccine and lasting for about 4 hours. After 4 hours weak for several hours.
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| 72 | 2021-03-05 | chills, fatigue, headache |
Tiredness, mild diarrhea ,mild headache, achy all over, chills, began late evening the day I receive...
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Tiredness, mild diarrhea ,mild headache, achy all over, chills, began late evening the day I received the shot. Continued through the next day and then on the morning of the second day felt fine after a restful night sleep. Mostly I felt punk and rested.
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| 72 | 2021-03-05 | fatigue, fever, chills |
24 hours after injection had chills, fever(100-101) and fatigue. Lasted until 4:00 am next morning....
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24 hours after injection had chills, fever(100-101) and fatigue. Lasted until 4:00 am next morning. I was fine after that, got up walked 3 miles as I have been doing. Continued to feel fine until 10:pm that night, fever(100), chills and fatigue again until about 5:00 am next morning. No symptoms since. No Tylenol first night, did take it with second round.
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| 72 | 2021-03-05 | fatigue |
Fatigue - on morning after second vaccination injection (03/05/2021) - napped from 11:30 am - 1:15 p...
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Fatigue - on morning after second vaccination injection (03/05/2021) - napped from 11:30 am - 1:15 pm MST - fatigue resolved.
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| 72 | 2021-03-05 | malaise, fever |
Fever and feeling under the weather. I took two tylenol shortly after fever started. Fever was go...
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Fever and feeling under the weather. I took two tylenol shortly after fever started. Fever was gone about four hours later. Then just felt under the weather for another 12 hours.
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| 72 | 2021-03-05 | fever | Fever 99.7 |
| 72 | 2021-03-05 | fever | Extreme shaking, leg weakness, slight fever. I couldn?t move at all. It was like I was paralyzed. |
| 72 | 2021-03-06 | cough, fever, chills |
Heavy chest cough, fever, chills, body aches, slight nauseated feeling, problem sleeping,, got bette...
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Heavy chest cough, fever, chills, body aches, slight nauseated feeling, problem sleeping,, got better Saturday but then same symptoms returned Saturday night and continue today, joint pain, muscle pain
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| 72 | 2021-03-06 | headache, chills | Chills, vomiting,headache |
| 72 | 2021-03-06 | headache, influenza like illness, nasopharyngitis |
Received 1st vaccine 1/28/21. No adverse effects. On approximately 2/14/21 I started feeling cold/...
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Received 1st vaccine 1/28/21. No adverse effects. On approximately 2/14/21 I started feeling cold/flu like symptoms & had a slight headache for 3 days. Symptoms not severe just cold like & lasted a week. received 2nd vaccine 2/21/2021. My husband had both his vaccinations by 2/15/2021, On 2/21/2021 He hade severe cold & flu symptoms. Took him to urgent care where we both tested positive for Covid/19 & my husband also tested positive for the flu. Just don?t understand how we both tested positive for covid after receiving both vaccnations, We re tested 3/5/3021 & still tested positive. How much longer do we need to wait to be retested?
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| 72 | 2021-03-06 | headache |
Almost immediately I got a headache. The headache intensified and muscle pain ensued. The muscles in...
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Almost immediately I got a headache. The headache intensified and muscle pain ensued. The muscles in my arms, legs and even the headache felt as if something inside was vibrating. It has been eight days, and none of the symptoms have abated. I am now very uncertain ifI can tolerate a second dose on March 20. I cannot take anything except Tylenol, and that doesn't touch the pain.
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| 72 | 2021-03-07 | headache |
1st vaccination on January 30 I had a very intense headache whole 24 hours until I could take a pain...
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1st vaccination on January 30 I had a very intense headache whole 24 hours until I could take a pain killer. 2nd vaccination on February 27 had a slight headache 1st day. THIRD day I had 3 straight days of EXTREME dizziness and nausea, throwing up a few times over the 3 days. Then on 8th day dizziness and nausea returned for a day (yesterday). I hope this does not continue off and on.
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| 72 | 2021-03-07 | headache |
Tested positive for Covid; Really bad headache; Shooting pain; This is a spontaneous report from a n...
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Tested positive for Covid; Really bad headache; Shooting pain; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sales representative. A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# not provided), via an unspecified route of administration on 26Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had really bad headache with shooting pain exactly one week after COVID vaccine (noted on 02Feb2021). The patient also tested positive for COVID one week later on 03Feb2021. Outcome of the events were unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
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| 72 | 2021-03-07 | headache | headaches, nausea, complete body aches, |
| 72 | 2021-03-07 | lethargy, nasopharyngitis |
Days 1 and 2, 24 and 25 Feb 20201, severe interior cold, forced napping, lethargy. Day 6, 01Mar21, w...
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Days 1 and 2, 24 and 25 Feb 20201, severe interior cold, forced napping, lethargy. Day 6, 01Mar21, worked at computer for 15 minutes, became dizzy and with brain fog. Did the strain in my immune system rekindle symptoms from the April 2019 concussion? From then on, I used my sunglasses when working at computer. Day 8, 03 March 2021, resumed half of a mild weight-lifting routine. Days 9, 10 and 11, 4-6Mar 2021, forced napping, lethargy, some brain fog. This pattern, light exercise or chores followed by day(s) of lethargy and napping, closely resembles April through September 2020+plus as I recovered from what appeared to be COVID-19 in March 2020. The test at that time was negative. Day 12, Sunday I learned about this site. Today, Day 13, I'm a bit lethargic but OK, having done nothing since Friday. Haven't yet attempted any significant chore.
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| 72 | 2021-03-07 | malaise, headache, fatigue |
Headache; Tired; feeling unwell; This is a spontaneous report from a contactable consumer (Patient)....
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Headache; Tired; feeling unwell; This is a spontaneous report from a contactable consumer (Patient). A 72-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left arm on 02Feb2021 at the age of 72 years old at a single dose for COVID-19 immunisation. The patient medical history was none. Concomitant medications included ibuprofen and paracetamol (TYLENOL). The patient previously took keflex [cefalexin monohydrate] and experienced allergy, first dose of BNT162B2 (lot number: EI8982) on arm left on 12Jan2021 04:00 PM at the age of 72 years old for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. It was reported that on 02Feb2021 20:00 PM, Headache started about 5-7 hours after injection. Continued for another 24 hours. Tired and feeling unwell also for the 30-36 hours after injection. The patient assessed the events as non-serious. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the events on an unspecified date in Feb2021.
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| 72 | 2021-03-07 | malaise |
Patient complained of dizziness appoximately a couple minutes after recieving first pfizer dose. Pt ...
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Patient complained of dizziness appoximately a couple minutes after recieving first pfizer dose. Pt was offered a seat. Pt blood pressure monitored. First blood pressure 98/53. Reassessed patient, patient stated she did not feel better. Rapid response team called. Blood pressure progressively decreased down to 72/41. Pt stated she felt worse. RRT transferred patient to Emergecy Room.
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| 72 | 2021-03-07 | fever, fatigue, chills | Chills, fever, extreme fatigue and body aches |
| 72 | 2021-03-07 | fever, headache |
Extreme headache, dizzy - can't walk without support. This is 3 days after. Low BP 82/59, low grade ...
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Extreme headache, dizzy - can't walk without support. This is 3 days after. Low BP 82/59, low grade fever. Difficulty with urination.
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| 72 | 2021-03-07 | fever |
Patient is a 72-year-old female presenting with fever and altered mental status. History is obtaine...
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Patient is a 72-year-old female presenting with fever and altered mental status. History is obtained for the patient and her husband. She got her second dose of Pfizer vaccine for Covid on 3/6/21. On 3/7/21, she woke with fever and urinary symptoms. She have an episode of incontinence and urinary frequency and urgency today. She was too weak to get up out of the recliner at home. She did have a fever this morning, which resolved with Tylenol. She also has been confused much lower mentally than normal. She is on 4L chronically for COPD, DM, HTN, HLP, CAD, previous DVT. She has had sepsis previously. She was admitted to the hospital, and received one dose of IV Rocephin, IV fluids, and tylenol.
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| 72 | 2021-03-07 | fever | High fever of 102.4 for almost 12 hours with tylenol. Fever gone in 2 days. |
| 72 | 2021-03-08 | chills, headache |
Chills; Headache; Muscle aches; This is a spontaneous report from a contactable pharmacist. A 72-yea...
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Chills; Headache; Muscle aches; This is a spontaneous report from a contactable pharmacist. A 72-year-old non-pregnant female patient (reporter's mother) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 05Feb2021 at 08:00 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, fibromyalgia, sleep apnea. The patient was not diagnosed with COVID prior to the vaccination. The patient had no known allergies. Concomitant medications included hydrochlorothiazide/valsartan, celecoxib, duloxetine. There were no other vaccines administered within 4 weeks of the vaccination. On 06Feb2021 at 06:00, the morning after the vaccination, the patient experienced chills, headache, and muscle aches. The patient was treated for the events with 600 mg of ibuprofen and the symptoms subsided. Since the vaccination, the patient was not tested for COVID. The clinical outcome of chills, headache, and muscle aches was resolving. Information on the lot/batch number has been requested.
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| 72 | 2021-03-08 | chills, fever | Fever, chills, diarrhea, |
| 72 | 2021-03-08 | fatigue, headache |
Received 02.14.21: Pain at left arm injection site - duration 2 days. 0n 02.17.21, sudden onset of ...
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Received 02.14.21: Pain at left arm injection site - duration 2 days. 0n 02.17.21, sudden onset of headache (moderate severity); overwhelming fatigue; difficulty lifting left arm. Took ibuprofen and slept for approx. 20 hours.
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| 72 | 2021-03-08 | headache, nasopharyngitis |
Pain in left arm, across back and right shoulder, chest pain, headache, very cold, and severe weakne...
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Pain in left arm, across back and right shoulder, chest pain, headache, very cold, and severe weakness. It lasted about 4 hours, from 9am to 1:15pm.
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| 72 | 2021-03-09 | body temperature increased, headache |
Temp of over 100 up to 103 Bad headache Late in second day symptoms were like MS exacerbation, weak,...
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Temp of over 100 up to 103 Bad headache Late in second day symptoms were like MS exacerbation, weak, unable to walk
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| 72 | 2021-03-09 | chills, fever, headache |
in less than a minute I had a vasvagal syncope response and my blood pressure got so high that the m...
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in less than a minute I had a vasvagal syncope response and my blood pressure got so high that the machine couldn't take it--in the 200's/100 something. I was taken to the ER and monitored for a few hours and labs. BP came down slowly, but not perfect. I was released around 7pm. Event happened at 3:46pm. The next day I had chills first, then I had a slight fever, a terrible headache in the back of my head, dizziness and night sweats. By the 2nd day after I am feeling better.
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| 72 | 2021-03-09 | fatigue, sleepiness, headache |
Immediately upon leaving the COVID shot parking lot at Hospital, I began to feel pain shooting down ...
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Immediately upon leaving the COVID shot parking lot at Hospital, I began to feel pain shooting down my arm all the way to my fingertips. Then I started to feel disoriented. Then, as I was driving myself home, I felt constriction in my chest, like I was barely holding onto consciousness, then pain shooting up my shoulder into the left side of my neck, the left side of my face, my left eye and into the left side of my head. My heart was pounding, my head was hurting intensely and I wondered whether I was having a stroke while trapped in stop and go traffic. The intense pain continued while I drove, for about 30 minutes. Then it subsided somewhat -- but continued through the evening. I could not get to The pain continued in my arm, up the left side of my body and into my head all night. I could not sleep. My heart was pounding. Somehow I dozed off around 2 or 3am. The next day I felt groggy and tired, with the more moderate pain continuing in my arm and all the way to my hand. Finally, on Monday morning, I was able to reach my doctor's office. I was told to go the ER, which I did. They could find nothing "emergent." The pain, tiredness and headaches continued through Thursday. Friday I started to feel better -- a week after the shot on Saturday, 2/27.
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| 72 | 2021-03-09 | fatigue | extreme fatigue, unable to stand alone, extreme pain in joints, weakness, nausea, glassy eyes |
| 72 | 2021-03-09 | fever, fatigue, chills | Chills Dizziness, fever extreme fatigue |
| 72 | 2021-03-10 | fatigue, fever |
Adverse Event: sore arm, could not raise right arm above should height, fever 100.4; onset at 4-5 h...
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Adverse Event: sore arm, could not raise right arm above should height, fever 100.4; onset at 4-5 hours after injection. Very tired; achy especially painful in knees and lower back. Took one Tylenol every 4 hours on Tuesday and Wednesday. Felt fine at 4:30 a.m on the 11th of March. Slept most of Tuesday from 5 p.m until next day. Wednesday, again achy, fever, exhausted, pain in joints, arm warm to the touch. Slept thru most of the day.
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| 72 | 2021-03-10 | fatigue |
After first Shot: First day: headache, slightly sore arm , achy, fatigue Next few days: elevated hea...
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After first Shot: First day: headache, slightly sore arm , achy, fatigue Next few days: elevated heart rate 1 week after shot: even higher heart rate, pain when breathing, pain in chest and right shoulder, extreme fatigue After second shot: Shortness of breath, pain with breathing,fast heart rate, extreme fatigue, achy
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| 72 | 2021-03-10 | headache, fever, chills |
Starting 24 hours after second dose, patient experienced fever, chills, body aches, headaches throug...
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Starting 24 hours after second dose, patient experienced fever, chills, body aches, headaches throughout Thursday and Friday. On Saturday, she noticed a little 'movable lump' on her lower right jaw (opposite side from vaccine site). By Monday the lump had grown to 3.5cm. That day she saw a doctor who examined her and was uncertain if it was due to a vaccine. A CBC taken that day was completely normal. Nothing was prescribed. Since Monday, the lump is hard but slightly tender and sometimes warm to the touch, but it has been getting smaller. Patient notes her temperature has been slightly higher than normal for her (~98.3') but otherwise she feels fine and the lump does not impede her swallowing, breathing, or talking.
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| 72 | 2021-03-10 | headache |
Within seconds of receiving the vaccine shot in my arm, I felt a feeling of a nerve sensation shooti...
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Within seconds of receiving the vaccine shot in my arm, I felt a feeling of a nerve sensation shooting across my lower face. My lower face, both sides, turned numb. I also instantly got a headache, not severe, the pain was about a 4 on a scale of 1 to 10 with 10 being the worst. After waiting 15 minutes, I asked to talk to a medical person and was directed to an EMT. I explained my facial numbness and he knew nothing about it and just said to see a doctor if it moved to any other part of my body. Over the following days, my jaw, lips and gums have been feeling a numb tingling feeling, exactly as if I have had Novocain at the dentist and it is wearing off. After one week, the symptoms were continuing and I was worried, so I called the advice nurse. After explaining my symptoms to her she advised me to immediately have someone drive me to the nearest emergency room. I went to the ER where I was seen by the dr. He did some research and said there have been a couple of other reports of people having these symptoms. He thought they would go away and wasn?t concerned. It has been 11 days now and my jaw, gums and lips still feel numb and tingly. The feeling comes and goes.
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| 72 | 2021-03-10 | headache |
Left ear hurt 11 pm 1-25-21; Violent pain/claws ripping flesh off half of face/head 2 am 1/26/21; no...
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Left ear hurt 11 pm 1-25-21; Violent pain/claws ripping flesh off half of face/head 2 am 1/26/21; non-amblitory, could not support weight, major balance issues. Televisit 1/26/21=earache. Blacked out cold 5 min, non responsice 30 min 2 am 1/26/21; woke with Bell's Palsey; Ddumb televisit 1/28/21=BP. Urgent Care visit-EKG (normal), bloodwork, urine lab work. 2/1/21 Saw NEURO = MRI brain w/contrast to rule out cancer (2/4/21; Two weeks of solid hallucinations 24/7. Horrendous balance issues-almost non-amblitory from onset 1/26/21 to present. Lost 9 pounds in 2 weeks.(I was 104 now 95 pounds). I was walking 5 mi a day, walked 1/24/21, healthy. Devastating pain to left side of head/face, esp ear. PAIN
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| 72 | 2021-03-10 | headache |
Bell's Palsy. Right facial paralysis, right eye won't close fully. Blurry vision and teary right eye...
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Bell's Palsy. Right facial paralysis, right eye won't close fully. Blurry vision and teary right eye. Headache. Symptoms started within 36 hours. Now in day #5. No change in symptoms
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| 72 | 2021-03-10 | fever, fatigue | Moderate fever, aches and fatigue |
| 72 | 2021-03-10 | fever, headache, chills |
Starting 24 hours after her second dose (Wed), patient experienced fever, chills, body aches, and he...
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Starting 24 hours after her second dose (Wed), patient experienced fever, chills, body aches, and headaches throughout Thursday and Friday On Saturday she noticed a little 'movable lump' on her lower right jaw (opposite side from vaccine site). By Monday the lump had grown to 3.5cm. That day she saw a doctor who examined her and was uncertain if the lump was due to the vaccine. She had a CBC taken that day that came back normal. Nothing was prescribed. Since Monday, the lump is still hard, slightly tender, and sometimes warm to the touch, but it has been getting smaller. Pt notes her temperature has been slightly higher than normal for her (~98.3') but otherwise she feels fine and the lump does not impede her swallowing, breathing, or talking.
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| 72 | 2021-03-10 | throat irritation, nasal congestion, nasopharyngitis |
Head cold; Diarrhea; developed a kind of allergies like a scratchy throat; Congested; This is a spon...
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Head cold; Diarrhea; developed a kind of allergies like a scratchy throat; Congested; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9262), via an unspecified route of administration on 25Jan2021 (at the age of 72-years-old) as a single dose for COVID-19 immunization. The patient's medical history included 'thyroid' from an unspecified date and unknown if ongoing. Concomitant medications were not reported. On an unknown date, reported as all of the sudden, the patient experienced a kind of allergy like a scratchy throat and then I was congested, a bad head cold (started last week) and from last night I started to have diarrhea. The clinical outcome of head cold, diarrhea, scratchy throat and congested was unknown.
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| 72 | 2021-03-11 | chills, body temperature increased, fatigue |
Around 11:00 a.m. the day following receipt of the 2nd dose vaccine, I experienced horrible body ach...
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Around 11:00 a.m. the day following receipt of the 2nd dose vaccine, I experienced horrible body aches and fatigue. I went to bed but couldn't get any sleep because of muscle cramps and charley horses. Around 4:00 p.m. I experienced chills and had to wrap myself in a blanket over my clothes. At that point I took my temperature and it was 100.4. I took it again a few minutes later and it was 99.4. I went back to bed and slept until 3:00 a.m. when I woke up to get some water. I got up today at 7:30 a.m. and all symptoms were gone.
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| 72 | 2021-03-11 | fatigue, headache, chills | Sore arm at injection site Headache Chills Fatigue |
| 72 | 2021-03-11 | headache, body temperature increased | 100.2 temp, body aches, headache, stomachache, vomiting. |
| 72 | 2021-03-12 | chills, fever |
Redness in the shot given area (small red area -somewhat hard to the touch) acey body, low grade fev...
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Redness in the shot given area (small red area -somewhat hard to the touch) acey body, low grade fever, chills and diarrhea.
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| 72 | 2021-03-12 | fatigue |
I was fine when getting the injection and my ½ hour wait. I was fine during dinner and after dinner...
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I was fine when getting the injection and my ½ hour wait. I was fine during dinner and after dinner and until about 9 hours after the injection when my arm felt exceedingly sore. I had been watching a free Amazon Prime cute movie while knitting a blanket for my grandson. When the movie was over and I was clearing my knitting, I noticed my super sore arm. I got up to check my face in the mirror to be sure that I was not having a reaction. But I did have a reaction with a rash on my chest and face 9 hours after the injection. My arm really hurt for three days but is fine now. When I saw my red face and chest, I took a Zyrtex D and a Benadryl. It did not seem to help the redness to go away. When I felt some tightening of my throat and started to feel that I might be starting to lose some clarity of thought, I quickly watched a minute video on how to use my new kind of generic epipen and jabbed myself in the leg and called 911. I felt much better after the epipen in terms of my thinking and throat. Basically, the medics that came to the house and said that I had taken what they would give me at the hospital and it was up to me if I wanted to go to the emergency room or not; they would take me but I would need a ride home. With the pandemic and 48 new cases, I decided to stay home and I went to bed; the rash on my face was gone in the morning. The next days I just felt muscle soreness all through my body (day 2) and felt tired (next two days) but had no fever at any time. I am fine today. I appear to have two very small areas on my chest that probably related to the reaction.
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| 72 | 2021-03-12 | headache |
Pfizer-BioNTech COVID-19 Vaccine EUA headache for one day muscle aches for 2 days upset stomach for ...
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Pfizer-BioNTech COVID-19 Vaccine EUA headache for one day muscle aches for 2 days upset stomach for 1-2 days
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| 72 | 2021-03-12 | headache |
Headache been almost immediately. Headache and body aches followed. Neither Tylenol nor aspirin help...
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Headache been almost immediately. Headache and body aches followed. Neither Tylenol nor aspirin helps. I am now on prednisone, but that doesn't seem to help either. It has been two weeks. I want to get th second dose but am afraid this is an allergic reaction.
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| 72 | 2021-03-12 | influenza like illness | Intense flu like symptoms |
| 72 | 2021-03-12 | sleepiness, fatigue, headache, throat pain |
Within 15 seconds I got a sore throat. Within 5 minutes I had muscular pain all over body. Chills....
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Within 15 seconds I got a sore throat. Within 5 minutes I had muscular pain all over body. Chills. Felt very tired. Headache. Nurse checked oxygen level within 10 minutes and it was well above normal. Nurse put me in recliner and I slowly calmed down and felt sleepy. Left in one hour walking to car and driving home. These symptoms lasted 7 days. Very irritated for 7 days. Very uncomfortable.
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| 72 | 2021-03-13 | headache |
Woke up the following morning after receiving the shot with a headache that increased during the day...
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Woke up the following morning after receiving the shot with a headache that increased during the day. Taking Tylenol 500mg but barely relieves the pain. Took 100mg and headache still increased.
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| 72 | 2021-03-13 | headache |
Chest pain (5/10), bilateral jaw numbness, left back pain, and headache. Oxygen 6 liters. Taken to t...
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Chest pain (5/10), bilateral jaw numbness, left back pain, and headache. Oxygen 6 liters. Taken to the ED>
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| 72 | 2021-03-13 | headache |
After first shot, pain in arm, up neck across back and into arms and fingers. Hives on the inside of...
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After first shot, pain in arm, up neck across back and into arms and fingers. Hives on the inside of upper thighs. After second shot, severe headache. I couldn't stand light for first 24 hours then continuing headache for 4 days. First 24 hours, pain in arms to fingers, neck, upperback, ache all over. Second and third day nausea.
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| 72 | 2021-03-14 | chills, fatigue, sweating | night chills, sweating, dry heaves, weakness, tiredeness |
| 72 | 2021-03-14 | chills, nasopharyngitis, headache |
severe Brain fog still 5 days later dysfunctional; severe whole body muscle pain even my fingers hur...
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severe Brain fog still 5 days later dysfunctional; severe whole body muscle pain even my fingers hurt 48 hours; severe whole body muscle pain even my fingers hurt 48 hours; drooling woke me up soaked the pillows; headache worse in my life 48 hours; dropping things hands wouldn't work; vomiting; severe diarrhea still problematic; Chills/cold shaking so hard teeth chattered; Chills/cold shaking so hard teeth chattered; Chills/cold shaking so hard teeth chattered; Still can't function normally 5 days now after 2nd shot; Still stuck in the house to weak to leave; Cognitive dysfunction; could not drive; trouble speaking; pins and needles both arms and legs; ataxia; received second dose of bnt162b2 on 19Feb2021; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 72-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer) , via an unspecified route of administration on 19Feb2021 01:15 pm on left arm at single dose for covid-19 immunisation. Medical history included Known allergies: iodine dye X-rays from an unknown date and unknown if ongoing. The patient's concomitant medications were none. The patient previously took first dose of bnt162b2 (COVID 19, brand: Pfizer) on 22Jan2021 at arm at single dose for covid-19 immunization. The patient experienced cognitive dysfunction (cognitive disorder) (medically significant) on 19Feb2021 18:00 with outcome of not recovered, could not drive on 19Feb2021 18:00 with outcome of not recovered, trouble speaking on 19Feb2021 18:00 with outcome of not recovered, pins and needles both arms and legs on 19Feb2021 18:00 with outcome of not recovered, ataxia on 19Feb2021 18:00 with outcome of not recovered, severe brain fog still 5 days later dysfunctional on an unspecified date with outcome of not recovered, severe whole body muscle pain even my fingers hurt 48 hours on an unspecified date with outcome of not recovered, severe whole body muscle pain even my fingers hurt 48 hours on an unspecified date with outcome of not recovered, drooling woke me up soaked the pillows on an unspecified date with outcome of not recovered, headache worse in my life 48 hours on an unspecified date with outcome of not recovered, dropping things hands wouldn't work on an unspecified date with outcome of not recovered, vomiting on an unspecified date with outcome of not recovered, severe diarrhea still problematic on an unspecified date with outcome of not recovered, chills/cold shaking so hard teeth chattered on an unspecified date with outcome of not recovered, still can't function normally 5 days now after 2nd shot on an unspecified date with outcome of not recovered , still stuck in the house to weak to leave on an unspecified date with outcome of not recovered. No treatment received. She is not pregnant. Facility type vaccine was hospital. No other vaccine in four weeks. The patient reported that "Cognitive dysfunction, could not drive, trouble speaking, pins and needles both arms and legs, ataxia, stumbling. 72 hours of ataxia severe Brain fog still 5 days later dysfunctional severe whole body muscle pain even my fingers hurt 48 hours drooling woke me up soaked the pillows , headache worse in my life 48 hours dropping things hands wouldn't work vomiting and severe diarrhea still problematic Chills/cold shaking so hard teeth chattered Still can't function normally 5 days now after 2nd shot Still stuck in the house to weak to leave , still ataxic." No COVID prior vaccination. No COVID tested post vaccination. Information about Lot/Batch number is requested.
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| 72 | 2021-03-14 | fatigue |
burning sensation in lower back and both legs, dizziness, head fog, fatigue all lasted 24 hrs Have...
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burning sensation in lower back and both legs, dizziness, head fog, fatigue all lasted 24 hrs Have developed tinnitus with high pitch noise which seems to be in both ears.
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| 72 | 2021-03-14 | fatigue |
I stayed in the parking lot for 15 minutes with no reaction. I drove to get gasoline, but within fiv...
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I stayed in the parking lot for 15 minutes with no reaction. I drove to get gasoline, but within five minutes, my face became flushed, a little puffy, and very hot. I put cold compresses on it for about 10 minutes. When it was less red, I left to return to home. I had no fever. I had only a sore arm and extremely tired for 36 hours. No breathing difficulties -- during the flush or afterwards.
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| 72 | 2021-03-14 | fatigue |
03.11.21 Thursday Day 1: Arm sore and swollen by bedtime, c. 2:00 am Friday. 03.12.21 Friday ...
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03.11.21 Thursday Day 1: Arm sore and swollen by bedtime, c. 2:00 am Friday. 03.12.21 Friday Day 2: Arm remains sore and more swollen than yesterday. Mild nausea all day. Moderate ?acidity? all day. Mild muscle aches all day but now seem to be lessening (8:43 pm). Started feeling unusually tired around 6 pm. 03.13.21 Saturday Day 3: Arm sore at vaccine site only. Nausea stronger. Acidity stronger ? feels like undilute sulfuric acid is burning a hole in my stomach. Extremely unpleasant. Less fatigued than yesterday. Very mild muscle aches. 03.14.21 Sunday Day 4: Nausea mild. Acidity mild. Unpleasant. More energy than any day since vaccine. 03.15.21 Monday Day 5: Very mild nausea and acidity, but still unpleasant. Slept too late but good energy level otherwise.
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| 72 | 2021-03-14 | head discomfort, fatigue |
Nausea. Fatigue, pressure back of head, dizzy, jittery, sleeplessness, hot feeling top portion if...
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Nausea. Fatigue, pressure back of head, dizzy, jittery, sleeplessness, hot feeling top portion if stomach.
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| 72 | 2021-03-14 | headache, fatigue, chills, fever |
I had chills for 2 hours. headache. fever of 101.6. vomiting all over the place. I couldn't even dri...
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I had chills for 2 hours. headache. fever of 101.6. vomiting all over the place. I couldn't even drink a sip of water. cramps. leg pain. pain inbetween my shoulders. I could barely stand up, I was very weak. I went to the hospital and got a few shots to help with the vomiting. (Finigan) and medicine for the cramps and muscle aches. Fatigue and headache still lingers.
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| 72 | 2021-03-14 | headache, fever, fatigue, chills |
Bedridden for 48 hours+ with overwhelming fatigue, fever, chills, severe headache, overall severe j...
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Bedridden for 48 hours+ with overwhelming fatigue, fever, chills, severe headache, overall severe joint pain, sensation of swelling in L axilla although no actual swelling noted, pain at injection site, leg cramping, mouth pain (gums & teeth)
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| 72 | 2021-03-14 | headache | Headache, stiff neck, weak body, fuzzy thinking, shaky, unstable walking, metal taste in mouth. |
| 72 | 2021-03-15 | fatigue |
Severe rash started on my hips and became beet red, burning and itching intensely. Over the next 2 ...
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Severe rash started on my hips and became beet red, burning and itching intensely. Over the next 2 days the rash spread up my back, and to the top of my thighs. The second day it spread down my legs to my feet (but not as severe) and on my arms down to my hands. My head also began itching. This lasted for about 10 days and has now cleared up. I experienced extreme exhaustion and dry mouth. I still feel tired and have a dry mouth when arising.
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| 72 | 2021-03-15 | fatigue |
The day after second vaccine I awoke with left underarm and neck lymph nodes swollen, tender, uncomf...
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The day after second vaccine I awoke with left underarm and neck lymph nodes swollen, tender, uncomfortable, with slight redness to area. Over course of next 5 days I felt more tired than usual as swelling subsided. After first vaccine I only experienced left arm soreness at injection site, mild headache and some tiredness for first 24-36 hrs.
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| 72 | 2021-03-15 | head discomfort, headache |
I am reporting the below as everything written has NEVER happened to me before in my 72 years of liv...
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I am reporting the below as everything written has NEVER happened to me before in my 72 years of living. This has all taken place since I have had the Vaccine Injection on Wednesday, February 24th. I am attributing all of this as a possible reaction to the vaccine or maybe coincidence. I wanted to report what has taken place so you all can assess if this is a possible adverse reaction, a direct effect from the vaccine or just coincidence. Please let me know if anything like this has been reported and what your thoughts about the matter. Wednesday, February 24th 11:15am Pfizer Vaccine right arm ?about an hour later discomfort on shot side that went from the shoulder up the right side of the neck. Was gone by next day. Thursday, February 25th Day seemed to be normal. When I went to bed that evening a pressure and pounding on the left top side of the head, on the part line. Lasted 5-6 hours and then went away for that episode. Friday, February 26th Day started off OK, walked 2 miles and then ran some errands. *3:00pm I bent down to pick up something and when I came up I had extreme light headedness like I have never had before. I was able to get myself collected and then continued to get ready to go out. *6:00pm I just sat in a chair in the restaurant and BAM the room started spinning at about 500 miles (that is the speed that it felt like) an hour. My arms were flailing as I was trying to grab something to old onto. Just when I was about to fall off of the chair my husband walked up and grabbed me as he could see that something was going on and he said that I was white as a sheet. Once I got somewhat collected, I knew immediately that I had to throw up. My husband took me to the restroom. I had severe dry heaves that just would not stop. I wasn?t breathing properly so my hands and feet were numb, tingly and very white in color. Then I had to have a bowel movement. We phoned for the ambulance to take me to the hospital jus to make sure that I did not have a stroke, or it was my heart, or a vessel had burst in the head. The Paramedic tested me for a stroke and I passed the test. *8:00pm or so I had another episode with room going around at top speed and I started having dry heaves. Nurse gave me medicine in the IV for nausea. My Doctor said that everything was Benign. He said that the CT patient scan was negative and all other tests were OK. Saturday, February 27th I was released from the hospital and went home. I did very little that day. I slept that night from 10:00pm until 10:00am the next day. Sunday, February 28th I was lightheaded, had a headache, and ears ringing all day. I just did not feel myself at all. Tuesday, March 9th Around noon I had a severe lightheadedness/spinning episode, eyes felt like they were spinning. Laid down for about 2 hours and when I got up I was able to function and the spinning had gotten better. Headache all night long, ears ringing, feeling of lightheadedness. Wednesday, March 10th Not quite as dizzy, headache all day, back of neck and left side of head sore to touch. Pounding on left top side of head ? along the part line, where I had the same discomfort the 2nd day after the vaccine. Thursday, March 11th Having discomfort on left side of head. To the right of the left ear, going down to the neck. I can touch those areas and add to the discomfort. Friday, March 12th On Monday, March 7th I noticed a red spot on the right side behind where I was given the injection. I tried to treat it myself but my remedies were not helping. Contacted my Dermatologist on Thursday, March 11th. She saw me today, Friday, March 12th. She is not sure if it is a possible aftermath of the vaccine or something else. Had some bloodwork run to rule how Shingles. Prescribed some medication for Shingles to take until Monday when the bloodwork report is due for review. Blood work was negative for Shingles. Ever since the episode on February 26th I have NOT felt myself at all. Lightheaded, nausea, headache, pressure in head and feels heavy, not steady on my feet, discomfort in back of head near neckline, on/off discomfort in the top of the head with a pounding force. BLOOD PRESSURE IS NOW HIGHER THAN NORMAL ESPECIALLY WITH BOTTOM NUMBER BEING HIGH. I have never had a Blood Pressure problem, although as I have aged the top number has elevated but not enough to take medicine. However, the lower number is now elevated (high 80-?s, low mid range 90?s) and Cardiologist is going to make a decision on whether I should start on a low dose medicine. I am to take my 2nd Pfizer shot tomorrow ? Wednesday, March 17th at 11:00am. Thank You for reviewing the above writings. I look forward to the conclusion VAERS makes on my situation.
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| 72 | 2021-03-15 | headache, fever, chills | Fever 101.9, headache, nausea, burning sensation in spine, chills |
| 72 | 2021-03-15 | fever, headache, fatigue, chills |
Have had chills, fever, aches, headache, dizziness since the 12th. Better but still fatigued and di...
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Have had chills, fever, aches, headache, dizziness since the 12th. Better but still fatigued and dizzy when I get up
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| 72 | 2021-03-16 | cough, chills, sneezing, fatigue, fever |
Afib,5hours in length on Tues March 10th BP at 176/89 on Wed at home and Thurs at Dr's office Ongoi...
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Afib,5hours in length on Tues March 10th BP at 176/89 on Wed at home and Thurs at Dr's office Ongoing in up and down cycles: chills,tight chest,foggy brain,bronchial cough with thick mucous ,some green, intense sneezing, nausea,diarrhea, Today,Wed March 17th very slow brain function low fever,diarrhea,very tired,hard to focus, less sneezing,no green mucous in cough.
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| 72 | 2021-03-16 | fever, fatigue |
Within 72 hours fevers, body aches, myalgia, exhaustion, poor appetite. Sx resolved after 7-10 day...
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Within 72 hours fevers, body aches, myalgia, exhaustion, poor appetite. Sx resolved after 7-10 days.
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| 72 | 2021-03-17 | fatigue, headache, chills | headache, chills, exhaustion lasted about 6 hours |
| 72 | 2021-03-17 | fatigue, malaise, headache, chills |
Just lots of symptoms for 48 hours after: injection site pain, tiredness, headache, muscle aches, ch...
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Just lots of symptoms for 48 hours after: injection site pain, tiredness, headache, muscle aches, chills, nausea, feeling unwell, feeling hot (but no actual temperature). I did NOT have a severe allergic reaction, just
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| 72 | 2021-03-17 | headache, chills, fever |
Arm started to hurt at injection site in the evening , then feeling somewhat achy & headachy. Progr...
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Arm started to hurt at injection site in the evening , then feeling somewhat achy & headachy. Progressed to chills, body aches, fever, joint pain, and minor nausea through a good part of the night. This morning I still feel headachy and have a low fever. Have not taken any pain reducers.
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| 72 | 2021-03-17 | headache, fever |
The morning following first dose I woke up with a headache, body aches, slight fever, dizzy & nausea...
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The morning following first dose I woke up with a headache, body aches, slight fever, dizzy & nausea. These went on for the next week. I didn't go into work February 26th. But did go in partial days all the next week. Very uncomfortable. The headache got worse each day until it was very bad. On March 10th I woke up with my left arm in excruciating pain and the headache. Went to urgent care and doctor gave me a shot of Tromodol. When I got to the parking lot, I became very dizzy and my legs gave out and fell in the parking lot down to t he ground. Went to ER and waited for about 3.5 hours and left and went home. Went back to ER on March 12th due to arm in constant pain. Not able to sleep or relax. Wait this time was 3 hours and I was in too much paid so my daughter took me around the corner to urgent care. I was given steroid, muscle relaxer and a cream for my arm. My left arm from muscle up to shoulder and into wrist continues to hut. Today is 3/18/2021.
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| 72 | 2021-03-17 | sweating |
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Dizziness / Lighthead...
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Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild
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| 72 | 2021-03-18 | chills, headache, fever |
headache, joint ache, low fever, chills, 17 hours later took one advil. on the third day from the va...
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headache, joint ache, low fever, chills, 17 hours later took one advil. on the third day from the vaccination I am fine.
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| 72 | 2021-03-18 | cough, chills, malaise, headache |
RA; no energy/weak; OA; coughing; chilling; diarrhea; headache; we are not hungry but food is tastel...
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RA; no energy/weak; OA; coughing; chilling; diarrhea; headache; we are not hungry but food is tasteless/no taste; fibro; no taste/food was tasteless; She did not feel very well; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for her husband and herself. This is the first of two reports for herself. Only this case is serious. A 72-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot # EN6201, via an unspecified route of administration on 10Feb2021 17:15 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included unspecified products in two weeks. There was no other vaccine in four weeks.The patient experienced coughing, weak, no taste, chilling, diarrhea, no energy, headache all on 11Feb2021. She did not feel very well on the day she took her shot on 10Feb2021 but did not have a fever. She was not hungry but food was tasteless.It was also reported that "she had RA OA and fibro. and take thyroid medicine besides medicine for the others. Adverse event start date: 11Feb2021". No treatment was received for all events and events outcome was not resolved.The patient did not have COVID prior vaccination and no COVID tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021207100 same reporter/product, similar events, different patient
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| 72 | 2021-03-18 | fatigue, chills |
Fatigue, shaky, crooked, ache all over, chills. Vaccine was Sunday pm, reaction started after 4-mile...
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Fatigue, shaky, crooked, ache all over, chills. Vaccine was Sunday pm, reaction started after 4-mile walk Monday pm, missed meeting. Took 2 Tylenol, slept. Tues-Thurs: fatigue, chills, aches, diminished over the days. I rested and slept. Today=Friday, declared myself cured, took shorter walk, got tired, normally don?t get tired. *Today I discovered why I felt crooked: right shoulder higher because it?s swollen, down to mid-way between elbow & wrist, down to waist, some of side of body.* Treatment still only rest, but still I'm not so fatigued, aching easy to ignore. Never had fever (temp around 96.8 which is normal for me). I never felt too bad. Except for overpowering fatigue, I felt like doing things.
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| 72 | 2021-03-18 | fatigue, chills |
sore arm, chills, and extreme urge to urinate lasted 1 hr took oxycodone/tylenol. exhausted next 24h...
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sore arm, chills, and extreme urge to urinate lasted 1 hr took oxycodone/tylenol. exhausted next 24hr
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| 72 | 2021-03-18 | fatigue, cough |
2/22/21 Patient presented to ED w/ cough, SOB and fatigue. Initial RA pulse ox 86%. She was admitted...
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2/22/21 Patient presented to ED w/ cough, SOB and fatigue. Initial RA pulse ox 86%. She was admitted and was found to have COVID and was admitted. She was treated with med nebs and prednisone. She was maintained on O2 per nasal canula until 3/2/21. She reportedly had been having symptoms for 2 wees prior to admission so Remdesivir was deferred. Hospital course prolonged by very slow progress with rehab and she was discharged to rehab on 3/3.
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| 72 | 2021-03-18 | fatigue, headache |
Injection site soreness for 3 days, extreme tiredness, severe headaches, and red rash around armpit ...
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Injection site soreness for 3 days, extreme tiredness, severe headaches, and red rash around armpit area, not itchy but under both arms.
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| 72 | 2021-03-18 | headache, chills, fatigue |
head ache chills fatigue loss of appetite pain at location of injection gradually t spread to overal...
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head ache chills fatigue loss of appetite pain at location of injection gradually t spread to overall pain dizzy symptoms are resolving still noticing dizziness by day 2
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| 72 | 2021-03-18 | throat pain, fatigue, fever |
Fever of 3 degrees; extreme fatigue; nausea; dizziness; loss of appetite; loss of smell/taste; loss ...
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Fever of 3 degrees; extreme fatigue; nausea; dizziness; loss of appetite; loss of smell/taste; loss of smell/taste; sore throat; This is a spontaneous report from a contactable consumer. A 72-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the right arm on 06Feb2021 (Batch/Lot number was not reported) at 72-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did have COVID prior to the vaccination. Medical history included penicillin allergy, Brazil nuts allergy, COVID-19 (recovered from COVID 11 days prior); all from an unknown date and unknown if ongoing. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; citalopram (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; famotidine (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. On 07Feb2021 at 04:00, the patient experienced fever of 3 degrees (non-serious), extreme fatigue (non-serious), nausea (non-serious), dizziness (non-serious), loss of appetite (non-serious), loss of smell/taste (non-serious), sore throat (non-serious); which the patient described as "like a mini COVID storm." There was no treatment received due to the events. The patient underwent lab tests and procedures which included body temperature: 3 degrees on 07Feb2021. The clinical outcome of the events was recovered in Feb2021. The patient was not tested for COVID post vaccination. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
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| 72 | 2021-03-19 | headache, fatigue, fever, malaise |
Minor chest fluttering few minutes after shot. Later that day, yesterday and less today dizziness, w...
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Minor chest fluttering few minutes after shot. Later that day, yesterday and less today dizziness, weakness, stumbling, few words not coming out quite correctly. These challenges seem to be improving. Tiredness, headache, unwell feeling, arm pain, fever.
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| 72 | 2021-03-19 | headache, fatigue, fever |
101 degree F fever, fatigue, headache, nausea, muscle and joint aches required bed rest and Aleve. ...
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101 degree F fever, fatigue, headache, nausea, muscle and joint aches required bed rest and Aleve. Fever down to 99 deg this morning, and symptoms resolved this morning
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| 72 | 2021-03-19 | sweating, malaise |
Within a few minutes, felt faint, unwell, did faint, came to, hot and sweaty, retching, heartbeat 11...
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Within a few minutes, felt faint, unwell, did faint, came to, hot and sweaty, retching, heartbeat 110.
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| 72 | 2021-03-20 | headache |
Dry heaves, nausea, headaches, back pain. Started with dry heaves & headache on the 6th of March. ...
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Dry heaves, nausea, headaches, back pain. Started with dry heaves & headache on the 6th of March. Continued with both and added intermittent nausea. Began to have back pain during the 1st week. Unable to eat more than 1-2 bites with nausea. Took OTC pain medications. Tele-health call to PCP on 3/16/21 and obtained prescription for Zofran, which help a little. Eventually, symptoms started to subside the week of 3/24/21.
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| 72 | 2021-03-21 | fatigue, headache | Headache, body aches, arm pain injection site, tiredness, nausea |
| 72 | 2021-03-21 | headache, chills, fatigue | Severe headache, nausea, vomiting, muscle and joint pain, weakness, fatigue and chills |
| 72 | 2021-03-21 | headache, fatigue |
I felt fatigue even the day of the second vaccine. Then about 2 days after I had a severe and sudde...
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I felt fatigue even the day of the second vaccine. Then about 2 days after I had a severe and sudden bout of plantar facsitis, then increase in other arthritis symptoms. Then a week after I suffered a stomach virus. Then latter that same week for two days I experienced severe right leg pain. Then developed cluster rashes on the whole right leg. Went to Urgent care since we are wintering out of state. Was diagnosed with Shingles which I have never had and hope to never have again. The blisters are improving but the pain remains. I very strongly feel this is ALL due to the second dose of this vaccine. I certainly feel the second dose of this vaccine should not be given for at least 6 months.
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| 72 | 2021-03-21 | headache | Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Headache-Medium |
| 72 | 2021-03-22 | fatigue | Weakness, body ache, fatigue |
| 72 | 2021-03-22 | head discomfort, chills |
Started with "Brain Fog" on day 2 after vaccine. Then by the next day had pressure in head with ear...
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Started with "Brain Fog" on day 2 after vaccine. Then by the next day had pressure in head with ear pain. Also, had some chills. Called doctor on day 4 but was not treated. On day 7 was started on an antibiotic which did help the pressure but did not help the ear pain and noise in ear. Better now but still has "noise in head" but states it is improving.
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| 72 | 2021-03-22 | headache |
Headache and body aches were mild. Then, began to have burning in eyelids and down side of nose star...
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Headache and body aches were mild. Then, began to have burning in eyelids and down side of nose started and continues until now. It decreased after dermatologist perscribed medication. On 3/13 went to hospital with severe chest pain. They determined it was muscular-sceletal. While in the hospital and to this day has burning in bottoms of feet. Has weakness and numbness in both legs and feet. The weakness decreases ability for activity- very uncomforatable and making her unsteady when up. She also has some weakness in her arms.
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| 72 | 2021-03-22 | fever, chills | Fever, severe chills, aches, nausea |
| 72 | 2021-03-22 | fever, fatigue, headache |
Shaking, joint pain, fever of 101, loss of appetite, headache, tiredness, nausea, pain and redness a...
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Shaking, joint pain, fever of 101, loss of appetite, headache, tiredness, nausea, pain and redness at injection site. These symptoms persisted for 48 hours.
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| 72 | 2021-03-23 | headache, sweating | Nauseous, headache, sweating |
| 72 | 2021-03-23 | lethargy |
Got the vaccine, got very dizzy immediately after and kept her for 30 minutes and gave her water. ...
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Got the vaccine, got very dizzy immediately after and kept her for 30 minutes and gave her water. Then driving home she started feeling itchy, and could feel little hives in each ear. She was then very lethargic that night and all the next day Sunday, and then first thing Monday morning was covered with a large hives and a rash. She was covered from one end of her body to the other and into her joints where she was not able to bend her joints. She tried to use cortisone, but that made it worse. Also tried Benadryl lotion and Calamine lotion, which also did not help. She then went to the doctor and he prescribed steroids. She has had pain as if somebody was sticking needles in her. In the past 2 days her lips are numb and swelled, and on the right cheek plus her two eyes there is a big swollen area and her eyes are burning. Now her entire body is peeling as if she had a bad sunburn. Now her blood sugar due to the steroids is from 250-475. The site of the vaccine itself was ok.
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| 72 | 2021-03-23 | nasal congestion |
my ears started feeling like they were stopped up and my nose started feeling stuffy.; nose started ...
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my ears started feeling like they were stopped up and my nose started feeling stuffy.; nose started feeling stuffy; felt flushed; my face was red; what feels like my heart quivering for several seconds followed 3 or 4 times by very slight pain; what feels like my heart quivering for several seconds; This is a spontaneous report received from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at left arm on 08Mar2021 09:30 AM at single dose for COVID-19 immunization. Medical history included gastroesophageal reflux disease, osteoarthritis, nodules on thyroids and allergy to Aspartsme. No covid tested post vaccination. Patient was not pregnant at the time of vaccination. Concomitant medication included pantoprazole sodium sesquihydrate (PANTOPRAZOLE 40). the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously took Sulfanomide (Sulfa drugs) and had allergy (swelling), codeine and had allergy (nausea). The symptom that has made patient concerned enough to report the possibility of a side effect is: she had her shot this morning and between about 8:55 and 9:15 this evening she had 9 or 10 episodes of what feels like her heart quivering for several seconds followed 3 or 4 times by very slight pain, just below her right breast, she has never experienced such a thing before. (she took baby aspirin around 9:20 in case she was having some kind of heart thing). It's 9:45 pm, and the quivering episodes haven't happened for the last 30 minutes, so maybe they're all cleared up. Earlier, within 30 min of getting the vaccine, her ears started feeling like they were stopped up and her nose started feeling stuffy. Then as she was driving home she felt flushed and looked in the mirror and her face was red, she took one Sudafed in case it was allergies, and those symptoms improved quite a lot. Adverse event start date was 08Mar2021 10:00 AM. Since the vaccination, the patient has not been tested for COVID-19. Unknown if treatment received for ears started feeling like they were stopped up and nose started feeling stuffy. Outcome of what feels like my heart quivering for several seconds followed 3 or 4 times by very slight pain was recovered. Outcome of felt flushed and face was red was recovering and outcome of other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
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| 72 | 2021-03-23 | fever |
Fever of over 101 degrees developed during the night, approximately 12 - 15 hours after receiving se...
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Fever of over 101 degrees developed during the night, approximately 12 - 15 hours after receiving second dose. Fever lasted for nearly 24 hours and did not respond to Extra Strength Tylenol. Allergic red rash appeared over trunk of body overnight following injection, within 12 - 18 hours. Rash continued to spread to inside of arms, thighs, across back and abdomen, and neck. Treating with Benadryl oral and topical. Pain and soreness in arm where injection was received began a few hours after injection, lasting about 24 hours.
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| 72 | 2021-03-24 | chills, headache, malaise, fever, fatigue |
Injection site pain, feeling unwell Tiredness, swollen lymph nodes Headache, light headedness Chills...
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Injection site pain, feeling unwell Tiredness, swollen lymph nodes Headache, light headedness Chills Fever
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| 72 | 2021-03-24 | nasal congestion, runny nose, fever, throat pain |
Date and time adverse event started: 3-7-21 low grade fever X3 days,sore throat, itching to inside o...
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Date and time adverse event started: 3-7-21 low grade fever X3 days,sore throat, itching to inside of ear, congestion, runny nose, wheezing- asthma. Benadryl Recommended antihistamine (benadrly,claritin, zyretec), decongestion, analgesic (tylenol, ibuprofen, naproxen), lots of fluids; caller verbalized understanding. informed her to get covid tested due to expressing covid like symptoms & if + to wait until after her quarantine period to receive the 2nd dose; caller verbalized understanding.
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| 72 | 2021-03-24 | productive cough, cough |
Persistent hypoxemia as well as intermittent cough and sputum production along with shortness of bre...
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Persistent hypoxemia as well as intermittent cough and sputum production along with shortness of breath , required hospitalization.
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| 72 | 2021-03-25 | headache, fatigue | Headache, extreme fatigue, muscle aches, nausea |
| 72 | 2021-03-25 | fever, chills |
Chills - started within an hour Sore muscles and joints - 2 hours Palpitations - 12 hours Fever - 24...
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Chills - started within an hour Sore muscles and joints - 2 hours Palpitations - 12 hours Fever - 24 hours Rash - 48 hours
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| 72 | 2021-03-26 | chills, fever, fatigue | Brain Fog, extreme fatigue affecting my balance, muscle aches, loss of appetite, chills, fever |
| 72 | 2021-03-26 | influenza like illness, sweating, fatigue |
Received second Covid shot at noon, by 5pm beet red from neck to waist, even all the way down both a...
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Received second Covid shot at noon, by 5pm beet red from neck to waist, even all the way down both arms. At 11 pm went to bed with large lump in my throat, felt like I was breathing thru a straw plus whole body freezing from inside out. Could not get warm. Added layers of clothes and blankets and laid like that all nite, no sleep. 7am called nurse, advised to remove some of the layers, drink hot liquids and Tylenol every four hours. By mid afternoon the cold was gone but severe achy bones, even the bottom of my feet hurt. Next day hot and cold and ache. Fourth day dripping sweat all day and flu like symptoms. Took three showers to get sweats down plus the entire time had been taking Tylenol every four hours. Day five just drained, felt like I'd been through the wringer.
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| 72 | 2021-03-27 | fatigue, fever, sweating | Dizzy, muscular pain, fever, excessive sweating, upset stomach, feeling out of breath, fatigue |
| 72 | 2021-03-30 | headache, chills, fever |
body aches; headache; both arms sore , left arm pit sore; chills; fever; This is a spontaneous repor...
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body aches; headache; both arms sore , left arm pit sore; chills; fever; This is a spontaneous report from a contactable consumer(Patient). A 72-years-old female patient received bnt162b2 (Pfizer- BioNTech Covid 19 Vaccine, Lot Number: EL3248 ), dose 1st via an unspecified route of administration, administered in Arm Left on 05Feb2021 as single dose for covid-19 immunisation. Medical history included high blood pressure , overweight and covid-19 (if covid prior vaccination: Yes). Concomitant medications included Losartan 100 mg, rosuvastatin 10mg, vita C 1000mg. The patient previously took statins and experienced drug hypersensitivity. Patient experience body aches, headache, both arms sore, left arm pit sore, on and off chills and fever all were on 06Feb2021 02:15. Treatment was not received for the adverse event. Patient was not pregnant. The outcome of the recovering.
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| 72 | 2021-03-30 | headache |
Headache; Nausea; localized, large red spot where she received the injection; This is a spontaneous ...
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Headache; Nausea; localized, large red spot where she received the injection; This is a spontaneous report from a contactable consumer. A 72-year-old female consumer(patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL9264, Expiration date: unknown) via an intramuscular route of administration in left arm on 28Jan2021 at 9:30 am as single dose for COVID-19 Immunization. The patient's medical history included Osteopenia(ongoing) diagnosed 20 years ago, patient had allergies with grasses, trees, and dust. The patient also allergic to penicillin and Succinylcholine, which is a muscle relaxer. The patient clarified she shouldn't say allergic, but more so hypersensitive. The patient reported that she took nothing but over-the-counter supplements. On 06Feb2021 patient experienced localized, large red spot where she received the injection, Headache and Nausea. The patient also stated that 9 days after vaccination she developed "COVID arm", she clarified it was a localized, large red spot where she had received the injection, she had no reaction or redness or anything else when she received the injection on 28Jan2021. After 9 days of vaccination, on 06Feb2021 (Saturday)the patient first noticed the spot at the injection site she also had a headache and nausea. She was actually awakened at 2am on 06Feb2021 by the headache. She did not notice the spot at the injection site at this time, but she wasn't looking for it. Caller didn't notice the spot until taking a shower. She confirms she recovered completely from the headache and nausea on 08Feb2021 and the spot was also gone. The patient did not require hospitalization. The outcome for the events was recovered on 08Feb2021. No follow-up attempts are possible. No further information is expected.
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| 72 | 2021-03-31 | malaise |
angioedema; Face itching; feel unwell; my face was swelling, dark red; my face was swelling, dark re...
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angioedema; Face itching; feel unwell; my face was swelling, dark red; my face was swelling, dark red/Palms of both hands were swelling and dark red/feet turning red; Palms of both hands were swelling and dark red.; Wheezing; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female patient (Not pregnant at the time of vaccination) received first dose of bnt162b2 (Batch/Lot Number: EN6198), via an unspecified route of administration in left arm on 03Mar2021 10:45 as single dose for covid-19 immunization. Relevant medical history included: Heart disease, HTN (hypertension), asthma, hereditary factor X deficiency, breast cancer 5 years ago all from an unknown date and unknown if ongoing. The patient was allergies to Lisinopril and povidone-iodine (BETADINE). The patient's concomitant medications were not reported. The patient experienced angioedema, face itching, feel unwell, face was swelling, dark red, dark red/palms of both hands were swelling and dark red/feet turning red, palms of both hands were swelling and dark red, wheezing on 05Mar2021 17:00. The patient felt fine on the 1st and 2nd day post vaccination. Thrilled to finally get 1st dose Pfizer. On 05Mar2021, she began to feel unwell. She looked in mirror, her face was swelling, dark red. Palms of both hands were swelling and dark red. Also feet turning red. Wheezing. Face itching. She was a retired nurse and she knew this was angioedema. Her husband drove her to ED (emergency department). She was given methylprednisolone sodium succinate (SOLUMEDROL) IM and prescription for prednisone. The outcome of events was not resolved. The events resulted in emergency room/department or urgent care. Treatment included: IM methylprednisolone sodium succinate (SOLUMEDROL) in ED and oral prednisone for 3 days. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, has the patient hasn't been tested for COVID-19.; Sender's Comments: Based on temporal association and known drug profile, a contributory role of the suspect drug cannot be excluded in the development of the reported events. Relevant medical history includes allergies to lisinopril and betadine, which suggests potential for drug allergies. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 72 | 2021-04-01 | sweating |
Pfizer-BioNTech COVID-19 Vaccine EUA 72 year old female healthy, not on any medications, came to hos...
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Pfizer-BioNTech COVID-19 Vaccine EUA 72 year old female healthy, not on any medications, came to hospital for her first covid vaccine. After approximately 10 minutes vaccination, she started feeling dizzy, light headed, slightly nauseated. Reports sweating and cold hand. Patient was taken to the emergency department and later admitted to the hospital with new onset afib/aflut with RVR following first dose of Pifzer Covid-19 vaccination. Further workup revealed reduced EF on ECHO and elevated LFTs. Patient was treated and discharged home.
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| 72 | 2021-04-04 | fever |
Patient in usual state of health, apporx 1.5 days after vaccination, health declined with confusion,...
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Patient in usual state of health, apporx 1.5 days after vaccination, health declined with confusion, inability to speak or find correct words for communication, sitting up on her own, incontinent episode x1, admitted to hospital for fever, vaccine reaction, discharged home
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| 72 | 2021-04-06 | fever |
I have got lump under my left arm and it's rather sore; I ache from head to toe; I have got a temper...
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I have got lump under my left arm and it's rather sore; I ache from head to toe; I have got a temperature of 102; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. Medical history included none. There were no concomitant medications. The reporter stated that I am experiencing some side effects, I ache from head to toe, I have got lump under my left arm which is where I got the injection (Clarified as Covid-19 Vaccine by Pfizer) in my left arm and it's rather sore and I have got a temperature of 102. The patient not received any treatment for the events. The outcome of the events was reported as unknown.
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| 72 | 2021-04-07 | fatigue |
woke up with body aches, fatigue, muscles just hurt, 2nd COVID vaccine on Tuesday. Had COVID back in...
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woke up with body aches, fatigue, muscles just hurt, 2nd COVID vaccine on Tuesday. Had COVID back in October 2020, Took 400 mg ibuprofen PTA.
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| 72 | 2021-04-11 | fatigue, cough |
Pt received first dose of the Pfizer COVID 19 vaccine on 3/30/2021. She presented to the ED on 4/1...
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Pt received first dose of the Pfizer COVID 19 vaccine on 3/30/2021. She presented to the ED on 4/11/2021 with fatigue, cough, hypokalemia, and generalized weakness. She was admitted to an inpatient unit and tested for COVID-19 which came back positive. Anticipated discharge is today, 4/12/2021
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| 72 | 2021-04-17 | chills, fatigue |
faint; tired; chills; mild diarrhea; This is a spontaneous report from a contactable consumer (patie...
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faint; tired; chills; mild diarrhea; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received bnt162b2 dose 1 intramuscular in right arm on 13Feb2021 16:00 PM (Lot number unknown) at single dose for COVID-19 immunization. The patient had known allergies to penicillin and shellfish. Other medical history was not provided. The patient's concomitant medications included atorvastatin, vitamin, fish oil, probiotic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient became faint, tired and had chills which caused mild diarrhea from 13Feb2021 05:00 PM. The patient did not receive treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The patient received the bnt162b2 dose 2 intramuscular in Right arm on 06Mar2021 01:15 AM (Lot number unknown) at single dose for COVID-19 immunization. The outcome of the event events was recovered. Information on the lot/batch number has been requested.
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| 72 | 2021-04-17 | cough, respiratory tract congestion |
congestion in her chest; The congestion in her chest is, she knows it's there, it's tight,; cough; a...
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congestion in her chest; The congestion in her chest is, she knows it's there, it's tight,; cough; arm was sore; This is a spontaneous report from a contactable consumer (patient) reporting for herself. This is report 1 of 2. A 72-year-old consumer (female) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9266, Expiry date: May2021) via an unspecified route of administration on 25-FEB-2021 at left arm around 11:30 -12:30 and patient received second dose BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8730/GR8730) via an unspecified route of administration on 25Mar2021 both as a single dose for COVID-19 immunization. Medical history and concomitant medication reported as diabetes and blood pressure medicine (From: Unspecified To: Ongoing), has since about 2015 or 2013 or something like that. She declines to provide her medication. She is not a serious diabetic. Sometimes she does not have to even take the diabetes medication because she keeps her A1C is so low she doesn't have to take the diabetes shots. She did not receive any other vaccines within four weeks prior to the vaccination. She didn't have any other real problems with the first dose of Pfizer COVID-19 Vaccine other than her arm getting sore. For her second Pfizer COVID-19 Vaccine she don't have to bother her arm. She had a little cough started sometime last week before she took the second Pfizer COVID-19 Vaccine. The cough doesn't happen all the time. She was coughing quite regular every 2-3 minutes before. She got the Diabetic Tussin cough syrup which has no sugar or alcohol. After taking that cough started quieting down. She was asking is it a regular cough or did the Pfizer COVID-19 Vaccine cause the cough. She's taking it once a day sometimes twice a day. It is nasty cause it's got nothing in it. Maybe she is not taking it enough, it says to take it every 4 hours, maybe she is not taking it enough, she does not know. She is taking it maybe once or twice daily, maybe she takes it more. She reports it's not a constant cough. She also has some congestion in her chest. The congestion in her chest it's tight, she just knows it's there. Her chest congestion is staying about the same. If she gets rid of the cough, she'll get rid of the chest congestion she guesses. Caller reported that people are not educating themselves on these shots, referring to the Pfizer COVID-19 Vaccine shots. They'll tell you it's gone kill you; that she does not believe because some people have died, they took the shot and they didn't get a chance to take the second shot and they passed away. And they are telling her not to get the vaccine because it's going to hurt her. She's going to put it in God's hands and take that Pfizer COVID-19 Vaccine to help prevent or at least have it in her system. She's 72 years old and concerned about herself. The outcome of the event arm sore is unknown, little cough with outcome recovering, congestion in her chest outcome not recovered. Follow up (29Mar2021): This is a Follow-up spontaneous report received from a contactable consumer reporting patient information, event information, concomitant medication. Follow-up attempts are needed. Information on lot/batch number was obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021347466 Pfizer
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| 72 | 2021-04-17 | sinus congestion, cough, fatigue, sweating, malaise, throat pain, fever, sleepiness |
hoped she wasn't having a heart attack; Elevated Pulse/high pulse/pulse was 165 beats per minute/cli...
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hoped she wasn't having a heart attack; Elevated Pulse/high pulse/pulse was 165 beats per minute/climbed up to 195; Drenched in sweat/sweating/sweating like a dog in the middle of the night; Wasn't feeling well; Tightness in chest; Cough; Sinuses congested; Sore; Puffy, bubbled up arms, inflamed; Puffy, bubbled up arms, inflamed; Feverish/felt hotter than usual; Really, really tired/wiped out tired; so sleepy; Sore Arm/her arm started to hurt; Nauseous; Sore Throat/throat hurts; eyes half closed/eyes closing; Puffy Face; blood clot; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733, expiry date: unknown), via an unspecified route of administration, on 29Mar2021 11:45, as single dose, for COVID-19 immunisation. Medical history included ongoing latex allergy (developed welts where the straps met the skin) diagnosed 20-30 years ago; ongoing dye allergy (developed warm soreness to leg, tightness in the chest, could not breathe) diagnosed many years ago; sulphite allergy (diagnosed about 1975-1980; cannot eat processed foods, bleached foods, frozen pre-made foods; tries to eat only single item foods; last anaphylactic reaction after eating olive oil at a restaurant because it had sulphites in it; Mother was possibly allergic to sulphites; Son also allergic to sulphites); and blood pressure that runs low. The patient previously took epinephrine and experienced epinephrine allergy; ciprofloxacin (CIPRO) and experienced Cipro Allergy (eyes closed, got puffy, couldn't breathe); amoxicillin for abscessed tooth and had a reaction because of the sulphites in it; epinephrine (EPIPEN) and experienced epinephrine allergy (does not use it anymore); plantago ovata (METAMUCIL) which she then found out the orange one had sulphites. Historical vaccine included flu shot for immunization and she experienced 104-degree temperature and was sick as a dog and she went to the emergency room (she had flu shot maybe 3 times). Ongoing concomitant medication included multivitamins. The patient got her first dose of BNT162B2 on 29Mar2021 at 11:45. On the same day, once she got home, she became really, really tired/wiped out tired; was so sleepy; experienced sore arm/her arm started to hurt; was nauseous; had sore throat/throat hurt; eyes half closed/eyes closing and puffy face. On 30Mar2021, the patient experienced elevated pulse/her pulse got too high/pulse was 165 beats per minute/climbed up to 195. Her heart rate was 194 at some point for a couple of minutes then stayed at 165 for a long time. She hoped she wasn't having a heart attack. She had tightness in her chest, wasn't feeling good and was coughing. She stayed in her bed to wait out her symptoms. These lasted for 10 minutes (as reported). She started meditating hoping her heart rate would decrease and it did after about 15-20 minutes. The patient also felt feverish/felt hotter than usual. Before she took the vaccine on 29Mar2021, her temperature was at 96. She stated that her temperature usually runs low as 95-06 degrees. She also felt like her sinuses were congested; was sore; had puffy, bubbled up arms, inflamed. The patient hoped it was not a blood clot she developed. At the time of the report, the patient stated that her heart rate was 61 beats per minute, earlier it was in the 70s; and her temperature was at 96.3. Her second dose is scheduled on 19Apr2021 and mentioned that if these were her reactions with the first dose, she is questioning getting the second dose. The outcome of "blood clot", "hoped she wasn't having a heart attack", "Wasn't feeling well", "Tightness in chest", cough, and sinuses congested was unknown. The patient recovered from "Drenched in sweat/sweating/sweating like a dog in the middle of the night", and "Elevated Pulse/high pulse/pulse was 165 beats per minute/climbed up to 195" on 30Mar2021; and was recovering from "Sore Arm/her arm started to hurt", and "eyes half closed/eyes closing". The outcome of the remaining events was not recovered. Information on the lot/batch number has been obtained. Additional information is expected.
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| 72 | 2021-04-20 | chills, malaise, headache |
loses her voice; she just sat down in a chair, and everything went black for a second; second COVID-...
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loses her voice; she just sat down in a chair, and everything went black for a second; second COVID-19 Vaccine exasperated her spinal cord leak symptoms because her lightheadedness, and equilibrium being off, started on 25Mar2021; second COVID-19 Vaccine exasperated her spinal cord leak symptoms because her lightheadedness, and equilibrium being off, started on 25Mar2021; She hurt more, too, in her L4 & L5 vertebrae; not feeling well; body was aching/She hurt more, too, in her L4 & L5 vertebrae, and had pain throughout her whole body.; Headache; Chills; Her Oral Lichen Planus was more pronounced since her second COVID-19 Vaccine dose; Her Oral Lichen Planus was more pronounced since her second COVID-19 Vaccine dose; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 24Mar2021 13:53 (at 72-years-old) as single dose for COVID-19 immunization. Medical history included ongoing Spinal leak (Diagnosed with a spinal leak about 1-1/2 years ago. She said she has had spinal leaks, on and off, since that time.), ongoing Oral lichen planus (Stated she was diagnosed with Oral Lichen Planus between 10-15 years ago), ongoing Rheumatoid arthritis (Stated she was diagnosed with Rheumatoid Arthritis at least 3 years before she was diagnosed with Oral Lichen Planus. She said she had been tested for food allergies & as long as she stayed away from gluten, chicken, tomatoes & some other things, she did not have a problem with her rheumatoid arthritis. She said gluten, in particular, triggered her rheumatoid arthritis.), Gluten (triggered her rheumatoid arthritis), fractured her L4 vertebrae in last summer 2020, sciatica from Feb2020 (pinched sciatic nerve since Feb2020), Bone density issue. Stated her family has a history of autoimmune diseases, like Lupus. Concomitant medications included diphenhydramine, paracetamol (EXTRA STRENGTH TYLENOL PM, NDC Number: 50580-937-19, Lot Number: SLA006, Expiration Date: Aug2024); ibuprofen (ADVIL, UPC Number: 305730154604, Lot Number: EG1007, Expiration Date: Jul2023); gabapentin ("ACI Health", Expiration Date of 05Mar2022). The patient previously took first dose of bnt162b2 (Lot number: EN6198) on 02Mar2021 (at 72-years-old) Intramuscular on left arm for covid-19 immunization but experience Left arm was sore, left arm soreness went away after 2-3 days. The patient previously took Flu vaccine but experienced Mouth sores. Reported she had both COVID-19 Vaccine doses. She said she got the typical side effects of a headache, chills, not feeling well, and her body was aching. She clarified those side effects started late the night of her second COVID-19 Vaccine shot (24Mar2021). She said those side effects were mild, and resolved in about 2 days. She said she didn't think much of those side effects, until the next day (25Mar2021), when the other side effects started (blacked out, lightheaded, equilibrium was off). She said her left arm was sore after her first COVID-19 Vaccine dose. She said she didn't treat her left arm soreness, and the left arm soreness went away after 2-3 days. Reported on 25Mar2021 at about 11:30AM, she blacked out. She said she just sat down in a chair, and everything went black for a second. She said she then got really lightheaded, and her equilibrium was off. Reported she had spinal leaks, on and off, for the past 1-1/2 years. She clarified that her doctors didn't think the spinal cord leaks would be contraindicated with the COVID-19 Vaccine. She said all her doctors said it was up to her if she wanted to get the COVID-19 Vaccine because she previously had problems with the flu vaccine. She clarified she had a flu vaccine about 15 years ago, and the day after the flu vaccine, she got mouth sores, and the mouth sores got worse. She said her local doctors didn't know how to treat her mouth sores, so she went to the clinic. She said the clinic doctors told her she had Oral Lichen Planus, and the Oral Lichen Planus was caused by the flu vaccine she had received. She stated she did not have any information (NDC, Lot, & Expiration Date) for the flu vaccine she received back then. She stated she has not had a flu vaccine since that time. Reported her spinal cord leaks caused equilibrium, and lightheadedness. She said she thought her second COVID-19 Vaccine exasperated her spinal cord leak symptoms because her lightheadedness, and equilibrium being off, started on 25Mar2021 11:30. She said her lightheadedness, and equilibrium being off was still going on. Reported she hurt more, too, in her L4 & L5 vertebrae, and had pain throughout her whole body. She clarified she fractured her back (specifically her L4 vertebrae) last summer (2020), and her L4 vertebrae had since healed. She said she had a pinched sciatic nerve since Feb2020. She clarified her L4 and L5 vertebrae move because she had 3 blood patches to treat her spinal cord leaks. She said when the blood patches were done a lot of force was used to stop the spinal leaks. She said the first blood patch caused her buttocks to really hurt. She said she had 2 more blood patches. She said she was not too sure about second blood patch, but with the 3rd blood patch, she was miserable. She said she had physical therapy weekly, and she may have to have her back fused. She said she had a bone density issue that apparently was mentioned in her medical records when she was in her 50s. She said she was never treated for her bone density issue until after she fractured her L4 vertebrae in 2020. No further details provided. Reported her last blood work was 3-4 months ago. No further details provided. Reported her Oral Lichen Planus was more pronounced since her second COVID-19 Vaccine dose (Mar2021). She clarified she started to get Oral Lichen Planus mouth sores a couple days after she received her second COVID-19 Vaccine. She said she can go months without having any issues, and then get the Oral Lichen Planus mouth sores. She said she took medication to manage her Oral Lichen Planus. She said with the medication, the Oral Lichen Planus mouth sores are gone within 24-48 hours. She said with her latest Oral Lichen Planus mouth sores, she put her medication on the mouth sores, and the mouth sores seemed to settle down, but the mouth sores didn't go away completely. She said the day before yesterday (03Apr2021), her Oral Lichen Planus mouth sores got worse again, and are staying that way, even with using the medication. Oral Lichen Planus Treatment: Stated she was applying Clobetasol Propionate Ointment UPS 0.05% to her mouth sores after she eats, or about 3-4 times a day. NDC Number: 51672-1259-6, Lot Number: 332450, Expiration Date: Aug2021. For other treatment she had medication she takes every day, and she continued to take the medication to help her symptoms. She said she had physical therapy twice a week for about 1-1/2 hours, as well as, doing physical therapy on her own. She clarified she does the physical therapy for her sciatica and vestibular issues, saying she was not steady on your feet. She said she does physical therapy about 4 hours a week. Reported her doctors told her she would not survive the Corona Virus if she were to get it because of her underlying health issues. No further details provided. Reported her doctors said there was no information reporting that the COVID-19 Vaccine was contraindicated in people with spinal cord leaks, and how the COVID-19 Vaccine would affect people with spinal cord leaks. She said she thought she may have been fighting things because the COVID-19 Vaccine was acting like the flu vaccine (when she first developed Oral Lichen Planus). She said she thought her symptoms after her second COVID-19 Vaccine dose may have had something to do with her spinal cord leak because she had similar symptoms (lightheadedness & equilibrium issues) with her spinal cord leak. She said with her spinal cord leak, she also had pain and loses her voice. No further details provided. The outcome of the events she just sat down in a chair, and everything went black for a second was recovered on 25Mar2021; headache was recovered in Mar2021; chills was recovered in Mar2021; not feeling well was recovered in Mar2021; body was aching/she hurt more, too, in her l4 & l5 vertebrae, and had pain throughout her whole body was recovered in Mar2021; loses her voice was unknown; while for other events was not recovered.
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| 72 | 2021-04-20 | fever, dehydration, chills, headache, sweating |
Dry heaves; diarrhea; headache; ringing in her ears; dizziness; fever; chills/ shaking with chills; ...
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Dry heaves; diarrhea; headache; ringing in her ears; dizziness; fever; chills/ shaking with chills; sweats; Freezing; dehydrated; This is a spontaneous report from a contactable consumer who reported for herself. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: ER8732, via an unspecified route of administration, administered in left arm on 25Mar2021 at 16:30 as single dose for COVID-19 immunisation. Medical history included ongoing osteoarthritis. She had severe osteoarthritis and took medication for the arthritis pain. She said she had been taking the osteoarthritis pain medication for a couple years. Concomitant medications were not reported. Patient has no additional vaccines administered on same date of the Pfizer vaccine and has no prior vaccinations (within 4 weeks). Patient with a history of severe osteoarthritis said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 25Mar2021. The next day on 26Mar2021, she had terrible diarrhea, headache, ringing in her ears, dizziness, fever, chills and sweats. She was admitted to hospital from 29Mar2021 to 31Mar2021. Consumer wanted to know if she should still receive the 2nd dose. She further reported that she got her COVID-19 Vaccine late in the afternoon on 25Mar2021. She said she seemed fine after she got her COVID-19 Vaccine. She said the next morning on 26Mar2021, she woke up with terrible diarrhea, (really bad) headache, ringing in her ears, and dizzy. She said everything went sideways on 26Mar2021. She clarified she also had the chills, was soaking wet with sweat (but never seemed to have a fever). She said she was either sweating, freezing, or shaking with chills. She said she kept having diarrhea. She said on 29Mar2021 she had dry heaves with the diarrhea, and finally went to the Emergency Room. She said while she was at the hospital, she overhead hospital staff saying they thought she had the COVID-19 Virus. She said she treated as if she had the COVID-19 Virus by the hospital staff. She said she had a negative COVID-19 Virus nasal swab test, and the negative COVID-19 nasal swab test had come back within an hours-time on 29Mar2021. She said she was admitted to the hospital because she was dehydrated, and the doctor wanted to make sure she was over her diarrhea and getting better. The adverse events required a visit to the emergency room. She said she was hesitant about getting the second COVID-19 vaccine because of her severe side effects. She had blood work and a urinalysis done at the hospital in Mar2021. Diarrhea and dehydration treatment: Reported she took 3 doses of anti-diarrheal medication on 27Mar2021, and another dose on the morning of 29Mar2021 before she went to the Emergency Room. She said her diarrhea had kind of stopped after the morning of 29Mar2021, because she was unable to provide a stool sample when she went to the Emergency Room. Reported while she was admitted to the hospital, she was given IV fluids. She said she was unsure which IV fluids she was given. Patient reported she had recovered completely from all her reported symptoms in Mar2021.
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| 72 | 2021-04-23 | chills, headache, fever |
she had a 102°F temperature/her temperature that went up to almost 102; headache/bad headache/horri...
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she had a 102°F temperature/her temperature that went up to almost 102; headache/bad headache/horrible headache; nausea; chills; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201), second dose via intramuscular in upper left arm on 09Feb2021 at 16:30 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (Lot number: EL3249) via intramuscular in upper left arm on 19Jan2021 at 17:30 as single dose for COVID-19 immunization. In Feb 2021, about 30 hours after the second vaccine, the patient experienced 102 degree Fahrenheit/her temperature that went up to almost 102, headache/bad headache/horrible headache, nausea and chills. The patient underwent lab test and procedures which included body temperature was 102 degree Fahrenheit. Therapeutic measures were taken as a result of the events include baby aspirin. Then three hours later she took two more baby aspirin and her temperature went down after each time she took aspirin, states everything went down after the aspirin, the chills, nausea, and headache went down. She was reading literature and it looks like by taking an aspirin she may have stopped the production of antibodies. She is asking if this is true and if she has to be revaccinated or what she has to do. By the time she stared to go to bed she started to get a headache. She clarified that all of her other symptoms started in the middle of the night the same day she received the second dose. By 11Feb2021, in the early morning around 01:30am or 04:30am (both of the times she took aspirin) she recovered from all the side effects except she still has a very slight temperature. By 09:00 on 11Feb2021, her temperature was down to 100 or 99. The outcome of the event pyrexia was recovering, and was recovered for headache, nausea and chills.
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| 72 | 2021-04-24 | fatigue |
Tired, can't sleep; Tired, can't sleep; Heart racing, described as irregular arrhythmia; Heart racin...
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Tired, can't sleep; Tired, can't sleep; Heart racing, described as irregular arrhythmia; Heart racing, described as irregular arrhythmia/Heart pounding, hard pounding; Arm barely sore; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 72-years-old , via an unspecified route of administration, administered in Arm Left on 31Mar2021 11:40 am as single dose for covid-19 immunisation. Medical history included ongoing food allergy, she had anaphylactic shock from a food allergy (she was 40 at the time and she doesn't eat anything she is allergic to), sinus infection and then got horrible hives under her eyes. No Prior Vaccinations (within 4 weeks). Concomitant medication was eye drops every night. No additional vaccines administered on same date of the Pfizer Suspect. The patient previously took epipen had two episodes when she was 40. She is bad about carrying her EpiPen, she forgets it. She was allergic to Amoxicillin. At 11:40 am last Wednesday patient had the vaccine, and around 4 or 5 pm, her heart started pounding for 10 seconds, and it felt like forever. An hour later, her heart started pounding again. It happened twice an hour apart and the second time lasted longer. It described as hard pounding. It started at 4 or 5 pm and then for 4.5 hours there was nothing, but then her heart started racing. At around 4 or 5 pm her heart was pounding, than around 9:30 pm her heart started racing and beating fast, she could feel it. She lives in a rural community and her husband called the local fire station and asked if he could take her there, to the station, so that she could have her heart checked. She was hooked up to a monitor and the paramedics said that she had an irregular arrhythmia and needed to go to the hospital by ambulance. Her heart rate was 115 to 130 beats, then 140 beats, at the hospital. It was about 11pm when she was evaluated and then left in the ambulance, as she was 45 minutes from the hospital. The paramedics would have, the arrhythmia, on record and that 5 minutes before she got to the hospital, the paramedic said her heart rhythm was normal. She was not admitted to the hospital, but held in observation and left the hospital at 4:30 in the morning. She hasn't felt anything after that. it was only one time she thought her heart was going faster, after that, but it didn't happen again. It is currently no problem and even at the hospital, the heart racing stopped and it was normal. The doctor in the emergency room said she was totally normal. Her arm was barely sore, when touched, and noticed this when she was being helped to the bathroom in the emergency room, maybe later in the afternoon, it was not hurting. But she didn't have any other events. She was tired the next day on 01Apr2021. She was up all night in the emergency room. people say that one will be tired, as an effect, but she can't say that it is because of the vaccine, or if she only had 3 hours of sleep. She hasn't been sleeping but she can't attribute it to the vaccine. She can't attribute this to the vaccine, that she has been tired lately and not sleeping. Event outcome of irregular arrhythmia and Heart racing, described as irregular arrhythmia/Heart pounding, hard pounding was recovered on 31Mar2021, of Arm barely sore was recovered on 02Apr2021, of the remaining was unknown. Information about Batch/Lot number has been requested.
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| 72 | 2021-04-24 | malaise |
Vomiting; Diarrhea; lost alot of weight; diverticulitis; brain fog, can't think clearly; stomach pai...
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Vomiting; Diarrhea; lost alot of weight; diverticulitis; brain fog, can't think clearly; stomach pains; violently ill; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient' medical history and concomitant medications were not reported. The patient experienced vomiting and diarrhea. Mostly diarrhea. The vomiting started 05Mar2021 in the middle of the night. She was vomiting so much she went to the Emergency room by ambulance. They kept her in the hospital for a couple of days, but she did not have diarrhea at this time. It was like three days later that she suddenly became violently ill. At the time she did not tie it to the vaccine administration, she thought she had food poisoning or something. She then had severe diarrhea. She cannot recall the exact onset date of when the diarrhea began. She can't get the dates together because she knows she became very sick. Patient recalls that when she got out of the hospital, she was having stomach pains. The stomach pains were feeling more severe on 18Mar2021. On 19Mar2021, she went to a check up with her gynecologist for an annual check up and did tell her gynecologist about the stomach pain and having a lot of stomach issues, but the doctor had no idea about it, she's a gynecologist. The patient's gastroenterologist thought maybe she had diverticulitis not related to the Pfizer COVID-19 vaccine and on 27Mar2021, they started her on Cipro and Flagyl, but the diarrhea just kept getting worse even with the meds and its just been getting worse and worse and worse. Cipro and Flagyl were stopped after 5 days because her gastroenterologist told her that maybe all of her flora was cleared out, and the flora was causing the diarrhea. No one knows what was causing her diarrhea. Oddly enough, she was feeling a little better today. She feels like she doesn't have diarrhea today, but she doesn't know because sometimes she has diarrhea for a couple of hours and then she feels just fine for a couple of hours. She also has brain fog. She was feeling like she could not think straight. She confirmed she does not have this feeling today. It got really bad after the second shot. The brain fog started between the time of first and second shot, when she had the diarrhea. It was like a week to ten days after the first shot, but she does not know exactly when brain fog started. It comes and goes, doesn't have it right now, and didn't have it yesterday. She stated that the brain fog seems to have gone away about 5 days ago. She had all these blood tests and cat scan and they all came back negative that she is in perfect health. She has no other issue except this constant diarrhea. Caller states she doesn't have any issues with any of her abdominal organs, her gall bladder and intestines are all fine. She has lost 5 pounds explaining that a month ago she weighed 136 pounds and now she weighs 130 pounds. The diarrhea is without any known medical known ideology and is very debilitating because she has lost a lot of weight. The outcome of events was reported as "unknown". Follow-up attempts are completed. The following information on the batch number has been requested.
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| 72 | 2021-04-26 | cough, nasopharyngitis |
107 °F fever; a bit of a cold the same night she got vaccinated; Blood Pressure Elevated; Cough; He...
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107 °F fever; a bit of a cold the same night she got vaccinated; Blood Pressure Elevated; Cough; Heart Rate Elevated; Felt palpitations; This is a spontaneous report from a contactable other health care professional. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Left on 09Apr2021 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Thyroid Condition States was diagnosed about 23 years ago, ongoing High Blood Pressure Diagnosed 3-4 years ago. Concomitant medications included ongoing levothyroxine taken for thyroid condition; ongoing hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ) taken for hypertension. On an unspecified date, the stated she had a 107 °F fever, "a bit of a cold the same night she got vaccinated, took amoxicillin and is responding good." On 09Apr2021, the blood pressure elevated, cough, Heart Rate Elevated, Felt palpitations. The patient underwent lab tests and procedures which included blood pressure measurement: 140 some high blood pressure problems, sometimes it goes to 140, blood pressure measurement: 170 on an unspecified date blood pressure went up as high as 170, blood pressure measurement: 157/68 on an unspecified date her blood pressure is still going up at times 157/68, body temperature: 107 fahrenheit on an unspecified date 107 °F fever, heart rate: 102 on unspecified date Her heart rate was also 102 , heart rate: 82 on unspecified date Her heart rate is 82. The outcome was recovering. Relatedness of drug to reaction(s)/event(s): Reaction assessed : Blood Pressure Elevated. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection. Drug result : Related. Relatedness of drug to reaction(s)/event(s). Reaction assessed : Cough. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection. Drug result: Related. Relatedness of drug to reaction(s)/event(s). Reaction assessed : Heart Rate Elevated. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection; Sender's Comments: Based on the current available information after FU and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hyperpyrexia cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 72 | 2021-04-26 | malaise, headache, fever, chills |
chills; Fever/fever 99.9; Malaise; Headache; This is a spontaneous report from a contactable consume...
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chills; Fever/fever 99.9; Malaise; Headache; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot Number: EL8952) (at the age of 72-years-old) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included azilsartan kamedoxomil (EDARBI) and torsemide (MANUFACTURER UNKNOWN) both taken for an unspecified indication from an unspecified start date and ongoing. The patient previously received BNT162B2 (COMIRNATY), dose 1, administered in Arm left (Batch/Lot number: EK9231) (at the age of 72-years-old) for covid-19 immunisation and experienced malaise, nausea, no appetite and throwing up bile. On 03Feb2021, the patient experienced chills, fever, malaise, headache. The events not resulted in emergency room/physician office. The outcome of events was unknown.
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| 72 | 2021-04-28 | fatigue, headache |
mild stroke; loss of taste and smell; loss of taste and smell; fatigue; headache; This is a spontane...
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mild stroke; loss of taste and smell; loss of taste and smell; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN8732) via an unspecified route of administration on 23Mar2021 at 08:45 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, and a-fib (atrial fibrillation), all from unspecified dates and unspecified if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. Concomitant medications ("other medications in two weeks") included carvedilol, hydrochlorothiazide and losartan, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On 24Mar2021 the patient experienced loss of taste and smell, fatigue and headache and on 26Mar2021 the patient experienced mild stroke. All events resulted in an emergency room visit and resulted in hospitalization from 26Mar2021 to 29Mar2021. The clinical course was reported as follows: "Second dose on 23Mar2021, loss of taste and smell, fatigue, headache on 24Mar2021 and 25Mar2021. Went to (Hospital name) on Friday 26Mar2021 and diagnosed with a mild stroke. Stayed in hospital until Monday 29Mar2021. Prescribed a blood thinner (Eliqus) per already engaged cardiologist. As of 13Apr2021 still no taste or smell; gaining energy." Therapeutic measures were taken in response to the adverse events and included treatment with "medications to lower blood pressure and a blood thinner". The patient underwent a nasal swab COVID-19 test post vaccination on 26Mar2021 which was negative. The clinical outcomes of the events loss of taste and smell were not recovered; mild stroke, fatigue and headache were recovered/resolved on unspecified dates.
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| 72 | 2021-05-04 | headache, sinusitis |
I developed a headache; My sinuses became inflamed and I have developed a possible sinus infection.;...
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I developed a headache; My sinuses became inflamed and I have developed a possible sinus infection.; This is a spontaneous report from a contactable consumer (reported for herself). A 72-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EL9262) administered in left arm via an unknown route of administration on 26Jan2021 at 14:00 pm as SINGLE DOSE for covid-19 immunization. Medical history included hypertension, blood cholesterol, gastrooesophageal reflux disease, diabetes mellitus, hypersensitivity. On 26Jan2021 5 house after taking the vaccine, the patient sinuses became inflamed and developed a possible sinus infection and headache. The patient was treated with Celecoxib and Azithromycin on 08Feb2021. The outcome of events was not recovered. Prior to vaccination the patient was not tested for covid-19. The patient had no other vaccine in four weeks.
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| 72 | 2021-05-10 | fatigue, malaise, headache, cough, chills, fever |
Tiredness; Headache; Muscle pain; Joint pain; Chills; Fever; Feeling unwell; Cough; loss of appetite...
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Tiredness; Headache; Muscle pain; Joint pain; Chills; Fever; Feeling unwell; Cough; loss of appetite; Cataract; 'started feeling really ill'; painful injection site; A 72-years-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL9265, Expiration date: unknown), via an unspecified route of administration on 28Jan2021 in left arm at a single dose for covid-19 immunization. The patient's medical history included asthma, nerve injury, chronic nerve damage and blood pressure measurement. Patients concomitant medications included losartan for blood pressure abnormal at the dose of 100 mg per day, atenolol for blood pressure abnormal, albuterol (SALBUTAMOL)) for asthma at the dose of 1.25mg, esomeprazole sodium (NEXIUM) for gastroesophageal reflux disease. On 02Feb2021, she had a cataract implant on the right side. Which was the side her headaches were on. She didn't know if it was from the vaccine or not. Five days later after surgery, on an unspecified date in Feb2021, the patient experienced started feeling really ill. She was pending a procedure on her other eye as well. She got lots of symptoms. The patient experienced tiredness, headache muscle and joint pain, chills, fever, her injection site was painful, and she was feeling unwell. The patient underwent lab tests and procedures which included body temperature which was 101.2. A couple of days after the vaccine she felt well. On 05Feb2021, then all the sudden she just felt tired and couldn't do anything. She was laying and sitting all day. She had no appetite. It had persisted. She didn't have an appetite when she eats. She couldn't taste the food. She didn't feel as bad. She could feel herself getting better. She was taking more vitamin c and more vitamins. On same date, she had a cough. She had been taking Theraflu and lung support for her chest since she developed the cough. She had fever and which was up to 101.2. It kept fluctuating. This morning it was 96. She had muscle and joint every day, but this was triple the pain of her normal pain. She had been drinking a Gatorade. She took nexium for acid reflux, and she had been taking that for a while. That was why she thinks she couldn't taste as much. She got the vaccine because with everything going on, it was the right thing to do. The reporter assessed cataract as medically significant. The outcome of events tiredness, headache, muscle pain, joint pain, fever, feeling unwell was recovering, while chills, painful injection site were recovered, cough and loss of appetite were not recovered and the outcome of started feeling really ill was unknown. She was scheduled for her second dose on 18Feb2021.
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| 72 | 2021-05-10 | fever, chills, fatigue, lethargy, malaise |
Covid 19 vaccine exacerbated her chronic fatigue syndrome; Covid 19 vaccine exacerbated her chronic ...
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Covid 19 vaccine exacerbated her chronic fatigue syndrome; Covid 19 vaccine exacerbated her chronic fatigue syndrome; atrial fibrillation; tachycardia/ heartrate got was 222 beats per minute; missing heartbeats; chills; fever; fatigue; lethargic; felt crummy; This is a spontaneous report received from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 13Apr2021 15:00 (Batch/Lot number was not reported) at age of 72 years as single dose for covid-19 immunisation. Medical history included ongoing chronic fatigue syndrome at age 32 (she had been doing natural therapy and had gotten herself to a stable period but her chronic fatigue syndrome was still an issue sometimes), atrial fibrillation (had been admitted to the hospital because of it, she was not admitted to the hospital when she had atrial fibrillation after receiving her Covid 19 vaccine). The patient's concomitant medications were not reported. Historical vaccine included the first flu vaccine she every received sent her over the moon. Clarified she was in bed sick after receiving the flu vaccine. Patient was calling because she didn't do well with her first Pfizer Covid 19 vaccine. After the Covid 19 vaccine she experienced chills and fever on 13Apr2021 for a couple days. Then she had fatigue on 13Apr2021and that was a few days of her own chronic fatigue syndrome flaring up. She also had some problems with her heart like atrial fibrillation and tachycardia on 18Apr2021. She saw her cardiologist and he wanted her to do the dye stress test where she ran on the treadmill. The day her stress test was scheduled was the same day as her second Covid 19 vaccine. She was calling to find out if she can get the dye at her stress test and run on the treadmill and get the Covid 19 vaccine on the same day. Or does she need to put the stress test off for a couple weeks. She felt like the dye from the stress test and the Covid 19 vaccine might be too many chemicals in her body for one day. She felt like the Covid 19 vaccine exacerbated her chronic fatigue syndrome. She reported that something as simple as to much sugar or to much sun or exertion can also exacerbate her chronic fatigue syndrome. She was prepared in her thinking that the Covid 19 vaccine would be difficult for her because of her history with chronic fatigue syndrome. She had chills and a fever for a few days after the Covid 19 vaccine. She did not take her temperature to get a recorded number. She was lethargic and really felt crummy on 13Apr2021 for about the first 3 days. On day 4 she was better. Then the heart stuff started. Clarified, the atrial fibrillation and tachycardia started. She took medicine as needed for her atrial fibrillation and tachycardia. She had the atrial fibrillation and the tachycardia for about 3 days in a row. She reported she was stable now. She was able to monitor her heartrate on her watch. She then printed out her heart rate readings from her watch to take to her doctor. The highest her heartrate got was 222 beats per minute and that happened a couple times. Her watch only showed her heart rate as 150 beats per minute but when she printed the information it showed her true heart rate. She did see an electrophysiologist before she received her first dose of the Covid 19 vaccine. She was preparing herself for if anything was going to go wrong when she received the vaccine, she wanted to know what to do. She wanted to prepared in case the Covid 19 vaccine caused her any trouble. She was prescribed Diltiazem by her cardiologist to take as needed when she was having the tachycardia and atrial fibrillation. She was taking 15mg three times a day on the three days that she had the atrial fibrillation and tachycardia and it helped. She received her first dose of the Covid 19 vaccine on 13Apr2021 and according to her watch she started missing heartbeats on 14Apr2021. The atrial fibrillation and the really bad heart stuff started on 18Apr2021 and went on until 22Apr2021. She would say her heart issues started to resolve on the afternoon of the 22Apr2021. She was still missing heart beats according to her watch but nothing bad. She saw her cardiologist on Friday, 23Apr2021 and at that appointment she was in normal sinus rhythm. She has had some ups and downs since the 23Apr2021. Her second Covid 19 vaccine was scheduled for 04May2021 at 11:00AM. She did have a 3D echocardiogram and based on that, the doctor wanted to rule out any blocked arteries and that's why she's doing the stress test. AEs (atrial fibrillation and tachycardia) require a visit to Physician Office. Outcome of events chills, fever, lethargic, felt crummy was recovered on 17Apr2021, and the other events was unknown.
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| 72 | 2021-05-13 | fatigue, body temperature increased |
This is a spontaneous report from a contactable other HCP (healthcare professional), the patient. A ...
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This is a spontaneous report from a contactable other HCP (healthcare professional), the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: E11283) via an unspecified route of administration on 19Dec2021 at 12:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included "HTH GERD" and sulfa allergy, both from unspecified dates and unspecified if ongoing Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (received within two weeks of the vaccination) included pantoprazole sodium sesquihydrate (PROTONIX), losartan and anastrazole, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received demerol for an unspecified indication on an unspecified date and experienced allergy (reported as "known allergies: Eli sulfa demerol"). On 08Jan2021 at 12:00 the patient experienced severe cellulitis on trunk anterior/ posterior, elevated temp white count pain, fatigue, SOB (shortness of breath) and chest pain. All events were serious for hospitalization on an unspecified date, for 5 days. All events resulted in a doctor or other healthcare professional office/clinic visit and an emergency room/department or urgent care visit. The events required treatment with antibiotics for 6 weeks. The clinical outcomes of the events severe cellulitis on trunk anterior/ posterior, elevated temp white count pain, fatigue, SOB (shortness of breath) and chest pain were all recovered/resolved with sequel (recovered with lasting effects) on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available the reported events more likely represent intercurrent medical conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 72 | 2021-05-13 | fatigue, pneumonia, headache |
Pericarditis; Pneumonia; Tachycardia; Headache; Achy; Fatigue; Heart rate was higher; Pain in my bac...
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Pericarditis; Pneumonia; Tachycardia; Headache; Achy; Fatigue; Heart rate was higher; Pain in my back, in my shoulder; I was very ill, I was unable to do anything; Pain in my back, in my shoulder; pain in my chest; Sed Rate was 48; by 04Feb2021 and 10Mar2021 my White blood count went down from 16,600 to 11,400; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 72-years-old via an unspecified route of administration administered in arm left on 27Jan2021 (Batch/Lot Number: Unknown) as 1st dose, single for covid-19 immunisation. Medical history included hypertension (blood pressure high) from an unknown date and unknown if ongoing, pacemaker from an unknown date. Concomitant medication included a 10 mg high blood pressure pill (unspecified). The patient reported that after her COVID shot on 27Jan2021, she had the headache, achy, fatigue on unspecified dates; but she know that her heart rate was higher, she was exercising. It was higher than it normally was and her pacemaker, she have a pacemaker and she happen to have a pacemaker check 4 days after her COVID shot which they monitor every 7 months and it was working and it was pacing 100 percent of the time which was much higher than it had been before and the week after the shot she started having pain in her back, in her shoulder and it was hard to breathe, it's hard when she breathe and by the next day she ended up in the emergency room where she was diagnosed with pneumonia, tachycardia and pericarditis all on unspecified dates. She further reported that she was still suffering from them. She have some other tests on the 04Feb2021in the ER, her hemoglobin was 14.6 and on 10Mar2021 it was 11.6 so, it gone down 3 points, by 04Feb2021 and 10Mar2021, her White blood count went down from 16,600 to 11,400 and her Sed rate count (ESR or sed rate) was 48 (clarification unknown). She was very glad that she had the vaccination and was not sad that she had it but she was very ill, she was unable to do anything but lie around for about 25 days from 27Jan2021 to 25Mar2021 so for 2 months, and she still have pain in her chest not as bad as she had, it's not like intense with every single breathe, it's only if she take deep breath. She had the second shot of the vaccine on 17Feb2021 and got sicker faster after the second shot. The patient underwent lab tests and procedures which included haemoglobin: 14.6 on 04Feb2021, haemoglobin: 11.6 on 10Mar2021, red blood cell sedimentation rate: 48 on an unspecified date, white blood cell count: 16,600 on 04Feb2021, white blood cell count: 11,400 on 10Mar2021 and heart rate: higher on an unspecified date. Therapeutic measures were taken which included treatment with prednisone, flecainide, antibiotic for pneumonia and some kind of morphine pill for pain (given in the emergency room). On 24Mar2021, she had a cardioversion to try to deal with the tachycardia and in order to do that she had to take Eliquis. The outcome of erythrocyte sedimentation rate increased and white blood cell high was unknown and for the other events was not recovered. Information on Batch number/Lot number has been requested.
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| 73 | 2021-01-05 | headache |
The patient completed her 15 minute observation with no post injection reaction. At 1:15 pm, the pat...
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The patient completed her 15 minute observation with no post injection reaction. At 1:15 pm, the patient called complaining of right eye drooping, right facial tingling, mild shortness of breath, facial flushing and new onset headache. She arrived at ED at 2:06 pm presenting with facial swelling, tingling and shortness of breath. At that time, she stated her shortness of breath had actually improved and stated "probably just nerves". She still had a funny sensation in her face. She denied any focal numbness or weakness in her extremities. She stated she felt a little lightheaded. She had no sensation of throat swelling, difficulty swallowing. Physical Exam in ED: Constitutional: She appears well-developed and well-nourished. HENT: Head: Normocephalic and atraumatic. Eyes: EOM are normal. Neck: Normal range of motion. Cardiovascular: Normal rate and regular rhythm. Pulmonary/Chest: Breath sounds normal. No respiratory distress. Abdominal: Soft. There is no abdominal tenderness. Musculoskeletal: Normal range of motion. Neurological: She is alert and oriented to person, place, and time. Patient has symmetric facial numbness, she has right periorbital swelling causing what appears to be a facial droop however her mouth seems symmetric, she has negative Romberg's, she has full strength and symmetric sensation throughout Skin: Skin is warm and dry. Psychiatric: She has a normal mood and affect.
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| 73 | 2021-01-06 | fatigue, influenza like illness |
Lot# is on card at work. Had COVID in April. Flu like symptoms. Tired, ached from head to toe. No ap...
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Lot# is on card at work. Had COVID in April. Flu like symptoms. Tired, ached from head to toe. No appetite. Went home and slept for 5 hours. Next day felt a little better. Today she is back to normal.
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| 73 | 2021-01-08 | fever, chills, headache | Headache, Myalgia, Fever, NauseaVomiting, Chills Narrative: |
| 73 | 2021-01-11 | fatigue, headache |
Arm pain; headache; tiredness; extreme weakness; This is a spontaneous report from a contactable con...
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Arm pain; headache; tiredness; extreme weakness; This is a spontaneous report from a contactable consumer (reported for herself). A 73-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 05Jan2021 13:15 at single dose at left arm for COVID-19 immunization. Medical history included High cholesterol, Fibromyalgia, Protein S Deficiency, Anxiety, known allergies: Scallops. Concomitant medications received in two weeks included warfarin, esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), fluoxetine, clonazepam (KLONOPIN), rosuvastatin calcium (CRESTOR), fenofibrate (FENOFIBRAT). Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021, the patient experienced Arm pain, headache, tiredness, extreme weakness. No treatment was received for the adverse events. The report was non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.
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| 73 | 2021-01-19 | fatigue, body temperature increased, chills |
1/15/2021 and 1/16/2021 Extremely tired and fatigued and started having heavy night sweats, sleeping...
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1/15/2021 and 1/16/2021 Extremely tired and fatigued and started having heavy night sweats, sleeping 10-11 hours on both nights. 1/17/2021 Chills and temperatures between 99 and 101.2 degrees 1/18/2021 Temperature of 100.1 degrees in the morning with gradual decline to 98.9 degrees in the evening 1/19/2021 and 1/20/2021 Temperature normal 1/13/2021 to 1/15/2021 Injection site "sore" 1/15/2021 Injection site became hard and painful to the point where I was not able to move the arm without pain at the level of 10 or above which of course limited my use of the arm 1/20/2021 Injection site still painful and difficult to lift or move the arm without pain at a level of 4-5.
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| 73 | 2021-01-19 | throat pain, fatigue |
Fatigue, generalized aching, Mild- moderate right side sore throat and slight soreness back and swel...
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Fatigue, generalized aching, Mild- moderate right side sore throat and slight soreness back and swelling back of roof of mouth and tenderness neck glands unilaterally. Difficult/painfulswallowing -takes considerable effort to swallow.
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| 73 | 2021-01-19 | fever | Low grade fever with Tylenol( 99.6) |
| 73 | 2021-01-22 | fatigue |
Started feeling fatigued day of shot. Next morning very tired and throughout day, slightly aching mu...
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Started feeling fatigued day of shot. Next morning very tired and throughout day, slightly aching muscles all day as well. No other symptoms.
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| 73 | 2021-01-24 | fatigue, fever |
Caregiver stated the patient woke up next day complaining about being achy, feverish, entire body ac...
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Caregiver stated the patient woke up next day complaining about being achy, feverish, entire body aches and no strength. Caregiver stated on 1/23/2021 patient was having same symptoms with loss of appetite and fatigue. On 1/25/2021 caregiver noticed 2x2 red spot around the injection site that warm sore to touch. Caregiver reached out to the PCP and was told to keep an eye on red spot and put a damp warm rag on it.
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| 73 | 2021-01-24 | headache |
STROKE SYMPTOMS 5 DAYS LATER. SEVERE HEADACHE, DIZZINESS , SLURRED SPEACH, TROUBLE REMEMBERING SOME...
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STROKE SYMPTOMS 5 DAYS LATER. SEVERE HEADACHE, DIZZINESS , SLURRED SPEACH, TROUBLE REMEMBERING SOME WORDS, DIFFICULTY SIGNING NAME, HIGH bp WAS ADMINISTERED EMERGENCY CLOT BUSTING DRUG IV AND THEN TRANSFERRED TO NEUROLOGY HOSPITAL. SYMPTOMS OF SLURRED SPEECH, DISAPPEARED NEXT DAY, WRITING HAND RETURNED TO NORMAL RAPIDLY AFTER IV. SLIGHT HEADACHE REMAINED FOR A COUPLE OF DAYS
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| 73 | 2021-01-24 | fever |
Fever for 10 hours, swelling of arm, tenderness and what appears to be a rash that itches still ther...
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Fever for 10 hours, swelling of arm, tenderness and what appears to be a rash that itches still there at 5 days after vaccination.
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| 73 | 2021-01-25 | throat pain, headache, fever |
Headache Fever Body Aches pain in fingers and toes and knees outside of throat felt achy and sharp ...
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Headache Fever Body Aches pain in fingers and toes and knees outside of throat felt achy and sharp pain pain in eyes hoarse throat
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| 73 | 2021-01-26 | chills, throat pain, runny nose, cough |
Woke up with mild symptoms - a runny nose, intermittent mild chills, cough and sore throat. Lasted ...
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Woke up with mild symptoms - a runny nose, intermittent mild chills, cough and sore throat. Lasted 24 hours. I mention this, though 6 days after the vaccine because of my immunocompromised state.
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| 73 | 2021-01-26 | malaise, chills, fatigue, headache | Headache, chills ,feeling unwell, tiredness |
| 73 | 2021-01-26 | malaise |
Patient reported she began feeling unwell (disoriented, dizzy, clammy). Vitals taken x8. Blood press...
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Patient reported she began feeling unwell (disoriented, dizzy, clammy). Vitals taken x8. Blood pressure was 198/91. Per clinical nursing director, EMS called. EMS checked vitals again and blood pressure was 130/82. At that time EMS and patient decided that patient did not need to be transported to hospital at this time. Patient left with husband. At time of departure patient was oriented and reported feeling well.
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| 73 | 2021-01-27 | headache |
Nausea and vomiting beginning 12 hours after injection, headache, muscle weakness, painful injection...
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Nausea and vomiting beginning 12 hours after injection, headache, muscle weakness, painful injection site
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| 73 | 2021-01-27 | runny nose | Runny Nose 48 Hours after receiving vaccination |
| 73 | 2021-01-28 | chills, fatigue, headache, fever |
Aching joints of the wrists, knees and ankles. Fever, chills and dull headache. Fatigue. By the seco...
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Aching joints of the wrists, knees and ankles. Fever, chills and dull headache. Fatigue. By the second day, symptoms had disappeared and I felt fine! Temperature was normal, just slight fatigue.
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| 73 | 2021-01-28 | chills, influenza like illness, headache, fatigue |
overall soreness, extreme soreness in arm, headache, flulike symptoms: chills, weakness, fatigue, na...
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overall soreness, extreme soreness in arm, headache, flulike symptoms: chills, weakness, fatigue, nausea, dizziness (the last two symptoms were brief)
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| 73 | 2021-01-28 | nasal congestion, fatigue, headache, throat pain |
1/24/21 woke with body ache, nasal congestion, headache 1/25/21 same symptoms plus sore throat and f...
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1/24/21 woke with body ache, nasal congestion, headache 1/25/21 same symptoms plus sore throat and fatigue 1/26/21 all of the above symptoms plus loss of taste and smell 1/27/21 all of the above 1/28/21 all of the above No fever at any time
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| 73 | 2021-01-28 | nasal congestion, headache, fatigue |
This is a spontaneous report from a contactable other health professional. A 73-year-old female pat...
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This is a spontaneous report from a contactable other health professional. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EV0140, via an unspecified route of administration in the left arm on 03Jan2021 13:00 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. Patient was not pregnant at vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication included Simvastatin, Gabapentin, Flonase, Claritin and multi (not specified). The patient previously took codeine and experienced allergy. Within two days (on 05Jan2021), patient experienced headaches, body aches, fatigue, nasal congestion. Strength not yet fully recovered ten days out. The outcome of events was recovering. Patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
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| 73 | 2021-01-28 | throat pain |
after second dose of vaccine, patient had Internal jugular (IJ) vein thromboembolism, acute, right; ...
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after second dose of vaccine, patient had Internal jugular (IJ) vein thromboembolism, acute, right; Mucositis; Sore throat. Admitted for Chemotherapy-induced neutropenia; Infection of venous access port. Discharged after one day.
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| 73 | 2021-01-29 | chills, fatigue |
Site soreness. 24 hours had sharp pain in left chest muscle.lastef over an hour. Hurt to take deep b...
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Site soreness. 24 hours had sharp pain in left chest muscle.lastef over an hour. Hurt to take deep breaths. Them couldn't get warm. Shivering. Felt fevered but no elevated temp registered. Lasted about another hour. Tired/weak after. Noal next day.
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| 73 | 2021-01-30 | headache, chills | Severe chills and shaking, headache |
| 73 | 2021-01-30 | influenza like illness, fatigue |
initially severe fatigue after about 5 days started to feel flu like pain symptoms through out body...
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initially severe fatigue after about 5 days started to feel flu like pain symptoms through out body then the symptoms became horrible pain that kept be bed ridden for 3 days. the body pain finally dissipated but feeling of fatigue continued
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| 73 | 2021-01-31 | chills, fatigue, fever |
she had a high fever of 102 degrees. She said she had a high fever all night, and her fever was a li...
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she had a high fever of 102 degrees. She said she had a high fever all night, and her fever was a little less this morning. She said her last temperature was 100.6; Ache/ Pain/ lingering body aches; Chills; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248 and expiry date: Apr2021), via an unspecified route of administration on right upper arm on 14Jan2021 12:10 at a single dose for COVID-19 immunization. Medical history included ongoing Blood pressure high diagnosed 8-10 years ago and Arthritis for between 10-15 years started in her finger, and then progressed to other areas of her body. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications included Gabapentin. The patient did take her regular prescription medication, Gabapentin last night (14Jan2021; She takes 1 Gabapentin 100mg capsule before she goes to bed each night). On 14Jan2021 19:30, the patient experienced fever of 102 F, chills, body aches and fatigue, lasting all night. Then Fever of 100.6 F during the day (15Jan2021), with some lingering body aches. The patient reported that she had a high fever of 102 degrees. She said she had a high fever all night, and that her fever was a little lower this morning (15Jan2021). She said she checked her temperature a short time ago, and her temperature was 100.6. She said last night (14Jan2021), she had bad aches, pains, chills, and fatigue. She clarified she had a lot of little aches and pains. She said she was not sure if the aches were muscle or joint. She said her aches, pains, chills and fatigue did improve today (15Jan2021). The patient declined any treatment for the events. Reported she was told to not to take anything to treat any symptoms she may experience after receiving the COVID-19 Vaccine. She clarified she was told if her arm hurts at the location she received the COVID-19 Vaccine injection, to not take anything for the arm pain. She said the aches and pains she experienced last night after receiving the COVID-19 Vaccine went to her arthritis spots. The vaccination facility type was hospital. The events did not require a visit to Emergency Room or Physician Office. No prior vaccinations (within 4 weeks). No COVID prior vaccination. Patient was not COVID tested post vaccination. The outcome of the events was recovering.
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| 73 | 2021-01-31 | chills, influenza like illness, fatigue |
Flue like symptoms, right arm hurt and felt very cold, body ached, , felt dizzy like vertigo, had th...
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Flue like symptoms, right arm hurt and felt very cold, body ached, , felt dizzy like vertigo, had the chills, needed to sleep. went to bed early around 8 and slept through the night getting up once to go to the bathroom. Has breakfast just toast the next morning and had to get back into bed and slept 4 more hrs. Body still aching. slept with heating pad and iced my arm. I felt a little better the next day around 2 pm. I drank lots of fluids and rested the rest of the day. Next day still felt weak. 3 days later feeling ok. I am worried about my next vaccine due on the 14th of Feb. Would like to know what to take. My doctor referred me to you with no instructions......
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| 73 | 2021-01-31 | fatigue |
Pinpoint itchy rash on arms, back, chest and abdomen, Noticed at 2:00 AM, 14 hours after shot give...
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Pinpoint itchy rash on arms, back, chest and abdomen, Noticed at 2:00 AM, 14 hours after shot given. Very tired feeling. Went to ER for treatment on Sat AM, Was told to take Zyrtec and/or Benedryl and make appt with PCP. Rash gone on Monday 02/01/21. Have appt with Dr , PCP, Wed 02/03/21 for follow up. Will discuss having second shot??
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| 73 | 2021-01-31 | fatigue |
Redness, heat , swellling ,soreness down whole arm, hot, itching , acheing, tired, arm is still so...
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Redness, heat , swellling ,soreness down whole arm, hot, itching , acheing, tired, arm is still sore. Pt stated Reaction much worse on 2nd Vaccination
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| 73 | 2021-01-31 | headache, fatigue |
minor headache to start, but unrelieved 4 days later even with use of Excedrin. On 31 Jan dizziness...
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minor headache to start, but unrelieved 4 days later even with use of Excedrin. On 31 Jan dizziness began, becoming persistent on 1 February. Mental fatigue.
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| 73 | 2021-01-31 | headache | Sore arm with soreness and itching, next day headache and nausea |
| 73 | 2021-01-31 | headache |
Not feeling great; Slight headache; Breathing is heavier; Below her breast line is a tightness she c...
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Not feeling great; Slight headache; Breathing is heavier; Below her breast line is a tightness she can't really describe; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: SL3246), via an unspecified route of administration in right arm, on 12Jan2021 at 10:45, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took varicella zoster vaccine (SHINGLES VACCINE) for immunization and had a little reaction but just the normal things. On Tuesday morning, the patient got the COVID-19 shot and was fine. This morning (15Jan2021), the patient was not feeling great, has a slight headache, her breathing is heavier, and below her breast line is a tightness she can't really describe. The patient asked if these were a side effect of the COVID-19 vaccine and wondering if this is normal. As a treatment for the events, the patient took paracetamol (TYLENOL). The patient asked if she can or should get a test, a COVID-19 test. It has been so many days since having the vaccine, 4 days later, she is wondering if she might have COVID-19. The patient isn't sure and is just asking a question. It is confirmed that she has not had a test or tested positive for COVID-19. The outcome of "Not feeling great" was unknown. The patient had not recovered from the remaining events.
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| 73 | 2021-01-31 | sweating |
Progress Notes Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/29/2021 Subjectiv...
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Progress Notes Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/29/2021 Subjective Patient is a 73 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience throat tightness, body tingles, itching, eye and ear pressure, dizziness, weakness,chest tightness, sweating, and feeling flushed She denied hives, loss of sensation, SOB. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress and tongue swelling. ALLERGY REVIEW OF SYSTEMS Previous Reactions: PCN Objective Vitals Vitals: 01/29/21 1514 01/29/21 1521 01/29/21 1526 01/29/21 1539 BP: (!) 153/97 (!) 154/116 (!) 167/90 (!) 172/84 Pulse: 59 64 59 55 SpO2: 99% 94% 96% 99% Blood Sugar 97 collected at 1500 Physical Exam No Rashes or Hives noted. No facial swelling , no wheezes. HEENT Pharynx is clear without exduate. No facial or tongue swelling. Lungs CTA all wheeze No SOB. Neck is supple. No swelling is noted. pt is anxious and nervous. No sign of anaphalyxis No stridor, no swelling Assessment/Plan Treatment included: antihistamines Benadryl 25 mg, Pepcid 10 mg Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Mild reaction, improving. Pt refused any further medications or assessment at the ER. Her husband will pick her up.
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| 73 | 2021-01-31 | fever |
Patient had a fever on Saturday 1-30-2021, from about Noon until about 8 pm. Highest fever was 101.7...
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Patient had a fever on Saturday 1-30-2021, from about Noon until about 8 pm. Highest fever was 101.7. I treated it with Ibuprophen, and that successfully reduced the fever. The fever had an adverse affect on her Alzheimer's. the condition was temporary, and by Sunday morning, 1-31-2021, she was back to normal.
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| 73 | 2021-02-01 | chills, headache, sweating |
she thinks she broke the sweat/big sweat; couldn't eat anything/was not even eating; She had the chi...
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she thinks she broke the sweat/big sweat; couldn't eat anything/was not even eating; She had the chills; nausea; She had a terrible headache; Feeling freezing cold; she was going to faint; She thought she was losing her mind; slight pain in her arm/sore arm/sore spot; She feels weak, and is still weak; She couldn't walk; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283) via an unspecified route of administration in the left arm on 10Jan2021 at single dose for COVID-19 immunization. There was no medical history. There were no concomitant medications. The patient had the first dose of the vaccine on 10Jan2021 and didn't have a reaction, but had a slight pain in her arm on 10Jan2021. Her sore arm started on 11Jan2021. There was a sore spot and when she would pick up her arm it was sore and achy. No pain, but sore and achy. It lasted for a day or two. She didn't have any symptoms until Saturday the 16Jan2021, this past Saturday she thought she was dying. She had chills, nausea, feeling freezing cold, and had a headache. She thought she was losing her mind. The headache just stopped today. She had the chills that would not stop and she thinks she broke the sweat on Sunday (17Jan2021). She had a little nausea and couldn't eat anything on 16Jan2021. She had a terrible headache, which just stopped about 2 hours ago. She stated she must have to take 10 Tylenol over the course of time, every 4 hours. On Saturday 16Jan2021 she was just laying on the floor in pain. She was not even eating, just drinking water. All of her symptoms stopped this morning around 5 AM (18Jan2021). She had a big sweat. She is unsure if she had a fever because she does not have a thermometer. She is unsure if she has recovered completely from these symptoms. She feels weak, and is still weak (on Jan2021). She cannot go out or get dressed or shower. She is not strong enough. She is just sitting up now, no longer laying in bed. She couldn't walk (on Jan2021) and was afraid she was going to faint on 16Jan2021. She can walk a little bit now and feels a little bit better. She has been out of it for three days, She hasn't felt good. She asked if side effects can appear 6 days later? Is this normal to have a reaction 1 week after getting it? She asked are the side effects worse after the second dose? She asked is this Covid or side effects, what are the COVID symptoms? She asked should she take the second one if she had these side effects? Caller clarifies this is the Pfizer COVID Vaccine. Whoever vaccinated her did not give her the paper about it afterwards. Her neighbor brought it to her cause they went together. She did not realize she could experience these things. She did not expect them a week after getting the vaccine. She thought she had COVID. She asks, "do you think I have COVID?" She is just now getting better and it has been 3 days of experiencing these symptoms. Should she get the second vaccine? She is trying to do the right thing. Event outcome of chills, nausea, feeling freezing cold, and headache was recovered on 18Jan2021, for was going to faint and couldn't walk was recovering, for weak was not recovered, while for others was unknown.
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| 73 | 2021-02-01 | fatigue |
Patient reported an anaphylactic reaction (throat swelling, trouble breathing) to ibuprofen. She al...
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Patient reported an anaphylactic reaction (throat swelling, trouble breathing) to ibuprofen. She also indicated she developed a rash all over her body to a flu vaccine in 1970s, attributed to her egg allergy. Due to her extensive allergies and the fact that she has not gotten a vaccine since 1970s, I would need to monitor her for 30 minutes. (Even though none of her allergies cross react with ingredients in covid Pfizer vaccine. I gave patient vaccine and had her sit in waiting room to be monitored. After 5 or so minutes I noticed her head down, I asked if she was feeling okay she said yes just very tired. I asked if any trouble breathing she said no but her mouth feels dry. Another five minutes go by and patients head is down again, I again ask if she is okay she says yes just very tired and she wasn't before vaccine. I ask if any trouble breathing/swallowing, she said it's a little hard to swallow but she thinks its because her mouth is dry. I get patient a water and ask if she is okay if I give her a Benadryl. She says yes so I give her 50mg Benadryl by mouth. Another 5 minutes go by and again I have to ask patient how she was feeling, she said fine. I ask how her throat is, she says it just feels kind of tight. Due to this progression of allergic reaction (although slow, clearly progressing) I told patient I will have to call for an ambulance. Paramedics showed up after 5-10 minutes and took care of patient. I relayed all this info to them as well as the dispatcher on the phone. Paramedics took patient to hospital conscious and breathing on her own.
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| 73 | 2021-02-01 | headache |
bad headache; a lot of muscle aches and pain; body aches from her toes to top of her head; arthritis...
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bad headache; a lot of muscle aches and pain; body aches from her toes to top of her head; arthritis that was acting up because it was cold; arthritis that was acting up because it was cold; chest hurts, left center of chest sharp pains; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via intramuscular route of administration on 13Jan2021 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included blood pressure and arthritis. Concomitant medications included unspecified blood pressure medications and some "probiotic type thing". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021, Thursday night, the patient had a lot of muscle aches and pain and has body aches from her toes to top of her head which were persisting. She thought it might be her arthritis that was acting up because it was cold but states it is more than that. Her chest also hurts, not constantly, towards the left center of her chest, what were like sharp pains but it was not normal. She is still having the chest pain, states it is not anything she can clock by time, it goes and comes back, only lasts a very short time, it hurts about a minute or two and then goes away. Last night (18Jan2021), she also developed a bad headache that went away when she slept but now that she is awake it is coming back. At the time of report, the outcome of the events not recovered. Information about lot/batch has been requested.
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| 73 | 2021-02-01 | sleepiness, cough, headache, lethargy |
Low grade headache starting immediately after shot - continuing through present; Lethargy and sleepi...
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Low grade headache starting immediately after shot - continuing through present; Lethargy and sleepiness starting 1/30 and continuing to present; Deep chest cough and tightness in chest starting 2/2/21
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| 73 | 2021-02-02 | chills |
Had shot at 4:26pm Ate a light dinner(lentil soup and omelette) Woke up around 2:30 am felling naus...
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Had shot at 4:26pm Ate a light dinner(lentil soup and omelette) Woke up around 2:30 am felling nauseas and had diarhea and chills which continued through the night and following day. Very weak and passed out briefly when feeding my dogs.Ate a bland diet and drank plenty of water for the next few days. Felt better on Saturday January 30th
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| 73 | 2021-02-02 | fatigue, headache | Extreme fatigue, very dizzy, headache, confusion |
| 73 | 2021-02-02 | fatigue |
O2 sat 70% on RA; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2...
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O2 sat 70% on RA; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2 sat 70% on RA, now intubated and in multiorgan failure; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2 sat 70% on RA, now intubated and in multiorgan failure; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2 sat 70% on RA, now intubated and in multiorgan failure; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2 sat 70% on RA, now intubated and in multiorgan failure; This is a spontaneous report from a contactable physician. A 73-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose intramuscular on 03Jan2021 for Covid-19 immunisation, administered at nursing home/senior living facility. Medical history included alcohol use, diverticulitis, iron deficiency anaemia (IDA), asthma, hypertension, anxiety, recent C. diff infection, allergies to penicillin. She was not pregnant. The patient had not experienced Covid-19 prior vaccination. Concomitant medication included apixaban (APIXABAN), bioflavonoids nos, calcium ascorbate, hesperidin, rutoside, sodium ascorbate, zinc amino acid chelate (VITAMIN C [BIOFLAVONOIDS NOS;CALCIUM ASCORBATE;HESPERIDIN;RUTOSIDE;SODIUM ASCORBATE;ZINC AMINO ACID CHELATE]), cyanocobalamin (B-12), furosemide (LASIX), simethicone (manufacturer unknown), tramadol (manufacturer unknown), vancomycin (manufacturer unknown) oral, omeprazole (PROTONIX), amlodipine (manufacturer unknown), vitamins nos (MULTIVITAMIN), thiamine (manufacturer unknown), aripiprazole (ABILIFY), atorvastatin calcium (LIPITOR), clonazepam (KLONOPIN), folic acid (manufacturer unknown), sertraline hydrochloride (ZOLOFT). The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 10Jan2021, 7 days after getting vaccine, the patient developed shortness of breath and fatigue, rheumatoid arthritis, O2 sat 70% on RA, now intubated and in multiorgan failure. The events resulted in Emergency room/department or urgent care, hospitalization, life threatening illness for immediate risk of death from the event. The patient was hospitalized for the events for 18 days. Patient received treatment with corticosteroids, antibiotics, antifungals, dialysis, mechanical ventilation, inhaled Epoprostinol. The patient underwent lab tests and procedures which included SARS-CoV-2 test: unknown in Jan2021. Pre / post vaccination, the patient has been tested for COVID-19 with unknown result. The with outcome of events was not recovered.; Sender's Comments: Based on the temporal gap between the vaccination and the event onset, the Company considered that there was not a reasonable possibility that the events were related to suspect vaccine BNT162B2. The patient's advanced age, underlying medical conditions and multiple concomitant medications could be contributory to the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 73 | 2021-02-03 | chills, cough, fatigue, headache, fever |
the thermometer that marked 100°F orally (she says that the fever was higher in the night); States ...
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the thermometer that marked 100°F orally (she says that the fever was higher in the night); States she is shrinking. Weight varies; cough; 86 of oxygen saturation/O2 saturation was anywhere between 86-88; pulse was 133/rapid pulse, it was 133/rapid heartbeat; her breathing was above 94; shooting pain/stabbing pain at the injection site/extremely excruciating stabbing pains in her arm with the shot; shivers; headache/splitting headache; freezing; slight breathing difficulty; slight body aches; Sore arm; Fatigue; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284, expiration date unspecified), via an unspecified route of administration on 15Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included high blood pressure diagnosed 15 years ago, maybe; High cholesterol diagnosed 20 years ago, she doesn't know, reflux diagnosed 20 years ago, maybe more, prediabetes and allergy induced asthma which she carries an inhaler, and she has used it maybe three times a year. Patient reported that she was tested and they don't know for sure, but she reported that she may have allergy induced asthma as she has to take, carries an inhaler, and she has used it maybe three times a year, in the fall when leaves are falling down, the leaves get moldy, and she was driving in her car, or walking in a wooded area, she gets tightness, takes her inhaler and was fine, that's the extent, no other circumstances; fall or she had where a plant was blooming outdoors, she gets tightness, and she took her inhaler, and was good for the next year, so sitting in the environment and nothing further materializes, if she takes the inhaler three or two times a year, considering what other people have, she thought this was insignificant. There were no concomitant medications. The patient reported that she got vaccinated this Friday and had nothing but a sore arm afterwards, on 16Jan2021 and was fine all day, evening, all day Saturday. She just had soreness at the site, she had no redness at the site of injection, but the weird part: she doesn't think anyone would believe, 33 hours later, at midnight, she was still up, on her way to bed, and all of a sudden she experienced extremely excruciating stabbing pains in her arm with the shot, it was stabbing, excruciating, and immediately at the same time, she had shivers/shivered and had a splitting headache, was freezing and had to put socks on, and had noticed very slight difficulty breathing, and since it was midnight, she didn't want to wake up her husband, she dozed off, and was up at 0530. She had body aches, slight, it was the least, but the stabbing stopped in her arm. She slept from 12:30 to 05:30, and the shivering and aches stopped, but the headache was still on, so she took a pill for the headache. She took the thermometer that marked 100F orally; she stated that the fever was higher in the night and she assumed with the shivering, she had a greater fever than 100. Also, the oximeter indicated 133 pulse and 86 of oxygen saturation. By 10:00, it all had resolved. She has an oximeter, and since she still had the feeling of difficulty breathing, she put it on, but her pulse was 133, that was when she was feeling better. It was reported that all symptoms were gone except for rapid pulse, it was 133 and the slight breathing, and her 02 saturation was anywhere between 86-88, it varied, and by 10:00, all issues resolved, her heartbeat was down to normal, her breathing was above 94, or whatever, everything was fine, and has been fine since then. Maybe she had fatigue on Saturday and Sunday, on Sunday was like after the flu, after you finish, you have fatigue and was a little out of it, this was on Sunday. On an unspecified date, the patient stated that she was shrinking and weight varies. Patient stated that the only thing she does have, says she has a cough, but because she needs a drink, she was not sick and she gets to drink water. She felt like the reaction she had was in the limit of a severe allergic reaction due to the rapid heartbeat and her difficulty breathing. She would like to know if there was information about these side effects reported so she can determine if she was going to have the second dose of the vaccine. Outcome of events states she was shrinking, weight varies and cough was unknown; and outcome of the rest of events was recovered on an unspecified date.
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| 73 | 2021-02-03 | fatigue, fever | Chest tightness/heaviness, fatigue, "rubber arms", temp 100.6, |
| 73 | 2021-02-03 | headache, fatigue |
PAIN, TENDERNESS AND SWELLING OF LYMPH NODES IN SAME ARM AS INJECTION- LASTED 4 DAYS., FATIGUE,HEADA...
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PAIN, TENDERNESS AND SWELLING OF LYMPH NODES IN SAME ARM AS INJECTION- LASTED 4 DAYS., FATIGUE,HEADACHE, AND NAUSEA FOR 24 HOURS.
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| 73 | 2021-02-03 | influenza like illness, chills, headache |
flu-like symptoms; chills; headache; left arm was bruised - still black and blue; Pain in arm; body ...
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flu-like symptoms; chills; headache; left arm was bruised - still black and blue; Pain in arm; body ache; changes from her lower extremities freezing and sometimes it was her whole body; changes from her lower extremities freezing and sometimes it was her whole body; This is a spontaneous report from a contactable consumer (patient's husband). A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK9231), via an unspecified route of administration in the right arm on 12Jan2021 at a single dose for covid-19 prophylaxis; apixaban, oral from an unspecified date and ongoing at 5 mg, twice daily as blood thinner medication and atrial fibrillation. Medical history was not reported. Concomitant medication included ongoing dronedarone hydrochloride (MULTAQ) for blood pressure and heart beat, ongoing pravastatin for cholesterol, and dronedarone for blood pressure. For the past couple of days, she had had flu like symptoms. She has had a headache, body aches and chills. It changes from her lower extremities freezing and sometimes it was her whole body. Patient also had a pain in arm. Her left arm was bruised - still black and blue. All of these occurred on 13Jan2021. She did not have a fever. Today (20Jan2021), she was ok. When they went through the check in they asked if patient was on a blood thinner and she was. The patient's husband was wondering if the reactions had anything to do with the vaccine and if the blood thinner medication (Apixaban) she was taking would have caused the bruise. The patient was supposed to get the second vaccine 02Feb2021. Reporter was asking if it is ok to get the second dose. The action taken in response to the event for apixaban was unknown. Outcome of event chills was recovered on 19Jan2021, after 6 days; events flu like symptoms and lower extremities freezing and sometimes it was her whole body was unknown while recovering for other events.
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| 73 | 2021-02-03 | malaise |
Light headed; lack of appetite; achy; nauseous; sick feeling; This is a spontaneous report from a co...
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Light headed; lack of appetite; achy; nauseous; sick feeling; This is a spontaneous report from a contactable consumer (Patient). A 73-Year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EH9899), via an unspecified route of administration at Arm Right on 07Jan2021 10:30 at the 73 years old at single dose for COVID-19 immunization. The medical history was none. The concomitant medications were vitamin C (ascorbic acid), atorvastatin (strength 5 mg), valsartan (strength 80 mg). There was no other vaccine in four weeks. On15Jan2021 08:00 the patient experienced Light headed, lack of appetite, achy, nauseous, sick feeling. The events were continuing though lighter for at least another 3 days. There was no treatment received for all the adverse events. The patient had no Covid prior vaccination. There was covid tested post vaccination. The patient underwent lab tests and procedures, which included Nasal Swab negative on 18Jan2021. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 73 | 2021-02-03 | malaise |
Patient's primary care provider received a death certificate to be signed for this patient. He spoke...
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Patient's primary care provider received a death certificate to be signed for this patient. He spoke with the patient's husband and son, who reported that the patient had pain and swelling at the vaccine administration site after receiving the vaccine and was feeling unwell after receiving the vaccine. The patient's family reported that they found her unresponsive on 2/2/21 and called 9-1-1. The patient was pronounced dead upon arrival of emergency responders.
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| 73 | 2021-02-03 | nasal congestion, headache |
nasal congestion; headache; This is a spontaneous report from a contactable consumer (patient). This...
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nasal congestion; headache; This is a spontaneous report from a contactable consumer (patient). This 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283 and expiry date unknown), via an unspecified route of administration on 16Jan2021 20:15 at a single dose on the right arm for COVID-19 immunization. Medical history included high blood pressure, NTM lung infection, and laryngopharyngeal reflux (LPR). Concomitant medications included amlodipine, HCTZ, potassium bicarbonate, sodium alginate (GAVISCON ADVANCE), and telmisartan. The patient has no known allergies. Patient is not pregnant. The patient did not receive other vaccine in four weeks. The patient had no COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. On 18Jan2021, the patient experienced nasal congestion and headache. No treatment was received. Outcome of the events was recovering.
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| 73 | 2021-02-03 | throat pain |
Client presented for 1st dose Pfizer Covid vaccination. 45 minutes after receiving vaccination clien...
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Client presented for 1st dose Pfizer Covid vaccination. 45 minutes after receiving vaccination client complained of Intermittent chest pain in Left Upper Chest. Pulse regular, strong rate of 68. Resp 20, regular. BP138/90. 911 called. Pt now complaint of jaw pain on left side and throat soreness. Client was pale with no sweating. Fidgeting in seat. At 10:48 am EMS arrived. Client immediately transported to Hospital.
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| 73 | 2021-02-03 | fever, chills, throat pain, headache | FEVER, BODY ACHES, MILD SORE THROAT, NAGGING HEADACHE, NAUSEA, AND CHILLS |
| 73 | 2021-02-04 | fatigue |
tired; mildly sore arm; This is a spontaneous report from a contactable nurse (patient). The 73-year...
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tired; mildly sore arm; This is a spontaneous report from a contactable nurse (patient). The 73-years-old female patient received bnt162b2 (BNT162B2, lot number: EL3302, Expiry Date: 31May2021) via an unspecified route of administration in Left arm on 21Jan2021 10:45 at SINGLE DOSE to gain immunity against Covid-19. Medical history included asthma well controlled Diagnosed 6 years ago. No Prior Vaccinations within 4 weeks. There were no concomitant medications. The patient experienced mildly sore arm on 21Jan2021, tired on an unspecified date. The AEs did not require a visit to emergency room or physician office. The outcome of the event mildly sore arm was recovering. No follow-up attempts possible. No further information expected.
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| 73 | 2021-02-04 | headache, body temperature increased |
Headache A severe feeling of burning on my facial skin and a flushing of the skin My forehead felt...
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Headache A severe feeling of burning on my facial skin and a flushing of the skin My forehead felt as though I had a severe sunburn A slightly elevated temperature: normal is 97.3 elevated 98.6 All day 02/01, Partial day 02/02, Redness gone and feeling of burning less severe 02/03 and 02/04. 02/05 a couple of episodes of sensation of facial burning and slightly elevated temp
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| 73 | 2021-02-04 | sinus headache | Sinus headache, nausea, joint pain |
| 73 | 2021-02-05 | dehydration |
Patient presented to the ED shortly after receiving her COVID vaccine with hypertension, altered men...
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Patient presented to the ED shortly after receiving her COVID vaccine with hypertension, altered mental status, and a near syncopal episode upon arrival at the ED. Patient also reported some throat tightness and nausea. Patient received the first does of the Pfizer COVID vaccine about one hour PTA. Patient began having hypertension noted to be in the 180-215 systolics and patient reports baseline of 120s systolic. Patient was brought directly from the vaccine clinic to the ED. Upon arrival at the ED, patient experienced a syncopal episode and eventually came out of this but was confused. It was reported in the notes that patient was slightly dehydrated which could have contributed to her symptoms. Once the patient recovered from this episode and hypertension was resolved, patient was discharged home to follow up with PCP.
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| 73 | 2021-02-05 | fever, chills, headache |
Temperature 101.3, severe headache, chills, fever, diarrhea, body aches, unable to move left arm, hi...
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Temperature 101.3, severe headache, chills, fever, diarrhea, body aches, unable to move left arm, high heart rate, difficulty breathing
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| 73 | 2021-02-06 | cough, throat irritation |
Persistent Swollen tight uncomfortable throat, initially a burning sensation ~ 12 hours, difficulty...
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Persistent Swollen tight uncomfortable throat, initially a burning sensation ~ 12 hours, difficulty swallowing cleocin cap and foods, dry cough This is my second day with symptoms
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| 73 | 2021-02-07 | body temperature increased, chills |
No reaction until 10pm. Injection site became sore and tender, Had chills during the night. Follo...
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No reaction until 10pm. Injection site became sore and tender, Had chills during the night. Following morning was running 102 degree temperature, heart rate was 107 and blood pressure was 90/60. Took two 650 mg tylenol and temperature was back to normal within 5 or 6 hours. Heartrate never got below 102 until late afternoon and blood pressure was still low at bedtime. Uneventful night and all was normal the following morning. No reaction since.
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| 73 | 2021-02-07 | fatigue | Had nausea and fatigue, no appetite |
| 73 | 2021-02-07 | headache, chills, fever | Woke up with chills, fever 101.4, headache, body ache No energy. |
| 73 | 2021-02-07 | headache | Headache, muscle ache, joint ache, raised heart rate, difficulty breathing |
| 73 | 2021-02-07 | headache |
immedietly following injection a headache with pain that increased thru out the day. Managed ...
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immedietly following injection a headache with pain that increased thru out the day. Managed to sleep that night . Next morning got up at 7 , felt fine until 10 . The extreme pain hit suddenly. Started in my head and spread thru out the day to my ears , jaw, neck , back , and by late afternoon to my knees. There are not words to describe the intensity of the pain. In my life time I have not endured such pain. It was very frightening. I have friends and family members who have received the vaccine without this reaction. That was a Friday. Since I have been better , have a headache still, but it is bearable. Have not taken any pain medication. My main concern now is the 2nd vaccine. I can not go thru this again. What is the result if I do not take the 2nd vaccine ?
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| 73 | 2021-02-07 | headache |
Pt states they felt eyelids hot and felt a heachache. Pt stayed for additional monitoring. Pt denie...
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Pt states they felt eyelids hot and felt a heachache. Pt stayed for additional monitoring. Pt denies any other c/o. Pt aloc x 4. Resp. unlabored and even. Pt later states her eyelids feel normal and headache went away. Pt d/c home.
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| 73 | 2021-02-09 | body temperature increased, sweating, chills |
12 hours after receiving vaccine, patient developed sweats, chills, temperature to 101.4, and myalgi...
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12 hours after receiving vaccine, patient developed sweats, chills, temperature to 101.4, and myalgias. Symptoms lasted 48 hours. Over last 24 hours patient has developed redness and itching over the injection site on the right arm.
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| 73 | 2021-02-09 | malaise, fever |
feeling very dizzy; Very sick feeling; low grade fever; Vertigo; My head does not feel like it's att...
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feeling very dizzy; Very sick feeling; low grade fever; Vertigo; My head does not feel like it's attached to my body; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 12:30 at single dose in left arm for COVID-19 immunisation. Patient age at vaccination was 73 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included heart stent. The patient has no known allergies. Concomitant medications included lisinopril, clopidogrel besylate (CLOPIDOGREL), metoprolol, rosuvastatin. On 21Jan2021 16:00 the patient started feeling very dizzy, vertigo, she stated: 'It's two days now I still feel it, very sick feeling, had a low grade fever, my head does not feel like it's attached to my body'. No treatment was given for the events. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. Information about Batch/Lot number has been requested.
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| 73 | 2021-02-09 | fever, chills |
Vaccine at 12:20 pm. Side effects started out with arm pain and then chills and nausea.the same as w...
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Vaccine at 12:20 pm. Side effects started out with arm pain and then chills and nausea.the same as when had first dose. 4:30 pm -acetaminophen 500mg 10:30pm severe right arm and shoulder pain 8/10. Nausea 11:30 acetaminophen 500 mg. Was trying to not take any medication for fear it would effect negatively the vaccine efficacy. continued nausea Did not sleep first night kept waking groaning in pain/R arm shoulder 5:00 am acetaminophen 500 mg body aches and continued severe arm pain. 10:40 am acetaminophen 500 mg " and " and nausea 11:30 am severe body aches, chills and fever 99* with 500mg Acetaminophen. my Normal temp (96.8) 3:30 pm "
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| 73 | 2021-02-10 | chills |
Pt without contraindications to receive vaccine. Vaccine given at approx. 1125. Patient waited requi...
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Pt without contraindications to receive vaccine. Vaccine given at approx. 1125. Patient waited required 15 min. w/o reaction. Pt remained for husband's 15 minute wait. During this time, patient felt dizzy and nauseousl and generally weak at 1150. Nourishments provided without relief. Rapid response called at 1155. Team arrived assessed patient. VS179/81 82 pulse, O2 - 96%. Dr. from Urgent Care came to check patient. Told to observe patient and repeat VS, patient ok per Dr. VS repeated at 1215 - 185/92, pulse 84, O2 sat 98%. Patient with c/o pressure to chest, chills and hives. Patient remained stable, husband present. 911 called. EMS Station 28 B shift arrived at 1225 and assumed care of patient. 1245 Ambulance arrived Unit 217 assumed care of patient.
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| 73 | 2021-02-10 | fatigue |
Resident uneventful evening/night. Ate breakfast, baseline status. Found by staff to be unresponsive...
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Resident uneventful evening/night. Ate breakfast, baseline status. Found by staff to be unresponsive at 0945 this AM, almost 25 hrs after vaccine administration. BP at that time 77/30, recheck 81/35. No respiratory distress, oxygen saturations WNL. Remianed afebrile. Over the next hour, she did open her eyes once, but remianed non responsive to staff. Daughter at bedside. Over the next few hours, slowly responding. Was awake and responsive, eating ice cream. PCP has been notified, ongoign onitoring to occur. Spoke to Physican associated with RCAT Care Center. She does infact feel this was an adverse/significant side effect of the vaccination as manifested thru extreme fatugue and exhaustion.
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| 73 | 2021-02-10 | throat irritation |
Lips and tip of tongue burning. Lips are cracked a little swollen. Very painful. Feels like razor cu...
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Lips and tip of tongue burning. Lips are cracked a little swollen. Very painful. Feels like razor cuts. Sometimes scratchy throat. Very small white spots on bottom lip
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| 73 | 2021-02-11 | headache, fever | Fever, muscle pain, head ache joint pain. Treated with Tylenol. |
| 73 | 2021-02-11 | malaise, influenza like illness |
beginning with itchy soles of my feet and both palms, and progressing through the day with the addit...
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beginning with itchy soles of my feet and both palms, and progressing through the day with the addition of grotesquely swollen knees and hives on legs, arms, and a few on my back. The hives presented as large welts all very itchy. I applied Calamine lotion and took a Loratadine pill, and the hives and itch subsided dramatically. I also developed flu-like symptoms of malaise and wheezing. At no time did I have a fever nor did my throat swell or close. Saturday, 24 hours after the first Loratadine pill, the hives and swelling reappeared but disappeared within 15 minutes of taking another Loratadine pill. Sunday through today, the swollen knees and wheeze remain but diminished in severity
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| 73 | 2021-02-11 | fever, sweating | severe sweating significant migraine fever-low grade muscle pain in thighs |
| 73 | 2021-02-14 | chills, headache, body temperature increased | Chills, muscular aches, headache, slight temperature general feeling miserable |
| 73 | 2021-02-14 | headache, chills, body temperature increased, fatigue |
I woke around 4:45 this morning and I noticed my arm was sore so I got out of bed and had the chills...
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I woke around 4:45 this morning and I noticed my arm was sore so I got out of bed and had the chills. I wrapped up and made some hot coffee, and then made some hot tea. I was also drinking water in between as I felt thirsty but you still could not warm. I was shaking and shivering from the chills. I took two extra strength Tylenol, and with 40 minutes I stopped shaking but I stayed wrapped up as I did not want to get cold again. I went and took my temperature and it was almost 102. I also have a headache, it was like shooting pains in my head and now it feels like a achy fever. I also feel tired.
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| 73 | 2021-02-14 | headache |
Dizziness with very high blood pressure 193/94; Major Headache; Dizziness with very high blood press...
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Dizziness with very high blood pressure 193/94; Major Headache; Dizziness with very high blood pressure 193/94; shakiness; This is a spontaneous report from a contactable consumer (patient) reported for that a 73-years-old female patient (no pregnant) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982) , via an unspecified route of administration on 30Jan2021 14:30 at single dose at right arm for covid-19 immunisation. Medical history included blood pressure. Concomitant medication included pantoprazole, metoprolol, atorvastatin, metformin. The patient previously took Cefdinir and experienced allergy. The patient experienced dizziness with very high blood pressure 193/94, also shakiness, major headache on 30Jan2021 16:30. Adverse event result doctor or other healthcare professional office/clinic visit. The patient had EKG. Therapeutic measures were taken as a result of events included unspecified medication. The outcome of events was recovered with sequelae. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.
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| 73 | 2021-02-14 | headache |
Patient is a 73 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the CO...
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Patient is a 73 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15-minute waiting period after the injection, the patient began to experience lightheadedness and headache, flushed, left deltoid where vaccination given hot to touch, nausea. She denied rash, difficulty breathing, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, rapid progression of symptoms, respiratory distress and skin changes. Patient with flushing, headache, left arm warm to touch, and nausea after first vaccine administration of Pfizer in the 15-minute waiting period. Blood pressure elevated, SpO2 is 98-99% on room air, pulse 68. Patient notes that she has reactions with medications and vaccines. Water provided. After sitting for a few minutes, patient reports that she is no longer lightheaded, headache is almost gone, nausea has resolved. ALLERGY REVIEW OF SYSTEMS: Waves of nausea: Lightheaded with some dizziness, headache: Previous Reactions: Adverse reactions to medications in the past. Objective Vitals Vitals: 02/09/21 1145 BP: (!) 179/63 Pulse: 68 SpO2: 98% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: Extraocular Movements: Extraocular movements intact. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Musculoskeletal: General: No swelling. Right lower leg: No edema. Left lower leg: No edema. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water and patient took Tylenol before vaccine administration Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Patient feeling back to normal. BP 152/76 at 1203. All symptoms have resolved. Left deltoid without swelling, redness, rash. Patient ambulating without difficulty. She is cleared to drive home. If she should have symptoms return or worsen, she is to call PCP or go to ER.
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| 73 | 2021-02-14 | fever, headache, fatigue, chills | vomiting, nausea, headache, fever, chills, fatigue |
| 73 | 2021-02-14 | fever | fever, diarrhea, headache, sore arm, sore underarm, mouth sores (cheeks, tongue, under tongue, gums) |
| 73 | 2021-02-15 | chills, fatigue, headache |
Date and time adverse event started: #1 vaccine cause swelling and pain to injection arm several hou...
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Date and time adverse event started: #1 vaccine cause swelling and pain to injection arm several hours after shot then was better the next day, was itching. #2 vaccine on right arm but it almost immediately caused numbness and tingling to left arm, felt tired. ~2 hours after vaccine, felt generalized pain and exhaustion, headache started, then 2 hours later developed chills and shivering, T 99F, leg cramps, nausea, difficulty swallowing and speech garbled. Numbness, tingling, dysphagia and speech garbled eased up after about 24 hours. She took APAP and icepack to neck to ease headache. Stayed in bed most of the time, didn't sleep well. Headache subsided, continued to have chills and aches. Now has lingering fatigue, today has "ears on fire," chills and nauseous. Brand and lot of vaccine: Pfizer#1lot FL9262, Pfizer#2lot EL9267 (caller stated it is hard to read) Date and time of vaccination: (list both if they received both shots): #1 Pfizer Jan 23, 2021
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| 73 | 2021-02-15 | chills, sweating |
chills, sweats, (no fever), severe stomach cramping, vomiting for 24 hours, called immunologist, pre...
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chills, sweats, (no fever), severe stomach cramping, vomiting for 24 hours, called immunologist, prescribed medication to stop nausea, son had to drive 4 hours to be with me for 48 hours until I could hold liquids. Day 4 after onset much better. Day 5, getting back to normal.
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| 73 | 2021-02-15 | headache | Three days after vaccine on Feb 1 headache, red and burning face and ears |
| 73 | 2021-02-16 | fatigue |
Pt had onset of weakness in lower legs and forearms immediately following the vaccine and is very fa...
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Pt had onset of weakness in lower legs and forearms immediately following the vaccine and is very fatigued since receiving the vaccine.
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| 73 | 2021-02-16 | headache, body temperature increased | HA, chilly, muscle pain, joint pain, temp =100 |
| 73 | 2021-02-16 | productive cough, upper-airway cough syndrome |
Started with sinus drainage, which became constant and intermingled with blood. Arm was sore, joi...
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Started with sinus drainage, which became constant and intermingled with blood. Arm was sore, joint and muscular aches. Then progressed to persistent productive cough. No fever during this time. These symptoms lasted until 2/15/2021.
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| 73 | 2021-02-17 | sweating |
At 4am I woke up sweating/sweating profusely; nausea/extremely nauseous; dizziness/dizzy/extremely d...
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At 4am I woke up sweating/sweating profusely; nausea/extremely nauseous; dizziness/dizzy/extremely dizzy; vomit; lost bladder control; I was very weak, I couldn't wipe. I couldn't hold a cloth/had no hand strength; terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life; a little arm pain; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at deltoid left on 26Jan2021 at 13:20 (at the age of 73 years) at single dose for COVID-19 immunization. The patient medical history was none. There were no concomitant medications. The patient reported a little arm pain on 26Jan2021, I woke up sweating/sweating profusely, nausea/extremely nauseous, dizziness/dizzy/extremely dizzy and vomit , all on 27Jan2021 at 4:00; lost bladder control, terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life, and those are classic heart attack symptoms, she had no cardio and respiratory symptoms; I was very weak, I couldn't wipe. I couldn't hold a cloth/had no hand strength, all on 27Jan2021. Therapeutic measures were taken as result of little arm pain an included treatment with aspirin. The patient outcome of the events was recovered. The information on the batch number has been requested.
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| 73 | 2021-02-17 | fever |
almost comatose/couldn't get a response; really really hot/took her temperature it was 101.8/fever; ...
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almost comatose/couldn't get a response; really really hot/took her temperature it was 101.8/fever; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported for two patients. This is the first of two reports. A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318 and expiration date 31May2021), via an unspecified route of administration in the right arm on 02Feb2021 at a single dose for COVID-19 immunization. Medical history included ongoing Type 1 diabetic; Alzheimers from 2014 and ongoing, about 7 years ago; and covid-19 from Dec2020 to Dec2020. There were no concomitant medications. At 4 am yesterday morning (03Feb2021), she developed side effects. The patient's husband woke up at 4 am and touched the patient to make sure she was okay like he does every night. When he did, patient was really really hot. He took her temperature it was 101.8. She was almost comatose, and he couldn't get a response from her. He gave her fluid with a straw on her lips. At 7:30 am, 3.5 hours later, she was still hot. He was putting cold compresses on her. He called the hospice nurse, and she came and checked her vitals. She had a fever of 101.5 that time. He continued cold compresses. Her vitals were stable. Then about afternoon, her fever broke, and she became coherent. The rest of yesterday, and today she seems to be fine. She had a side effect that caused her to have a fever and be out of it. He couldn't get a response from her until noon yesterday. When the fever broke around noon, that is when she became more responsive and back to normal. Outcome of the events was recovered on 03Feb2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021156644 same reporter/drug, different patient/event
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| 73 | 2021-02-18 | sweating |
Exactly 12 hours after the shot, I experienced a severe wave of nausea, dizziness, faintness, and bo...
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Exactly 12 hours after the shot, I experienced a severe wave of nausea, dizziness, faintness, and body sweats that lasted 15 minutes. It gradually subsided.
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| 73 | 2021-02-19 | headache, fever, fatigue | fever, headache, extreme weakness and tired |
| 73 | 2021-02-21 | chills, headache, sweating |
This is not a critical reaction but want to report in order to help build up the information availab...
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This is not a critical reaction but want to report in order to help build up the information available to healthcare professionals going forward. Morning after chills, neck stiffness, pain back of head left side. Applied heating pad to neck. By late morning I was nauseous , and weak as a kitten. Took a 500 mg Tylenol and slept for about 4 hours. Woke up in a sweat but chills gone and am now able to eat a little bit. Back of head and neck still very sore. The injection site is sore but no rash; right arm seems to have "phantom pain" as well ( I experienced this with Shingles shot in December 2020 too).
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| 73 | 2021-02-21 | fatigue, headache |
Vaccine at 945 am Friday Calves of both legs cramped rock hard at 10 pm Friday and remained so for 1...
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Vaccine at 945 am Friday Calves of both legs cramped rock hard at 10 pm Friday and remained so for 18 hours. Had to use heating pad and massage to help feet relax from en pointe position so I could walk to the bathroom. Legs were sore after 18 hours but not cramped . Also massive headache made my eyes light sensitive all day Saturday and Sunday until about 9PM. Extreme exhaustion. Recovering today, Monday. Still tired an s slight residual headache at times but not bad enough for painkiller.
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| 73 | 2021-02-21 | fatigue | Fatigue and brain fog, or dullness from Tuesday 02/09/2021 through Friday 02/12/2021. |
| 73 | 2021-02-21 | malaise |
Pfizer-BioNTech COVID 19Vaccine EUA Fever of 99 degrees, slept for 32+ hours followed by aches for 1...
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Pfizer-BioNTech COVID 19Vaccine EUA Fever of 99 degrees, slept for 32+ hours followed by aches for 12 hours. General malaise,
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| 73 | 2021-02-21 | fever, chills |
fever, chills, swollen lymph nodes in armpit under site of injection, which disappeared after 10 day...
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fever, chills, swollen lymph nodes in armpit under site of injection, which disappeared after 10 days. Metal smell and taste which lingers.
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| 73 | 2021-02-21 | sleepiness |
I was extremely sleepy. I went to sleep Saturday night, got up at 8 am. At 9:30 am I was so sleepy...
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I was extremely sleepy. I went to sleep Saturday night, got up at 8 am. At 9:30 am I was so sleepy I could hardly walk. I went to bed and slept for 7 hours without waking up. When I got up I felt better.
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| 73 | 2021-02-22 | body temperature increased |
Red inflamed 5" x 2" hot reaction at injection site. No pain itching or swelling. Temperature of ~10...
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Red inflamed 5" x 2" hot reaction at injection site. No pain itching or swelling. Temperature of ~100 F
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| 73 | 2021-02-22 | chills, fatigue |
Symptoms occurred about a week after the first AND the second covid vaccination. Lot number of fir...
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Symptoms occurred about a week after the first AND the second covid vaccination. Lot number of first is EI9262 and of second (as above) EN6201. In addition to expected fatigue and chills (I experienced no sore arm or fever) I developed symptoms of gallbladder attack with extreme abdominal pain and vomiting. These lasted for just over 2 days.
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| 73 | 2021-02-22 | dehydration |
I had passed out hitting a table bumped head and back.; very dry mouth; felt very light headed; Thou...
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I had passed out hitting a table bumped head and back.; very dry mouth; felt very light headed; Thought maybe I may have been dehydrated; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at Left arm on 06Feb2021 07:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included High blood pressure. Concomitant medications included losartan, atorvastatin calcium (LIPITOR) and vitamins. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient woke up 1:30 am 07Feb2021very dry mouth, used restroom, felt very lightheaded, went back to room, next thing she heard was glass breaking. She had passed out hitting a table bumped head and back. Her boyfriend was with she helped she up. Said her legs went out from under her. Thought maybe she may have been dehydrated though she had drunk water throughout the day and before bedtime. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date in Feb2021.
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| 73 | 2021-02-22 | malaise, cough, fever | FEVER 100 COUGH ACHING MALAISE |
| 73 | 2021-02-23 | chills, headache |
2/6/2020 and 2/7/2020: severe chills/horrible headache--rizatriptan 2/11/2020 through 2/14/2020: sev...
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2/6/2020 and 2/7/2020: severe chills/horrible headache--rizatriptan 2/11/2020 through 2/14/2020: severe abdominal pain; low backahe; headache--aleve and rizatriptan 2/21/2020 through 2/25/2020 severe stiff neck; headache; aleve X4 pills Only a sore arm from the fist vaccine.
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| 73 | 2021-02-23 | headache |
About 20 minutes after vaccine, the right side of my face (including nose, some of my tongue) felt n...
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About 20 minutes after vaccine, the right side of my face (including nose, some of my tongue) felt numb or tingly. Very mild. Symptoms disappeared within, say, a half hour and did not return. The following morning I had fleeting head aches on right side - each lasting a' second or so only, and several hours apart. By the afternoon they disappeared. I am having no other symptoms. My arm never hurt at the injection site. I'm not even concerned but feel I should mention this reaction because I will be getting a second shot on March 16. Is it safe? Again, I have no symptoms any longer and feel great.
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| 73 | 2021-02-23 | fever, chills |
Upset stomach a few hours after injection. Next day Saturday left arm sore at shot area, and contin...
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Upset stomach a few hours after injection. Next day Saturday left arm sore at shot area, and continued upset stomach. Sunday night slight cramping in stomach. Monday AM Full blown cramping , afternoon 99.2 fever, chills, hands cold continued severe cramping. Took Tylenol. Tuesday slight cramping from stomach to rectum, normal temp. Wednesday slight cramping comes and goes. Feeling much better.
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| 73 | 2021-02-23 | fever, malaise |
Feeling sick, AFIB occurrences, had a fever on 2nd day of 100.8, left shoulder hurt from shot and ju...
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Feeling sick, AFIB occurrences, had a fever on 2nd day of 100.8, left shoulder hurt from shot and just felt very bad all over!
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| 73 | 2021-02-24 | chills |
Bad shaking chills, my whole body was shaking started almost exactly 24 hrs after 2nd dose Shaking ...
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Bad shaking chills, my whole body was shaking started almost exactly 24 hrs after 2nd dose Shaking lasted about 20 minutes and I continued feeling chilled till bedtime
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| 73 | 2021-02-24 | fatigue, fever, chills |
Started with chills for about 1 hour then fever (about 100.4) and tired. It was now in the middle ...
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Started with chills for about 1 hour then fever (about 100.4) and tired. It was now in the middle of night when chills ended then I was very restless. It lasted about 24 hours then I felt fine - no fever.
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| 73 | 2021-02-24 | headache, fatigue |
Tingling of fingers and numbness of left cheek. Did not get any worse after 30 minutes. Extremely t...
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Tingling of fingers and numbness of left cheek. Did not get any worse after 30 minutes. Extremely tired and sore arm that day. Day 2 - tired easily, no stamina. Dizzy and nauseous after showering at3:30 pm. By 10:30, both hands were red and itched. Sometime in the night woke with a very sharp, painful headache. Did not last. No real problem again until Saturday. Nausea at 11:20 am. Sunday I sat all day doing taxes - no symptoms noted. Monday after walking - rapid heart rate and very tired after what is normal activity. By 4:30 I was tingling all over my body. Tuesday night my ankles are swollen for the first time in years. Only happened that nigh. Wednesday morning, the tingling is very strong in my calves. and I had a sharp pain in the area of my Achilles tendon. I believe that the vaccine has exacerbated the neuropathy (undiagnosed) of the bottom of my feet. Today I am reporting because I fell for no reason getting out of a chair, and the tingling is in my legs, arms, shoulders. I had not heard until today that the vaccine could affect the nervous system. The effects are the worst they have been and it has been one week since I had the vaccine. Should I get the second shot? Due March 11,2021.
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| 73 | 2021-02-24 | malaise, headache |
COPD on 2L BL O2 requirement, hypothyroidism, cachexia, GERD with similar presentation earlier this ...
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COPD on 2L BL O2 requirement, hypothyroidism, cachexia, GERD with similar presentation earlier this month post-covid vaccine # 1, who presetned for feeling sick and SOB. Patient received her second dose of the covid vaccine on 2/19/21, 3 days prior to presentation. The following day, she started having "breathing issues" so she was given a dose of prednisone. 1 day prior to presentation, her breathing had improved but she was feeling generally sick, so she was given tylenol but not pred. Then, today, day of admission, patient was having bodyaches, weakness, headache, and breathing issues again. She took prednisone this morning, but still had to turn up her O2 because her work of breathing kept fluctuating. Admitted 2/22/21 ? 2/24/21.
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| 73 | 2021-02-24 | malaise, fever, chills, influenza like illness |
On Feb. 12th at 2PM symptoms started with lower back pain, pain in abdomen and stomach, cramping, ch...
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On Feb. 12th at 2PM symptoms started with lower back pain, pain in abdomen and stomach, cramping, chills, ear ache, pain level 8. Felt sick all over, like having the flu and then whole body ached, not just GI track. Left arm injection site was red, sore to touch, swollen (slightly). Doctor couldn't get vaccination needle into arm muscle the first time and so had to try a second time. Intense cramping of GI track started up again 8:45AM on Feb. 13th. By 4PM Feb. 15th fever 102F, chills, felt freezing cold and had to wrap myself in a heating blanket. Pain level 10, especially in pancreas. Fever broke around 2:30AM Feb. 16th and later when I was up at 8AM I felt very weak, faint, pancreas ached. Pancreatic pain lasted another 3 days. Pancreatic pain stayed around level 5. On Feb. 17th took ibuprophen. Pain level reduced to 1. This was the only time that I took pain medication between Feb. 10th and 17th, because I am conservative about using Ibuprophen, Tylenol, and have a high threshold for pain.
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| 73 | 2021-02-25 | chills, headache | Chills, Body aches, Headache |
| 73 | 2021-02-25 | fatigue |
Patient was tired and slept for two days after vaccine. Then had nausea and general "blah" feeling ...
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Patient was tired and slept for two days after vaccine. Then had nausea and general "blah" feeling for the next 2 1/2 weeks and had nose bleeds. On Day 4 she did vomit. After second shot, she complained of constipation and aching on over. She vomited twice.
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| 73 | 2021-02-25 | headache |
Within three hours I experienced stiffness in my left knee which escalated to incapacitating pain an...
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Within three hours I experienced stiffness in my left knee which escalated to incapacitating pain and inability to support my weight, this lasted for three days with 2nd day being the worst pain and discomfort. Also had a headache for most of the day on the second day. Four days following vaccine I started to notice the injection site was getting itchy, then on day Five it was increasing and started getting red, swollen, hot and itch increased. Day Six it is still itchy, red, hot and swollen. Red site is about the size of an orange. As of Day Six, No fever, headache or other symptoms and knee has returned to normal discomfort.
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| 73 | 2021-02-25 | headache | headachy urination decreased |
| 73 | 2021-02-25 | lethargy, headache, fever |
Fever 101.9; severe headache; muscle aches; joint pain; weakness; brain fog; lethargy; nausea; This ...
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Fever 101.9; severe headache; muscle aches; joint pain; weakness; brain fog; lethargy; nausea; This is a spontaneous report from a contactable nurse (patient). A 73-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at 10:30 at single dose in right arm for COVID-19 immunisation at the age of 73-year-old. Lot number was EM9810. The patient was not pregnant at the time of vaccination. Medical history included asthma, psoriasis, psoriatic arthritis, cardiac arrhythmia. Past drug history included allergy to Tetracycline. Concomitant medications included metaprolol, montelukast sodium (SINGULAR), simethicone (PEPSID), clonixin lysinate (SKELAXIN), Vitamin D. On 04Feb2021, the patient experienced fever 101.9, severe headache, muscle aches, joint pain, weakness, brain fog, lethargy, nausea. Fever and headache continue 9 days after the injection. On 11Feb2021, Covid test at one week was negative (nasal swab). The patient was treated with Tylenol. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has been tested for COVID-19.
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| 73 | 2021-02-25 | fever, sweating, fatigue, chills |
ran a fever of 101 degrees; lots of chills; sweating; dizziness; she was not quite herself; aching i...
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ran a fever of 101 degrees; lots of chills; sweating; dizziness; she was not quite herself; aching in her shoulder, into her back; aching in her shoulder, into her back; weak and unable to function; weak and unable to function; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), intramuscular on 16Jan2021 1:45 PM at a single dose on the left shoulder, right at the very top for COVID-19 immunization. Medical history included ongoing lupus since 1999. Concomitant medications reported were none. The patient experienced aching in her shoulder, into her back, dizziness, she was not quite herself on 16Jan2021; she ran a fever of 101 degrees, had lots of chills and sweating on 18Jan2021; she became weak and unable to function, and tired on an unspecified date in Jan2021. The patient stated she got the first dosage of the COVID-19 vaccine and had some side effects. She received the first COVID-19 vaccine on 16Jan2021. She had some aching in her shoulder and stuff on 16Jan2021. For 2 days, she was weak and unable to function. She ran a fever of 101 degrees on 18Jan2021 and was sweating head to toe. At the time of report, she currently had no fever, but was feeling very fatigued. She stated she is trying to make her next appointment, but she can't pull up the paperwork. She wants to know what to do about the side effects. Her next appointment on 13Feb2021. Her shoulder hurt an hour after she received the vaccine on 16Jan2021. That night and the next day, the whole shoulder even into her back started hurting. Like when she rolled over and laid down, she would say "ohhh, I can't lay that way". This lasted for a couple of days. Her shoulder is still tender, but it is much better. She can lift it up, move it around and it's not causing her any difficulty. She stated she became weak. The first night after receiving the vaccine in the middle of the night, she kind of had like a dizziness, she was not quite herself. She thought it was just part of the vaccine. The next day, she couldn't do anything. She was down for 2 days after that. On the 17Jan2021 and 18Jan2021, she was feeling really happy. On 18Jan2021, she started to have a fever. She had a fever that night and part of the next day. She had lots of chills. The fever and chills have seemed to go away. She just feels really fatigued after. She woke up twice and her whole body was soaked. She states that is all gone now. She has had no fever. She had a very good night last night. She stated her aches and pains were at a minimal. She stated she is 73 years old, so she is going to have aches and pains as it is. At the time of the report, all she has is fatigue. She added that the fatigue isn't coming from her, it's from the vaccine. She was very active usually. But at the time of the call, she would get up to do a little and then she would have to sit back down. She was very tired. She was feeling weak and out of pocket. She was so tired. She didn't want to do anything. She stated she must find someone who can print her new paperwork. She plans to call her doctor and see what he thinks about her receiving the second shot. She feels she really needs to get the second shot. During the report, she made the comment "I'm sorry, I'm choking on my cough". The patient underwent COVID-19 test on 14Jan2021 with result of negative. She also underwent blood test on an unspecified date with unknown results. The reported adverse events did not require a visit to the physician office or emergency room. Outcome of the event fatigue was not recovered, while outcome of the other events was recovered on an unspecified date in Jan2021. Information on the Lot/Batch number has been requested.
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| 73 | 2021-02-26 | fatigue |
sore upper left arm 2 days, fatigue 5 days, muscle & joint pain 5 days, diarrhea 4th day rested a...
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sore upper left arm 2 days, fatigue 5 days, muscle & joint pain 5 days, diarrhea 4th day rested and slept for fatigue took Tylenol first 2 days, and ibuprofen thereafter for pain took bismuth subsalicylate for diarrhea
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| 73 | 2021-02-26 | headache, chills, body temperature increased, fatigue |
Slightly elevated temp, mild nausea, chills, muscle aches, fatigue, mild headache. All this started ...
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Slightly elevated temp, mild nausea, chills, muscle aches, fatigue, mild headache. All this started 6 days after the vaccine. On the 6th night after the shot, symptoms lasted about 8 hours. Then started up worse during the night of the 7th day, especially the chills, elevated temp, fatigue and nausea. Symptoms such as the chills are starting to subside about 10 hours later but some such as mild fatigue still remain. Is this normal for symptoms to show up nearly a week after the shot?
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| 73 | 2021-02-26 | headache, fatigue |
Fatigue, shortness of breath, digestive issue, headache. Symptoms took 10 days to mostly go away. ...
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Fatigue, shortness of breath, digestive issue, headache. Symptoms took 10 days to mostly go away. Still have shortness of breath. Took Tylenol and got lots of sleep.
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| 73 | 2021-02-26 | headache, sleepiness |
Extremely mild: headache, site injection soreness. Mild: difficulty breathing - required oxygen & ...
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Extremely mild: headache, site injection soreness. Mild: difficulty breathing - required oxygen & sleepiness. Also, antagonized my dry eye problem - requiring drops every couple of hours round the clock instead of just twice a day.
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| 73 | 2021-02-26 | fever, fatigue, headache | Low grade fever, headache, fatigue , arm pain and heat. |
| 73 | 2021-02-26 | runny nose, fatigue |
extreme fatigue,sore guns,canker sores,loss of appetite,diarrhea, rectal bleeding, no smell, no tast...
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extreme fatigue,sore guns,canker sores,loss of appetite,diarrhea, rectal bleeding, no smell, no taste, extreme thirst rash on front of both legs and both arms,night sweats, runny nose
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| 73 | 2021-02-27 | chills, fever | Sore arm for 24hrs, chills and low grade fever (99.1). 28 hrs |
| 73 | 2021-02-27 | fever, chills |
Fever, chills, muscular aches, nausea...approx. 14 hrs. after injection...had a "tin" taste immediat...
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Fever, chills, muscular aches, nausea...approx. 14 hrs. after injection...had a "tin" taste immediately after the injection, lasting about 15 minutes
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| 73 | 2021-02-27 | fever, headache, chills | Fever 102.1 headache chills soreness at injection site |
| 73 | 2021-02-28 | body temperature increased, headache | All day. |
| 73 | 2021-02-28 | body temperature increased, malaise, headache, chills |
Woke up at 2:30 AM,2/25, with chills and just didn't feel good,a little ache. Could not sleep becaus...
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Woke up at 2:30 AM,2/25, with chills and just didn't feel good,a little ache. Could not sleep because I was just uncomfortable all over. Felt a little light headed. At 7:00 took temp,99.2,- my normal is around 97.7. Right arm was feverish and extremely sore,more so than first vaccine. All that day fever went up to 101.2 by the afternoon. Drank liquids all day. had a headache most of the day with all over joint pain. Never had the flu but think this must be how you feel. Fever broke around 3:00AM on 2/26. Upper arm remains sore, swollen,red and feverish as of today,3/1
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| 73 | 2021-02-28 | chills, headache |
Headache nausea chills weakness severe arm pain right arm . Recovered in 10 hours followed by ...
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Headache nausea chills weakness severe arm pain right arm . Recovered in 10 hours followed by slight headache for several days.
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| 73 | 2021-02-28 | chills |
Female patient experiencing chills 30 minutes after Pfizer vaccine administered. No other symptoms r...
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Female patient experiencing chills 30 minutes after Pfizer vaccine administered. No other symptoms reported. Vitals 140/90, HR 70, SPO2 100% on room air, Respirations 22, Temp 97.3 axillary. Patient appears anxious but states she is not. Emergency response activated/ 911 called. Benadryl administered via IM on right deltoid. Paramedics arrive at 1054hrs. Takes patient via gurney to further assess in ambulance. Patient is vitally stable. Refused further care. Left AMA.
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| 73 | 2021-02-28 | fatigue, cough |
Nausea, diarrhea, rib cage pain so bad I couldn't lie down/sleep, exhaustion, Muscle aches and pain,...
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Nausea, diarrhea, rib cage pain so bad I couldn't lie down/sleep, exhaustion, Muscle aches and pain, loss of appetite, cough,
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| 73 | 2021-02-28 | malaise |
she's not feeling well; This is a spontaneous report from a contactable consumer (patient's daughter...
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she's not feeling well; This is a spontaneous report from a contactable consumer (patient's daughter-in-law) via the Pfizer-sponsored program. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 26Jan2021, at single dose, for covid-19 immunization. Medical history included covid-19 - the patient has been tested positive on an unspecified date but it's 2 months now, and they said that it's still in her. Concomitant medications were not reported. The patient had the first shot yesterday 26Jan2021 and she's not feeling well on Jan2021. The outcome of the event was unknown. Information on the lot/ batch number has been requested.
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| 73 | 2021-02-28 | fever |
has had a fever since this time; her ileostomy had a blockage that day and she vomited all night; he...
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has had a fever since this time; her ileostomy had a blockage that day and she vomited all night; her ileostomy had a blockage that day and she vomited all night; it was very severe and sore and she is just getting over the soreness; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL1283, first dose) solution for injection intramuscular in left deltoid on 18Jan2021 at 14:20 (at the age of 73-years-old) at single dose for COVID-19 vaccination. Medical history included ongoing type 2 diabetes, ongoing active carcinoid cancer of liver, ongoing Ileostomy from Jul2002, surgery in 2001, second primary colon tumor, acid reflux and neuropathy in feet and legs. Concomitant medications included amlodipine besilate for blood pressure, lisinopril for blood pressure, metformin, sitagliptin phosphate (JANUVIA) and gabapentin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient has had a fever since this time on 18Jan2021 and was very severe and sore and she is just getting over the soreness in Jan2021. Temperature was 102 F on 18Jan2021, 101 F on 19Jan2021, the having a fever in varying degrees like 99 F or 100 F after in Jan2021. On 18Jan2021, her ileostomy had a blockage that day and she vomited all night. Treatment for the event fever included ibuprofen (ADVIL). The outcome of the event fever was not recovered. The outcome of the events vomited and ileostomy had a blockage was unknown. The outcome of the event pain was recovering.
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| 73 | 2021-02-28 | respiratory tract congestion |
irregular heart beat; congestion in the chest; dizzy/the dizziness she was having and feeling now af...
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irregular heart beat; congestion in the chest; dizzy/the dizziness she was having and feeling now after getting the vaccine was definitely more noticeable; This is a spontaneous report from a contactable consumer (the patient). A 73-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left deltoid/ left upper arm in the shoulder on 26Jan2021 around 14:00 (at the age of 73-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: stroke about 4-5 years ago in June, dizziness, blood pressure. The patient also had difficulty writing stuff down; besides having a number issue, she had issues writing numbers down. Concomitant medication included apixaban (ELIQUIS) from an unspecified date and ongoing as a blood thinner. The patient stated she was on ten different medications. These medications were added after the stroke. Before the stroke she was not on any medication. The patient did not have any vaccines administered on same date of the Pfizer COVID vaccine. The patient got the pneumonia vaccine (unspecified), but thinks it was longer than 4 weeks before. She did not remember, but she believed it had been a month and a half to 2 months (at the age of 73-years-old) since getting the pneumonia vaccine for immunization. The patient had the COVID shot on Tuesday of this week (26Jan2021), and she didn't seem to have much of a reaction other than what they expected except at 21:00 that night, she got pretty dizzy. She was still dizzy now. It was enough for her to have to walk with a cane in order to try and keep herself leveled. She could not move quickly. She did not know why she had this reaction. She called her doctor the next day, and he did not understand why. She mentioned she was reading material and saw this could be a severe side effect/situation. The doctor mentioned they were trying to find out if it was related to the blood pressure. She wanted to know if this is part of the side effect, dizziness? When the patient was attempting to provide the zip code, she stated her mind was going blank and could not remember the zip code. She later found something with it written on it and provided those details. She explained she had a stroke when trying to provide her current age. She stated numbers are hard for her. She stated she would be 74 in March, and questioned how old that would make her now, she later confirmed as 73. She read information today about the COVID vaccine, and she saw that one should be cautious about the vaccine if have a bleeding disorder, and she commented she was on a blood thinner. She went to the doctor last week and mentioned she was having dizziness. She clarified she had dizziness before getting the COVID-19 vaccine. When she went to the doctor, they thought it was due to blood pressure as the problem. They changed her blood pressure medication by placing on a higher dose. Then she started having more dizziness, and the dose was taken back down to the dose she was on before. She also added, she has an irregular heartbeat (unspecified date). She went to the doctor because of congestion in the chest (unspecified date); that was why she went to the doctor. The doctor asked about dizziness and she said she was having a little. However, the dizziness she was having and feeling now after getting the vaccine was definitely more noticeable. The clinical outcome of dizzy was recovering (as reported). The outcome of the other events was unknown. Information on Lot/Batch number has been requested.
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| 73 | 2021-03-01 | body temperature increased |
About ten days after vaccination, hives began to show up on my lower abdomen . Since then, hives app...
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About ten days after vaccination, hives began to show up on my lower abdomen . Since then, hives appeared in many areas of my body as well as itching where there are no hives. My eyes are also itchy. The hives and itching become worse when my body heats up during exercise or when covered by warm clothing or blankets. I'm taking 2 Benadryl every six hours, which provides relief but not entirely. This has been going on for 9 days now. I eliminated eggs and Teeccino Dandelion Dark Roast from my diet several days ago and cut my probiotic dosage in half, thinking these might be the culprits, but so far I continue to itch and have hives.
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| 73 | 2021-03-01 | chills, fever |
Chills and fever began at approx. 1:30 a.m. on February 27. Continued until late mid-day on March 1...
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Chills and fever began at approx. 1:30 a.m. on February 27. Continued until late mid-day on March 1. Extreme weakness and nausea. Had no appetite. Very dry mouth. Fever lessened by evening of March 1. Weakness and feeling of lightheadedness continuing as of today, March 2, morning. No more nausea today. No fever today Able to eat small amount of food
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| 73 | 2021-03-01 | fatigue, chills | Chills, nausea, fatigue soreness and stiff at shot site. |
| 73 | 2021-03-01 | fatigue, headache |
I started having lower back pain within hours of the 2nd shot, along with major headache, exhaustion...
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I started having lower back pain within hours of the 2nd shot, along with major headache, exhaustion By that night I had chills, exhaustion, back pain Since then, my back has been in spasm. Extremely, extremely painful spasm The pain is not movement related. I am fine while sleeping and generally while walking. Sitting or standing still brings on the pain
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| 73 | 2021-03-01 | fever, headache, fatigue | Strong headache fever jaw pain as if broken shortness of breath strong muscle soreness fatigue |
| 73 | 2021-03-02 | fatigue |
Diarrhea and vomiting Unable to keep anything, even water, down until 2:00 pm...still on soda cracke...
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Diarrhea and vomiting Unable to keep anything, even water, down until 2:00 pm...still on soda crackers and Gatorade at 3:00. Chills around 3:00 pm Fatigue This may have been a food-poisoning incident. If so, I don?t know the source, but it feels like food poisoning.
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| 73 | 2021-03-02 | fatigue |
Chronic fatigue and feeling cold like I can't get warmed up, but no fever, tense, jittery feeling wi...
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Chronic fatigue and feeling cold like I can't get warmed up, but no fever, tense, jittery feeling with the coldness and fatigue gets worse as day goes by. Hard to rest and relax because of the cold and tense feeling This lasted the entire 3 weeks between dose 1 and dose 2. I got dose 2 on Feb. 19 and have had same fatigue that isn't going away. Fatigue and coldness is not worse with 2nd dose, but I heard that side effects were only supposed to last a few days. To get warmed up I feel like I have to take a hot bath which also helps the tension. Also later in the day I feel like I can't move properly, I just have to stay still, moving is too much of an effort.
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| 73 | 2021-03-02 | headache, fatigue |
Headaches that have continued to get worse and have become like visual migraines. Have only been ha...
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Headaches that have continued to get worse and have become like visual migraines. Have only been happening once a day but the lingering headache and weakness in body continues through the day. With lots of fatigue.
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| 73 | 2021-03-02 | headache |
severe cramps; mild headache; lower abdominal pain across lower abdomen; This is a spontaneous repor...
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severe cramps; mild headache; lower abdominal pain across lower abdomen; This is a spontaneous report received from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), on 15Feb2021 at 09:30 AM (at the age of 73-year-old) on left arm at single dose for COVID-19 immunization. It was reported that patient was not pregnant at the time of event and at the time of vaccination. The patient's medical history was reported as none including no known allergies and no covid prior vaccination. The patient's concomitant medications included simvastatin (ZOCOR). The patient previously received the first dose of BNT162B2 (lot number EL1283), on 25Jan2021 09:30 AM (at the age of 73-year-old) on left arm for COVID-19 immunization, no other vaccines were administered in four weeks prior to vaccination. On 16Feb2021 at 10:00 AM the patient experienced mild headache severe cramps and lower abdominal pain across lower abdomen. The event "severe cramps" was reported as serious with criteria medically significant while the other events were reported as non-serious. No treatment for the events was received. No covid test was performed post vaccination. The outcome of the events was not resolved.
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| 73 | 2021-03-02 | sinus pain |
rt. hand fingers tingling, 15-20 minute later ears turned red, sinuses started aching, shaky week fe...
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rt. hand fingers tingling, 15-20 minute later ears turned red, sinuses started aching, shaky week feeling
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| 73 | 2021-03-03 | chills, body temperature increased |
Temp of 100 degrees, muscle aches, chills lasted about 24 hours. Following day three episodes of dia...
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Temp of 100 degrees, muscle aches, chills lasted about 24 hours. Following day three episodes of diarrhea
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| 73 | 2021-03-03 | chills, fever |
Around 3 PM on 3/2 arm was extremely sore and became worse as time progressed. By 6 PM developed...
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Around 3 PM on 3/2 arm was extremely sore and became worse as time progressed. By 6 PM developed aches, chills and low grade temperature. Became lightheaded. Could not sleep due to symptoms. No appetite but drank herbal tea and water with added electrolytes. That severity of symptoms lasted until 3/4 at 6 AM. Still am having some residual effects as one might have with the flu ? fatigue etc. Temperature is gone no more chills appetite still diminished.
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| 73 | 2021-03-03 | fatigue |
Overwhelming tiredness for 2 days Fatigue- Slept all through nights A little foggy mind Redness and...
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Overwhelming tiredness for 2 days Fatigue- Slept all through nights A little foggy mind Redness and swelling around site of injection- still demonstrating on third day March 4
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| 73 | 2021-03-03 | headache |
She has immune issues and stress/ methylprednisolone for immune issues; She has immune issues and st...
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She has immune issues and stress/ methylprednisolone for immune issues; She has immune issues and stress/ methylprednisolone for immune issues; severe headache/ pain in the base of her skull; nausea; vomiting; had pain at the top of her spine where the spine meets the skull; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (BNT162B2, lot number: EL9264) via an unspecified route of administration, on 01Feb2021 12:45PM at a single dose on top of left arm for COVID-19 immunization. The vaccine was given at a Clinic which is an off shoot of the hospital. The patient did not receive any vaccinations within 4 weeks prior to receiving BNT162B2. Medical history included Wegner's disease, immune issues and stress. She stated that there would be one doctor providing medication for stress and other doctor providing other medications. She has immune issues and stress. Concomitant medications included buspirone from an unspecified date and ongoing (been on it for quite a few years), clonazepam from an unspecified date and ongoing (been on it for quite a few years), fluticasone propionate (FLOVENT) from an unspecified date and ongoing (been on it a little over a year or two and it was prescribed by her pulmonologist), hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) from an unspecified date and ongoing (has been on it for more than 5 years and was prescribed by her primary care), methylprednisolone for immune issues, bupropion hydrochloride (WELLBUTRIN), and nebulizer for saline for Wegner's disease (It is prescribed by her ear, nose, and throat doctor). The patient previously received a flu shot in 2020 and experienced sore arm and achy feeling. On 01Feb2021 18:45, the patient experienced severe headache, nausea, vomiting, and pain in the base of her skull. A lot of people thought it was throwing her into a migraine. She has never had a migraine in her life. It was awful and pretty extreme. Severe headache, nausea, vomiting, and pain in the base of her skull started about six hours after the shot (at 18:45) and proceed a good 24 hours later. She also had pain at the top of her spine where the spine meets the skull. She would say that the symptoms stopped on 02Feb2021. She has recovered almost completely. She is still not quite completely 100 percent. The reported adverse events did not require a visit to emergency room or physician office. Some relatives said she should have gone in, but she did not. Outcome of the events was recovered on 02Feb2021.
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| 73 | 2021-03-03 | fever, fatigue | Fever of 101, severe body aches, fatigue |
| 73 | 2021-03-03 | fever, headache |
Heart skipping and racing for apx. 2 hours after vaccination. Headache Low grade fever Body ac...
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Heart skipping and racing for apx. 2 hours after vaccination. Headache Low grade fever Body aches. Pain in all bone including ankles, fingers, and toes and arches
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| 73 | 2021-03-03 | sinus disorder, chills, fatigue, headache, nasopharyngitis, malaise |
food poisoning; First got really sick; nausea/She got sick to her stomach; head colds/feels like com...
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food poisoning; First got really sick; nausea/She got sick to her stomach; head colds/feels like coming down with a cold; Feeling unwell/she wasn't feeling well; Dry heaved for 40 minutes. Saliva in her stomach was coming up, not food. Felt like it lasted forever.; sinus problems.; vomiting; Pain injection site; Slight headache; Chills, feels like coming down with a cold; Tired; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: RL3249), via an unspecified route of administration at left arm on 26Jan2021 14:00 (also reported as 17Jan2021 - pending clarification) at SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks. Medical history included diabetes, cancer (prior to receiving COVID-19 shot. Stated she was 14 years cancer free), allergy, shingles shot which hurt at the injection site, shrinks every year (Doesn't know exact number, but a little under 5 feet). The patient had no family medical history. Concomitant medication included mometasone furoate (FLONASE [MOMETASONE FUROATE]). On an unspecified date, the patient experienced she got sick to her stomach, food poisoning, "nausea/She got sick to her stomach," "head colds/feels like coming down with a cold," "feeling unwell/she wasn't feeling well," "dry heaved for 40 minutes. Saliva in her stomach was coming up, not food. Felt like it lasted forever," sinus problems, vomiting, and first got really sick. On 26Jan2021, the patient experienced tired, slight headache, chills feels like coming down with a cold, and pain injection site. The patient reported that she received the first dose of the Pfizer vaccine and experienced side effects including nausea, head colds, and sinus problems. She was concerned that this may be covid and if it will be safe for her to get the second dose of the vaccine as scheduled. The patient further reported that she first got really sick. Never had the flu and always gets head colds or food poisoning on an unspecified date. After reading material passed out, perhaps she was treating COVID and not a cold or allergy. The patient took first COVID-19 shot on 26Jan2021. Thought everything was fine. The patient was close to bedtime then noticed she wasn't feeling well. Looked at side effects and has like six of them at the same time. Right as she was going to rest, she got sick to her stomach. Never was sick to her stomach except when she was food poisoned. The patient had dry heaved for 40 minutes. Saliva in her stomach was coming up, not food. Felt like it lasted forever on an unspecified date. The patient asked that if she does have COVID, should she take the second shot? Wanted to get tested because Pfizer materials says exactly what her headache and sinus stuff was about. Now she was scared. The patient also reported that she wanted to take the second COVID-19 shot. If she does have COVID, thinks it's not the thing to do right now. It was confirmed she has not had a positive COVID test after receiving the first COVID-19 shot. Should have read material prior to and maybe wouldn't have taken the first COVID-19 shot. Confirmed symptoms she mentioned occurred after the COVID-19 shot. The patient came home from COVID-19 shot feeling fine. Didn't get sick until close to bedtime. Appointment for COVID-19 shot was 2:30PM. Clarified six symptoms previously mentioned: The patient had pain at injection site just two days and was gone. Began shortly after she got home from the COVID-19 shot. Went to lift arm up and it didn't feel good. Began an hour or two after COVID-19 shot. The patient was tired unusually early in the day. Felt like she didn't want to do anything. Couldn't use her left arm. Clarified left arm was injection arm. Tiredness has subsided and only lasted a couple of days. It was further reported that patient never gets headaches. It started after vomiting which didn't last long. It bothered her and then was gone by the time she went to sleep. The patient had chills, feels like coming down with a cold on an unspecified date which subsided right before dinner around 3PM-4PM. The patient had to put on a fluffy robe to keep warm. It was also reported that the patient did not have a fever. It was also reported that shingles shot hurt at injection site where pain lasted a week and a half. Temperature went from 98.6 degrees to 99 degrees. The patient was taking stuff now and monitoring to see if she can see any signs. The patient was feeling unwell on an unspecified date which has subsided except for allergies and she was concerned. The patient also experienced dry heaving: didn't have anything in her stomach on an unspecified date which subsided. Even after she ate yesterday, hasn't had any dry heaving except for night of the COVID-19 shot. The patient underwent lab tests and procedure which included body height: little under 5 feet (doesn't know exact number), temperature: went from 98.6 degrees to 99 degrees, and COVID test: negative (she has not had a positive COVID test after receiving the first COVID-19 shot). Therapeutic measures were taken as a result of sinus disorder which included sinus medication and was squirting Flonase in her nose. On an unspecified date, the patient recovered from slight headache. The patient had not yet recovered from the event nausea and vomiting. The outcome of the events chills, tired, food poisoning, first got really sick, head colds/feels like coming down with a cold, feeling unwell/she wasn't feeling well, dry heaves, sinus problems, and pain injection site were unknown.
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| 73 | 2021-03-04 | headache |
Severe case of shingles in left arm. Electrical shock type pain from left mastoid thru neck, shoulde...
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Severe case of shingles in left arm. Electrical shock type pain from left mastoid thru neck, shoulder, arm to palm, thumb and finger tips. Muscular pain from neck (felt like pinched nerve) thru shoulder to wrist (felt like carpel tunnel). Blooming painful pustule rash from shoulder to wrist on inner arm for one week. Post-herpetic and muscular pain continues through rash scabbing and drying, to date March 6, 2021. This is my second event in 37 years.
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| 73 | 2021-03-04 | headache |
March 1st--bedtime meds did not work causing me to have muscle pain and spasms. Next day all MS symp...
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March 1st--bedtime meds did not work causing me to have muscle pain and spasms. Next day all MS symptoms that had been in remission were now present. no strength in left injection arm, all muscles weakened. slight headache. All subsided about ten pm.
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| 73 | 2021-03-04 | headache | headache, body ache |
| 73 | 2021-03-04 | malaise, fever, fatigue |
My reaction was not bad enough to require medical attention but I am reporting it to add to the data...
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My reaction was not bad enough to require medical attention but I am reporting it to add to the data base. A few hours following the vaccination, my eyes burned like crazy. The day after my second dose of the vaccine, I became excessively fatigued. My arm hurt, I had a very slight fever (99.2 and my normal temp in 97.6) and felt a general malaise. I went to bed and after 10 hours of sleep felt much better the following day, although still fatigued. However, the next day, my arm hurt to move it and I discovered swelling under my arm and my lymph node was enlarged. The swelling went down after a couple of days and all of my symptoms were gone in about five days.
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| 73 | 2021-03-04 | fever |
tenderness at injection site, low grade fever, aching in all joints-started at 12:30-7;30 3/5/21, 3 ...
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tenderness at injection site, low grade fever, aching in all joints-started at 12:30-7;30 3/5/21, 3 doses of advil,vomiting
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| 73 | 2021-03-05 | chills, headache | Nausea Vomiting Diarrhea Headache Chills Rash, Pain, Swelling, Redness at site area |
| 73 | 2021-03-05 | chills, sweating, fever | Hot sweaty thirsty Slight nausea At night whole body chills Whole body shivers Fever |
| 73 | 2021-03-05 | headache |
Started vomiting at 5 o?clock morning after the shot. Went to ER at 3 o?clock in the afternoon, was ...
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Started vomiting at 5 o?clock morning after the shot. Went to ER at 3 o?clock in the afternoon, was administered IV and vomiting was stopped about 4 o?clock in the afternoon. Severe diarrhea, intense headache. Was given nausea medicine and medicine to stop diarrhea, medicine for headache. Was sent home with prescriptions for nausea, diarrhea.
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| 73 | 2021-03-05 | headache | Headache, pain in both eyes, sore right arm. |
| 73 | 2021-03-06 | chills, fever, sleepiness, fatigue |
Fatigue in afternoon following injections. Then proceeded by chills, fever, and nausea during the n...
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Fatigue in afternoon following injections. Then proceeded by chills, fever, and nausea during the night (including dry vomiting). Chills laster another day, and fatigue (frequent naps) lasted for two more days. Total of 4 days of adverse conditions.
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| 73 | 2021-03-06 | fatigue, headache, chills |
Extreme muscle pain, followed by severe headache, exhaustion, chills ,nausea 4 days after first covi...
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Extreme muscle pain, followed by severe headache, exhaustion, chills ,nausea 4 days after first covid shot
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| 73 | 2021-03-06 | headache, fever |
2 am,,went to get out of bed, collapsed because legs wouldnt hold her up. Headache, 2 poilt fever, a...
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2 am,,went to get out of bed, collapsed because legs wouldnt hold her up. Headache, 2 poilt fever, arm rashes shoulder to wrist. Body aches and bad weakness for about a week. Rashes on arm and swollen arm lasted 9 days.
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| 73 | 2021-03-06 | headache |
Day 6 after 2nd dose had debilitating headache lasting 3 days, muscle shaking, dizziness and some fo...
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Day 6 after 2nd dose had debilitating headache lasting 3 days, muscle shaking, dizziness and some foggy thinking. this is day 10 headache duller now but other symptoms present
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| 73 | 2021-03-07 | fatigue, headache |
3/4 Evening: injection site VERY sore. Too painful To sleep on. Disturbed sleep due to pain. 3/5:...
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3/4 Evening: injection site VERY sore. Too painful To sleep on. Disturbed sleep due to pain. 3/5: Morning; headache, fatigue Evening/overnight: arm still tender 3/6: Morning: fatigue, nausea, headache, lack of appetite, stomach upset. Hot flashes, no fever detected Afternoon: very nauseous, vomiting, headache Evening/overnight: not getting restful sleep 3/7: Morning: mild headache/lack of appetite Evening/overnight: woke in the middle of the night with severe stomach cramps, loose stool, nausea amd vomiting. No fever detected. 3/8 continues to be nauseous, lack of appetite and extreme fatigue.
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| 73 | 2021-03-07 | fatigue, headache |
Very next MORNING! My blood sugar readings every morning had been running @ 100 . HOWEVER, next m...
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Very next MORNING! My blood sugar readings every morning had been running @ 100 . HOWEVER, next morning after Covid shot, my blood sugar was 350. It continued that way for days. I started using more insulin the night before (when I usually take it). So I HAD been taking only 45 units at night. I was cautious and increased to 65 units on the 3rd night. That reduced my morning blood sugar readings to 220. Per my doctor's instructions, I have been taking that amount every night, but my blood sugar has only gone down to 175. This was my MAIN concern. But here are the other physical effects that have occurred since 2-25: great thirst, Joints hurt, teeth hurt, confusion, headache, fatigue, sleeping almost all day - all of these days since the shot. Something new started just last night (3-7-2021). Both of my legs hurt so much I could not fall asleep. They still hurt this morning. My joints ache in my hips, knees - Much worse than they normally do.
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| 73 | 2021-03-07 | fatigue, headache |
Severe breathing distress lasting 3 days Diarrhea 2 days. Injection site pain. Headache joint pAin...
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Severe breathing distress lasting 3 days Diarrhea 2 days. Injection site pain. Headache joint pAin Fatigue
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| 73 | 2021-03-07 | fatigue |
48hours and still have fatigue and joint pain; 48hours and still have fatigue and joint pain; This i...
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48hours and still have fatigue and joint pain; 48hours and still have fatigue and joint pain; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration on the left arm on 28Jan2021 at 09:00 AM at a single dose for COVID-19 immunisation. The patient medical history was none. There were no allergies to medications, food, or other products. Concomitant medications included rosuvastatin calcium (CRESTOR) at 5mg, vitamin D and zinc. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced fatigue and joint pain on 28Jan2021 at 14:00 and after 48 hours also, was experiencing the events. The patient assessed the events as non-serious. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 73 | 2021-03-07 | fever | Weakness, nausea, fever. Symptoms lasted approximately 36 hours. |
| 73 | 2021-03-08 | chills, fatigue, headache, fever |
Chills, fever 101, Body aches, fatigue, Headache, nausea, swollen glands, SOB. started on 2/27 gradu...
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Chills, fever 101, Body aches, fatigue, Headache, nausea, swollen glands, SOB. started on 2/27 gradually improved and then a week later on 3/6/21 experienced body aches, chills , fever, chest tightness, headache which has resolved by 3/8/21..
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| 73 | 2021-03-08 | chills, fever |
no pain at left arm at injection site but left arm tremor started approximately 8 hrs after injecti...
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no pain at left arm at injection site but left arm tremor started approximately 8 hrs after injection and developed into body chills, fever up to 102 degrees, body aches and pains which continued for 17 hrs and then resolved with only OTC home treatment
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| 73 | 2021-03-08 | chills, fever |
Awakened at 2:00 am with low grade fever and muscle and bone aches. (ankle, knees, hip joints, back)...
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Awakened at 2:00 am with low grade fever and muscle and bone aches. (ankle, knees, hip joints, back) Experienced low grade fever and chills occasionally for3 days following injection. Today is day 4 and I have no side effects.
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| 73 | 2021-03-08 | fatigue, chills, headache | Cold chills for about five hours next day extreme headache extreme fatigue |
| 73 | 2021-03-08 | fatigue, malaise, influenza like illness, fever, sweating, chills, headache |
Arm is very sore and it hurts in the muscle, this is very sore in the spot where they give me the in...
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Arm is very sore and it hurts in the muscle, this is very sore in the spot where they give me the injection; I have a slight fever of a 100; I feel I am cold, I have the chills; Headache; joint pain; muscle pain unbelievable; nauseous; I was sick all day; symptoms felt like when you are getting the flu and when you get the flu vaccine; tiredness; sweating; This is a spontaneous report from a contactable consumer, the patient. This 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 05Feb2021 (at the age of 73 years-old) for COVID-19 vaccination. Medical history included Parkinson's disease, bulging disc in the back and shoulder, anxiety, thyroid, had very bad case of, was in the hospital for 12 days and they were just supposed to put her on the ventilator, but then started to recover a little bit, was hesitating on taking the shot. But when she called the doctors they said no you can take it, even the neurologist said that you can take it because she had this disease and should be taking it. Historical vaccine included unspecified reaction from an unspecified flu vaccine on an unknown date. Concomitant medications included dexlansoprazole (DEXILANT), levothyroxine, paroxetine for anxiety, carbidopa, levodopa for Parkinson's disease, metoprolol succinate (METOPROLOL ER ACTAVIS) 25 mg, one a day and vitamin D NOS. On 05Feb2021, the patient experienced slight fever of a 100, felt cold, chills, headache, joint pain, muscle pain unbelievable, nauseous and was sick all day. On 06Feb2021, the patient's arm was very sore in the spot where they gave the injection and has no rash, it's not red in that area or any place else, It's just very sore and it hurts in the muscle, this is very sore in the spot where they gave the injection. On an unknown date in 2021, symptoms felt like when you are getting the flu and when you get the flu vaccine just a little more tiredness. Treatment to reduce the fever included acetaminophen (TYLENOL) and is sweating. Treatment was received for chills. The clinical outcome of slight fever of a 100, felt cold, chills was recovered on an unknown date. The clinical outcome of arm very sore in the spot where they gave the injection, headache, joint pain, muscle pain unbelievable, nauseous, sick all day, symptoms felt like when you are getting the flu and flu vaccine, tiredness and sweating was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 73 | 2021-03-08 | fatigue, fever, chills | fever, body aches, chills, fatigue, tender arm |
| 73 | 2021-03-08 | malaise, fatigue, headache |
Severe headache lasting 36 hours, fatigue and malaise for at least a week. No treatment except for...
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Severe headache lasting 36 hours, fatigue and malaise for at least a week. No treatment except for rest.
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| 73 | 2021-03-08 | fever, chills, fatigue, headache, influenza like illness | Flu like symptoms Fever/chills headache fatigue body aches |
| 73 | 2021-03-08 | fever, chills |
13 days after my first vaccine shot I awoke with chills, fever, temp, vomiting and body aches. It la...
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13 days after my first vaccine shot I awoke with chills, fever, temp, vomiting and body aches. It lasted two days although better the second day. Low grade fever followed on and off for several days.
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| 73 | 2021-03-08 | throat irritation, cough |
20 minutes after the vaccination I had an itchy throat and had the urge to cough. I asked if I could...
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20 minutes after the vaccination I had an itchy throat and had the urge to cough. I asked if I could use my inhaler. Nurse took me to a room with a doctor. I used my inhaler. The doctor suggested Benadryl. Discussion about me driving home. I declined the shot as the doctor was concerned about me driving. I said I would take Benadryl at home. We waited 15 minutes more and I was released. I used Benadryl and my inhaler during the rest of the day. Both day1 and day 2, I was coughing on and off. Day three I feel better.
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| 73 | 2021-03-09 | fatigue, chills, headache | Headache, chills, indigestion; muscle aches; fatigue |
| 73 | 2021-03-09 | fatigue, chills |
Chills, nausea, aches and slight dizziness with some fatigue. These lasted for approximately 14 hou...
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Chills, nausea, aches and slight dizziness with some fatigue. These lasted for approximately 14 hours.
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| 73 | 2021-03-09 | fatigue, headache | Severe headache, slight nausea, very sore arm, tiredness. Lasted through the day and evening |
| 73 | 2021-03-09 | fatigue |
Feeling of elevated heart rate, tired. BP 148/77, HR 98, O2sat 96. Denies chest pain, shortness of b...
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Feeling of elevated heart rate, tired. BP 148/77, HR 98, O2sat 96. Denies chest pain, shortness of breath, headache, dizziness. Palpitations resolved. Discharged in stable condition.
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| 73 | 2021-03-09 | fever, chills, headache |
Fever, itching very bad. Stinging, rash , chills , headache. In bed for a week. Had rash for sever...
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Fever, itching very bad. Stinging, rash , chills , headache. In bed for a week. Had rash for several days.
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| 73 | 2021-03-10 | throat irritation |
Vague chest tightness and tickle in her throat. .Improved with albuterol treatment. Hx of nausea w...
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Vague chest tightness and tickle in her throat. .Improved with albuterol treatment. Hx of nausea with PEG - no anaphylaxis with PEG.
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| 73 | 2021-03-11 | body temperature increased, headache |
Headache and temperature of 100.6, took Tylenol and Ibuprofen at usual time in evening, went to bed,...
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Headache and temperature of 100.6, took Tylenol and Ibuprofen at usual time in evening, went to bed, was fine next morning
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| 73 | 2021-03-11 | body temperature increased | Temperature of 100.8, finally broke after taking Ibuprofen and Tylenol Arthritis |
| 73 | 2021-03-11 | cough, runny nose |
Patient received second dose of Pfizer on February 4th. She tested positive for Covid-19 on March 9t...
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Patient received second dose of Pfizer on February 4th. She tested positive for Covid-19 on March 9th. Symptoms started March 4th, She was exposed by her children on March 2nd. She only has a cough and runny nose.
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| 73 | 2021-03-11 | headache, fatigue, fever |
shortly after injection was provided left arm pain 2:45PM. 6:00 AM Headache 6:00 took Aleve 220mg ...
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shortly after injection was provided left arm pain 2:45PM. 6:00 AM Headache 6:00 took Aleve 220mg for arm pain, headache 3:30 PM arm pain, fever, headache, body aches, fatigue 5:30 PM Aleve 220 mg for symptoms
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| 73 | 2021-03-11 | headache, fatigue |
Sore arm as expected. Fatigue (still in effect, ) Severe headache ( helped/resolved by Tylenol). Som...
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Sore arm as expected. Fatigue (still in effect, ) Severe headache ( helped/resolved by Tylenol). Some queasiness/dizziness
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| 73 | 2021-03-12 | body temperature increased |
nausea, elevated temp, excessive urination, swollen soft tissue (mouth, tongue), painful urination -...
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nausea, elevated temp, excessive urination, swollen soft tissue (mouth, tongue), painful urination - bladder and kidneys, extreme weakness, no interest in food.
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| 73 | 2021-03-12 | chills, fatigue, headache | Chills, headache, body aches, fatigue |
| 73 | 2021-03-12 | fever |
muscle ache, especially neck and hips and fever of 99.8 F. the evening of day after injection . Fee...
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muscle ache, especially neck and hips and fever of 99.8 F. the evening of day after injection . Feeling normal by second day.
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| 73 | 2021-03-13 | headache, lethargy, fever |
Presented with fever and hypoxia - determined to be SIRS. No infectious source found. Other symptom...
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Presented with fever and hypoxia - determined to be SIRS. No infectious source found. Other symptoms included confusion, lethargy, aches, headache and fever.
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| 73 | 2021-03-13 | headache |
3/13/2021 had migraine aura for 25 minutes followed by moderate headache twice. 3/14/2021 had migra...
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3/13/2021 had migraine aura for 25 minutes followed by moderate headache twice. 3/14/2021 had migraine aura for 20 minutes followed by moderate headache.
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| 73 | 2021-03-14 | chills, fatigue |
36 hours after shot skin discoloration (brown/red flat patches) developed on both upper inner thighs...
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36 hours after shot skin discoloration (brown/red flat patches) developed on both upper inner thighs and around both armpits. Discoloration has not gone away and after about a week, the discolored areas on both thighs were 'puffy' with some edema. These areas were not itchy nor was there a raised rash - just discoloration. The area around the injection site has no discoloration. For first few days also had some chills and tiredness, but these are gone.
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| 73 | 2021-03-14 | cough, throat irritation |
,MARCH 11TH HAVING CONSTANT COUGHING AND SCRATCHIY THROAT EVERY 5 MINUTES THOUGH IT WAS ALERGIES/CO...
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,MARCH 11TH HAVING CONSTANT COUGHING AND SCRATCHIY THROAT EVERY 5 MINUTES THOUGH IT WAS ALERGIES/COLD - BUT SITUATION BECAME WORSE SINCE MARCH 11TH
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| 73 | 2021-03-14 | fatigue, headache, chills, fever, cough, runny nose |
Developed COVID. Fever, chills, muscle aches, runny nose, cough, nausea, headaches, fatigue, loss ...
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Developed COVID. Fever, chills, muscle aches, runny nose, cough, nausea, headaches, fatigue, loss of taste and smell
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| 73 | 2021-03-14 | fatigue, headache |
None with Shot 1 Shot 2 : Headache, fatigue, nausea, vomiting, diarrhea, nightmares, unclear thinki...
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None with Shot 1 Shot 2 : Headache, fatigue, nausea, vomiting, diarrhea, nightmares, unclear thinking, instability on feet 2days recovery except for headache and fatigue remain Imodium Zofran Sumatriptan Fully recovered except for headache and fatigue
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| 73 | 2021-03-14 | fatigue, fever, headache | Headache, Fever (100.4), nausea, fatigue. Lasted thru the entire day. |
| 73 | 2021-03-14 | fatigue, fever, runny nose, chills, headache |
Developed COVID. Detected by PCR. Had fever, chills, muscle aches, runny nose, nausea, headaches, f...
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Developed COVID. Detected by PCR. Had fever, chills, muscle aches, runny nose, nausea, headaches, fatigue, loss of taste and smell.
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| 73 | 2021-03-14 | fever, headache, chills |
chills, fever, headache, nausea, weakness, and arm pain at site. Called Dr. spoke with staff and tol...
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chills, fever, headache, nausea, weakness, and arm pain at site. Called Dr. spoke with staff and told it will go away in a couple of day. Stayed in bed all day on the 12th of March and woke up about 8:00 on the 13th and only symptom which I still have today is sore arm at point of vaccination. other meds Lorazepam .05mg,Aspirin 81 mg, Acyclovir 400 mg, Vita D, Vita B12,Align, Estroven. Turmeric, One a day vitamins,Coq10
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| 73 | 2021-03-14 | throat irritation |
The patient had her second vaccination for Coronavirus this afternoon. She was asymptomatic for 15 m...
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The patient had her second vaccination for Coronavirus this afternoon. She was asymptomatic for 15 minutes afterwards, but while driving home she developed tingling of her lips and the feeling of heat in her throat. She went back to the outpatient center where she had the vaccination, where they assessed her. She was not hypoxemic, tachypneic, or hypotensive. There was no visible angioedema. She had no rash or shortness of breath. The vaccinations center administered Claritin and Pepcid and referred the patient here to the emergency department for evaluation. The vaccination occurred 1 hour ago now. The patient says that she feels better, but continues to have the sensation of "heat" in her throat. She has no history of prior allergic reactions. She has no chest pain, difficulty breathing, nausea, vomiting, rash, or itching.
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| 73 | 2021-03-15 | fatigue |
First does had soreness of area of injection overnight., no other adverse reaction. Second does had ...
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First does had soreness of area of injection overnight., no other adverse reaction. Second does had the same soreness of area of injection overnight, in addition to bodyacnes and soreness, for about a day and a half. After that I continues to experience fatigue, I go to sleep at night and have difficulty getting up in the morning due to feeling very fatigued. It takes about an hour before I can feel like completing my day. During the day I feel like I need a nap. Before the shot I was able to complete my day as normal.
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| 73 | 2021-03-15 | headache |
pt. is alert but complain of light headache and flush. VS BP 151/106, HR 97. symptoms was resolved...
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pt. is alert but complain of light headache and flush. VS BP 151/106, HR 97. symptoms was resolved and patient went home.
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| 73 | 2021-03-15 | nasal congestion |
In first 15 minutes, no adverse reaction. In second 15 minutes, while driving home, my lips, throat,...
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In first 15 minutes, no adverse reaction. In second 15 minutes, while driving home, my lips, throat, nasal passages began to go numb, tingle, swell. This lasted a day and a half. No breathing obstruction.
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| 73 | 2021-03-16 | chills, fever, fatigue | Fever, Chills, Vomiting, Weakness, Tired, Rapid Heartrate |
| 73 | 2021-03-16 | chills | Chills and body aches |
| 73 | 2021-03-16 | chills |
32 hours post vacc. injection, administered at a medical center (a community site-not my primary pro...
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32 hours post vacc. injection, administered at a medical center (a community site-not my primary provider), Sx began w/ nausea, low abdominal pain, stiff neck and achy pain at base of skull. W/in 20 minutes nausea became vomiting x5 events which stopped when Ondansetronws taken, authorized by an on-call physician at the clinic (my primary care provider). Chills w/out fever begun about 30 minutes post first episode of vomiting and continued into the earliest hours of 2/28/21 (4:00am). I reviewed my Sx not only with the clinic staff, but also my primary care physician on 3/2/21. She has provided prn Rx for possible Sx as needed for dose 2, March 19th, 2021.
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| 73 | 2021-03-16 | chills |
11PM - 6AM awoke shivvering from head to toe..woozy, head buzzing, couldn't see much except lavende...
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11PM - 6AM awoke shivvering from head to toe..woozy, head buzzing, couldn't see much except lavender splotches when eyes open; no strength in arms or legs: collapsed trying to get out of bedroom to bathroom & couldn't get up unassisted; collapsed again trying to get from bathroom back to bed - couldn't scoot or pull/raise myself up with my arms; needed help to sit & rest& collect myself; arms/legs had no strength at all.... couldn't move unassisted; took unknown amount of time for husband to help me back to bed....once in bed slept until 6AM.. still weak the following day but vision back to normal - used walker to get around..head still buzzing
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| 73 | 2021-03-16 | chills |
1:30 AM MY ARM WAS THROBING AND I HAD CHILLS VERY BAD MY ENTIRE BODY ACHE ALL OVER AROUND 10:00 AM ...
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1:30 AM MY ARM WAS THROBING AND I HAD CHILLS VERY BAD MY ENTIRE BODY ACHE ALL OVER AROUND 10:00 AM THINGS HAD CALM DOWN BY NOON EVERYTHING WAS GONE.
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| 73 | 2021-03-16 | sweating |
3:56pm- 71/F in post vaccination area witnessed multiple episodes of vomiting yellow emesis. Appears...
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3:56pm- 71/F in post vaccination area witnessed multiple episodes of vomiting yellow emesis. Appears diaphoretic, initial BP 220/110, HR 110. O2 95%, RR 22. Pt received the vaccine at 3:46pm. She denies blurred vision, no headache, no chest pain or SOB. Denies abdominal pain but her daughter states she recently had a hernia repair and has had issues with cyclic vomiting induced with certain foods or stress, which her doctors are monitoring her for. Her daughter states she was feeling sick before she got her vaccine. Patient states she took her morning medication at 7am, had some breakfast at 10am and states she feels it was some pineapple she ate that caused her to start feeling nauseous. She adds that she is taking several blood pressire medications but when she begins to vomting her blood pressure "gets really high." Pt is AOx4, able to speak in clear complete sentences. 4:05pm- BP 210/120, HR 82, 97%, RR 24. Pt continues to vomit intermittently but states she is starting to feel better. Onsite nurse manager, lead and site lead aware. EMS services requested. 4:10pm- BP 191/100, HR 86, 96%. No vomiting witnessed. 4:14pm- Ems arrives on scene. BP sitting 156/91, standing 140/92. Pt states she feels better. Parameduc offers to transfer her to the hospital but patient declines. Her daughter is at side and she states she would rather her daughter take her home since she is feeling better. Educated regarding when to seek medical attention. Pt AOx4, resp even, skin warm and dry, not actively vomiting, speaks in clear complete sentences. Assisted to POV via wheelchair. Pt in no apparent distress.
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| 73 | 2021-03-16 | sweating |
Patient received 2nd dose of Pfizer COVID-19 vaccine. She immediately developed diaphoresis and eye...
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Patient received 2nd dose of Pfizer COVID-19 vaccine. She immediately developed diaphoresis and eye tearing. Diaphoresis worsened. Patient reported nausea. Epinephrine administered and transferred patient to emergency department. ED did not feel epinephrine helped Patient observed and then discharged.
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| 73 | 2021-03-16 | sweating | Diaphoretic. lightheaded |
| 73 | 2021-03-16 | lethargy, throat pain, fever |
Slight fever (1 degree above normal), slight sore throat, very sore muscles (shoulders, upper arms, ...
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Slight fever (1 degree above normal), slight sore throat, very sore muscles (shoulders, upper arms, neck, back hips, upper legs), lethargic. Sore throat resolved within a 8 hours. Fever resolved within 24 hours. Muscle pain still in progress 33 hours later. Have not taken any OTC treatments because I do not want to impede the vaccine's work.
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| 73 | 2021-03-16 | fever, malaise, headache, fatigue |
Fever, Headache, Diarrhea, Fatigue, generally feeling bad After 9 days got covid test which was nega...
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Fever, Headache, Diarrhea, Fatigue, generally feeling bad After 9 days got covid test which was negative. Then went to doctor for diarrhea which was really bad( 4-6 times a day. Stool test diagnosed me with c diff. On antibiotic until March 20,2021, Diarrhea getting better but not back to normal
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| 73 | 2021-03-17 | fatigue |
Extremely tired for the next month, and then was hospitalized with 2 blood clots in lungs and severe...
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Extremely tired for the next month, and then was hospitalized with 2 blood clots in lungs and severe anemia (cause not determined yet, as to whether not making platelets or losing blood). Had two blood transfusions and iron transfusion.
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| 73 | 2021-03-17 | headache, cough |
Allergic Reaction within 10 minutes: Large itchy hive on forehead, a red rash on both hands, headac...
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Allergic Reaction within 10 minutes: Large itchy hive on forehead, a red rash on both hands, headache, mild dry cough. After 40 minutes of observation by a hospital nurse, I went home and took an allergy pill, as advised (Benedryl). I am recovered.
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| 73 | 2021-03-17 | lethargy |
Within the first 15 min. a sharp pain was felt in my upper arm about six inches below the injection ...
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Within the first 15 min. a sharp pain was felt in my upper arm about six inches below the injection sight. The pain subsided and I thought no more about it. My arm was sore for about 5 days. I was extremely tired the first day or so and took a day time nap the next day which is unusual for me. I felt lethargic for two weeks and went into what I call a funk - a very minor depression. Exactly two weeks later the funk lifted and I felt normal. I received my second shot on 2/19/21. About that time (can't remember if it was before or after the second shot) I felt a sharp pain in my left arm in the same spot where the initial pain was. I massaged my arm and took Tylenol and that was the end of it. I've had a couple of other episodes since with less discomfort each time. I have simply massaged my arm and it's gone away. After the second shot I slept for about 2 to 3 hours in the afternoon the next day. I felt somewhat lethargic for a few days and a minor funk for a few days, but nothing more. The pain in my arm is the unusual symptom. I broke that arm just below the elbow two years ago. I don't know if that might have anything to do with the situation or not.
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| 73 | 2021-03-17 | malaise |
On 03/08/2021, patient began not feeling well. She complained of nausea, vominting and diarrhea. He...
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On 03/08/2021, patient began not feeling well. She complained of nausea, vominting and diarrhea. Her husband reported that she received the first vaccine in 02/2021 and complained of not feeling well. Patient died on 3/12/2021.
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| 73 | 2021-03-17 | fever, headache, chills, fatigue |
Chills - fever of 100.8 - extreme headache - arm pain and rash by injection site - joint pain throu...
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Chills - fever of 100.8 - extreme headache - arm pain and rash by injection site - joint pain through the whole body - swollen lymph nodes on left side of neck - pain so bad couldn't roll over in bed - fatigue
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| 73 | 2021-03-17 | fever |
Slight fever day after vaccine 2nd dose. Red rash appeared 2 days after below vaccination site. Red ...
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Slight fever day after vaccine 2nd dose. Red rash appeared 2 days after below vaccination site. Red and itchy and remains over 2 weeks later
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| 73 | 2021-03-17 | sneezing, runny nose |
I began experiencing dizziness/vertigo when lying down or getting up. This only lasted 30 seconds o...
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I began experiencing dizziness/vertigo when lying down or getting up. This only lasted 30 seconds or less and improved after a few weeks. Upon receiving my second vaccination on 3/16/21 the dizziness has immediately gotten a bit worse. It has only been a few days since my second dose. I also have a slight runny nose and a little sneezing after the second dose but this is veery minor.
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| 73 | 2021-03-18 | fatigue |
Patients physician calls about confusion with cognition and memory issues. She is also still having ...
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Patients physician calls about confusion with cognition and memory issues. She is also still having balance issues with extreme fatigue.
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| 73 | 2021-03-18 | fatigue | Dizziness/light-headed, nausea/quesey, tiredness |
| 73 | 2021-03-18 | headache, fever, chills |
Injection 2: day one: slight fever, chills, extreme muscle pain in both arms, legs and feet, head...
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Injection 2: day one: slight fever, chills, extreme muscle pain in both arms, legs and feet, headache, chest pain. First day. Injection 1: day one thru day three. Same as injection one. Headache was severe all three days.
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| 73 | 2021-03-18 | headache |
Numbness in forehead, Headache and metallic taste in the mouth. Event only lasted about 30 seconds t...
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Numbness in forehead, Headache and metallic taste in the mouth. Event only lasted about 30 seconds to 1 minute. After that event went away.
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| 73 | 2021-03-18 | sweating |
Swelling of right hand including sore joints in wrist and fingers. This resolved by 3/1/2021. Hot ...
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Swelling of right hand including sore joints in wrist and fingers. This resolved by 3/1/2021. Hot flashes including drenching sweat , red neck and face and raised blood pressure. This occurred randomly. It was an almost daily event until 3/5/2021. This then reduced to 1 event every 2-3 days until the present. Last occurred on 3/18/2021.
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| 73 | 2021-03-18 | malaise |
TIA; I felt really lousy; This is a spontaneous report from a contactable consumer (patient). A 73-y...
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TIA; I felt really lousy; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), dose 2 at the age of 73-year-old, via an unspecified route of administration on 26Feb2021 as single dose for COVID-19 immunisation. Medical history included high blood pressure (don't have really high blood pressure but the doctor has her on blood pressure medicine, have no diabetes or whatever, and had allergies. Concomitant medication included amlodipine besylate 5 mg, taken every morning. She takes most of her medicines in the morning and had taken that stuff at about 5 o'clock or so early in the morning. The patient was previously vaccinated with the first dose of BNT162B2 on 05Feb2021 at the age of 73-year-old and hand no problem. The patient stated that when she had the first COVID vaccination she had no problem and then Friday she went to get the second one, it was 3 weeks later, when she had first one she stated that she had allergies, so they had her wait 15 minutes, no problem. When she went for the second one, thankfully someone drove her that was outside the 'game court' location. When they gave it they said, she pull up and will let her know after she pull up and will decide if she has to wait 15 minutes or 30 minutes and they asked her if she had allergies, and she said yes, they said pull over here and she has to wait 30 minutes and all she know was, it's probably 2 minutes from the time she got the vaccine until she got to the place to wait. She would say 15 minutes after she got it on 26Feb2021, she felt really lousy and told her friend, they 'said' she was having a Trans Ischemic Attack (TIA), and took me to the hospital and everything. An ambulance was called on 26Feb2021 at around 8 o'clock that morning, right after she had the vaccine and carried her straight in the hospital. She was discharged the next day 27Feb2021 at about 7 PM. The patient had a CT scan of her brain, MRI of her brain, and then cardial, something with reference to her heart, she forgot, all with unknown results. The body weight right now was about 150 pounds. The outcome of the events was unknown.
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| 73 | 2021-03-19 | chills, fatigue | Vomiting,diarrhea, chills joint pain all joints, dizziness Exhausted, breathlessness |
| 73 | 2021-03-19 | headache, body temperature increased, chills, fatigue |
Started with chills and upset stomach. After about 30 minutes felt sick to my stomach, still chills...
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Started with chills and upset stomach. After about 30 minutes felt sick to my stomach, still chills and felt weak. Went to bed with normal covers, spread and an extra quilt. Temperature was 101.0. stayed in bed until noon then went to the couch. Still felt weak and extremely tired. Temp down to 99 but developed a bad headache. Took Tylenol and laid on the couch all day - did not eat still felt queasy. Went to bed around 8:00pm. Got up about 10:00 on Friday and felt almost back to normal and got better as the day went on. I also noticed quite a bruise at the site.
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| 73 | 2021-03-19 | headache, fever, chills | Sore right arm, fever, nausea chills, rash, headache |
| 73 | 2021-03-19 | headache |
High blood pressure (190/70) Painful headache due to high blood pressure Heart palpitations Hives on...
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High blood pressure (190/70) Painful headache due to high blood pressure Heart palpitations Hives on left arm above elbow
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| 73 | 2021-03-19 | fever, chills, sweating |
3 hours after extreme nausea. 10 hours after shaking chills(rigors) lasting in waves for 6 hours the...
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3 hours after extreme nausea. 10 hours after shaking chills(rigors) lasting in waves for 6 hours then intermittently for 5 hours. Low grade Temp 100.3 Degrees , when I could take it. Inconvenience of urine during the rigors. ?Migraine like? headache on right side involving my teeth for 12 hours and slowly abated after 24 hours. Unable to eat or drink for 42 hours with exception of one cup green tea and 1/2 slice of provolone cheese., forced down only to take my Pradaxa. After rigors, whole body sweats for 8 hours. As of today, I have had plain oatmeal and tea.
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| 73 | 2021-03-20 | fatigue, chills |
Chills; tiredness; This is a spontaneous report from a contactable consumer (patient). A 73-year-old...
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Chills; tiredness; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, in left arm on 02Feb2021, at 16:30 (at the age of 73-year-old) as single dose for COVID-19 immunisation. Medical history included High BP and stage 3 kidney disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. The patient concomitant medication included valsartan at the dose of 160 mg and levothyroxine at the dose of 88ug. The patient didn't receive any vaccine within 4 weeks prior to the vaccine. The patient experienced chills and tiredness on 03Feb2021 at 12:00. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unknown date in Feb2021. Information on the lot/batch number has been requested.
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| 73 | 2021-03-20 | fatigue, sleepiness |
3/10 could not stay awake beyond 9PM 3/11 10 AM, tired, nauseous, continued to 8PM when could no lo...
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3/10 could not stay awake beyond 9PM 3/11 10 AM, tired, nauseous, continued to 8PM when could no longer stay awake, slight aching at injection site 3/12 slept 10 hours, continue to feel tired, less energy to present date 3/21/21.
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| 73 | 2021-03-20 | fatigue |
disorientation, difficulty talking, difficulty walking, exhaustion. This has happened before, for in...
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disorientation, difficulty talking, difficulty walking, exhaustion. This has happened before, for instance as a result of flu. She recovers in a few days. This is NOT a stroke or heart related event.
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| 73 | 2021-03-20 | fatigue |
Woke up around 10 am, turned to my head to the left in bed, and had extreme virtigo, nausea and one ...
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Woke up around 10 am, turned to my head to the left in bed, and had extreme virtigo, nausea and one bout of vomiting. After a two hour nap felt better although still fatigued and a little off. Next day still fatigued and off but virtigo disappeared.
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| 73 | 2021-03-21 | fatigue, headache, chills, fever | Exhaustion, headache, fever, muscle aches, joint paint, chills, vomiting, diarrhea, dizziness |
| 73 | 2021-03-21 | headache, chills, fever, sweating |
Symptoms of muscle ache, then fever, then chills.started late afternoon, Tue., March 16, at 4:15 pm....
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Symptoms of muscle ache, then fever, then chills.started late afternoon, Tue., March 16, at 4:15 pm. At 2:am next morning, March 17, sudden severe nausea and diarrhea, severe headache, hot flashes and sweats continued for 2 hours. Intermittent syncope twice.
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| 73 | 2021-03-22 | cough, sweating |
Hospital Discharge Summary Note: Patient is a 73-year-old female with a past medical history signifi...
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Hospital Discharge Summary Note: Patient is a 73-year-old female with a past medical history significant for hypertension, hyperlipidemia, hypothyroidism, and breast cancer. She presented to the emergency department with reports of possible allergic reaction to Pfizer vaccine. Patient received her first dose of: Vaccine earlier today and approximately 5 minutes later developed a cough, diaphoresis, and lightheadedness. She was given 50 mg oral Benadryl in the ED. Patient then complained of tingling sensation throughout her body and was continuously coughing. She was brought to the emergency department for evaluation. Patient noted she felt jittery and "disconnected". In the ED her cough and dizziness significantly improved. Upon examination, patient was noted to have right lower extremity weakness. She denied any weakness. CT of the head was performed to rule out stroke. Neurology was consulted. CT head brain was negative however patient was still having right-sided weakness. Emergency department physician confirmed the patient was able to get up without difficulty after receiving her vaccine at 1415 immediately following her vaccine. It was determined she was within the window for TPA. Patient was transferred to the ICU for further management.
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| 73 | 2021-03-22 | fatigue, headache | painful arm that received the vaccine, gas and cramping, headache, fatigue, stiffness |
| 73 | 2021-03-22 | headache, lethargy, nasopharyngitis, sweating |
AT 3:00am on Monday 3/15/2021 I woke up with severe headache & body aches. I was disoriented & leth...
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AT 3:00am on Monday 3/15/2021 I woke up with severe headache & body aches. I was disoriented & lethargic. My friend came over took my blood pressure it was 144/75 I was freezing and the room was 80degrees I had absolutely no appetite. My head felt like it was going blow up Next day was Tuesday 3/16/2021 I woke still groggy & bad headache but now I was hallucinating & i was burning up & sweating profusely Next day 3/17/21 still out of sync & very disoriented Thursday 3/18/21 had video dr appt at 1:00pm he told me to ride it out gave me something to sleep & some tramadol for pain Friday 3/19/21 started coming out of it I felt like i was dying if thats what it feels like
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| 73 | 2021-03-22 | sleepiness, fatigue | patient felt tired sleepy with an upset stomach |
| 73 | 2021-03-23 | chills, fever |
About 9.5 hours after the injection, I started feeling a bit shaky. Seemed to be on left side of che...
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About 9.5 hours after the injection, I started feeling a bit shaky. Seemed to be on left side of chest. Shakiness got stronger and stronger, spread across chest and into head. By 10 hours after injections, hands were shaking, voice, was shaking, teeth chattering. The worst lasted about 20 minutes, and then started to subside in reverse order ending on left side of chest. By 90 minutes after initiation, all shaking was gone. During the worst of it, I could sometimes control the shaking briefly with slow breathing. But then shaking would return. Fitful sleep through the night. Aches and low fever next day.
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| 73 | 2021-03-23 | chills | Weak, aching, chilling |
| 73 | 2021-03-23 | fatigue, headache |
Sat. Mar. 20 at about 9:30 experienced back ache at center right . The back pain got worse overnigh...
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Sat. Mar. 20 at about 9:30 experienced back ache at center right . The back pain got worse overnight . On Sun. Mar 21 had headache in addition to back ache and very tired. Used BioFreeze on my back and took Tylenol throughout the night Sat. and all day Sun. All symptoms were gone by Mon. Mar 22.
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| 73 | 2021-03-23 | headache, fatigue, runny nose, chills, influenza like illness, cough |
started about 15 hours after dose # 2 on 18Feb2021.I had flu like symptoms.; achy legs; achy back; ...
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started about 15 hours after dose # 2 on 18Feb2021.I had flu like symptoms.; achy legs; achy back; chills; fatigue; Headache; runny nose; mild cough; This is a spontaneous report from a contactable consumer. This 73-year-old female consumer (patient) reported that she received the second dose of BNT162B2 (Lot number: EN6200) at single dose for covid-19 immunization on 18Feb2021 (08:15 AM, at left arm). Relevant history included allergies with Sulfa drugs. Relevant concomitant drug was unknown. The patient received the first dose of BNT162B2 (Lot number: EN9625) for covid-19 immunization on 28Jan2021 (08:15 AM, at left arm). The patient did not receive other vaccine in four weeks. No other medications received in two weeks. The patient stated about 15 hours after dose # 2 on 18Feb2021, at 11:30 PM, she started to have flu like symptoms (achy legs and back, chills, and headache which recovered by 7:00 am the following day. Started about 7 am the day following, very runny nose(used 2 boxes of tissue in 24 hours) and had intermittent headache and fatigue. At the reporting time (day 3) and she was still having very runny nose and mild cough. No treatment was received. Outcome of event was resolving. The patient was not infected COVID prior vaccination. The patient did not have COVID test post vaccination.
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| 73 | 2021-03-24 | fatigue |
Heart attack; she might have a little bit of heart cell damage; tired; This is a spontaneous report ...
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Heart attack; she might have a little bit of heart cell damage; tired; This is a spontaneous report from a contactable nurse (patient). A 73-year-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EN6207, Expiration date: Jul2021, NDC number was unknown), via an unspecified route of administration, in right deltoid on 10Mar2021 14:10 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Family medical history relevant to adverse event was not provided. The patient received historical vaccine of first dose bnt162b2 (Lot number: EL9267, Expiration date: May2021) right deltoid on 12Feb2021 for covid-19 immunisation. Patient did not receive prior Vaccinations (within 4 weeks). Caller is a retired Registered Nurse who states she felt it was important to report, that she had a heart attack 70 hours after receiving the Covid vaccine on 13Mar2021. Her doctor informed her she probably should report it. Caller states she's not 100 % sure it's the Covid vaccine. Informs she has no other cardiac issues, health issues or problems with medications, stating they narrowed it down. Patient was taken by ambulance and then to the Emergency Room. States she was admitted to the hospital and had testing done on heart, stress test echo, on heparin IV drip, aspirin. Hospitalized for 4 days. Patient states supposedly she will have a complete recovery, right now she is just tired. Was told she might have a little bit of heart cell damage on an unspecified date in Mar2021, but not anything really significantly. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. As per the reporter for the heart attack seriousness criteria reported as Life threatening and Caused/prolonged hospitalization. patient was in hospital for Heart attack from 13Mar2021 to 16Mar2021. As per the reporter drug result reporter as related. The patient underwent lab tests and procedures which included testing done on heart and stress test echo with unknown results in 2021. Therapeutic measures were taken as a result of heart attack. The outcome of the events was unknown.; Sender's Comments: Based on known drug safety profile, there is possibility of causal association between the reported events Heart attack,Heart injury and the suspect vaccine BNT162B2 cannot be Excluded.Also there is limited information in the case provided,Consider also possible contributory effects from patient's medical history and surgical history.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
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| 73 | 2021-03-24 | headache, fatigue, fever, chills |
one day of fatigue, then 2 1/2 weeks later sore muscles, chills, headache, tight chest. Fever develo...
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one day of fatigue, then 2 1/2 weeks later sore muscles, chills, headache, tight chest. Fever developed. Subsiding now at 3 1/2 weeks.
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| 73 | 2021-03-24 | sweating |
Woke up at 3:00 am drenched in cold sweat, unable to focus, loss of equilibrium, nausea. Feeling be...
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Woke up at 3:00 am drenched in cold sweat, unable to focus, loss of equilibrium, nausea. Feeling better by noon. ongoing waves of brain fog, pressure behind my eyes. I seek no treatment, hope it will improve with time. Would like to know if it is advisable to have the second dose. I do not want to repeat the previous experience. Are you able to advise? Thank you
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| 73 | 2021-03-25 | chills, fatigue | chills, fatigue, swollen face, rt side of neck sore |
| 73 | 2021-03-25 | chills, fatigue |
Chills; fatigue; Severe abdominal cramping; Gallbladder attack; This is a spontaneous report from a ...
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Chills; fatigue; Severe abdominal cramping; Gallbladder attack; This is a spontaneous report from a contactable consumer, patient. A 73-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) intramuscularly in the left arm on 26Jan2021 at 03:30 AM (at the age of 73-years-old) as a single dose (Batch/Lot Number: EI9262), and received the second dose intramuscularly, in the left arm on 16Feb2021 (at the age of 73-years-old) as a single dose (Batch/Lot Number: EN6201), for COVID-19 immunisation . Medical history included Penicillin allergy from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included hydrochlorothiazide/ramipril (RAMIPRIL HCTZ). About a week after both Covid-19 vaccine injections, the patient experienced chills, fatigue, severe abdominal cramping, and gallbladder attack. The patient stated that the chills and fatigue, were expected, but she had severe abdominal cramping and what appeared to be a gallbladder attack. The patient did not have a sore arm or fever. No treatment was received for the events. The patient recovered from the events, chills, fatigue, severe abdominal cramping, and gallbladder attack.
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| 73 | 2021-03-25 | fatigue |
Shortness of breath, tiredness, anxiety. BPs 145/65 (pulse 68), 121/63 (pulse 66). O2 sats 94% to 95...
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Shortness of breath, tiredness, anxiety. BPs 145/65 (pulse 68), 121/63 (pulse 66). O2 sats 94% to 95%. Had a rough morning and was a bit anxious. Let the patient vent about her day - SOB resolved.
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| 73 | 2021-03-25 | headache, sweating, runny nose, fever, chills, fatigue |
Got the vaccine and within 30-an hour she was seated, waiting and she developed a tingling/numbness ...
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Got the vaccine and within 30-an hour she was seated, waiting and she developed a tingling/numbness on her bottom lip to the center of her lip. It spread throughout the entire bottom lip. Then it moved to the left hand corner of her mouth as well, and then moved up to the left side of her face to her eye, and then to the corner of the left hand of her head. This is a tingly pressure, and it then developed into a hard headache concentrated in one spot. She went into heavy sweating. The pharmacist was watching her and came over to her, she was there for about an hour and a half. She had a bottle of water trying to cool off, and her tongue was getting a bad taste in her mouth, and numbness in the back of her tongue. The pharmacist gave her Benadryl to take and she sat there for a while and was starting to feel really shaky, and she thought she would go back to her apartment to get out of being around other people. She was feeling weak to walk, and overwhelmingly tired. Once she did get into her apartment she her taste buds felt dry. After several days of this reaction, little by little it subsided, but the sweating and chills continue even up until today, 3/26/21. She goes to bed dry and wakes up soaked from sweat due to profuse sweating. She has been yawing a lot lately and if she does yawn she immediately has chills. It's been back and forth with the chills/fever. She can be perspiring on one end and the other end cold. She tried to talk to her doctor but told her to seek out UC for her symptoms as he is too busy. There is eye strain that is bothering her which leads her into wanting to sleep and sleeps for extended periods of time and really exhausted. Has also had runny nose, hands and feet swelling. Her right hand is kind of like a tingling/weakness sensation.
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| 73 | 2021-03-25 | nasopharyngitis | Patient fainted, was losing consciousness, she complained she was cold |
| 73 | 2021-03-26 | chills | Had heartburn for 3 days (in addition to incredible chills, dizzy. Vomiting) |
| 73 | 2021-03-26 | fatigue |
After 12 hrs. neuropathy in feet and torso, shortness of breath, chest tightness continued for 3 day...
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After 12 hrs. neuropathy in feet and torso, shortness of breath, chest tightness continued for 3 days went to urgent care checked out OK but symptoms persist to this day. On 3/13 severe dizziness and vomiting and blacking out and went to ER. Admitted overnight. Pulmonologist prescribed course of Prednisone on 3/15 and ending on 3/25. Some relief for chest tightness Neuropathy has gotten steadily worse with inclusion of face and lower leg. On 4th day began some ringing in ears which is to this day louder. Have fatiugue, sleep issues, trouble focusing my brain and eyes. Everything is worse today. Can't hold my head up. Will someone please help me
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| 73 | 2021-03-27 | fatigue, fever, chills | Chills Fever of 101 degrees Tiredness Slight head "wooziness" |
| 73 | 2021-03-27 | headache, fever |
That Thurs evening arm neck hurt...then killer headache. Went to bed fever, body aches joints burned...
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That Thurs evening arm neck hurt...then killer headache. Went to bed fever, body aches joints burned. Sat fever back to normal. Didn't eat just drank water. Sunday skin felt prickly...yep shingles. Took valcyclovor and applied Ravensara.
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| 73 | 2021-03-27 | throat irritation, malaise |
Received Pfizer Vaccine #1 at the facility on 3/26/21. Approx 5 minutes after receiving the Vaccine,...
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Received Pfizer Vaccine #1 at the facility on 3/26/21. Approx 5 minutes after receiving the Vaccine, patient reported not feeling well. Complaint of dizziness. Then reported her tongue and throat didn?t feel right and then proceeded to report her throat was tightening up. Administered Benadryl 50mg PO and almost immediately patient reported feeling relief. She was monitored for an additional 30 minutes after improvement of symptoms and stated she felt well enough to go home. Her friend accompanied her to the vaccine site and was driving her home.
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| 73 | 2021-03-28 | fatigue |
Had one fainting episode; Very tired; low energy (it has been almost 3 weeks); problems with high bl...
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Had one fainting episode; Very tired; low energy (it has been almost 3 weeks); problems with high blood pressure; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262), at vaccination age of 73-year-old via an unspecified route of administration in the left arm on 02Feb2021 16:00 as a single dose for covid-19 immunisation. Medical history included hypertension and PCN allergies (penicillin allergy). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive other vaccine in four weeks. Concomitant medication included unspecified medication. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), at vaccination age of 73-year-old via an unspecified route of administration in the left arm on Jan2021 15:15 as a single dose for covid-19 immunization. On 25Feb2021 06:00 PM, the patient was very tired, low energy (it has been almost 3 weeks), had one fainting episode though the patient doesn't know if it was related, and problems with high blood pressure. The fainting episode is reported, the other problems have been ongoing since second shot. The events required emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included blood pressure was high on 25Feb2021 and nasal swab (sars-cov-2 test) was negative on 22Feb2021. The outcome of the events was recovering. Information on the lot/batch number for first dose has been requested.
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| 73 | 2021-03-28 | headache, chills |
Was awoken w bad headache/eye ache in middle of night follow vaccination (2nd Covid) previous mornin...
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Was awoken w bad headache/eye ache in middle of night follow vaccination (2nd Covid) previous morning. Over the next few hours, experienced bad muscle pains throughout body, cd barely move. Chills, cd not get warm, even wearing thermal underwear top & bottom, fleece jacket, in bed w flannel sheets, one quilt, one thick heavy woolen blanket & a woolen throw blanket. Cd not get out of bed for many hours. Eventually, Saturday 3/27 took temp--100.5, v high for me as normal morning temp is 96.7-97.1. Oxygen saturation 94% (normal for me--89-99%). Most scary, pulse rate of 92 (normal resting pulse for me--68-72) while I was inert, in bed.
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| 73 | 2021-03-28 | sweating |
within 8-10 minutes of shot, i began to sweat under my arms, my chest and back and head began to itc...
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within 8-10 minutes of shot, i began to sweat under my arms, my chest and back and head began to itch; blood pressure: 178/90; within 8-10 minutes of shot, i began to sweat under my arms, my chest and back and head began to itch; This is a spontaneous report from a contactable other health professional (patient). A 73-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 73-years-old, administered in Arm Left on 25Jan2021 12:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included one kidney, left was removed due to cancer, no residual cancer, allergic to juniper. The patient was not pregnant. Concomitant medication included ezetimibe (ZETIA), escitalopram oxalate (LEXAPRO), pravastatin (PRAVASTATIN), and probiotics; all taken for an unspecified indication, start and stop date were not reported. Patient reported that, "Within 8-10 minutes of shot, I began to sweat under my arms, my chest and back and head began to itch. EMT took my blood pressure: 178/90, oxygen level was good. They called the EMT Ambulance, and transported me to the medical center > they treated me with IV Benadryl and steroids and I went home within two hours, with no further issues." The events started on 25Jan2021 12:00 PM. The adverse events resulted in Emergency room/department or urgent care, Hospitalization (0 days). The patient received IV Benadryl, steroids and prescription for Medrol for events. The patient underwent lab tests and procedures which included blood pressure measurement: 178/90 on 25Jan2021, oxygen saturation: good on 25Jan2021. The patient recovered on 25Jan2021 14:00. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination. Facility type vaccine was Health Clinic/Facility. At the advice of her allergist she declined to get the 2nd dose of the Pfizer vaccine. Her questions is should she take a the J&J vaccine and wanted to know if Pfizer could give guidance on the matter. Information about lot/batch number has been requested.; Sender's Comments: Based temporal association, the reported events in relation to suspected drug BNT 162b2 cannot be totally excluded. Case will be reassessed pending new information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
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| 73 | 2021-03-29 | fatigue |
Oxygen level decreased; Heart rate increased; couldn't get out of bed; Tired; Dizziness; joints hurt...
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Oxygen level decreased; Heart rate increased; couldn't get out of bed; Tired; Dizziness; joints hurts; This is a spontaneous report from a contactable consumer via medical information team.A 73-years-old female patient received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number :unknown) via an unspecified route of in Arm Right on 04Feb2021 07.00 as single dose for covid-19 immunisation. Medical history included asthma from 1971 , oesophageal spasm from 1981, diverticulitis ,concussion syndrome, anaphylactic shock .She has had anaphylactic shocks 4 times in her life. Concomitant medication included fluticasone propionate/ salmeterol xinafoate (ADVAIR) taken for asthma, fluticasone propionate/salmeterol (WIXELA INHUB) taken for asthma. On 04Feb2021 the patient stated couldn't get out of bed. On 09Feb2021 the patient experienced oxygen level decreased, heart rate increased. In Feb2021 patient experienced tired , dizziness and joints hurts.It was reported that She didn't have any anaphylactic shock after the COVID-19 vaccine. She had no reaction. After receiving the vaccine, she sat there with her husband for half an hour. In fact, nothing was wrong with her for 2 hours after receiving the vaccine. Then all of a sudden later on that day, she couldn't get out of bed. It was like she was sleeping, but wasn't sleeping. This lasted from Thursday around 11 a.m. until Monday, that kind of thing. She went to the doctor that Tuesday because she had her physical already scheduled .When she went to the doctor, it was determined her heartrate was 120. Her heartrate sitting or resting is usually in the 80's. Then, her heartrate was 120's four days after the vaccine. She didn't realize a racing heartrate was one of the severe effects of the vaccine. She didn't feel her heart was racing. Her doctor instructed her to drink Gatorade and Pedialyte and she is still tired after doing all of that. Her doctor said she should have the shot, even though her blood heartrate went up 40. Her oxygen level is usually at 98 although she does have asthma, and her level was at 90. It was lower, under 98. She explains she had an EKG done at the doctors.She stated she was extremely dizzy in the beginning when she did get up and take a shower. Every day, her husband helped her get in the shower and take a shower. She received her first EKG when she went to the doctor on Tuesday 09Feb2021. The only thing wrong was her heart rate was 120. Her heart rate is usually high anyway usually 80 and sometimes 90. Thee has only been one time in the last 25 years, her heart rate went to 126. On 15Feb2021 EKG which showed HR as 106, oxygen was 96. The patient did not received prior vaccinations within 4 weeks. The outcome of the events dizziness was recovering, outcome of the event joints hurts was not recovered and outcome of the events were unknown
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| 73 | 2021-03-29 | throat pain, cough, runny nose |
Extremely itchy hives scalp, neck, ears, forearms, ankles and lower legs, abdomen/severe case of hiv...
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Extremely itchy hives scalp, neck, ears, forearms, ankles and lower legs, abdomen/severe case of hives; Occasional wheezy cough; sore throat; runny nose; Occasional wheezy cough; This is a spontaneous report from a contactable consumer, the patient. A 73-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL9269), via an unspecified route of administration, administered in Arm Left on 11Feb2021 at 15:30 (at the age of 73 years old) as SINGLE DOSE for covid-19 immunization; chlorphenamine maleate, dextromethorphan hydrobromide, paracetamol, phenylephrine hydrochloride (ALKA SELTZER PLUS COLD &COUGH FORMULA, Lot number not provided), (reported as 'Alka Seltzer Plus Severe Cough, Mucous, Congestion') orally on 24Feb2021 at 22:00 1 DF single dose (LIQUID GEL CAP) for sore throat runny nose and wheezy cough. Medical history included hypothyroidism, osteoporosis, drug hypersensitivity (Allergy to: Penicillin). Concomitant medication(s) included levothyroxine (LEVOTHYROXINE); atorvastatin (ATORVASTATIN); alendronate sodium (ALENDRONATE). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 24Feb2021 the patient experienced occasional wheezy cough, sore throat, runny nose. On 25Feb2021 The patient experienced extremely itchy hives scalp, neck, ears, forearms, ankles and lower legs, abdomen/severe case of hives. The clinical course as reported by patient is as follows experienced Extremely itchy hives scalp, neck, ears, forearms, ankles and lower legs, abdomen. Possibly reacted to combination of vaccine and 1 gel capsule of Alka Seltzer Plus Severe Cough, Mucous, Congestion Liquid Gel which I took for a sore throat, runny nose and cough. Have never had hives before. Have never had reaction to gel cap. Had NO reaction to vaccine first 13 days. Yesterday had a wheezy cough, runny nose, sore throat. Didn't think due to vaccine. Took gel cap about 10pm 24Feb2021. Within 2 hours had severe case of hives still present over 12 hours later, though lessened. Occasional wheezy cough. New symptom last 2 days. Not sure if linkage. Treatment was given as a result of occasional wheezy cough, sore throat and runny nose. No Treatment was given for hives. The clinical outcome of the hives was recovering while the remaining events wheezy cough, sore throat and runny nose were not recovered.
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| 73 | 2021-03-30 | fatigue |
couldn't concentrate at all or read the newspaper; extreme fatigue and exhaustion; slept 19 hours ou...
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couldn't concentrate at all or read the newspaper; extreme fatigue and exhaustion; slept 19 hours out of a 24 hour period; brain fog; This is a spontaneous report received from a contactable physician reporting for herself. A 73 years old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283) at single dose via an unknown route in right arm on 08Feb2021 14:00 for Covid-19 immunization. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284) on 18Jan2021 12:30 PM in right arm for Covid-19 immunization. Medical history included chronic mild-medium renal failure s/p left nephrectomy and adrenalectomy in 2017 due to left renal cancer, followed by severe renal failure one month p/o. Breast cancer p/o left mastectomy and reconstruction in 2005, hysterectomy in 2007, and mild hypertension which was treated. Patient had no known allergies to medications, food, or other products. Other medications the patient received within 2 weeks of vaccination included citalopram, bupropion, lisinopril, zolpidem, etc. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021 11:00, patient experienced extreme fatigue and exhaustion. Patient slept 19 hours out of a 24 hour period and had significant brain fog, where she couldn't concentrate at all or read the newspaper. No treatment was received for the events. Outcome of the events was resolved.
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| 73 | 2021-03-30 | headache, fatigue |
roof of mouth felt numb; heart raced, then felt palpitations; strong headache; face flushed; exhaust...
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roof of mouth felt numb; heart raced, then felt palpitations; strong headache; face flushed; exhaustion for 36 hours; This is a spontaneous report from a contactable consumer (patient reported herself). A 73-year-old non-pregnant female patient received BNT162B2 (COVID 19, Formulation: Solution for injection, Lot number: EL9269) via an unspecified route of administration on 06Feb2021 11:00 AM at single dose for Covid-19 immunization. The patient's medical history included coronary artery disease (CAD), arthritis and known allergies/allergies. Concomitant medications were not reported. Other medications in two weeks: Yes. Facility type vaccine: facility. On 06Feb2021 11:00 AM, the patient experienced roof of mouth felt numb, heart raced, then felt palpitations, strong headache across eyes and forehead, face flushed and exhaustion for 36 hours. Covid was not tested prior or post vaccination. The patient did not receive any treatment for the events. Outcome of the events was recovered on an unspecified date.
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| 73 | 2021-03-30 | headache |
She was been down for over a week, the Covid symptoms; weakness of bones; nauseous; headaches; she m...
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She was been down for over a week, the Covid symptoms; weakness of bones; nauseous; headaches; she missed the 2nd dose; Tested positive for COVID; Tested positive for COVID; sick; This is a spontaneous report from a Pfizer Sponsored Program. Two contactable consumers (patient's husband and patient herself) reported that a 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 07Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 14Mar2021, the patient tested positive for COVID, sick, she missed the 2nd dose, weakness of bones, nauseous, headaches, serious side effects and she was been down for over a week, the COVID symptoms on an unspecified date. He does not have any adverse reaction at all. The report was received as, he does not have any adverse reaction at all. The reason for call is not for him personally. It is for his fiance. For the first dose, he had his dose on 14Mar2021. Prior to that first dose, 3 weeks before that, is when he had first dose. She and him went together for first dose. She has one dose and had to go back to her hometown for a family emergency and was not able to go for second dose. In the interim, she got a COVID test and she tested positive. She did not come for second shot or they would have gone together. What does she have to do after testing positive and missing her second dose? He was going to have her call directly. He said she has all the information about what they used and what protocol for test she took. Reporter stated, "Well I have a situation. My wife and I on 7Feb2021 got our 1st dose. In the interim she had to go out of town to her family and she tested positive after her 1st dose. My question is, I went and had my 2nd dose on 14Mar2021. I got mine, but she didn't get hers. She would like to know, how long she had wait before she gets the 2nd dose." Reporter stated, "Since I have you on the phone you can get the side effects. She had serious side effects. She was been down for over a week, the Covid symptoms. She is not asthmatic. She had weakness of bones, nauseous, headaches no fever or coughs but all the other symptoms." She may be taking thyroid medications. That's all I know. Reporter stated, "I hope I don't have to go on hold for another 2 hours and 45 minutes." The doctor's don't know. She is recovering. I already spoke with the safety team and reported this.: Spoke from attached document and emailed as requested Spoke from (LAB- 1457-6.0 Revised: 25Feb2021) under section 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA "The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19." Therapeutic measures were taken as a result of she was been down for over a week, the COVID symptoms, sick, weakness of bones, nauseous, headaches and serious side effects with reported as, she is taking some vitamins. The patient underwent lab tests and procedures which included COVID-19 test: positive on 14Mar2021. The outcome of events was recovering. Information on the lot/batch number has been requested.
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| 73 | 2021-03-30 | headache |
sore arm; Left arm achiness; a little light headedness/slight lightheadedness; slight blurred vision...
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sore arm; Left arm achiness; a little light headedness/slight lightheadedness; slight blurred vision/slight blurry/ fuzzy vision; slight headache; This is a spontaneous report from a contactable Consumer. A 73 year old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: UNKNOWN, expiry date: 31May2021), via an unspecified route of administration on 30Jan2021 as single dose for covid-19 immunisation. The patient medical history included ongoing Lymphocytosis and the patient is allergic to eggplant, Aspirin and penicillin.The patients concomitant medications were unknown.On 30Jan2021, the patient received the 1st dose of the vaccine and experienced nothing major but a sore arm that resolved, a little light headedness and ever so slight blurred vision that resolved on the night of the shot. she had her first Pfizer shot and she had the usual side effects that evening of a slight headache and feeling achy afterwards. She says after the shot she was fine, but a little bit of lightheadedness and a little bit of fuzzy vision but it was minimal. She says it's like if you're looking in the distance at a stop sign, it was a little fuzzy. These happened last Saturday. These two symptoms were very slight, the lightheadedness was nowhere near passing out and the little bit of blurry vision was ever so slight and gone several hours later. Outcome of event sore arm; Left arm achiness, a little light headedness/slight lightheadedness, slight blurred vision/slight blurry/ fuzzy vision and slight headache was recovered. No follow up attempts are possible. No further information is expected.
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| 73 | 2021-03-30 | fever |
Nausea; Dizziness; Vomiting; Fever; This is a spontaneous report from a contactable consumer (patien...
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Nausea; Dizziness; Vomiting; Fever; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: EL1283), via an unspecified route of administration on 21Jan2021 13:00 (at the age of 73-years-old) as a single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included unspecified medications. On 21Jan2021, consumer stated, "I got the Pfizer vaccine on Thursday (21Jan2021) at 13:00 and I started having at 13:23 I started having nausea and a little dizziness and then I have had nausea and vomiting twice but nausea was constant. On an unspecified date in Jan2021, the patient had fever. Consumer stated, I am kind of dizzy. So, I got to walk slow. Therapeutic measures were taken as a result of events included pepcid for nausea and Tylenol for fever. The consumer stated, "I am really having side effects. I thought it is going way. And I wanted to know how long I would have side effects." The outcome of the events was not recovered.
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| 73 | 2021-03-30 | runny nose |
Bells Palsy; runny nose; This is a spontaneous report from a contactable consumer (patient). A 73-ye...
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Bells Palsy; runny nose; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 08Mar2021 11:30 (Batch/Lot Number: EN6199) as single dose for covid-19 immunisation. Medical history included diabetic, arthritis, torn right shoulder, neuropathy plantar fasciitis arthritis back pain, allergies: sulfa, antibiotics, indomethacin, amoxicllin, sulfacetamide. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication from an unspecified start date and ongoing; allopurinol (ALLOPURINOL) taken for an unspecified indication from an unspecified start date and ongoing; atenolol (ATENOLOL) taken for an unspecified indication from an unspecified start date and ongoing; fluoxetine (FLUOXETINE) taken for an unspecified indication from an unspecified start date and ongoing; diclofenac (DICLOFENAC) taken for an unspecified indication from an unspecified start date and ongoing; furosemide (FUROSEMIDE) taken for an unspecified indication from an unspecified start date and ongoing; metformin (METFORMIN) taken for an unspecified indication from an unspecified start date and ongoing; pregabalin (PREGABALIN) taken for an unspecified indication from an unspecified start date and ongoing; simvastatin (SIMVASTATIN) taken for an unspecified indication from an unspecified start date and ongoing; levothyroxine sodium (SYNTHROID) taken for an unspecified indication from an unspecified start date and ongoing; vitamin d nos (VITAMIN D NOS) taken for an unspecified indication from an unspecified start date and ongoing; amitriptyline (AMITRIPTYLINE) taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced bells palsy on 12Mar2021 with outcome of not recovered, runny nose on 12Mar2021 with outcome of recovering. Clinical course: the consumer said that the Bell's palsy started Friday with a runny nose, her right side nostril. She said Saturday she had it where she can't move the right side of her face properly, and that is when she called to make her doctor's appointment for this morning. The reported events required visit to: Physician office. The patient received prednisone 1 daily for 7 days as treatment for the event Bells Palsy.
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| 73 | 2021-03-31 | fatigue |
Pain at injection site lasting more than 24 hours; fatigue; This is a spontaneous report from a cont...
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Pain at injection site lasting more than 24 hours; fatigue; This is a spontaneous report from a contactable consumer (patient). This 73-years-old not pregnant female patient received,at hosptial, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) administered in Arm Left on 08Mar2021 as SINGLE DOSE at age of 73 years for covid-19 immunisation . Medical history included pneumonia from an unknown date and unknown if ongoing (but have since been vaccinated for it 2x in last 4 yrs ), iodine allergy from an unknown date and unknown if ongoing. No other vaccine received in the last four weeks .Concomitant medicatoins includes: OTC vitamins & health aids.The patient experienced pain at injection site lasting more than 24 hours on 08Mar2021 21:00 with outcome of unknown and fatigue on 08Mar2021 21:00 with outcome of unknown. No treatment recevied for the events.No covid prior vaccination: No covid tested post vaccination. Information about lot/batch number has been requested.
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| 73 | 2021-04-01 | headache |
Patient presented to the ER with a severe headache on 3/30. CT found subdural hematoma as well as i...
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Patient presented to the ER with a severe headache on 3/30. CT found subdural hematoma as well as intra-axial hemorrhage in the left axial lobe. The patient was life flighted from our facility.
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| 73 | 2021-04-01 | sleepiness, fatigue |
Bell's Palsy partial facial paralysis on both sides; Eyesight is dimmed; throbbing pain mostly in ri...
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Bell's Palsy partial facial paralysis on both sides; Eyesight is dimmed; throbbing pain mostly in right eye/ Occasional shooting pain in eye; Eyes watering; Groggy; Dizzy; Extreme fatigue; Brain foggy; Forgetful; Sleep cycle distorted; Essential tremors in hands; Dull pain in back of head near neck; slightly garbled/ voice difficult to understand; Sensitive to loud noises; This is a spontaneous report from a contactable Other-HCP (patient). A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 01Mar2021 16:30 (Batch/Lot Number: en6198; Expiration Date: 01Mar2021) as single dose for covid-19 immunisation. Medical history included COPD. Concomitant medication included salbutamol (VENTOLIN [SALBUTAMOL]);and fluticasone propionate/ salmeterol xinafoate (ADVAIR). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: em9809) on 07Feb2021 04:00 PM, in left arm for covid-19 immunisation at age of 73 years old. The patient experienced eyesight was dimmed, even when she can manage to open her eyelids, occasional shooting pain in eye, eyes watering, throbbing pain mostly in right eye, Bell's Palsy partial facial paralysis on both sides: can't smile, voice difficult to understand, slightly garbled, groggy, dizzy, brain foggy, forgetful, extreme fatigue, sensitive to loud noises like dog's bark, sleep cycle distorted, essential tremors in hands are greater than usual, and dull pain in back of head near neck and all on 02Mar2021 05:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient is not pregnant. The treatment was received. No covid prior vaccination and no covid tested post vaccination. The patient underwent lab tests and procedures which included MRI (magnetic resonance imaging): unknown result on unspecified date. The outcomes of events were recovering.; Sender's Comments: Based on a plausible temporal association, the company cannot completely rule out a causative role of BNT162B2 to the onset of facial paralysis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 73 | 2021-04-06 | fatigue |
Neuropathy; Shortness of breath; chest tightness; ringing in ears; fatigue; brain fog; dizziness; vo...
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Neuropathy; Shortness of breath; chest tightness; ringing in ears; fatigue; brain fog; dizziness; vomiting; vision changes; This is a spontaneous report from a contactable consumer. A 73-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot Number: EN6205), via an unspecified route of administration, administered in Arm Right on 09Mar2021 15:00 as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, glaucoma, Manages cholesterol, controlled high BP and iodine contrast. The patient's concomitant medications were not reported. The patient experienced neuropathy, shortness of breath, chest tightness , ringing in ears, fatigue, brain fog, dizziness, vomiting and vision changes on 10Mar2021 03:00. The patient was hospitalized for all of the events for 2 days on an unspecified date. The patient underwent lab tests and procedures which included Nasal Swab: negative on 13Mar2021. The patient was not pregnant. Outcome of the events was not recovered.
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| 73 | 2021-04-17 | fatigue |
Could understand words but could not answer back; Her symptoms came out as if she was having a strok...
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Could understand words but could not answer back; Her symptoms came out as if she was having a stroke.; Bad headache/migraine; Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6207, expiry date: Jul2021), via an unspecified route of administration, administered in left arm on 19Mar2021 10:45 at single dose for COVID-19 immunization. The patient's medical history included diabetes from Jun2001 and ongoing. The patient's concomitant medication included metformin taken for diabetes from Jun2001 and ongoing. The patient previously received flu shot from immunization (she had the flu shot 20 years ago had bad reaction to). Facility where the most recent COVID-19 vaccine was administered was at the hospital. The vaccine was not administered at military facility. The patient received the vaccine on 19Mar2021 and she felt fine that Friday. On 20Mar2021 (Saturday), she started having a bad headache and took Aleve. She took Aleve 3 times 4 hours apart because she still had a bad headache. She started losing the ability to bring out words. She stated that her headache was gone. On 21Mar2021 (around 4 o clock), her husband was in the kitchen and asked her a question but could not understand her and asked again. She could not say the words but she could spell them. Her husband asked her another question, she tried to talk but she could not answer back. At that point her husband said they were going to the hospital. She was admitted for 3 days from 21Mar2021 to 23Mar2021. The doctor told her she was having a migraine because it had lasted for 2 days. She also spoke with her primary care provider, who looked it up and said this could be a side effect. She was told the migraine may take away the ability to talk. Her headache has been gone but continues to feel very tired (extremely tired since 19Mar2021). Her symptoms came out as if she was having a stroke on an unspecified date. The event 'could not understand words but could not answer back' required an emergency room visit.The patient underwent lab tests and procedures which included CAT scan, MRI, and contrast test, all with negative result on 22Mar2021. The outcome of the event 'could understand words but could not answer back' was recovered on 22Mar2021, the event 'bad headache/migraine' was recovered on 21Mar2021, not recovered for extremely tired, and unknown for the event 'stroke'.
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| 73 | 2021-04-24 | fatigue |
Extreme fatigue; decreased energy; needed to sleep most of the day; difficulty maintaining balance; ...
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Extreme fatigue; decreased energy; needed to sleep most of the day; difficulty maintaining balance; heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, lot number: EN6200), via an unspecified route of administration, administered in Arm Left on 09Mar2021 12:00 (received at the age of 73-years-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to receiving bnt162b2. Medical history included asthenia and known allergies to Sulfa drugs, NSAIDS. The patient was not pregnant. She did not have covid prior vaccination. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; and vitamins. The patient experienced extreme fatigue (fatigue) (disability, life threatening), decreased energy (asthenia) (disability, life threatening), needed to sleep most of the day (hypersomnia) (disability, life threatening), difficulty maintaining balance (balance disorder) (disability, life threatening), heart palpitations (palpitations) (disability, life threatening), all on 11Mar2021 04:00. These conditions started 2-3 days after the first vaccine (as reported). The adverse events resulted in Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient did not receive any treatment for the adverse events. Outcome of the events was recovered on an unspecified date in 2021. The patient was not tested for covid post vaccination.
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| 73 | 2021-04-24 | headache |
had a stroke; instantly had a pounding headache; blood pressure was elevated; This is a spontaneous ...
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had a stroke; instantly had a pounding headache; blood pressure was elevated; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. On 25Mar2021, she received the first COVID-19 vaccine and instantly had a pounding headache. She went to her doctor who said her blood pressure was elevated and was going to do more testing. She and her sister went away thinking she just needed to relax but then had a stroke in the hotel that same day and was in the hospital for 3 days (until 28Mar2021). She has never had high blood pressure and no history of headaches. The doctor in the hospital thought that this could be related to the vaccine since she had no high blood pressure or headaches before. She asked the doctors if she should get the second one and they all said they don't know enough about the vaccine to give her guidance. Outcome of the events were unknown. Information about the Lot/batch number has been requested.
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| 73 | 2021-04-26 | headache, fever |
Severe headache several days; Fever; This is a spontaneous report from a contactable consumer (patie...
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Severe headache several days; Fever; This is a spontaneous report from a contactable consumer (patient). This 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EN6202 expiry date was not provided), via unknown route of administration in the left arm, 26Feb2021 12:15 as single dose for COVID-19 immunisation. Patient's medical history included COPD (chronic obstructive pulmonary disease). Concomitant medications were not reported. No COVID-19 prior vaccination. No COVID-19 tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took blood pressure medications in two weeks. On an unknown date, the patient had severe headache several days and a fever. No treatment medications were reported. Outcome of the events were recovering. No follow-up attempts are possible. No further information is expected.
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| 73 | 2021-04-27 | throat pain, fatigue |
This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration (injection), administered in the right arm on 12Feb2021 at 13:00 (batch/lot number: EL9267) as a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis from 1991 and ongoing (diagnosed 30 years ago; doctor said that he didn't know if she has RA because she's taken all of those infusions and it may just be severe osteoarthritis), ongoing thyroid (disorder), thyroid was removed, knee replacement left leg from 2020 (she had knee replacement last year on her left knee), Achilles tendon tear - reported that she had to have surgery last to repair her right Achilles tendon as it tore, cholesterol (abnormal) from 1991 and ongoing (diagnosed with cholesterol problems 30 years ago), ongoing depression (diagnosed with depression a couple years ago), ongoing sleep problems (experienced sleep problems for a long time), blood pressure (abnormal) from 2013 and ongoing (diagnosed with blood pressure problems 8 years ago), physical therapy, lymphedema, and unable to recall exact dates. There was no family medical history. No prior vaccinations (within 4 weeks). Concomitant medications included amitriptyline taken to help her sleep from an unspecified start date and ongoing (she has been taking this medication for years and years); folic acid taken for arthritis from an unspecified start date and ongoing (she has been taking this medication for years and years); levothyroxine taken for thyroid, start and stop date were not reported (she has been taking this medication for years and years); chlordiazepoxide (LIBRIUM) taken for sleep from an unspecified start date and ongoing (she has been taking this medication for years and years); losartan taken for blood pressure from an unspecified start date and ongoing (she has been taking this medication for years and years); meloxicam taken for arthritis from an unspecified start date and ongoing (began taking for 10 or 15 years after switching from celecoxib); metoprolol taken for blood pressure from an unspecified start date and ongoing (she has been taking this medication for years and years); omeprazole taken for stomach from an unspecified start date and ongoing (helps her stomach with all of the medications she has to take); pravastatin taken for cholesterol from an unspecified start date and ongoing (she has been taking this medication for years and years); desvenlafaxine succinate (PRISTIQ) taken for depression from an unspecified start date and ongoing (she started taking over a year ago, a year and a half or maybe two years ago); levothyroxine sodium (SYNTHROID) taken since thyroid was removed from an unspecified start date and ongoing (she has been taking since 15 years ago, for a long time); temazepam taken to help her sleep from an unspecified start date and ongoing (she has been taking this medication for years and years); cholecalciferol (VITAMIN D3) taken for an unspecified indication from an unspecified start date and ongoing (she has been taking this medication for years and years). The patient previously took BNT162B2 first dose on 21Jan2021 via injection in the right arm (lot number: EL3047 or EL3247; expiration date unknown) for COVID-19 immunization; and celecoxib (CELEBREX). The patient experienced extensive deep vein thrombosis on 06Apr2021; leg pain and feet swollen/ leg was like a balloon/ leg started to swell on 05Apr2021; throat hurts and tired on an unspecified date. The patient was calling about the Pfizer Covid-19 vaccine. She reported that she and her husband received both doses of the Pfizer Covid-19 vaccine. She received her first dose of the Covid-19 vaccine on 21Jan2021 and her second dose on 12Feb2021. She reported that she has had no complications before such as blood clots or problems with her blood or anything. She reported that on Monday, 05Apr2021, her leg started to swell. She reported that on the following day, 06Apr2021, her leg was so swollen that she couldn't put it down. She reported that she went to the emergency room on 06Apr2021 and was found to have an extremely extensive deep vein thrombosis. She reported that she was calling to complete a safety report. She stated that she doesn't want a deep vein thrombosis to happen to anyone else if her thrombus was from the Covid-19 vaccine. She reported that she and her husband thought they were so lucky as they had no side effects whatsoever following the Covid-19 vaccine doses. She reported that she was not saying that the deep vein thrombosis was from the Covid-19 vaccine but she has never had any blood or clotting problems in her life. Throat hurts: She reported that she thinks that when she was intubated, that whoever intubated her caught her tongue and cut it. She reported that she and her son and husband had been seeing news stories about the (Company name) vaccine. She reported that she has friends that were waiting for the (Company name) vaccine. She reported that her son wanted to send a text message so that others could be aware of the problems they might have. Leg pain: She reported that she went to the dentist on 05Apr2021 and was fine. She reported that when she got home from the dentist, her husband asked if she wanted to the take dog for walk. She reported that she put a leash on her dog and walked to the end of her driveway and said to her husband that she couldn't walk because her leg hurt so much. She reported that she had 2 surgeries last year, a knee replacement in her left leg and an Achilles tendon repair in her right leg. She reported that when she was released from physical therapy that the therapist told the caller that she might have lymphedema. She reported that the physical therapist directed her to go to a clinic that had no doctor where the clinic staff wanted her to buy a (dollar)10,000 piece of equipment to pump up her legs in the morning and at night. She reported that she came home from the clinic and called the podiatrist that repaired her Achilles tendon. She reported that she went to see the podiatrist that day and that the podiatrist ordered an ultrasound. She reported that a vascular surgeon called her regarding the ultrasound and stated that there was nothing wrong with the veins in her legs. She reported that the surgeon stated that they could tell there was nothing wrong with the her because her feet weren't swollen and instructed her to follow up in 9 months. She reported that on 05Apr2021, she went back into her house after experiencing the leg pain. She reported that her feet were not swollen and she was not that concerned. She reported that she thought maybe she was just tired and laid down. She reported that when she woke up the next morning, 06Apr2021, that her feet were like balloons. She reported that her son called a friend of his who was an orthopod. She reported that her son's friend instructed her son to take her to the emergency room, recommending that they bypass a certain hospital. She reported that she went to the emergency room on 06Apr2021. She reported that the emergency room staff did an ultrasound as soon as the caller arrived. She reported that the emergency room staff called the vascular surgeon. She reported that the vascular surgeon stated that if he had been in the caller's hospital room 5 minutes earlier that the would have done the surgery then, but that he had to lay her on her stomach to perform the surgery and she had eaten some cookies and drank diet soda. She reported that on the following day, 07Apr2021, the vascular surgeon put a scope in her vein and pulled out the clot. She reported that the physician was extremely concerned because the clots were very extensive. Leg pain: She reported that the leg pain was still ongoing. She reported that it hurts when she walks. She reported that she doesn't know if the leg pain has gotten worse. She reported that her leg pain on 06Apr2021 was excruciating and off the charts. Feet swollen: She reported that the swelling in her feet has maybe gotten slightly better. She reported that her feet were wrapped tightly with ace bandages. Leg swollen like a balloon: She reported that her leg was still swollen but it's gotten better, maybe about 90%. Extensive deep vein thrombosis: She reported that the deep vein thrombosis was removed on 07Apr2021 from her left leg. She reported that she was at end of her life and she had trips planned. She reported that she had a trip planned recently to go to Las Vegas with her daughter. She reported that her daughter was not able to take the trip, and stated she didn't know what would have happened if she had experienced the blood clot while in Las Vegas. She reported that she received both doses of the Covid-19 vaccine in her right arm, as she was in the car and her husband was driving. First dose: Date: 21Jan2021; Lot Number: She reported the lot number as EL3047, then stated that the handwriting was hard to read and that the lot number was either EL3247 or EL3047. She stated when reporting on her history that she has no concept of time and was unable to recall exact dates. She reported that while in the emergency room and during admission, the hospital staff did labs, but she has no idea what the results were. Vaccination facility type was drive through clinic at (clinic name). Vaccine administered at military facility: No. The adverse events leg pain, swelling in feet and leg, extensive deep vein thrombosis required a visit to the emergency room. Did not require a visit to the physician's office. The patient was hospitalized for 6 days for extensive deep vein thrombosis from 06Apr2021 to 12Apr2021. The patient underwent lab tests and procedures which included CT scan of chest: normal on an unspecified date, ultrasound: there was nothing wrong with the veins in her legs on an unspecified date, ultrasound: unknown results on an unspecified date. The outcome was not recovered for the event leg pain; recovering for the event feet swollen/ leg was like a balloon/ leg started to swell; and unknown for the rest of the events.; Sender's Comments: Reported events are assessed as intercurrent medical conditions probably associated to patients underlying conditions and are therefore unlikely related to BNT162B2.
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| 73 | 2021-04-28 | dehydration, chills |
didn't eat or drink much of anything/couldn't eat or drink; She was probably dehydrated; GFR of 52; ...
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didn't eat or drink much of anything/couldn't eat or drink; She was probably dehydrated; GFR of 52; blood pressure 82/50; skin tenting; dizziness/orthostatic dizziness/dizzy; Nausea vomiting; Nausea vomiting; chills and cold sweats; chills and cold sweats/all sweaty, cold; felt blah; sore arm after 2nd dose; This is a spontaneous report from a contactable nurse reporting for herself. A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in arm left on 07Apr2021 at 13:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received BNT162B2 on 16Mar2021 (at the age of 73-years-old) for COVID-19 immunisation and experienced Sore arm and feeling blah. Clinical course was as follows: She spent 50 years in neurology and neuroscience, she was a crazy RN that did neurology right out of school, she was recommended for that specialty. She is not sure if she had a reaction to the vaccine or if it is just her. Her 2nd dose was last Wednesday, 07Apr2021. She had a sore arm and felt blah. Just like after the 1st shot. On Saturday night (10Apr2021) at 0200, she was awakened with chills, cold sweat, dizziness, nausea and vomiting. She was sick as a dog for 2 days and didn't eat or drink much of anything. She went to the doctor who sent her to an infusion center. She is down to 5' 2" and weighed too much. She has not been able to lose weight for a couple years. She gained 40 pounds when she turned 50 years old. After the shot, she had a sore arm and felt blah like she did after the first dose, but she thought everyone felt that way. She missed a day of gym class because of her really sore arm. This got better like after a flu shot, it was nothing. This time she had a really sore arm and felt blah after the shot but then on Saturday morning this whole thing started happening. She woke up very restless, was all sweaty, cold, dizzy and was too miserable to try and take her blood pressure. Her blood pressure tends to run low. Her symptoms of the sore arm resolved at 06:00 Saturday (08Apr2021). She had nausea and vomiting and couldn't eat or drink. That lasted through Monday morning. She had some back pain with this, but she has back pain normally as she is a little old lady. She had a scheduled Oncology appointment Monday, as did her husband. She experienced orthostatic dizziness. She woke up plain dizzy. Her doctor gave her a liter of fluids and it helped her. This was something that needed to be addressed. It was serious. It was all serious. She had nothing left to vomit. She is an old lady with Breast Cancer. Her creatinine level of 1.10 which dropped her GFR of 52, she calculated the GFR using a computer program. This is what lead to the doctor giving her a liter of fluid. She had an appointment scheduled and her doctor sent her to the infusion centers for a liter of D5NS. She was sent home afterwards and encouraged to drink fluids. She also had a CBC and chemistry panel with her blood work. She was worried because her skin was tenting badly, and she couldn't keep anything down. She was probably dehydrated. Her blood pressure at the doctor's office was 82/50. She didn't care that her skin was tenting. She has been drinking a lot of fluids as advised after her liter of fluids at the infusion center. She is interested in researching the MRNA process because it is used it in other things. The way the vaccine was developed, it should have dissipated after 48 hours. She likes to research everything. She and her husband experienced a year from Hell starting in August of last year. All events are considered serious. The patient underwent lab tests and procedures which included blood creatinine: 1.10 and blood pressure measurement: 82/50 on 12Apr2021, blood test, full blood count and investigation with unknown results and glomerular filtration rate: 52 on an unspecified date. The outcome of the events chills and cold sweat was recovered on 12Apr2021, skin tenting and orthostatic dizziness was recovered on 13Apr2021, vomiting and nausea was recovered on 14Apr2021, pain in arm was recovered on 10Apr2021, feeling abnormal was recovered on an unspecified date, while of the rest was unknown.; Sender's Comments: Based on a temporal association and the known drug safety profile, the reported events are considered possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 73 | 2021-05-03 | fatigue |
chronic lyme disease; could not breath/shortness of breath; knees swelled up; eyes burned; significa...
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chronic lyme disease; could not breath/shortness of breath; knees swelled up; eyes burned; significant fatigue; increase in body pain; my knees are still damaged, especially in the back; knees still damaged, especially in the back; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 73-year-old via an unspecified route of administration, administered in Arm Right on 28Mar2021 14:00 (Lot Number: ER8733) as single dose for covid-19 immunisation. Medical history included hepatitis c, persistent lyme disease (ongoing), Known allergies: some antibiotics and foods. There was no other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination. There were no concomitant medications. The patient experienced could not breath, had to walk around for 20 minutes, she had chronic lyme disease. Her knees swelled up, her eyes burned, she had shortness of breath. Now three weeks later her knees were still damaged, especially in the back and she still had significant fatigue and increase in body pain, but the shortness of breath upon walking had improved. The back of her knees had never been this bad. She -would never have another shot-think it would kill her. The events start date was 28Mar2021. No treatment was received. The outcome of event Dyspnoea was recovering, of knees still damaged, especially in the back, fatigue and increase in body pain was not recovered, of other events was recovered with sequel.
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| 73 | 2021-05-04 | headache, chills, fatigue |
Headache; extreme exhaustion; Felt like she was freezing and had the chills; arm is still sore; This...
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Headache; extreme exhaustion; Felt like she was freezing and had the chills; arm is still sore; This is a spontaneous report from a contactable consumer. This 73-year-old female consumer reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL9264)intramuscularly into the left arm on 05Feb2021 17:00 (at the age of 73-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter said that she had some adverse events after receiving the vaccine. On 05Feb2021, the patient stated that her arm was still sore. The hcp that gave her the injection was not gentle. She said that she noticed the soreness in her arm on Friday night. Laying in bed if she laid on that side, she noticed that it was sore and not up to par. She said that she did not expect it to last this long. On 06Feb2021, the patient reported of extreme exhaustion after receiving the injection which was like having Covid all over again and felt like she was freezing and had chills both of which resolved on 07Feb2021 after a good nights sleep at about 10:00 to 12:00. She had 3 weeks of it with Covid though. She said that it started about 18 hours after she had the shot. She stated that she felt fine when she woke up, but after she started doing some stuff, she just could not function. On 07Feb2021, she had a bit of a headache which recovered on the same day. She said that she took a couple of Tylenol and it seemed to resolve. She had Covid over the holidays and that her brain does not always match her tongue when she was trying to explain her symptoms. She stated that she was not looking forward to the second vaccine because everyone she spoke with said that the side effects are worse with the second vaccine than they are with the first. No further details provided. No prior vaccinations within four weeks nor any relevant tests done. Outcome for exhaustion, headache and chills was recovered/resolved whereas it was recovering/resolving for pain in arm.
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| 73 | 2021-05-10 | malaise |
Patient reported feelings of malaise, SOB, and non-specific symptoms on 4/22. Patient sought medical...
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Patient reported feelings of malaise, SOB, and non-specific symptoms on 4/22. Patient sought medical care for symptoms on 05/08/2021. Patient was noted to have multiple large ecchymosis scattered over upper and lower extremities bilaterally; Plt. count came back at 7k, and patient was diagnosed with ITP (no prior history of ITP).
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| 73 | 2021-05-11 | fatigue |
Patient started 18-24 hours with loss of strength- inability to bear weight, and confusion with inab...
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Patient started 18-24 hours with loss of strength- inability to bear weight, and confusion with inability to communicate- both expressive and receptive, moaning and complete loss of awareness. The initial episode lasted approximately 4 hours. These episodes repeated for the next 3 days. She was taken to the Emergency Room by ambulance 3 days after the vaccine and a workup was completed. It was negative at the time of exam. She did have a mild anemia, but CT and laboratory work were otherwise negative. She had recovered strength and her memory. Later that evening she was again unresponsive except to painful stimuli and was like that over night. She was fatigued but was repulsive the next day. She never gained her full strength back. Over the next 4 weeks, she had progressively more of the periods of unresponsiveness and amnesia that stayed progressively longer and recovery was even less in-between the periods of unresponsiveness. She was placed on Hospice Care and succumbed on March 9, 2021, 1 month after her first vaccine.
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| 74 | 2020-12-31 | lethargy | Lethargic, not eating |
| 74 | 2021-01-05 | headache, chills |
Headache, sore arm, vomiting, diarrhea, chills Took injection @ approx. 10:45 am on 1/4/21; symptom...
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Headache, sore arm, vomiting, diarrhea, chills Took injection @ approx. 10:45 am on 1/4/21; symptoms started about 3:30pm and lasted from 6-8 hrs. Headache & sore arm lingering on 1/6/21.
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| 74 | 2021-01-06 | throat irritation, headache |
Headache, dizziness, chest tightness, scratchy throat; No treatments provided in clinic. Patient mon...
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Headache, dizziness, chest tightness, scratchy throat; No treatments provided in clinic. Patient monitored until EMS arrived. Patient care handed over to EMS.
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| 74 | 2021-01-07 | headache |
Headache; Itchiness; Phlebitis; Looks like little flea bites on her skin. There isn't that many, its...
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Headache; Itchiness; Phlebitis; Looks like little flea bites on her skin. There isn't that many, its mostly on her upper torso and they are sporadically placed.; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported), intramuscularly on the right deltoid, on 27Dec2020 (10:00) at a single dose for COVID-19 immunization at the hospital. Medical history included hypertension; hypothyroidism; was allergic to shellfish probably over the last 20 or 30 years; and was allergic to penicillin and sulfa "many, many years ago". Concomitant medications included HCTZ for hypertension; losartan potassium (COZAAR) for hypertension; levothyroxine sodium (SYNTHROID) for hypothyroidism; amlodipine for hypertension; omeprazole for hypertension; and ongoing lansoprazole (PREVACID). The patient previously took Fluzone Quadrivalent influenza vaccine on 17Oct2020 for vaccination, and had itchiness. On 28Dec2020, the patient had headache; itchiness; phlebitis; and had what looked like flea bites on her skin which were not that many, and was mostly on the upper torso and sporadically placed. The patient had received diphenhydramine (BENADRYL) as treatment for the events. The patient was told that since itchiness was not a part of the normal side effects, the itchiness was considered an adverse reaction and that she could not get her second shot which was scheduled for 16Jan2021. The outcome of the events was recovering for 'headache', 'pruritus' and 'phlebitis'; and was recovered on an unspecified date for 'looked like flea bites on her skin'.
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| 74 | 2021-01-11 | chills, headache |
Headache; Sore arm; Vomiting; Diarrhea; Chills; This is a spontaneous report from a contactable cons...
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Headache; Sore arm; Vomiting; Diarrhea; Chills; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO142), via an unspecified route of administration in left arm, on 04Jan2021 at 10:45, at a single dose, for COVID-19 immunization. The patient's medical history included arrhythmia, right shoulder reverse replacement, and fusion at L5S4. The patient's concomitant medications included metoprolol tartrate, digoxin, levothyroxine, and montelukast sodium (MONTEL). The patient previously took codeine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 04Jan2021 at 3:30 PM, the patient experienced headache, sore arm, vomiting, diarrhea, and chills. The events were considered non-serious. No treatment received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Jan2021.
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| 74 | 2021-01-11 | fatigue, chills, fever |
Pt started experiencing severe temperature night of 1/08/2021 with chills very fatigue. Severe all o...
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Pt started experiencing severe temperature night of 1/08/2021 with chills very fatigue. Severe all over the body.
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| 74 | 2021-01-12 | headache, chills |
Got really sick overnight; Headache; Chills; Body aches; Nausea; Joints hurt; This is a spontaneous ...
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Got really sick overnight; Headache; Chills; Body aches; Nausea; Joints hurt; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899), via an unspecified route of administration on 04Jan2021 (at the age of 74-years-old) as a single dose for COVID-19 vaccination. Medical history included thyroid disorder. Concomitant medications included levothyroxine from an unknown date at 100 (units not provided) for thyroid. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) on an unknown date (at the age of 74-years-old) as a single dose for COVID-19 vaccination. After the patient received the second BNT162B2 vaccine dose, overnight the patient got really sick, the patient experienced headache, chills, body aches, nausea, and joints hurt, all on unknown dates in Jan2021, per the patient it started during the night. The patient received ibuprofen (ADVIL) as treatment for the events. The clinical outcome of got really sick overnight and chills were unknown and the outcome of the events headache, body aches, nausea, and joints hurt was not recovered. It was also reported that the patient has been tested for COVID-19 with unknown results, the patient stated they get a COVID test every week at work.
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| 74 | 2021-01-13 | chills, sleepiness |
very weak and sleepy; very weak and sleepy; Vomiting; Shivers; had gotten sick; Pain injection site;...
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very weak and sleepy; very weak and sleepy; Vomiting; Shivers; had gotten sick; Pain injection site; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot EL3246, expiry date not reported), intramuscular on 05Jan2021 13:30 at a single dose in the upper left arm for COVID-19 prophylaxis. There were no medical history and concomitant medications. Patient had no prior vaccinations (within 4 weeks). Patient asked if there was any contraindication to getting the second dose. Patient reported having vomiting and shivers the day after receiving the vaccine as well as pain at injection site which was reportedly now resolved. Patient was calling about the Covid-19 vaccine and reported that she received the vaccine this past Tuesday 05Jan2021. She said that she was very sick the next day (06Jan2021). She said that 5 people went with her to get the vaccine and she was the only one who had gotten sick. Patient clarified that she had vomiting throughout the day the next day after receiving the vaccine. She also reported that she had shivers for hours and hours. She said that she had blankets and quilts on her and she could not stop shivering. She said that when she went to the doctor, the doctor thought it was because of the vaccine. Patient wanted to know if she should she take the second shot and if these will happen to her again or not and asked if there are any contraindications. She said that the vomiting started in the morning around 10:00 on 06Jan2021. It lasted a couple of hours until about 13:00 06Jan2021. She said that the shivers were bad, and she had big time shivering and there was nothing she could do to stop the shivering. The shivering lasted from 10:00 06Jan2021 until about 5-6 in the evening 06Jan2021. As the day progressed the pain where they gave her the shot was very bad on 05Jan2021. She said that she had pain at the injection site (pain injection site) on 05Jan2021. She said that it only hurts now if she touches the area. She said that the site previously it hurt without touching it. Patient was very weak and sleepy the next day. She said that she felt very weak and sleepy on 07Jan2021. She said that it lasted throughout the entirety of the day and she fell asleep and felt better today (at the time of the report). She said that today she felt fine. The events did not require emergency room visit but events required physician's office visit. The events were reported as not serious. Therapeutic measures were taken as a result of the events weak and sleepy. The patient recovered from vomiting on 06Jan2021 13:00, from shivers on 06Jan2021, from weak and sleepy on 07Jan2021. The patient was recovering from pain injection site. The outcome of the event sick was unknown.
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| 74 | 2021-01-13 | malaise, fatigue |
tiredness; stress; feeling terribly; This is a spontaneous report from a contactable consumer (patie...
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tiredness; stress; feeling terribly; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date Apr2021) intramuscular on 31Dec2020 11:30 at single dose in the left arm for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient called for information about if severe tiredness and stress are symptoms reported for the administration of the Pfizer's COVID-19 vaccine and how to properly manage them. The patient reported that she was administered with the Pfizer's COVID-19 vaccine on 31Dec2020 and since then she has been experiencing severe tiredness and stress (31Dec2020). The patient reported that she has spoken with her physician and he could not provide guidance about how to proceed with this particular situation. She received the first dose of Pfizer Biontech Covid vaccine on 31Dec2020. She was feeling terribly, she has severe, severe tiredness that comes over her and stress. She was overwhelmed by what was happening to her and she was asking if anybody else has experienced this. Her second dose was supposed to be on 21Jan2021. The outcome of the events severe tiredness, feeling terribly and stress was not recovered.
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| 74 | 2021-01-14 | fever |
fevers of 101; getting worse; she is so sick; felt 'nausea, chilly and hot'/she is feeling hot; fel...
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fevers of 101; getting worse; she is so sick; felt 'nausea, chilly and hot'/she is feeling hot; felt 'nausea, chilly and hot'/nauseous; arm been sore; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 05Jan2021 09:30 at single dose for prevention. Medical history included covid-19 from Jul2020, hair loss. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fevers of 101 on an unspecified date with outcome of unknown, felt 'nausea, chilly and hot'/nauseous on 08Jan2021 with outcome of not recovered, felt 'nausea, chilly and hot'/she was feeling hot on 08Jan2021 13:00 with outcome of not recovered, getting worse on an unspecified date with outcome of unknown, arm been sore on 06Jan2021 08:00 and on 08Jan2021 08:00 with outcome of not recovered, she was so sick on an unspecified date with outcome of unknown. Clinical course: She had it on Tuesday and arm been sore since then. now she gotten very nauseous. Her temperature is around 98 degrees Fahrenheit now and she is feeling hot. She does not have a temperature. After transfer caller stated ' I felt nauseous but now its gone, but also getting worse.' She was usually 96 or 97 degrees Fahrenheit. She was nauseous. Is this normal after 4 days. There was no prescriber. She was more sore on Wednesday than she is now. It is better yesterday and now than on Wednesday when it was real sore. She did something she should not have done. She went to a yoga class and had not eaten. Afterwards, she had a strawberry and did not feel like eating. Then she said she did not take her pills, which are mostly vitamins. The thought of taking pills made her sick. After she took them she ate something and has been nauseous ever since. She did not confirm if she needed glasses prior to getting the vaccine. She had COVID in Jul2020. She is taking a lot of vitamins. She had hair loss and is taking Biotin. She takes very few prescribed medications. Now she was so sick she would not think of taking them. No further details provided. The patient underwent lab tests and procedures which included body temperature: 98 degrees fahrenheit on unknown date. Information on the Lot/batch number has been requested.
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| 74 | 2021-01-17 | pneumonia |
patient suddenly developed pneumonia 7 days after vaccination and died the evening of developing pne...
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patient suddenly developed pneumonia 7 days after vaccination and died the evening of developing pneumonia
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| 74 | 2021-01-18 | chills, fever |
At approximately 4pm on Jan 11, 2021, I began to have hard chills and fever that reached 104.9. I wa...
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At approximately 4pm on Jan 11, 2021, I began to have hard chills and fever that reached 104.9. I was admitted to ICU at the Hospital. My blood pressure dropped to dangerous levels. I was diagnosed with sepsis and the doctors determined it was caused by the vaccine.
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| 74 | 2021-01-19 | headache | Unable to move head and neck due to soreness |
| 74 | 2021-01-20 | chills, headache |
Got shot at 12:45 pm and at 6 pm the night I started feeling a little cold and by 7 pm I was really ...
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Got shot at 12:45 pm and at 6 pm the night I started feeling a little cold and by 7 pm I was really cold with chills and a headache. It lasted 24 hours.
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| 74 | 2021-01-20 | throat irritation |
30 minutes after immunization, patient complained of "fat tongue", swelling feeling to left side of ...
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30 minutes after immunization, patient complained of "fat tongue", swelling feeling to left side of tongue, scratchy throat-"strep like feeling", and metallic taste, described as nail polish remover taste. 50 mg po was administered and MOD contacted, pt was monitored for 20 minutes at which time patient stated symptoms had improved and was feeling fine. Patient was kept another 30 minutes before patient left. At time of discharge patient stated was feeling drowsy from Benadryl but was doing well otherwise.
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| 74 | 2021-01-21 | chills, headache | Chills, muscle ache, headache. |
| 74 | 2021-01-21 | fatigue, malaise, chills, headache |
Day 1 - nothing Day 2 - nausea (mild progressing to severe), vomiting (x2),...
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Day 1 - nothing Day 2 - nausea (mild progressing to severe), vomiting (x2), dull headache, no appetite, fatigue, chills (on/off) Day 3 - nausea (moderate), Pancreatitis-like symptoms (lasted 1 day), no appetite, fatigue, erratic blood sugars, chills (on/off) Day 4 - fatigue, chills (on/off), no appetite, generally feeling unwell. Day 5 and continuing, generally not feeling well, no appetite, chills (on/off) NO FEVER AT ANY TIME
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| 74 | 2021-01-21 | headache |
As I was getting ready for bed my joints felt achy. Around 11:00 p.m. it felt like every joint in my...
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As I was getting ready for bed my joints felt achy. Around 11:00 p.m. it felt like every joint in my body was on fire. Also add headache could not hardly stand to lay my head on the pillow. About 4 AM I could not tolerate the situation any longer and took 600 mg of Tylenol. After that was able to rest some. The next day after the vaccination my joints were achy moderately and I have a headache. The injection site was tender to the touch and arm range of motion decreased and arm sore. Took 400 ibuprofen about 4 PM day after injection to ease Reactions
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| 74 | 2021-01-22 | malaise, fatigue, throat irritation, sinus congestion |
Do not know if the symptoms were related to the vaccine. They started 4-5 days after Pfizer Covid-19...
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Do not know if the symptoms were related to the vaccine. They started 4-5 days after Pfizer Covid-19 vaccination. Intermittent Scratchy throat, stuffy sinuses, extreme fatigue felt as if I was coming down with or fighting a cold. Symptoms lasted on and off for about 4-5 days. Nothing materialized. After that I felt fine
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| 74 | 2021-01-23 | chills, headache |
Approx 7:00pm on the 22nd of January had a dull headache. The next day had muscle pain, joint pain...
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Approx 7:00pm on the 22nd of January had a dull headache. The next day had muscle pain, joint pain, and chills. Also injection site was sore. Took Advil for pain and aches.
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| 74 | 2021-01-23 | chills |
Starting about 11PM, left arm from fingers up my arm to below my ear, across to my right shoulder ac...
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Starting about 11PM, left arm from fingers up my arm to below my ear, across to my right shoulder ached, had chills, and could not get comfortable in bed. Once up at 7 AM took two Advil 200mg with relief
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| 74 | 2021-01-24 | fatigue, headache, sleepiness |
Injection at 7:30 p.m. Noticed frequent yawning. Went to bed early, tired. Awoke earlier than usual....
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Injection at 7:30 p.m. Noticed frequent yawning. Went to bed early, tired. Awoke earlier than usual. Slight headache that continued until it got troublesome so took Advil iii plus Tylenol500 i with coffee. Relief from headache but continued tired. Mild headache returned mid afternoon. Bed early at 9:p.m. but headache (especially in the bones behind my ears) was keeping me awake so I took Advil iii plus Tylenol 500 with half cup coffee. (This was the pain relief regimen that my dentist had recommended and it had been effective) Woke up this morning feeling fine.
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| 74 | 2021-01-24 | fatigue | Lack of energy Feel exhausted |
| 74 | 2021-01-24 | headache, fatigue | injection site pain, fatigue, headache periodically, muscle and joint pain |
| 74 | 2021-01-24 | headache |
Approximately 15 minutes after receiving vaccine, pt. c/o dizziness, headache and shakiness. Pt. wa...
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Approximately 15 minutes after receiving vaccine, pt. c/o dizziness, headache and shakiness. Pt. was immediately assessed by Physician. Also assessed by local EMS. BP: 160/60, HR: 70, RR: 24-28, O2 sates: 98%. Pt. declines to be transported to the emergency room. Plans to make appt. with PCP.
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| 74 | 2021-01-24 | headache |
Approximately 10-15 minutes after receiving vaccine, pt. c/o dizziness, headache and shakiness. BP:...
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Approximately 10-15 minutes after receiving vaccine, pt. c/o dizziness, headache and shakiness. BP: 160/60, HR: 70, RR: 24-28, O2 sats: 98%. No other symptoms noted. Pt. assessed local EMS. Declines going to emergency room today. Pt. plans to go to urgent care or call PCP.
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| 74 | 2021-01-24 | sleepiness, headache, malaise, chills, fever |
Developed hives on my face, on my head, on top of my back and they also itch in addition to the all ...
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Developed hives on my face, on my head, on top of my back and they also itch in addition to the all over itching; headaches; Pain around my face, my left arm; Developed severe itching from head to toe; I was running a temperature of 102; I could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move; I could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move; Appetite lost; Chills; soreness more than usual from the shot; Soreness in my arm, my neck; Soreness in my arm, my neck/ pain around her face, her left arm; I got stiff neck, my back, my lower back; Massive weakness; Confusion; terrible sleepiness; Diarrhea; I still don't feel good; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot EL3248, expiration Apr2021) at 6:00AM on 07Jan2021 for Covid-19 immunization. The patient had her first dose on 19Dec2020 and had side effects from it but very few. The patient was worked at COVID rooms to clean rooms in hospital as a housekeeper and so her exposer to the hospital made her in first group to get the vaccine. Medical history included allergies (had anaphylactic shock from Amoxicillin and from Tylenol, she cannot take Tylenol), anxiety, and high blood pressure. Concomitant medications included acetylsalicylic acid (ASPIRIN) on regular basis, bisoprolol fumarate, loratadine (CLARITIN) for allergies, escitalopram for anxiety, mometasone furoate (FLONASE) for allergies, losartan, magnesium, omeprazole, and triamterene. On the first day (07Jan2021) she had soreness more than usual from the shot, soreness in her arm, her neck. She got stiff neck, back, lower back. She had gotten the shot at 6 am, then worked at that time and by the time she got home at noon, she had massive weakness, some confusion, terrible sleepiness and by evening, she developed diarrhea. On the second day (08Jan2021) the pain increased the weakness increased, and she was running a temperature of 102. She could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move pretty much. She could not eat and lost appetite, and she developed the chills on that evening. On the third day (09Jan2021) she was running a temperature of 101 so it had gone down. She still had headaches, and pain around her face, her left arm and developed severe itching from head to toe, and on the next day (10Jan2021) she developed hives on her face, on her head, on top of her back and they also itch in addition to the all over itching. The temperature was gone, she had no temperature when she developed the hives. At the report day, she stated that she had not gone back to work as she broke out in the horrible hives and she still did not feel good. Only cold ice packs on the hives/ itching and no more treatment received for the events. The fever and itching resolved on 10Jan2021, and outcome of all other events was unknown.
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| 74 | 2021-01-24 | sleepiness |
received 3 shots of COVID vaccine; almost "like fell asleep". She was hardly open her eyes this morn...
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received 3 shots of COVID vaccine; almost "like fell asleep". She was hardly open her eyes this morning/couldn't eat dinner because people couldn't wake her up; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at SINGLE DOSE for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medications were not specified (reported the patient was taking bunch of medications, but the reporter did not know exactly what they were). Historical vaccine included first dose bnt162b2 on 24Dec2020 and second dose bnt162b2 on 11Jan2021, both for COVID-19 vaccination. She didn't have any side effect from the first shot or the second shot. The patient received 3 shots of COVID vaccine, received 1st dose of vaccine on 24Dec2020, 2nd dose on 11Jan2021. Then inadvertently given another dose yesterday, on 12Jan2021. Immediately after the 3rd dose of vaccine, the patient almost "like fell asleep". She was hardly open her eyes this morning. The patient was in a nursing home. The nursing home staff was finding it difficult to feed her now. The patient couldn't eat dinner because people couldn't wake her up. The patient just had the COVID test, no other lab test. The outcome of the events was unknown. Information of lot/batch number has been requested.
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| 74 | 2021-01-24 | throat irritation | symptoms of rash and scratchy throat two weeks after injection |
| 74 | 2021-01-25 | chills, headache |
Headache, chills, diarrhea for 5 days, then better for a day, then it started again to a lesser ext...
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Headache, chills, diarrhea for 5 days, then better for a day, then it started again to a lesser extent. Now 11 days out I am better. Sometimes have mild headache.
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| 74 | 2021-01-25 | fever |
Initially soreness around injection site later followed by vertigo, nausea and vomiting. which reso...
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Initially soreness around injection site later followed by vertigo, nausea and vomiting. which resolved after 48 hours. Dizziness continued and on fourth day I developed body aches, low grade fever (100.9) and nausea. which lasted for three days.
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| 74 | 2021-01-26 | chills, nasal congestion, headache | Strong nasal Congestion, head ache, and chills. |
| 74 | 2021-01-26 | chills, fever |
fever; severe chills/could not get warm; her breathing was deep; drop in blood pressure; mild swelli...
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fever; severe chills/could not get warm; her breathing was deep; drop in blood pressure; mild swelling/Swelling of Left Arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration in the left arm on 11Jan2021 10:00 at a single dose for COVID-19 vaccine (because she's 74 and high risk). Medical history included hypertension. Concomitant medication included irbesartan oral (by mouth) from an unspecified date (maybe 3 years ago) and ongoing at 300 mg once daily (150mg, 2 tablets once a day in the morning) for hypertension as blood pressure medication. The patient received the first dose of vaccine on Monday (11Jan2021) morning (AM) at 10 at the county (public) health department. She had no problem at all until yesterday Tuesday, she experienced mild swelling; the swelling happened in the upper left arm (swelling of left arm) which started on 12Jan2021, this was also the same side that she got her vaccine on, the left arm. On 13Jan2021 she woke up at 4AM [also reported as thirty (30) hours after the shot] in which she started to have severe chills (horrendous chills), could not get warm under the blanket for an hour and a half. It lasted a long time. Her severe chills did stop, she used an electric (heated) blanket. This morning on 13Jan2021 at 8:30, she woke up with the fever, which she was able to reduce with acetaminophen (did take two acetaminophen). Her fever was also gone. She was a little concerned because she thought her breathing was deep too on 13Jan2021. She did some relaxing breathing which helped. It lasted a long time. The patient also experienced a drop in blood pressure on 13Jan2021. Her blood pressure has been running the past few days at 133/80 on 11Jan2021. Today (13Jan2021), she took her blood pressure and it was at 93/50. It went to 87/56 after drinking some salty soup on 13Jan2021 (the bottom number in the blood pressure was going up a little, and the top number was going down a little). Her blood pressure has been normal 133/70 on Jan2021, but this morning it was 90/50 on 13Jan2021. Her blood pressure has been running normal the last couple of days like 133/90 on Jan2021. She was shocked it was lower. She knew they talk about dizziness and weakness, but she didn't experience that. She was concerned about that sudden drop in blood pressure. She did some research and started eating some salty soup and stuff (has been drinking salty soup). Her bottom number went up to 53 on Jan2021. She was concerned about that drop there. She was wondering if that was a side effect of the vaccine (result of the vaccine). She asked if drop in blood pressure was a concern. She had no positive test for Covid before the vaccine. She never had any tested, she's been pretty isolated. She had no antibody test. She has had no issues with vaccine in the past. Therapeutic measures were taken as a result of severe chills/could not get warm, fever, her breathing was deep, and drop in blood pressure. The outcome of swelling of left arm/mild swelling and drop in blood pressure was not recovered; of severe chills/could not get warm was recovered on 13Jan2021 05:30 and fever was recovered on 13Jan2021; and of her breathing was deep was recovering.
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| 74 | 2021-01-26 | cough, chills, fatigue, headache, malaise, fever |
Severe headache; tiredness; muscle pain; chills; fever 99.7; joint pain; feeling unwell; cough; no a...
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Severe headache; tiredness; muscle pain; chills; fever 99.7; joint pain; feeling unwell; cough; no appetite; This is a spontaneous report from a contactable consumer reported for self. This 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246) via unspecified route of administration at 08Jan2021 10:30 AM at single dose in right arm for COVID-19 immunization. The patient is not pregnant. The age at vaccination is reported as 74 years old. The patient medical history and concomitant medications were not reported. The patient previously received benzoin and experienced allergy. The patient experienced severe headache, tiredness, muscle pain, chills, fever 99.7, joint pain, feeling unwell, cough, no appetite at 15Jan2021 18:00 PM. The events are reported as non-serious by reporter. The patient received no treatment. The patient was not diagnosed with COVID-19 prior to and since the vaccination. The patient was recovering from the events.
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| 74 | 2021-01-26 | headache, fatigue |
tiredness for 6 hrs after receiving shot; muscle aches on arm receiving shot and slight headache nex...
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tiredness for 6 hrs after receiving shot; muscle aches on arm receiving shot and slight headache next morning.
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| 74 | 2021-01-27 | cough |
Patient states right after she received the vaccine, she had a small "coughing spell" for the first ...
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Patient states right after she received the vaccine, she had a small "coughing spell" for the first 15 minutes. The coughing stopped. When the patient went home she noticed hives on her face and upper chest that lasted 1-2 hours and went away on their own.
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| 74 | 2021-01-27 | fatigue |
tired; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, up...
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tired; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date not reported), via an unspecified route of administration in the right arm on 12Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history included anxiety (needed to calm down), blood pressure abnormal, blood cholesterol abnormal, rheumatism, and osteopenia; all were ongoing. Concomitant medications included losartan potassium for blood pressure abnormal, atorvastatin blood cholesterol abnormal, sulindac for rheumatism, carvedilol for blood pressure abnormal, alendronate sodium for osteopenia, and venlafaxine; all were ongoing. On 12Jan2021, the patient experienced strong pain on her shoulder, upper arm, breast and neck area. On an unspecified date, the patient was also tired. Clinical outcome of event tired was unknown while for the other events was recovered on 13Jan2021.
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| 74 | 2021-01-27 | headache, fatigue |
Extreme fatigue, headache, SOB, palpitations, dizziness, fogginess; went to ED at 10:00 AM Tuesday m...
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Extreme fatigue, headache, SOB, palpitations, dizziness, fogginess; went to ED at 10:00 AM Tuesday morning
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| 74 | 2021-01-27 | lethargy, chills, fever, cough, headache, fatigue |
Shallow breath with spastic cough On again off again fever and chills Headaches Fatigue, lethargic, ...
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Shallow breath with spastic cough On again off again fever and chills Headaches Fatigue, lethargic, not able to do much No appetite Urine strong odor, different color, and frequent Cramping in hands and feey
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| 74 | 2021-01-28 | chills, fatigue, headache |
Significant left-arm pain, fatigue, general muscle ache, nausea, headache, chills Began 12 hours aft...
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Significant left-arm pain, fatigue, general muscle ache, nausea, headache, chills Began 12 hours after vaccination Symptoms still present, but beginning to improve after 48 hours
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| 74 | 2021-01-28 | chills | Chills, joint pain, no fever, muscle ache |
| 74 | 2021-01-28 | fever |
Severe urgent diarrhea; Feels like she might be getting a little fever; This is a spontaneous report...
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Severe urgent diarrhea; Feels like she might be getting a little fever; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date unknown), via an unspecified route of administration to right deltoid (shoulder) on 15Jan2021 at around 10:30-10:40 AM at a single dose for COVID-19 immunization. Medical history included chronic fatigue syndrome, fibromyalgia, problems with her colon, back surgery, and flashes. Concomitant medications included ibuprofen given on unspecified date for back surgery, and unspecified hormones, vitamins, and laxatives. The patient previously received the flu vaccine on unspecified date and experienced like she got the flu and relapse of her chronic fatigue syndrome. She also received hepatitis C vaccine, hepatitis B vaccine, pneumonia vaccine, and shingles vaccine; all on unspecified dates. The patient had not received prior vaccinations within four weeks. On 15Jan2021, the patient experienced severe urgent diarrhea and felt like she might be getting a little fever. It was further described as: Patient had an odd reaction within maybe 30 minutes to 1 hour after that dose was administered of severe urgent diarrhea. Patient mentioned she felt like she might be getting a little fever; but she was not sure and did not have a thermometer to check that. Severe urgent diarrhea: She mentioned she had not seen that side effect posted anywhere for the vaccine so she felt it was an odd reaction; although she did see that it was a side effect of the virus, so maybe it was not that odd of a reaction for the vaccine now that she thought about it. She described this event as completely crazy, the urgency to go to the bathroom, she almost did not make it home to the bathroom. It just hit her like she has never experienced before. It cleaned out her colon really well. She also felt like she might be getting a little fever but mentioned that at her age she gets hormone flashes so it could be that; and was humid at the time of report and thought so it could just be from that. The outcome of the events was unknown. Information regarding Batch/ Lot number has been requested.
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| 74 | 2021-01-28 | fever | Started running a fever of 100 12 hours later |
| 74 | 2021-01-30 | chills, headache |
Developed intractable headache that woke me from a sound sleep and lasted for 15 hours, with body ac...
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Developed intractable headache that woke me from a sound sleep and lasted for 15 hours, with body aches and chills. Left arm sore for three days.
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| 74 | 2021-01-30 | fever, fatigue, headache |
Next day: fever 100.2 Muscle aches, joint pain, nausea, fatigues, head ache all day thru early eveni...
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Next day: fever 100.2 Muscle aches, joint pain, nausea, fatigues, head ache all day thru early evening Day 2: no fever, joint pain, muscle aches, head ache and nausea all less then day before
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| 74 | 2021-01-31 | cough |
Pt has a history of asthma. Pt states after she recieved the vaccine she started coughing. Pt states...
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Pt has a history of asthma. Pt states after she recieved the vaccine she started coughing. Pt states she used her albuterol inhaler. Pt states she also took 50MG of benadryl. Pt states her symptoms are gone at this time. Pt's vitals are stable. Pt refused transport to hospital.
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| 74 | 2021-01-31 | fatigue, headache |
Two hours after the vaccine I had heart palpitations, my lips were tingling and I felt fatigue and a...
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Two hours after the vaccine I had heart palpitations, my lips were tingling and I felt fatigue and appetite loss. This lasted about 30 minutes. 36 hours after vaccine I experienced headache, swollen tender left lymph node above collarbone and elevated BP 167/90. This improved after taking Advil.
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| 74 | 2021-01-31 | fatigue |
exhausted; slept most of day/night; pain in scalp, pimples, bumps; pain in scalp, pimples, bumps; so...
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exhausted; slept most of day/night; pain in scalp, pimples, bumps; pain in scalp, pimples, bumps; sore left eye; blood pressure very high and hard to control; shingles; This is a spontaneous report from a contactable consumer. A 74-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration on 08Jan2021 13:30 at single dose for covid-19 immunisation. Vaccine location was left arm. No other vaccine was received in four weeks. Medical history included hypertension, neuropathy peripheral, asthma/allergies, headache, allergy to medications, food. Concomitant medications included azelastine, fluticasone propionate (FLONASE), metoprolol, gabapentin, levothyroxine sodium (LEVOTHYROXINE). The patient experienced shingles on 08Jan2021 (immediately after she got the shot), exhausted on 09Jan2021 03:30, slept most of day/night on 09Jan2021 03:30, pain in scalp, pimples, bumps on 09Jan2021 03:30, sore left eye on 09Jan2021 03:30, blood pressure very high and hard to control on 09Jan2021 03:30. Patient was treated with Valacyclovir, lisinipril, metropolis, aquafor. The outcome of shingles was unknown. The outcome of exhausted, slept most of day/night, pain in scalp, pimples, bumps, sore left eye, blood pressure very high and hard to control was not recovered.
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| 74 | 2021-01-31 | headache, chills, fever |
Constant headache fever ( 99.7) chills achy muscles no appetite Feeling somewhat better 48 hours lat...
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Constant headache fever ( 99.7) chills achy muscles no appetite Feeling somewhat better 48 hours later -- but not all better
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| 74 | 2021-01-31 | fever | Fever 101F. Shingles noted on 2nd day. Took Enbrel injection on01/23/2021 |
| 74 | 2021-02-01 | chills, fever | Chills, fever 101 |
| 74 | 2021-02-01 | chills | Cant get her breath, intensely weak, chills. |
| 74 | 2021-02-01 | chills |
Teeth started chattering in the middle of the night; This is a spontaneous report from a contactable...
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Teeth started chattering in the middle of the night; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient experienced teeth started chattering in the middle of the night in Jan2021. The patient did not receive any treatment from event. The outcome of event was unknown. Information on the lot/batch number has been requested.
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| 74 | 2021-02-01 | fatigue | Weakness, Tiredness |
| 74 | 2021-02-01 | headache, fatigue, cough, chills, throat pain, body temperature increased |
Day 1-3 severe chills, severe headache, tired, joint pain/body aches, temp >101 Day 3-6 or 7 sore th...
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Day 1-3 severe chills, severe headache, tired, joint pain/body aches, temp >101 Day 3-6 or 7 sore throat, nausea, vomiting, diarrhea, altered taste Also complaint of intermittent acute shortness of breath and cough
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| 74 | 2021-02-01 | malaise, headache, chills, fatigue |
No energy has been really bad today; Tiredness; Headache; Muscle pain; Chills; Joint pain; Feeling u...
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No energy has been really bad today; Tiredness; Headache; Muscle pain; Chills; Joint pain; Feeling unwell; arthritis; she can't go to sleep until 1 am/unable to sleep/She can go to sleep at the drop of the hat in the afternoon which is not usual; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), intramuscular on 15Jan2021 14:15 at single dose on the left deltoid (also reported as "left arm") for COVID-19 immunization (reported as "Prevention"). Vaccination facility type was retirement community, not a military facility. Medical history included "blood pressure", reflux (her esophageal flapper bottom is deteriorated), blood disorder (reported as indication of aspirin: "blood thinner") and depression. Concomitant medications included acetylsalicylic acid (ASPIRIN [ACETYLSALICYLIC ACID) as a blood thinner, citalopram hydrobromide (CELEXA) for depression, hydrochlorothiazide for blood pressure, omeprazole for reflux (It is because her esophageal flapper bottom is deteriorated) and multivitamin; patient reported that she was taking all prior to the vaccine and did not think any were relevant to the report. There were no previous vaccine (reported as "Additional Vaccines Administered on Same Date of the Pfizer Suspect. None"). The patient reported that she got the injection last Friday (15Jan2021). She was still feeling the symptoms of everything with the exception of injection site pain and swelling and redness. She did not have any swelling of lymph nodes or nausea. With the exception of those items listed, she had all the other side effects. On 16Jan2021, the patient experienced tiredness, headache, muscle pain, chills, joint pain and feeling unwell. The patient stated that muscle pain and joint pain could also be attributed to arthritis. Patient mentioned that chills could have been Sunday, but she thought Saturday (16Jan2021). Patient did not have a fever. Patient also mentioned that unable to sleep was a chronic problem. She can go to sleep at the drop of the hat in the afternoon which was not usual. Then at night, she could not go to sleep until 1 am. She did not wish to list this as a side effect and did not feel it was attributed to the vaccine. No energy has been really bad today (19Jan2021), but she still thinks it was persistent. Patient will get another dose in 3 weeks. No emergency room (ER) or physician's office required. Patient wanted to know if it was common to get these side effects. Outcome of the events tiredness, headache, muscle pain, chills, joint pain, feeling unwell and No energy was not recovered while for other events was unknown. There was no investigation assessment. Information on the lot/batch number has been requested.; Sender's Comments: The reported insomnia is considered unrelated to BNT162B2 administration since mentioned as a pre-existing condition
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| 74 | 2021-02-01 | fever, chills |
low grade fever of 99.6 Fahrenheit and 99.7 Fahrenheit. She said it was 100.1 Fahrenheit only once; ...
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low grade fever of 99.6 Fahrenheit and 99.7 Fahrenheit. She said it was 100.1 Fahrenheit only once; chills; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3247) via an unspecified route of administration on the arm left on 18Jan2021 11:00 at single dose for COVID-19 immunisation. Medical history included thyroid. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid and ongoing. The patient did not receive other Vaccinations within 4 weeks. The patient had low grade fever of 99.6 Fahrenheit and 99.7 Fahrenheit. She said it was 100.1 Fahrenheit only once on 19Jan2021, chills on 19Jan2021. The event did not require a visit to physician or emergency room (ER). The caller stated she took the first dose of the vaccine yesterday (18Jan2021) and today (19Jan2021) has had a low grade fever of 99.6 Fahrenheit and 99.7 Fahrenheit. She said it was 100.1 Fahrenheit only once. Fever was reported as worsened. Today 19Jan2021, she first noticed the chills, now she did not have chills but she had a fever that was going up. She is scheduled to receive the next dose of the vaccine 08Feb2021. The outcome of the event fever was not recovered, of the event chills was recovered on 19Jan2021.
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| 74 | 2021-02-02 | fatigue, chills, fever |
The evening of shot #2 on 1/29/21, I got a fever of 100.4. Had serious chills, took hot baths, slept...
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The evening of shot #2 on 1/29/21, I got a fever of 100.4. Had serious chills, took hot baths, slept fitfully. Felt tired. Fever continued until 5 pm the next day (Saturday). Didn?t eat much. Fever broke late afternoon on 1/30 and I felt better. Slept better. But was very, very tired the next two days (1/31 and 2/1). Felt normal the 4th day, 2/2. My first shot was on 1/12/21 and I had no reaction other than a sore arm. For 24 hours.
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| 74 | 2021-02-02 | fatigue, chills | Chills. muscle ache, joint pain, rash at injection site, extremely tired |
| 74 | 2021-02-02 | headache | Nausea, vomiting, Temp over 100, extremely weak, head ache |
| 74 | 2021-02-02 | headache |
Immediately after receiving Covid vaccine, patient felt dizzy and developed headache. She was brough...
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Immediately after receiving Covid vaccine, patient felt dizzy and developed headache. She was brought to stretcher where she laid down and then felt numbness and tingling around mouth. Her throat also felt dry. She was given water and rested for several minutes. Symptoms did not worsen and she started to feel better. After 30 minutes patient states she feels much better. Throughout entire episode, patient was conversant and did not experience any severe symptoms.
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| 74 | 2021-02-02 | sweating |
Flushing and sweating - signs of diaphoresis 10-15 minutes after the vaccine dose. FS 119 per patien...
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Flushing and sweating - signs of diaphoresis 10-15 minutes after the vaccine dose. FS 119 per patient. BP 154/85 (baseline, 120's/60's), pulse 64. Given juice, rested, felt better after 15 minutes.
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| 74 | 2021-02-02 | fever, chills, headache |
Was fine the day of receiving vaccine. The next morning when woke up, was unable to move legs. State...
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Was fine the day of receiving vaccine. The next morning when woke up, was unable to move legs. Stated could not get out of bed, could not walk, has severe weakness. flank pain, nausea, headache, fever, and chills
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| 74 | 2021-02-03 | chills, malaise, headache, fatigue |
she felt very cold and unwell; she felt very cold and unwell; dizziness; headache; extreme fatigue; ...
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she felt very cold and unwell; she felt very cold and unwell; dizziness; headache; extreme fatigue; fogginess/Foggy brain was described as she was not able to focus very well; Strong chills was not going away almost like a feeling of ice in her veins; Arm ache at the site; She was not able to get work done due to extreme fatigue and foggy brain/It was very disturbing and interfering with ability to do work; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration in the left arm on 16Jan2021 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had her first COVID19 vaccine dose. Immediately, on 16Jan2021, she felt very cold and unwell. She also experienced dizziness, headache that started right after the shot, extreme fatigue that started later in the day and fogginess that started right after the shot. Strong chills was not going away almost like a feeling of ice in her veins. She is taking paracetamol (TYLENOL) and ibuprofen for these. The events were not improving. She was just surprised, she was ok with a day's worth, but it was hanging on dizziness (not enough to fall down), but she has to hold onto a rail to go upstairs which was not normal. She doesn't feel like she is real anchored. Headache was described as very bad and is not changing. Foggy brain was described as she was not able to focus very well. She was not able to get work done on Jan2021 due to extreme fatigue and foggy brain. She also experienced arm ache at the site on 06Jan2021 for which the patient expected. It is reducing some, the ache is not as bad as it was while the other things seem to be growing and it is still there. She had to be set aside when she took the shot, because she had these reactions after she got the shot. She had to be watched because of her almost immediate reactions. The patient wants an advice on what to do now, if there is any help for the side effects, and if this will go away. It was very disturbing and interfering with ability to do work. Outcome of the vaccination site pain was recovering while of the remaining events was not recovered.
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| 74 | 2021-02-04 | chills, sleepiness, fever |
Day 1: nothing Day 2: dizzy, chills, extreme sleepy, fever of 102.2, fever broke during sleep at nig...
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Day 1: nothing Day 2: dizzy, chills, extreme sleepy, fever of 102.2, fever broke during sleep at night Day 3: nothing
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| 74 | 2021-02-04 | fever, fatigue |
First dose : Second day of vaccination very mild fatigue , moderate pain in arm Second dose : ...
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First dose : Second day of vaccination very mild fatigue , moderate pain in arm Second dose : pain in the arm began the day of vaccination, second day at noon began chills, fatigue, joints pain and and fever at around 4 pm , highest reading 100.4 Third day feeling good for
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| 74 | 2021-02-05 | headache, chills, influenza like illness | Unable to lift arm and soreness. Flu like symptoms - muscle aches, chills, headache |
| 74 | 2021-02-05 | headache |
Pt presents to the ED today with c/o room spinning dizziness beginning while at work today about 1 h...
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Pt presents to the ED today with c/o room spinning dizziness beginning while at work today about 1 hour PTA with associated HA. After onset she reports that she drank a cup of warm water but still felt dizzy. Pt reports that she received the Pfizer vaccine on January 4th. Pt denies CP and SOB at this time. Vertigo onset 9 days after receiving first dose of Pfizer C19 vaccine. Duration several hours, resolved spontaneously. Likely BPPV.
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| 74 | 2021-02-05 | malaise |
About 3-4 hrs. after 2nd Covid vaccine, sore arm. Next day: sore arm, bones ached, injection site p...
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About 3-4 hrs. after 2nd Covid vaccine, sore arm. Next day: sore arm, bones ached, injection site pain and swelling, muscle and joint pain, feeling unwell
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| 74 | 2021-02-06 | headache | Severed headache Couldn?t lift arm |
| 74 | 2021-02-07 | chills, headache, nasopharyngitis, fever |
12 hours after SECOND Pfizer covid: Fever 104; chills, body aches, nausea, headache, severe body ac...
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12 hours after SECOND Pfizer covid: Fever 104; chills, body aches, nausea, headache, severe body ache, for 48 hours, then fever subsided and diarrhea and cold-like symptoms set in.
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| 74 | 2021-02-07 | chills, fever, headache |
At 3:30 am after receiving the vaccine the day before at about 11 am, woke up with chills, low-grade...
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At 3:30 am after receiving the vaccine the day before at about 11 am, woke up with chills, low-grade fever (99.4 when normal temperature is in low 97s). Also had a fairly bad headache, a fast heartbeat of up to 111, hips and legs ached, and felt a bit nauseated. At about 9 am took 1 extra-strenghth Tylenol, with little help. At 1 pm took 2nd Tylenol and all symptoms were pretty much gone by 3 pm in the afternoon.
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| 74 | 2021-02-07 | headache, chills, cough |
Couldn't hold a cup to drink; Pharangitis; Couldn't get warm; Strange odor in her nose, like burning...
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Couldn't hold a cup to drink; Pharangitis; Couldn't get warm; Strange odor in her nose, like burning plastic; Taste started to diminish; Painful bilateral lower back pain; Cough/Dry cough; Bad headache; Severe shaking chills; Muscles and joints ached; Muscles and joints ached; This is a spontaneous report from a contactable nurse (patient). A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration at left deltoid on 20Jan2021 at 9:30-9:45 am at SINGLE DOSE for COVID-19 immunization. Medical history included exposure to radiation from 2017 to an unknown date and did lose some of her sense taste due to 2 massive doses of radiation in 2017). There were no concomitant medications. Historical vaccine included two doses of shingles vaccine (SHINGRIX) for Immunization and experienced shaking, chills, and muscle and joint pain after the vaccine. The patient experienced bad headache (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, Severe shaking chills (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, muscles and joints ached (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, couldn't hold a cup to drink on an unspecified date with outcome of unknown, painful bilateral lower back pain on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, cough/dry cough on 20Jan2021 17:00 with outcome of not recovered (reported as worsened), strange odor in her nose, like burning plastic on 21Jan2021 with outcome of not recovered, taste started to diminish on 21Jan2021 with outcome of not recovered, pharangitis on an unspecified date with outcome of unknown, couldn't get warm on an unspecified date with outcome of unknown. Details were as follows: the patient received the COVIED in the morning of 20Jan2021. By 5pm she had developed a headache, severe shaking, chills, muscle and joints pain, severe lower back pain, and a dry cough; she was miserable. A few years ago after her double dosing of the shingles vaccine she had a similar reaction of shaking, chills, and muscle and joint pain. She has no product details for that product, no NDC, Lot, or expiry to provide. The patient confirmed that the shingles shot was 2 doses, not a double dose given at one time. When asked a seriousness criteria it was explained that the symptoms that started on the 20th, she felt they were disabling. She couldn't get warm, stop shaking, couldn't hold a cup and the pain was severe and she has high tolerance for pain. By around 3pm that day on the 21Jan2021 everything but the dry cough had resolved, and that had gotten worse. She also developed new symptoms. She had strange odor in her nose, like burning plastic and her sense of taste started to diminish. She did lose some of her sense taste due to 2 massive doses of radiation in 2017, She has no product information, NDC, Lot or Expiry for that radiation but after that she did have taste, some of it did come back. On the 21Jan2021, it was less, the sense of taste and now today she has no taste at all. For the muscle and joint pain she took Aleve. She was told if she was feeling worse over the weekend to go to the ER or urgent care. The patient was wondering and thinking this was her normal response to the vaccine just like she had a normal response that shingles vaccine.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 74 | 2021-02-07 | headache, chills, nasal congestion, throat pain, fatigue |
Start of an ear infection; Stuffy nose; Sore throat; Headache; Muscle and joint pain; Muscle and joi...
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Start of an ear infection; Stuffy nose; Sore throat; Headache; Muscle and joint pain; Muscle and joint pain; Chills; Dry mouth; White coating all over tongue; Nausea; Unbelievable thirst; Slight swelling at injection site; Injection site pain; Tiredness; swollen tonsils; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL1283), via an unspecified route of administration in the right arm on 13Jan2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included Transverse Myelitis ongoing from 2016, neurologic lime disease ongoing from 1992 due to which the patient gets migraines (from 1992), H. Pylori in May2019 and the patient is hard of hearing, ongoing from an unknown date. The patient's concomitant medications included unspecified migraine medication. On 13Jan2021 the patient experienced injection site pain, slight swelling at injection site, tiredness, and unbelievable thirst. On 14Jan2021 the patient experienced headache, muscle and joint pain, chills (which come and go), nausea (which is off and on), dry mouth, and white coating all over tongue. On 15Jan2021 the patient experienced stuffy nose and sore throat. The patient stated she still has tonsils on her right side where she has the earache and they are swollen (from an unknown date in Jan2021). On 17Jan2021 the patient experienced start of an ear infection (earache on the right side). The patient has had no fever and no redness. The patient stated she knows injection site pain is standard for a lot of people. The patient stated on Monday, 18Jan2021 she saw her provider and went over some of this. She stated she would not think that 4 days later she would still be feeling the side effects. The patient was inquiring if this only occurs with the first dose or will it also occur with the second? She is scheduled for the second one on 05Feb2021. The patient asked what was the time frame between injections? The patient was treated for the ear infection Neomycin/Polymyxin Sulfate ear drops and for the tiredness she has been walking around and trying light exercises. The patient turned down other medication as she did not want it to have any effect with the vaccine. The patient asked if there were any recommendations for the nausea and headaches. She stated she does have her migraine medication which she is trying to use to deal with the headaches. The clinical outcome of the injection site pain and slight swelling at injection site was recovered on 14Jan2021 and the white coating all over tongue recovered on 18Jan2021. The clinical outcome of the tiredness and start of an ear infection was recovering. The clinical outcome of the headache, muscle and joint pain, chills, nausea, stuffy nose, sore throat, thirst, and dry mouth was not recovered. The clinical outcome of the swollen tonsils was unknown.
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| 74 | 2021-02-07 | malaise |
feeling icky all day; Rash on front and back of nect; chest, and little bit down both arms; Muscle a...
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feeling icky all day; Rash on front and back of nect; chest, and little bit down both arms; Muscle aches; This is a spontaneous report from a contactable consumer(patient).A 74-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3246), via an unspecified route of administration on 12Jan2021 16:45 at single dose, left upper arm for COVID-19 immunization. Medical history and concomitant medications reported as none. The patient had a little bit of muscle aches on 12Jan2021 after the vaccine kind of all day. Other days it came and went. On 19Jan2021 the patient felt icky all day. She got a rash on the front and back of her neck. Rash was also on her chest and a little bit down both arms. She went to a walk-in clinic. Wasn't sure if it would be related to the COVID-19 Vaccine, but was advised to report it. Events required a visit to walk-in clinic. The outcome of the events was unknown.
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| 74 | 2021-02-07 | fever, chills |
Fever and chills starting 12 hours after injection. Temperature 101.7 then and now 5 hours later! Un...
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Fever and chills starting 12 hours after injection. Temperature 101.7 then and now 5 hours later! Unable to sleep, restlessness! Lower legs itch. Site is sore! Had been to to not take ibuprofen or Tylenol to help antibodies form! Can I take Benadryl? I had none of these adverse effects with 1st dose!
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| 74 | 2021-02-08 | fatigue | Joint and muscle pain, fatigue |
| 74 | 2021-02-08 | headache |
Diagnosed with sixth nerve palsy; Diarrhea; Headache; Nausea; This is a spontaneous report from a co...
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Diagnosed with sixth nerve palsy; Diarrhea; Headache; Nausea; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiry date: Mar2021), via an unspecified route of administration on 02Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included hypertension. Concomitant medication included cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), calcium (CALCIUM), rosuvastatin (ROSUVASTATIN). The patient experienced double vision and diagnosed with sixth nerve palsy on Jan2021, diarrhea and headache and nausea on 2021. The reporter stated "I am calling in reference to reporting possible side effect or adverse reaction to the vaccine. It is in reference to my mother, she had the first dose on 02Jan2021 and 14 days later, she started with double vision, ended up in the hospital. She was in the hospital 4 days (4 nights), diagnosed with sixth nerve palsy." The patient was hospitalization from 18Jan2021 to 22Jan2021. Reporter stated, "She was in hospital, she has visiting nurse now for physical therapy that comes to house and they going to redraw her labs tomorrow Wednesday. They were basically normal, all the lab results were normal." Therapeutic measures were taken as a result of double vision, diagnosed with sixth nerve palsy. Outcome of the events was unknown.
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| 74 | 2021-02-08 | fever, chills |
started with acute symptoms chills, fever, nausea. aches, and after i started to feel better and th...
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started with acute symptoms chills, fever, nausea. aches, and after i started to feel better and then full body rash from my face down my whole body.
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| 74 | 2021-02-08 | fever |
1/30/21 Rash on abdomen and left upper are. 2/1/21 Flu symptoms- muscle aches, low grade fever. 2/...
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1/30/21 Rash on abdomen and left upper are. 2/1/21 Flu symptoms- muscle aches, low grade fever. 2/6/2021- Arm red, hot swollen at injection site
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| 74 | 2021-02-09 | sleepiness, malaise, fatigue |
She was tired.Fatigue; she just could not get out of bed, she was sleepy; Did not feel good; This is...
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She was tired.Fatigue; she just could not get out of bed, she was sleepy; Did not feel good; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ET3248, expiration date was not reported), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. Medical history included thyroid disorder and hypertension which the patient mentioned that she does not have really but she takes hypertension medicine. Concomitant medication included levothyroxine sodium (SYNTHROID) and amlodipine besilate, telmisartan (TELMISARTAN AND AMLODIPINE) which was a substitute of TWYNSTA with LOT# is 3108115, expiry date: Oct2021. The patient had her vaccine on 19Jan2021 which was a Tuesday, and on 20Jan2021 on a Wednesday, she had side effects and then she started feeling better like on the Friday. But just a while ago, she had another side effect episode. She queried how long these will last or what do she needed to do. She asked if she can take her vitamins and everything else. She mentioned that she had to go back to her second one on 09Feb2021. She was tired. She just could not get out of bed, she was sleepy. She just did not feel good and kind of fatigued. Events all on 20Jan2021 on a Wednesday with outcome of recovering.
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| 74 | 2021-02-10 | fatigue |
she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; she had a cut to...
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she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; right breast hurts; it radiates around to her back; Fatigue; and can't lift or pull anything and it really, really hurts; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunisation. Medical history included sinus disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received a flu shot on an unspecified date. Consumer is calling about the Pfizer COVID-19 vaccine, and says she just spoke to a nurse who told her to call and find out if her experience for what she had after her first shot on Friday of the past week had been reported before. She says that on Saturday (23Jan2021), she woke up and her right breast hurt, there is something in there, it radiates around to her back, along with having fatigue. She says she was told to see if anyone else reported this, she expected normal stuff like, flu stuff, this is not that. She says she is on her way to urgent care to have that looked at. She asks if condition persists, she is supposed to get her second dose on 12Feb, does she get it? She got her first dose last Friday (22Jan2021) then woke up Saturday and can't lift or pull anything and it really, really hurts. She says to add to this, which she talked to two doctors (docs) who said it was unrelated, that night she had a cut to the top of the roof of her mouth that had uncontrollable bleeding, she went to the emergency room for that and got a shot to help her coagulate blood, and will be seeing an ENT so hopefully that will be under control. No further details provided about shot to help her coagulate blood. She got the flu shot but that was Thanksgiving, way back, not recent. She is going to get her sinuses checked out, they did a CAT scan yesterday, and is going to the doctor for that 1Feb. She is concerned that the breast pain started last Saturday and is still really painful, she doesn't know why all of a sudden that happened, so she is going to the urgent care to see if they can do something for it, and will be getting an appointment with her OBGYN. For her right breast hurting, she took Tylenol and Ibuprofen, that is all she has done. Tylenol, LOT: PPAO33, EXP: Sep2022. Ibuprofen, LOT: 113132. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on 27Jan2021. Therapeutic measures were taken as a result of she had a cut to the top of the roof of her mouth that had uncontrollable bleeding she had a cut to the top of the roof of her mouth that had uncontrollable bleeding and right breast hurts. The outcome of the events was unknown.
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| 74 | 2021-02-10 | headache, malaise |
First I got the shot on the 3rd, that Saturday I ate breakfast and I got sick as a dog. I threw up m...
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First I got the shot on the 3rd, that Saturday I ate breakfast and I got sick as a dog. I threw up my whole breakfast. I have been throwing up every day since that day, every day and every thing I eat comes right back up. I can't keep any food in my stomach. I've got headaches, I've never had a headache in my life until I had these. The headaches are unbearable. I have not had a bowel movement since I had the virus and that's been how many days? Many. I can't sleep, I'm sick. I feel like heck, I'm scared to eat because everything I eat comes back up. I can hardly drink anything because I am diabetic, I barely drink any water. I'm a mess.
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| 74 | 2021-02-10 | lethargy | pt became lethargic, stopped eating. No fever; no nausea |
| 74 | 2021-02-11 | fever |
Achy whole body, abdominal area bloated/gas filled, fever of 101 deg (normal temperature runs 97.x) ...
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Achy whole body, abdominal area bloated/gas filled, fever of 101 deg (normal temperature runs 97.x) Lasted 2 1/2 days
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| 74 | 2021-02-12 | chills, body temperature increased |
Rash/welts developed over entire body (face, trunk, arms and legs) within 1 hour of receiving vaccin...
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Rash/welts developed over entire body (face, trunk, arms and legs) within 1 hour of receiving vaccine. Itching started that evening. Next day went to PCP who ordered 3 doses of prednisone 20mg and benadryl 25mg every 6 hours PRN. Day 2, rash/welts increased as well as itching. Evening of day 2, rash to legs progressed to purpura, temp of 102.7, chills and extreme pain to bilateral hips which prompted taking to ED and being admitted to progressive care unit.
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| 74 | 2021-02-14 | chills |
second shot given 2/5/21 at 0700 first vaccine given 1/15/21 lingering sx is no taste started on 1/1...
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second shot given 2/5/21 at 0700 first vaccine given 1/15/21 lingering sx is no taste started on 1/14/21 had chills and aches on 2/6/21... fatigue and body aches is improved
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| 74 | 2021-02-15 | headache, fatigue, body temperature increased, throat irritation, respiratory tract congestion, chills |
It began with a scratchy throat on Monday evening following the Saturday Vaccine and I ran a temp fo...
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It began with a scratchy throat on Monday evening following the Saturday Vaccine and I ran a temp for the next three days with it reaching a spike of 101. I also was congested and had chills, headache and extreme fatigue. Now I still get a slight evening temp and I'm still dealing with the congestion/allergy - especially in the evenings. It's now been about 10 days since receiving the first vaccine. I'm very nervous about receiving a second injection.
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| 74 | 2021-02-15 | headache, fatigue, fever | High fever, fatigue, headache |
| 74 | 2021-02-15 | fever |
About 15 minutes after vaccination, patient began to experience acute pyrexia and nausea. No vomiti...
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About 15 minutes after vaccination, patient began to experience acute pyrexia and nausea. No vomiting. No syncope. Vital signs within normal limits. Borderline tachy. No hypertension, but some shortness of breath and some lightheadedness.. After 1st vaccination , developed body aches and wrist burning on 2nd day. Taken to ED where BP 129/77, HR 80, O2 sat 97%. EKG showed NSR. Symptoms resolved on own.
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| 74 | 2021-02-16 | chills, fever | low fever chills aches nausea lasted 3 hours |
| 74 | 2021-02-16 | headache, chills |
First night (2/12 - 2/13): chills and tremendous thirst, vomiting 2/13 : vomiting subsides through...
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First night (2/12 - 2/13): chills and tremendous thirst, vomiting 2/13 : vomiting subsides throughout the day, body aches, headache 2/13 night: shortness of breath for about 6 hours; p02 = 84. Breathing better next morning and p02 back to 96; no more vomiting
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| 74 | 2021-02-16 | malaise |
During the 15 minute observation period, patient began to not feel well complaining of difficulty wa...
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During the 15 minute observation period, patient began to not feel well complaining of difficulty walking and a strange feeling in her legs. When she did not improve and continued to have difficulty walking, she was transported to the ER for continued monitoring and evaluation.
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| 74 | 2021-02-17 | fatigue, head discomfort, chills, dehydration, malaise |
Nausea; Dizziness and room spinning; room was spinning; her white blood cell count was elevated; Kid...
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Nausea; Dizziness and room spinning; room was spinning; her white blood cell count was elevated; Kidney failure and allergic reaction; Allergic Reaction; still wasn't feeling normal; Could not keep head up and was in bed; breathless; extreme fatigue; exhausted and weak; Heart was banging fiercely; Totally dehydrated; Urinating a great deal more; Chills, shakes and felt terrible; Chills, shakes and felt terrible; sicker every single day/sick/felt terrible; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on the left arm on 18Jan2021 14:30 at a single dose for prevention for COVID. Medical history included hip replacement on 04Jan2021 and fibromyalgia (When her children were younger, she was told she had Fibromyalgia). Family history includes diabetes (father late onset) and very rare cancer (mother). There were no concomitant medications. It was reported that the patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and got sick the next day (19Jan2021). She also mentioned that she got sicker every single day. Then after 8-9 days, she said she started to feel better, but still wasn't feeling normal. She said she had extreme fatigue, was breathless, and felt exhausted and weak on an unspecified date. She said she was supposed to receive the 2nd dose of the vaccine this Monday (unspecified date), but because of her side effects, she was told that she can come back to receive the 2nd dose after 6 weeks. She wants to know if this is acceptable. The patient reported that on 19Jan2021, she woke up in the middle of the night with chills, shakes, and felt terrible. She cancelled her plans for Tuesday (as reported). On Wednesday, she forced herself to get up and went out for lunch and came home. She could not keep her head up and went back to bed and that lasted several days. It got worse before it got better. She ended up being hospitalized for 4 days (25Jan2021 to 29Jan2021). It appeared to be she was in Kidney Failure and experienced allergic reaction on 25Jan2021 and her white blood cell count was elevated (unspecified date). She went to the ER and they kept her 6-8 hours and discharged her on a Friday and by Monday, she was admitted to the hospital. The first ER visit, she was there for 6-8 hours and they sent her home. They gave her IV fluids and took a lot of tests. The patient's first ER visit was on 22Jan2021, and was kept for 6-8 hours and released. She was given IV fluids and they did a lot of tests. She went to see her doctor and sent her to the emergency room. They took her blood, EKG and everything seemed ok. Creat was 1.0 and by Monday it was 1.6 and then on Friday it was 1.9 (unspecified dates). She was admitted to hospital on Monday and they gave her IV fluids and did kidney test and admitted her as soon as she could get a room. She never had a problem before with her kidneys. They did bacteria test and they were normal. The patient called her doctor on 24Jan2021, because she was nauseous, dizzy, and room was spinning and she felt worse. She went to his office on Monday morning and he put her right in the hospital (unspecified date). She got worse and now it is improved. Heart was banging fiercely on 22Jan2021 20:00. They took an Echocardiogram. She has never had a cardiac problem and could not find anything wrong with her heart. The patient started feeling a bit better. She was sick as can be through Sunday. By Tuesday (unspecified date), she was a little better and today is a little better. She is urinating a great deal more because of fluids, but later said it started the day after she got it. She had to get an aide to take care of her. The patient experienced totally dehydrated on 22Jan2021 14:00 and urinating a great deal more on 19Jan2021 03:00. Therapeutic measures were taken as a result of kidney failure, allergic reaction and white blood cell count was elevated. The outcome of the events sicker every single day/sick, chills, shakes and felt terrible was not recovered; event could not keep head up and was in bed recovered with sequel; events nausea, dizziness and room spinning, heart was banging fiercely, totally dehydrated, urinating a great deal more was recovering; while unknown for the rest of the events.
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| 74 | 2021-02-17 | fatigue |
A 74-years-old female patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, via an unspec...
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A 74-years-old female patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, via an unspecified route of administration on 27Jan2021, at 74 yeras of age, at single dose for COVID-19 immunization. The patient's medical history included allergy to codine. The patient was not pregnant at the time of vaccination. The patient has not been tested for COVID-19 since the vaccination. Concomitant medication included fluoxetine hydrochloride (PROZAC). On 27Jan2021 by 15:00 the patient felt extremely tired and her eyes burned a lot. The reported events resolved on an unknown date without any treatment. . Information on the lot/batch number has been requested.
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| 74 | 2021-02-18 | headache |
Day 1: pounding headache, radiating pain from top of head down the neck on the left side (pain scale...
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Day 1: pounding headache, radiating pain from top of head down the neck on the left side (pain scale 3-4) Day 2: pain on left side of head and neck intensifies to an 8-9 (treatment: ibuprofen), loss of mobility in face. (PCP emailed with no immediate response) Day 3: full loss of mobility and control on entire left side of face. Emergency room visit diagnosis: Bell's Palsy. Head neck pain persist (no more ibuprofen taken because of stomach pain) ER doctor prescribes 5 day course of Prednisone. Day 4-7: Bell's Palsy symptoms persist unchanged. (Treatment: Acupuncture, 2 visits) Pain on left side of head neck persist at a pain scale of 2-3.
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| 74 | 2021-02-21 | chills |
side effects started about 8 pm in the evening , my skin started to itch like crazy and broke out in...
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side effects started about 8 pm in the evening , my skin started to itch like crazy and broke out in hives all over my body but not on my face. The next morning i woke up and saw a dermatologist who said if sounded like it was from the injection. prescribed Allegra once a day and Benadryl 4 times a day. the next morning, my bottom lip was swollen. then my face broke out in hives in the evening and with i would wake up it was gone but i did have two puff pockets under my eyes. i called my primary care Dr. My Dr prescribed me the epi pen just incase she needed it. Friday i also had chills By Saturday i stated to improve. I was taking antihistamine and Benadryl together. By Sunday i started to take less of the Benadryl and by Monday i has stopped al together.
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| 74 | 2021-02-21 | headache, chills |
Cold chills,bad headache and lower back and neck ache/pain from 12:30 on the 18th till 19th then co...
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Cold chills,bad headache and lower back and neck ache/pain from 12:30 on the 18th till 19th then cold chill stopped back and head ache pain continues till Saturday 20th am Tylenol was taken didn't help much I continue to get slight headache as of today 22nd Monday fine now except slight head and back pain
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| 74 | 2021-02-21 | headache |
swollen neck, very limited head mobility (but improving), excruciating headaches; diagnosed at Emer...
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swollen neck, very limited head mobility (but improving), excruciating headaches; diagnosed at Emergency Department as bilateral posterior neck pain. The question I need answered is, IS IT WISE TO TAKE THE SECOND SHOT on 3/1?????
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| 74 | 2021-02-22 | fatigue | Extremely tired and aches all over. Slight upset stomach. No appetite. |
| 74 | 2021-02-23 | chills |
Extreme drop in blood pressure: Vaccine at 3:30 PM first drop @ 5:15 Pm to 84/51 HR 93; @ 5:50 PM 8...
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Extreme drop in blood pressure: Vaccine at 3:30 PM first drop @ 5:15 Pm to 84/51 HR 93; @ 5:50 PM 80/41 HR95; 7:00 PM 128/60 HR 50; 3:40 AM 85/46 HR 58-Irregular. This continued -the up 7 down till this writing (2/24 @ 9:30 AM). Also body aches, chills, barely able to move. No headache this time. Almost forgot - vomiting from 8:00 PM (2/23) till midnight (approx). I have vision difficulty from time of vaccination till now. I think that is all. General not feel goods!
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| 74 | 2021-02-23 | fever |
swollen neck lymph nodes five days after shot; My left arm was swollen; low grade fever; This is a s...
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swollen neck lymph nodes five days after shot; My left arm was swollen; low grade fever; This is a spontaneous report from a contactable consumer reporting for herself. A 74-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1283), via an unspecified route of administration (left arm) on 21Jan2021 15:00 at SINGLE DOSE for covid-19 immunisation. Medical history included cholesterol (abnormal) from an unknown date. Patient is not pregnant. No other vaccines were given in four weeks. Patient did not have COVID prior vaccination and patient was not tested for COVID post vaccination. Concomitant medications (medications in two weeks) included pravastatin from unspecified date for cholesterol (abnormal); estrogens conjugated (PREMARIN), allopurinol (ELAVIL), ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10), aminobenzoic acid, biotin, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (B COMPLEX) from an unspecified date for an unspecified indication. The patient experienced low grade fever on 25Jan2021 that went away but the following morning on 26Jan2021, the patient also experienced swollen neck lymph nodes five days (five days as reported) after shot. Patient stated she does not know if it was going away. Patient's left arm was also swollen on 26Jan2021. Left arm was described as swollen just little bit, not much but that's gone down. The patient stated there was no fever as of reporting, but the swollen lymph node was being reported and since she has been up, it's gone down considerably but she can just feel them a little bit on her neck. Treatment was not given. She mentioned she has a person coming to do a work at the house and wanted to know if it is okay if she still comes. She asked if she should be alarmed about the side effect. She mentioned she was just concerned about if she needs to be concerned about this or if she can be around people. She mentioned she wear masks anyways but just need to know if it is okay if people come into her home. Outcome of the events low grade fever and left arm was swollen was recovered on Jan2021, while unknown for swollen neck lymph nodes five days after shot.
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| 74 | 2021-02-23 | fever |
12 hours after injection, I got nauseated, flushed, low grade temperature, racing heart, did not sle...
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12 hours after injection, I got nauseated, flushed, low grade temperature, racing heart, did not sleep entire night.
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| 74 | 2021-02-24 | fatigue | On Sunday i started to get Very light headed and off balance and very very tired. |
| 74 | 2021-02-24 | head discomfort |
on 2/24/21 noted discomfort starting on scalp on top of head going down to left eyebrow, onto left o...
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on 2/24/21 noted discomfort starting on scalp on top of head going down to left eyebrow, onto left orbit down face on left side of nose, also a fever blister on bottom lip starting 2/22/2021,discomfort continues. have not called M.D. Lysine ointment on lip. no other treatment
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| 74 | 2021-02-24 | fever, headache |
Feb. 19 upon going to bed about 10:00; muscle aches in shoulders, arms, legs, knees. Feb 20 upon wak...
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Feb. 19 upon going to bed about 10:00; muscle aches in shoulders, arms, legs, knees. Feb 20 upon waking about 5:00AM; headache, continuation of pain muscles and joints, fever 101.3. Feb22 I don't know if related to vaccine, but fever blisters.
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| 74 | 2021-02-25 | headache, fatigue, chills |
I had heavy chills from 6pm on the 24th until 2am on the 25th. Then, more heavy chills from 6am on ...
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I had heavy chills from 6pm on the 24th until 2am on the 25th. Then, more heavy chills from 6am on the 25th until 1 pm on the 25th. My headache was moderate but relentless throughout those days and into the 27th. I was extremely tired, having no energy or interest in doing anything but lying down. My body ached all over and I was somewhat dizzy and nauseated. I took a Tylenol during the night of the 25th. Today is the 26th and I am still very tired and my eyes are bleary.
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| 74 | 2021-02-25 | headache, fever, chills, fatigue |
WEEK 1: fever, chills, headache, weakness WEEK 2: fever, chills, migraines, weakness, GI symptoms WE...
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WEEK 1: fever, chills, headache, weakness WEEK 2: fever, chills, migraines, weakness, GI symptoms WEEK 3: periodic chills, periodic headaches, weakness, periodic exhaustion, GI symptoms, elevated pancreatic enzymes WEEK 4: weakness, GI symptoms, shortness of breath, exhaustion, heart block
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| 74 | 2021-02-25 | malaise, fatigue |
I was fine the first day. The 2nd day I wasn't feeling well, my stomach was bothering me. At 8:30 PM...
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I was fine the first day. The 2nd day I wasn't feeling well, my stomach was bothering me. At 8:30 PM I went to bed because I didn't feel good, I laid in bed for a few minutes and then jumped up because I began to violently vomit. After I vomited I felt weak, I was sitting with my back against the wall my husband came to check on me. He walked away and when he came back I was unresponsive, laying on the floor and he said my eyes rolled in the back in of head. He called 911. I was unresponsive for about a 1-2 minutes. EMS arrived, by the time they had arrived I had crawled into bed, and they took my vitals and they were fine, they asked me if I wanted to go to the hospital but I declined as I was afraid to go. I went to sleep. The next day I felt weak and tired, I had a burning feeling in my stomach, I took some TUMS, I didn't much that day. I rested most of the next day. Yesterday I felt a little better and today I am fine. I have a doctor's appointment 2/26/2021 at 2PM to see the ARNP at my doctor's office.
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| 74 | 2021-02-25 | fever, headache, chills | Sore arm headache muscle aches fever chills |
| 74 | 2021-02-26 | chills, fatigue |
I have been very sick to my stomach, tired, weak, shaky, nauseas, loose stool, stomach cramps, chill...
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I have been very sick to my stomach, tired, weak, shaky, nauseas, loose stool, stomach cramps, chills and an all over listless feeling that started about 18 hours after I received vaccine and still remains 4 days later
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| 74 | 2021-02-26 | chills | Chills gone next morning |
| 74 | 2021-02-26 | fatigue, runny nose |
15 minutes after injection, clear nasal drainage. 30 minutes after injection, more clear nasal drain...
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15 minutes after injection, clear nasal drainage. 30 minutes after injection, more clear nasal drainage and slightly bloody nostril. Tired in evening of injection, slight soreness right are. Next day, up performing usual home kitchen activities, reading, making and drinking coffee. Then SUDDENLY at exactly 23 hours after the injection, began experiencing extreme difficulty breathing, unable to speak in full sentences. Called Primary Providers Office and was directed to go to an emergency room ASAP.
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| 74 | 2021-02-26 | sweating, chills |
PALPATATIONS, SWEATY HANDS, BODY TINGLING. PALPATATIONS RESOLVED PATIENT STILL FELT COLD AND CHILLS ...
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PALPATATIONS, SWEATY HANDS, BODY TINGLING. PALPATATIONS RESOLVED PATIENT STILL FELT COLD AND CHILLS STARTED. SHE WAS SENT TO THE ED FOR EVAULATION.
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| 74 | 2021-02-27 | chills | Chills 2nd day: Sciatica seizing up hips area. Joint pain in both knees |
| 74 | 2021-02-27 | fatigue, chills |
Severe fatigue; loss of muscle strength; loss of energy; chills; occasional tremors; full-body rash....
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Severe fatigue; loss of muscle strength; loss of energy; chills; occasional tremors; full-body rash. Treatment - bed rest. Outcomes - OK after 4 days.
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| 74 | 2021-02-27 | fatigue, chills |
Tested positive for COV2T antibodies on 1/18/2021. Starting 1/31/21: Severe fatigue; loss of muscle ...
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Tested positive for COV2T antibodies on 1/18/2021. Starting 1/31/21: Severe fatigue; loss of muscle strength; loss of energy; chills; occasional tremors; full-body rash. Treatment - bed rest. Outcomes - OK after 4 days.
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| 74 | 2021-02-27 | fatigue, fever, chills |
Extremely sore arm that night; fever of 100.7, miasma, tired, chills, did not sleep; Tired all the n...
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Extremely sore arm that night; fever of 100.7, miasma, tired, chills, did not sleep; Tired all the next day with a fever at 5pm of 100.5; Sunday no temperature but loss of taste, diarrhea, stomach discomfort.
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| 74 | 2021-02-27 | headache | Severe headache, nausea and vomiting |
| 74 | 2021-02-28 | headache, fatigue |
rapid heart beat; headache; pain in her arm at the injection site; quivering in chest and palpitatio...
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rapid heart beat; headache; pain in her arm at the injection site; quivering in chest and palpitations; quivering in chest and palpitations; lightheadedness; tired; anxious; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 1st of two reports. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date: May2021), via an unspecified route of administration on 22Jan2021 at 15:30 at a single dose on left arm for COVID-19 immunisation. Medical history included triglycerides high, obesity, blood clotting issues, thyroid disorder and blood cholesterol abnormal from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, rosuvastatin calcium, aspirin (acetylsalicylic acid) and vitamin D3. The patient experienced rapid heartbeat, headache, quivering in chest and palpitations, lightheadedness, pain in her arm at the injection site, tired on 23Jan2021 and anxious on 22Jan2021. The patient stated that on Saturday (23Jan2021), she noticed pain in her arm at the injection site, a headache, and feeling of like she was quivering in her chest. She was also experiencing palpitations, lightheadedness, and periods of rapid heartbeat. On Monday, the symptoms were a little less but yesterday and today she has had a lot of palpitations, quivery feelings in her chest and rapid strong heart beats. On Saturday, she took an aspirin for headache. On Sunday, she had just a mild headache and by Monday (25Jan2021) it was gone. She wanted to know if these are normal reactions and if she should call the doctor, or what she should do about them. The patient underwent lab tests and procedures which included blood triglycerides: high and body mass index: high on Jan2021; heart rate: rapid on 23Jan2021. Therapeutic measures were taken as a result of headache. The outcome of the events pain in her arm at the injection site and headache was recovered on 25Jan2021, while of the rest was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021116966 same reporter/drug, similar events, different patient
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| 74 | 2021-02-28 | headache, sleepiness, fatigue |
Sunday morning I woke up 5:30am with a mild headache. I had a cup of coffee & toast and 5:45 took ...
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Sunday morning I woke up 5:30am with a mild headache. I had a cup of coffee & toast and 5:45 took 1 500mg Tylenol. Felt sleepy, so went back to sleep. I took Tylenol 6 hours later, but this time added 2 tablets of cold calm. Then did drink water throughout the day. Slept afternoon and felt a bit better by 5pm. Took an other Tylenol at 8pm and did not take cold calm. Woke up 5:10 Monday morning, feeling much rested and no headache. I see my Primary Doctor on Thursday and will tell her my reaction.
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| 74 | 2021-02-28 | headache | headache, full body aches for 36 hours |
| 74 | 2021-02-28 | fever, chills |
At 10am on Thursday February 25, I SUDDENLY experienced the onset of violent chills, shaking so hard...
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At 10am on Thursday February 25, I SUDDENLY experienced the onset of violent chills, shaking so hard I couldn't initially place a thermomenter in my mouth. Moments later, this was accompanied by throbbing pain in my lower back. Eventually I was able to take my temperature and I had fever. My daughter contacted my primry care physician who told us to go the emergency room. By the time we went to hospital, the chills had stopped as well as the lower back pain. I was quarantined (though they knew I had been vaccinated for COVID) until they tested me for COVID, the test came back negative in an hour. They did a number of tests and I was discharged around 6:00 pm that evening
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| 74 | 2021-03-01 | chills | I got chills the day after the shot. It happened mid day for 3 hours. |
| 74 | 2021-03-01 | chills |
about 4 hours after the shot I realized my heart was racing and my throat felt ticklish. I also noti...
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about 4 hours after the shot I realized my heart was racing and my throat felt ticklish. I also noticed that the insides of both forearms were a bluish mottled color. Then I started uncontrollable shivering that lasted about 90 minutes. We went to the ER within 15 minutes of symptoms starting.
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| 74 | 2021-03-01 | dehydration |
75 yo female on plavix here for second covid without any issues with first covid c/o lightheadess 1...
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75 yo female on plavix here for second covid without any issues with first covid c/o lightheadess 18 min after second covid. pt admitted to poor hydration . vital sign stable and exam unremarkable lightheadness resolved after drinking bottle water
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| 74 | 2021-03-01 | fatigue |
With the first vaccine on 1/29/21 I feel slight soreness at injection site and itching all over abou...
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With the first vaccine on 1/29/21 I feel slight soreness at injection site and itching all over about eight hrs after which lasted a day. With the second vaccine on 2/16/21 I felt itching after about six hours for a day and took Benedyl and tylenol. In the 21th I began to be sore all over, my knees, back, shoulders, ached and it was painful to rise from a seated position. It was all my joints were inflamed. I did not have a temperature, my blood pressure went down to 119/55. I am taking warm baths, tylenol, and waiting for the pain to subside. I also feel fatigued. I will call my primary Doc if I don't continue to improve.
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| 74 | 2021-03-01 | headache, chills, sweating |
sweating; Chills; AFIB; Heart rate racing; Lightheadedness and dizzy and felt like she would pass ou...
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sweating; Chills; AFIB; Heart rate racing; Lightheadedness and dizzy and felt like she would pass out.; Nausea; Muscle ache; Headache; Second dose arm hurt at injection site; compromised immune status; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), intramuscular at arm left on 13Feb2021 at 10:30 (at the age of 74 years) at single dose for COVID-19 immunization. Medical history included primary biliary cholangitis (PBC, autoimmune condition and was diagnosed 10 years ago), diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, diabetes and obesity, all from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular at arm left on 24Jan2021 and experienced sore arm. The patient experienced headache and arm hurt at injection site, both on 13Feb2021 at 19:00; heart rate racing, AFib, lightheadedness and dizzy and felt like she would pass out, all on 14Feb2021 at 07:30; nausea, muscle ache, both on 14Feb2021 at 03:00, chills on 14Feb2021 at 15:00 and sweating on 14Feb2021 at 16:00. The patient outcome of the events was recovering.
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| 74 | 2021-03-01 | headache, chills |
Day 1 and 2 no redness or swelling at site. Slight headache and chills day 1. Day 3 swelling, redn...
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Day 1 and 2 no redness or swelling at site. Slight headache and chills day 1. Day 3 swelling, redness and itching at site. No improvement on day 7. No pain associated or other symptoms. Just red, itchy, and large lump above injection site. Using Benadryl cream on the site.
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| 74 | 2021-03-01 | lethargy |
Dizziness for two days, lightheaded ness for the next 5 days ,nausea for 5 days, vomiting, 1 day, le...
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Dizziness for two days, lightheaded ness for the next 5 days ,nausea for 5 days, vomiting, 1 day, lethargic 6 days. Unable to eat, 4 days In bed because of mentioned symptoms, 6 days Took Ibuprofen as tolerable Took anti nausea OTC. Called the doctor twice and was told to ? hang in there?. Have never felt worse for so long in my lifetime.
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| 74 | 2021-03-02 | chills, headache, fever |
Fever; Chills; Aches and pains; hurting all over; Headache like my head was going to explode; This i...
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Fever; Chills; Aches and pains; hurting all over; Headache like my head was going to explode; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3302; expiration date: unknown) at vaccination age of 74-year-old via an unspecified route of administration on 19Jan2021 at a single dose for covid-19 immunization. Medical history included type 2 diabetes, autoimmune thyroid disease and complex migraine (migraine chronic, complex migraine). The patient's concomitant medications were not reported. The patient reported that last Friday (29Jan2021, also reported as two weeks later), she got a fever, chills, aches and pains. She was hurting all over and she had a headache like her head was going to explode. So, she wanted to know could that be a delayed reaction to the shot (vaccine). The patient mentioned that treatment for the problems included acetaminophen, butalbital, and caffeine (FIORICET). The outcome of the events was unknown.
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| 74 | 2021-03-02 | fatigue |
a rash all over [her] body; A swelling face; Being tired; This is a spontaneous report from a contac...
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a rash all over [her] body; A swelling face; Being tired; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, batch/lot number and expiry date unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient experienced a rash all over her body, a swelling face, and being tired on an unspecified date after receiving the first dose of the COVID-19 vaccine. She said that her throat was ok, hadn't itch and she doesn't have a fever. The outcome of the events was unknown. Information about batch/lot number has been requested.
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| 74 | 2021-03-02 | headache, fatigue |
light headed; slight headache; tired; Upper arm became sore and a bit swollen/Upper arm more swollen...
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light headed; slight headache; tired; Upper arm became sore and a bit swollen/Upper arm more swollen and sore.; Upper arm became sore and a bit swollen/Upper arm more swollen and sore.; Did not sleep well overnight (always do) and woke up very tired; sick to stomach; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3248, expiry date not reported), via an unspecified route of administration in the left arm on 30Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included Raynaud's phenomenon. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received fluvastatin sodium (LESCOL) and experienced drug hypersensitivity, and nifedipine (ADALAT) and experienced drug hypersensitivity. On 30Jan2021 17:30, in the evening the patient became light headed, had a slight headache and was tired. Her upper arm became sore and a bit swollen. She did not sleep well overnight (always do) and woke up very tired, sick to stomach. Her upper arm was more swollen and sore. No therapeutic measures was taken as a result of the events. Clinical outcome of the events was recovering.
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| 74 | 2021-03-02 | headache, malaise |
Nauseated; Fogginess; Light headache; Just not feeling general malaise, Do not feel good; This is a ...
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Nauseated; Fogginess; Light headache; Just not feeling general malaise, Do not feel good; This is a spontaneous report from a contactable nurse (patient herself). A 74-year-old female patient BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EN5318, Expiry date: 31May2021), via an unspecified route of administration on left deltoid, first dose on 30Jan2021 13:30 at single dose for COVID-19 vaccination. Medical history included condition on thyroid from an unknown date and unknown if ongoing for thyroid. Concomitant medication included levothyroxine. Patient had given her side effects. She had her vaccine 2 days ago (30Jan2021 13:30). She have had fogginess and have been nauseated, light headache and just not feeling, general malaise, all on an unspecified date in 2021. Due date of Second Vaccine was on 20Feb2021. Treatment in response to the event was trying to get liquids and rest. She got the vaccine at an hospital. Patient had a thyroid test, CBC test and a CMP, they are all normal and had COVID test that was negative on unspecified dates. The action taken in response to the event was unknown.
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| 74 | 2021-03-02 | headache |
Bad headache; This is a spontaneous report from a contactable consumer (patient). A 74-year-old fem...
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Bad headache; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL8920, expiry date unknown), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. Medical history included COVID from Nov2020 to an unknown date. The patient's concomitant medications were not reported. The patient stated that she had a very slight case of COVID in Nov2020 and her family doctor told her about three weeks ago that she needed to get the vaccine. However, he did not tell the patient that she needed to wait 90 days from when she had COVID (as reported). So, she got the Pfizer vaccine about two months and a week after she had COVID itself. Ever since about five days after she had the vaccine, on an unspecified date in Jan2021, she came down with a bad headache and have had a headache since that day. She is on day nine of a headache and this is the headache that require medication. It is not the headache that you think is going way because it has not. She wanted to know if she got the headache because she got the vaccine too soon after having COVID. The patient got medicine for the headache because she had to go to the emergency room for the event. She had blood work done on an unspecified date but had unknown results. The outcome of the event was unknown.
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| 74 | 2021-03-02 | fever, chills, headache, malaise |
12 hrs after shot I was suddenly sicker than I?d ever been in my life: body shaking chills, fever, ...
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12 hrs after shot I was suddenly sicker than I?d ever been in my life: body shaking chills, fever, headache, body aches. Today I still have fever, body aches, head ache, diarrhea. Haven?t been able to eat.
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| 74 | 2021-03-02 | fever, headache, chills |
Fever 99.6, headache (similar to sinus headache) body aches, chills all day, next day headache rema...
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Fever 99.6, headache (similar to sinus headache) body aches, chills all day, next day headache remains took Tylenol
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| 74 | 2021-03-02 | fever, headache, cough, chills |
fever, chills, HA, vomiting, diarrhea, chest tightness, SOB, nonproductive cough; received 1000 mg a...
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fever, chills, HA, vomiting, diarrhea, chest tightness, SOB, nonproductive cough; received 1000 mg acetaminophen, GI cocktail, liter ND, liter LR, zofran on discharged, mild tacyhpnea with accessory muscle usage (minimal); abdominal tenderness in epigastric area,
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| 74 | 2021-03-02 | fever |
chest pains; fever over a 100°F; AFib; diabetic; COPD; stomach issues; This is a spontaneous report...
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chest pains; fever over a 100°F; AFib; diabetic; COPD; stomach issues; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received first dose on 25Jan2021 and experienced health issues in Jan2021 as AFib, diabetic, COPD, stomach issues, and reported to "have a lot of issues". The primary doctor thought it's better for her to get the dose than get COVID-19. Patient also reported that about 20 minutes after the first dose on 25Jan2021, patient had chest pains, from one side clear across the other side and took a Nitro, and patient had fever over a 100 degree F for 24 hours. The outcome of the events was unknown. Information on about lot/batch number has been requested.
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| 74 | 2021-03-03 | chills | Woke up Whole body and hands uncontrollably shaking Chills shaking |
| 74 | 2021-03-03 | fatigue, body temperature increased, headache |
Swelling; Redness moved from actual site down my arm about 6 to 7 inches; Hot to touch area on right...
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Swelling; Redness moved from actual site down my arm about 6 to 7 inches; Hot to touch area on right arm; A little headache at the back of the head; Itching; More pain when l lift my arm, my arm pits/Hurting under her arm when she was lifting; Swollen glands; My temperate was 100.8; had difficulty lifting her right arm; Tired, very tired; Tenderness at vaccinate site; More pain when l lift my arm, my arm pits/pain in arm/pain in her right arm/a lot of pain; I feel tugging and redness when I raise my arm, It's not red its blotchy; I feel tugging and redness when I raise my arm, It's not red its blotchy; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscularly at site of right arm on 28Jan2021 at single dose for COVID-19 immunisation. Medical history included (synthroid: Taking for years), prevent urinary tract infection (UTI) (methenamine: started a year and a half ago), vitamin supplementation (Preservision Areds 2 eye vitamins more than a year ago; Vitamin C with Zinc 8-9 months ago), dry eyes (Thera tears: dry eye therapy. she has not been consistent with taking), cholesterol (simvastatin: taking 20 years or more), allergic to Sulfa Drugs and Tetracycline, obesity (had been fighting it for 30 years), removed polyps (had a flat polyp that was a little more dangerous the first time and it was removed; non-cancerous), got the flu (08Jun months later, got the flu, went to the hospital and developed PNA) and eczema (took calcium 1200mg). Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid; methenamine for prevent UTI; ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2) for vitamin supplementation; ascorbic acid, zinc (VITAMIN C WITH ZINC) for vitamin supplementation; carmellose sodium (THERA TEARS) for dry eyes; simvastatin for cholesterol; calcium for eczema. The patient previously took Flu vaccine (Injection site was left arm, intramuscularly) in Oct2018 and experienced pain in injection site and redness in arm; took the first dose of BNT162B2 with lot number: EL3246, intramuscularly in left arm site at 09:00 on 08Jan2021. Clinical course: After the second dose of vaccination, patient noticed tenderness at vaccinate site at 13:00 and had pain in arm on 28Jan2021, but on 29Jan2021, the pain was worse, and she had difficulty lifting her right arm at 16:00. On 30Jan2021, she started noticing more pain when she lifted her arm, her arm pits, it was hurting under arm when she was lifting. She thought maybe there were swollen glands but did not feel it. her temperate was 100.8, and she took some paracetamol (TYLENOL), by the evening, her temperature was at 98.6 normal. On 31Jan2021, she noticed a lot of pain, itching and redness, redness moved from actual site down her arm about 6 to 7 inches at 14:00. The pain in her right arm was not as bad as it was, but the redness in the area and itching was there, it was hot to touch area on right arm, and she tried cold compresses and took paracetamol. Also, it was hurting under her arm when she was lifting. She experienced something like that before with a Flu vaccine. She noticed when she looked it up, the information states, yes. And it was still going on today, not so much pain, just swelling and redness, looked like what Moderna calls a covid arm. She had no temperature, a little headache on 31Jan2021 at the back of the head and tired, very tired, she was tired from 29Jan2021, and was better from 01Feb2021. She took paracetamol last night, and cold compress. she used to take baby aspirin; she didn't know if it would be a problem. She read not to take paracetamol or ibuprofen before vaccination. She felt tugging and redness when she raised her arm, it was not red its blotchy. She didn' t feel any swelling. The last 7 to 8 months, she was running high blood counts, 12.3 (high) and she had no infection, her doctor was a little nervous, the last one on 15Jan2021, it was down to 10.2 within normal range. Her immune system was very active. She had a flu shot in Oct2018 at age of 72 y/o and by 08Jun months later, she got the flu. She went to the hospital and developed PNA. In 2019 and again this past Aug2020, she had a Colonoscopy where they removed polyps. She had a flat polyp that was a little more dangerous the first time and it was removed. It was non-cancerous. The doctor was just watching it. Last blood results were 2 weeks prior to having first shot on 15Jan2021. The only thing that showed was her Liver enzymes were a little elevated. She was told that if she hadn't gotten the vaccine, it would have been worse, her doctor gave me the zpack. They were calling it a subcutaneous sensitivity, she had eczema, she forgot to mention that. She was taking calcium 1200mg, she forgot to tell her that also. The outcome of events pain in arm, redness and feeling hot was not recovered; of events tiredness, body temperature increased, itching and headache was recovering; of rest events was unknown.
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| 74 | 2021-03-03 | fatigue, malaise |
pain in her arm; tired; feeling unwell; This is a spontaneous report from a contactable nurse (patie...
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pain in her arm; tired; feeling unwell; This is a spontaneous report from a contactable nurse (patient). A 74 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration (on left arm) on 27Jan2021 13:30 (at the age of 74-years-old), single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had the vaccine last Wednesday. Since then she has had pain on her arm mostly on the upper side of the arm. She took Tylenol and it went away. Adds she felt so tired and generally unwell, like the flu. Mentions it is like muscle pain in her left arm that come back whenever she moves around. All of this started on Wednesday. Adds it is not that severe, like if you have the flu. Mentions she does get muscle pain sometimes when she is working around the house but this is different. She is scheduled for the second dose of the vaccine 17Feb2021. She is starting to get worried about taking the second dose of the vaccine if it is going to be like this and wants to ask about that. She received the first dose of the vaccine on 27Jan2021 at 13:30PM in the left arm. That night, Wednesday night she noticed the pain in her upper arm. She took Tylenol and then the morning it went away. Friday it came back and she took Tylenol again and it went away. But when she works or walks around there is pain again. Seriousness not provided. The event pain in her arm was assessed as recovering, other events recovered on 31Jan2021. Information on the lot/batch number has been requested.
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| 74 | 2021-03-03 | fatigue, throat pain, chills, headache |
Within 4 hrs of receiving the vaccine (on Saturday), developed headache, fever, chills, sore throat,...
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Within 4 hrs of receiving the vaccine (on Saturday), developed headache, fever, chills, sore throat, sore arm, fatigue. Symptoms faded during following day (Sunday) and by Monday left only with fatigue which resolved by Tuesday.
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| 74 | 2021-03-03 | fatigue |
I had some of the listed side effects. i.e., pain and redness at injection site and fatigue. However...
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I had some of the listed side effects. i.e., pain and redness at injection site and fatigue. However, by Feb 21 noticed swelling under my armpit on the left side as well as somewhat swollen nodes in the left side of my neck. The swelling under my arm became worse over the next two days. When I raised my left arm I felt considerable pain. Over the next 2 days I also had swelling in my left forearm near bend in my elbow. I also had a rash the size of a patch above the injection site. I looked this issue up online and found reports that approximately 16% of women who had received the 2nd Covid shot experienced swelling under the armpit. I contacted my doctor by e mail . I switched from taking tylelnol to advil. All side effects are gone except there is still a little swelling in armpit. I contacted my Doctor and will see her on March 15th if the swelling is not gone.
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| 74 | 2021-03-03 | lethargy, fever |
Severe pain (entire arm) and redness; feverish/temperature fluctuations-highs and lows for her; extr...
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Severe pain (entire arm) and redness; feverish/temperature fluctuations-highs and lows for her; extreme itching at site; lethargy; reporter let person know these events not terribly unusual, vaccinee (sp?) wanted to report because continuing to have this
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| 74 | 2021-03-03 | malaise |
Had the runs (diarrhea); Felt numbness in my cheek; Getting nauseous; Not feeling good. Cant do too ...
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Had the runs (diarrhea); Felt numbness in my cheek; Getting nauseous; Not feeling good. Cant do too much of anything, just sit/ sick; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient (also age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9269), intramuscular from 30Jan2021 17:00 (5pm) in the left arm at SINGLE DOSE for covid-19 immunization. The patient was vaccinated at a Pharmacy (Pharmacy/drug store). Medical history included ongoing thyroid condition diagnosed at least 10 years ago. Concomitant medication included levothyroxine (LEVOTHYROXINE) at 50mcg tablet once a day by mouth (Taking it for years) for Thyroid/ thyroid condition. For prior vaccinations: The higher dose, senior dose of the flu shot (for immunization), she stopped taking it when the lower dose came out. She gets very sick with the senior dose. She does not know the name and does not have lot number of the senior dose of the flu shot to provide. It was stated to the patient that there may be too much protein in it. The patient is asking if she should get 2nd dose after having negative experience post vaccination of 1st dose. The patient received first dose of vaccine on sat (30Jan2021) evening. It was reported that as soon as she got to her car, "I thought I felt numbness in my cheek. It didn't stay, went right away. My husband thought i was just nervous. It was also stated that she then started "getting nauseous" about 30min after vaccine. The patient has "been sick since I had it.. not sure if its normal? It was also reported that she "had the runs" (diarrhea) for one day, that has now resulted. It was also said that "I'm not feeling good. cant do too much of anything, just sit". The patient asked if this is normal and "when will I feel better"? It was also reported as she had the first dose of the Pfizer covid vaccine late Saturday afternoon at 5pm. She has been feeling nausea and sick since then. She asks if this is normal and how long it will stay. The treatment used was taking Tylenol. It was noted that if she does not do anything and lays down it will go away but if she starts doing too much she will get real nauseous again. It was added that the patient and her husband went to get the vaccine on the same day. It was noted that she felt a little numbness on her face, in her right cheek and then it went away after 20 to 30 seconds. Her husband said she may have been nervous and may have caused that herself. She is a hyper type. The outcome of the event Felt numbness in my cheek recovered on 30Jan2021; for all other events was unknown. There was no additional vaccines administered on same date. No events requires visit to emergency room or physician office. No prior vaccinations (within 4 weeks) reported.
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| 74 | 2021-03-03 | fever, headache, chills |
initially had low grade fever, headache, chills that started 6-8 hours after the vaccine then abated...
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initially had low grade fever, headache, chills that started 6-8 hours after the vaccine then abated, went for routine physical examination and found to be hypertensive, BP over 140 systolic taken 3 times in the primary care physician's office. Later began doing BP monitoring at home, BP running from 130-140 with a high of 154 systolic, diastolic 70-78. There have been no associated headaches, dizziness, etc.
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| 74 | 2021-03-04 | chills, headache |
Felt like the flu that night & all the next day. Achey, painful joints, off-balance slightly, chill...
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Felt like the flu that night & all the next day. Achey, painful joints, off-balance slightly, chills, no fever that i know of, headache, extremely painful left arm up & down, into shoulder & scapula. . Stayed home all day., took Tyleno, benedril dye free the day after injection when feeling so bad
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| 74 | 2021-03-04 | fatigue, fever, headache | Low grade temperature, muscle aches, fatigue, mild headache. |
| 74 | 2021-03-04 | headache, chills | headache, body aches and serve chills |
| 74 | 2021-03-04 | headache |
2nd Shot, 2nd day headache, bad muscle ache, third day slight headache redish injection site, fourth...
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2nd Shot, 2nd day headache, bad muscle ache, third day slight headache redish injection site, fourth day bad headache, indigestion and bad diarrhea. Injection site large red, purple, orange (size 2-1/2 " x 1-1/2" very sore. Today, 3/5; reaction site sore but brusing fading. Feel good. 1st Shot was slightly sore arm. Never had fever, cough, chills or vomitting. *** DID NOT CONTACT DOCTOR; WAS NOT EMERGENCY. Just felt like I had flu but thought I should report bad arm reaction.
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| 74 | 2021-03-04 | headache |
After injection, that night woke up with a blinding headache but it has gone away. Swollen, burning,...
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After injection, that night woke up with a blinding headache but it has gone away. Swollen, burning, itching, soreness and can't sleep on that side.
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| 74 | 2021-03-04 | headache | Joint pain mild headache |
| 74 | 2021-03-04 | headache |
After receiving her vaccine client stated that she has headache and dry throat. Vital signs obtaine...
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After receiving her vaccine client stated that she has headache and dry throat. Vital signs obtained by EMS BP 163/83, HR 79, O2 sat 96% Client states she feels better. Client discharged home by EMS.
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| 74 | 2021-03-04 | malaise, fatigue, headache |
Almost threw up last night; joint pain; Few little odd pains; soft pain that make her feel weak and ...
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Almost threw up last night; joint pain; Few little odd pains; soft pain that make her feel weak and then go away; Nauseous; No dizziness, but unsteadiness; Tired; Headaches; began to feel a little bad/ generally didn't feel well/Malaise; Feels like the stomach flu; Weak; Gentle muscle ache; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via an unspecified route of administration on 28Jan2021 15:30 in left arm at single dose as Covid vaccine, etanercept (ENBREL, 50 mL/mg, Solution for injection in pre-filled pen, lot number: 1119808, expiry date: Apr2023) via an unspecified route of administration from an unspecified date and ongoing at 1 DF weekly to the stomach area for rheumatoid arthritis, methylprednisolone (MEDROL, tablet) oral from an unspecified date and ongoing at 3 mg, daily (1.5 tablets daily for total of 3 mg) for rheumatoid arthritis, methotrexate (tablets) oral from an unspecified date and ongoing at 20 mg, weekly (2.5 mg tablets, 20 mg total) for rheumatoid arthritis. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic or chromosomal abnormalities, endocrine abnormalities (including diabetes and obesity) and took levothyroxine, rheumatoid arthritis. She had had regular blood work for rheumatoid arthritis and that was normal for her, they were relatively normal and her ESR was down. No additional vaccines administered on same date of BNT162B2. No other vaccines given the same day or 4 weeks prior. The patient's concomitant medications included levothyroxine daily for endocrine abnormalities. It was a daily thing for the body and the body couldn't live without it if it did not have it. The patient previously took the Shingrix vaccine and it was terrible for her and put her into a rheumatoid arthritis flare and was taking prednisone and was getting better and the wap she was in a rheumatoid flare. No prior vaccinations received within 4 weeks prior to the first administration date of the suspect vaccine. The patient was taking 3 medicines for rheumatoid arthritis that might or might not affect the RNA in the vaccine. She wondered if etanercept would have an effect on the vaccine since it was shipped on ice overnight. She did not think they would affect anything. Nobody has said anything about the medications and she just wanted to get the vaccine. Her doctor knows nothing about the interactions and none of them seem to know if it is normal to have these symptoms 4 days after getting the vaccine. She felt great the first 2 days after getting the vaccine and then began to feel a little bad. She was having some symptoms maybe 4 days on 01Feb2021 after receiving the Covid vaccine and wanted to know if that was sort of normal. It was unusual for her, but she had nauseous, not dizziness, but unsteadiness, tired, also headaches and generally didn't feel well. She felt like she might have the stomach flu, but had not had that in so many years. She also felt weak. No temperature. Gentle muscle ache. On 01Feb2021 Monday night she had the nausea. On 02Feb2021 Tuesday, she had it again, and had it again today and almost threw up last night. Just the malaise or tiredness had gotten worse. She could not tell the difference between the rheumatoid arthritis, joint pain and muscle pain and this with the vaccine. She was having a few little odd pains, but nothing that she hadn't had before. It was more of a soft pain, they made her feel weak and then they went away. It was more muscle than joint. The events did not require a visit to emergency room or physician office. She was supposed to get a second dose but felt she shouldn't, it might put her back into a rheumatoid flare. She was just getting over it and afraid to go through that with the Covid vaccine also. The action taken in response to the events for etanercept, methylprednisolone and methotrexate was dose not changed. The outcome of events nausea, unsteadiness, tired (tired was reported as worsened), generally does not feel well, feels like the stomach flu, weak, few little odd pains; soft pain, joint pain was not recovered, of other events was unknown.
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| 74 | 2021-03-04 | fever, cough, headache, fatigue |
24 hours after vaccine given fever of 102 chills, loss of appetite body aches head ache cough loss ...
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24 hours after vaccine given fever of 102 chills, loss of appetite body aches head ache cough loss of taste and smell extreme tiredness. Lasting 8 days with cough still present. Took Tylenol, doctor did a Covid test with negative results. I had Covid 19 previously in November 2020 with same symptoms lasting 14 days
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| 74 | 2021-03-05 | headache, chills, fever |
Pfizer-BioNTech COVID 19 Vaccine EUA. I had chills, fever of 101.7, headache, stomach upset which s...
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Pfizer-BioNTech COVID 19 Vaccine EUA. I had chills, fever of 101.7, headache, stomach upset which started on 2/10 at 5 pm and lasted for several hours. The chills came and went for about a week, the headache lasted for several days and the stomach upset for a week. I had my second shot, lot number EN6203, on February 22, had the chills and headache about 5 pm on Monday, March 1st that lasted about 5 hours. Then on Friday, March 5th at 11:30 pm, I woke up with the chills, headache and fever of 101.5. The chills last for 4 hours, headache the next day until noon and fever broke about 7 am.
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| 74 | 2021-03-05 | headache |
Dizziness started day after 1st shot lasting a few hours and occurring every few days. By 3rd week ...
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Dizziness started day after 1st shot lasting a few hours and occurring every few days. By 3rd week dizziness was all day long. The 4th week and after Shot #2 2/9/21 Lot #EN6201 dizziness lasting 24 hours a day. Lightheadedness with occasionally headache. Not serious vertigo or nausea. Had MRI negative, waiting on heart monitor results from cardiologist, had hearing next, ruled out BPPV. Taking meclzine and seems to help somewhat. VNG test maybe next. This is the only significant event in the last 3 months.
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| 74 | 2021-03-06 | headache | About 12 hours after getting the vaccine, patient started getting severe headaches |
| 74 | 2021-03-06 | headache |
Patient had a headache left sided radiating to her neck and upper back when she got out of her car t...
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Patient had a headache left sided radiating to her neck and upper back when she got out of her car to use the restroom.
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| 74 | 2021-03-06 | sinus disorder, chills, headache |
EAR ACHE PAIN, JOINT PAIN, UPSET STOMACH, HEAD ACHE, CHILLS, SINUS. NO TREATMENT AND NO OUTCOMES!...
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EAR ACHE PAIN, JOINT PAIN, UPSET STOMACH, HEAD ACHE, CHILLS, SINUS. NO TREATMENT AND NO OUTCOMES!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! WHERE DO I GET THE TREATMENT???????????????????????????????????
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| 74 | 2021-03-07 | dehydration |
Patient was admitted to hospital on 3/3/21 for weakness and dehydration. Had presented to ED with na...
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Patient was admitted to hospital on 3/3/21 for weakness and dehydration. Had presented to ED with nausea, vomiting, and diarrhea for 3 days. Tested COVID 19 positive. Found to be hyponatremic. Was treated with IV fluids. Discharged on 3/6/21. Follow labs on 3/8/21.
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| 74 | 2021-03-07 | fatigue, chills, fever |
strong chills, low fever, nausea and some vomiting, muscle aches, fatigue for the whole day after va...
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strong chills, low fever, nausea and some vomiting, muscle aches, fatigue for the whole day after vaccine. Fatigue the second day after vaccine. Okay now (3rd say after vaccine)
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| 74 | 2021-03-07 | fatigue, chills |
The day after receiving my vaccine I woke up tired, body aches, chills, upset stomach all day. The n...
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The day after receiving my vaccine I woke up tired, body aches, chills, upset stomach all day. The next day I was fine.
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| 74 | 2021-03-07 | headache |
tongue swelled; shaking like Parkinson's- she was cold; shaking like Parkinson's- she was cold; Head...
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tongue swelled; shaking like Parkinson's- she was cold; shaking like Parkinson's- she was cold; Headache; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported) (at 74 years of age), via an unspecified route of administration in the arm on 01Feb2021 at a single dose for protection against COVID-19. She will be 75 in September, date of birth unknown. Medical history included cancer in which she doesn't know when was diagnosed but was supposed to be cancer free and hypertension. The patient's concomitant medications were not reported. The patient got to the ER last night (01Feb2021), she went to the health department to get the shot, then the ER. It was reported that last night, the patient was shaking like Parkinson's- she was cold, her tongue swelled, and she had a headache. The patient was not admitted. Shaking like Parkinson's, cold outcome: the patient felt better, she was a little quivery, but was given a steroid and IV last night, and her tongue was not swollen now. Headache: is still ongoing, but improving, she still has it. The outcome of tongue swelled was recovered on an unknown date; shaking like Parkinson's- she was cold and headache was recovering. Therapeutic measures were taken as a result of the events.
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| 74 | 2021-03-07 | fever, chills, fatigue, headache | Headache, fever, chills, stomach cramps very fatigue, couldn't stay awake |
| 74 | 2021-03-08 | chills, headache |
First two days: slight dizziness, nausea, chills, sore arm - only lasting about 1/2 hour each day. ...
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First two days: slight dizziness, nausea, chills, sore arm - only lasting about 1/2 hour each day. Evening of day two: Headache started. and continues each day getting a little worse each day. Took Ibuprofen-helped slightly Day five: Bad headache all day and from previous night. Contacted doctor through MY Chart. He said persistent headaches with Pfizer vaccine were uncommon and suggested a treatment.. I declined as I had used that medication 30+years ago and didn't like it. Day six: Better Day seven: Better Day eight: Still with headache, sinus drainage, chest pain (like I was coming down with a cold) Day nine: No chest pain, drainage and headache, ringing in ears Day ten: More drainage and headache, ringing in ears
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| 74 | 2021-03-08 | chills | Chills, Nausea, Diarrhea, Low Temperature (96) Symptoms lasted for 8 hours |
| 74 | 2021-03-08 | fatigue, chills |
pt states that several days after getting the vax she started feeling extreme fatigue, SOB, and chil...
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pt states that several days after getting the vax she started feeling extreme fatigue, SOB, and chills that lasted for 3 days. Pt states that she did not contact her PCP since the symptoms subsided.
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| 74 | 2021-03-08 | fatigue |
1st 24 hrs-injection site swelling, hot, pain; 2nd 24 hrs-severe abdominal cramps & diarrhea; next 5...
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1st 24 hrs-injection site swelling, hot, pain; 2nd 24 hrs-severe abdominal cramps & diarrhea; next 5 days-nausea, weakness & fatigue - could not eat or smell or even look at food.
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| 74 | 2021-03-08 | headache, chills |
pt stated a few day after getting the vax she developed headache, muscle aches and pain, nauseated, ...
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pt stated a few day after getting the vax she developed headache, muscle aches and pain, nauseated, swollen lymph nodes, chills, dizziness, weakness, and had anxiety. Pt called ambulance and transported to ER. She was tested for covid w/ negative results. Had blood work w/ abnormal results (mild leukopenia). She was prescribed Benadryl. Her DX ; Dizziness, uncertain, mild medication reaction to the Covid vax. She was released and told to FU w/ PCP. Her FU appt is 3/12/2021.
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| 74 | 2021-03-08 | headache |
On Sunday around 2:00 p.m. I got cold inside. Around 10:00 p.m. that same day I got a headache and ...
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On Sunday around 2:00 p.m. I got cold inside. Around 10:00 p.m. that same day I got a headache and my arm where I got the shot was swollen in that area and it hurt. On Monday, March 8th my headache was gone and the coldness went away, but my arm was still swollen, sore and red. On Tuesday, March 9th I called the doctor and he told me to put ice on it. When I get other shots my arm swells a little and it is gone in two days along with the redness, but not this time. It is warm to the touch too.
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| 74 | 2021-03-08 | fever, chills, fatigue |
Soreness at injection site Fever of 100 degrees Chills Body Aches Tiredness At 8:00 pm on March 3 I...
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Soreness at injection site Fever of 100 degrees Chills Body Aches Tiredness At 8:00 pm on March 3 I took 1 full dose (325 MG) aspirin. By the next morning, all symptoms except tiredness were gone. Tiredness remained on March 4, but was gone by March 5th, 2021
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| 74 | 2021-03-08 | fever, fatigue |
Fever to 102.2, severe aching, fatigue. took Tylenol ES every 4 hours for 24 hours. only Aching the...
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Fever to 102.2, severe aching, fatigue. took Tylenol ES every 4 hours for 24 hours. only Aching the next day, for the most part, only fatigue for next day or so. Did not seek medical attention.
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| 74 | 2021-03-08 | fever |
Light headed and slight fever on day of injection. Since that time, arm is swollen and red and sli...
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Light headed and slight fever on day of injection. Since that time, arm is swollen and red and slightly sore.
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| 74 | 2021-03-09 | fatigue |
Called patient to follow up on her reaction to the COVID vaccine administered on 3/4/21. She was tra...
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Called patient to follow up on her reaction to the COVID vaccine administered on 3/4/21. She was transported by EMS to the ER after having anaphylaxis to her second Pfizer vaccine. She states she was hospitalized in the ICU overnight and was discharged home this afternoon. Patient feels she is doing much better. She does note feeling very tired from all the medications they gave her. She plans to call her PCP on Monday to schedule an appointment and has follow up scheduled with allergy specialist. She denies any further questions or concerns. Patient is appreciative of phone call. Progress Notes: 3/4/2021 Subjective Patient is a 74-year-old female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 30-minute waiting period after the injection, the patient began to experience hoarse voice. She denied rash, difficulty breathing, difficulty swallowing, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms. PMH of anaphylaxis x 3, with one hospitalization. ALLERGY REVIEW OF SYSTEMS: Patient complains of chest tightness (she later developed chest tightness when she was in the bay prior to epi-pen administration.) Patient denies chills, fever, malaise/fatigue, facial swelling, cough, shortness of breath, wheezing, rash, hives, eczema, itching of skin and abdominal pain Hoarse voice.: Negative for nausea: + lightheaded.: Previous Reactions: anaphylaxis to medications. Never to vaccines. Pt's husband with her today. He states she progresses rapidly with her anaphylaxis and wishes for her to get epi pen now based on her symptoms. She typically starts out this way. Vitals: 03/04/21 1135 03/04/21 1140 BP: (!) 187/100 (!) 163/95 Pulse: 93 95 Resp: 18 16 SpO2: 100% 100% Physical Exam Constitutional: Appearance: She is well-developed. She is not toxic-appearing or diaphoretic. Comments: flushed HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear airway. Voice is hoarse. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: benadryl 50 mg IM R leg antihistamines and epinephrine x 1 at 1136 in L leg Follow up response to treatment: good. She started to have return of symptoms when AMR was leaving with her. Patient discharge: Transported to ED by ambulance. Differential Diagnosis: Anaphylaxis (dyspnea, stridor, drooling, tongue swelling) Pt with early onset of presumed anaphylaxis that responded well to epi-pen. Pt sent to ED for closer observation/treatment via AMR. Husband voiced great appreciation of pt's care today. 3/4/2021 11:40 PM Addendum: ED charge nurse, RN was notified of patient coming.
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| 74 | 2021-03-09 | headache | Headache, right eye pain. BP 127/70 (pulse 76), 103/66. O2 sats 100%. |
| 74 | 2021-03-09 | sweating, headache, fatigue, malaise |
Shaky, I have a headache off and on. on the 28th I woke up in the night covered in sweat but felt be...
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Shaky, I have a headache off and on. on the 28th I woke up in the night covered in sweat but felt better when I woke up. I haven't felt completely well. On Monday 3/8 I had vertigo and nausea and my arm was sore. I feel disoriented, like I just cant concentrate well. extremely tired, I feel like I could sleep all day.
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| 74 | 2021-03-09 | sweating |
Progress Notes APRN (Nurse Practitioner) Family Medicine Cosigned by: MD at 3/4/2021, 8:45 AM Expand...
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Progress Notes APRN (Nurse Practitioner) Family Medicine Cosigned by: MD at 3/4/2021, 8:45 AM Expand All Collapse All COVID VACCINE CLINIC 3/3/2021 Patient Date: 3/3/2021 Subjective Patient is a 74 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience diaphoresis. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , collapse, drooling, hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. Past Medical History: Diagnosis Date ? Allergy all year ? Anxiety ? Arthritis ? Asthma exercise induced ? Calculus of gallbladder without mention of cholecystitis or obstruction Cholelithiasis; ? Diabetes mellitus ? Diabetes mellitus, type 2; ? Diverticulosis of colon (without mention of hemorrhage) Diverticulosis without Hemorrhage ? Esophageal reflux GERD; ? Hearing loss ? Hypertension ? Irritable bowel syndrome Irritable Bowel Syndrome ? Past Hospitalization Diagnosis: Chest Pain, atypical; at: Health Center; Approximate Date: 18000101; ? Nextgen Comments Palpitations/SVT; Anxiety disorder; HRT; Microscopic hematuria ? Osteoarthrosis, unspecified whether generalized or localized, unspecified site Osteoarthritis; ? Other and unspecified hyperlipidemia Hyperlipidemia, Pure; ? Pancreatitis ? PONV (postoperative nausea and vomiting) ? Type II or unspecified type diabetes mellitus without mention of complication, not stated as uncontrolled; DM type II w/o comp; ? Unspecified essential hypertension Hypertension ? Unspecified hemorrhoids without mention of complication Hemorrhoids; ? Unspecified tinnitus ALLERGY REVIEW OF SYSTEMS: Patient complains of headaches (frontal, reports from using her hearing aids and is loud in the expo center. Present prior to vaccine today. ). Patient denies chills, fever and malaise/fatigue; Previous Reactions: none Pt reports she last ate around 10 am. She declines any food/snacks from bay today. Objective Vitals Vitals: 03/03/21 1355 BP: (!) 115/99 Pulse: 73 Resp: 16 SpO2: 97% Blood Sugar 134 collected at 1354 Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic (no visual diaphoresis. ) HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Flushed sensation Pt observed for 15 minutes. t Symptoms resolved. BG good and pt able to ambulate w/o dizziness, lightheaded, sob, cp. Follow up with pcp if not improving or worsening. Continue to monitor BG and BP at home. Pt and pt's husband voices appreciation of care today. APRN Electronically Signed 3/3/2021 1:57 PM Division of Health.
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| 74 | 2021-03-09 | sweating |
her face flushed out; she got hot and sweaty; she got hot and sweaty; for three days following getti...
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her face flushed out; she got hot and sweaty; she got hot and sweaty; for three days following getting the vaccine, she felt like she had been punched in the arm; she is losing her voice; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL1283 and expiry date was unknown) via an unspecified route of administration, into left arm on 15Jan2021, as single dose for COVID Prevention. Medical history and concomitant medications were not reported. Patient stated that quickly after getting the vaccine, her face flushed out, and she got hot and sweaty. For three days following getting the vaccine, she felt like she had been punched in the arm, she was not just sore, but it felt like she had been punched. Stated that she was losing her voice. Patient received no other vaccines on the same day as the COVID vaccine. Patient wondering if other people are having the problem with the face flushing from the vaccine. Outcome of the events was unknown.
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| 74 | 2021-03-09 | nasopharyngitis, headache |
11:00 pm - ish: Site of injection began burning which became more intense throughout the night. Cold...
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11:00 pm - ish: Site of injection began burning which became more intense throughout the night. Cold sweats, severe aching and muscle weakness especially in legs, nauseous, severe headache. I tried to drink a little water. Didn't have enough energy and was too cold to get up to get any medication. Slept a little. I was awake early in the morning, but too cold to get out of bed. At 8:30 a.m. I got up and could hardly walk. Dizzy, muscle weakness as if muscles had turned to Jell-O.. Sat down and threw up, mostly dry heaves, which lasted a few minutes. Fitful sleep until 11:00 a.m. when I began to feel better. Drank more water and just rested for a few hours. I ate some applesauce and made a batch of white rice which I ate around 6:00 p.m. Achiness in lower extremities continued until bedtime (10:00 p.m.) when I took a Meloxicam (15 mg) which my GP prescribed for achiness in my neck due to arthritis. I take this drug only when needed and thought it would help the aching in my legs. Maybe it did...maybe it was a coincidence that the achiness was alleviated enough for me to go to sleep. I am almost 100% today. It takes a little longer at my age to fully recover from any illness however slight. I would like to add that I am grateful to be vaccinated.
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| 74 | 2021-03-09 | fever, malaise |
Feeling sick/doesn't feel very well; hives (on neck and shoulder); Feverish; Achy; cannot move; This...
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Feeling sick/doesn't feel very well; hives (on neck and shoulder); Feverish; Achy; cannot move; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included "coronavirus" and allergies. The patient's concomitant medications were not reported. On an unspecified date, the patient was feeling sick and developed hives (on neck and shoulder). She wanted to know if she needs to get the second dose since she is afraid to have the side effects again. Patient was feeling feverish and achy, cannot move and doesn't feel very well on an unspecified date. She stated that the place where she received the vaccine had several sites set up. She got the first at one site. She is scheduled for her second dose at another site, but she read or heard it should be done at the same site. She wanted to know if it is safe to have the second shot. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 74 | 2021-03-10 | fatigue, chills, body temperature increased |
Onset of Chills a couple of hours after vaccinated. Temperature 99-100. Fatigue. Lasted most of t...
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Onset of Chills a couple of hours after vaccinated. Temperature 99-100. Fatigue. Lasted most of the day through the evening. Took Tylenol and it helped with the temperature. Better next day
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| 74 | 2021-03-10 | headache, fatigue | discomfort in arm for two days, minor headache one day, felt tired for approximately six days. |
| 74 | 2021-03-10 | headache |
Forty-five minutes after the injection my heart began to race to the extent that it was very alarmin...
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Forty-five minutes after the injection my heart began to race to the extent that it was very alarming. After an hour or so I took a very mild tranquilizer (.25 mg of clonazepam), which I take rarely (my doctor only prescribes .5 mg, 30 pills per year), and my heart calmed down. I also had "standard" side effects, namely, headache and sore arm.
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| 74 | 2021-03-11 | fatigue |
Patient calling to report she received second COVID-19 vaccine 3 days ago. Patient is having difficu...
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Patient calling to report she received second COVID-19 vaccine 3 days ago. Patient is having difficulty functioning since vaccination. Patient is fatigued, body aches. Patient states that she is having a "hard time getting around" due to exhaustion. Able to stand and walk without difficulty. Able to do some of normal housework. No fevers. PCP performed labs - D-dimer elevated, troponin negative, EKG normal. Sent to ED for concern of PE. CTA-PE negative. D/C'd home in stable condition.
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| 74 | 2021-03-11 | headache |
body was burning up and face became very red. Had no temperature but was extremely hot after on weer...
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body was burning up and face became very red. Had no temperature but was extremely hot after on weer. Now have temporal pain in right hs hand temple with intermittent shooting pains
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| 74 | 2021-03-12 | fever |
Pfizer-BioNTech COVID-19 Vaccine EUA: in clinic visit three days after vaccination patient reports f...
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Pfizer-BioNTech COVID-19 Vaccine EUA: in clinic visit three days after vaccination patient reports fever one day after vaccination and two days after vaccination suddenly felt hot and fell to her knees holding onto a couch. Able to ambulate to bed afterwards. Patient also reports swollen lymph node in left axilla. Patient denies chills, headache, blurry vision, nausea, vomiting, abdominal pain, myalgias, or respiratory symptoms. Does not report loss of consciousness, rash, or injury after fall but does report not eating or drinking prior to fall. Vital signs within normal ranges except blood pressure 135/70 mmHg. Advised to keep hydrated and eat well.
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| 74 | 2021-03-13 | chills, headache |
Almost immediate total body flushing and tingling, including numbness/tingling on left side of face....
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Almost immediate total body flushing and tingling, including numbness/tingling on left side of face. After 10 min. shivering though not feeling cold for about 5-10 min. Then later in afternoon continuous light numbness on left side of face. Slight headache. It's almost 3:00 p.m. on 3/14 and left side of face still feels somewhat numb but right side feels ok. Smile is even both right after the injection when nurse checked and now. Never a problem breathing.
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| 74 | 2021-03-13 | fatigue | Dizziness, weakness, very tired |
| 74 | 2021-03-14 | chills, nasopharyngitis, headache | Chills and headache, like I have a head cold. |
| 74 | 2021-03-14 | cough |
Pt received both Pfizer COVID-19 vaccines on 1/27/2021 and 2/17/2021. Pt reported a cough on 3/8/20...
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Pt received both Pfizer COVID-19 vaccines on 1/27/2021 and 2/17/2021. Pt reported a cough on 3/8/2021, around the same time her daughter was admitted inpatient for COVID-19 (had not received vaccine yet). PCP tested her for COVID-19 via SARS-CoV-2 PCR on 3/8/2021 and it was positive. Pt has only had mild symptoms thus far.
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| 74 | 2021-03-14 | fatigue | muscle soreness, fatigue |
| 74 | 2021-03-14 | headache, chills |
extreme joint pain; severe muscle pain; headache; chills; nausea; This is a spontaneous report from ...
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extreme joint pain; severe muscle pain; headache; chills; nausea; This is a spontaneous report from a non-contactable consumer. A 74-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) intramuscularly on 03Feb2021 (at the age of 74-years-old) as a single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis; osteoarthritis; and allergies to medications, food, or other products; all from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included meloxicam from an unknown date for osteoarthritis, which the patient had discontinued 2-3 days prior to immunization. The patient received the vaccine on 03Feb2021, the following day, 04Feb2021, the patient felt like she "got hit by a truck;" she complained of extreme joint pain, severe muscle pain, headache, chills and nausea. The events were reported as non-serious and did not require hospitalization. It was unknown if treatment was provided for the events. The patient reported she gradually improved over the next 3-4 days and resolved. The clinical outcomes of extreme joint pain, severe muscle pain, headache, chills, and nausea were recovered in Feb2021. It was also reported the patient had not been tested for COVID-19 since vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 74 | 2021-03-14 | headache, fatigue |
lower jaw numbness/felt a little numbing in her jaw on right side; Fatigue; Headache; pain in her fa...
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lower jaw numbness/felt a little numbing in her jaw on right side; Fatigue; Headache; pain in her face/incredible face pain, throbbing; slept most of the two days following the vaccine; face became bright red with swelling and intense in her cheeks and forehead; face became bright red with swelling and intense in her cheeks and forehead; disoriented; dizzy/wooziness; This is a spontaneous report from a contactable consumer herself. A 74-years-old female patient started to receive bnt162b2 (Pfizer-Biontech covid-19 vaccine, Solution for injection lot number: EN5318 and expiration date: unknown) intramuscularly from 29Jan2021 18:10 at single dose for prevent covid. Medical history included stroke from Apr2018 to an unknown date since she had a stroke 3 years ago. Concomitant medication included rivaroxaban (XARELTO) for stroke 30 mg, once a day. The patient previously took diphtheria vaccine. Caller states she spoke to safety agent and gave them all of her information. Caller states she received the first dose of the Pfizer COVID vaccine Friday at 6:15 pm. Caller states after waiting the recommended 15 minutes at the vaccination facility after receiving the first dose caller states four minutes later she began to experience lower jaw numbness that lasted a few seconds 29Jan2021. Caller states her face became bright red with swelling and intense in her cheeks and forehead In Jan2021. Caller states these symptoms were only in her face and no where else. Caller states she was taken back to the vaccination facility and the nurse monitored her every ten minutes for about 30 minutes until she cooled down and then she was sent home. Caller states during this time she was disoriented and dizzy In Jan2021. Caller states the next day she experienced pain in her face and to this day she still gets some pain but no more redness in her face. Caller states she is scheduled for the second dose on 19Feb2021. Caller states she read somewhere online that if you had a severe allergic reaction to the first dose you should not receive the second dose. She stated that within roughly five minutes of receiving the vaccine that she began to experience a numbing in the chin and the surrounding area. She stated that within a few minutes of the onset of numbness that her face began to swell, and turn extremely red as if sunburned. She stated that within a few minutes of the onset of numbness that her face began to swell, and turn extremely red as if sunburned. She also experienced wooziness and a dizziness. She said the experience subsided in approximately 40 minutes of its onset. She is scheduled to receive the second dose on the 19th of Feb, but has some concerns about receiving it due to her experience. The patient had Fatigue, Headache in 29Jan2021. She clarifies her slight headache pain came back with the fatigue, reports it comes and goes. Her headache is off and on. After about 5 minutes of waiting she felt a little numbing in her jaw on the right side. Then 2 minutes later her face got bright, bright red, like there was real heat coming from it. She also had swelling in her face. It was very strange. She is asking if it is safe to get the second dose which is scheduled for 19Feb2021. This reaction lasted about 40 minutes. Her face was all flushed and burning hot red. It took a couple of hours for her face to come back to her normal color. After this faded, she reports she was left with incredible face pain, it was throbbing. She was extremely fatigued and is still fatigued, she can do very little. She is managing to cook. She slept most of the two days following the vaccine. The outcome of the events Numbness recovered on 29Jan2021,red face recovered in 2021, event pain in her face/incredible face pain, throbbing recovered in 31Jan2021, event Fatigue was recovering and other events unknown.
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| 74 | 2021-03-14 | headache, runny nose |
watery eyes; runny nose; slight headache; This is a spontaneous report from a contactable consumer. ...
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watery eyes; runny nose; slight headache; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose on 25Feb2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the 1st dose of bnt162b2 (BNT162B2) on 01Feb2021 for COVID-19 immunisation and she experienced she passed out and fell to the floor before daylight and dizziness on 01Feb2021. The patient experienced watery eyes, runny nose and slight headache in 2021. No treatment was received. No admission to hospital due to the events. The outcome of events was recovered in 2021, she was fine now. Information about lot/batch number has been requested.
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| 74 | 2021-03-14 | headache | head ache, moderate lower G.I.cramps, Watery stools x 3, hot flashes and flushing after eating x4 |
| 74 | 2021-03-15 | chills, headache | Chills, aches in joints, head, skin. Slight indigestion. |
| 74 | 2021-03-15 | chills |
Action taken: Pt brought to assessment tent 10 minutes after vaccination given c/o chest heaviness/f...
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Action taken: Pt brought to assessment tent 10 minutes after vaccination given c/o chest heaviness/feeling odd, along with the shakes and chills. VS taken and doctor notified of patient arrival. Reviewed Pt. History and any medical problems. Pt stated she is currently being treated for Sinus Problems and saw her doctor yesterday who encouraged her to get her vaccination today. She is on a Prednisone taper, and takes HCTZ for BP, and had a cardiac procedure done last year for chest discomfort, and nothing was found. Discussed with doctor the need to call EMS. Pt resistant to this but explained that they would assess her and then she could decide what kind of treatment from there. Pt still resistant to having EMS called, but call placed as per protocol. EMS Arrived and report given. Pt still resistant to being transported to hospital, after approx 15 minutes EMS convinced patient of the risks and needs of being transported versus the risks of driving there herself. Pt transported via EMS hospital.
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| 74 | 2021-03-15 | malaise |
dizziness, hotflasshes, not feeling good. BS-109; VS 164/72-66; 173/95-72; 171/65-68; 160/65. ...
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dizziness, hotflasshes, not feeling good. BS-109; VS 164/72-66; 173/95-72; 171/65-68; 160/65. Dizziness resolved but still doesn't feel good.
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| 74 | 2021-03-16 | headache | Severe severe headache. Nausea and diarrhea. Plus sore arm. |
| 74 | 2021-03-17 | cough |
Patient brought back to chemo room for 1st dose of Pfizer BioNTech vaccine. LOT: ER2613 Man Exp: 07...
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Patient brought back to chemo room for 1st dose of Pfizer BioNTech vaccine. LOT: ER2613 Man Exp: 07/20/2021. Patient appeared anxious about receiving vaccine but was alert and oriented x4 and ambulatory with no other complaints. No previous reactions to vaccinations per patient. Patient received Covid vaccine at 1002, patient started coughing and complaining of chest tightness at 1005 with auditory wheezing. First Epi given at 1005 and O2 was placed on patient via face mask at 15L. 911 was then called. O2 saturations at beginning of reaction in the high 80's and dropping, HR 150's. Unable to obtain blood pressure throughout episode at clinic. IV access attempted and unsuccessful x1 at clinic. Saturations continued to drop into low 70's with no improvement of respiratory symptoms. Decision was made to give second Epi and was given at 1010. Before second attempt to establish IV access EMT arrived. Patient was transferred to stretcher and taken to Ambulance via EMS staff.
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| 74 | 2021-03-17 | dehydration, fatigue, fever |
caller states that his mother has become increasingly more tired, has a fever of 102, c/o chills, fe...
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caller states that his mother has become increasingly more tired, has a fever of 102, c/o chills, feeling dehydrated. Tingling in legs and feeling unsteady on feet. Was working in garage earlier today however had to lay down due to fatigue. Caller gave his mom 2 tylenol approx 20 min prior to calling, reports that he feels that is helping. Reports that she is A/Ox3 just "tired". Advised to increase fluids and monitor fever and effectiveness of tylenol. If she doesn't improve in the next hour, or if she begins to experience any chest pain, SOB or neuro changes, caller needs to take her to contact her PCP and/or ER. Spoke with son, his mom is doing much better, no fever and symptoms have resolved.
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| 74 | 2021-03-17 | malaise, fever, headache, sleepiness |
Became ill two days after vaccination, slight fever , nausea, headache, forgetful , unsteady on feet...
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Became ill two days after vaccination, slight fever , nausea, headache, forgetful , unsteady on feet , sleepy
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| 74 | 2021-03-17 | fever | hallucinations with high fever lasting about 36 hours |
| 74 | 2021-03-18 | chills, fever, headache |
Joint ache, head and neck ache, skin ache, chills, slight fever. Started night of second shot, Mon...
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Joint ache, head and neck ache, skin ache, chills, slight fever. Started night of second shot, Monday, stopped about 24 hours laterTuesday. Started again third night, Wednesday, stopped next morning. Started again Thursday night and is continuing on Friday (today). Secondary starts are not as strong as first night but are still very uncomfortable and do not allow for a good night?s sleep. Have been taking aspirin and Advil.
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| 74 | 2021-03-18 | fatigue, headache |
autoimmune disorder; Sjogrens disease; tired; Headache; Joint pain; throat felt like it was closing;...
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autoimmune disorder; Sjogrens disease; tired; Headache; Joint pain; throat felt like it was closing; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EL9261, Expiration Date: May2021) via an unspecified route of administration in the right arm on 06Feb2021 (at the age of 74-year-old) as 0.3ml, single for COVID-19 immunisation. The patient relevant medical history included Lichen planus from an unknown date in Nov2020 and ongoing (get sores on her tongues and inside of her cheek and monitored by dentist every six months). The concomitant medication was not reported. On 06Feb2021, (Saturday) the patient experienced tired, headache, joint pain, states she also felt like her throat was closing. It was reported that she has been tested for sjogrens disease and the doctor stated she may have an autoimmune disorder on an unknown date. States her symptoms started several hours after the vaccine on the same day, states when she woke up the next morning, she felt fine. The patient stated that she had epi pen, wondered if when her throat felt like it was closing should she have used that. The outcome of the events autoimmune disorder, sjogrens disease was unknown while for other events tired, headache joint pain and throat felt like it was closing was recovered on 07Feb2021.
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| 74 | 2021-03-18 | fatigue, headache |
she slept and slept and slept; bad headache; very tired; muscle aches and pains; where she had gotte...
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she slept and slept and slept; bad headache; very tired; muscle aches and pains; where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that; where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3249, Expiration date: May2021), via an unspecified route of administration in left arm 03Feb2021, at 10:50 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient medical history included Prediabetes (5 years ago) and obviously overweight and had cat bite. The concomitant medication was not reported. The patient previously took historical vaccine, on an unknown date in Jan2021 (she got the first dose three weeks before on a Wednesday), first dose of bnt162b2 for COVID-19 immunisation and had no reaction. On 03Feb2021 (early evening) the patient experienced a bad headache and was very tired. Caller says where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that. She says she also had muscle aches and pains. The patient took Aspirin (UPC 9629513147, LOT: P115130, EXP: May 2021) for the event muscle aches and pains at a dose of 325mg, one before bed, took three during night total. The patient reported that she slept and slept and slept on an unknown date in Feb2021. It was reported that patient lots of bloodwork done over the years but if she eats correctly it goes away, then if she gets into the sugar, it comes back. The outcome of the events, where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that and she also slept and slept and slept was unknown while for other events was recovered on an unknown date in Feb2021.
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| 74 | 2021-03-18 | fatigue, malaise, chills, fever, headache |
Sore injection site; joint aches; Chills; headache; nausea; vomiting; muscle pain; listless; fever; ...
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Sore injection site; joint aches; Chills; headache; nausea; vomiting; muscle pain; listless; fever; no appetite; Not feeling well; still tired; sleeping a lot; Very fearful of taking the second shot; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Feb2021 (Lot Number: EM0910) as single dose for covid-19 immunization. Medical history included mild chronic obstructive pulmonary disease, asthma, bronchitis, sinus infection and sulfa allergy from unknown dates. The patient previously took and experienced allergies to acetaminophen, montelukast sodium, hydroxyzine, budesonide-formoterol fumarate and pseudoephedrine hcl. On 09Feb2021, at 01:00, the patient experienced sore injection site with outcome of unknown; joint aches with outcome of unknown; chills with outcome of unknown; headache with outcome of unknown; nausea with outcome of unknown; vomiting with outcome of unknown; muscle pain with outcome of unknown; listless with outcome of not recovered; fever with outcome of unknown; no appetite with outcome of unknown; not feeling well with outcome of unknown; still tired with outcome of not recovered; sleeping a lot with outcome of not recovered; very fearful of taking the second shot with outcome of not recovered. No treatments were given for the events. Details were as follows: the adverse events included sore injection site, joint aches, chills, headache, nausea, vomiting, muscle pain, listless, fever, no appetite, not feeling well, all in that order. Worst side effects were gone by the third day; she was still tired, sleeping a lot and was listless. The patient was also very fearful of taking the second shot. The events resulted in doctor or other healthcare professional office or clinic visit on an unspecified date.
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| 74 | 2021-03-18 | fatigue |
Soreness in arms/shooting pains in her right arm that are shooting; Breasts are sensitive/Her breast...
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Soreness in arms/shooting pains in her right arm that are shooting; Breasts are sensitive/Her breasts are very sensitive and sore; Breasts are sensitive/Her breasts are very sensitive and sore; Swelling in her calves, her left and right arms; Swelling in her calves, her left and right arms/her hand was swollen, and her whole arm was like a log, it has been very uncomfortable; Her arm is very, very sore at the site of injection/Her right arm where vaccine was given her elbow is still swollen and sore below injection, and swelling where arm is connected to elbow.; Her joints in her elbows, wrists, and ankles are hurting/lot of joint pain; Nauseous; lymph nodes were affected and swelling; Tired; Swelling everywhere; Her right arm where vaccine was given her elbow is still swollen and sore below injection, and swelling where arm is connected to elbow.; uncomfortable; This is a spontaneous report from Social Media by a contactable consumer (patient). A female patient of 74-year-old received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via unspecified route of administration in right arm on 05Feb2021 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient medical history included chronic kidney disease from an unknown date in 2012. The concomitant medication was not reported. The patient stated that have not had any other recent vaccinations or started any new medications. The patient reported that on an unknown date Feb2021, soreness in arms, she has had swelling in her calves, her left and right arms. She said her arm is very, very sore at the site of injection, her breasts are very sensitive and sore, nauseous and later went away, had a lot of joint pain and swelling everywhere, her lymph nodes were affected and swelling, her right arm where vaccine was given her elbow was still swollen and sore below injection and also specified that swelling where arm is connected to elbow. It was also reported that hand was swollen, and her whole arm was like a log, it has been very uncomfortable on an unknown date in Feb2021. The patient has been tired on an unknown date in Feb2021 and patient worried about recovery of events. The patient stated that lymph nodes took 2-3 days, which started Sunday (as reported). It was reported that patient was still in sore, the breasts are super sensitive, which was weird. The patient also had strange shooting pains in her right arm that are shooting through it. The patient left arm was sore, but not as sore as her right. She said her knuckles were cracking when her hands move, and her right wrist was very sore but that was not so bad now. The patient stated that she thought these events were due to her good immune system. The joints were still sore, her elbows, all of the upper part of her body were also sore. The patient also reported that she was told older people don't have much reactions, but she certainly had. The patient had not seen doctor for the events. The patient took acetaminophen (LOT M045G, EXP Dec2023) as a treatment medication for the events. The outcome of the events nauseous was recovered on an unknown date in Feb2021, for the events swelling everywhere, uncomfortable, tired, lymph nodes were affected and swelling, breasts are sensitive/her breasts are very sensitive and sore was unknown while for rest of the events was not recovered
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| 74 | 2021-03-18 | headache, throat pain |
about 10 days after 2nd dose of pfizer covid vaccine developed a headache and sore scratchy throat t...
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about 10 days after 2nd dose of pfizer covid vaccine developed a headache and sore scratchy throat that persists advised evaluation .
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| 74 | 2021-03-20 | headache | Bad headache, back ache, chills. shot arm hurt |
| 74 | 2021-03-21 | body temperature increased, chills, fatigue |
She received her 2nd vaccine and started feeling very chilled and tired around 6:30 that evening, st...
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She received her 2nd vaccine and started feeling very chilled and tired around 6:30 that evening, started shaking and feeling like restlessness. She went to bed and covered up under lots of covers, and just froze. She put on extra clothes, layers of blankets and her legs felt swollen, painful. She kept having to urinate a lot, could not sleep, was awake all night, her arm started hurting as well, could not lay on that side, and then started getting cold/hot flashes. She felt as though her heart was racing, and her brain as well trying to figure out what was happening. Her husband took her temperature in the morning and it was 101.9, which her normal is 97.9. At that point she was exhausted from being up all night, and was frightening and couldn't stop trembling all night long into Saturday. When day broke on Saturday shew as not able to get out of bed for the entire day. She could not eat, had no appetite and drank water day. On Sunday she felt a little better, ate breakfast and the rest of the day went okay other than being exhausted. This morning, 3/22/21, she still feels lofty, is able to function and feels a little removed/foggy feeling. She is still not feeling completely well, but is on her way. Not steady on her feet yet. She took some Bayer aspirin for the symptoms.
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| 74 | 2021-03-21 | headache, chills, fatigue |
#2 shot Feb 28th - March 2 headaches,pain in lungs, extreme fatigue-went to bed for a few days then ...
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#2 shot Feb 28th - March 2 headaches,pain in lungs, extreme fatigue-went to bed for a few days then I was able to walk around but chills,fatigue for 3 weeks
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| 74 | 2021-03-22 | chills, headache, head discomfort, fever, paranasal sinus discomfort |
fever; Pressure in my head; dizziness; Headaches; sinus pressure; body aches in my upper back, arms ...
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fever; Pressure in my head; dizziness; Headaches; sinus pressure; body aches in my upper back, arms and fingers; chills; This is a spontaneous report from a contactable a nurse, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in the right arm on 18Feb2021 at 09:00 AM (at the age of 74-years-old) (Batch/Lot Number: EN6200) as a single dose for COVID-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing, psoriasis from an unknown date and unknown if ongoing, and allergy to penicilin and sulfa drugs, from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received the first dose of BNT162b2 on 29Jan2021 at 09:00 (Lot Number: EL3249) for COVID-19 immunisation. Concomitant medications included estradiol for an unspecified indication, start and stop date were not reported; levothyroxine for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 18Feb2021, at 09:30 AM, the patient experienced the events, fever, pressure in head, dizziness, Headaches, sinus pressure, body aches in upper back, arms and fingers, chills. The patient did not receive treatment for the events. The patient was recovering from the events, fever, pressure in head, dizziness, headaches, sinus pressure, body aches in upper back, arms and fingers, and chills.
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| 74 | 2021-03-22 | chills |
Caller is pt's wife, all information was obtained from caller. 74 year old male received 1st dose of...
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Caller is pt's wife, all information was obtained from caller. 74 year old male received 1st dose of Pfizer COVID-19 Vaccine Lot# EL8982 at location on 01/25/2021 @ 10:30. On 01/28/2021 pt started feeling chills, which resolved in 2-3 weeks. Pt started feeling back pain around 02/15/2021, went to Clinic around 02/17/2021 for the pain. The 2nd dose of Pfizer vaccine was due on 02/17/2021, pt had to cancel 2nd dose appointment due to Clinic appointment. Clinic staff told pt back pain was most likely due to a pinched nerve or lower back problems that comes with age. No x-rays or blood work was performed at Clinic. On 02/21/2021 pt stood up and felt even worse lower back pain, couldn't walk, pt went to ER and was admitted for 5 days, discharged 02/26/2021. Blood work was done and showed hyperkalemia, proteinuria, and kidney failure, upon discharge ER staff told pt to follow up with nephrologist. Nephrologist appointment is scheduled for 04/01/2021. Pt takes Morphine sulfate IR 15mg, Atenolol 50 mg, Fenosteride 5 mg, and Terazosin 10 mg. Pt has Myeloma, Hypertension, and Benign Prostatic Hyperplasia. Caller denies pt has any allergies. Pt will receive oncology treatment 03/29/2021, the oncologist alerted the caller the 2nd dose must be administered to the pt before oncologic treatment. Caller asked if the pt should get the second dose due to the kidney failure occurring after the 1st dose was administered. Currently pt is only experiencing lower back pain. Pt was advised that it is unlikely the vaccine caused kidney failure and the pt should get the second dose as soon as possible. SPI was consulted and Dr. was notified.
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| 74 | 2021-03-22 | headache |
excruciating pain all over the body and headache which started after covid vaccine on 3/8 Pfizer. Sy...
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excruciating pain all over the body and headache which started after covid vaccine on 3/8 Pfizer. Symptoms started 3/12. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache.
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| 74 | 2021-03-22 | lethargy |
swelling, redness, and itching at the site - body pain, lethergy, - started about 4 hours after inj...
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swelling, redness, and itching at the site - body pain, lethergy, - started about 4 hours after injection and lasted another 36 hours
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| 74 | 2021-03-22 | fever | High fever, general weakness leading to fall and hospitalization |
| 74 | 2021-03-23 | headache |
patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruc...
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patient received COVID-19 vaccine on 3/8 with symptoms starting on 3/12. patient complains of excruciating pain all over the body and headache. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache. She could hardly walk and get out of bed due to the pain. Labs unremarkable. Patient also has intolerances to atorvastatin and rosuvastatin with history of muscle cramps.
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| 74 | 2021-03-23 | pneumonia | admit 2/18, vaccine 1/9, 2/3. PNA, COVID+. Treated w/zinc, dexa, abx. DCd to home. |
| 74 | 2021-03-23 | fever, chills, headache |
Patient is a 74 year old y.o. female with history of atrial fibrillation, hypothyroidism who present...
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Patient is a 74 year old y.o. female with history of atrial fibrillation, hypothyroidism who presents with acute onset early this a.m. nausea vomiting and change in mental status. History was obtained from the husband as patient is minimally responsive to verbal stimuli at this time. He states she was in her usual state of health until when she awoke this morning. Yesterday in usual state of health that she did have her 2nd COVID vaccine with the Pfizer variant. He states that day she was in her usual state of health with some mild arm pain on the left where she received the vaccine. This morning she awoke with a headache, fever, chills however was ambulating and conversing appropriately. She had no appreciable focal deficits at that time per the husband. She ate breakfast however she subsequently began vomiting. She progressed to a change in mental status with minimal responsiveness. She would say 1 or 2 words and that was it. They then presented emergency department. Diagnosed with severe sepsis, acute encephalopathy, acute meningitis, liver shock, autoimmune hepatitis, ascending cholangitis, acute pancreatitis.
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| 74 | 2021-03-24 | fatigue, chills |
First day, excruciating pain over my entire body, could hardly get out of bed, chills, hot flashes, ...
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First day, excruciating pain over my entire body, could hardly get out of bed, chills, hot flashes, nausea, extreme tiredness that sleep did not help. Also, hot flashes during night. took Tylenol. Second day, pains were mostly gone, but nausea and a sore arm where the injection was given, and dizziness, and tiredness. But if I would lie down, I couldn't sleep. Later that day my injection site was swollen, redness (about size of an orange) sore to the touch and itched, and was hard. The third day my injection sites pain went further to my left breast, up to my shoulder. It had spread and was now a light pink. A small amount of dizziness.
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| 74 | 2021-03-24 | headache | Pressure in the back of the ears, tingling all over, headache |
| 74 | 2021-03-24 | malaise |
she had low pressure; she passed out at one point; She is very pale in her face.; lightheaded/Dizzy;...
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she had low pressure; she passed out at one point; She is very pale in her face.; lightheaded/Dizzy; She felt very bad the second day; She had an allergic reaction; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 02Mar2021 09:45 (Batch/Lot Number: EL9262) as single dose for covid-19 immunization. Medical history included seizure (she had convulsions as a child). There were no concomitant medications. The patient experienced she passed out at one point on 03Mar2021, she had low pressure on 03Mar2021 at 08:00. The patient also experienced she is very pale in her face, lightheaded/dizzy, she felt very bad the second day and she had an allergic reaction on Mar2021. Reporter states She had an allergic reaction. The first day she felt fine, the second day she had low pressure and she passed out at one point and the rest of the day she had low blood pressure. She felt very bad the second day and Monday was the same and she is still feeling light headed and dizzy today. She says the first dose was given on the 05Feb2021 and her second dose she just had that on 02Mar2021 and that is the dose she is reporting about today. She says it was 03 Mar when she started having low blood pressure and passed out. She says she is still light headed and dizzy today, that is ongoing. She has not checked her blood pressure today but she feels like it is still low. She is very pale in her face. The patient underwent lab tests and procedures which included blood pressure measurement: low pressure on an unspecified date (she had low pressure). Outcome of she had low pressure and lightheaded/Dizzy was not recovered. Outcome of all the other events was unknown.
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| 74 | 2021-03-25 | headache, body temperature increased |
Nausea, vomiting, dry mouth, headache, slightly elevated temperature. Unable able to sit up or get ...
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Nausea, vomiting, dry mouth, headache, slightly elevated temperature. Unable able to sit up or get out of bed except to vomit. Unable to eat or drink, even water. I tried sitting up around 11 p.m. but after less than 5 minutes I felt nauseous. Slept fitfully through the night but felt more normal when I got up at 7 a.m. on 03/20 (next e morning)
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| 74 | 2021-03-25 | headache |
Malignant hypertension Blood Pressure up to 220/108 within 12 hours after first dose vaccine Chest ...
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Malignant hypertension Blood Pressure up to 220/108 within 12 hours after first dose vaccine Chest pain, SOB, headache and dizziness, ankles and wrists aches.. sever spinal pain. Debilitating pain and weakness
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| 74 | 2021-03-28 | malaise |
Covid vaccine monitoring documentation. Patient presented to ED 3/25/21 from home. Patient reported ...
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Covid vaccine monitoring documentation. Patient presented to ED 3/25/21 from home. Patient reported generally not feeling well x 1 week. Patient reported body aches, SOB, difficulty breathing. Daughter reported patient significantly got worse from prior night before arrival until patient woke up. Patient had contacted their PCP and was put on a Zpack which did not have improvement. Patient stated they received their second covid vaccine on 3/15/21, Pfizer EN6204. SARS-CoV-2 COVID-19 documented positive 03/25/21 16:14. Patient was admitted for monitoring/treatment. First covid vaccine received 2/22/21 Pfizer EN6198, second vaccine received 3/15/21 Pfizer EN6204. Patient received 2 doses but was not 14 days post second dose. SARS-CoV-2 COVID-19 documented positive 03/25/21.
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| 74 | 2021-03-30 | chills, throat irritation |
Chills; Irritation in throat; Swelling of tongue; Unable to swallow solids; This is a spontaneous re...
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Chills; Irritation in throat; Swelling of tongue; Unable to swallow solids; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), dose 2 via an unspecified route of administration, administered in the right arm on 25Feb2021 for covid-19 immunization. The patient's medical history was not reported; She takes other unspecified medications, though declined to provide details. The patient previously took BNT162B2 (Lot EM9809) on 04Feb2021 as first single dose for covid-19 immunization and hydrochlorothiazide and experienced anaphylactic reaction on an unspecified date (reported as years ago). The patient experienced the following medically significant events: irritation in throat on 27Feb2021 with outcome of recovered; swelling of tongue on 27Feb2021 with outcome of not recovered; unable to swallow solids on 27Feb2021 with outcome of not recovered; chills on an unspecified date with outcome of unknown. Details were as follows: the reporting nurse received both doses of the Covid-19 vaccine. She received the first dose on 04Feb2021. She received the second dose on 25Feb2021. 48 hours after the second dose she developed a really sore throat way down in the back of her throat. Her tongue also started swelling. She took diphenhydramine (ASSURED) 50mg. Her tongue was swollen the next day and she was unable to swallow solids. She went to a Covid clinic and was prescribed a diphenhydramine mouthwash. She was still unable to swallow. She has been taking diphenhydramine and Ibuprofen. It waxes and wanes. She had to take diphenhydramine to go to sleep. She thinks it is a reaction to the vaccine. She read about the ingredients and is not allergic to anything in the vaccine. She clarified that she did not have a sore throat. Her throat was irritated. It felt like pop rocks in the back of her throat. She saw a provider on 01Mar2021. She thinks her histamine level is too high. She also had chills last night, date unspecified. She had them once since 27Feb2021 and again last night. She was unable to confirm if they are ongoing or resolved. She had to turn up her electric blanket to 8. She was not shaking but just had chills. Years ago she had an anaphylactic reaction to hydrochlorothiazide. This felt similar to that. She was walking around fine and then started having swelling. She did not have difficulty breathing. She hoped it was not anaphylaxis. The diphenhydramine mouthwash was a compound of lidocaine, diphenhydramine and Maalox. The ratio was 1:1:1. The diphenhydramine 50 mg was a liquid children's allergy relief medication. Therapeutic measures were taken as a result of the events as aforementioned. Relatedness of drug to reaction for irritation in throat, swelling of tongue, unable to swallow solids and chills per primary source reporter of assessment was reported as related. The outcome of irritation in throat was recovered on 28Feb2021; the outcome of swelling of tongue and unable to swallow solids was not recovered; the outcome of chills was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of irritation in throat, swelling of tongue, unable to swallow solids due to temporal relationship and the known product safety profile. The clinical presentation is suggestive of a severe allergic reaction, involving the tongue and throat. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 74 | 2021-03-30 | headache, fatigue |
mouth sores; slightly swollen upper lip; swelling/pain injection site; swelling/pain injection site;...
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mouth sores; slightly swollen upper lip; swelling/pain injection site; swelling/pain injection site; fatigue; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EKU176, Brand: Pfizer, Expiration date: Unknown) via an unspecified route of administration in right arm on 18Jan2021 14:00 as single dose for covid-19 immunisation. Medical history included bronchiectasis, degen scoliosis, fibromyalgia, peptic esophogitus and swollen lymph nodes for 24 hrs, fatigue and headache for 4-5 days for first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL1284, Brand: Pfizer, Expiration date: Unknown) via an unspecified route of administration in right arm on 02Jan2021 11:00 as single dose for covid-19 immunisation. There was special history of allergies reported. Concomitant medication pantoprazole sodium diclofenac sodium 40 mg, Misoprostol (50-200) (ARTHROTEC) and lisinopril for unspecified indication. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On an unspecified date in Jan2021, the patient experienced mouth sores, slightly swollen upper lip, swelling/pain injection site, fatigue and headache. The patient hasn't been tested PCR for COVID-19 post the vaccination. Therapeutic measures were not taken as a result of events. The outcome of the events were not recovered.
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| 74 | 2021-03-30 | headache, head discomfort |
Stomach upset; Headache; It was like black darkness was coming over my head; Afraid; I was going to ...
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Stomach upset; Headache; It was like black darkness was coming over my head; Afraid; I was going to faint; I got really weak; Felt like I was going to threw up; Light-headed; I did feel like I was going to lose consciousness; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) (Batch/Lot Number: EL9261 and Expiry Date was Unknown) via an unspecified route of administration on 28Jan2021 12:45 at single dose for covid-19 immunization. Medical history included diabetes and asthma. Concomitant medications included empagliflozin (JARDIANCE) and lisinopril. Consumer (Retired Nurse) stated, "I had my COVID Vaccine first dose yesterday 28Jan2021 at 12:45 in the afternoon and I was standing in my kitchen cooking and all of sudden I got really weak and light headed and it was like black darkness was coming over my head. I was afraid, I was going to faint. My stomach was upset. I made up to the bathroom, sat on the toilet, had a bowel movement and felt like I was going to threw up, never did threw up. I got real tired from headache and I just sat there until I thought it was safe to stand, which I did. So, I was reading in my little brochure and it said what to call this number to report any side effect so I was not dizzy but I did feel like I was going to lose consciousness." The patient assessed the events as non-serious with outcome of unknown. Reported causality for COVID Vaccine to events for stomach upset, headache was related.
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| 74 | 2021-03-30 | headache |
Started with rapid heart beats; Lungs sore; Headache; sore all around; Chest wall was painful; Weakn...
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Started with rapid heart beats; Lungs sore; Headache; sore all around; Chest wall was painful; Weakness; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in right arm on 22Feb2021 05:00 (Lot Number: EN6203) at single dose for COVID-19 immunisation. Medical history included rapid heart beats control by medication, anxiety. Concomitant medications included metoprolol; alprazolam; and other vaccine (lot number: EL8982) received on 22Feb2021 in arm. The patient previously took codeine and experienced allergies; received bnt162b2 on 26Jan2021 (lot number: EN6203) in arm for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Started with rapid heart beats, lungs sore, headache, sore all around. Chest wall was painful. Weakness. Most of all systems went away, after the week of March12. Except the bad headache. They were still present. Events all started from 22Feb2021 05:00, resulted in Emergency room/department or urgent care. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Events were considered non-serious per reporter.
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| 74 | 2021-03-30 | fever |
104 fever for two days; This is a spontaneous report from a contactable consumer (patient). A 74-yea...
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104 fever for two days; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration, at the age of 74 years old and administered in left arm on 05Mar2021 14:00 at single dose for covid-19 immunization. Medical history included osteoporosis, penicillin allergy and COVID-19. In addition, the patient had COVID test via Nasal Swab with result Negative on Jan2021. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has been tested for COVID-19. The patient experienced 104 fever on 06Mar2021 06:00 for two days. Treatment Tylenol was received. The outcome of the event was recovered with sequelae (reported as Recovered with lasting effects) on 08Mar2021 06:00. This case reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: The reported event hyperpyrexia was confirmed with temperature value below 106.7°F, a value which, from a medical point of view is not consistent with hyperpyrexia. The Company therefore coded this event as pyrexia.
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| 74 | 2021-03-31 | fatigue, headache |
a little tired; passed out; weakness; disorientation when walking; headache; nausea; hand on the si...
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a little tired; passed out; weakness; disorientation when walking; headache; nausea; hand on the side that she got the vaccine was cold; Second dose: pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received BNT162B2, dose 2, via intramuscular, administered in right arm on 16Mar2021 10:00 AM (Lot Number: EN6204; Expiration Date: Jun2021) as single dose for COVID-19 immunisation. Vaccination facility type was hospital. Medical history included eczema from 2017, she had eczema all over her back and arms and had mild allergies to mold and juniper. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 at the age of 74-year-old on 23Feb2021 at 10:00AM (lot number: EN6198, Expiry: Jun2021) intramuscular injection in left arm and experienced pain at injection site and couldn't sleep. The patient also took Prolia shots for arthritis. The patient experienced headache, nausea, pain at injection site and hand on the side that she got the vaccine was cold on 16Mar2021, passed out, weakness and disorientation when walking on 17Mar2021, a little tired on 18Mar2021. The clinical course included: The patient was calling about the second vaccine that she got on 16Mar2021 (Tuesday). She was calling about the after effects. They were quite huge. She had a headache, nausea, weakness, and disorientation when walking. Stated she obviously had pain at the site of injection. Stated some of it was her own fault, and at first she felt fine. On the same day that she got her second dose of the covid vaccine, she had a glass of wine and was not too hungry. She ate a little that evening. The next morning she passed out. Clarified that she had two glasses of wine, not one. Caller's daughter was a doctor. Caller referd to her daughter as doctor daughter. Stated that she told her daughter about what happened. Her daughter told her it was because she was dehydrated. Her daughter told her that it was called vagus something or another. Her daughter was not there with the caller. Her daughter called it vagus something, she does not remember. Her daughter told her that it had to do with inflammation and her immune system. Caller stated she also has arthritis. Her daughter told her that she was stupid for drinking wine after receiving the second dose of the covid vaccine and not eating a full meal. Whenever she passed out and fell, she did not hurt herself but it was a wake up call. She realized she was vulnerable. She was calling because she did not know why no one told her to drink a lot of water after receiving the vaccine. She got a Prolia shot in July and the nurses told her to drink a lot of water. She was asking why the nurses who gave her the covid vaccine are not saying that to people. Her daughter told her to call the doctors office about this, and she told her daughter that it was over with now, she's 95%, she was a little tired on 18Mar2021. She was unconscious for 15 seconds per her husband. Her husband was shouting her name, and she did not hear anything. She wanted to call and report that the nurses should tell people to drink water. One more thing, her daughter told her that the covid vaccine was slowly released. About 10 hours after receiving the second dose of the covid vaccine her hand on the side that she got the vaccine was cold. She got the vaccine about 10AM, and about 10PM at night is whenever her hand got cold. She had pain at the injection site where she had the first dose of the vaccine too. She had more pain at injection site after the second dose of the vaccine. It was not awful, but only if she pressed on it. Clarified that she gets Prolia shots twice a year for her arthritis. Luckily whenever she started to get dizzy, she braced her self, whenever she fell, she did not fall from an upright position. She was crouched over, and fell against trays that fell with her. Her doctor daughter told her that inflammation was because of her immune system. One other thing was that she has been stung in the past and had extreme reactions from yellow jackets in the 90's. She thought her immune system was sensitive. One other things related to her autoimmune from 3 years ago. She moved to a city in 2012. Everyone told her after 5 years she would develop allergies. In 2017, she had eczema all over her back and arms. It was not just like a topical thing where she scratched and itched, it was under her skin. She went to a dermatologist and he took a biopsy, but the results just said eczema. She went to an allergist, he finally found a space on her underarms where he could do a test. The test showed that she had mild allergies to mold and juniper. Juniper is a tree that they have there, she has one in her back yard. Her allergy was very mild. She tried everything, and in 4 months it went away. Now she just latherers her skin with coconut oil. Her diagnosis that this autoimmune issue was related her immune response from the yellow jacket reaction is a self diagnosis. A doctor had never told her this, this was coming from her own self. Clarified that she is calling about the second dose of the pfizer covid 19 vaccine. Headache: It was not a bad headache, it was more like pressure all across the top. Whenever she went to sleep, the headache started. She got the second dose of the covid vaccine on 16Mar2021. She had a little bit of a headache this morning. A cup of coffee with milk made it better. Nausea: It started whenever she did not want to eat dinner. She could tell her stomach was not right. The nausea and headache started together about 12 hours after her vaccine at 10:00 PM. Weakness: She noticed weakness on the next day whenever she got up to use the bathroom. Clarified as the early morning of 17Mar2021. Her weakness was about 90 percent resolved. Disorientation when walking: Clarified that her disorientation was in reference to walking only right before she fell. She was not mentally disoriented. Mentally she knew that she was not doing well. Second dose: pain at injection site: The pain only lasted for about 2-3 hours. It was now absolutely minimal. She would have to press on it to feel anything. Her hand on the side that she got the vaccine was cold: She got the second dose of the covid vaccine around 10:00 AM, and noticed her hand was cold about 5:00 PM., about 7-8 hours later. Whenever she went to bed, she was cold. She thought that it resolved by the next morning. The morning after receiving the second dose of the covid vaccine, she passed out: She passed out about 8:15 AM. The outcome of the events headache, nausea, weakness, pain at injection site was recovering. The outcome of the events disorientation when walking and her hand on the side that she got the vaccine was cold was recovered on 17Mar2021. The outcome of the other events was unknown.
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| 74 | 2021-03-31 | malaise |
doesn't feel that well; It hurt there at where the needle went in, in the beginning; something is ha...
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doesn't feel that well; It hurt there at where the needle went in, in the beginning; something is happening to her arm but it is not where the needle went in/it hurts down toward the elbow and it penetrates through the epidermis, endodermis and the muscle and feels like it's at the bone; something is happening to her arm but it is not where the needle went in/it hurts down toward the elbow and it penetrates through the epidermis, endodermis and the muscle and feels like it's at the bone; something is happening to her arm but it is not where the needle went in/it hurts down toward the elbow and it penetrates through the epidermis, endodermis and the muscle and feels like it's at the bone; something is happening to her arm but it is not where the needle went in/it hurts down toward the elbow and it penetrates through the epidermis, endodermis and the muscle and feels like it's at the bone; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6205), via an unspecified route of administration, administered in the left arm on 03Mar2021 (at the age of 74 years old) at a single dose for COVID-19 immunization. Medical history included lumbar spine infusion (operations on spinal cord) from an unknown date and unknown if ongoing. There were no concomitant medications. It was reported that the patient needed the call handler to speak slowly, she doesn't feel that well. She had the first dose of BNT162B2 last 03Mar2021 and the second dose will be on 23Mar2021. She said something was happening to her arm but it was not where the needle went in, that is not where it is. It hurt there at where the needle went in, in the beginning but now it hurts down toward the elbow and it penetrates through the epidermis, endodermis and the muscle and feels like it's at the bone. She hopes it was not a blood clot. She has been looking at the website and they say people could have blood clots and she does not know if this was a blood clot, she can't hardly lift her arm, it was the left side that the shot was in because her right side is partially paralyzed due to effect of lumbar spine infusion and so when she tried to get up sometimes she can hardly lift that arm and so she didn't know what to do if she should call the primary care doctor to see if she has a clot but she read it and it says to call this number if you are having compactions and she been on hold over and hour and a half. It was hurting and the feeling like she couldn't hardly raise the arm or get any kind of strength in it. She knew in Europe they have had few people who have had blood clots, and she thought could that be a sign of a blood, like blood not moving through her veins like it is supposed to. It is not moving it has not made it to her heart yet. She says it is associated with the product, this is the only thing she has had in her arm she knows it is the product. She said her birthday just passed. She turned 75 years old but when the issue started in her arm she was 74 years old. It did not start the first week, the first week it was just sore around where the shot went in but then last week it started happening where it was hurting down her arm and she was getting close to the second shot which she doubts she will have but it is the 23rd which is next week. She used to be 5'2" but the operations on her spinal cord, she guesses she might be 4''10 now. She does not know because she can't hold her head up straight because the doctor that fused it, she indented it instead of it being more out and because of that her head is forward and down. It was also reported that she hasn't been to the doctor she only goes to pain management for him to check out her body and everything and renew prescriptions. The outcome of the events was unknown.
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| 74 | 2021-04-01 | headache, chills, fever, dehydration |
weak; lightheaded; My blood pressure low 80's to 90's over 40's to 50's all thru night; dehydrated p...
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weak; lightheaded; My blood pressure low 80's to 90's over 40's to 50's all thru night; dehydrated prior to this admit; shaking; chills; severe headache; right mid and low back pain; high fever up to 103 degrees; Not able to get out of bed except to get to nearby bathroom; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 74-years-old via an unspecified route of administration, administered in arm left on 05Mar2021 15:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation. Medical history included anal cancer (h/o anal cancers/p chemo & RT2013), hypertension, hypothyroidism and new fe deficiency anemia dx during this admit from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient has known allergies to Ampicillin, clindamycin, trilafon, imipramine. The patient reported that 4.5 days after 1st dose of Pfizer vaccine on morning of 10Mar2021 09:00, the patient woke up with shaking chills, severe headache, right mid and low back pain, high fever up to 103 degrees within 1/2 hr of onset and not able to get out of bed except to get to nearby bathroom to use toilet when needed. The patient took Tylenol 500 mg up to 5 doses by 10:00 am of 11Mar2021 when fever would not abate; the patient was weak and lightheaded on an unspecified date and since lived alone called a number to take her to ER. On an unspecified date, her blood pressure was low 80's to 90's over 40's to 50's all thru night and 1000 more mg of Tylenol was given at 4:00 am and fever then lowered to 99 or 100. Full infectious work up negative for bacterial sources including abdominal and pelvic cat scan, abdominal ultrasound, CXR, urine culture, she received 2 1/2 liters of IV fluid and IV Ceftriaxone and Flagyl in ER. In case bacterial cause which was not found including blood cultures, due to her BP still not improved by 5:00 am as she was dehydrated prior to this admit, she was admitted on medicine floor for 2 days. The patient underwent lab tests and procedures which included abdomen scan: unknown result on an unspecified date, blood pressure measurement: low 80's to 90's over 40's to 50's all thru night on an unspecified date; still not improved on an unspecified date, body temperature: high fever up to 103 degrees on 10Mar2021; 99 or 100 on an unspecified date, chest x-ray: unknown result on an unspecified date, culture urine: unknown result on an unspecified date, sars-cov-2 test: negative on 10Mar2021, ultrasound abdomen: unknown result on an unspecified date. Therapeutic measures were taken as a result of the events which included IV, fluids, 1 dose of 2 different IV antibiotics (Ceftriaxone and Flagyl) and Tylenol. The patient was recovering from the events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 74 | 2021-04-06 | chills, headache, dehydration |
her blood pressure was very low the next morning; she felt really weak; nausea; she lost a lot of fl...
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her blood pressure was very low the next morning; she felt really weak; nausea; she lost a lot of fluids/I was so dehydrated; hadn't eaten anything; stated she started salivating and then threw up; stated she threw up once; she had a severe headache; she was shivering all evening and she couldn't get warm; she had body aches; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249, NDC number: Unknown, Expiration Date: May2021, Manufacturer: Unspecified) via an unspecified route of administration at right arm on 15Jan2021 at single dose for COVID-19 immunisation. Medical history of patient included knee pain and anxiety. Patient's concomitant medications included tramadol, paracetamol both 500 mg for knee pain and hydroxyzine hydrochloride (25mg tablet up to three times a day as needed by mouth, she does not take every day) for anxiety. On 15Jan2021 after vaccination patient experienced salivating and then threw up, stated she threw up once, severe headache, shivering all evening and she couldn't get warm, body aches, nausea, lost a lot of fluids/I was so dehydrated, hadn't eaten anything and her blood pressure was very low the next morning, she felt really weak on 16Jan2021. She required urgent care trip for IV fluids, "She was so dehydrated" and was "miserable" with her symptoms. She said she lost a lot of fluids and hadn't eaten anything. Patient wants to get the second COVID-19 vaccine dose because she is scheduled to have a knee replacement on 26Feb2021. She said she also had to deal with the pain in her knee, clarifying that is why she is getting a knee replacement. IV fluids (clarified as Saline), tylenol given as treatment. She reported when she got home she drank Pedialyte to try to rehydrate herself. She reported she went to urgent care on Saturday (16Jan2021), and by Monday 18Jan2021, she was feeling better, but she didn't golf on Tuesday, 19Jan2021. patient underwent lab tests and procedures which included blood pressure measurement which very low, influenza virus test and sars-cov-2 test was negative on 16Jan2021, blood test was fine. Patient said yes for investigation assessment. The outcome of event was recovered on 15Jan2021 for Increased salivation and Vomited and for all other event outcome was recovered on Jan2021.
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| 74 | 2021-04-09 | cough |
February 17, 2021: Patient received 1st dose of PfizerBioNTech vaccine. Reported mild cough, nause...
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February 17, 2021: Patient received 1st dose of PfizerBioNTech vaccine. Reported mild cough, nausea and bone pain lasting one week. However, she felt it wasn't severe enough to contact me as her asthma specialist. No cough per patient for the week prior to the second dose of PfizerBioNTech. March 10, 2021: Patient received 2nd dose of PfizerBioNTech vaccine at 1:10pm. Said she had mild chest tightness during the waiting period and used her Ventolin but she attributed it to the characteristics of the waiting room area. Between 5:00pm and 6:00pm (~4 hours later), she became light-headed, vomited and began to cough frequently. She contacted her primary care physician who told her to use Mucinex and contact me if needed. March 12, 2021: Patient contacted my office in the early afternoon. Unable to stop coughing while on telephone. Came to office approximately 90 minutes later. Physical Exam; Peak Flow 210 (personal best 310-320), oxygen saturation 93-95% (typically 97-98%), temp-98.2 F. Intractable cough with scattered bilateral expiratory wheezes on auscultation. Heart rate 132 and regular. Patient treated with Levalbuterol 1.25 mg nebulization with subsequent modest improvement in frequency of cough, pulse 102, oxygen saturation 96-97%. She declined going to emergency department of hospital because she did not want to get infected with COVID-19 from a patient in the waiting room. She declined Prednisone when told that the corticosteroid might reduce the efficacy of the 2nd dose of the vaccine. Placed on Budesonide 1 mg bid and Levalbuterol 1.25 mg q4-6h prn. March 16th: Patient reported her cough was 70% improved and wanted to stop Budesonide. Patient was told to continue Budesonide daily at 1 mg q day. April 5th: Patient contacted my office because of continued coughing and wheezing. Had been hospitalized March 25-27 for the cough.
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| 74 | 2021-04-12 | fatigue, headache |
Two days after receiving vaccine patient and family reports patient developed nausea and headache. s...
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Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report.
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| 74 | 2021-04-13 | cough |
Patient presented to the hospital for low hemoglobin, hematuria, abdominal pain, and cough. The pati...
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Patient presented to the hospital for low hemoglobin, hematuria, abdominal pain, and cough. The patient tested positive for COVID-19 upon admission to the hospital on 3/24/2021. CXR showed mild pulmonary vascular congestion. The patient was on 2L/min supplemental oxygen throughout admission.
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| 74 | 2021-04-15 | chills, fatigue, headache |
Strong Fatigue. Chills in fingers and toes, headache in back of neck, muscle pain in arms and should...
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Strong Fatigue. Chills in fingers and toes, headache in back of neck, muscle pain in arms and shoulder, soreness at injection site, slight vision impairment lasting 24 hours
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| 74 | 2021-04-15 | fever |
Patient is a 74 year old female with PMH of morbid obesity and seizure disorder who presented to the...
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Patient is a 74 year old female with PMH of morbid obesity and seizure disorder who presented to the ER on 2/13/2021 with weakness and fever. Patient tested positive for COVID-19 on 2/13 and was treated with a five day course of oral dexamethasone and remdesivir. Antibiotics were started on admission, but serial chest x-rays were mostly stable and all culture results remained negative. Antibiotics were discontinued on 2/15. Patient discharged to home on 2/18/2021
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| 74 | 2021-04-23 | fatigue |
very tired; sleeping alot; dizzy spells; diarrhea; This is a spontaneous report from a contactable c...
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very tired; sleeping alot; dizzy spells; diarrhea; This is a spontaneous report from a contactable consumer. A 74-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration on 04Feb2021 13:30 (at the age of 74-years) as SINGLE DOSE in Arm Left for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included Lung cancer (lobectomy), copd, emphysema. The patient previously took Pcn (penicillin), codeine, morphine, Indocin and had drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Prior to the vaccination the patient was not diagnosed with COVID-19. On 05Feb2021, the patient experienced very tired, sleeping alot, dizzy spells and diarrhea. The patient did not receive any treatment. Since the vaccination the patient had not been tested for COVID-19. The outcome of events was not recovered.
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| 74 | 2021-04-24 | chills |
I fainted and hit my head.; I fainted and hit my head.; passing out; stomach cramps; diarrhea; chill...
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I fainted and hit my head.; I fainted and hit my head.; passing out; stomach cramps; diarrhea; chills; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20Mar2021 12:45 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation. Medical history included Thyroidectomy. Concomitant medications included pravastatin sodium (PRAVASTATIN SODIUM); levothyroxine sodium (SYNTHROID); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient received first dose of BNT162B2 on 27Feb2021 at 74-years-old for COVID-19 immunization: lot number=EN6203, lot unknown=False, administration date=27Feb2021, vaccine location=Left arm, dose number=1. On 22Mar2021 16:00, the patient fainted and hit her head. On 21Mar2021, the patient had stomach cramps, diarrhea and chills. I was wondering if passing out was an uncommon side effect. The outcome of the events was recovered. The patient received treatment for the events.
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| 74 | 2021-04-24 | malaise, headache |
Headache like my head was going to explode/severe headache like migraine/Pain level 10/10; headache ...
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Headache like my head was going to explode/severe headache like migraine/Pain level 10/10; headache like migraine/chronic migraine; symptoms of a stroke; weakness on my right side from tongue to nose; weakness on my right side from tongue to nose; extreme nausea; general malaise; My shot arm feel like felt like I had been hit for several days; This is a spontaneous report from a contactable consumer (the patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318) via an unspecified route of administration on 09Feb2021 at age of 74-year-old at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302) on 19Jan2021 at age of 74-year-old for COVID-19 Immunization, the patient had no soreness or reaction until 10days later on 29Jan2021 when she had a low fever ~0.5-1 degree with chills and aches like a fever for 3 days, the patient experienced aches and pain; hurting all over on 29Jan2021, the patient took no medications, there were no further reaction. The second shot given on 09Feb2021, the patient's shot arm felt like she had been hit for several days beginning 10Feb2021. On 11Feb2021, the patient got a severe headache like migraine. Pain level 10/10. She had chronic migraine with all symptoms of a stroke (extreme nausea and weakness on her right side from tongue to nose, extreme headache about left side of the head). The headache on 11Feb2021 was overlap headache. On both sides of head and nausea. No other migraine symptoms. It lasted for 3 days. The patient was hospitalized due to the event(s) headache like my head was going to explode/severe headache like migraine/ chronic migraine. The patient took only butalbital, caffeine, paracetamol (FIORICET, 50, 325-40) from 11Feb2021 to 12Feb2021 at 40mg caff for several headache like migraine; promethazine (PHENERGAN) from 11Feb2021 to 12Feb2021 at 25mg for several nausea. The patient had several events general malaise where she didnot feel like doing her thing until today 30Mar2021. She had taken no medications or seen a doctor about it. The outcome of "headache like my head was going to explode/severe headache like migraine/pain level 10/10", "headache like migraine/chronic migraine" was recovered in 2021. The outcome of other events was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021145090 same patient, same drug, different event, different dose separated in times
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| 74 | 2021-04-26 | chills, headache, fever |
troponin: high troponin levels; pain on the back of her head and her back; pain on the back of her h...
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troponin: high troponin levels; pain on the back of her head and her back; pain on the back of her head and her back; Chills; fever; She was shaking badly; Fainted; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 24Mar2021 11:15 (Lot Number: ER8727; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 74 years). Medical history included ongoing rheumatoid arthritis, melanoma, depression, heart attack (had a heart attack 7 or 8 years ago) and covid (covid in the first week of January). Concomitant medications included levothyroxine sodium (SYNTHROID) and escitalopram oxalate (LEXAPRO) for depression. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 for covid-19 immunisation and experienced rash with itching and a lump and swelling (74 years). The patient fainted on 24Mar2021, chills and fever on 24Mar2021 20:00, pain on the back of her head and her back and a couple of places like anyone would get when they fall on 25Mar2021 and she was shaking badly on 24Mar2021. The patient underwent lab tests and procedures which included blood work: unknown results and troponin: high troponin levels on an unspecified date. Therapeutic measures were taken as a result of tremor included Aleve. Outcome of the events chills and pyrexia was recovered on 25Mar2021 (four hours) while outcome of the events head pain and back pain was recovering. Outcome of the remaining events was unknown.
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| 74 | 2021-04-26 | chills |
body aches; diuresis; shortness of breath with pO2 = 84; chills (used every blanket that I could fin...
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body aches; diuresis; shortness of breath with pO2 = 84; chills (used every blanket that I could find; tremendous thirst; vomiting; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non pregnant female patient second dose received bnt162b2 (BNT162B2, solution for injection, single dose; age at time of vaccination 74-year), via an unspecified route of administration in left arm on 12Feb2021 13:15 as single dose for covid-19. Medical history included Multiple connective tissue disorder; COVID-19. The patient concomitant medication included prednisone (unknown formulation) from 29Jan2021 at 10 mg, daily. The patient previously received first single dose of bnt162b2 on 22Jan2021 single dose for Covid-19 immunization (age at time of vaccination 74-year). Also had Sulfa drugs allergy. the patient receive other vaccines within 4 weeks prior to the COVID vaccine; other medications the patient received within 2 weeks of vaccination was Prednisone 10mg/day. On 12Feb2021 23:00, chills (used every blanket that I could find), tremendous thirst, vomiting. In the morning and next day (13Feb2021) body aches and diuresis. Next night (13FEB2021) shortness of breath with p02 84. By morning of (14Feb2021) shortness of breath was gone and p02 back to 96. Vomiting and aches continued for part of the day. Patient not received treatment for the adverse event. The reported seriousness for all events was non serious. Prior to vaccination, the patient diagnosed with COVID-19; Since the vaccination, the patient not tested for COVID-19. The outcome of the events chills, tremendous thirst, vomiting, body aches and diuresis was reported as recovering and the patient recovered from the event shortness of breath on 14Feb2021. Information on the lot/batch number has been requested.
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| 74 | 2021-04-26 | headache |
chest pain; feeling occasional pain and tightness to my heart; feeling occasional pain and tightness...
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chest pain; feeling occasional pain and tightness to my heart; feeling occasional pain and tightness to my heart; She also had tenderness in muscle where site of vaccine was; headache; Left arm pain; This is a spontaneous report from a contactable consumer reporting for herself. A 74-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 27Jan2021 (Batch/Lot Number: EL3248) as single dose for covid-19 immunisation (Age at vaccination 74 years) . Medical history included atrial fibrillation from 2019 (AFib was diagnosed a couple of months before Dec2019) , chronic obstructive pulmonary disease from Dec2019 , medical device implantation (Watchman device inserted), anaemia , oesophagogastroduodenoscopy , oesophageal stenosis, obesity. Concomitant medication(s) included clopidogrel bisulfate (PLAVIX) from Jul2019 to an unspecified stop date; metoprolol (METOPROLOL) taken for heart rate irregular from Nov2019 to an unspecified stop date. The patient previously took bnt162b2 for covid-19 immunisation on 06Jan2021. The patient also took aspirin (E.C.) and experienced haemorrhage. The patient experienced feeling occasional pain and tightness to my heart on 30Jan2021 with outcome of not recovered , chest pain on an unspecified date with outcome of not recovered , she also had tenderness in muscle where site of vaccine was on 28Jan2021 with outcome of recovering , headache on 28Jan2021 with outcome of recovering , left arm pain on 28Jan2021 with outcome of recovered. No follow-up attempts are possible. No further information is expected.
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| 74 | 2021-04-27 | malaise |
Aching legs; Gradually getting worse; Her memory is affected; Muscle aches and pains; Felt out of so...
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Aching legs; Gradually getting worse; Her memory is affected; Muscle aches and pains; Felt out of sorts; Arm was sore; This is a spontaneous report from a contactable other hcp (nurse). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in arm right on 18Jan2021 at 09:00 (Lot Number: EL3247, Expiration Date: Apr2021) as single dose for COVID-19 immunization. The patient's medical history included spinal fusion surgery from 2019 to an unknown date. The patient previously received 1st Shingrix injection and experienced her arm turned really red and swelled up (so her doctor told her not to take the 2nd injection). There were no concomitant medications. On 19Jan2021, the patient experienced arm was sore. On 21Jan2021, the patient felt out of sorts. On 22Jan2021, the patient experienced muscle aches and pains. She is not sure if the muscle aches are due to her just getting old or from the vaccine. The muscle aches are especially in her legs. On an unspecified date, the patient experienced aching legs, gradually getting worse and her memory is affected. She is gradually getting worse, but doesn't know if it's the weather, or is it a possibility that it's the vaccine. The patient's memory is affected, then clarified that it has nothing to do with the vaccine, she is just getting old. She asked if people have reported muscle aches and pains for weeks after. She is due to have the second injection on 08Feb2021. No family medical history relevant to events. The events did not result in emergency room visit or physician office visit. The outcome of the muscle aches and pains was not recovered and was unknown for the rest of the events. Follow-up attempts are completed. No further information is expected.
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| 74 | 2021-04-28 | headache, fever, chills | Severe chill, fever 100,6, headache , weakness |
| 74 | 2021-04-30 | cough, respiratory tract congestion, nasopharyngitis |
She feels she has a cold in her chest; cold; influenza A; Hacking cough; voice affected; chest burni...
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She feels she has a cold in her chest; cold; influenza A; Hacking cough; voice affected; chest burning; Difficulty breathing; chest congestion; This is a spontaneous report from a contactable consumer. This 74-year-old female consumer reported that she started to receive the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9266) via an unspecified route of administration in arm left on 03Mar2021 08:45AM (at the age of 74-year-old) at single dose for COVID-19 immunisation. First dose of BNT162b2 (Lot number GM or EM9809) was taken on 10Feb2021 (at the age of 74-year-old) in left arm (way up high on the shoulder) for COVID-19 immunisation. Relevant medical history included bronchitis, chronic obstructive pulmonary disease (due to environmental toxins), allergy to different dyes (allergic to yellow, purple, and blue dye) and allergy to medications. The patient has never been a drinker or smoker. Concomitant medications were not reported. A week or so after the second dose, she thought she was having a cold. It has affected her voice and breathing. She thought she had bronchitis. She was going to her doctor on 04May2021. She had a hacking cough and she doesn't know what she has if it isn't a cold. She wondered if it was connected to the vaccine or is it bronchitis. The more she talks the more difficulty in her chest. She was prescribed Robitussin DM cough syrup by her doctor and was taking honey lemon cough drops. She also had congestion in her chest ever since. She has been having like a cold in her chest. It was heard how she was sounding. She never thought it was connected to the vaccine and never expected this to last for this long. The patient asked whether it could be a residual side effects of the vaccine and questioned if this could have had any effect on the COPD. She stated she was not having any problems with it and she has had it for years. Her cough has been the same, she takes a dose of DM cough syrup or a cough drop during the day. Robitussin was working. She was drinking lots of fluids, between 74-96 ounces of water per day. The doctor told her she had A influenza, but she thought she had COVID because she had all the symptoms, but they said A influenza and treated her for influenza A. That morning she had difficulty breathing like bronchitis, her chest was burning inside and was always like that, her talking aggravates everything and she had deep breathing. Her physician said her chest was clear after she thought she had bronchitis at her previous visit. She does not have any questions, she was calling to report an event, she is calling her doctor for further guidance. Cough, difficulty breathing, voice changed required a visit at physician office. Onset date for hacking cough, voice affected, chest burning, difficulty breathing and chest congestion was 10mar2021, while onset date for the other events was unknown. Hacking cough, voice affected, chest burning, difficulty breathing and chest congestion were not resolved, outcome of the other events was unknown.
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| 74 | 2021-04-30 | headache |
severe headache; This is a spontaneous report from a contactable consumer (patient). Follow-ups (05A...
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severe headache; This is a spontaneous report from a contactable consumer (patient). Follow-ups (05Apr2021) were received from same reporter and processed together with initial information. A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 26Feb2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced severe headaches 2.5 days following 1st Pfizer shot and she took Tylenol and Ibuprofen. Doctor sent her to hospital for CT Scan which was normal (negative for anything). The patient's headaches dissipated right before receiving 2nd Pfizer shot. The outcome of event was recovered on an unspecified date in Mar 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 74 | 2021-05-04 | malaise |
Generally not feeling well after first shot. Shortness of breath the day after getting the second sh...
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Generally not feeling well after first shot. Shortness of breath the day after getting the second shot. The patient died the day after getting the second shot.
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| 74 | 2021-05-06 | fatigue |
I was hospitalized with covid; I was hospitalized with covid; kind of weak; tired; This is a spontan...
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I was hospitalized with covid; I was hospitalized with covid; kind of weak; tired; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 30Mar2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Last week (unspecified date), she was hospitalized with COVID, just came home after a week in the hospital, just came home last night. She was asking whether she can get the second dose and if there is any guidance on timing of the second dose. She was in the hospital 2 weeks ago and they tested her, and she was negative and last Monday she didn't feel good and went to the hospital and she has COPD and she tested positive on Monday and they kept her. She already has 1 shot and is supposed to get the 2nd on the 24th and she doesn't know if she should wait 14 days. Stated she was kind of weak. She was starting to get tired and not able to complete report. Clarified it was the Pfizer Covid vaccine and she got the 1st dose 30Mar2021 and was due for the 2nd dose 24Apr2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on Apr2021 then positive on Apr2021. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 74 | 2021-05-07 | headache |
Blood pressure high/ Her blood pressure got high, the bottom number (diastolic) got up to 101. The h...
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Blood pressure high/ Her blood pressure got high, the bottom number (diastolic) got up to 101. The highest the top number (systolic) got was 158; head congestion/pressure; head congestion/pressure; Headache; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiry Date of COVID-19 Vaccine: unknown), via intramuscular in left arm on 01Feb2021 15:30 as single dose for covid-19 immunisation. Medical history included cancer from Nov2017, Verbatim was reported as cancer, she explains she started chemo in late Jan2018 and ran through that year. Starting in Aug2018, she had radiation every day, Intestinal cellulitis, this was diagnosed about 8 years ago; kidney problem and blood pressure. Concomitant medications included simvastatin 40 mg, tablet via mouth at once a day at night taken for blood pressure, start and stop date were not reported, caller verifies it was through insurance and is dispensed in a pharmacy bottle. lisinopril dihydrate 10 mg, tablet via mouth once a day before she goes to bed taken for blood pressure, start and stop date were not reported, it was dispensed in a pharmacy bottle. On 02Feb2021, the patient experienced headache; on an unknown date experienced blood pressure high/ her blood pressure got high, the bottom number (diastolic) got up to 101. the highest the top number (systolic) got was 158, head congestion/pressure. The report received as, caller received her COVID-19 shot on 01Feb2021. She is recorded to get the next vaccine on 19Feb2021. However, she read to not get the second vaccine before 21 days. She had trouble with first shot and is worried about getting in early. The caller confirms she received the vaccine on Monday, 01Feb2021.The caller states right at first while receiving the COVID-19 vaccine, she felt it go into her body. She clarifies further she felt it inside her. She could feel it. That didn't bother her or anything. She may have gotten a slight headache that night, but she had a worse headache the next day. The next day, Tuesday, 02Feb2021, she had a headache for most of the day. She was congested in the head. She wasn't normally congested in the head or have like pressure, the vaccine made her have it. She took Mucinex, but that didn't relieve her headache. She took Tylenol and that helped for a while. Caller provides the following product information for the Mucinex and Tylenol she took. Caller states she is sure the Mucinex (Lot: W000597049, Expiry date: Nov2014) was old because she doesn't take it very often. The caller clarifies she doesn't have Tylenol (Lot# 4HE16818, Expiry date: May2017), she actually has the Acetaminophen (Pain Reliever/Fever Reducer). What she was most worried about was what happened around Wednesday. She clarifies it wasn't the day after receiving the vaccine, it was the next day- Wednesday, Thursday, and Friday. Her blood pressure got high, the bottom number (diastolic) got up to 101. The highest the top number (systolic) got was 158. Having that bottom number at 101 was kind of scary. She was on blood pressure medicine and her daughter was going to take her to the hospital, but she went ahead and took her blood pressure earlier than what she would normally take it. The blood pressure medicine brought her blood pressure down within a half an hour. When probed for the outcome of her blood pressure, she explains she hasn't taken her blood pressure in the last day or two but she can tell when her blood pressure was high so she doesn't go through the trouble of taking it when it was not. She verifies she has recovered completely from the high blood pressure. Caller confirms she didn't go ahead and go anywhere. It was years and years, she doesn't take flu shot. Caller mentions her husband took the COVID-19 vaccine the same time as her and had no ill effects at all. The patient was not experienced the events in emergency room or physician office visit. The patient underwent lab tests and procedures which included blood pressure measurement: high and 158/101 on an unknown date (the bottom number (diastolic) got up to 101. The highest the top number (systolic) got was 158. Having that bottom number at 101). Therapeutic measures were taken as a result of the events with Mucinex, Tylenol and Acetaminophen (Pain Reliever/Fever Reducer). Outcome of the event Blood pressure high/ Her blood pressure got high, the bottom number (diastolic) got up to 101. The highest the top number (systolic) got was 158 was recovered on an unknown date and for remaining events outcome was unknown. Information on Lot/Batch number has been requested.
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| 74 | 2021-05-07 | headache |
a measles like rash on her chest, arms and midriff developed; itchy; a measles like rash on her ches...
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a measles like rash on her chest, arms and midriff developed; itchy; a measles like rash on her chest, arms and midriff developed; rash on her chest, midriff, arms, and bottom of legs; She states that she experienced a headache and a sore arm; She states that she experienced a headache and a sore arm; This is a spontaneous report from a contactable consumer (the patient). A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206; expiration date was not reported), via an unspecified route of administration Arm right on 06Mar2021 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER2613; expiration date was not reported), via an unspecified route of administration on 27Mar2021 (at the age of 74-years-old) as single dose for covid-19 immunization. The patient's medical history Included High Blood Pressure. Concomitant medications included diphenhydramine hydrochloride(BENADRYL) for rash; coal tar, dimeticone, zinc oxide(ECZEMA CREAM) for Itching; Metoprolol Tartrate; SIMVASTATIN; LOSARTAN; POTASSIUM CHLORIDE (KLOR CON) for potassium dropped; Amlodipine Besilate; hydrochlorothiazide for high blood pressure. On 11Apr2021, the patient noticed a measly like rash on her chest, midriff, arms, and bottom of legs, measles and it was very itchy, On 28Mar2021 Headache recovered on 2021, on 27Mar2021 a sore arm recovered on 28Mar2021. The patient instructed to took Benadryl for a week and if the rash persists to come in to the office for an examination and also eczema cream in addition to taking the Benadryl for the itching. Outcome of the events rash on her chest, arms and midriff developed (rash), itchy was not recovered, measles outcome was unknown, headache and a sore arm outcome was recovered. The patient received the second dose on 27 MAR 2021. She experienced a headache and a sore arm for day and a half after the vaccine. Then last week she also had a headache for two days in a row, but that could be due to the change in the weather, she doesn't know what that is. She said that a week and a half ago a rash, a measles like rash on her chest, arms and midriff developed. She wasn't sure if it was because she was working outside, or related to the vaccine. She did find a couple of ticks on her. She called the local farm bureau and they said no, it wasn't from the ticks because the ticks would of burrowed their head into the skin. It was probably because she was outside. The patient has been taking Benadryl do to the fact that she has been outside and she has been very itchy. Everything is in bloom right now, but she was wearing long pants and long sleeves with gloves. The patient's itching is horrible. The patient night before up all night took Benadryl. She got a cream her husband use to used for eczema, it was an anti-itch cream, and she also used Aveeno eczema cream that has calamine lotion in it. The patient hasn't gone and seen her doctor yet because she felt better two days later and thought it was subsiding. The patient might be because she takes a shower and then she is alright for a couple of hours because of all the creams she is using. The last night she was up till 3 am because of the itching. She stated that she knows you are not suppose to take other peoples medication but she had Prednisone 10 mg in the house, from her husband when he would have eczema flare ups, and she took that at 3 in the morning. She said that her doctor thought there has been too much time from when she got the vaccine for it to be related so she googled and it said that people can get a measles like rash, and read something about being on their toes, but hers wasn't on her toes. Her rash was just her chest, arm, part of her legs and midriff. She stated that she is nervous, and she lost her husband a year ago on 28 APR and she doesn't know, if it is just nerves/stress or if it due to the reaction. The patient when she went to go get the vaccine they had asked her if she ever had reaction to a vaccine and she said a year ago when she had the pneumonia shot, she got cellulitis 2 inches above and 2 inches below the injection site. Her doctor thought it was cellulitis and she had to take antibiotics for a week. She stated that she had to wait longer then the normal 15 minutes because of her previous reaction so they made he wait for 30 mins when she got the covid vaccine. The first shot did not hurt at all. She asked that because she said that the second vaccine hurt immediately, it was discomforting. She thought she hit a nerve. She said it was like someone ran a nail down all the way down to her elbow. She doesn't know if she hit a nerve or what, but it was very painful. Clarified her headache started Sunday night after the vaccine and went away Monday. The patient thought the rash might be shingles, but then she was like no, that is only suppose to be on one side of a body. She stated that she needs to get the new shingles shot because the one that she had years ago isn't good anymore. She hasn't had new shingles immunization yet because she had to get the COVID shot. She doesn't know if the itching started because she saw the ticks or not but it started immediately. She states that she got the ticks off of her and shook her hair out. She states that she took Benadryl, she didn't have the fast acting Benadryl she had the 24 hour relief Benadryl. She went to the store and got fast acting Benadryl and has been taking them ever since Monday. She took Benadryl 25mg two only at night. Lot S200513 exp. May 2023. The patients second dose received on 27Mar2021 on right arm with lot number ER2613. She was told to get the vaccine in the dominant arm which is her right arm. She used to always get vaccines in her left arm because you were suppose to get it in her nondominant arm because of the movement. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Follow-up #1(PRD 22Apr2021): This is a spontaneous report from a contactable consumer. This 74-year-old female consumer (patient) reported for herself that: updated new events Headache: (From: 28Mar2021 To: 2021), sore arm: (From: 27Mar2021 To: 28Mar2021), a measles like rash on her chest, arms and midriff developed. Updated Concomitant Products Metoprolol, hydrochlorothiazide, simvastatin, Losartan, Klor-Con, Amlodipine for high blood pressure, she states that the last bone density test she had her numbers were good but her doctor put her on this prophylactically. Critical Calcium supplement maximum plus for bone density. The patient's blood pressure medication and vitamins but they haven't changed since she has been going to her current doctor for 5 or 6 years. No follow-up attempts are needed. No further information is expected.
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| 74 | 2021-05-13 | headache, fever, fatigue |
3 days sick; Threw up; Headache; 101.8 Fever; Ached all over; Very tired; This is a spontaneous repo...
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3 days sick; Threw up; Headache; 101.8 Fever; Ached all over; Very tired; This is a spontaneous report from a contactable consumer (reporting herself). This 74-Year-old Female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6198), via an unspecified route of administration in arm on 01Mar2021 at 14:50 as a single dose for COVID-19 immunization. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Ph9264), via an unspecified route of administration in arm on 09Feb2021 at 10:00 as a single dose for COVID-19 immunization. The patient's medical history reported as MONO-EBU started one year ago and its ongoing. The concomitant medication were not reported. On 01Mar2021, the patient experienced three days sickness, very tired, threw up, headache, 101.8 fever, ache all over in bed 3-day. The outcome of the event three days sickness was recovering, very tired was recovered and other events was unknown.
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| 75 | 2021-01-01 | chills, fever |
Fever, chills, nausea beginning about 6 hours after the vaccination and continuing for about 36 hour...
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Fever, chills, nausea beginning about 6 hours after the vaccination and continuing for about 36 hours
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| 75 | 2021-01-04 | throat irritation, throat pain | DAY AFTER VACCINATION, DEVELOPED SORE/SCRATCHY THROAT |
| 75 | 2021-01-09 | fever, chills |
Pfizer-BioNTech COVID-19 Vaccine 1st and 2nd day had side effect of chills for a couple hours each ...
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Pfizer-BioNTech COVID-19 Vaccine 1st and 2nd day had side effect of chills for a couple hours each day and low grade fever the 2nd day. No side effects the 3rd day.
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| 75 | 2021-01-10 | chills |
Extreme pain in bone, not muscle, of left arm started approximately 30 minutes after injection. 4 ...
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Extreme pain in bone, not muscle, of left arm started approximately 30 minutes after injection. 4 hours later chills started . Both symptoms continue 12 days later.
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| 75 | 2021-01-10 | fatigue |
Mild arm soreness at site the following day Significant fatigue on the following five days and now ...
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Mild arm soreness at site the following day Significant fatigue on the following five days and now Heart palpitations and elevated BP on day four Mild nausea on day five
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| 75 | 2021-01-13 | malaise |
after 6 hrs injection of 2nd dose, left arm was swollen felt tender. That night, I feel chilled; n...
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after 6 hrs injection of 2nd dose, left arm was swollen felt tender. That night, I feel chilled; not feeling very good. Next day same prblem especially chilled; went to bed under blanket to warm up Its now 12:36 next day, no improvement
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| 75 | 2021-01-14 | fatigue |
feeling fatigue; "just not herself, out of whack in her body"; diarrhea; This is a spontaneous repor...
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feeling fatigue; "just not herself, out of whack in her body"; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer-Biontech Covid-19 Vaccine; unknown lot number and expiration date), via an unspecified route of administration on 07Jan2021 at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient reported that she received the Covid 19 vaccine on 07Jan2021 then the day after (08Jan2021), she began feeling fatigue, "just not herself, out of whack in her body", and diarrhea. The patient reported that she was fine now. She inquired if those were normal. The outcome of the events was recovered on Jan2021. Information on the lot/batch number has been requested.
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| 75 | 2021-01-15 | headache | Soreness at injection site, mild headache |
| 75 | 2021-01-17 | headache |
altered taste; altered sense of smell; slight left arm soreness; slight headache; This is a spontane...
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altered taste; altered sense of smell; slight left arm soreness; slight headache; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283 and expiration date not provided), via an unspecified route of administration left arm first dose on 08Jan2021 at single dose for covid-19 immunisation. There were no medical history and concomitant medications. It was reported that patient got the first shot of the Pfizer Covid 19 vaccine last Friday 08Jan2021. Stated that she had normal slight arm soreness and slight headache on Saturday 09Jan2021. Stated that she woke up this morning 11Jan2021 and had altered taste and sense of smell. Stated that she has not heard of this as reaction to the shot. Stated that she feels fine. Stated that she put on perfume that was old and fixed grits with cheese which she could barely taste. Stated that she tried other things and noticed that she has altered sense of taste and smell. The patient did not received treatments for the events. The outcome of the events slight left arm soreness and slight headache was recovered on 09Jan2021 and not recovered for the other events.
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| 75 | 2021-01-18 | dehydration, chills |
Chills, nausea, vomiting , diarrhea Then all day. Very ?deep? sleep. Then extreme dehydration. So ...
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Chills, nausea, vomiting , diarrhea Then all day. Very ?deep? sleep. Then extreme dehydration. So to ER for fluids. Don?t know how to go back. Original start of the event date was 01/14/2021. In am
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| 75 | 2021-01-18 | fatigue, headache |
injection site pain, very tired kept falling asleep, headache, bad muscle and joint pain, feeling un...
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injection site pain, very tired kept falling asleep, headache, bad muscle and joint pain, feeling unwell and wanting to sleep all day
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| 75 | 2021-01-19 | throat irritation |
Immediately after administration of the vaccine the patient reported feeling flushed, rapid heartbea...
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Immediately after administration of the vaccine the patient reported feeling flushed, rapid heartbeat and because of her previous history of reaction to chemicals she became anxious. Pt further evaluated by NP and pt c/o itching to back of throat. No SOB. At time of NP evaluation heart rate within normal limit, 84. Alert and oriented. No acute distress. Pt very anxious. Pt monitored for one hour with no issues or emergent care needed.
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| 75 | 2021-01-20 | headache |
5 min post injection angioedema s begin; flushing, flushing to genital area, progressed to GI, throa...
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5 min post injection angioedema s begin; flushing, flushing to genital area, progressed to GI, throat, HA, B/P170 (never this high); eyesight blurred. Systemic w/o urticaria
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| 75 | 2021-01-20 | headache |
Severe headache; Nausea; Throwing up; I got so sick; Body ache; I was in pain everywhere; This is a ...
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Severe headache; Nausea; Throwing up; I got so sick; Body ache; I was in pain everywhere; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EK5730), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunisation. Medical history included migraine, depression, AFib, COVID-19 in Jun2020, and sleep disorder. Concomitant medications included prednisolone, ciprofloxacin, warfarin, timolol, sleep medications (unspecified), and eye drop (unspecified). The patient experienced body ache; stated that she was in pain everywhere on ; severe headache, nausea, throwing up, The patient stated that she felt like she had COVID all over again. She got so sick. It was reported that she worked for a clinic (also reported as a hospital) and on Friday (08Jan2021), she got the COVID shot. By Friday evening, she had body ache, and by Saturday, she was in pain everywhere. She also had severe headache, nausea, and was throwing up on 09Jan2021. According to her, the whole thing felt like she had COVID all over again and this went on through yesterday, she still had the headache today and some nausea. She stated that they were supposed to report this. When further clarified, the patient stated that she was tested yesterday again, just because it felt like COVID and because she had COVID way back in June last year. Stated that it felt like that all over again. She went to the [unclear statement], after hours to urgent care yesterday, they tested her again for COVID. She did not have COVID, she was clear, she was negative for COVID. Stated that she now knows that's what she has was just a result to the shot. When probed to clarify if it was the first dose or the second dose, the patient stated that she was just calling to ask. According to her, she was due to have it, the 29 (not clarified). She doesn't know if she should do it, she got so sick, she had been throwing up and everything. The patient was inquiring if she should do the second dose. The patient stated that she was about 150 lbs. and she does get her INR checked. As treatment, the patient took Tylenol and then took Zofran for the nausea. Outcome of the events 'Severe headache' and 'Nausea' was not recovered, while for the other events was unknown.
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| 75 | 2021-01-21 | cough |
On observation after vaccine, patient reported swelling in her mouth and lips. Patient took 2 benad...
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On observation after vaccine, patient reported swelling in her mouth and lips. Patient took 2 benadryl 25mg and stated she felt better. Advised patient to go to ER and patient refused. Asked patient to stay for extended observation. About 30 min later, patient stated she was coughing and feeling slight tightness in her chest. At this point, patient was agreeable to go to the ER and patient was taken.
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| 75 | 2021-01-21 | headache |
During monitoring period post vaccine, pt experienced 8/10 head pain. Emergency services was called ...
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During monitoring period post vaccine, pt experienced 8/10 head pain. Emergency services was called and arrived onsite for assistance. Vital signs taken by Nurse when I arrived onsite.
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| 75 | 2021-01-21 | headache |
Minor headache, stomachache, resolved in less than 30 minutes. Vital signs measured, blood pressure ...
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Minor headache, stomachache, resolved in less than 30 minutes. Vital signs measured, blood pressure 163/117, repeat in 15 minutes without intervention on a different blood pressure measuring device was 150/87.
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| 75 | 2021-01-21 | malaise |
Immediately after injection, my face and body turned RED. Nothing else. Just RED. I thought maybe B...
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Immediately after injection, my face and body turned RED. Nothing else. Just RED. I thought maybe BP, but never had that happen before. I was anxious as I have anxiety disorder! But my face was RED and TIRED looking. I asked staff what wrong. No swelling at that time! 4:40 PM. That nite, my heart started POUNDING HARD all night, not stop. Ativan not help. I slept, weird dreams, wake up and still heart pounding. 8 am --- got up and hands, arms, extremities SWOLLEN!! Heart still pounding, Felt like allergic to MSG or nitrates or preservatives or too much salt. Felt weird.. Not faint-- just weird. Tired from the pounding heart. Not fatigued. I did have sore arm, but it was NOT an issue. My hands, toes were red.
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| 75 | 2021-01-22 | headache, fatigue, chills |
01/15 Evening of injection developed headache; took 1 Aleve at 9:30 pm. Went to bed at 10:00 pm an...
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01/15 Evening of injection developed headache; took 1 Aleve at 9:30 pm. Went to bed at 10:00 pm and woke at 3:00 am on 1/16 with headache and nausea. At 7:00 am and all day remained in bed with headache, nausea (unable to eat or drink until evening when I had water, 1 scrambled egg and 1 piece of toast), fatigue. My arm was mildly sore at injection site. On 1/17 nausea, chills resolved. Headache better. Fatigue better but remained for about 3 days.
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| 75 | 2021-01-24 | fatigue, headache |
I began feeling deeply fatigued and achy about six hours after the vaccination and went to bed. The...
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I began feeling deeply fatigued and achy about six hours after the vaccination and went to bed. The aches and fatigue continued the next day and evening and, additionally, I had a swelling in my left wrist of the arm that I had the shot in. That swelling was painful; it was about an inch across and looked like it contained fluid. All those symptoms continued for two more days and then the swelling began to subside and is now gone.. Today, the morning of the fifth day after the vaccination, I awoke at 3 a.m. with severe body aches, took two Tylenol and eventually was able to sleep again. I am feeling better but very, very tired and have some bodyaches and headache but not as severe.
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| 75 | 2021-01-24 | fatigue |
1/16/21 - left arm pain, tired 1/17/21 -fever blister on lower lip 1/19/21 - pain at Rt upper gum , ...
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1/16/21 - left arm pain, tired 1/17/21 -fever blister on lower lip 1/19/21 - pain at Rt upper gum , lesion on gum
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| 75 | 2021-01-24 | fatigue |
I had two symptoms that are normal, they were on the list of side effects, I had soreness on my left...
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I had two symptoms that are normal, they were on the list of side effects, I had soreness on my left arm, I couldn't sleep on my left arm due to this soreness. This started the day the soreness started. The following day and up till now I felt very tired and like I needed to take a nap. Due to work I have not been able to nap. On Sunday I noticed I had a fever blister on the right side of face, under my lip by my chin. It looked like a herpes blister. I rarely get them unless there is a serious stressor to my body or if my body is emotionally stressed. Valacyclozir I took 4 of those in the morning and 4 tablets in the evening after noticing them. I put a cream on the blister. On Tuesday or Wednesday 3 or 4 days after the vaccine I felt a pain in my gum by back two teeth, the gums were very painful when I brushed my teeth or put my tongue on it. I went to the dentist Friday the 22nd, however the dentist said it was intraoral herpes that he believes it is looked to the vaccine. Dr. believes the COVID vaccine activated the dormant herpes in my system . He said says it is located over the Greater Palatine Foramen. The herpes on my chin went away. I still feel light sensitivity and fatigued. Dr recommended to see my dermatologist. Either the 22nd or 23rd I had a virutal appointment with my dermatologist. She recommended I take 4 Valacyclozir in the AM and PM. And then 1 day for 10 days. Both doctors recommended not getting the 2nd dose until the herpes vaccine goes away. Once it goes away they suggested taking the Valacyclozir before taking the 2nd dose. I am still not feeling normal. My dentist said he was going to consult a group of dentists to see if any other dentists have seen the correlation between the COVID vaccine and activating the herpes virus. I plan to consult my PCP about if I should delay the 2nd dose.
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| 75 | 2021-01-24 | headache, fatigue | headache,nausea,diarrhea,arm swelling. fatigue |
| 75 | 2021-01-24 | headache |
During monitoring period post Pfizer COVID-19 vaccine, patient significant head pain with decline vi...
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During monitoring period post Pfizer COVID-19 vaccine, patient significant head pain with decline vital signs. Emergency services was called and arrived onsite for assistance. Patient monitored and refused to transfer to ER.
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| 75 | 2021-01-24 | influenza like illness | Woke Sunday January 24 with flu like symptoms |
| 75 | 2021-01-25 | fatigue, body temperature increased, chills, cough, headache | Elevated temperature of 100, chills, joint pain, non productive cough, mild headache, exhaustion. |
| 75 | 2021-01-25 | headache |
C/O tongue feeling thick, feels hot and has headache. Given Benadryl 50 mg IM RDM and Epinephrine (...
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C/O tongue feeling thick, feels hot and has headache. Given Benadryl 50 mg IM RDM and Epinephrine (1:1000 aq) 0.5ml). No improvement and transported via ambulance to ER. Contacted by RN later and reports treated and released at ER.
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| 75 | 2021-01-26 | chills |
About 24-26 hours after the vaccine, I had chills for about 3 hours. Vaccine was on Monday, 1/25, C...
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About 24-26 hours after the vaccine, I had chills for about 3 hours. Vaccine was on Monday, 1/25, Chills on Tuesday, 1/26
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| 75 | 2021-01-26 | throat irritation |
Progress Notes 1/26/2021 Patient: ...
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Progress Notes 1/26/2021 Patient: Date: 1/26/2021 a 75 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 30 minute waiting period after the injection, the patient began to experience scratchy throat. She denied difficulty breathing, difficulty swallowing and throat tightness. This provider was notified of patient reaction and she was then assessed in the emergency bay area. ALLERGY REVIEW OF SYSTEMS: Patient denies facial swelling, chest tightness, shortness of breath, wheezing and dizziness Previous Reactions: Patient reports a history of previous reaction after receiving an allergy shot many years ago. She is unsure of entire course of events but states she did need medical treatment including a shot. Objective Vitals Vitals: 01/26/21 1412 01/26/21 1439 BP: 135/78 137/63 BP Location: Right arm Patient Position: Sitting Pulse: 90 80 SpO2: 95% 98% Blood Sugar 88 collected at 1415 Physical Exam Vitals signs and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: She is well-developed. She is not ill-appearing or diaphoretic. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Pharynx: Oropharynx is clear. No pharyngeal swelling or oropharyngeal exudate. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No tachypnea or respiratory distress. Breath sounds: Normal breath sounds and air entry. No stridor or decreased air movement. Skin: General: Skin is warm and dry. Neurological: Mental Status: She is alert and oriented to person, place, and time. Gait: Gait (with cane assist) normal. Psychiatric: Speech: Speech normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: no therapy. Patient was observed for 65 minutes s/p injection. She states only symptom of itchy throat improved. Patient accompanied to building exit . Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash)
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| 75 | 2021-01-27 | chills, fatigue, malaise, sweating |
Dizziness; history included compromised immune status; history included compromised immune status; g...
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Dizziness; history included compromised immune status; history included compromised immune status; getting really tired/fatigue; Gets real sweaty; chills; almost passed out at doctor's office; Nausea; Felt cold; Blood in urine; Feeling unwell; Feeling bad; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1686), intramuscular in the left upper arm on 08Jan2021 at 15:45 at 0.3 mL, single for COVID-19 immunization. Medical history included Leighten Plantar Alopecia (hair follicle is an enemy), skin infection (infection in body most of the time, at least on skin), diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, obesity, autoimmune disorder (diagnosed 8 months ago). She has lost some height, prior to taking the vaccine and she said it was related to age. There were no concomitant medications. The patient experienced feeling unwell on 10Jan2021; blood in urine on 10Jan2021 at 17:00; nausea at 10:00, chills at 11:00, almost passed out at doctor's office at 10:00, felt cold - all on 11Jan2021; getting really tired/fatigue on 14Jan2021 at 09:30; gets really sweaty on 13Jan2021 at 10:00; and dizziness on unknown date. The patient had the first shot on Friday (08Jan2021). On Sunday (10Jan2021), she started feeling bad. She was feeling good about getting it and had no reaction. She has an autoimmune disorder that made her a little afraid to take, but with all the indications, they said it would be much better for her to take it than to get the COVID virus. Sunday (10Jan2021), she does not feel good. So, she started having blood in urine. She thought she had a UTI and had not had one in 20 years. It felt like that is what she had and with the blood in urine. She just took Tylenol and waited until Monday morning because she does not like sitting in doctor's office. They gave her a cup to give sample and said she didn't need to see provider. They will have it checked and in the meantime call in a prescription. It kept getting worse and worse. She was about to passed out in the doctor's office on 11Jan2021, she got nauseous and almost threw up. She got in the car with her husband and he was trying to get her home. She got chills and got so cold and could not warm her body up. Her husband gave her Phenergan and it kind of knocked her out for a while to ease her nausea. She was thinking of going later today (14Jan2021), when she gets enough energy, to get a COVID test. She does not know if it will give false positive or not. She had chills and now she gets sweaty since 13Jan2021. She took her temperature and she did not have one. She just now got up. It is 10:00. She got up this morning (14Jan2021) and was really tired. She was not sweating this morning. Tiredness is kind of new, and when she talked to the nurse, she sort of felt like maybe it was a reaction to the COVID vaccine, but then she talked to her daughter and she said the symptoms she was having are usually symptoms that occur with second dose of the vaccine. It is not uncommon for people to have symptoms she was having. She wanted to know if she should have a COVID test. If she has had just one shot, would the test give a false positive coming from the COVID. They were asking if patient should take the second dose, and should she continue her UTI medication. Doctor's visit to give urine sample on 11Jan2021 (results: negative for UTI). She did not see a doctor though. They sent sample and prescribed a sulfa based medication for a UTI. She did start feeling a little better and stopped having blood in her urine. She plans to continue it because she does not like to stop taking an antibiotic. She did not have any clue that it was not a UTI until the nurse from her provider's office called to tell her results of urine sample was negative. Outcome of event getting really tired/fatigue was not recovered; events almost passed out at doctor's office, blood in urine, chills, and gets really sweaty was recovering; and unknown for other events.
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| 75 | 2021-01-27 | headache | c/o headache |
| 75 | 2021-01-27 | fever |
muscle and joint very sore; muscle and joint very sore; arm shoulder swollen (still on swollen after...
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muscle and joint very sore; muscle and joint very sore; arm shoulder swollen (still on swollen after 3rd day); Fever; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL8982 via an unspecified route of administration on 15Jan2021 10:00 at SINGLE DOSE for covid-19 immunisation. Vaccine location= Left arm, dose number= 1 Medical history included hypertension, blood cholesterol increased, overweight, back pain, hip arthroplasty, spinal operation. Concomitant medication included estradiol (ESTRACE), triamterene (TRIAMTERENE), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), melatonin (MELATONIN). The patient previously took dilaudid and experienced drug hypersensitivity. On 16Jan2021 01:00 patient experienced muscle and joint very sore, arm shoulder swollen (still on swollen after 3rd day), fever, all with outcome of recovering. The action taken was not applicable.
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| 75 | 2021-01-28 | throat pain |
I noticed that same afternoon one side of my mouth/throat was sore, in the back on the left. I tried...
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I noticed that same afternoon one side of my mouth/throat was sore, in the back on the left. I tried gargling with salt water, then later with baking soda in water. Ate some yoghurt later. No real difference. Today (next day) I see white blotches on side of tongue in back. I feel fine other than this, no other adverse reactions. Hurts....bothersome still in the back of my throat when talking or eating.
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| 75 | 2021-01-28 | fever, chills, fatigue, headache |
Started with injection site Hurting, Developed tiredness, light headache, hurting all over, had chil...
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Started with injection site Hurting, Developed tiredness, light headache, hurting all over, had chills for 3 nights fever range from 100 degrees up to 103.8, had nauseau and vomited one day, my face- looked a little swollen and cheeks were pink, was in bed mostly for 13 days. Called My Doctor after about 4 days , he prescribed MethyIIPredisolone 4 mg tablets, seems to bring fever down and stop chills, still feeling really bad, went to Urgent Care and they did Covid Test which was Negative, had virtual call with their doctor , and they prescribed a "Z Pak" Did not stated feeling better until 13 day. When taking Predisone, I started having chest pains, when I only had 4 more pills to take. Had to take 2 Nitro and discontinued Predisone. Still weak and tired.
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| 75 | 2021-01-28 | fever, chills |
Low grade fever; Chills; Rash; This is a spontaneous report from a contactable healthcare profession...
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Low grade fever; Chills; Rash; This is a spontaneous report from a contactable healthcare professional. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 10Jan2021 at single dose for COVID-19 immunization. Medical history included urinary tract infection (UTI). Patient stated she was on an antibiotic for a UTI before having the vaccine. No other vaccine in four weeks. No COVID prior vaccination. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Patient stated that she broke out with a rash across chest and legs approximately 24 hours (on 11Jan2021) after having the vaccine. Patient states she had a low grade fever and chills 4 days post covid-19 vaccination (on 14Jan2021). The events resulted in doctor or other healthcare professional office/clinic visit The patient received treatment for the events. The patient was given a steroid shot by dermatologist. Patient was tested for COVID test post vaccination (covid test type: Nasal Swab) which showed negative result. The outcome of the events was not recovered. Information on the batch/lot number has been requested.
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| 75 | 2021-01-29 | chills, fatigue |
4:30 - 6:30 pm on 1/29/2021 nausea, chills, dry heaved, bowel purge (not diarrhea) No treatment -sle...
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4:30 - 6:30 pm on 1/29/2021 nausea, chills, dry heaved, bowel purge (not diarrhea) No treatment -slept Fine after this event but tired
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| 75 | 2021-01-30 | chills |
Pfizer-BioNTech COVID-19 Vaccine EUA. Adverse events: chills, joint and muscle pain, nausea and vomi...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Adverse events: chills, joint and muscle pain, nausea and vomiting. Events decreasing after one day.
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| 75 | 2021-01-30 | headache |
Medication error: Patient was administered Pfizer vaccine that was not diluted. Confirmed with Pfi...
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Medication error: Patient was administered Pfizer vaccine that was not diluted. Confirmed with Pfizer that 0.3mL of undiluted vaccine contains 150mcg dose. Patient was observed for several hours following immunization, and following in the days following. The only adverse effect described was a headache in the 24 hours post-vaccine that resolved. No other ADRs reported. Internal investigation into error in preparation in progress. This was reported to Pfizer, who could provide no comment on anticipated adverse effects or guidance on patient care plan (if dose counts as valid, if dose #2 should proceed). Have submitted a consult question to CDC-Info / CISA for any guidance available for undiluted dose errors. Awaiting response.
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| 75 | 2021-01-30 | throat irritation | fast heartbeat, itchy throat, vomiting |
| 75 | 2021-01-31 | chills, fever | Chills, nausea, fever(102) Saturday except for temperature of 100 all symptoms were gone. |
| 75 | 2021-01-31 | headache, chills, fatigue |
rigors; muscle aches; head ache; pain in my inner ears; photophobia; feeling of exhaustion; too weak...
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rigors; muscle aches; head ache; pain in my inner ears; photophobia; feeling of exhaustion; too weak to walk further than the bathroom; This is a spontaneous report from a contactable other hcp. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 09Jan2021 13:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication included benazepril (BENAZEPRIL), diltiazem (DILTIAZEM), rivaroxaban (XARELTO) and estrogen/methyl te. The patient previously had the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 21Dec2020. The patient stated, "I woke from sleep about 12 hours later (10Jan2021) with rigors, muscle aches, head ache and pain in my inner ears as well as photophobia and feeling of exhaustion. The rigors had resolved by 8am but other symptoms persisted. I was too weak to walk further than the bathroom. I was able to consume only warm liquids, although I had no nausea, vomiting or diarrhea. Note that since onset post infectious irritable bowel symptoms in February after visiting a city, weeks before the pandemic was recognized, I have had very abnormal but not absent sense of taste and smell, making me wonder whether I was infected in February without the usual symptoms." The patient recovered from rigors on 10Jan2021, outcome of the event weakness was unknown while other events were not recovered.
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| 75 | 2021-01-31 | fever, chills, headache, malaise, fatigue | chills, fever, joint pain, headache, tiredness, feeling unwell |
| 75 | 2021-02-01 | fatigue, malaise, headache |
Nausea, headache, fatigue, lung tightness, muscle heaviness, foggy brain (lack of concentration and ...
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Nausea, headache, fatigue, lung tightness, muscle heaviness, foggy brain (lack of concentration and focus) , GI Increase in bowel movements, general malaise. These symptoms have lasted 6 days so far at varying intensity The lung tightness occurred on day 1 and day 4. The nausea has been persistent. The headache was on day 1 and 3. Foggy brain on day 2 and 5. Fatigue everyday. I am concerned about getting the second shot
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| 75 | 2021-02-02 | fever |
01/26/1021 -shortness of breath, 01/27/2021 shortness of breath & low grade temp, 01/27/2021 wheezin...
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01/26/1021 -shortness of breath, 01/27/2021 shortness of breath & low grade temp, 01/27/2021 wheezing & 100.0 temp; taken to ER, admitted to hospital ; released from hospitol on 01/30/2021, with oral antibitoics & predinsone.
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| 75 | 2021-02-02 | sleepiness |
Patient noted to have irregular breathing in bed and unable to arouse. Provided life saving measures...
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Patient noted to have irregular breathing in bed and unable to arouse. Provided life saving measures in the field x 30 minutes and transferred to hospital. Noted to have heart arrhythmia which suspected to cause cardiac arrest.
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| 75 | 2021-02-03 | chills | Flu like symptons, aches, weakness,chills |
| 75 | 2021-02-04 | fever, chills, fatigue |
severe chills; Fever; Dizziness; not feeling quite right; heart pains; Nauseated; threw up; Tirednes...
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severe chills; Fever; Dizziness; not feeling quite right; heart pains; Nauseated; threw up; Tiredness; muscle aches; a little swelling in her face; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EK5730) intramuscularly on arm left on 09Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included heart problems from May1966 and ongoing (heart problems/She had open heart surgery at that time and had stents put in a couple of times since then), bone spurs and arthritis in her feet. Concomitant medications were none. Patient used to receive unspecified injections in her feet because she has bone spurs and arthritis in her feet. Patient experienced heart pains in Jan2021, dizziness on 10Jan2021, not feeling quite right on 10Jan2021, severe chills on 11Jan2021, fever on 11Jan2021, nauseated in Jan2021, threw up in Jan2021, tiredness in Jan2021, muscle aches in Jan2021, a little swelling in her face in Jan2021, weakness in Jan2021. The outcome of the events was unknown. Patient received her first Pfizer vaccine on 09Jan2021. Patient explains she has had adverse reactions to the vaccine ever since she received it. Patient confirms she took the vaccine on Saturday, 09Jan2021. On Sunday, 10Jan2021, she started having a little bit of dizziness and feeling just not quite right. Sunday night, she went to bed and woke up at around 3:30 a.m. with severe chills and a fever. Her fever was a little over a 100. She states it took about 2 hours to get her chills under control. She took 2 Tylenol at that time. That day (11Jan2021) she ran fever off and on all day. The next day (12Jan2021), she seemed to be better. She had a low-grade fever, but she was better. She was just kind of tired from the day before. But then, that night, she ended up with the same thing again- she woke up at 4am with chills. Her fever had gone up 101.7, and she ended up taking 2 Tylenol and so forth. She got up that morning around 10 am, and was nauseated. She threw up that morning. She felt really bad. She was experiencing tiredness, muscle aches. (At this point it was about Tuesday (12 Jan) or Wednesday (13 Jan). There was one day during the day, she felt better, but a day went by and she ended up having the chills and fever again. Every time her fever kept going up. Her fever this particular night was 102 something. About Wednesday night, when she had the chills and fever, her fever went up to 103.8. That next morning, she called her doctor's office and tried to get an appointment. She could not get an appointment with the office. Her office ended up doing a televist and sending her a Prednisone pack to take for the reaction that it seemed she was having. She started the prednisone pack which seemed to take the fever down and the chills ended up stopping. Caller clarifies further she believes she has recovered from the fever and chills. The Prednisone pack seemed to kind of make those symptoms go away. However, she still felt really bad. This went on all weekend again. Tuesday of this week, (19Jan2021), she still felt really bad. She called her doctor again and her doctor wouldn't see her because of the symptoms she is having after receiving the COVID-19 vaccine are the same symptoms of the actual COVID-19 virus. She clarifies further the adverse effects of the shot are also same ones as the COVID-19 virus. Her doctor suggested she either go to the Emergency Room or to an Urgent Care. Patient called the Urgent Care and they were able to do a COVID test on her to check and see if she did have COVID-19. She confirms this test was on Tuesday, 19Jan2021. The results came back negative. However, they did another swab test. The patient is unsure what the second swab test was for but was told it would be a couple days before they would have the results of this test. At this point, they put her on a Z-pak. Patient mentions she has heart problems. She has nitroglycerin for any problems that she has. She started having some heart pains when she was down to about 3 tablets of that Prednisone pack she was taking. When she took one of the Prednisone tablets, within 30 minutes of taking it, she started having chest pains. She clarifies it started in her throat and went down to her chest. She took 2 nitroglycerin's to get her feeling back to normal/better. Caller doesn't provide NDC, Lot number or expiration date for the Nitroglycerin she took when probed. Patient mentions her cheeks had been pink. She doesn't really know but she may have a little swelling in her face. She can't figure that out herself. She was experiencing dizziness and weakness. Today is the first day which is the 13th day after receiving the vaccine, she has felt like trying to get this stuff together and her thoughts together to try and figure out what is going on with her. She tried calling her primary doctor and this urgent care and she couldn't get anybody to see her. Patient got her Prednisone pack filled at (Pharmacy name), (Address details) The prescription was issued to her on Thursday, 14Jan2021, but she didn't start taking the pack until Saturday. On Saturday, that's when her fever had went up to 103 and she knew she needed to take the Prednisone pack. They are 4mg tablets and she started out taking 6 tablets the first day and then her dose decreased every day. NDC: 164793723369, Lot: 20K0041P, she believes the second digit is a zero and not a "D", Expiry date: Aug2022. Z-pak: patient states she no longer has the box, therefore she is not sure of the dose and how it was prescribed. She makes the comment she believes the first day it was 2 tablets. NDC: Unknown, Lot: 7996030, Expiry: Feb2022. She clarifies she did not take Tylenol as stated earlier. She took Kirkland's brand, Acetaminophen. They are 500mg tablets. She provides the following product information: Lot: 2GE1779B. The last digit is either a "B" or an 8/, Expiry date: May2015; patient clarifies she knows they just bought this bottle, but she thinks her husband put his extra pills in the wrong bottle. No further details were provided or obtained in regard to this statement. The patient wants to find out about this and what is going on with her. To her understanding and her reading information, she is scheduled to take her next shot 27Jan2021. She is not supposed to take it then, correct? Investigations: patient confirms she had a COVID-19 test done (she is not sure what type of test- PCR, Antibody, etc), they swabbed her nose and the results came back negative. She had a second test done, where they swabbed her nose again, but she hasn't got the results back. She isn't sure what that test is for. Vaccination Facility Type was Hospital. Additional Vaccines Administered on Same Date of the Pfizer Suspect was no. Did any AE(s) require a visit to: Emergency Room was No, she is trying to keep herself out of the hospital. Physician Office? Her doctor would not see her but offered a virtual visit. She did go to the Urgent Care. Prior Vaccinations (within 4 weeks): Caller states she went to the foot doctor on 22Dec2021 (pending clarification). She was given injections in her feet because she has bone spurs and arthritis in her feet. Patient does not know exactly what kind of injection it was. She confirms she has no name, ndc, lot and expiry date for the injections she received. Patient asks the call handler, what should she have done on this? She was lost. She read the information that was provided to her and she doesn't feel there was sufficient information on what to do if you had a reaction. She guesses the best thing she can be told is to call #. She didn't know it was a # emergency. She didn't know what she was supposed to do. It was hard for her to get any information out of anybody as to what to do. The outcome of the events was unknown.
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| 75 | 2021-02-04 | fever |
severe arm pain; Fever; This is a spontaneous report from a contactable consumer (patient). A 75-yea...
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severe arm pain; Fever; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3249) via an unspecified route of administration in left arm on 20Jan2021 09:45 at single dose for Covid-19 immunization. Medical history included high blood pressure; thyroid disease; high cholesterol; prior stroke; prior to vaccination, the patient was diagnosed with COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient experienced severe arm pain and fever on 20Jan2021 14:30. No treatment received for the adverse events. This is a non-serious report. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Jan2021.
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| 75 | 2021-02-05 | malaise, headache, body temperature increased, sweating, chills |
I woke up feeling sick with headache and pain in abdomen, went to bathroom and sat down, I was burni...
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I woke up feeling sick with headache and pain in abdomen, went to bathroom and sat down, I was burning up and perspiration was dripping down my body, i felt like i might throw up and that was the last though until I came to on the floor of our walk in shower. It took me a while to orient myself and get up and sat down again on toilet still with pain in head and disoriented. next thing i know i am coming to wedged between the toilet tank and the vanity. I managed to get back on the toilet and sat there wondering what was happening to me. I could tell i was getting better so i just sat there a while longer until i though my legs would hold me so i could get back to the bed. I laid in bed the rest of the night unable to sleep with headache and shivering with being cold even under my blankets. I stayed in bed Saturday then called the doctor first thing Monday morning. I got in to see her at 10:30 Monday morning. She ordered a full blood panel and urinalysis and heart monitor for 48 hours. The blood panel and urinalysis reports are all ok. Have not received report yet from the heart monitor. Doc said I cannot take the second shot.
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| 75 | 2021-02-05 | fever, chills |
Dizzy, light-headed, unable to balance, fever, lack of appetite, chills, slight nausea for about 36 ...
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Dizzy, light-headed, unable to balance, fever, lack of appetite, chills, slight nausea for about 36 hours Tylenol 2x500mg
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| 75 | 2021-02-06 | dehydration | Dizzy. Pt reports poor hydration |
| 75 | 2021-02-06 | fatigue |
Vaccine given 1/13; symptoms began 1/21-burning and intermittent blurry eyes/double vision, drooping...
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Vaccine given 1/13; symptoms began 1/21-burning and intermittent blurry eyes/double vision, drooping left eyelid, drooping left side of mouth, fatigue; went to ER on 1/22, blood work, EKG, MRI normal, ER MD didn't know the cause but if symptions persisted, go to internal medicine MD; symptoms improved but saw Dr. on 1/28. She referred me to a neurologist. By 1/31, most of my symptoms had cleared. On 2/4, neurologist exam showed weakness in facial muscles, diagnosed condition as viral Bell's Palsy. Following medical exams, I read CDC report which referenced Bell's Palsy in Unsolicited Adverse Events section. Am sending this report
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| 75 | 2021-02-07 | cough | Lightheaded, cough, mild wheeze that responded to albuterol Dizziness |
| 75 | 2021-02-07 | fatigue, chills, influenza like illness |
Very tired & intense joint pain all night. Next day, chills & flu like symptoms (a very upset stomac...
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Very tired & intense joint pain all night. Next day, chills & flu like symptoms (a very upset stomach) After 48 hours, side effects disappeared completely.
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| 75 | 2021-02-07 | headache |
accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; ...
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accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; continues to have muscle pain; weakness; shortness of breath when she walks; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 16Jan2021 04:00, she went to bed at night and woke up at 4 AM with a severe headache. She took Aleve and went back to bed. When she woke up at 8:30 AM her headache was very severe and was accompanied with very severe chest pain. She immediately took her to the ER. They did a very thorough work up to check on her heart and Aorta. They managed her severe pain with two doses of morphine followed by two days of Dilaudid. The imaging and symptoms left her with a newly discovered diagnosis of Pericarditis. The medical professions were sure this was a result of the COVID vaccine. They continued to treat her for a few days and sent her home with anti inflammatories to help. She continues to have muscle pain, weakness and shortness of breath when she walks. She is scheduled to take her 2nd dose on February 5th but we are very concerned and hesitant as we don't want to cause any more damage to her heart. The patient was hospitalized for events 'headache', 'chest pain;', 'pericarditis' and 'pain' for 4 days. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not received any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included imaging: pericarditis on 16Jan2021 and Nasal Swab: negative on 16Jan2021. Therapeutic measures were taken as a result of all the events which included Colchicine and prednisone, morphine and dilaudid. The outcome of the events was recovering. The events "headache", "chest pain", "pericarditis"and "severe pain" were assessed as serious due to hospitalization and disability. The events "myalgia", "asthenia" and "dyspnea" were assessed as serious due to disability. The events ('headache', 'chest pain;', 'pericarditis' and 'pain') resulted in emergency room visit. Information on the lot/batch number has been requested.
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| 75 | 2021-02-07 | sweating, malaise, headache |
At 9:55 am, five minutes post vaccine, patient reports to observation nurse feeling dizzy, left side...
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At 9:55 am, five minutes post vaccine, patient reports to observation nurse feeling dizzy, left sided neck pain, flush, and sudden left sided headache. Staff was notified EMS crew immediately. B/P 151/83, Also diapheretic. Patient reported not feeling well at all and would like to go to the hospital. Transported to local hospital. for evaluation
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| 75 | 2021-02-07 | productive cough |
Went to ER on 2/5 with Shortness of breath and productive cough since first vaccine given. Diagnosed...
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Went to ER on 2/5 with Shortness of breath and productive cough since first vaccine given. Diagnosed with hypoxemia, and COVID pneumonia. Admitted to hospital
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| 75 | 2021-02-07 | fever, headache, chills | Chills, muscle pain, joint pain, bad headache, fever reaching 101 (I am usually about 97.2) |
| 75 | 2021-02-08 | sweating, chills |
Diarhea, vomiting, chills, sweats, mild rash all over the body, injection site pain and swelling, mu...
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Diarhea, vomiting, chills, sweats, mild rash all over the body, injection site pain and swelling, muscle soreness.
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| 75 | 2021-02-08 | fever, headache |
Arm was itching approximately an hour after receiving vaccine and continues to date. At 9 pm low gra...
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Arm was itching approximately an hour after receiving vaccine and continues to date. At 9 pm low grade fever and headache. Took Tylenol. At 6 am on 2-9-2021 headache persisted so again took Tylenol. Headache is a dull ache. No fever.
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| 75 | 2021-02-08 | sleepiness, headache |
Numbness in lower extremities, not able to walk independently, headaches, dizziness, hypertensive, s...
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Numbness in lower extremities, not able to walk independently, headaches, dizziness, hypertensive, sleeping 16+hours a day, and poor to no reflexes.
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| 75 | 2021-02-09 | chills, headache, fatigue |
Work up with a headache and sore arm and fatigue. Took 2 Tyneol, which helped. Later in mid mornin...
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Work up with a headache and sore arm and fatigue. Took 2 Tyneol, which helped. Later in mid morning started getting the chills which lasted until 8:00 p.m. on the same day. Am fine now.
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| 75 | 2021-02-09 | chills, fever |
really bad chills; fever; joint pain; soreness/achiness; she was really stiff and she could not walk...
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really bad chills; fever; joint pain; soreness/achiness; she was really stiff and she could not walk real good; she was really stiff and she could not walk real good; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247, expiration date May2021), intramuscularly on right arm on 23Jan2021 10:50 at 0.3 mL single for COVID-19 immunization. Medical history included ongoing arthritis, right knee replacement from Aug2019 to an unknown date, ongoing high blood pressure, a long list of antibiotics that she was allergic to/certain types of mycin, allergic to penicillin, covid-19 from 23Dec2020 to an unknown date. Concomitant medications included unspecified a lot of medications. The patient previously took flu vaccine in 2020 for immunization, codeine and experienced drug allergy (she cannot take codeine), norvasc and experienced drug allergy (certain types of mycin, several types of blood pressure medication like norvasc). The patient woke up early at 6:00am on 24Jan2021 with really bad chills, fever and joint pain. Her temperature was 101.6 after taking Tylenol. Her arm felt like there was a small "know" in it. Some soreness, but feeling better. The patient had a really bad day yesterday on 24Jan2021, she experienced really hard chills about 5 or 6 episodes of chills. Her temperature got up to 101.6 and that was with Tylenol. She felt better today and her temperature was back to normal on 25Jan2021. She had soreness, achiness, she was still sore in regards to her muscle. She got over covid. She was diagnosed with covid on 23Dec2020, about 30 days ago. She got the first dose of the vaccine on 23Jan2021 and she was scheduled then since she was told to wait about 30 days after being diagnosed with COVID. She heard the second shot might be more intense and asks if that was right. She called the doctor. When querying lot number, she put her glasses back on to read the stamp on the card. She had to get under the lamp since it was kind of blurry. She could not read the lot number on the card and had to get a magnifying glass and then was able to provide lot. The first episode of chills happened during the night and woke her up about 6 am on 24Jan2021, when she got up she was really stiff and she could not walk real good. She had to hold on to something when she got up to go to the bathroom. The chills that were so bad were yesterday from 11 till about 4 or 5. Around 6 or 7 pm yesterday she had lighter chills. She got real red in the face since she was hot and her temperature was going up. Reported she took Tylenol earlier than she should have taken it since it was scaring her. Her temperature was good since she woke up. It was about 100 when she went to bed last night on 24Jan2021. The achiness and soreness started when she got up around 6am yesterday and it was still there but much better. Reports she had arthritis and her joints were sore anyways but this soreness was more. She had a lot of medication that she takes but does not feel they are relevant to provide at this time. The outcome of events joint pain and pain was recovering. The outcome of event fever was recovered on 25Jan2021. The outcome of event chills was recovered in Jan2021. The outcome of rest events was unknown.
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| 75 | 2021-02-09 | fatigue, fever |
felt wiped out; Joint pain; Fever as high as 100; arm hurt; This is a spontaneous report from a cont...
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felt wiped out; Joint pain; Fever as high as 100; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261) intramuscular, on 22Jan2021 at single dose in left arm for COVID-19 immunisation. Patient age at vaccination was 75 years. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246) received on 02Jan2021 at single dose. Relevant medical history included COVID-19 last Mar2020 and knee replacement on 12Jan2021. The patient received no concomitant medications. The patient reported she had the 2 shots. After both shots, her arm hurt, she felt wiped out, and she had joint pain. After the second shot, she did run a fever as high as 100. She said that she had the second shot on Friday 22Jan2021 and on Saturday she was wiped out. She felt more tired for 3 full days after the first shot and after the second shot she was just wiped out for 1.5 days. The event wiped out had resolved in Jan2021, while outcome of other events was unknown.
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| 75 | 2021-02-09 | fatigue |
75-year-old woman who presented to the emergency room 2 days after vaccination with chest tightness,...
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75-year-old woman who presented to the emergency room 2 days after vaccination with chest tightness, fatigue and was found to have pericardial effusion without tamponade. It was noted that patient has had intermittent syncope since August of 2020 and clinical interpretation is likely that pericardial effusion pre dated vaccination. In her workup for dizziness and syncope she had not previously undergone EKG, chest x-ray or echocardiogram therefore pericardial effusion could have been missed. I elected to report the pericardial effusion to be on the side of caution.
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| 75 | 2021-02-09 | fatigue |
Joint pain; arm hurt; felt wiped out; This is a spontaneous report from a contactable consumer. A 7...
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Joint pain; arm hurt; felt wiped out; This is a spontaneous report from a contactable consumer. A 75-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL3246), intramuscular on 02Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient was calling about the Covid-19 vaccine and reported that she had the 2 shots. She said that after both shots, her arm hurt, she felt wiped out, and she had joint pain. She felt more tired for 3 full days after the first shot and after the second shot she was just wiped out for 1.5 days. The patient said that after the first vaccine, she had not had knee surgery, but before the second the second vaccine she had knee surgery. The patient clarified that it was a knee replacement on 12Jan2021. The outcome of the events was unknown.
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| 75 | 2021-02-09 | headache, body temperature increased | Slight headache; joints aching mild; temperature -100.2 |
| 75 | 2021-02-10 | body temperature increased, headache, chills | Severe chills, temperature 101, severe headaches, thirst, weakness, body aches , insomnia |
| 75 | 2021-02-10 | chills, headache |
muscle aches; nausea; vomiting; weakness; chills; Diarrhea; Joint pain; It scared me that I was so s...
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muscle aches; nausea; vomiting; weakness; chills; Diarrhea; Joint pain; It scared me that I was so sick.; Slight headache like a little pressure on her head / Horrible headache; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number EL9262 (the patient was not sure of the second letter), via an unspecified route of administration in left arm on 23Jan2021 at 16:15 at single dose for COVID-19 immunization. Medical history included sinus infection. The patient was not pregnant at the time of vaccination. Facility where the COVID-19 vaccine was administered was Hospital. The patient has not been tested for COVID-19 since the vaccination. Concomitant medication included amoxicillin, clavulanic acid (AUGMENTINE) for sinus infection and pravastatin. The patient stated that when she went home after vaccination, she had a slight headache, like a little pressure on her head when she went to bed but that was supposed to be normal. So, she went to sleep and the next morning she woke up and she had every single side effects: the nausea was horrible, she must have thrown up 15 times, she had diarrhea and joint pain. She did not think she had any fever but she did had chills and muscle pain, weakness and had horrible headache. The events onset date was reported as 24Jan2021 at 12:00 AM (except for headache which started on 23Jan2021). No treatment was administered for these events. The patient stated that it scared her that she was so sick. All the reported events were assessed as non-serious. The patient reported that 3 days later she was still feeling very weak. At the time of the report the events headache, muscle aches, nausea, vomiting and chills had recovered with sequelae, the event weakness had not yet resolved, whereas the outcome of the events diarrhea, joint pain and sickness was unknown.
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| 75 | 2021-02-10 | fatigue |
tingling of lip and face; tingling of lip and face; numbness on left side of face/numbness was not i...
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tingling of lip and face; tingling of lip and face; numbness on left side of face/numbness was not in her throat but it was on her neck behind her ear; blood pressure spiked; tired; she didn't sleep well; Chest pain; This is a spontaneous report from a contactable nurse (patient herself). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: lot number: E19262, via an unspecified route of administration, left arm, on 26Jan2021 10:00 at a single dose to not get Covid and to protect others around her. Medical history included mini stroke at least 8-10 years ago and neuropathy in face from ministroke. Concomitant medication included gabapentin for neuropathy in face from ministroke. The patient had no prior vaccinations (within 4 weeks). The patient previously took pregabalin (LYRICA): but was changed to gabapentin. On 26Jan2021, the patient experienced tingling of lip and face, numbness on left side of face, blood pressure spiked and chest pain. On 27Jan2021, the patient experienced tired. The events were described as: After getting the vaccine, she experienced tingling of the lip and left side of her face. She had numbness on the left side of her face. The numbness was not in her throat but it was on her neck behind her ear. Her blood pressure spiked. She drover herself to the emergency room. Her blood pressure was 160 something over 101. She was unable to specify the exact number. Then her blood pressure decreased to 104 over 80 something and it increased to 202 systolic. She was unable to specify the reading. She was tired on 27Jan2021 because she didn't sleep well in the hospital. She signed out against medical advice. The patient had a full work up to include a CT scan, MRI and doppler: results were not provided (unknown results). The patient wanted to know if recommendations were made in regard to taking the second dose if they have had adverse events. The patient was hospitalized from 26Jan2021 to 27Jan2021 (1 day) for tingling of lip and face, numbness on left side of face and blood pressure spiked. Chest pain was considered medically significant by the reporter. The outcome of she didn't sleep well was unknown. The patient was recovering from tingling of lip and face and tired. The patient has not recovered from numbness on left side of face. The patient recovered from blood pressure spiked and chest pain on 27Jan2021.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 75 | 2021-02-10 | headache, fever, chills, cough |
terrible aches all over; headache; there is something wrong with her smell/she can smell but things ...
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terrible aches all over; headache; there is something wrong with her smell/she can smell but things do not smell right; She has chills really bad; felt really awful; nausea; She had a fever; dry cough; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date:31May2021), via an unspecified route of administration on the left arm, on 22Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included atrial fibrillation from Nov2019, heart attack 2016, stent placed from 2016, and cardiac ablation from Aug2020. There were no concomitant medications. Patient had her first dose on 22Jan2021 and she felt all the side effects like nausea, fever, chills, headache on 24Jan2021 and wanted to know if that is normal. She also experienced dry cough on Jan2021. Patient reported she was fine and did not even feel it. She was fine that day and the next day. By the third day she started getting every symptom in the world. The one that really bothered her, and she cannot find any information on it was the dry cough. She was asking if dry cough is a reported side effect. She further clarified that the dry cough started either the same day she received the vaccine or the next day and all her other symptoms started on Sunday afternoon (24Jan2021). She had a fever and still has fever at the time of report, and had improved slightly since she takes Tylenol every 6 hours which was keeping the fever at bay. But her temperature was still over 100. She had terrible aches all over which has slightly improved and a headache (she does not think she has one now), and stated it had improved. The nausea was off and on and there was something wrong with her smell. She can smell but things do not smell right. She smelled something like gasoline earlier but she knew it was not gasoline. She thought about food and she wanted to gag, and her taste seems ok. She has chills really bad and clarified all symptoms aside from the dry cough started Sunday around 4 in the afternoon. She felt really awful and took her temperature and it was 101 on Jan2021. The chills are off and on and when her fever goes up, then her chills go up. Outcome of the events of nausea, chills and felt awful was unknown, for events dry cough and something wrong with smell was not recovered, and for the remaining events was recovering. Patient was asking if she somehow contracted covid in between getting her vaccine and now. She had a negative covid test a long time ago when she was going to have procedures done. She confirmed she has not had a covid test recently and stated it was just seems weird since she felt fine right after getting the covid shot.
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| 75 | 2021-02-10 | headache, fever, chills |
On day 2 I had a low grade fever On day 10: High blood pressure 205/77 for over an hour. ...
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On day 2 I had a low grade fever On day 10: High blood pressure 205/77 for over an hour. Difficulty breathing; A fast heartbeat(90); Dizziness; Chills; Uncontrollable shaking for over an hour. Rash on face for less than an hour Starting on day 11: Blood pressure gradually reduced to my normal level over days Headache continued for several days
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| 75 | 2021-02-10 | headache |
Approximately 35 red spots about 1/4 inch each with a pinhead sized head appeared across stomach and...
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Approximately 35 red spots about 1/4 inch each with a pinhead sized head appeared across stomach and reaching around to back on right and left sides of trunk. Spots were observed at bedtime, Not sure when they first appeared. No itching. Roof of mouth and gums were sore later in the night and mild headache occurred. Spots started disappearing on their own over the course of a week.
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| 75 | 2021-02-10 | fever, chills | Patient became weak, had the chills, and spiked a fever. |
| 75 | 2021-02-10 | fever, headache | Headache Fever all over body pain |
| 75 | 2021-02-10 | fever | Systemic: Fever, Systemic: Abdominal Pain |
| 75 | 2021-02-10 | throat irritation |
Mild throat irritation noted 29 minutes after administration of 2nd covid19 vaccine. Patient speakin...
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Mild throat irritation noted 29 minutes after administration of 2nd covid19 vaccine. Patient speaking full complete clear sentences. No escalation of symptoms and no new symptoms during monitoring period (extra 20 min). No shortness of breath. Suspect that recent steroid injection to hip 2/4/2021 may have helped diminish reaction to the vaccine. Diphenhydramine 25 mg PO x 1 given prior to discharge from clinic
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| 75 | 2021-02-11 | headache |
Jan 18 COVID vaccine usf 11:30 am pfizer vaccine first dose, starting feeling bad: headache the next...
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Jan 18 COVID vaccine usf 11:30 am pfizer vaccine first dose, starting feeling bad: headache the next day had class collapsed and stubbed toe, bleeding etc. ambulance came and assessed, PT felt so weak could not stand but was declared ok to drive by emt, got home and collapsed on the floor and crawled around for 6 days, lived on boiled eggs and rice cakes, doctor said call an ambulance, ambulance picked her up and took her to hospital, hospital took care of her for 16 days, got discharged yesterday (2-9-2021)
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| 75 | 2021-02-11 | malaise |
On 2/7/21 resident complainted of not feeling well, nausea, vomiting and weakness sent to ER passed ...
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On 2/7/21 resident complainted of not feeling well, nausea, vomiting and weakness sent to ER passed away.
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| 75 | 2021-02-14 | chills, fever |
body is very sore; severe chill rigors; couldn't get out of the bed because the rigors were so inten...
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body is very sore; severe chill rigors; couldn't get out of the bed because the rigors were so intense that legs would not support her; a slight fever; This is a spontaneous report from a contactable consumer reported for herself. A 75-years-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 30Jan2021 11:30 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included venlafaxine, levothyroxine, diclofenac, gabapentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the 1st dose of BNT162B2 on 09Jan2021 11:30 AM for covid-19 immunization. Initially the patient noticed a slight fever 11 hours after vaccine on 31Jan2021. Then about 12 hours after her vaccine on 31Jan2021, she had severe chill rigors for about 2.5 hours. She couldn't get out of the bed because the rigors were so intense that her legs would not support her. On 31Jan2021 12:00 AM, (12 hours after the rigors), her entire body was very sore, feeling as if she had been run over by a truck. No treatment received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. Information on the Lot/Batch number has been requested.
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| 75 | 2021-02-14 | malaise, throat pain, headache, fatigue |
sore throat; headache; don't feel well; weak; nauseated; hoarse; she feels tired; her mind is just k...
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sore throat; headache; don't feel well; weak; nauseated; hoarse; she feels tired; her mind is just kind of foggy; This is a spontaneous report by a contactable consumer (patient). This 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3247), via an unspecified route of administration at single dose in the left upper arm on 20Jan2021 07:30 for Covid-19 immunisation. Medical history none. There were no concomitant medications. The patient experienced headache on 26Jan2021 with outcome of unknown, don't feel well in Jan2021 with outcome of unknown, weak in Jan2021 with outcome of unknown, nauseated in Jan2021 with outcome of unknown, sore throat on 28Jan2021 with outcome of not recovered, hoarse in Jan2021 with outcome of unknown, she feels tired in Jan2021 with outcome of not recovered, her mind is just kind of foggy in Jan2021 with outcome of unknown.
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| 75 | 2021-02-15 | chills |
Chills and muscle weakness that started on 2/13 PM and then mom suffered a basal ganglia stroke on 2...
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Chills and muscle weakness that started on 2/13 PM and then mom suffered a basal ganglia stroke on 2/14 PM.
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| 75 | 2021-02-15 | cough, throat clearing, throat irritation |
Pt was instructed to wait 30 minutes for observation following vaccination due to history of allergi...
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Pt was instructed to wait 30 minutes for observation following vaccination due to history of allergic reaction and anaphylaxis. About 33 minutes following injection, pt began feeling tightness and scratching of the throat and feeling the need to cough/clear throat frequently. Pt refused Epi-pen administration, but accepted Benadryl 50mg orally. EMS was called. Pt refused transport via ambulance but drove self to the ED for eval/monitoring.
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| 75 | 2021-02-15 | fatigue, chills, fever, sleepiness |
Fever bet. 100 and 101 for 4 days, plus diarrhea, chills, nausea, tired, sleepy; Dr. was contacted ...
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Fever bet. 100 and 101 for 4 days, plus diarrhea, chills, nausea, tired, sleepy; Dr. was contacted by husband; recommended going to emergency room if I got worse.
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| 75 | 2021-02-15 | fatigue |
Profound fatigue and generalized soreness most severe on days 2 and 3 after vaccination, but lasting...
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Profound fatigue and generalized soreness most severe on days 2 and 3 after vaccination, but lasting seven days. No fever or chills. Arm sore, warm and swollen, but not red. It is the severity of the reaction and its duration that prompts this submission.
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| 75 | 2021-02-15 | fever, headache, fatigue |
Received Pfizer vaccine at 1:00 p.m. on Friday 2/12. Mild headache at 10:00 p.m. Friday evening, 9 h...
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Received Pfizer vaccine at 1:00 p.m. on Friday 2/12. Mild headache at 10:00 p.m. Friday evening, 9 hours after vaccine. Awake at 2:00 a.m. with nasty headache and 102.5 fever. Fever and headache continued throughout the next day with fever diminishing to 101.7 and later 99.9 Fever subsided after 20-24 hours. Headache and mild nausea continued but diminished gradually through Sunday and into Monday a.m. At 72 hours symptoms are basically gone, but left very tired.
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| 75 | 2021-02-15 | fever, headache | Headache; Fever (100.5); Body aches; Lasted 12 hours only. |
| 75 | 2021-02-16 | fever, chills, headache, fatigue | Low grade fever Chills Mild headache Tiredness |
| 75 | 2021-02-17 | fatigue |
This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female pa...
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This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 29Jan2021 (at 14:30) at single dose on the left arm for COVID-19 immunisation, administered at clinic. Relevant medical history included persistent genital arousal disorder. Past drug history included allergy to codeine. The subject was receiving concomitant medications (unspecified). No other vaccine was received in four weeks. On 01Feb2021, the patient developed severe fatigue, inflammation, swelling, and soreness under tongue....5 days and counting (as reported). The events were assessed as non-serious. The patient had not recovered from the events. Information on the Batch/Lot number has been requested.
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| 75 | 2021-02-17 | headache |
Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue...
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Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; headache; high bp/ had a BP 173/113; short of breath; couldn't sleep; restless; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Ten minutes after she reported having a headache, which she ignored. 2 hours later, very high blood pressure (BP), short of breath (SOB) and restless occurred. All night on 25Jan2021 and the next day on 26Jan2021, the patient couldn't sleep, short of breath, restless. The patient called PCP and was told to go to the ER. She did and had a BP 173/113, SOB. She was admitted, CT scan was ok. She had very bad rash blue red swollen on thigh. Heart enzymes was normal. She was discharged two days later referral to a dermatologist. The outcome of events was unknown. Information on the batch number has been requested.
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| 75 | 2021-02-18 | sweating |
Palpitations, flushing, sweating. BP 190/120 (pulse 119), 210/88, 175/88. Sent to ED and cancelled s...
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Palpitations, flushing, sweating. BP 190/120 (pulse 119), 210/88, 175/88. Sent to ED and cancelled second vaccine dose.
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| 75 | 2021-02-18 | malaise, chills, influenza like illness | Flu-like symptoms, muscle aches, chills, feeling unwell |
| 75 | 2021-02-21 | body temperature increased, headache, fatigue | Sore arm; Temp of 100 for 2 days; general aches; fatigue; zero energy; headache on day 3 |
| 75 | 2021-02-21 | cough, productive cough, throat pain, throat clearing |
About 11 am I was masked in church and developed a tickle in my throat. I cleared my throat to no r...
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About 11 am I was masked in church and developed a tickle in my throat. I cleared my throat to no relief. I took 2 cough drops. About 11:30 I got a bottle of water. No relief after drinking 8 ounces. I left the service, went outside, removed my mask and was coughing forcibly for about 15 minutes or so. Expectorated clear phlegm 6 - 8 times. Gradually I settled to normal. Just some residual soreness in throat. This was an unusual occurrence for me. I was covid positive in early Dec, but had a very mild case. Back in the 70's I would have reaction to allergy shots. I waited in the office 15 minutes, but 45 minutes later when I arrived home I had huge hives and severe itching.
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| 75 | 2021-02-21 | headache |
Severe shaking during teh night with chest congestion and headache. Resolved by teh following day at...
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Severe shaking during teh night with chest congestion and headache. Resolved by teh following day at 3pm
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| 75 | 2021-02-22 | chills | Face swelling, chills |
| 75 | 2021-02-22 | headache, chills |
generalize aching, chills with no fever, pain at the site of injection, headache, lasting for one d...
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generalize aching, chills with no fever, pain at the site of injection, headache, lasting for one day. Tylenol helps with the symptoms.
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| 75 | 2021-02-23 | fatigue, headache |
Vaccine administration error: Undiluted vaccine was given. Patient was monitored from 1/20/21 to 2/...
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Vaccine administration error: Undiluted vaccine was given. Patient was monitored from 1/20/21 to 2/4/21. Injection site pain, tiredness and headaches were the only symptoms reported by patient.
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| 75 | 2021-02-23 | fatigue |
Bell's palsy; blood pressure increased; chest pain; breathing difficulty; weakness; tired; loss of a...
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Bell's palsy; blood pressure increased; chest pain; breathing difficulty; weakness; tired; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (lot number: EL9262), via an unspecified route of administration, at arm left, on Jan2021 at single dose for COVID-19 immunisation. Medical history included Prediabetes from 2019 (reported as diagnosed two years ago), overweight from an unknown date, ongoing arthritis from 2017 (reported as about 4 years ago), gets worse now. There were no concomitant medications. Caller states she just has a question, states she took the test about 2 weeks ago, clarifies the Pfizer vaccine and due for next one on Sunday, caller wanted to find out if what she experienced could be due to the vaccine, states she had a reaction for almost two weeks (also reported that all the events started on 05Feb2021, pending clarification), states her blood pressure went up, she had chest pain in her chest, weakness, loss of appetite, states it lasted about 24 hours, no exact dates provided. Also experienced Bell's Palsy states it comes and goes, that when she talks the saliva comes down the side of her mouth. States her Blood pressure went really high, 145/90 or so, lasted about 24 hours. Did not know if she was having a heart attack. Does see a cardiologist because of a family history of cardiac issues. The outcome of the event Bell's Palsy was not recovered, of the other events was recovered on Jan2021 (reported as lasted for 24 hours).
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| 75 | 2021-02-23 | headache | Head ache, nausea |
| 75 | 2021-02-23 | influenza like illness, headache |
flu like symptoms; diarrhea; severe/bad headache; nausea; This is a spontaneous report from a contac...
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flu like symptoms; diarrhea; severe/bad headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot number: EL9261; expiry date: unknown) at the age of 75 years old, via an unspecified route of administration in the right arm, on 23Jan2021 09:00, at a single dose, for COVID -19 immunization. The patient had no relevant medical history and was not taking concomitant medications. Patient reported that she got the Pfizer Covid vaccine shot on 23Jan2021 at 9:00. On 24Jan2021, about 2:00, the next morning, she felt like she got hit by a bus further described as flu like symptoms including nausea, diarrhea, and a severe/ bad headache. The events were treated with Phenergan at home. These symptoms lasted about a day; patient completely recovered on 25Jan2021.
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| 75 | 2021-02-23 | fever, body temperature increased, chills, fatigue, headache |
Evening Feb. 15, chills, fever, muscle aches, and headache and exhaustion. Night sweats with tem...
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Evening Feb. 15, chills, fever, muscle aches, and headache and exhaustion. Night sweats with temp. up to 101.8. Day temps 99 to 100. Have lasted to the present time. Treatment fluids and aspirin. Chest x-ray and urinalysis clear. Covid nasal test yesterday, Feb.23. The second Pfizer vaccine scheduled for today, Feb. 24, was cancelled.
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| 75 | 2021-02-23 | fever |
2/19 woke up with pain in right arm, swelling at site, hot to touch, reddish discoloration, stinging...
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2/19 woke up with pain in right arm, swelling at site, hot to touch, reddish discoloration, stinging, itchy, and noted right above the swollen are three red areas size of tip of my pinky. (these redish spots same on my first vaccination). A few hours after I took my temp and was 99.1. I double checked and 99.1. I took one Motrin for fever and couple hours no fever. Today 2/24= Lump swelling decreased and warm to touch. I have been applying Hydrocortisone Cream 1% for mild itching.
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| 75 | 2021-02-24 | fatigue |
VR stated burning sensation through neck and up into head. VR noted fatigue within 5 min of vaccinat...
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VR stated burning sensation through neck and up into head. VR noted fatigue within 5 min of vaccination. Observed for an extra 15 min. vitals stable. symptoms subsided within 5 min of onset
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| 75 | 2021-02-24 | headache, influenza like illness, lethargy |
Day 2: flu like symptoms. W/o fever. Confined to bed Day 3: same but part time in bed Day 4: redu...
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Day 2: flu like symptoms. W/o fever. Confined to bed Day 3: same but part time in bed Day 4: reduction in flu like symptoms but disoriented and lethargy and headache Day 5: disoriented and lethary Day 6: same Day 7: shakey and lethargic Day 8: same
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| 75 | 2021-02-24 | headache |
Pt developed chest tightness approx 10-15 minutes post vaccination. Also c/o HA and dizziness. BP 1...
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Pt developed chest tightness approx 10-15 minutes post vaccination. Also c/o HA and dizziness. BP 138/63 HR 66 SpO2 98% RA Pt brought to ER
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| 75 | 2021-02-24 | respiratory tract congestion, fever, fatigue, throat pain |
Mild reaction lasting 48 hours - achy arm at injection site, brain fog, congestion, slight sore thro...
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Mild reaction lasting 48 hours - achy arm at injection site, brain fog, congestion, slight sore throat, fever: 98.9-99.9, fatigue
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| 75 | 2021-02-25 | chills, fatigue, sleepiness | Worst flu ever symptoms. Chills; fatigue: sleepiness, |
| 75 | 2021-02-25 | fatigue |
absolute neutropenia, relative lymphocytosis, normocytic anemia and a typical monocular cells; Incre...
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absolute neutropenia, relative lymphocytosis, normocytic anemia and a typical monocular cells; Increasing fatigue and shortness of breath; Increasing fatigue and shortness of breath; absolute neutropenia, relative lymphocytosis, normocytic anemia and a typical monocular cells; absolute neutropenia, relative lymphocytosis, normocytic anemia and a typical monocular cells; This is a spontaneous report from a health care professional, the patient. A 75-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration from in the right arm on 29Jan2021 at 13:30 (at the age of 75-years-old) as a single dose, for COVID-19 vaccination. Medical history included heart valve replacement (under the care of cardiologist for heart valve leakage causing some shortness of breath & fatigue, but was manageable), thyroid cancer, breast cancer female and tricuspid valve disease. Patient did receive concomitant medications in two weeks but details were not provided. The patient previously took penicilin and experienced drug hypersensitivity.. No other vaccines were given within 4 weeks. Since the vaccination the patient had not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. On 01Feb2021 at 12:00, The patient experienced absolute neutropenia (medically significant) and relative lymphocytosis, normocytic anemia and a typical monocular cells, and increasing fatigue and shortness of breath (in 2 weeks since vaccine on 29Jan2021; almost debilitating). The patient underwent lab tests included Blood test 4 months earlier results were normal on an unspecified date, Blood Test during routine check-up on 02Jan2021, revealed absolute neutropenia, relative lymphocytosis, normocytic anemia and a typical monocular cells. . No treatment was given for the events. Consumer inquired if the vaccine can contribute to increase in fatigue and shortness of breath and new blood work reading. The clinical outcome of the events absolute neutropenia, lymphocytosis, normocytic anemia and a typical monocular cells, and increasing fatigue and shortness of breath was not recovered.
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| 75 | 2021-02-25 | headache, fever, sweating |
After vaccine, the next day 3-4am woke up with horrible headache, slight fever, sweaty. injection si...
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After vaccine, the next day 3-4am woke up with horrible headache, slight fever, sweaty. injection site raised and red and still is, also has trouble keeping liquid or food in. Still gets fleeting headaches and sweats ever morning.
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| 75 | 2021-02-25 | headache | Really bad headache and need to sleep for at least 36 hours. No treatment. |
| 75 | 2021-02-25 | sweating | patient was diaphoretic x 15 secs. symptoms resolved. |
| 75 | 2021-02-25 | sneezing, runny nose, nasal congestion, malaise |
Vaccinated on Saturday, woke up Sunday with ringing ears, general malaise, dizziness, stuffed up sin...
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Vaccinated on Saturday, woke up Sunday with ringing ears, general malaise, dizziness, stuffed up sinuses, red burning eyes, constant sneezing and dripping nose, weak and shaky on my feet. Lose of appetite, constipation and nausea.. It lasted for 4 days and on Wednesday I called my medical care giver and she said that I probably had an allergic reaction to the vaccine and to not take the next dose, as this had been my first. I am still, periodically week and dizzy, and still have little appetite.
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| 75 | 2021-02-27 | head discomfort |
Patient received the Covid-19 vaccine. She reports symptoms of Other: Itchy face flushed, foggy feel...
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Patient received the Covid-19 vaccine. She reports symptoms of Other: Itchy face flushed, foggy feeling pressure in the head I have observed Patient having red face itchy face foggy pressure in the head. Vital signs: 0843 BP 170/80 HR 96 RR 18 Pulse Ox 98% 0846 BP 182/80 0857 BP 168/84 HR 88 RR 16 Pulse Ox 97% 0910 BP 180/90 HR 88 RR 16 Pulse Ox 97% 0925 BP 200/90 HR 88 RR 16 Pulse Ox 97% Treatment/intervention Monitored offered water Benadryl 25 mg po @ 0850 by an RN, Benadryl 25 mg po @ 0914 by an RN 0925 patients BP continued to be out of normal range patient stated that she took her BP medications this am. Face still flushed. 0925 ambulance called to transport patient to the ED. 0925 ambulance her report given.
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| 75 | 2021-02-27 | headache, chills |
Severe headache, took tylenol, lasted approx 24 hrs. Chills, bundled up and slept eventually, lasted...
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Severe headache, took tylenol, lasted approx 24 hrs. Chills, bundled up and slept eventually, lasted approx. 10 hrs. 3 days later red rash started on left arm from inj. site almost to elbow and width of arm. Have taken 2 benadryl. Still have rash. It's Sunday 02/28/2021
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| 75 | 2021-02-27 | headache |
Tingling /numb hands and feet, tired, no energy, night sweats, abdominal pain, burning on bottom of ...
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Tingling /numb hands and feet, tired, no energy, night sweats, abdominal pain, burning on bottom of feet, muscle weakness, dry mouth, joint pain, headache,...
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| 75 | 2021-02-28 | chills, fatigue |
hurting in her chest, like she has to keep breathing; feeling kind of weird/ feeling bad; feeling ki...
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hurting in her chest, like she has to keep breathing; feeling kind of weird/ feeling bad; feeling kind of weird, off balance; Upset stomach; Chills; She cannot function very good, She is feeling so bad and cannot do nothing; At night time it is hard to try to do something and she cannot do it because she is tired; can hardly breathe at night; it kind of feels like she has an ear ache but she does not have an earache; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via intramuscular route of administration on 14Jan2021 (at the age of 75-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) from an unknown date (per patient diagnosed quite a while ago and she goes to a pulmonary doctor). Concomitant medications included unspecified inhaler at two puffs per day if needed and unspecified recue inhaler one puff a day as needed, both ongoing for one year for COPD. The patient did not receive any other vaccines within four weeks prior to the vaccination or any other prior vaccinations or any vaccinations on the same date of the vaccination. The patient experienced chest pain, feeling abnormal, feeling off balance, upset stomach, chills, cannot function very good, tired, can hardly breathe at night and ear discomfort, all in Jan2021. The patient reported she received the vaccination on 14Jan2021 by her primary doctor. She is feeling kind of weird and has an upset stomach. She is asking how long this will last. She is worried about taking the second dose. She is supposed to have the second dose on 04Feb2021. She cannot function very good, states it kind of feels like she has an ear ache but she does not have an earache. Her balance is off and she can hardly breathe at night. All her symptoms started on the third day after getting the shot (Jan2021). She reports the feeling weird and off balance feeling feel like you are drunk. It aggravates her because she cannot function right. She also experienced chills started the third day after the shot and the chills have recovered completely. The patient reported that she was alright the first day. She has hurting in her chest, like she has to keep breathing which also started the third day after getting the shot and has been going on all this time. At night time it is hard to try to do something and she cannot do it because she is tired, states it is the worst part, She is feeling so bad and cannot do nothing. She has a hard time breathing. The events did not require a visit to emergency room or physician office. The patient did not have any relevant tests. The clinical outcomes of the events chest pain, feeling abnormal, feeling off balance, upset stomach were not recovered. The patient recovered from the chills in Jan2021. The outcome of the cannot function very good, she is feeling so bad and cannot do nothing, tired, can hardly breathe at night and ear discomfort was unknown.
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| 75 | 2021-02-28 | chills, headache, body temperature increased |
At 9:30 A.M. on 2/23, I noticed that I had a slight headache. My left arm was, as I had expected, p...
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At 9:30 A.M. on 2/23, I noticed that I had a slight headache. My left arm was, as I had expected, painful and red near the injection site. As the day progressed, I became aware of more reactions: chills, body aches, increasing headache, arm pain, and changes in my temperature (I usually have a temperature of 97.6, but measured 96.6 and in the evening, 100.4). I felt listless and nauseous by dinnertime. By the morning of 2/24, nothing was improved, so I took 2 Tylenol, which I repeated 7 hours later and 7 hours after that. By the morning of 2/25, I began feeling better and stopped the Tylenol. My symptoms gradually continued to improve through 2/28.
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| 75 | 2021-02-28 | headache, chills |
After 24 hours for about 6 hours and again 48 hours for about 6 hours: chills, body aches, headache,...
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After 24 hours for about 6 hours and again 48 hours for about 6 hours: chills, body aches, headache, dizzy, nausea; then after 9 days (February 25), same symptoms for about 6 hours.
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| 75 | 2021-02-28 | headache, sleepiness, fever |
On day after had severe muscle ache; severe headache; nauseous; so cold (could not get warm); had a ...
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On day after had severe muscle ache; severe headache; nauseous; so cold (could not get warm); had a fever; slept for 15 hours; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration on 26Jan2021 17:00 at single dose for covid-19 immunisation. Medical history included mitral valve prolapse and COVID-19. Concomitant medication included bimatoprost (LUMIGAN), colecalciferol (D3), zinc (ZINC), and ubidecarenone (COQ10). The patient experienced severe muscle ache, severe headache, nauseous, so cold (could not get warm), had a fever and slept for 15 hours on 26Jan2021 21:00. The patient received no treatment. The outcome of the events was recovered with sequelae on an unspecified date.
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| 75 | 2021-02-28 | malaise, headache, body temperature increased, fatigue, chills |
Injection site pain, Chills, 102 fever 24 hours for 3 days, headache, tiredness, muscle pain, joint ...
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Injection site pain, Chills, 102 fever 24 hours for 3 days, headache, tiredness, muscle pain, joint pain, feeling unwell
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| 75 | 2021-02-28 | malaise, fever, fatigue |
Pt was brought to ED due to altered mental state, apparently after pt received first Covid vaccine, ...
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Pt was brought to ED due to altered mental state, apparently after pt received first Covid vaccine, she didn't feel quite well, fatigued; after recent 2nd Covid vaccine, pt had been noted to be confused with poor appetite. Pt also with recent dx hypopituitarism - has been on desmopressin/ prednisone - per report from family members, pt had been drinking a lot of water. In ED, Pt was noted with hyponatremia - NA 124, Lactic acidosis 2.1, low grade temp - PCT wnl.
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| 75 | 2021-02-28 | productive cough | Spiting up white flem ,when getting up in the morning and during the day !pain left side !Lung? |
| 75 | 2021-02-28 | fever, malaise |
Fever; feels lousy; This is a spontaneous report from a contactable consumer reporting for herself. ...
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Fever; feels lousy; This is a spontaneous report from a contactable consumer reporting for herself. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL8982/expiration date: not provided), via an unspecified route of administration, on 26Jan2021 at 18:10 (at the age of 75 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included 3 cardiac stents on an unknown date. Concomitant medication was not provided. On 27Jan2021 at 15:00, the patient experienced fever all day. The patient's highest body temperature was on 27Jan2021 at 101.9 F and on 28Jan2021, the temperature was 101.4 F. On 27Jan2021 (time unspecified), the patient stated that she feels lousy. The outcome of the events fever and feels lousy was not recovered.
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| 75 | 2021-02-28 | sinusitis, fever, fatigue, chills |
Pfizer-BioNTech COVID-19 Vaccine EUA 2" diameter red and itchy area around injection site and 3" lon...
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Pfizer-BioNTech COVID-19 Vaccine EUA 2" diameter red and itchy area around injection site and 3" long by 1/4" wide red line from injection site to arm pit, that lasted 1 week. Also, 101 temp, some chills, light headache, upper teeth hurt (like in sinus infection) and tired that lasted 1 day.
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| 75 | 2021-03-01 | cough |
itching tongue face lips, mild swollen tongue and lips, neck pain, hoarse voice, cough, pale. Pr...
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itching tongue face lips, mild swollen tongue and lips, neck pain, hoarse voice, cough, pale. Progressively worse in order listed over 10 minutes. Chewable benadryl 12.5 mg x 4 given. Pt reported improved symptoms within 10 minutes and was asymptomatic at 30 minutes.
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| 75 | 2021-03-01 | fatigue, influenza like illness |
Same day -fatigue, slept for 4 hrs. 4pm to 8pm. Increasing generalized pain, fatigue, and discomfort...
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Same day -fatigue, slept for 4 hrs. 4pm to 8pm. Increasing generalized pain, fatigue, and discomfort first night, through next day. 101 fever. Severe flu symptoms. Started to abate on Wednesday.
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| 75 | 2021-03-01 | fatigue, throat pain, cough |
Started coughing one week after receiving vaccine. Then woke up next morning with sore throat, "coul...
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Started coughing one week after receiving vaccine. Then woke up next morning with sore throat, "couldn't swallow." The symptoms "wouldn't let up" then patient reports by Saturday Feb 20, she felt "washed out," couldn't breathe, lost all energy, and had a RA attack. Her knees are still throbbing today.
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| 75 | 2021-03-01 | fatigue |
thought it was my tooth bleeding because that's what it looked like if you cut yourself; the phlegm...
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thought it was my tooth bleeding because that's what it looked like if you cut yourself; the phlegm she spitted up this morning had blood in it; she started to bleed/nose bleed coming out of my mouth; achy; tired; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) via an unspecified route of administration on 28Jan2021 08:05 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included an unspecified sinus disorder, unspecified allergies and reflux usually after eating, all from unknown dates and unknown if ongoing. The patient's historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) on 06Jan2021 with no specified side effects. The patient's concomitant medications were reported as unspecified medications for sinus problems and allergies. The patient stated that she got the second dose on "Thursday." She experienced side effects "that everybody has like achy and tired for two days." She continued to say that she normally spits up phlegm in the morning from sleeping overnight because she has sinus issues and she snores. This morning ("Saturday") it was pinched with blood and she was bleeding, just bleeding. She's not bleeding anymore because she has a mouthwash medication to make gargles and also with salty water. She thought it was her tooth bleeding because that's what it looked like if you cut yourself. It has stopped. She also noted that it was more like a nose bleed coming out of her mouth. She gargled with warm salted water. Treatment of the events blood in sputum, nose bleed and tooth disorder included using a mouthwash medication to make gargles and also warm salt water. The clinical outcomes of achey and tired for two days were reported as unknown. The clinical outcomes of blood in sputum, nose bleed and tooth disorder were reported as recovered on an unspecified date in Jan2021.
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| 75 | 2021-03-01 | headache, fatigue |
Body and muscular aches in entire body. Slight headache. Extreme fatigue. Symptoms continued From 1...
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Body and muscular aches in entire body. Slight headache. Extreme fatigue. Symptoms continued From 1:30 am on 2/26 for approximately 24 hours.
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| 75 | 2021-03-01 | headache, fatigue | Severe headache Goosebumps Fatigue Dizziness |
| 75 | 2021-03-01 | lethargy, influenza like illness |
Lethargic; Flu like symptoms; Lower part of my leg, I have little bit rash, a redness; Lower part of...
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Lethargic; Flu like symptoms; Lower part of my leg, I have little bit rash, a redness; Lower part of my leg, I have little bit rash, a redness; I have few spots on my right forearm; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration at the age of 75 years, on 22Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing and anticoagulant therapy from an unknown date and unknown if ongoing. Concomitant medication included dronedarone hydrochloride (MULTAQ) at 400mg, twice daily and apixaban (ELIQUIS) at 5mg, two times daily. The patient stated, "Both my husband and I took the Covid the first shot on 22Jan2021 which was week ago today. I noticed about 4 days later (Jan2021) like I started feeling you know flu like symptoms but they were mild, if I took two an Extra strength Tylenol it went away. You know what I mean. So that one for about may be one, two may three days and that was it. I was very lethargic. The only thing I did notice that on both my legs from the ankles of about midways I have you know my leg, the lower part of my leg, I have little bit rash, a redness. It does not itch, it was not hard to the touch. My body temperature was normal. It was little red or pinkish to a little bit of red. Now, I noticed tonight that I have few spots on my right forearm. Like I said we have shot on 22nd, everything was fine, no immediate reaction or anything else and everything is okay. I just you know I feel fine but is this normal?" The patient stated, "No, they are healthy and safe about 20-25 minutes. Everything was fine and then let us go and I said couple of days later it hasn't progressed, it is very, it is on both of my lower legs from ankles midway up my legs and I noticed couple of spots on my left forearm but it hasn't gotten any worst and it hasn't gotten spread on any place other than right forearm." The patient also stated, "You mean the rash or any other the symptoms. We have the shot Friday, Saturday, Sunday, Monday. I was say this past Tuesday, around 26th (further not clarified)." The patient stated, "It was there on my legs. It hasn't moved. It hasn't gotten any worse and it is only on front it is not back on my legs. The only thing I noticed tonight that it is couple of spots on my right forearm." The consumer stated, "No, I went to see my doctor the other day for her to take look at it. I went to see PA at my doctor's office, I saw her and she said if it doesn't get worse it would probably go away." The patient also stated, "The only thing that I had done right before the Covid Vaccine. I had injection in my knee of amniotic fluid for a torn meniscus but that should not affect it." The patient underwent lab tests and procedures which included body temperature: normal on an unspecified date. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.
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| 75 | 2021-03-01 | fever |
I didn't feel good the nite I had the shot, next day I stayed in bed with 101 fever. The 6th of Feb...
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I didn't feel good the nite I had the shot, next day I stayed in bed with 101 fever. The 6th of Feb, fever gone, but large lymph gland under the shot arm was obvious. I have done lymphatic massage everyday since, and finally on Feb 26, it finally dissipated and will have a Mammo in May.
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| 75 | 2021-03-02 | chills |
Patient experienced chills and flushing minutes after vaccine administration. Vital Signs stable. Sp...
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Patient experienced chills and flushing minutes after vaccine administration. Vital Signs stable. Spontaneous improvement. No medications offered.
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| 75 | 2021-03-02 | headache, fatigue, chills |
Extreme tiredness; nausea; feeling like I was run over by a truck; chills; headache; weakness; This ...
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Extreme tiredness; nausea; feeling like I was run over by a truck; chills; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received first dose BNT162B2 (Solution for injection, Lot number: EL9264) via an unspecified route of administration on 31Jan2021 16:00 at single dose in right arm for covid-19 immunisation. Medical history included breast cancer and hodgkin Lymphoma. Concomitant medication included simvastatin, vitamin d nos. The patient had extreme tiredness, nausea, feeling like I was run over by a truck, chills, headache, weakness on 01Feb2021 at 13:00 pm. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse event. The outcome of the events was recovering.
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| 75 | 2021-03-02 | throat pain, headache, sinus disorder |
AFib; Tingling sensation maybe her sinuses; Headache; Sore throat; Upper chest pain; aches (clarifie...
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AFib; Tingling sensation maybe her sinuses; Headache; Sore throat; Upper chest pain; aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); Nausea; Heart pounding; Lightheadedness; tingling feeling below her neck on the flat area of her upper chest; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left arm on 28Jan2021 11:00 at a single dose for COVID-19 immunisation. Medical history included Afib (diagnosed about 4-5 years ago) and stress. There were no concomitant medications. It was reported that when she got her first COVID-19 Vaccine, her arm didn't hurt, but she had a headache, sore throat, an upper throat and chest type of thing, aches (clarified as body or muscle ache in her arm or leg that occurred occasionally), a little nausea, heart pounding, and lightheadedness on an unspecified date in Feb2021. She said she has AFib (atrial fibrillation) on an unspecified date. She said she is scheduled to get her second COVID-19 Vaccine shot next Monday (22Feb2021), and wanted to know if her side effects are going to be worse. She clarified that her upper throat and chest type thing to be a tingling feeling below her neck on the flat area of her upper chest on an unspecified date in Feb2021. She said she spoke with her doctor on a video call. She said her doctor said her tingling sensation would not be from the COVID-19 Vaccine shot, and the tingling sensation maybe her sinuses on an unspecified date. She said her doctor put her on antibiotics for 10 days (prescribed Cephalexin 500mg capsules, twice a day for 10 days. She said she started the Cephalexin 500mg capsules on 05Feb2021 and finished the prescription yesterday, 15Feb2021. She said the Cephalexin 500mg capsules were dispensed in a pharmacy bottle). The patient stated that she has no other medical conditions, except stress. She said she and her husband have been quarantined, and the quarantine has felt like the longest 2 weeks of her life. It was reported that the patient still gets heart palpitations. She said the other side effects lasted 5-7 days, and improved during that time. She said the side effects have all resolved with the exception of the heart palpitations. The event atrial fibrillation was assessed as serious (medically significant). The outcome of the event heart pounding was not recovered, while recovered on an unspecified date in Feb2021 for the rest of the events.
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| 75 | 2021-03-02 | pneumonia |
pneumonia; This is a spontaneous report from a Pfizer-sponsored program. Contactable consumers repor...
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pneumonia; This is a spontaneous report from a Pfizer-sponsored program. Contactable consumers reported that a 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EL1284, via an unspecified route of administration on 26Jan2021 at single dose for COVID-19 immunization. Medical history included cholesterol (abnormal) and asthma. Concomitant medication included budesonide, simvastatin for cholesterol and benralizumab (FASENRA) for asthma. She has got a lot of other medications (at least 15 medications). The patient was hospitalized this week due to a pneumonia on 13Feb2021 (in between 1st dose and 2nd dose). The patient was in a hospital for 7 hours in and out. She was hospitalized in 13Feb2021. She missed the 2nd appointment today (16Feb2021) 11:30AM and they were informed that they need to call. The healthcare professional advised not to as she was on antibiotics (levofloxacin 750 mg) for pneumonia which was contracted after the first dose. She then wanted to reschedule her second dose. The patient underwent lab tests and procedures which included blood, x-rays, CAT scan and tested for virus, influenza. The tests were done in the hospital and she way okay.
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| 75 | 2021-03-02 | fever, cough |
Fell feverish on and off; a lot of coughing; a lot of wheezing; This is a spontaneous report from a ...
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Fell feverish on and off; a lot of coughing; a lot of wheezing; This is a spontaneous report from a contactable consumer (patient) for herself. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: pfizerbiontech) via an unspecified route of administration at left arm on 06Feb2021 at 04:00 AM at a single dose for COVID-19 immunisation. Age at vaccination was reported as 75-year-old. Medical history included fibromyalgia and arthritis. Allergies to medications, food, or other products reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included lisinopril, omeprazole and pregabalin. Facility where the most recent COVID-19 vaccine was administered at a drug store. The patient experienced adverse events included fell feverish on and off, a lot of coughing, a lot of wheezing; with adverse event start date on 11Feb2021 at 09:00 AM. The events were reported as non-serious. The outcome of events was unknown. Treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Information on the lot/batch number has been requested.
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| 75 | 2021-03-02 | fever |
has lupus and a couple days ago, she started having inflammation pain; has lupus and a couple days a...
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has lupus and a couple days ago, she started having inflammation pain; has lupus and a couple days ago, she started having inflammation pain; Fever; Achy; Pleuritic pain; Shortness of breath; O2 level was a little lower it was in the low 90's and she usually runs 96 to 97; This is a spontaneous report from a contactable consumer reporting for herself. A 75-years-old female patient received the second dose of bnt162b2 (BNT162B2)vaccine , intramuscular in the right arm on 08Feb2021 15:30 at single dose for covid-19 immunisation . Medical history included systemic lupus erythematosus , asthma, thyroidectomy . The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 vaccine on 18Jan2021. The patient has lupus and a couple days ago, she started having inflammation pain on 14Feb2021 with outcome of unknown, O2 level was a little lower it was in the low 90's and she usually runs 96 to 97 on Feb2021 with outcome of unknown , fever on 09Feb2021 with outcome of unknown , achy on 09Feb2021 with outcome of unknown , pleuritic pain on Feb2021 with outcome of recovering , shortness of breath on Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included oxygen saturation: low 90's. The second day, she had a little bit of a fever and was achy. She has lupus and a couple days ago, she started having inflammation pain. It has progressed and went to pleurisy pain. She has really been down for the count. She has had problems breathing with the pleurisy pain, but she has had no fever. She has had a little shortness of breath. She has a pusle oximetry and her O2 level was a little lower, it was in the low 90's and she usually runs 96 to 97.The patient has taken Tylenol and the pleurisy pain is better. She can breathe without pain. The patient is wondering if the vaccine causes problems or after affects for more than a week sometimes or if this is just plain lupus causing issues. Information on the lot/batch number has been requested.
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| 75 | 2021-03-02 | fever |
it showed a "CRP value" of 11.5 which is usually below 0.29 which shows inflammation; loss of appeti...
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it showed a "CRP value" of 11.5 which is usually below 0.29 which shows inflammation; loss of appetite; Nausea; breathing problems; mild fever; Muscle ache; Joint ache; Rapid heart rate up to 130; Itchy skin; roof of mouth itching; eyes were also really sore; This is a spontaneous report from a contactable Other HCP (patient). A 75-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6201), via an unspecified route of administration in the right arm on 11Feb2021 at single dose for COVID-19 immunisation. Medical history included ongoing asthma initially diagnosed at 21 years old, ongoing arthritis diagnosed 10-15 years before but she thinks she had it since she was 35, multiple joint replacements, past pneumonia. The patient's concomitant medications were not reported. The patient previously received methotrexate 25mg a week orally for arthritis but she quit taking it about 3 months before in preparation of getting the vaccine. The patient previously received the first dose of bnt162b2 on unspecified date (lot EL8982) at single dose for COVID-19 immunisation in the right arm. The patient experienced mild fever on 12Feb2021 with outcome of recovered on 14Feb2021, roof of mouth itching on 11Feb2021 with outcome of recovered on 11Feb2021, muscle ache on 12Feb2021 with outcome of recovered on 12Feb2021, joint ache on 12Feb2021 with outcome of recovering, breathing problems on 12Feb2021 with outcome of recovering, rapid heart rate up to 130 on 12Feb2021 with outcome of recovering, itchy skin on 11Feb2021 with outcome of recovered on 11Feb2021, it showed a "crp value" of 11.5 which is usually below 0.29 on 15Feb2021 with outcome of unknown, nausea on 12Feb2021 with outcome of recovered on 13Feb2021, loss of appetite on 13Feb2021 with outcome of recovered on 13Feb2021, eyes were also really sore on 11Feb2021 with outcome of recovered on 15Feb2021. An EKG performed on 15Feb2021 as pending results. The event of breathing problems was serious due to disability. The events mild fever, roof of mouth itching, muscle ache, joint ache, rapid heart rate up to 130 and itchy skin were medically significant. The patient reported that initially, the roof of her mouth started itching. It literally happened as soon as she had the vaccine. She took a Benadryl. She didn't have a skin irruption, but did have itchy skin. The next day, she had a low grade fever. She had muscle and joint aches. She had no rash, but a little nausea. She had breathing problems. She had asthma issues and wheezing after the vaccine. That is how she described her breathing issues. She had a rapid heart rate. It went up to 130. It could of been because of fever, her breathing, or pain. There was a period of days then it resolved. On 15Feb2021, she feels almost human. She had routine arthritis lab drawn on 15Feb2021. They showed a CRP level of 11.5 which shows inflammation. She normally was below 0.29 which was within normal limits. That was an extreme difference. That was a lot of inflammation. The patient had to get her nebulizer out to breathe. She has taken Tylenol a couple of times. Her lab work was essentially normal. The CBC and chemical panel was okay. The patient thoughts the fever was important because she has been immunocompromised for years by Methotrexate. She has had pneumonia before with no fevers. Her eyes were also really sore. They bothered her. She already had to use eye drops. That was 11Feb2021 it was gone on 15Feb2021 but it kind of lasted a few days. Her muscles were better, but her joints still hurt some. But her joints always hurt some. She has had multiple joint replacements. The muscles in her legs were severe Friday and Saturday. Her muscles aren't hurting now, but her joints were but that was kind of normal. Her peak flow was way down on 14Feb2021. It was at 250. She did finally get it up to 350 by using her nebulizer. Her best effort normally is 450. Her peak flow was down quite a bit. She has been having breathing changes for a year. They were not sure what it was about. It could be an acute episode of something. On unknown date (next morning as reported), her pulse was 90-100. Now her heart rate was only elevated with activity. Her heart rate was down in the 70s, but when moving it was in the low 100s. With activity it was still up. It was hanging out in the 70s except exercising. She considers walking across the room exercising. All her other labs were in within normal limits. The patient wanted to know if the inflammatory response was secondary to the vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 75 | 2021-03-02 | runny nose |
Runny nose; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female...
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Runny nose; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included citalopram hydrobromide (CELEXA). The patient experienced runny nose on 29Jan2021 08:00. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was recovering. Information on the lot/batch number has been requested.
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| 75 | 2021-03-02 | throat irritation |
Patient complaint of tickle/ itchiness in throat and was anxious and jittery at 1253. Then she had g...
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Patient complaint of tickle/ itchiness in throat and was anxious and jittery at 1253. Then she had generalized itchy fore head ,bilateral eyes, throat and ears. Vital signs within normal. Patient was placed in recumbent position and was given apple juice. Patient stated all symptoms resolved at1312 and was discharged home.
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| 75 | 2021-03-03 | chills, fatigue |
dizziness, lightheaded, chills in head and body, nausea, elevated blood pressure, frightening odd fe...
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dizziness, lightheaded, chills in head and body, nausea, elevated blood pressure, frightening odd feeling all over, fatigue
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| 75 | 2021-03-03 | chills, headache, fever |
Fever, chills, really bad headache. Took 200 mg of Acetaminophen at 9:AM (after 8 hours), and slep...
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Fever, chills, really bad headache. Took 200 mg of Acetaminophen at 9:AM (after 8 hours), and slept all day. Felt fine when I woke up. around dinner time.
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| 75 | 2021-03-03 | fatigue, headache |
severe reaction the day after 2nd shot. I have had 5 separate joint replacements d/t severe arthrit...
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severe reaction the day after 2nd shot. I have had 5 separate joint replacements d/t severe arthritis. I had severe pain in all of the replacements especially the 2 most recent. Even the 3 dental implants hurt. No Temp but severe fatigue, headache. Unable to get out of bed. It took 4 days to begin to start getting back to normal for me.
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| 75 | 2021-03-03 | headache |
HEADACHE, PRESENTS WITH FACIAL BUTTERFLY RASH AFTER COVID VACCINE. NO REDNESS AT INJECTION SITE. MED...
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HEADACHE, PRESENTS WITH FACIAL BUTTERFLY RASH AFTER COVID VACCINE. NO REDNESS AT INJECTION SITE. MEDICAL HISTORY SHOWS REACTIONS TO VACCINATIONS. AT 1305 BP 134/86 HR 78 O2SAT 95 SKIN WARM AND DRY DIAPHORETIC, AND BILATERAL FACIAL RASH. BREATH SOUNDS CLEAR BILATERALLY. PT ESCORTED TO TRIAGE AREA, VITALS TAKEN AND CONTINUE TO MONITOR. PT STATES FEELING LIGHT HEADED, PROVIDED PT JUICE TO DRINK. REASSES AT 1320 BP 140/82 HR 83 RESP 20 O2SAT 94 SKIN WARM AND DRY BILATERAL BREATH SOUNDS CLEAR. PT ESCORTED TO OBSERVATION AREA FOR 15 MINUTES AFTERWARDS PT CLEARED TO LEAVE.
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| 75 | 2021-03-03 | headache |
sore muscle around my neck; when in bed last night, she could not turn her head without it been so p...
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sore muscle around my neck; when in bed last night, she could not turn her head without it been so painful; had discomfort in her shoulder and stiffness; had discomfort in her shoulder and stiffness/neck was so stiff that it hurt to turn her/can hardly turn her neck; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264), via an unspecified route of administration on 30Jan2021 at 16:10 (4:10 pm) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 30Jan2021, the same night of vaccination, the patient had discomfort in her shoulder and stiffness. On Monday, 01Feb2021, patient reported that her "neck was so stiff that it hurt to turn her head". She can hardly turn her neck. She added when in an "upright" position "it is ok" but "when in bed last night, she could not turn her head without it been so painful" to the point where she felt like she "would cry out". On an unspecified date it was reported that patient had sore muscle around my neck. The patient mentioned she alleviates her pain with "Tylenol, hot compresses, took a towel and put hot water on it and then put it around my neck, and a cream for soreness". The patient took a Tylenol last night and put hot compress on it. And rubbed it with a muscle something for a sore muscle. But it still very painful. The patient doesn't know whether it's related to the vaccine or not. The outcome of the event sore muscle was not recovered while for the rest of the events was unknown.
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| 75 | 2021-03-04 | fatigue |
Patient reports a burning sensation in her chest, weakness, and fatigue. States this started Wednes...
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Patient reports a burning sensation in her chest, weakness, and fatigue. States this started Wednesday following the vaccine.
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| 75 | 2021-03-04 | headache, fatigue, fever, chills |
My mother had the COVID vaccine at 9 am. By 7:30 pm she felt weak, had muscles aches and severe head...
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My mother had the COVID vaccine at 9 am. By 7:30 pm she felt weak, had muscles aches and severe headache. As the night continued on she had fever chills that would come and go all night causing her not to get much sleep. Day two the chills were gone but still very achey, weak, tired and headache. Day three she is still tired and weak with headache.
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| 75 | 2021-03-04 | headache, malaise, fatigue, chills |
chills to where body was shaking, headache, tiredness, hard to get out of bed, just not feeling well...
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chills to where body was shaking, headache, tiredness, hard to get out of bed, just not feeling well . This lasted a day, feel better today
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| 75 | 2021-03-04 | headache |
Client verbalized feeling sudden headache after receiving the vaccine. Client was evaluated. Mrs....
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Client verbalized feeling sudden headache after receiving the vaccine. Client was evaluated. Mrs./Ms. was released to go home at 10:51 am after symptoms subsided accompanied by niece.
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| 75 | 2021-03-05 | sweating, chills, fatigue |
Was skiing on mountain - became extremely tired, muscles in legs hurting badly, back pain for 5 days...
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Was skiing on mountain - became extremely tired, muscles in legs hurting badly, back pain for 5 days before increased, Could hardly move, shortness of breath , had to stop constantly to get down the slopes to condo, very weak, laid down on bed, had chills and sweats off and on, felt achy all over - could hardly move around - in other words had symptoms of Covid 19 slept overnight. The next morning was much better although still a bit tired. It was very scary but I realized that it was a reaction to the vaccination.
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| 75 | 2021-03-06 | chills, fever, body temperature increased |
After about 5 days from second vaccination, went to the hospital with bowel problem; they required a...
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After about 5 days from second vaccination, went to the hospital with bowel problem; they required a urine analysis which showed I had "loads of white cells" and was given Bactrum. I have had no UTI for at least 25 years. In the meantime, I had chills, fever, and by Thursday, my temperature was 101 degrees. if I have an abundance of white blood cells, could the antigens have caused the UTI?
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| 75 | 2021-03-06 | fatigue |
On the morning after receiving the shot I came down with severe pain throughout my body and especial...
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On the morning after receiving the shot I came down with severe pain throughout my body and especially in both hips, along with fatigue. I was basically unable to get out of bed for 48 hours when the pain subsided.
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| 75 | 2021-03-06 | fatigue | extreme fatigue for one day, nausea and stomach pain for one day |
| 75 | 2021-03-07 | chills, headache |
Cold sweat; Within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms;...
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Cold sweat; Within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms; Headache; Diarrhea; Chills; Tenderness where the shot area is; Joint pain; Really bad flu; A little bit of a rash from it because my skin is all red from itching; A little bit of a rash from it because my skin is all red from itching; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN5318), via an unspecified route of administration on 02Feb2021 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included high cholesterol and eye disorder. Concomitant medication included atorvastatin, ubidecarenone (COQ-10), colecalciferol (VITAMIN D3), cyanocobalamin (VITAMIN B12), monascus purpureus (RED YEAST RICE) and unspecified OCUVITE for the eyes. On 02Feb2021 at 14:30, within 15 minutes of the vaccination, the patient was itching really bad (itchy in the ears, scalp, neck, chest, arms). The patient was kept in observation after the vaccination for an hour and was treated with diphenhydramine (BENADRYL) which did not seem to help. The patient drover home and went to bed. Her physician suggested that she see an allergist. The allergist was not sure what was in the vaccine and requested the patient ask her doctor for another referral. On 02Feb2021, the patient also experienced headache; diarrhea; chills; tenderness where the shot area was. On 03Feb2021, the patient woke up with cold sweats, like cold wet perspirations and chills again. On an unspecified date in Feb2021, the patient experienced joint pain and felt like she had a really bad flu, developed a little bit of a rash because the skin was all red from the itching, which she couldn't stop. The patient reported that she was treated for the events with diphenhydramine and paracetamol (TYLENOL). She questioned whether there were other reports of itchiness. The clinical outcome of "within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms", headache, diarrhea, chills, cold sweat was not resolved; while "tenderness where the shot area is", joint pain, really bad flu, "a little bit of a rash from it because my skin is all red from itching" was unknown.
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| 75 | 2021-03-07 | fever, headache, chills, dehydration |
Had felt chilled most of the day and around 8:30 the chills became extreme. Also felt feverish and ...
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Had felt chilled most of the day and around 8:30 the chills became extreme. Also felt feverish and slight headache. Was shaking badly. Took an excederin and got in bed. In about one hour, the symptoms stopped and I began to feel better. I drank a whole bottle of water as I felt dehydrated. Slept through the night and was ok the next day.
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| 75 | 2021-03-08 | chills, fever, headache |
Fever of 103, chills, body aches, headache, nausea, several large, red welts (hives??). Lasted about...
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Fever of 103, chills, body aches, headache, nausea, several large, red welts (hives??). Lasted about 40 hours, symptoms decreasing after about 30 hours.
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| 75 | 2021-03-08 | fatigue, fever, headache | Fever, intractable nausea and vomiting, fatigue, headache, body aches and diarrhea |
| 75 | 2021-03-08 | fatigue |
3/3/2021 6pm approximately Angioedema (Face) Hives (between the eyes & forehead) Extreme Fatigue 3/...
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3/3/2021 6pm approximately Angioedema (Face) Hives (between the eyes & forehead) Extreme Fatigue 3/9/2021 Swelling going down Drinking a lot of water & resting
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| 75 | 2021-03-08 | headache, fatigue, chills |
PATIENT AWAKENED DURING NIGHT WITH EXTREME CHILLS, HEADACHE, FATIGUE, FREQUENT DIARRHEA, URINARY FR...
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PATIENT AWAKENED DURING NIGHT WITH EXTREME CHILLS, HEADACHE, FATIGUE, FREQUENT DIARRHEA, URINARY FREQUENCY. THIS HAS NOT RESOLVED OR IMPROVED IN 6 DAYS AFTER VACCINATION #2
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| 75 | 2021-03-08 | headache, fatigue | Headache lightheadedness fatigue |
| 75 | 2021-03-08 | headache |
arthritis; fingers on right were all swollen; she could barely move her arm; right hand and wrist wa...
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arthritis; fingers on right were all swollen; she could barely move her arm; right hand and wrist was painful and swollen; right hand and wrist was painful and swollen; right hand and wrist was painful and swollen; right hand and wrist was painful and swollen; light headache; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3247), via an unspecified route of administration on 26Jan2021 at 10:40 (at the age of 75-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included arthritis from an unknown date, renal cancer since 07Dec2020 and ongoing, atrial fibrillation since 2006 and ongoing, partial nephrectomy on 06 Jan2021. She specified that she has an arthritis flare up about once a year and normally takes a Medrol dose pack. The patient's historical vaccines included an unspecified flu vaccine (MANUFACTURER UNKNOWN) on an unspecified date about ten years ago after which she had to go to the Emergency Room for right arm redness, swelling at the injection site and face swelling on right side. She did not get another flu shot for 10 years but did get one this year in Nov2020. Concomitant medication included metoprolol (MANUFACTURER UNKNOWN), flecainide acetate (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN, MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reports that she experienced a light headache. She clarified that she is in an unspecified program which includes an e-diary. As part of that program (app) she was sent a text every day for a week asking if she had any side effects; a couple times she had a headache. On the eighth day (03Feb2021) she had a reaction where her right hand and wrist was painful and swollen. Caller states she couldn't move her hand without pain. Caller states she put ice on her hand Wednesday evening and this helped a little. When ice was on her hand it helped with the pain but when it was removed it came back. She also reported fingers on right were all swollen and that she does have arthritis. She further described the events as on Wednesday she started getting a little pain in her right wrist joint. She does have arthritis, but this pain was stronger, and her hand and fingers on right were all swollen in comparison to her other hand, and her knuckles seemed bigger. States that the pain got very strong and by the next morning she could barely move her arm; even though it was only her wrist that hurt, moving any part of her arm made her wrist her more, so she started icing it and took Tylenol for Arthritis 650mg Extended Release; she took it twice, one each time and reported that it probably didn't work. Caller clarifies statement about it probably not working; stating that she didn't notice a difference after taking the Tylenol. She asked if these events, occurring eight days after the vaccine could be vaccine side effects or is this just a flare up on her arthritis that is unrelated to the vaccine. She added that she had been doing a lot of "chopping" while cooking on the night that this happened so that may have caused the flare up. She has a Medrol pack on hand for things like this (4mg tablets). She started it today and took two tablets before breakfast and one tablet at lunch. She states that it has already made a difference in her pain. She stated her concern, however, which is that she found that taking a steroid could affect the vaccine if taken before getting the vaccine, and right now she is in-between the two doses. Her second dose is scheduled for 16Feb2021. She inquired as to if she can finish this dose pack without messing up the vaccine. The clinical outcome of headache was reported as recovered. The clinical outcomes of hand swelling, wrist pain, hand pain and swelling of wrists were reported as not recovered. The clinical outcomes of arthritis flare up, swelling of fingers and could not move her arm were unknown.
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| 75 | 2021-03-09 | headache, chills |
nausea, muscle and joint aches, chill, headache, insomnia, dizziness, itchiness, swollen glands, bra...
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nausea, muscle and joint aches, chill, headache, insomnia, dizziness, itchiness, swollen glands, brain fog, rosacea,
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| 75 | 2021-03-10 | fatigue, chills, body temperature increased, headache |
Woke up with chills, mild headache, tiredness..... continued throughout the day, temp of 100.4 at 8...
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Woke up with chills, mild headache, tiredness..... continued throughout the day, temp of 100.4 at 8:00 pm, took ibuprofen. Symptoms gone by the next day.
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| 75 | 2021-03-11 | dehydration, fever | Nausea, vomiting, fever, generalize weakness, dehydration |
| 75 | 2021-03-11 | fatigue, headache | Mild headache; fatigue; joint aches; unsettled stomach; overall not well that lasted for 7 days |
| 75 | 2021-03-11 | fatigue |
When I was outside leaving the facility, I noticed a tight knot in my chest.Less than a half an hour...
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When I was outside leaving the facility, I noticed a tight knot in my chest.Less than a half an hour later,I had pulled over in the park and was trying to fix myself. Soon I realized breathing was not helping. It didn't seem to work. Exercise did not help. I started getting worse. I had difficulty getting back to my car I was fatigued my vision was getting blurry.My thinking was not sure. I couldn't figure out how to get my seat down in my car. Finally I got it down enough so I could recline. Then I decided to try to use my I watch pull up my Hart app.I measured over 155 bpm. I noticed that I was feeling better as my heart rate decreased to 141 bpm. I decided to drive home and left my car seat reclined. When I got h I stayed laying down in my bed for two hours because when I tried to get up I was way too dizzy. I've been unable to reach my primary care doctor when I got home. I left a voice messages. I called my sisters to tell them what was wrong and while on the phone St. Luke's was trying to call me and then my sister said she had to hang up because St. Luke's was trying to call her. I got up when I heard a knock on the door. It was the police. St. Luke's had called the police. My heart rate was normal before I got up Almost 3 hours after my shot. I spent the rest of the day and the next morning trying to find out what happened to me. I have spent days trying to get warnings about what to look out for. Finally I found this on your website as well as the handout I should've had before the vaccine because I would've known what was happening to me and what to do.
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| 75 | 2021-03-11 | pneumonia |
Chest pain DOE (dyspnea on exertion) Pneumonia of both lungs due to infectious organism, unspecified...
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Chest pain DOE (dyspnea on exertion) Pneumonia of both lungs due to infectious organism, unspecified part of lung Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present Death
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| 75 | 2021-03-11 | fever, headache, fatigue, chills |
101 degree fever, chills, headache, joint aching for a little over 24 hours. Fever broke around 24 h...
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101 degree fever, chills, headache, joint aching for a little over 24 hours. Fever broke around 24 hours. Fatigued for 72 hours. Treated with Tylenol. Hemorrhaged a blood vessel in right eyeball, not yet resolved. Seeking medical consultation today.
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| 75 | 2021-03-11 | fever |
Fever of 101 degrees for 3 days, The day after the fever left I woke up with a severe rash all over ...
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Fever of 101 degrees for 3 days, The day after the fever left I woke up with a severe rash all over my body on day 4 after the shot. The rash was severe with itching and stinging all over my body; including stomach, chest, upper back and lower back. buttocks. I went to urgent care. The Nurse Practitioner said it was a chemical rash from the COVID-19 shot. She gave me two shots and medication. The rash has gotten better but became localized on certain areas of my body including my arms and limbs. Itching and burning still occurring. Calamine lotion helped.
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| 75 | 2021-03-11 | runny nose, nasal congestion, productive cough, throat irritation | Runny nose, congested nose, scratchy throat. cough up phlegm |
| 75 | 2021-03-12 | chills, malaise, fatigue, headache |
2:00 p.m. day of injection - suddenly very tired; 6:00 p.m. heart pounding; 7:00 p.m. blood pressure...
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2:00 p.m. day of injection - suddenly very tired; 6:00 p.m. heart pounding; 7:00 p.m. blood pressure spiked to 181/93 (headache); 9:00 p.m. blood pressure dropped to 112/53 - then chills, muscle/joint pain, felt very unwell 3/7/2021 - small red itchy spot appeared on belly 3/9/2021 - full blown itchy red rash on belly
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| 75 | 2021-03-12 | fatigue, body temperature increased |
Pfizer-BioNTech COVID-19 Vaccine . Following morning, 2/20/21, upon rising, temp of 100.7 and fati...
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Pfizer-BioNTech COVID-19 Vaccine . Following morning, 2/20/21, upon rising, temp of 100.7 and fatigue all day. Normal upon rising 2/21/21.
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| 75 | 2021-03-13 | fatigue |
1st vaccine on 02/03/2021 left arm, had no side affects. 2nd vaccine on 02/24/2021, on second day, ...
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1st vaccine on 02/03/2021 left arm, had no side affects. 2nd vaccine on 02/24/2021, on second day, injection site got red, swollen, had hard knot, and deep itch at injection site right arm. On third day started getting brain fog, had hard time concentrating and felt extremely tired. Redness, swelling, hard knot, and deep itching has gone away. Still have a bit of brain fog but getting better. Knee joints are hurting. I got most of my energy back. It took 9 days for redness and swelling to go down. I did not seek treatment for symptoms.
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| 75 | 2021-03-13 | headache, fatigue |
Gastric distress 1 hour after first shot; Slight headache, Gastric distress for 5 days. After seco...
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Gastric distress 1 hour after first shot; Slight headache, Gastric distress for 5 days. After second shot,: Sore arm, slight headache, extreme fatigue on the second day, some fatigue on the third day. Two weeks after the vaccination : no issues
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| 75 | 2021-03-14 | chills |
Chills; Nausea; Diarrhea; This is a spontaneous report from a non-contactable consumer (patient). A ...
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Chills; Nausea; Diarrhea; This is a spontaneous report from a non-contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Feb2021 12:00 at single dose at left arm for covid-19 immunization. Medical history included TAVR, blood pressure, acid reflux from an unknown date and unknown if ongoing. Concomitant medications included lisinopril for blood pressure, atorvastatin, omeprazole for acid reflux, hydrochlorothiazide for water pill, spironolactone; all ongoing. The patient experienced chills, nausea, diarrhea all on 09Feb2021 with outcome of recovering. These symptoms were still there, but they're almost gone. Stated it seemed like they all came on together. No additional vaccines administered on the same date of the Pfizer vaccine considered as suspect. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Stated she had never had a reaction after previous vaccinations. No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
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| 75 | 2021-03-14 | headache, fever, head discomfort, fatigue |
Started out Friday, 3/12/21 around 2PM, headache, got worse as evening came, next morning, Saturday ...
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Started out Friday, 3/12/21 around 2PM, headache, got worse as evening came, next morning, Saturday 3/13/21, sore arm, head felt like someone stuffed it, afraid to take any medication or to eat anything. Felt like throwing up all day, but never did. Very tired all day, slept off and on half the day on the couch. Started to feel a little better around 8PM 3/13/21. Fever, usually my temperature is 97.7 or 97.8 but at one time it was 101. Very week and drained. Sunday 3/14/21, felt much better but head still hurt a little. Monday, 3/15/21 head hurt a little in the morning, but was okay by around 9AM. Pretty much back to normal after that.
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| 75 | 2021-03-15 | headache, runny nose |
?Pfizer-BioNTech COVID-19 Vaccine My upper lip began to swell about 5 hours after the injection ...
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?Pfizer-BioNTech COVID-19 Vaccine My upper lip began to swell about 5 hours after the injection and after a while turned into a terrible cold sore. I haven't had a cold sore in many, many years and have only gotten one if I have been in the sun too long or have a high fever. I called the doctor on call the following morning and asked for a prescription of acyclovir. Starting it that late resulted in not stopping the progression of the cold sore. Also had runny nose (haven't had a cold since masking started last year), and a red swollen arm..still red and swollen two days later and a terrible headache (started the day after injection and still bad today which is two days after).
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| 75 | 2021-03-16 | fatigue, malaise |
pt states that she starts nodding on and off due to extreme fatigue. She doesn't feel well and has...
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pt states that she starts nodding on and off due to extreme fatigue. She doesn't feel well and has trouble walking says she thinks its because her muscles are hurting. She says she doesnt feel right but doesnt know how to describe. Pt states she has had these symptoms going on about a month.
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| 75 | 2021-03-16 | headache |
Follow-up: spoke with Pt who states that some of the rash remains but has much improved, she applied...
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Follow-up: spoke with Pt who states that some of the rash remains but has much improved, she applied some topical Benadryl over it, and has had no itching since. the rash eventually spread from the arm to the shoulder and part of her collar bone, but has not progressed further. *mild headache and aches she only experienced the day of the shot and they only lasted a few hours. Advised: to call us with any questions. If she experience return of symptoms or worsening f/u with physician
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| 75 | 2021-03-16 | fever, fatigue |
99.9 fever, fatigue, rash on lower extremities fever and fatigue gone in 24 hours Rash being treated...
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99.9 fever, fatigue, rash on lower extremities fever and fatigue gone in 24 hours Rash being treated with Eucerin cream and hydrocortisone 1% cream mixture. Gradually improving after 6 days. NO STEROIDS as per CDC caution.
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| 75 | 2021-03-17 | chills |
Had chills all day of vaccine One week later chills on and off mot severe as first day Developed pai...
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Had chills all day of vaccine One week later chills on and off mot severe as first day Developed pain on rt side abdomen a week later which went from rt side abdomen now I. Hip the pain is constant and a week later nauseas in the morning
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| 75 | 2021-03-17 | cough |
Rash on my chest; I guess the rash joined one another on my chest, inside my legs and both my upper ...
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Rash on my chest; I guess the rash joined one another on my chest, inside my legs and both my upper arms; Cough; My left arm where I got the shot that arm, it was feverish, it was very hot; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2, lot no. EL9262, via an unspecified route of administration (left arm) on 24Jan2021 at a single dose for COVID-19 immunization at a hospital facility. They gave her a dose that was recommended. Medical history and concomitant medications were not reported. The patient reported a reaction that she had to her first vaccine. It was Pfizer BioNTech COVID-19 Vaccine EUA and she had that on 24Jan2021 and she had a little cough the following day (25Jan2021) which she did not have before and then she didn't recover from the cough but she woke up on the 27th with a little bit of rash on her chest and she just kind of ignored it but within four hours she had not just a rash, she had she guessed the rash joined one another on her chest, inside her legs and both her upper arms. She started taking Benadryl and it took about 125 mg of the Benadryl over 30 hours before she was able to get rid of the rash. It happened three days later at her house. She treated herself with Benadryl. She was not experiencing any kind of breathing problems or anything that she was alarmed about. She only took Benadryl 25 mg when she first saw it because the rash was not severe but within four hours even after she took the 25 mg, the rash became very severe and her left arm where she got the shot that arm, it was feverish, it was very hot on Jan2021. She didn't know next step with her second dose. She felt like rash was severe. Her rash took over 30 hours and taking 125mg Benadryl to get rid of it. So, she didn't know how to prepare or what to expect. She was due to get it on 14Feb. The patient recovered from rash generalized on Jan2021, not recovered from cough, while outcome of other event was unknown.
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| 75 | 2021-03-17 | fatigue, fever, sleepiness |
The next day I had joint aches, fever (100.6), tiredness, sleepiness and no appetite. It lasted one...
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The next day I had joint aches, fever (100.6), tiredness, sleepiness and no appetite. It lasted one full day.
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| 75 | 2021-03-17 | fatigue, fever |
Fever, body aches, fatigue loss of appetite; treated with ibuprofen and Oxycodone IR 5mg tab CII; re...
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Fever, body aches, fatigue loss of appetite; treated with ibuprofen and Oxycodone IR 5mg tab CII; rest (slept for almost 48 hours) Symptoms, except fatigue, pretty much gone in 48 hours
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| 75 | 2021-03-17 | headache |
Nausea, emesis, headach, exacerbation of chronic low back pain. The patient explains that she has be...
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Nausea, emesis, headach, exacerbation of chronic low back pain. The patient explains that she has been experiencing the nausea since her COVID-19 vaccination
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| 75 | 2021-03-17 | sinus pain |
Pain on left side of face, nasal cavities, mouth. Dull headache, fatigue The following morning when ...
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Pain on left side of face, nasal cavities, mouth. Dull headache, fatigue The following morning when I woke up the left side of my face was drooping especially in cheek and mouth areas
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| 75 | 2021-03-18 | fatigue |
Symptoms matched physical condition prior to medication for Parkinson's Disease and included; extrem...
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Symptoms matched physical condition prior to medication for Parkinson's Disease and included; extremity immobility and collapse, compromised ambulation, weakness and fatigue after limited exertion. The first day of incidence was on 3/15/2021 and was at the upper limit on 3/18/2021.
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| 75 | 2021-03-18 | headache |
severe headache; complete loss of taste and smell; complete loss of taste and smell; This is a spont...
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severe headache; complete loss of taste and smell; complete loss of taste and smell; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN9581), via an unspecified route of administration, in the left arm on 10Feb2021 at 4:15 PM (at the age of 75-years) as a single dose for COVID-19 immunization. Medical history included asthma, mite allergy, allergy to animal (cats, guinea pigs), Vasovagal Syncope. The patient had known allergies to sulfa and Iodopropynyl Butylcarbamate. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included pravastatin, ciclosporin (RESTASIS), calcium, and senior multivitamin. On 11Feb2021 about 9 hours after vaccine, at 01:00, the patient experienced severe headache and complete loss of taste and smell. No treatment was given for the events. The clinical outcome of severe headache, complete loss of taste and smell was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 75 | 2021-03-18 | sinus pain, throat pain, headache, fatigue |
6 hours after 2nd dose of vaccine I could feel my body starting to react. Aches and pains increased...
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6 hours after 2nd dose of vaccine I could feel my body starting to react. Aches and pains increased as the time went on. I went to bed and around 12 hours after the injection I got a headache that was unbearable. It felt like someone was hitting my head with an ax. The pain was excruciating. I went through the night with the pain feeling like my head would explode. In the morning I was totally exhausted and my body hurt all over. I took Tylenol and went back to bed. Put warm cloths on my head and face. My sinus hurt, my teeth hurt. my throat hurt. my eyes hurt. Awful!!! Spent the entire day in bed. I continued taking Tylenol every 6 hours. It did help a little. By Friday I was seeming to feel a little better. Still have mild headache and body aches and stomach upsets; but better than the first 24-36 hours. Hoping to continue to improve each day. Never expected any side effects as severe. Most people said sore arm and feeling tired. I do hope the worse is over.
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| 75 | 2021-03-20 | chills, fatigue, nasopharyngitis, throat pain, runny nose, sleepiness |
Cold like symptoms; chills; tiredness; sleepiness; runny nose; sore/red throat; sore/red throat; com...
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Cold like symptoms; chills; tiredness; sleepiness; runny nose; sore/red throat; sore/red throat; complete body ache and pain during night but was gone the next morning; This is a spontaneous report from a contactable Other HCP (patient). A 75-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3249) via unspecified route of administration in left arm on 19Jan2021, at 15:00 (at the age of 75-year-old) as a single dose for COVID-19 immunisation. The patient medical history included vertigo, mild heart attack and glaucoma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included glaucoma eye drops, dorzolamide and latanoprost. The patient didn't receive any vaccine within four weeks prior to vaccination. The patient previously took Fosamax and experienced light headedness (after 2 years). On an unknown date in Jan2021, the patient experienced (Night after vaccination), complete body ache and pain during night but was gone the next morning. On 01Feb2021, at 13:15 the patient had cold like symptoms starting 12 days after vaccination, chills, tiredness/sleepiness, runny nose, sore/red throat. The patient didn't receive treatment for the events. The outcome of the events complete body ache and pain during night but was gone the next morning was recovered on Jan2021 while for other events was recovering.
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| 75 | 2021-03-20 | fatigue, malaise, headache |
injection site pain; massive redness; swelling; bad headache; muscle and joint pain; muscle and join...
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injection site pain; massive redness; swelling; bad headache; muscle and joint pain; muscle and joint pain; tiredness; feeling unwell; This is a spontaneous report received from a contactable consumer. A 75-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on Right arm on 04Feb2021 02:45 PM at single dose.Patient Medical history included arthritis, hypertension, osteopenia. Historical vaccine included first dose of bnt162b2 via an unspecified route of administration (lot number: EL9265) on left arm on 14Jan2021 04:30 PM at Single Dose for COVID-19 immunisation. Concomitant medication included Amlodipine Besylate 2.5mg, Citalopram 10, captopril (METOPRIL). On 04Feb2021 22:30 patient experienced injection site pain, massive redness, swelling, bad headache, muscle and joint pain, muscle and joint pain, tiredness, feeling unwell after vaccination. patient was not pregnant, No treatment received for AE, patient had not Covid tested post vaccination, patient had allergies to Codine. Outcome of events was recovering. Information on the lot/batch number has been requested.
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| 75 | 2021-03-20 | malaise, chills |
Injection site pain; Muscle pain; front and back of my chest hurts; Chills; Feeling unwell; Swollen ...
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Injection site pain; Muscle pain; front and back of my chest hurts; Chills; Feeling unwell; Swollen lymph nodes that hurts like crazy; Swollen lymph nodes that hurts like crazy; arm got sore; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration date: 31May2021), via an unspecified route of administration on 03Feb2021 (at the age of 75 years) as single dose for covid-19 immunisation; potassium chloride (KLOR-CON M10), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included ongoing type 2 diabetes and ongoing high blood pressure. Concomitant medications included metformin; atorvastatin; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ). Consumer stated she got her Covid inoculation last Wednesday and in Feb2021, she was experiencing symptoms, adverse reactions. She had injection site pain still, muscle pain, her lungs are fine but when she breathe her front and back of her chest hurts. She had chills. She did not think she had a fever but she was definitely feeling unwell and the most difficult thing was swollen lymph nodes that hurts like crazy. She cannot read this too well. Lot was 2CI or EI EL3302 expires 31May2021. Her arm got sore but today she really started may be yesterday experiencing this muscle pain and the lymph stuff going on. Consumer stated she had no treatment. The last time her doctor gave her this new medication because she had run out of her potassium. It was called Klor-con M10 tablet. For lab work, consumer stated she did not know but right before she went there they took some blood and when the doctor gave her the Klor thing, she had a violent reaction to it. she threw up and had a lot of diarrhea and she have not taken it since. Results of lab work was unknown. The action taken in response to the events for potassium chloride was unknown. Outcome of events was unknown. Information about lot/batch number has been requested.
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| 75 | 2021-03-21 | dehydration, cough, malaise |
My arm was sore that night. I couldnt breathe very well when I woke up. I put my protable O2 on and ...
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My arm was sore that night. I couldnt breathe very well when I woke up. I put my protable O2 on and I ate, took my meds and went back to bed. I took a rescue inhaler to see if it would help. I stayed in bed all day wednesday. I coughed all night, I am on O2 all night. I seem to be parched, mouth is dry, drinking a lot of water. Thursday was just as bad, I wasnt feeling well. the breathing gets better a little every day but I am coughing up green mucus so I called my pulmonologist and he called in an antibiotic.
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| 75 | 2021-03-21 | fatigue |
Slight pain in left arm of injection site/Sore; Tiny pimple-like bumps on entire scalp, very itchy; ...
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Slight pain in left arm of injection site/Sore; Tiny pimple-like bumps on entire scalp, very itchy; Tiny pimple-like bumps on entire scalp, very itchy; Fatigue; This is a spontaneous report from a contactable (consumer). This non-pregnant 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration in the left arm on 12Feb2021 at 00:45 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to penicillin and derivatives from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had no concomitant medications. The patient previously received the first dose of BNT162B2 (lot number EL9262) in the left arm on 21Jan2021 at 10:15 (at the age of 75-years-old) as a single dose for COVID-19 immunization and experienced slight pain in left arm of injection site/sore. The patient had not received any other vaccines in the 4 weeks prior to the COVID vaccine. The patient reported that on 16Feb2021 at 16:00 she experienced slight pain in left arm of injection site, sore for 24hrs; tiny pimple-like bumps on entire scalp, further reported as very itchy; and fatigue which lasted 24hrs. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of slight pain in left arm of injection site/sore, tiny pimple-like bumps on entire scalp, very itchy, and fatigue were unknown. It was also reported that since vaccination the patient had not been tested for COVID-19.
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| 75 | 2021-03-21 | headache |
Headache next day after second vaccine. It has lasted 7 weeks. Also tinnitus has amplified so that...
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Headache next day after second vaccine. It has lasted 7 weeks. Also tinnitus has amplified so that I can?t stand it. Had MRI of brain. Went to ENT and went to allergist. Nothing found. Went to optometrist and my eyesight is fine
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| 75 | 2021-03-21 | fever, chills |
Admitted on 2/17/2021 with acute respiratory failure with marked hypoxia. Noted to have fever & chil...
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Admitted on 2/17/2021 with acute respiratory failure with marked hypoxia. Noted to have fever & chills, weakness and acute confusion ~ 3 days prior to admission. Placed on NIPPV, steroids, convalescent plasma and antibiotics. Patient died 2/24/2021
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| 75 | 2021-03-22 | fatigue, sleepiness |
Extremely tired kept falling asleep all day of shot; slept thru the night and most of next day; hive...
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Extremely tired kept falling asleep all day of shot; slept thru the night and most of next day; hives on left side of neck (received shot in left arm) diarrhea all day after shot; arm slightly sore. Did not feel sick; just had these reactions.
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| 75 | 2021-03-22 | fatigue |
~24 hours after injection, injection site became swollen, sore and itchy, and experienced extreme fa...
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~24 hours after injection, injection site became swollen, sore and itchy, and experienced extreme fatigue and joint pain lasting ~48 hours. Over following 3 days, arm swelling expanded to ~5" diameter with hard center and warm to touch, sore and itchy. Still swollen on Day 4 but beginning to resolve. Fatigue and joint pain resolved by end of Day 3.
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| 75 | 2021-03-23 | fatigue, throat pain, headache |
adverse events: headache, body aches, chills, sore throat, fatigue treatment: rest, extra vitamin D...
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adverse events: headache, body aches, chills, sore throat, fatigue treatment: rest, extra vitamin D outcome: lasted approximately 48 hours
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| 75 | 2021-03-24 | headache, fatigue |
She received the vaccine, she went to bed after she was tired for about an hour in the afternoon, an...
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She received the vaccine, she went to bed after she was tired for about an hour in the afternoon, and felt better. About 12 hours later she had a headache and took some Aleve. She woke up the next morning with a severe headache and chest pain that was excruciating. Her daughter took her to the hospital and did multiple tests and said that she had a pronounced inflammatory response to the vaccine and developed a pericardial effusion and pericarditis. They sent her home with steroids and Colchicine. They did not want to put her on NSAIDS due to possible ulcers. She all the COVID symptoms, and had severe pain still. Her daughter 3 weeks later took her to the cardiologist. She had an EKG and Echo and now was in atrial flutter due to the response to the vaccine. She was then sent to the ER again, and went there twice. He has put her on medications and now is doing better, she is still weak and has to take Colchicine for 3 months, is on blood thinners and now has sleep issues. They also put her on some hypertensive medications to make sure that she does not go back into atrial flutter. She is now back in sinus rhythm. She was advised not to get the 2nd vaccine due to the reactions from the first one. She was admitted the first time for 4 days and then 2 trips to the ER and then another admission for 4 more days, so a total of 10 days in the hospital.
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| 75 | 2021-03-24 | headache |
all face including eyes swollen and red; all face including eyes swollen and red; skin got creepy, d...
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all face including eyes swollen and red; all face including eyes swollen and red; skin got creepy, dry, itchy; injection site pain and was swollen a lot; little dizziness; nausea; Muscle pain more on back side of shoulder towards neck-unbearable pain; headache; neck disfigured; rash; injection site pain; brain fog big time - disorientated, felt like brain getting damage; I'm desperate; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: solution for injection, Lot no: EN5318) via intramuscular at left arm on 19Feb2021 at 03:10 (at the age of 75-years-old) at single dose for covid-19 immunisation (at hospital). Patient medical history not reported. Concomitant medications included levothyroxine; 0.075 mg once daily for hypothyroid since 20 years; ongoing and trazodone 100 mg 1 tab daily since 20 years; ongoing. On 19Feb2021 the patient experienced injection site pain and was swollen a lot, little dizziness, nausea, muscle pain more on back side of shoulder towards neck-unbearable pain, headache, all face including eyes swollen and red, all face including eyes swollen and red, skin got creepy, dry, itchy, brain fog big time - disorientated, felt like brain getting damage, she was desperate, skin got creepy, dry and itchy. my face and neck was disfigured that don't want my children and grant children see my face. Rash-swelling, itchy and flaky skin, got a little better on 01Mar, but I still have creepy skin, flackey, itchy around eye and eyelids were swollen and dry and felt like have stones rolling in my eyes and my brain fog was very bad. I want to know if my skin will ever get better. Patent took vit-d and all the vit. Covid. Patient received treatment as OTC, Tylenol, ibuprofen, aleve. No covid prior vaccination. The reporter reported seriousness criteria as non-serious. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 75 | 2021-03-25 | fatigue, cough |
symptoms started 2 days after getting the COVID vaccine having body aches, cough, headache, fatigue,...
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symptoms started 2 days after getting the COVID vaccine having body aches, cough, headache, fatigue, diarrhea and vomiting. Symptoms are getting worse and not better. Cough is productive thick white sputum with SOB. It has been 18 days with symptoms that are not improving. Scheduled appointment with doctor for further treatment. Canceled appointment for 2nd COVID vaccine
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| 75 | 2021-03-26 | nasal congestion, sneezing, runny nose, headache, fatigue |
extreme fatigue, headache, muscle pain, joint pain, nasal congestion, swollen glands, runny nose, 5 ...
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extreme fatigue, headache, muscle pain, joint pain, nasal congestion, swollen glands, runny nose, 5 days sneezing 2 days--all others EVERYDAY through today TX: Tylenol 3 days, Aleve 2, days continued
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| 75 | 2021-03-26 | nasopharyngitis, chills |
Vaccine at 3pm, this happened at 11:00pm. So cold, I felt like my bones were in ice. My hands tremb...
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Vaccine at 3pm, this happened at 11:00pm. So cold, I felt like my bones were in ice. My hands trembled badly and my teeth chattered because I was so cold. Nothing got me warm. I had 5 heavy blankets on me, didnt help. I fell asleep and woke up at 3:00am and was back to normal.
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| 75 | 2021-03-30 | headache, fatigue |
Tongue tingling; arm swollen; severe headache; tired; Arm still swollen red; This is a spontaneous r...
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Tongue tingling; arm swollen; severe headache; tired; Arm still swollen red; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (Solution for injection, Batch/Lot number: EL1283) via an unspecified route of administration in right arm on 20Jan2021 14:00 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included Heart palpitations, arthritis, obese. Concomitant medication included valsartan (DIOVAN), levothyroxine sodium (SYNTHROID), sertraline hydrochloride (ZOLOFT), atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]). The patient previously took omnicef and experienced allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced tongue tingling arm swollen, severe headache, tired. Arm still swollen red two weeks later on 20Jan2021 at 02:00 PM. Prior to vaccination, the patient was not diagnosed with COVID-19. The treatment of the adverse events was OTC Benadryl. The patient underwent lab tests and procedures which included nasal swab: negative on 30Jan2021. The outcome of the events was recovering.
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| 75 | 2021-03-30 | headache, malaise, fatigue |
Lung tightness with burning and pain/lungs were tight; Lung tightness with burning and pain; Headach...
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Lung tightness with burning and pain/lungs were tight; Lung tightness with burning and pain; Headache; nausea; Muscle heaviness; fatigue; brain fog(poor concentration and focus); brain fog(poor concentration and focus); general malaise; Increased bowel movements daily; This is a spontaneous report from a contactable pharmacist (Pharmacist). A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: El8982), via an unspecified route of administration, administered in Arm Left on 27Jan2021 10:30 as single dose for covid-19 immunisation at Health Clinic or administration facility. Medical history included gastrooesophageal reflux and osteoarthritis from an unknown date and unknown if ongoing. Concomitant medication included pravastatin taken for an unspecified indication, famotidine, ascorbic acid, betacarotene, colecalciferol, folic acid, minerals nos, retinol, tocopheryl acetate, vitamin b nos (CENTRUM [ASCORBIC ACID;BETACAROTENE;COLECALCIFEROL;FOLIC ACID;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS]), cyanocobalamin (B12), ergocalciferol (VIT D). The patient previously took biaxin and experienced drug hypersensitivity. On 27Jan2021 20:00, the patient experienced lung tightness with burning and pain/lungs were tight, headache, nausea, muscle heaviness, fatigue, brain fog (poor concentration and focus), general malaise and increased bowel movements daily. These symptoms lasted for 7 days. Two of the days my lungs were tight but I did not have shortness of breath. Nausea was everyday. Increased bowel movements daily. I am concerned that these effects lasted for 7 days. Does this put me at risk for serious side effects after the 2nd dose. The action taken in response to the event for BNT162B2 was not applicable. The outcome of events was recovering.
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| 75 | 2021-03-30 | lethargy |
no arm pain at injection site until following morning; my face became warm and beet red; my face bec...
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no arm pain at injection site until following morning; my face became warm and beet red; my face became warm and beet red; experienced incredible thirst; intermittent nausea and lethargy; intermittent nausea and lethargy; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient (non pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, in Arm Left on 02Feb2021 12:00 (12:00 PM) (age at vaccination 75 Years) as single dose for covid-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included known allergies to penicillin, NSAIDS, doxycycline, lidocaine and prednisone. Concomitant medication(s) included atorvastatin at 10 mg; calcium citrate (CITRACAL [CALCIUM CITRATE]); bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC [BIFIDOBACTERIUM INFANTIS;LACTOBACILLUS ACIDOPHILUS]); ubidecarenone (COQ-10) and Magn (as reported). Pateint reported that "on 02Feb2021 at 12:00 PM, Shortly after receiving first dose my face became warm and beet red, didn't realize until I'd gotten to my car and taken off my mask, at which time I also experienced incredible thirst. Other symptoms that day (02Feb2021), Wednesday and today have been intermittent nausea and lethargy, no arm pain at injection site until following morning (03Feb2021), okay now." No treatment was received for the events. This case is reported as non-serious. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Outcome "no arm pain at injection site until following morning" was recovered while other events was recovering. No follow-up attempts are possible. No further information is expected.
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| 75 | 2021-03-30 | pneumonia, malaise |
The first shot made me really sick like had the flu or pneumonia or something; The first shot made m...
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The first shot made me really sick like had the flu or pneumonia or something; The first shot made me really sick like had the flu or pneumonia or something; The first shot made me really sick like had the flu or pneumonia or something; Body was aching and hurting so bad; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 25Feb2021 as single dose for COVID-19 immunization. Medical history included high blood pressure and asthma from an unknown date. Concomitant medications included amlodipine taken for high blood pressure; hydrochlorothiazide taken for high blood pressure; and salbutamol sulfate (VENTOLIN) taken for asthma. It was reported that the first shot made the patient really sick like she had the flu or pneumonia or something. She also took some over the counter extra strength Tylenol as her body was aching and hurting so bad. The patient had lab test in the past 2 weeks in 2021, she had her blood drawn. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 75 | 2021-03-30 | throat irritation |
experience scratchy throat/itchy throat; This is a spontaneous report from a non-contactable other h...
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experience scratchy throat/itchy throat; This is a spontaneous report from a non-contactable other healthcare professional. A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular, administered in right arm on 26Jan2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jan2021, during her 30 minute waiting period after the injection, the patient began to experience scratchy throat/itchy throat. She denied difficulty breathing, difficulty swallowing and throat tightness. No treatment was received. Patient was observed for 65 minutes s/p injection. She states symptom of itchy throat improved. The outcome of the event was recovering. No follow up attempts are possible. No further information is expected.
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| 75 | 2021-03-31 | chills |
03/17/21: patient [resented and was admitted through the ED for chills and shortness of breath for ...
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03/17/21: patient [resented and was admitted through the ED for chills and shortness of breath for the last few days. 2 x rapid antigen test and tested COVID PCR positive. Per the EUA, hospitalizations to be reported irrespective of attribution to vaccine.
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| 75 | 2021-03-31 | fatigue |
Angioedema (Face); Hives (between the eyes & forehead); Extreme Fatigue; This is a spontaneous repor...
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Angioedema (Face); Hives (between the eyes & forehead); Extreme Fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 75-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 at 15:30 at single dose in left arm for COVID-19 immunisation at the age of 75-year-old. Lot number was EM9810. Medical history included possible atrial fibrillation, allergy to sulfa. Past drug history included allergy to antibiotic drugs, Betoptic, Motrin, Iodine, Nickel, Latex, Ragweed, Mold, Grass, Cat, Bee. The patient was not pregnant. On 03Mar2021 at 18:00 approximately, the patient experienced angioedema (Face), Hives (between the eyes and forehead), Extreme Fatigue. The patient was not treated for the events. The patient was recovering from the events. In 2017, IgG Anti-IgE resulted elevated. It was unknown if the patient had Covid before vaccination. The patient was not tested for Covid after vaccination. No follow-up attempts are possible. No further information is expected.
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| 75 | 2021-04-02 | throat irritation |
On13Mar2021, she started experiencing swelling of the lip/mainly the left side pretty much of her li...
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On13Mar2021, she started experiencing swelling of the lip/mainly the left side pretty much of her lips; Itching and swelling on the throat; Itching and swelling on the throat; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN6198, expiration date: Jun2021), via an unspecified route of administration on 09Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. There were no problems, no symptoms, no pain or nothing on the day of vaccination. On 13Mar2021, the patient started experiencing swelling of the lip at around 08:30 or 09:00 and itching and swelling on the throat. She didn't wake up then, she went to sleep and she slept until about 05:45 and she thought it would just go away but there was much more swelling. She took Benadryl but she is concerned about the swelling, it was still there. She took another Benadryl at 04:00 on Sunday and she took one the previous night at 12 o'clock and the swelling has diminished a lot but it was not gone away all together. She was concerned because of 2 reasons, one she was due for another shot in a couple weeks and another reason was she wanted to know if it came from the vaccine. She clarified that the swelling was on her lips, mainly the left side pretty much of her lips. It started with the bottom lip and it was kind of so now that it was the top and bottom, it was both lips on the left side. She gave a lot of thought to this and that night she did have some frozen blueberries and bananas. She never ate blueberries on their own she usually puts them in oatmeal or something like that, so she thought maybe it could be the results of the blueberries since she has never had that. The patient asked whether lip swelling was an expected side effect and whether there was any issue with receiving one dose instead of the two doses. Limited information was available over the call.
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| 75 | 2021-04-03 | headache, fever, sleepiness |
All the symptoms of COVID minus the chest congestion/does not know if she might have caught COVID-19...
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All the symptoms of COVID minus the chest congestion/does not know if she might have caught COVID-19; All the symptoms of COVID minus the chest congestion/does not know if she might have caught COVID-19; her temperature went up to 102 degrees; terrible joint pains; she could not stay awake at all; diarrhea; nauseousness; headache; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration, administered in the left arm on 12Feb2021 08:30 as a single dose for COVID-19 immunisation. Medical history included dental care from an unknown date and unknown if ongoing. No concomitant drugs were reported. The patient previously received penicillin as prophylaxis prior to dental care. The patient previously received the first dose of BNT162b2 in Jan2021 (about 3 weeks prior to second dose) (Lot Number: unknown) via an unspecified route of administration in the upper left arm for COVID-19 immunisation. The patient was administered her second dose of BNT162b2 on 12Feb2021. She initially had no reaction. Then on 12Mar2021, (about 3 weeks after second dose of BNT162b2), the patient experienced all symptoms of COVID minus chest congestion, described as temperature went up to 102 degrees; terrible joint pains; could not stay awake at all; diarrhea; nauseousness; headache. Patient called her doctor and thought she could get COVID test, but the doctor said she does not need it and told her not to worry. They automatically diagnosed the patient with late side effects. Doctor thinks it is late side effects of BNT162b2 because there are cases where the doctor has seen 3 weeks to a month out of people having side effects. She has had no known exposure to any infected persons; She has been isolating 99 percent of the time since this started. She went out a couple of times to the store but she was masked and did not get near anyone; The patient does not know if she might have caught COVID-19 infection and wonders if with these event symptoms, she might have caught a milder case of COVID. The patient reported that right now her temperature was 99.5 degrees. She did not use any antipyretic. The patient was recovering from the event, temperature went up to 102 degrees. Outcome of the events, all symptoms of COVID minus chest congestion/does not know if she might have caught COVID-19, temperature went up to 102 degrees; terrible joint pains; could not stay awake at all; diarrhea; nauseousness; headache was unknown. Information about lot/batch number has been requested.
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| 75 | 2021-04-04 | pneumonia |
Patient called PCP office 3/5 w/ c/o N/V/D, weakness and lightheaded when she stood up. Was advised ...
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Patient called PCP office 3/5 w/ c/o N/V/D, weakness and lightheaded when she stood up. Was advised to hold blood pressure medication. On 3/8, was feeling much worse and called 911. Upon arrival (8:55), patient A&O x 4 with poor oxygen saturation (O2: 88%). Given nebulized albuterol/ipratropium. BG: 247mg/dl. Patient has episode of dry heaving after which she vagaled down with HR in the 40s. Recovered on her own. Once the nebulizer treatment ended, she was place on nasal O2 at 3 liters/minutes. Given 4mg ondansetron. Lost consciousness and respirations became agonal. Pt was bagged via BVM and noted to be in PEA. CPR initiated, including intubation. Given 1mg epinephrine. NSR obtained after two rounds of CPR. Pt arrested again shortly after arrival to ED. ACLS initiated once more. Patient expired at 10:40 am.
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| 75 | 2021-04-05 | pneumonia |
Developed COVID 2.5 weeks after first vaccination. Presented to ED due to SOB; imagine test showed...
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Developed COVID 2.5 weeks after first vaccination. Presented to ED due to SOB; imagine test showed pneumonia, tested covid 19 +, treated with remdesivir, dexamethasone, and O2 resulting in improvement over 5 days. Upon discharged home with home oxygen and follow-up with PCP.
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| 75 | 2021-04-17 | cough, fatigue, sleepiness |
Gagging; Feels tired and sleepy all the time; Feels tired and sleepy all the time; Arm was really so...
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Gagging; Feels tired and sleepy all the time; Feels tired and sleepy all the time; Arm was really sore; Some choking; Anxiety; Cough during treatment; This is a solicited report (MARKETING PROGRAM NAME NOT AVAILABLE) based on the information received by Pfizer pharmacy. A contactable 75-year-old female consumer (patient)received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation; and treprostinil sodium, via inhalation from 12Feb2021 (Batch/Lot number was not reported) to an unspecified date and at 18-54 ug, 4x/day, via inhalation from an unspecified date (Batch/Lot number was not reported), at 36 ug, 4x/day for pulmonary arterial hypertension. Medical history included ongoing anxiety. The patient's concomitant medications were not reported. In Feb2021, the patient experienced event of cough during treatment. In 2021, the patient experienced event of gagging (retching). On 04Mar2021, the patient experienced event of anxiety; related it to going to the physician appointment. An additional dosage regimen of 36 ug (6 breaths), qid via IH route was added to Tyvaso. The patient reported that coughing (previously reported as cough) and gagging had improved after the treatment. The patient's current IH Tyvaso dose was 6 breaths four times a day. On 04 Mar 2021, 2 weeks 6 days after initiating IH Tyvaso, the patient had anxiety and related it to going to the physician appointment. The patient had reported ongoing anxiety since childhood. In 2021, the patient experienced the event of some choking. In 2021, the patient experienced the events of feels tired and sleepy all the time and arm was really sore (pain in extremity). The patient felt tired and sleepy all the time. Her arm was really sore and she was tired and sleepy. The outcome of the event cough and gagging was recovering while the outcome of the rest of the events was unknown. The action taken in response to treprostinil sodium for the events was unknown. An unspecified treatment was given to the patient for the event cough and gagging. The reporter assessed the causal relationship between the IH Tyvaso and the event of cough as possible. The reporter did not provide causality for the events of retching, choking, anxiety, fatigue, somnolence, and pain in extremity. No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of choking,cough,gagging,and other events cannot be excluded but also contributory effect from other suspect drug TREPOSTINIL SODIUM. consider also possible contributory effects from patient's medical history and concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 75 | 2021-04-17 | fatigue |
Exacerbation of COPD/having trouble breathing; extremely tired, couldn't get out of bed, couldn't mo...
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Exacerbation of COPD/having trouble breathing; extremely tired, couldn't get out of bed, couldn't move/tiredness; weakness; bleeding; Test: Iron; Result: Critically low; red blood cell was below 5; administered at the left upper forearm; This is a spontaneous report from a contactable nurse (patient) via Pfizer. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported, NDC number: 59267-1000-02), via an unspecified route of administration, administered in the left upper forearm on 01Mar2021 at the age of 75-years-old as single dose for COVID-19 immunization. The vaccine was administered to the patient at a pharmacy (in a grocery store). The patient had no prior vaccinations (within 4 weeks). The patient's medical history included retired (retired registered nurse), ongoing depression (has had this condition for probably 20 years), ongoing lung cancer (has had this condition for probably 3 years), ongoing bipolar (has had this condition for about 4 years), ongoing emphysema (has been severe for about 4 or 5 years), and ongoing chronic obstructive pulmonary disease (COPD) (has been severe for about 4 or 5 years). Concomitant medications included duloxetine taken for depression from an unspecified start date and ongoing (been taking this probably for 15 years); and arformoterol tartrate (BROVANA) (started taking this probably 5 years ago), budesonide (started taking this probably 5 years ago), tiotropium bromide (SPIRIVA) (has been taking this for probably about 4-5 years), oxygen (has been using this full time for 3 years), and Trilogy machine (she sleeps with this, it is an invasive intubation. She puts a big mask on and it pumps air in, pulls air out, letting her lungs rest. Her oxygen hooks up to it), all taken for emphysema and COPD from an unspecified start date and ongoing. The patient reported that she received the vaccine on 01Mar2021 and sometime in Apr2021 around Easter, she went to the hospital for COPD exacerbation, tiredness and weakness. The patient required a visit to the emergency room due to the events and reported that she went by ambulance to the hospital. The patient stated that she has these events often and it has nothing to do with the COVID vaccine. She went to the hospital with exacerbation of COPD and missed her date to get her last shot. She wanted to know whether she can get the 2nd dose of the vaccine with her experience after the 1st dose. The patient reported that she now weighs 177 after she has been pumped full of cortisone. The patient reported that her lung doctor was really the one that manages her medical. The patient reported that she thinks she came home from the hospital the day before Easter and she was in the hospital for 5 days (in Apr2021). She was sick before that, at home, and she finally had to call # to come and get her. She believes she had to call # the 5th day before Easter, but she was not positive. When asked to clarify what she meant by sick, the patient explained she was extremely tired, she couldn't get out of bed and couldn't move. She was having trouble breathing. She was on oxygen 24/7 and sleeps with a trilogy machine so she was having a lot of trouble, it was awful. She said she then found out at the hospital her red blood cell was below 5 and her iron was critically low. They had to give her 2 units of blood and an infusion. Then she went back yesterday and got another infusion and she has to go back next week for another infusion. The patient confirmed that she was hospitalized for COPD. She then stated she didn't know the exact date of when she was discharged from the hospital, but she was thinking it was the day she was scheduled for her second shot. She then clarified she came home Easter. The patient reported that she can't do much without having to sit down, catch her breath, and rest a little bit. She was improving but not as fast as she'd like to. While reading the vaccine record card, the patient stated "my eyes aren't as good as they used to be". Her pulmonologist stated she was going to die if she doesn't take the vaccine. If she catches COVID she was not going to make it, so her pulmonologist thinks her chances are better with the vaccine than without it. The patient said she goes all the time to the hospital; therefore, she doesn't think the events were related to the vaccine. She had been sick several times. They can't do anything about the bleeding, they can't go in to do anything because of her lungs, her lungs were so bad. No further details were provided regarding the bleeding she was speaking of. The patient reported that duloxetine doesn't come as 90 mg so she takes a 30 mg and 60 mg tablet; she mixes the Brovana and Budesoind and takes them at the same time, twice a day. She was given an albuterol solution, 0.5mg PRN (as needed), for her emphysema/COPD. She says she just started taking this from her last hospital stay. The patient reported that she did not remember her iron count, just that it was critically low. She did remember asking the nurse what could happen, and the nurse said a lot of things such as infection. She confirmed tests were done in regards to the lung cancer. Her lungs were too critical for any kind of invasive tests. It was reported that the events Exacerbation of COPD and "extremely tired, couldn't get out of bed, couldn't move" were assessed by the patient as unrelated to BNT162B2. The outcome of the events "Exacerbation of COPD/having trouble breathing" and " extremely tired, couldn't get out of bed, couldn't move/tiredness" was recovering, while the outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the narrative information provided, the reported events Chronic Obstructive Pulmonary Disease, Fatigue, Asthenia, Blood iron decreased, Red blood cell count decreased and Asthenia are assessed as intercurrent medical conditions and unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 75 | 2021-04-18 | cough |
Symptoms started around the day of vaccination which included cough and shortness of breath. Develop...
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Symptoms started around the day of vaccination which included cough and shortness of breath. Developed nausea and vomiting which led to presentation to emergency department. Patient was admitted and treated for COVID-19 infection.
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| 75 | 2021-04-23 | cough |
Wheezing; cough; Feverish feeling in her chest; This is a spontaneous report received from a contact...
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Wheezing; cough; Feverish feeling in her chest; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: EN5318) via an unspecified route of administration in the left arm on 06Feb2021 at 16:15 (at the age of 75-year-old) as a single dose for COVID-19 immunization in Pharmacy/drug store. Medical history included fibromyalgia, arthritis, sinus problems, acid reflux, high blood pressure and seasonal allergies. Concomitant medications included Omeprazole treated for acid reflux, Pregabalin and Tramadol for fibromyalgia and arthritis, lisinopril for high blood pressure, colecalciferol (VITAMIN D), Fish oil, loratadine (CLARITINE) for seasonal allergies and Hair Skin & Nails.The patient did not receive any other vaccines within four weeks prior to the vaccination and did not experienced any adverse reactions prior vaccination. Patient felt fine until 11Feb2021 and had been experiencing a lot of coughing and wheezing but had no fever. Patient was taking over the counter cough medicine to treat the reaction. Patient enquired if this reaction can happen 4-5 days after receiving the vaccine. On an unspecified date in Feb2021, the patient experienced feverish feeling in her chest. The outcome for the events coughing and wheezing was recovering and feverish feeling in her chest was not recovered.
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| 75 | 2021-04-23 | fever, respiratory tract congestion, lethargy, chills |
Fever; chills; chest and head congestion; chest and head congestion; lethargy; over all feeling of s...
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Fever; chills; chest and head congestion; chest and head congestion; lethargy; over all feeling of sick; This is a spontaneous report from a contactable consumer (reporting herself). A 75-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 03Feb2021 at 13:45 as a single dose for COVID-19 immunization. The patient did not received any other vaccines with 4 weeks prior to the COVID vaccine. The patient received metformin, metoprolol with in 2 weeks of COVID vaccination. The patient was allergic to ceclor, codeine. The patient medical history included diabetes, psoriatic, arthritis. On 04Feb2021 at 07:00, the patient experienced fever, chills, chest and head congestion, lethargy, over all feeling of sick. The patient received tylenol, musinex, bed rest, fluids as corrective treatment for the events. The outcome of the events was not recovered.
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| 75 | 2021-04-25 | fatigue |
Tired easily, rapid heart beat. Symptoms are better at this time, but not completely gone. Symptom...
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Tired easily, rapid heart beat. Symptoms are better at this time, but not completely gone. Symptoms started one week after vaccination, better at this time.
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| 75 | 2021-04-30 | headache, fatigue |
Body pains; Muscles and bone aches; Muscles and bone aches; Headache; Fatigue; This is a spontaneous...
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Body pains; Muscles and bone aches; Muscles and bone aches; Headache; Fatigue; This is a spontaneous report received from a contactable consumer (patient). This non-pregnant 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP7534) via an unspecified route of administration in the left arm on 29Mar2021 at 9:30 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies from an unknown date and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. Concomitant medications included citalopram hydrobromide (CELEXA), carvedilol, allergy pill, and fish oil, all from unknown dates for unknown indications. The patient previously received prochlorperazine edisylate (COMPAZINE), azithromycin, and fluoxetine hydrochloride (PROZAC), all from unknown dates for unknown indications and experienced allergies; the patient previously received the first dose of BNT162B2 (lot number not reported) on 08Mar2021 at 09:45 (at the age of 75-years-old) for COVID-19 immunisation. On 30Mar2021 at 02:30 the patient experienced body pains consisting of muscle and bone aches, headache and fatigue. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The clinical outcomes of body pains consisting of muscle and bone aches, headache and fatigue were recovering. It was also reported that since vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 75 | 2021-04-30 | fever, chills |
fever of 102.1; chills; This is a spontaneous report from a contactable consumer (patient). A 75-yea...
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fever of 102.1; chills; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in right arm on 17Feb2021 at 14:45 at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 27Jan2021 at 10:45 AM at single dose for COVID-19 immunization. Medical history included allergic to sulfa and penicillin. Concomitant medications included levothyroxine. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Feb2021 at 07:00, Patient had a fever of 102.1 and the chills on the next morning. Fever kept going down the next day and fine now. No treatment was received for the adverse events. The outcome of the events was recovered.
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| 75 | 2021-05-05 | headache |
FEELING LIGHTHEADED WHEN SHE STANDS. REPORTS NEAR SYNCOPE UPON STANDING AND GUIDED HERSELF DOWN WHIL...
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FEELING LIGHTHEADED WHEN SHE STANDS. REPORTS NEAR SYNCOPE UPON STANDING AND GUIDED HERSELF DOWN WHILE HOLDING A PLATE THAT DID NOT BREAK. REPORTS SLIGHT RIGHT SIDED HEADACHE DESCIRBED AS ELECTRICTY ONLY. NO CONFUSION. NO SPEECH CHANGES. WAS READING WSJ OUTLOUD TO DETERMINE. I ADVISED HER TO GO TO THE NEAREST EMERGENCY ROOM FOR EVALUATION AS I COULD NOT ATTRIBUTE HER SYMPTOMS TO VACCINE ADR. RESTING IN BED TO HELP ALEVIATE SYMPTOMS. NO MEDICATIONS. 5/2-Called the home and there was no answer, 2nd attempt. Message was left to call the Covid hotline for further follow up.
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| 75 | 2021-05-07 | chills, fatigue |
Tiredness; Tightness in her left leg that felt like a tunicate was left on; Chills on her left side ...
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Tiredness; Tightness in her left leg that felt like a tunicate was left on; Chills on her left side from her foot to her neck; Sore Left Arm; Chills; Wasn't feeling herself; Rash on the left side of her face; itchy; face felt like it was hot; Rash on the left side of her face; itchy; face felt like it was hot; Rash on the left side of her face; itchy; face felt like it was hot; This is a spontaneous report received from a contactable nurse (Patient herself). A 75-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via unknown route of administration on 03Apr2021 (Lot Number: ER8729, Expiry date: Jul 2021) as single dose for COVID-19 immunization. The patient medical history was breast cancer. The patient historical vaccine included BNT162B2 on (LOT:EJ1686 Expiration: 31MAR2021) on 13 Mar 2021 for COVID-19 immunization. The patient had no family history. The patient concomitant medications were not reported. The patient experienced chills on 04Apr2021, sore left arm on 13Apr2021, Rash on the left side of her face; itchy; face felt like it was hot on Apr2021, chills on her left side from her foot to her neck: on 17Apr2021, Tiredness on an unknown date and tightness in her left leg that felt like a tunicate was left on 17Apr2021, wasn't feeling herself Apr2021. The patient stated she wanted to send pictures of her rash on her face that her dermatologist diagnosed last Tuesday as a Covid Vaccine side effect. She had the first dose of the vaccine on 13Mar2021 and the second dose on 03Apr2021. They were both done at (withheld). With the first, she had no side effects, other than a sore left arm. The second she had a sore arm and a couple of chills at first. Then two weeks post second vaccination she wasn't feeling herself, and she went to see a primary about that, but that wasn't a definite that it was side effects from the vaccine. Then, the following week on a Thursday she got a rash about the same time but it was getting itchy so she decided someone should look at it. At first she thought it was from her mask, but it was only on the left side of her face. Caller states she wrote a message to her doctor about not feeling well but she didn't connect all of the other symptoms. She went to her primary for the chills on her left side from her foot to her neck and just not feeling like herself. She had a tightness in her left leg that felt like a tunicate was left on. Her face felt like it was hot. States it was really very weird and she was very tired. The tiredness comes and goes. States she was doing interviews yesterday for a long time, virtual interviews and by 12 noon she felt so tired and took a nap and felt out of sorts. She Didn't show her the rash because she thought it was just from her mask and she wasn't a dermatologist. Didn't mention it to her primary. States she tried to cancel the appointment but said she needed to come see her anyway. Thursday she had another appointment so she called the dermatologist when it started to itch and she said to the office, should she be worried. At first, said no time, and reported to doctor and fit her in at 13:30 and she looked at it and said it is really impressive for being 2 weeks old and thinks it is Covid vaccine related. Didn't know if she should report it or not. Maybe it is something. Was thinking the Covid rash was extensive. She still has the tiredness. It reminds her of the tiredness she had after radiation for breast cancer. States it wasn't during the radiation, but 4-5 weeks later and lasted about a month. States the tiredness is not from a lack of sleep, it is like a veil comes over her. States if she has taken 10 naps in her whole life, that is a lot for her and that didn't help. Treatment: Gel for the Rash; states for her leg issue the doctor ordered an MRI to rule out a back or disc problem. States she didn't put it together, one said it might be and another side not sure. At first she was offered the Moderna and she changed when they offered the Pfizer, because of the breast issues from the Moderna. Curious to see at some point if point if other people are experiencing rashes on their faces. Caller states she didn't know what type of rash was common, she assumed it was more of a bodily rash. Tetanus back in the Fall or maybe July thinks last July, she had GI stuff and her physician wasn't particularly believing it was from that. The event tiredness wsa assessed as serious (Medically significant), and tightness in her left leg that felt like a tunicate was left considered serious (Disability). The all other events were assessed as non-serious. The patient had physicians room visit (PCP and dermatologist) and not had emergency room visit. The causality assessment was unknown for all events. The outcome of the event rash on the left side of her face; itchy; face felt like it was hot and tiredness was not recovered, The outcome of all other events was recovered. Additional information requested.; Sender's Comments: Considering a plausible temporal relationship, a possible contributory role of suspect vaccine BNT162B2 to the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 75 | 2021-05-07 | throat pain |
rash on her scalp; flat macular rash; on her scalp the vesicles were breaking out basically; Pain in...
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rash on her scalp; flat macular rash; on her scalp the vesicles were breaking out basically; Pain in her throat one side, injection on the right side, just in the right peritonsillar fossa; very foggy; trouble sleeping; numbness; paresthesia; Shingles; Rash around her eye; Sore throat; Earache; This is a spontaneous report from a patient. A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 (Batch/Lot Number: EN6201) as a single dose (at the age of 75 years) for covid-19 immunization. The patient's medical history included lung Cancer from Aug2010 to Oct2010 (lung cancer survivor and had 35 days of treatments, 20Sep2010 was her last day of treatment. She says the end date for this condition was mid Oct2010, she has inoperable lung scarring, it's not COPD, more like a seasonal allergy, when she runs into an URI they up the prednisone to stop the spasms. She clarifies that URI stands for upper respiratory infection; ongoing sleep obstructive sleep apnea (patient uses a CPAP. She says she has had this condition prior to 2010, since the early 2000's), polymyalgia rheumatica from 2019 and ongoing,ongoing hypothyroidism (had this condition for 30 years probably) , hypertension from Feb2021 and ongoing; gastrooesophageal reflux disease (since the 1990's), chemotherapy and radiation (chemotherapy and radiation 10 years ago), postmenopausal and inoperable lung scarring from an unknown date and unknown if ongoing. Concomitant medication included prednisone (PREDNISONE) taken for polymyalgia rheumatica from; budesonide, formoterol fumarate (SYMBICORT) taken for lung neoplasm malignant; salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) taken for lung neoplasm malignant; omeprazole (PROTONIX [OMEPRAZOLE]) taken for gastrooesophageal reflux disease; levothyroxine sodium (SYNTHROID) taken for hypothyroidism from an unspecified start date and ongoing; calcium carbonate, vitamin d nos (CALCIUM + VIT D) taken for postmenopause from an unspecified start date and ongoing; ascorbic acid (VIT C) taken for postmenopause; hydrochlorothiazide (HYDRODIURIL) taken for hypertension from Feb2021 to an unspecified stop date. The patient received the first dose of BNT162B2 (lot:EL9262) in the left arm on 21Jan2021 at the age of 75 years for Covid-19 immunization. The patient experienced shingles, rash around her eye, sore throat, earache on 29Mar2021; numbness, paresthesia and trouble sleeping on 31Mar2021; very foggy on 03Apr2021; very foggy was reported as worsened/ trouble sleeping was reported as worsened, rash on her scalp, flat macular rash, on her scalp the vesicles were breaking out basically, pain in her throat one side, injection on the right side, just in the right peritonsillar fossa on an unspecified date. It was further reported that 5 and a half weeks later (after the vaccine) she developed shingles. She said it just recently came to her attention and might be related to the vaccine, but she was not sure if it was or not. She said she has not had the shingles vaccine, she had chemotherapy and radiation 10 years ago and never had any issues so she never got the vaccine for shingles. Patient is on a dose of gabapentin 800mg for the shingles, she has had a lot of difficulty with the dose and the shingles, She said she was little bit fuzzy, but that's probably because of the gabapentin, not the vaccine. Patient also mentioned she had a sore throat, it involves the right forehead, scalp, neck, she has an earache. She said the earache and the sore throat have passed but she still has the issue around her eye, a rash. She said the numbness and paresthesia started, she didn't pay much attention to it, then 2 days later she thought she should see the doctor. She says she saw a rash on her scalp, she didn't see the vesicles right away, she saw a flat macular rash. She says on her scalp the vesicles were breaking out basically. She says the sore throat has been interfering with her sleep, she can't use her CPAP, it got to disabling because she can't use her CPAP. She was very foggy. Trouble sleeping was medically significant moving into disabling because she was really foggy, more foggy as she goes along. She says the foggy is medically significant moving towards disabling, that up until today it was medically significant. She said for her throat she had to gargle a lot, it didn't go away with Tylenol. Tylenol NDC, lot, and expiration date not provided. She says the earache was there, it was annoying. She said the trouble sleeping was related to the shingles, she can't say the vaccine did it. The patient underwent lab tests and procedures included bloodwork on 02Apr2021 and everything came back normal. She said that was to test her kidney function following the HydroDiuril. She said the HydroDiuril was changed from 25mg to 12.5mg. She says she also had a screen of her inflammation markers of her lungs and that that was normal. She says both tests were done on 02Apr2021, that was the last ones, not the first ones done. The patient went to her doctor and ophthalmologist and was prescribed Valtrex. She does not know the dose and frequency, she says it is an antiviral for shingles. She says the gabapentin was for the pain for the paresthesia. The gabapentin was fluctuating, they keep increasing it due to discomfort, and she was up to 800mg in divided doses. She said she also was given eye drops, triple antibiotic polymixin. She had neomycin and another one, that it was the same as the ointment triple antibiotic for abrasions. She used that 3 times a day in her right eye. She also took a cortisone preparation eye drops and that they are also 3 times a day in her right eye. She says her ophthalmologist put her on a second course of Valtrex, she does not know the dose or frequency, saying that it varies according to her primary care physician. She says the total is 800 mg in divided doses. She says she is doing 200, 200, 400, she is trying to get off of it but that doesn't work so they are going to be increasing it. The organ involvement included respiratory and Dermatological/Mucosal. The patient was recovering from the events shingles and rash around her eye, recovered from sore throat, earache on 19Apr2021, not recovered from the events numbness, paresthesia, very foggy, trouble sleeping, and unknown outcome for all the other events.
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| 75 | 2021-05-10 | pneumonia |
On 3/23/21 pt had SOB so went to went to the Hospital ER. She had lab work, CT, Chest Xray, ECG 12 ...
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On 3/23/21 pt had SOB so went to went to the Hospital ER. She had lab work, CT, Chest Xray, ECG 12 lead. DX is pneumonia of right lower lobe of the lung. She was given Augmentin and released after 7 hours and told to FU w/ PCP. On 3/31/21 pt went to see her PCP due to having SOB. She was given a Covid Test which was negative. She was sent home and told to breath deeply and hopefully this symptom would go away. On 4/18/21 she went back to the Hospital ER for SOB. Pt was admitted with acute DVT and other blood clots as well as pleural effusion of the right lung. They did US on legs and Chest X-Rays. They found fluid around her right lung which they drained. She was prescribed Eliquis. Pt was discharged on 4/21/2021 and was told to FU w/ PCP. On 4/24/21 pt went back to the Hospital ER, because she had a bruising/blood clots in the groin area. She had 3 blood clots on the left side and one on the right side. They told her the bruising was from the Eliquis and they did a US. She was told she had the same blood clots that she had during her hospital stay and they were right where they were before. She was discharged. On 4/29/2021 she went back to her PCP due to SOB. She told her PCP about the DVT that was bothering her. She was sent to another Hospital. She had a stat Chest X-Ray- results were that her lungs were stable with inflammation around the right lung. She was told to FU w/ PCP in July 2021 and go back to ER if she had another episode w/ SOB.
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